Novo Aerofil Sedante

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Novo Aerofil Sedante uses

Novo Aerofil Sedante consists of Dimethicone, Metoclopramide Hydrochloride, Oxazepam.

Dimethicone:


This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum ) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and Novo Aerofil Sedante (Dimethicone) are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin ). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

Metoclopramide Hydrochloride:


1 INDICATIONS AND USAGE

Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are indicated for the:

  • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
  • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Limitations of Use:

Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 ) ].

Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are indicated for the:

  • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. (1)
  • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. (1)

Limitations of Use:

Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. (1, 8.4)

2 DOSAGE AND ADMINISTRATION

Gastroesophageal Reflux

  • Administer Novo Aerofil Sedante (Metoclopramide Hydrochloride) continuously or intermittently:
    • Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks.
    • Intermittent: Single doses up to 20 mg prior to provoking situation.

Acute and Recurrent Diabetic Gastroparesis (2.3)

  • Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks

Dosage Adjustment in Specific Populations (2.2, 2.3)

  • For gastroesophageal reflux and acute and recurrent diabetic gastroparesis, see Full Prescribing Information for recommended dosage reductions for elderly patients, in patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers.

2.1 Important Administration Instructions

Avoid treatment with Novo Aerofil Sedante (Metoclopramide Hydrochloride) for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)].

2.2 Dosage for Gastroesophageal Reflux

Novo Aerofil Sedante tablets may be administered continuously or intermittently in patients with symptomatic gastroesophageal reflux who fail to respond to conventional therapy:

Continuous Dosing

The recommended adult dosage of Novo Aerofil Sedante (Metoclopramide Hydrochloride) is 10 to 15 mg four times daily for 4 to 12 weeks. The treatment duration is determined by endoscopic response. Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 60 mg.

Table 1 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.

Intermittent Dosing

If symptoms only occur intermittently or at specific times of the day, administer Novo Aerofil Sedante (Metoclopramide Hydrochloride) in single dose up to 20 mg prior to the provoking situation. Consider dosage reductions for the populations and situations in Table 1.


Recommended Dosage


Maximum Recommended Daily Dosage


Adult patients


10 to 15 mg four times daily (thirty minutes before each meal and at bedtime)


60 mg


Mild hepatic impairment (Child-Pugh A)


Elderly patients [see Use in Specific Populations (8.5)]


5 mgElderly patients may be more sensitive to the therapeutic or adverse effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride); therefore, consider a lower starting dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 to 15 mg four times daily based upon response and tolerability. four times daily (thirty minutes before each meal and at bedtime)


Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.7)]


5 mg four times daily (thirty minutes before each meal and at bedtime), or

10 mg taken three times daily


30 mg


CYP2D6 poor metabolizers [see Use in Specific Populations (8.9)]


Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions (7.1)]


Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) [see Use in Specific Populations (8.6)]


Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations (8.6)]


5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily


20 mg

2.3 Dosage for Acute and Recurrent Diabetic Gastroparesis

The recommended adult dosage for the treatment of acute and recurrent diabetic gastroparesis is 10 mg four times daily for 2 to 8 weeks, depending on symptomatic response. Avoid Novo Aerofil Sedante (Metoclopramide Hydrochloride) treatment for greater than 12 weeks [see Warnings and Precautions (5.1)]. Administer the dosage thirty minutes before each meal and at bedtime. The maximum recommended daily dosage is 40 mg.

Table 2 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.

If patients with diabetic gastroparesis have severe nausea or vomiting and are unable to take oral Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets, consider starting therapy with Novo Aerofil Sedante (Metoclopramide Hydrochloride) injection given intramuscularly or intravenously for up to 10 days injection). After patients are able to take oral therapy, switch to Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets.


Recommended Dosage


Maximum Recommended Daily Dosage


Adult Patients


10 mg four times daily (30 minutes before each meal and at bedtime)


40 mg


Mild hepatic impairment (Child-Pugh A)


Elderly patients [see Use in Specific Populations (8.5)]


5 mgElderly patients may be more sensitive to the therapeutic or adverse effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride); therefore, consider a lower dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 mg four time daily based upon response and tolerability. four times daily (30 minutes before each meal and at bedtime)


Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.7)]


5 mg four times daily (30 minutes before each meal and at bedtime)


20 mg


CYP2D6 poor metabolizers [see Use in Specific Populations (8.9)]


Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions (7.1)]


Moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Use in Specific Populations (8.6)]


Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations (8.6)]


5 mg twice daily


10 mg

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3 DOSAGE FORMS AND STRENGTHS

Tablets:

  • 5 mg Novo Aerofil Sedante (Metoclopramide Hydrochloride): white, round, unscored, debossed “TV” on one side and “2204” on the other side.
  • 10 mg Novo Aerofil Sedante (Metoclopramide Hydrochloride): white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side.

Tablets: 5 mg and 10 mg Novo Aerofil Sedante (Metoclopramide Hydrochloride) (3)

4 CONTRAINDICATIONS

Novo Aerofil Sedante (Metoclopramide Hydrochloride) is contraindicated:

  • In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to Novo Aerofil Sedante (Metoclopramide Hydrochloride) [see Warnings and Precautions ( 5.1, 5.2 ) ].
  • When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).
  • In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Novo Aerofil Sedante (Metoclopramide Hydrochloride) may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor [see Warnings and Precautions (5.5)].
  • In patients with epilepsy. Novo Aerofil Sedante (Metoclopramide Hydrochloride) may increase the frequency and severity of seizures [see Adverse Reactions (6)].
  • In patients with hypersensitivity to Novo Aerofil Sedante (Metoclopramide Hydrochloride). Reactions have included laryngeal and glossal angioedema and bronchospasm [see Adverse Reactions (6)].
  • History of TD or dystonic reaction to Novo Aerofil Sedante (Metoclopramide Hydrochloride) (4)
  • When stimulation of gastrointestinal motility might be dangerous (4)
  • Pheochromocytoma, catecholamine-releasing paragangliomas (4)
  • Epilepsy (4)
  • Hypersensitivity to Novo Aerofil Sedante (Metoclopramide Hydrochloride) (4)
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5 WARNINGS AND PRECAUTIONS

  • Tardive Dyskinesia, Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS): Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson’s Disease. If symptoms occur, discontinue Novo Aerofil Sedante (Metoclopramide Hydrochloride) and seek immediate medical attention. (5.1, 5.2, 5.3, 7.1, 7.2)
  • Depression and suicidal ideation/suicide: Avoid use. (5.4)

5.1 Tardive Dyskinesia

Novo Aerofil Sedante (Metoclopramide Hydrochloride) can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Movements may be choreoathetotic in appearance. The risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased among the elderly, especially elderly women [see Use in Specific Populations (8.5)], and in patients with diabetes mellitus. Due to the risk of developing TD, avoid treatment with Novo Aerofil Sedante (Metoclopramide Hydrochloride) for longer than 12 weeks and reduce the dosage in elderly patients [see Dosage and Administration (2.2, 2.3)].

Discontinue Novo Aerofil Sedante (Metoclopramide Hydrochloride) immediately in patients who develop signs and symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients TD may remit, partially or completely, within several weeks to months after Novo Aerofil Sedante (Metoclopramide Hydrochloride) is withdrawn.

Novo Aerofil Sedante (Metoclopramide Hydrochloride) itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Novo Aerofil Sedante (Metoclopramide Hydrochloride) is contraindicated in patients with a history of TD [see Contraindications (4)]. Avoid Novo Aerofil Sedante (Metoclopramide Hydrochloride) in patients receiving other drugs that are likely to cause TD (e.g., antipsychotics).

5.2 Other Extrapyramidal Symptoms

In addition to TD, Novo Aerofil Sedante may cause other extrapyramidal symptoms (EPS), parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue Novo Aerofil Sedante (Metoclopramide Hydrochloride).

  • Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with Novo Aerofil Sedante (Metoclopramide Hydrochloride) dosages of 30 mg to 40 mg daily. Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages. EPS occurred more frequently in pediatric patients compared to adults (metoclopramide is not approved for use in pediatric patients). Symptoms can occur in the first 24 to 48 hours after starting Novo Aerofil Sedante (Metoclopramide Hydrochloride). Symptoms included involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions were present as stridor and dyspnea, possibly due to laryngospasm. Diphenhydramine hydrochloride or benztropine mesylate may be used to treat these adverse reactions. Avoid Novo Aerofil Sedante (Metoclopramide Hydrochloride) in patients receiving other drugs that can cause EPS (e.g., antipsychotics).
  • Parkinsonian symptoms (bradykinesia, tremor, cogwheel rigidity, mask-like facies) have occurred after starting Novo Aerofil Sedante (Metoclopramide Hydrochloride), more commonly within the first 6 months, but also after longer periods. Symptoms generally have subsided within 2 to 3 months after discontinuation of Novo Aerofil Sedante (Metoclopramide Hydrochloride). Avoid Novo Aerofil Sedante (Metoclopramide Hydrochloride) in patients with Parkinson’s disease and other patients being treated with antiparkinsonian drugs due to potential exacerbation of symptoms. Avoid treatment with Novo Aerofil Sedante (Metoclopramide Hydrochloride) for more than 12 weeks [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)].
  • Motor restlessness (akathisia) has developed and consisted of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, and foot tapping. If symptoms resolve, consider restarting at a lower dosage.

5.3 Neuroleptic Malignant Syndrome

Novo Aerofil Sedante (Metoclopramide Hydrochloride) may cause a potentially fatal symptom complex called neuroleptic malignant syndrome (NMS). NMS has been reported in association with Novo Aerofil Sedante (Metoclopramide Hydrochloride) overdosage and concomitant treatment with another drug associated with NMS. Avoid Novo Aerofil Sedante (Metoclopramide Hydrochloride) in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics.

Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately.

In the diagnostic evaluation, consider the presence of other serious medical conditions (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, serotonin syndrome, and primary central nervous system pathology.

Management of NMS includes:

  • Immediate discontinuation of Novo Aerofil Sedante (Metoclopramide Hydrochloride) and other drugs not essential to concurrent therapy [see Drug Interactions (7.1)].
  • Intensive symptomatic treatment and medical monitoring.
  • Treatment of any concomitant serious medical problems for which specific treatments are available.

5.4 Depression

Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal ideation and suicide. Avoid Novo Aerofil Sedante use in patients with a history of depression.

5.5 Hypertension

Novo Aerofil Sedante (Metoclopramide Hydrochloride) may elevate blood pressure. In one study in hypertensive patients, intravenously administered Novo Aerofil Sedante (Metoclopramide Hydrochloride) was shown to release catecholamines; hence, avoid use in patients with hypertension or in patients taking monoamine oxidase inhibitors [see Drug Interactions (7.1)].

There are also clinical reports of hypertensive crises in patients with undiagnosed pheochromocytoma. Novo Aerofil Sedante (Metoclopramide Hydrochloride) is contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas [see Contraindications (4)]. Discontinue Novo Aerofil Sedante (Metoclopramide Hydrochloride) in any patient with a rapid rise in blood pressure.

5.6 Fluid Retention

Because Novo Aerofil Sedante produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. Discontinue Novo Aerofil Sedante (Metoclopramide Hydrochloride) if any of these adverse reactions occur.

5.7 Hyperprolactinemia

As with other dopamine D2 receptor antagonists, Novo Aerofil Sedante (Metoclopramide Hydrochloride) elevates prolactin levels.

Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, including Novo Aerofil Sedante (Metoclopramide Hydrochloride).

Hyperprolactinemia may potentially stimulate prolactin-dependent breast cancer. However, some clinical studies and epidemiology studies have not shown an association between administration of dopamine D2 receptor antagonists and tumorigenesis in humans [see Nonclinical Toxicology ( 13.1 ) ].

5.8 Effects of the Ability to Drive and Operate Machinery

Novo Aerofil Sedante (Metoclopramide Hydrochloride) may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of central nervous system (CNS) depressants or drugs associated with EPS may increase this effect (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid Novo Aerofil Sedante (Metoclopramide Hydrochloride) or the interacting drug, depending on the importance of the drug to the patient [see Drug Interactions (7.1)].

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6 ADVERSE REACTIONS

The following adverse reactions are described, or described in greater detail, in other sections of the labeling:

  • Tardive dyskinesia [see Boxed Warning and Warnings and Precautions (5.1)]
  • Other extrapyramidal effects [see Warnings and Precautions (5.2)]
  • Neuroleptic malignant syndrome [see Warnings and Precautions (5.3)]
  • Depression [see Warnings and Precautions (5.4)]
  • Hypertension [see Warnings and Precautions (5.5)]
  • Fluid retention [see Warnings and Precautions (5.6)]
  • Hyperprolactinemia [see Warnings and Precautions (5.7)]
  • Effects on the ability to drive and operate machinery [see Warnings and Precautions (5.8)]

The following adverse reactions have been identified from clinical studies or postmarketing reports of Novo Aerofil Sedante (Metoclopramide Hydrochloride). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most common adverse reactions (in approximately 10% of patients receiving 10 mg of Novo Aerofil Sedante (Metoclopramide Hydrochloride) four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of Novo Aerofil Sedante (Metoclopramide Hydrochloride) administration.

Adverse reactions, especially those involving the nervous system, occurred after stopping Novo Aerofil Sedante (Metoclopramide Hydrochloride) including dizziness, nervousness, and headaches.

Central Nervous System Disorders

  • Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and other extrapyramidal symptoms
  • Convulsive seizures
  • Hallucinations
  • Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients who received 10 mg four times daily. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurred less frequently.
  • Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic agents).

Endocrine Disorders: Fluid retention secondary to transient elevation of aldosterone. Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia

Cardiovascular Disorders: Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention

Gastrointestinal Disorders: Nausea, bowel disturbances (primarily diarrhea)

Hepatic Disorders: Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when Novo Aerofil Sedante (Metoclopramide Hydrochloride) was administered with other drugs with known hepatotoxic potential

Renal and Urinary Disorders: Urinary frequency, urinary incontinence

Hematologic Disorders: Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia

Hypersensitivity Reactions: Bronchospasm (especially in patients with a history of asthma), urticaria; rash; angioedema, including glossal or laryngeal edema

Eye Disorders: Visual disturbances

Metabolism Disorders: Porphyria

  • Most common adverse reactions (> 10%) are restlessness, drowsiness, fatigue, and lassitude. (6)

To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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7 DRUG INTERACTIONS

  • Antipsychotics: Potential for additive effects, including TD, EPS, and NMS; avoid concomitant use.
  • CNS depressants: Increased risk of CNS depression. Avoid concomitant use and monitor for adverse reactions. (7.1)
  • Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine): See Full Prescribing Information for recommended dosage reductions. (2.2, 2.3, 7.1)
  • MAO inhibitors: Increased risk of hypertension; avoid concomitant use. (5.5, 7.1)
  • Additional drug interactions: See Full Prescribing Information. (7.1, 7.2)

7.1 Effects of Other Drugs on Novo Aerofil Sedante (Metoclopramide Hydrochloride)

Table 3 displays the effects of other drugs on Novo Aerofil Sedante (Metoclopramide Hydrochloride).


Antipsychotics


Clinical Impact


Potential for additive effects, including increased frequency and severity of tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS).


Intervention


Avoid concomitant use [see Warnings and Precautions (5.1, 5.2, 5.3)].


Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above


Clinical Impact


Increased plasma concentrations of Novo Aerofil Sedante (Metoclopramide Hydrochloride); risk of exacerbation of extrapyramidal symptoms [see Clinical Pharmacology (12.3)].


Intervention


Reduce the Novo Aerofil Sedante (Metoclopramide Hydrochloride) dosage [see Dosage and Administration (2.2, 2.3)].


Examples


quinidine, bupropion, fluoxetine, and paroxetine


Monoamine Oxidase Inhibitors


Clinical Impact


Increased risk of hypertension [see Warnings and Precautions (5.5)].


Intervention


Avoid concomitant use.


Central Nervous System (CNS) Depressants


Clinical Impact


Increased risk of CNS depression [see Warnings and Precautions (5.8)].


Intervention


Avoid Novo Aerofil Sedante (Metoclopramide Hydrochloride) or the interacting drug, depending on the importance of the drug to the patient.


Examples


alcohol, sedatives, hypnotics, opiates and anxiolytics


Drugs that Impair Gastrointestinal Motility


Clinical Impact


Decreased systemic absorption of Novo Aerofil Sedante (Metoclopramide Hydrochloride).


Intervention


Monitor for reduced therapeutic effect.


Examples


antiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates


Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations


Clinical Impact


Decreased therapeutic effect of Novo Aerofil Sedante (Metoclopramide Hydrochloride) due to opposing effects on dopamine.


Intervention


Monitor for reduced therapeutic effect.


Examples


apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine

7.2 Effects of Novo Aerofil Sedante on Other Drugs

Table 4 displays the effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride) on other drugs.


Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations


Clinical Impact


Opposing effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride) and the interacting drug on dopamine. Potential exacerbation of symptoms (e.g., parkinsonian symptoms).


Intervention


Avoid concomitant use [see Warnings and Precautions (5.2)].


Examples


Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine


Succinylcholine, Mivacurium


Clinical Impact


Novo Aerofil Sedante (Metoclopramide Hydrochloride) inhibits plasma cholinesterase leading to enhanced neuromuscular blockade.


Intervention


Monitor for signs and symptoms of prolonged neuromuscular blockade


Drugs with Absorption Altered due to Increased Gastrointestinal Motility


Clinical Impact


The effect of Novo Aerofil Sedante (Metoclopramide Hydrochloride) on other drugs is variable. Increased gastrointestinal (GI) motility by Novo Aerofil Sedante (Metoclopramide Hydrochloride) may impact absorption of other drugs leading to decreased or increased drug exposure.


Intervention


Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension Interaction does not apply to posaconazole delayed-release tablets, fosfomycin): Monitor for reduced therapeutic effect of the interacting drug. For digoxin monitor therapeutic drug concentrations and increase the digoxin dose as needed.

Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine): Monitor therapeutic drug concentrations and adjust the dose as needed. See prescribing information for the interacting drug.


Insulin


Clinical Impact


Increased GI motility by Novo Aerofil Sedante (Metoclopramide Hydrochloride) may increase delivery of food to the intestines and increase blood glucose.


Intervention


Monitor blood glucose and adjust insulin dosage regimen as needed.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of Novo Aerofil Sedante during pregnancy.

There are potential risks to the neonate following exposure in utero to Novo Aerofil Sedante (Metoclopramide Hydrochloride) during delivery [see Clinical Considerations]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of Novo Aerofil Sedante (Metoclopramide Hydrochloride) to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Novo Aerofil Sedante (Metoclopramide Hydrochloride) crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [see Warnings and Precautions (5.1, 5.2), Use in Specific Populations (8.4)].

Data

Animal Data

Reproduction studies have been performed following administration of oral Novo Aerofil Sedante (Metoclopramide Hydrochloride) during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area. No evidence of adverse developmental effects due to Novo Aerofil Sedante (Metoclopramide Hydrochloride) were observed.

8.2 Lactation

Risk Summary

Limited published data report the presence of Novo Aerofil Sedante (Metoclopramide Hydrochloride) in human milk in variable amounts. Breastfed infants exposed to Novo Aerofil Sedante (Metoclopramide Hydrochloride) have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation [see Data]. Novo Aerofil Sedante (Metoclopramide Hydrochloride) elevates prolactin levels [see Warnings and Precautions (5.7)]; however, the published data are not adequate to support drug effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Novo Aerofil Sedante (Metoclopramide Hydrochloride) and any potential adverse effects on the breastfed child from Novo Aerofil Sedante (Metoclopramide Hydrochloride) or from the underlying maternal condition.

Clinical Considerations

Monitor breastfeeding neonates because Novo Aerofil Sedante (Metoclopramide Hydrochloride) may cause extrapyramidal signs (dystonias) and methemoglobinemia [see Warnings and Precautions (5.1, 5.2), Use in Specific Populations (8.4)].

Data

In published clinical studies, the estimated amount of Novo Aerofil Sedante (Metoclopramide Hydrochloride) received by the breastfed infant was less than 10% of the maternal weight-adjusted dose. In one study, the estimated daily amount of Novo Aerofil Sedante (Metoclopramide Hydrochloride) received by infants from breast milk ranged from 6 to 24 mcg/kg/day in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks postpartum.

8.4 Pediatric Use

Novo Aerofil Sedante is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. The safety and effectiveness of Novo Aerofil Sedante (Metoclopramide Hydrochloride) in pediatric patients have not been established.

Dystonias and other extrapyramidal symptoms associated with Novo Aerofil Sedante (Metoclopramide Hydrochloride) are more common in pediatric patients than in adults [see Warnings and Precautions (5.1, 5.2)]. In addition, neonates have reduced levels of NADH-cytochrome b5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of Novo Aerofil Sedante (Metoclopramide Hydrochloride) use in neonates [see Use in Specific Populations (8.8)].

8.5 Geriatric Use

Novo Aerofil Sedante (Metoclopramide Hydrochloride) is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride); therefore, consider a reduced dosage of Novo Aerofil Sedante (Metoclopramide Hydrochloride) in elderly patients [see Boxed Warning, Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)].

8.6 Renal Impairment

The clearance of Novo Aerofil Sedante is decreased and the systemic exposure is increased in patients with moderate to severe renal impairment compared to patients with normal renal function, which may increase the risk of adverse reactions. Reduce the Novo Aerofil Sedante (Metoclopramide Hydrochloride) dosage in patients with moderate and severe renal impairment (creatinine clearance less than or equal to 60 mL/minute), including those receiving hemodialysis and continuous ambulatory peritoneal dialysis [see Dosage and Administration (2.2, 2.3), Clinical Pharmacology (12.3)].

8.7 Hepatic Impairment

Patients with severe hepatic impairment (Child-Pugh C) have reduced systemic Novo Aerofil Sedante (Metoclopramide Hydrochloride) clearance (by approximately 50%) compared to patients with normal hepatic function. The resulting increase in Novo Aerofil Sedante (Metoclopramide Hydrochloride) blood concentrations increases the risk of adverse reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B). Reduce Novo Aerofil Sedante (Metoclopramide Hydrochloride) dosage in patients with moderate or severe (Child-Pugh B or C) hepatic impairment [see Dosage and Administration (2.2, 2.3)]. There is no dosage adjustment required for patients with mild hepatic impairment (Child-Pugh A).

In addition, Novo Aerofil Sedante (Metoclopramide Hydrochloride), by producing a transient increase in plasma aldosterone, may increase the risk of fluid retention in patients with hepatic impairment [see Warnings and Precautions (5.6)].

Monitor patients with hepatic impairment for the occurrence of fluid retention and volume overload.

8.8 NADH-Cytochrome b5 Reductase Deficiency

Metoclopramide-treated patients with NADH-cytochrome b5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia. For patients with glucose-6-phosphate dehydrogenase deficiency with metoclopramide-induced methemoglobinemia, methylene blue treatment is not recommended. Methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal [see Overdosage (10)].

8.9 CYP2D6 Poor Metabolizers

Novo Aerofil Sedante (Metoclopramide Hydrochloride) is a substrate of CYP2D6. The elimination of Novo Aerofil Sedante (Metoclopramide Hydrochloride) may be slowed in patients who are CYP2D6 poor metabolizers (compared to patients who are CYP2D6 intermediate, extensive, or ultra-rapid metabolizers); possibly increasing the risk of dystonic and other adverse reactions to Novo Aerofil Sedante (Metoclopramide Hydrochloride) [see Clinical Pharmacology (12.3)]. Reduce the Novo Aerofil Sedante (Metoclopramide Hydrochloride) dosage in patients who are poor CYP2D6 metabolizers [see Dosage and Administration (2.2, 2.3)].

10 OVERDOSAGE

Manifestations of Novo Aerofil Sedante (Metoclopramide Hydrochloride) overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with Novo Aerofil Sedante (Metoclopramide Hydrochloride) use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with Novo Aerofil Sedante (Metoclopramide Hydrochloride) overdose and concomitant treatment with another drug associated with NMS [see Warnings and Precautions (5.1, 5.2, 5.3)].

There are no specific antidotes for Novo Aerofil Sedante (Metoclopramide Hydrochloride) overdosage. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may be fatal.

Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of Novo Aerofil Sedante (Metoclopramide Hydrochloride).

11 DESCRIPTION

Novo Aerofil Sedante (Metoclopramide Hydrochloride) hydrochloride, USP, the active ingredient of Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets, is a dopamine-2 receptor antagonist. Novo Aerofil Sedante (Metoclopramide Hydrochloride) hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows:

C14H22ClN3O2-HCl-H2O M.W. 354.3

Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are for oral administration. Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are available in 5 mg and 10 mg tablets.

  • Each Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablet, 5 mg contains 5 mg Novo Aerofil Sedante (Metoclopramide Hydrochloride) (equivalent to 5.91 mg of Novo Aerofil Sedante (Metoclopramide Hydrochloride) hydrochloride, USP).
  • Each Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablet, 10 mg contains 10 mg Novo Aerofil Sedante (Metoclopramide Hydrochloride) (equivalent to 11.82 mg of Novo Aerofil Sedante (Metoclopramide Hydrochloride) hydrochloride, USP).

Inactive Ingredients

Corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

\Client\X$\Products\Metoclopramide Tablets USP, 10 mg (ANDA 070184)\Submissions\2017-08-30 CBE-0 - AJK\Working\INSERT\Images\metoclopramide-sf1.jpg

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Novo Aerofil Sedante stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of Novo Aerofil Sedante (Metoclopramide Hydrochloride) in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine. The effect of Novo Aerofil Sedante (Metoclopramide Hydrochloride) on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs.

Novo Aerofil Sedante (Metoclopramide Hydrochloride) increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter. It has little, if any, effect on the motility of the colon or gallbladder.

12.2 Pharmacodynamics

Gastroesophageal Reflux

In patients with gastroesophageal reflux and low lower esophageal sphincter pressure (LESP), single oral doses of Novo Aerofil Sedante (Metoclopramide Hydrochloride) produced dose-related increases in LESP. Effects began at about 5 mg and increased through 20 mg. The increase in LESP from a 5 mg dose lasted about 45 minutes and that of 20 mg lasted between 2 and 3 hours. Increased rate of stomach emptying was observed with single oral doses of 10 mg.

12.3 Pharmacokinetics

Absorption

Relative to an intravenous dose of 20 mg, the absolute bioavailability of oral Novo Aerofil Sedante (Metoclopramide Hydrochloride) is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occurred at about 1 to 2 hours after a single oral dose. Similar time to peak was observed after individual doses at steady state.

In a single dose study of 12 subjects, the area under the drug concentration-time curve increased linearly with doses from 20 to 100 mg (5 times the maximum recommended single dose). Peak concentrations increased linearly with dose; time to peak concentrations remained the same; whole body clearance was unchanged; and the elimination rate remained the same. The mean elimination half-life in subjects with normal renal function was 5 to 6 hours. Linear kinetic processes adequately describe the absorption and elimination of Novo Aerofil Sedante (Metoclopramide Hydrochloride).

Distribution

Novo Aerofil Sedante (Metoclopramide Hydrochloride) is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about 3.5 L/kg), which suggests extensive distribution of drug to the tissues.

Elimination

Metabolism: Novo Aerofil Sedante (Metoclopramide Hydrochloride) undergoes enzymatic metabolism via oxidation as well as glucuronide and sulfate conjugation reactions in the liver. Monodeethylmetoclopramide, a major oxidative metabolite, is formed primarily by CYP2D6, an enzyme subject to genetic variability [see Dosage and Administration (2.2, 2.3), Use in Specific Populations (8.9)].

Excretion: Approximately 85% of the radioactivity of an orally administered dose appeared in the urine within 72 hours. After oral administration of 10 or 20 mg, a mean of 18% and 22% of the dose, respectively, was recovered as free Novo Aerofil Sedante (Metoclopramide Hydrochloride) in urine within 36 hours.

Specific Populations

Patients with Renal Impairment: In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease (ESRD) requiring dialysis), the systemic exposure (AUC) of Novo Aerofil Sedante (Metoclopramide Hydrochloride) in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of Novo Aerofil Sedante (Metoclopramide Hydrochloride) in patients with ESRD on dialysis was about 3.5-fold the AUC in subjects with normal renal function [see Dosage and Administration (2.2, 2.3) and Use in Specific Populations (8.6)].

Patients with Hepatic Impairment: In a group of 8 patients with severe hepatic impairment (Child-Pugh C), the average Novo Aerofil Sedante (Metoclopramide Hydrochloride) clearance was reduced by approximately 50% compared to patients with normal hepatic function [see Dosage and Administration (2.2, 2.3) and Use in Specific Populations (8.7)].

Drug Interaction Studies

Effect of Novo Aerofil Sedante (Metoclopramide Hydrochloride) on CYP2D6 Substrates

Although in vitro studies suggest that Novo Aerofil Sedante (Metoclopramide Hydrochloride) can inhibit CYP2D6, Novo Aerofil Sedante (Metoclopramide Hydrochloride) is unlikely to interact with CYP2D6 substrates in vivo at therapeutically relevant concentrations.

Effect of CYP2D6 Inhibitors on Novo Aerofil Sedante (Metoclopramide Hydrochloride)

In healthy subjects, 20 mg of Novo Aerofil Sedante (Metoclopramide Hydrochloride) and 60 mg of fluoxetine (a strong CYP2D6 inhibitor) were administered, following prior exposure to 60 mg fluoxetine orally for 8 days. The patients who received concomitant Novo Aerofil Sedante (Metoclopramide Hydrochloride) and fluoxetine had a 40% and 90% increase in Novo Aerofil Sedante (Metoclopramide Hydrochloride) Cmax and AUC0-∞, respectively, compared to patients who received Novo Aerofil Sedante (Metoclopramide Hydrochloride) alone [see Drug Interactions (7.1)].


Parameter


Novo Aerofil Sedante (Metoclopramide Hydrochloride) alone

(mean SD)


Novo Aerofil Sedante (Metoclopramide Hydrochloride) with fluoxetine

(mean SD)


Cmax (ng/mL)


44 ± 15


62.7 ± 9.2


AUC0-∞ (ng∙h/mL)


313 ± 113


591 ± 140


t1/2 (h)


5.5 ± 1.1


8.5 ± 2.2

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

A 77-week study was conducted in rats with oral Novo Aerofil Sedante (Metoclopramide Hydrochloride) doses up to 40 mg/kg/day (about six times the maximum recommended human dose on body surface area basis). Novo Aerofil Sedante (Metoclopramide Hydrochloride) elevated prolactin levels and the elevation persisted during chronic administration. An increase in mammary neoplasms was found in rodents after chronic administration of Novo Aerofil Sedante (Metoclopramide Hydrochloride) [see Warnings and Precautions (5.7)]. In a rat model for assessing the tumor promotion potential, a 2-week oral treatment with Novo Aerofil Sedante (Metoclopramide Hydrochloride) at a dose of 260 mg/kg/day (about 35 times the maximum recommended human dose based on body surface area) enhanced the tumorigenic effect of N-nitrosodiethylamine.

Mutagenesis

Novo Aerofil Sedante (Metoclopramide Hydrochloride) was positive in the in vitro Chinese hamster lung cell/HGPRT forward mutation assay for mutagenic effects and in the in vitro human lymphocyte chromosome aberration assay for clastogenic effects. It was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis assay with rat and human hepatocytes, and the in vivo rat micronucleus assay.

Impairment of Fertility

Novo Aerofil Sedante (Metoclopramide Hydrochloride) at intramuscular doses up to 20 mg/kg/day (about three times the maximum recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.

16 HOW SUPPLIED/STORAGE AND HANDLING

Each white, round, unscored, debossed “TV” on one side and “2204” on the other side, compressed Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablet, USP contains Novo Aerofil Sedante (Metoclopramide Hydrochloride) hydrochloride, USP equivalent to 5 mg Novo Aerofil Sedante (Metoclopramide Hydrochloride). Available in bottles of 100 (NDC 0093-2204-01) and 500 (NDC 0093-2204-05).

Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablet, USP contains Novo Aerofil Sedante (Metoclopramide Hydrochloride) hydrochloride, USP equivalent to 10 mg Novo Aerofil Sedante (Metoclopramide Hydrochloride). Available in bottles of 100 (NDC 0093-2203-01), 500 (NDC 0093-2203-05), and 1000 (NDC 0093-2203-10).

Dispense in a tight, light-resistant container. Store tablets at 20° to 25°C (68° to 77°F).

This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Inform patients or their caregivers that Novo Aerofil Sedante (Metoclopramide Hydrochloride) can cause serious adverse reactions. Instruct patients to discontinue Novo Aerofil Sedante (Metoclopramide Hydrochloride) and contact a healthcare provider immediately if the following serious reactions occur:

  • Tardive dyskinesia and other extrapyramidal reactions [see Warnings and Precautions (5.1, 5.2)]
  • Neuroleptic malignant syndrome [see Warnings and Precautions (5.3)]
  • Depression and/or possible suicidal ideation [see Warnings and Precautions (5.4)]

Inform patients or their caregivers that concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression [see Drug Interactions (7.1, 7.2)]. Explain that the prescriber of any other medication must be made aware that the patient is taking Novo Aerofil Sedante (Metoclopramide Hydrochloride).

Inform patients or their caregivers that Novo Aerofil Sedante (Metoclopramide Hydrochloride) can cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle [see Warnings and Precautions (5.8)].

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. Q 8/2017


MEDICATION GUIDE

Novo Aerofil Sedante (Metoclopramide Hydrochloride) TABLETS, USP

(MET-oh-KLOE-pra-mide), oral use


Read this Medication Guide before you start taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets and each time you get a refill. There may be new information. If you take another product that contains Novo Aerofil Sedante (Metoclopramide Hydrochloride) (such as Novo Aerofil Sedante (Metoclopramide Hydrochloride) injection, Novo Aerofil Sedante (Metoclopramide Hydrochloride) orally disintegrating tablets, or Novo Aerofil Sedante (Metoclopramide Hydrochloride) oral solution), you should read the Medication Guide that comes with that product. Some of the information may be different. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.


What is the most important information I should know about Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?

Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets can cause serious side effects, including:

Tardive dyskinesia (abnormal muscle movements). These movements happen mostly in the face muscles. You cannot control these movements. They may not go away even after stopping Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets. There is no treatment for tardive dyskinesia, but symptoms may decrease or go away over time after you stop taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets.

Your chances for getting tardive dyskinesia increase:

  • the longer you take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets and the more Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets you take. You should not take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets for more than 12 weeks.
  • if you are older, especially if you are an older woman.
  • if you have diabetes.

It is not possible for your healthcare provider to know if you will get tardive dyskinesia if you take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets.

Call your healthcare provider right away if you get movements you cannot stop or control, such as:

  • lip smacking, chewing, or puckering up your mouth
  • frowning or scowling
  • sticking out your tongue
  • blinking and moving your eyes
  • shaking of your arms and legs

See the section “What are the possible side effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?” for more information about side effects.


What are Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?

Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are a prescription medicine used in adults:

  • for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux when certain other treatments do not work.
  • to relieve the symptoms of slow stomach emptying in people with diabetes.

Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are not recommended for use in children.


Do not take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets if you:

  • have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets or a medicine that works like Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets.
  • have stomach or intestine problems that could get worse with Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets, such as bleeding, blockage or a tear in the stomach or bowel wall.
  • have a type of tumor that can cause high blood pressure such as pheochromocytoma.
  • have epilepsy (seizures). Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets can increase your chance for seizures and make them worse.
  • are allergic to Novo Aerofil Sedante (Metoclopramide Hydrochloride). Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets can cause serious allergic reactions. Stop taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets right away and get emergency help if you have any of these symptoms:
    • swelling of your tongue, throat, lips, eyes or face.
    • trouble swallowing or breathing.
    • skin rash, hives, sores in your mouth, or skin blisters.

Before taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets, tell your healthcare provider about all of your medical conditions, including if you:

  • have diabetes. Your dose of insulin may need to be changed.
  • had problems controlling your muscle movements after taking any medicine.
  • have Parkinson’s disease.
  • have a type of tumor that can cause high blood pressure (pheochromoctyoma).
  • have kidney or liver disease.
  • have or had depression or mental illness.
  • have high blood pressure.
  • have heart failure or heart rhythm problems.
  • have breast cancer.
  • drink alcohol.
  • have seizures
  • are pregnant or plan to become pregnant. Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets may harm your unborn baby if taken during the end of pregnancy. Talk to your healthcare provider if you become pregnant while taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets.
  • are breastfeeding or plan to breastfeed. Novo Aerofil Sedante (Metoclopramide Hydrochloride) can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets may affect the way other medicines work, and other medicines may affect how Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets work.

Tell your healthcare provider before you start or stop other medicines.

Especially tell your healthcare provider if you take:

  • another medicine that contains Novo Aerofil Sedante (Metoclopramide Hydrochloride), such as Novo Aerofil Sedante (Metoclopramide Hydrochloride) injection or Novo Aerofil Sedante (Metoclopramide Hydrochloride) oral solution
  • a medicine for Parkinson’s disease
  • a blood pressure medicine
  • a medicine for depression, especially a Monoamine Oxidase Inhibitor (MAOI)
  • an anti-psychotic medicine, used to treat mental illness such as schizophrenia
  • insulin
  • medicines that can make you sleepy, such as anti-anxiety medicines, sleep medicines, and narcotics

If you are not sure if your medicine is one listed above, ask your healthcare provider or pharmacist.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.


How should I take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?

  • Take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets exactly as your healthcare provider tells you. Do not change your dose unless your healthcare provider tells you to.
  • Novo Aerofil Sedante (Metoclopramide Hydrochloride) comes as a tablet you take by mouth.
  • You should not take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets for more than 12 weeks.
  • Take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets at least 30 minutes before each meal and at bedtime.
  • If you take too many Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets, call your poison control center at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?

  • Do not drink alcohol while taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets. Alcohol may make some side effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets worse, such as feeling sleepy.
  • Do not drive, operate machinery, or do other dangerous activities until you know how Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets affect you. Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets may cause sleepiness or dizziness.

What are the possible side effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?

  • Tardive dyskinesia (abnormal muscle movements). See “What is the most important information I need to know about Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?
  • Other changes in muscle control and movement, such as:
    • Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia). These muscle spasms can cause abnormal movements and body positions, and speech problems. These spasms usually start within the first 2 days of treatment. Rarely, these muscle spasms may cause trouble breathing. These spasms happen more often in adults less than 30 years of age.
    • Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinson's Disease, your symptoms may become worse while you are taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets.
    • Being unable to sit still or feeling you need to move your hands, feet, or body (akathisia). Symptoms can include feeling jittery, anxious, irritated or unable to sleep (insomnia), feeling the need to walk around (pacing) and tapping your feet.
  • Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating.
  • Depression, thoughts about suicide, and suicide. Some people who take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets become depressed, even if they have no history of depression. You may have thoughts about hurting or killing yourself. Some people who have taken Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets have ended their own lives (suicide).
  • High blood pressure. Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets can cause your blood pressure to increase.
  • Too much body water. People who have certain liver problems or heart failure and take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets may hold too much water in their body (fluid retention). Tell your doctor right away if you have sudden weight gain, or swelling of your hands, legs, or feet.
  • Increased prolactin. Tell your doctor if your menstrual periods stop, your breasts get larger and make milk, or you cannot have sex (impotence). These symptoms go away when you stop taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets.

Call your healthcare provider and get medical help right away if you:

  • feel depressed or have thoughts about hurting or killing yourself
  • have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating
  • have muscle movements you cannot stop or control
  • have muscle movements that are new or unusual

The most common side effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets include:

  • restlessness
  • drowsiness
  • tiredness
  • lack of energy

You may have more side effects the longer you take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets and the more Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets you take.

You may still have side effects after stopping Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets. You may have symptoms from stopping Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets such as headaches, and feeling dizzy or nervous.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


How should I store Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?

  • Store Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets in the bottle it comes in and away from light. Keep the bottle closed tightly.

Keep Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets and all medicines out of the reach of children.


General information about the safe and effective use of Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets for a condition for which they were not prescribed. Do not give Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets to other people, even if they have the same symptoms that you have. They may harm them.

You can ask your pharmacist or healthcare provider for information about Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets that is written for health professionals. For more information, call 1-888-838-2872.


What are the ingredients in Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets, USP?

Active ingredient: Novo Aerofil Sedante (Metoclopramide Hydrochloride) hydrochloride, USP

Inactive ingredients: corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate


This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. D 8/2017

NDC 0093-2204-01

Novo Aerofil Sedante (Metoclopramide Hydrochloride)

Tablets, USP

5mg

PHARMACIST: Dispense the accompanying

Medication Guide to each patient.

Rx only

100 TABLETS

TEVA

NDC 0093-2203-01

Novo Aerofil Sedante (Metoclopramide Hydrochloride)

Tablets, USP

10 mg

PHARMACIST: Dispense the accompanying

Medication Guide to each patient.

Rx only

100 TABLETS

TEVA

Oxazepam:


WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

DESCRIPTION

Novo Aerofil Sedante (Oxazepam) is the first of a chemical series of compounds, the 3-hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of disorders associated with anxiety, tension, agitation and irritability, and anxiety associated with depression. In tolerance and toxicity studies on several animal species, this product reveals significantly greater safety factors than related compounds (chlordiazepoxide and diazepam) and manifests a wide separation of effective doses and doses inducing side effects.

Novo Aerofil Sedante (Oxazepam) is 7 chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one and has the following structural formula:

Novo Aerofil Sedante (Oxazepam) is a white crystalline powder.

Each capsule for oral administration contains 10 mg, 15 mg or 30 mg of Novo Aerofil Sedante (Oxazepam).

Inactive ingredients: hypromellose, lactose (monohydrate), magnesium stearate and corn starch. The capsule shells and imprinting inks contain: gelatin, titanium dioxide, shellac, black iron oxide, propylene glycol and D&C Red #7 Calcium Lake E180. The 10 mg capsules also contain: methylparaben, butylparaben, propylparaben, benzyl alcohol, sodium propionate, edetate calcium disodium and sodium lauryl sulfate. The 15 mg ink also contains: D&C Yellow #10 Aluminum Lake. The 30 mg ink also contains: FD&C Red #40 Aluminum Lake #129 and FD&C Blue #2 Aluminum Lake #132.

Novo Aerofil Sedante (Oxazepam) Chemical Structure

CLINICAL PHARMACOLOGY

Pharmacokinetic testing in 12 volunteers demonstrated that a single 30 mg dose of a capsule, tablet or suspension will result in an equivalent extent of absorption. For the capsule and tablet, peak plasma levels averaged 450 mg/mL and were observed to occur about 3 hours after dosing. The mean elimination half-life for Novo Aerofil Sedante (Oxazepam) was approximately 8.2 hours (range 5.7 to 10.9 hours).

This product has a single, major inactive metabolite in man, a glucuronide excreted in urine.

Age (<80 years old) does not appear to have a clinically significant effect on Novo Aerofil Sedante (Oxazepam) kinetics. A statistically significant increase in elimination half-life in the very elderly (>80 years of age) as compared to younger subjects has been reported, due to a 30% increase in volume of distribution, as well as a 50% reduction in unbound clearance of Novo Aerofil Sedante (Oxazepam) in the very elderly (see PRECAUTIONS: Geriatric Use ).

ANIMAL PHARMACOLOGY AND TOXICOLOGY

In mice, Novo Aerofil Sedante (Oxazepam) exerts an anticonvulsant (anti-pentylenetetrazol) activity at 50-percent-effective doses of about 0.6 mg/kg orally. (Such anticonvulsant activity of benzodiazepines correlates with their tranquilizing properties.) To produce ataxia (rotabar test) and sedation (abolition of spontaneous motor activity), the 50-percent-effective doses of this product are greater than 5 mg/kg orally. Thus, about ten times the therapeutic (anticonvulsant) dose must be given before ataxia ensues, indicating a wide separation of effective doses and doses inducing side effects.

In evaluation of antianxiety activity of compounds, conflict behavioral tests in rats differentiate continuous response for food in the presence of anxiety-provoking stress (shock) from drug-induced motor incoordination. This product shows significant separation of doses required to relieve anxiety and doses producing sedation or ataxia. Ataxia-producing doses exceed those of related CNS-acting drugs.

Acute oral LD50 in mice is greater than 5000 mg/kg, compared to 800 mg/kg for a related compound (chlordiazepoxide).

Subacute toxicity studies in dogs for four weeks at 480 mg/kg daily showed no specific changes; at 960 mg/kg, two out of eight died with evidence of circulatory collapse. This wide margin of safety is significant compared to chlordiazepoxide HCl, which showed nonspecific changes in six dogs at 80 mg/kg. On chlordiazepoxide, two out of six died with evidence of circulatory collapse at 127 mg/kg, and six out of six died at 200 mg/kg daily. Chronic toxicity studies of Novo Aerofil Sedante (Oxazepam) in dogs at 120 mg/kg/day for 52 weeks produced no toxic manifestation.

Fatty metamorphosis of the liver has been noted in six-week toxicity studies in rats given this product at 0.5% of the diet. Such accumulations of fat are considered reversible, as there is no liver necrosis or fibrosis. Breeding studies in rats through two successive litters did not produce fetal abnormality.

Novo Aerofil Sedante (Oxazepam) has not been adequately evaluated for mutagenic activity.

In a carcinogenicity study, Novo Aerofil Sedante (Oxazepam) was administered with diet to rats for two years. Male rats receiving 30 times the maximum human dose showed a statistical increase, when compared to controls, in benign thyroid follicular cell tumors, testicular interstitial cell adenomas, and prostatic adenomas. An earlier published study reported that mice fed dietary dosages of 35 or 100 times the human daily dose of Novo Aerofil Sedante (Oxazepam) for 9 months developed a dose-related increase in liver adenomas.1 In an independent analysis of some of the microscopic slides from this mouse study, several of these tumors were classified as liver carcinomas. At this time, there is no evidence that clinical use of Novo Aerofil Sedante (Oxazepam) is associated with tumors.

INDICATIONS

Novo Aerofil Sedante (Oxazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

Anxiety associated with depression is also responsive to Novo Aerofil Sedante (Oxazepam) therapy.

This product has been found particularly useful in the management of anxiety, tension, agitation and irritability in older patients.

Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy.

The effectiveness of Novo Aerofil Sedante (Oxazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

CONTRAINDICATIONS

History of previous hypersensitivity reaction to Novo Aerofil Sedante (Oxazepam). Novo Aerofil Sedante (Oxazepam) is not indicated in psychoses.

WARNINGS

Risks from Concomitant Use with Opioids: Concomitant use of benzodiazepines, including Novo Aerofil Sedante, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Novo Aerofil Sedante (Oxazepam) concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Novo Aerofil Sedante (Oxazepam) than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Novo Aerofil Sedante (Oxazepam), prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when Novo Aerofil Sedante (Oxazepam) is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined.

As with other CNS-acting drugs, patients should be cautioned against driving automobiles or operating dangerous machinery until it is known that they do not become drowsy or dizzy on Novo Aerofil Sedante (Oxazepam) therapy.

Patients should be warned that the effects of alcohol or other CNS-depressant drugs may be additive to those of Novo Aerofil Sedante (Oxazepam), possibly requiring adjustment of dosage or elimination of such agents.

Physical and Psychological Dependence

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of Novo Aerofil Sedante (Oxazepam). The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage-tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving Novo Aerofil Sedante (Oxazepam) or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

USE IN PREGNANCY

An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobramate) during the first trimester of pregnancy has been suggested in several studies. Novo Aerofil Sedante (Oxazepam), a benzodiazepine derivative, has not been studied adequately to determine whether it, too, may be associated with an increased risk of fetal abnormality. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant, they should communicate with their physician about the desirability of discontinuing the drug.

PRECAUTIONS

General

Although hypotension has occurred only rarely, Novo Aerofil Sedante should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac complications. This is particularly true in the elderly patient.

Information for Patients

To assure the safe and effective use of Novo Aerofil Sedante (Oxazepam), patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Drug Interactions

The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.

Pediatric Use

Safety and effectiveness in pediatric patients under 6 years of age have not been established. Absolute dosage for pediatric patients 6 to 12 years of age is not established.

Geriatric Use

Clinical studies of Novo Aerofil Sedante (Oxazepam) were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects. Age (<80 years old) does not appear to have a clinically significant effect on Novo Aerofil Sedante (Oxazepam) kinetics (see CLINICAL PHARMACOLOGY ).

Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered. Greater sensitivity of some older individuals to the effects of Novo Aerofil Sedante (Oxazepam) (e.g., sedation, hypotension, paradoxical excitation) cannot be ruled out (see PRECAUTIONS: General ; see ADVERSE REACTIONS ). In general, dose selection for Novo Aerofil Sedante (Oxazepam) for elderly patients should be cautious, usually starting at the lower end of the dosing range (see DOSAGE AND ADMINISTRATION ).

ADVERSE REACTIONS

The necessity for discontinuation of therapy due to undesirable effects has been rare. Transient mild drowsiness is commonly seen in the first few days of therapy. If it persists, the dosage should be reduced. In few instances, dizziness, vertigo, headache and rarely syncope have occurred either alone or together with drowsiness. Mild paradoxical reactions; i.e., excitement, stimulation of affect, have been reported in psychiatric patients; these reactions may be secondary to relief of anxiety and usually appear in the first two weeks of therapy.

Other side effects occurring during Novo Aerofil Sedante (Oxazepam) therapy include rare instances of minor diffuse skin rashes-morbilliform, urticarial, and maculopapular, nausea, lethargy, edema, slurred speech, tremor, and altered libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. A case of an extensive fixed drug eruption also has been reported.

Although rare, leukopenia and hepatic dysfunction including jaundice have been reported during therapy. Periodic blood counts and liver-function tests are advisable. Ataxia with Novo Aerofil Sedante (Oxazepam) has been reported in rare instances and does not appear to be specifically related to dose or age.

Although the following side reactions have not as yet been reported with Novo Aerofil Sedante (Oxazepam), they have occurred with related compounds (chlordiazepoxide and diazepam): paradoxical excitation with severe rage reactions, hallucinations, menstrual irregularities, change in EEG pattern, blood dyscrasias including agranulocytosis, blurred vision, diplopia, incontinence, stupor, disorientation, fever and euphoria.

Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines.

OVERDOSAGE

In the management of overdosage with any drug, it should be born in mind that multiple agents may have been taken.

Symptoms

Overdosage of benzodiazepines is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases, and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, hypnotic state, stage one to three (3) coma, and very rarely, death.

Management

Induced vomiting and/or gastric lavage should be undertaken, followed by general supportive care, monitoring of vital signs, and close observation of the patient. Hypotension, though unlikely, usually may be controlled with norepinephrine bitartrate injection. The value of dialysis has not been adequately determined for Novo Aerofil Sedante (Oxazepam).

The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including “CONTRAINDICATIONS,” “WARNINGS,” and “PRECAUTIONS” should be consulted prior to use.

DOSAGE AND ADMINISTRATION

Because of the flexibility of this product and the range of emotional disturbances responsive to it, dosage should be individualized for maximum beneficial effects.


Novo Aerofil Sedante (Oxazepam)


Usual Dose


Mild-to-moderate anxiety, with associated tension, irritability, agitation or related symptoms of functional origin or secondary to organic disease


10 to 15 mg, 3 or 4 times daily


Severe anxiety syndromes, agitation, or anxiety associated with depression


15 to 30 mg, 3 or 4 times daily


Older patients with anxiety, tension, irritability and agitation


Initial

Dosage: 10 mg, 3 times daily.

If necessary, increase cautiously to 15 mg, 3 or 4 times daily


Alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal


15 to 30 mg, 3 or 4 times daily


This product is not indicated in pediatric patients under 6 years of age. Absolute dosage for pediatric patients 6 to 12 years of age is not established.

HOW SUPPLIED

Novo Aerofil Sedante (Oxazepam) Capsules, USP are available as:

10 mg: white capsules, imprinted GG 505 in black and pink ink bands and are supplied as:

NDC 0781-2809-01 bottles of 100 capsules

NDC 0781-2809-05 bottles of 500 capsules

NDC 0781-2809-10 bottles of 1000 capsules

15 mg: white capsules, imprinted GG 506 in black and red ink bands and are supplied as:

NDC 0781-2810-01 bottles of 100 capsules

NDC 0781-2810-05 bottles of 500 capsules

NDC 0781-2810-10 bottles of 1000 capsules

30 mg: white capsules, imprinted GG 507 in black and maroon ink bands and are supplied as:

NDC 0781-2811-01 bottles of 100 capsules

NDC 0781-2811-05 bottles of 500 capsules

NDC 0781-2811-10 bottles of 1000 capsules

Store at 20° to 25°C (68° to 77°F). Protect from moisture.

Dispense in a tight, light-resistant container.

REFERENCE

  • FOX, K.A., LAHCEN, R.B.: Liver-cell Adenomas and Peliosis Hepatis in Mice Associated with Novo Aerofil Sedante (Oxazepam). Res. Commun. Chem. Pathol. Pharmacol. 8:481-488, 1974.

MEDICATION GUIDE

Novo Aerofil Sedante (Oxazepam) (ox-AZE-e-pam) Capsules, C-IV

What is the most important information I should know about Novo Aerofil Sedante (Oxazepam)?

  • Novo Aerofil Sedante (Oxazepam) is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
  • Novo Aerofil Sedante (Oxazepam) can make you sleepy or dizzy, and can slow your thinking and motor skill.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Novo Aerofil Sedante (Oxazepam) affects you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Novo Aerofil Sedante (Oxazepam) without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Novo Aerofil Sedante (Oxazepam) may make your sleepiness or dizziness much worse.
  • Do not take more Novo Aerofil Sedante (Oxazepam) than prescribed.

What is Novo Aerofil Sedante (Oxazepam)?

  • Novo Aerofil Sedante (Oxazepam) is a prescription medicine used:
  • to treat anxiety disorders
  • for the short-term relief of the symptoms of anxiety or anxiety that can happen with depression
  • to treat anxiety, tension, agitation and irritability in elderly people
  • to relieve the symptoms of alcohol withdrawal including agitation, shakiness (tremor), anxiety associated with acute alcohol withdrawal.
  • Novo Aerofil Sedante (Oxazepam) is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep Novo Aerofil Sedante (Oxazepam) in a safe place to prevent misuse and abuse. Selling or giving away Novo Aerofil Sedante (Oxazepam) may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • It is not known if Novo Aerofil Sedante (Oxazepam) is safe and effective in children under 6 years of age.
  • It is known if Novo Aerofil Sedante (Oxazepam) is safe and effective for use longer than 4 months.

Do not take Novo Aerofil Sedante (Oxazepam) if you:

  • are allergic to Novo Aerofil Sedante (Oxazepam) or any of the ingredients in Novo Aerofil Sedante (Oxazepam). See the end of this Medication Guide for a complete list of ingredients in Novo Aerofil Sedante (Oxazepam).

Before you take Novo Aerofil Sedante (Oxazepam), tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have liver or kidney problems
  • have or have had problems with fainting or low blood pressure
  • are pregnant or plan to become pregnant. Novo Aerofil Sedante (Oxazepam) may harm your unborn baby. You and your healthcare provider should decide if you should take Novo Aerofil Sedante (Oxazepam) while you are pregnant.
  • are breastfeeding or plan to breastfeed. Novo Aerofil Sedante (Oxazepam) may pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Novo Aerofil Sedante (Oxazepam).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Novo Aerofil Sedante (Oxazepam) with certain other medicines can cause side effects or affect how well Novo Aerofil Sedante (Oxazepam) or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take Novo Aerofil Sedante (Oxazepam)?

  • See “What is the most important information I should know about Novo Aerofil Sedante (Oxazepam)?”
  • Take Novo Aerofil Sedante (Oxazepam) exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Novo Aerofil Sedante (Oxazepam) to take and when to take it.
  • If you take too much Novo Aerofil Sedante (Oxazepam), call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Novo Aerofil Sedante (Oxazepam)?

  • Novo Aerofil Sedante (Oxazepam) can cause you to be drowsy. Do not drive a car, operate heavy machinery, or do other dangerous activity until you know how Novo Aerofil Sedante (Oxazepam) affects you.
  • You should not drink alcohol while taking Novo Aerofil Sedante (Oxazepam). Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of Novo Aerofil Sedante (Oxazepam)?

Novo Aerofil Sedante (Oxazepam) may cause serious side effects, including:

  • See “What is the most important information I should know about Novo Aerofil Sedante (Oxazepam)?”
  • Low blood pressure. Novo Aerofil Sedante (Oxazepam) can cause low blood pressure especially in elderly people.
  • Withdrawal symptoms. You may have withdrawal symptoms if you stop taking Novo Aerofil Sedante (Oxazepam) suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping Novo Aerofil Sedante (Oxazepam) to avoid withdrawal symptoms.
  • Abuse and dependence. Taking Novo Aerofil Sedante (Oxazepam) can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

The most common side effects of Novo Aerofil Sedante (Oxazepam) include:

  • drowsiness
  • vertigo (sensation of loss of balance)
  • dizziness
  • headache

These are not all the possible side effects of Novo Aerofil Sedante (Oxazepam). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Novo Aerofil Sedante (Oxazepam)?

  • Store Novo Aerofil Sedante (Oxazepam) at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Novo Aerofil Sedante (Oxazepam) in a tightly closed container and out of the light.
  • Keep Novo Aerofil Sedante (Oxazepam) and all medicines out of the reach of children.

General information about the safe and effective use of Novo Aerofil Sedante (Oxazepam).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Novo Aerofil Sedante (Oxazepam) for a condition for which it was not prescribed. Do not give Novo Aerofil Sedante (Oxazepam) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Novo Aerofil Sedante (Oxazepam) that is written for health professionals.

What are the ingredients in Novo Aerofil Sedante (Oxazepam)?

Active ingredient: Novo Aerofil Sedante (Oxazepam)

Inactive ingredients: hypromellose, lactose (monohydrate), magnesium stearate and corn starch. The capsule shells and imprinting inks contain: gelatin, titanium dioxide, shellac, black iron oxide, propylene glycol and D&C Red #7 Calcium Lake E180. The 10 mg capsules also contain: methylparaben, butylparaben, propylparaben, benzyl alcohol, sodium propionate, edetate calcium disodium and sodium lauryl sulfate. The 15 mg ink also contains: D&C Yellow #10 Aluminum Lake. The 30 mg ink also contains: FD&C Red #40 Aluminum Lake #129 and FD&C Blue #2 Aluminum Lake #132.

For more information about Novo Aerofil Sedante (Oxazepam) Capsules, call 1-800-525-8747.

This Medication Guide has been approved by the U.S. Food and Drug Administration

For Medication Guides, please call 1-800-507-2130

09-2016M

2060

Sandoz Inc.

Princeton, NJ 08540

NDC 0781-2809-01

Novo Aerofil Sedante (Oxazepam)

Capsules, USP

10 mg CIV

Rx only

100 Capsules

SANDOZ

NDC 0781-2810-01

Novo Aerofil Sedante (Oxazepam)

Capsules, USP

15 mg CIV

Rx only

100 Capsules

SANDOZ

NDC 0781-2811-01

Novo Aerofil Sedante (Oxazepam)

Capsules, USP

30 mg CIV

Rx only

100 Capsules

SANDOZ

Novo Aerofil Sedante pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Novo Aerofil Sedante available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Novo Aerofil Sedante destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Novo Aerofil Sedante Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Novo Aerofil Sedante pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ANTIEMETIC GASTROKINETIC PILERAN (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."GOLDKIWI (DIMETHICONE) CREAM [SKINFOOD CO., LTD.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."OXAZEPAM CAPSULE [SANDOZ INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Novo Aerofil Sedante?

Depending on the reaction of the Novo Aerofil Sedante after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Novo Aerofil Sedante not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Novo Aerofil Sedante addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Novo Aerofil Sedante, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Novo Aerofil Sedante consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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