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DRUGS & SUPPLEMENTS
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What are the side effects you encounter while taking this medicine? |
Dimethicone:
Metoclopramide Hydrochloride:
Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are indicated for the:
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:
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)
Gastroesophageal Reflux
Acute and Recurrent Diabetic Gastroparesis (2.3)
Dosage Adjustment in Specific Populations (2.2, 2.3)
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)].
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 mg | |
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 |
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 mg | |
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 |
Tablets:
Tablets: 5 mg and 10 mg Novo Aerofil Sedante (Metoclopramide Hydrochloride) (3)
Novo Aerofil Sedante (Metoclopramide Hydrochloride) is contraindicated:
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).
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).
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:
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.
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.
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.
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 ) ].
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)].
The following adverse reactions are described, or described in greater detail, in other sections of the labeling:
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
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
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.
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 |
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 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. |
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.
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.
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)].
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)].
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)].
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.
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)].
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)].
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).
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.
Inactive Ingredients
Corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
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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.
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.
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 |
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.
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.
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:
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:
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:
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:
Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets are not recommended for use in children. |
Do not take Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets if you:
|
Before taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets, tell your healthcare provider about all of your medical conditions, including if you:
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:
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?
|
What should I avoid while taking Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?
|
What are the possible side effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets?
Call your healthcare provider and get medical help right away if you:
The most common side effects of Novo Aerofil Sedante (Metoclopramide Hydrochloride) tablets include:
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?
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:
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
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
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 ).
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.
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.
History of previous hypersensitivity reaction to Novo Aerofil Sedante (Oxazepam). Novo Aerofil Sedante (Oxazepam) is not indicated in psychoses.
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.
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.
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.
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.
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.
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.
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.
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 ).
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.
In the management of overdosage with any drug, it should be born in mind that multiple agents may have been taken.
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.
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.
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.
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.
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)?
What is Novo Aerofil Sedante (Oxazepam)?
Do not take Novo Aerofil Sedante (Oxazepam) if you:
Before you take Novo Aerofil Sedante (Oxazepam), tell your healthcare provider about all of your medical conditions, including if you:
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)?
What should I avoid while taking Novo Aerofil Sedante (Oxazepam)?
What are the possible side effects of Novo Aerofil Sedante (Oxazepam)?
Novo Aerofil Sedante (Oxazepam) may cause serious side effects, including:
The most common side effects of Novo Aerofil Sedante (Oxazepam) include:
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)?
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
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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The information was verified by Dr. Rachana Salvi, MD Pharmacology