Faradil

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Faradil uses

Faradil consists of Diazepam, Metoclopramide, Simethicone.

Diazepam:


Pharmacological action

Faradil is a benzodiazepine derivative tranquilizer. It provides anxiolytic, sedative, anticonvulsant, central muscle relaxant effect. The mechanism of action is associated with increased inhibitory effect of GABA in the CNS. Muscle relaxant effect is also due to the inhibition of spinal reflexes. This medication may cause anticholinergic effects.

Pharmacokinetics

Faradil (Diazepam) has rapid absorption. Cmax in plasma observed after 90 min. Plasma protein binding is 98%. Faradil (Diazepam) crosses the placental barrier into the cerebrospinal fluid; excreted in breast milk; metabolized in the liver; excreted by the kidneys - 70%.

Why is Faradil prescribed?

  • neuroses, borderline states with symptoms of stress, restlessness, anxiety, fear
  • sleep disturbance, motor stimulation of various etiologies in neurology and psychiatry, withdrawal syndrome in chronic alcoholism
  • spastic conditions associated with lesions of the brain or spinal cord, and myositis, bursitis, arthritis, accompanied by a voltage of skeletal muscle
  • status epilepticus
  • premedication before anesthesia as a component of combined anesthesia
  • relief labor, premature birth, abruptio placenta, tetanus

    Dosage and administration

    Faradil prescribed for oral, IV, IM, rectal use. The daily dose of Faradil (Diazepam) ranges from 0.5 mg to 60 mg. Single dose, frequency and duration of use are set individually.

    Faradil (Diazepam) side effects, adverse reactions

    CNS: drowsiness, dizziness, muscle weakness; rare - confusion, depression, blurred vision, diplopia, dysarthria, headache, tremor, ataxia; in single cases - a paradoxical response: excitement, anxiety, sleep disturbances, hallucinations. After IV injection is sometimes seen a hiccup. With prolonged use may develop drug dependence, memory impairment.

    Digestive system: rarely - constipation, nausea, dry mouth, excessive salivation; in single cases - raising the level of transaminases and alkaline phosphatase in blood plasma, jaundice.

    Endocrine system: rarely - increased or decreased libido.

    Urinary system: rare - incontinence.

    Cardiovascular system: when administered parenteral may be some fall in blood pressure.

    Respiratory system: when administered parenteral in single cases - respiratory disorders.

    Allergic reactions: rarely - a skin rash.

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    Contraindications

    Myasthenia gravis, severe chronic hypercapnia. Specifying a history of alcohol or drug dependence. Hypersensitivity to Faradil (Diazepam) and other benzodiazepines.

    Faradil (Diazepam) using during pregnancy and breastfeeding

    Faradil (Diazepam) should not be used in the I trimester of pregnancy, except in cases of extreme necessity. Faradil (Diazepam) taking during pregnancy may significantly change fetal heart rate.

    When used in obstetrics doses recommended to facilitate childbirth, newborns (most preterm) it is possible temporary muscular hypotonia, hypothermia, respiratory failure.

    When taken regularly during lactation breastfeeding should be discontinued.

    Should avoid the use of Faradil (Diazepam) in newborn infants, since they have not yet fully formed enzyme system involved in the metabolism of Faradil (Diazepam).

    Special instructions

    Faradil with caution used in patients with cardiac and respiratory failure, organic changes in the brain (in such cases are advised to avoid parenteral administration of Faradil (Diazepam)), with angle-closure glaucoma and predisposition to it, in myasthenia.

    There are needed special care when using Faradil (Diazepam) (especially at the beginning of treatment) for patients receiving long-term antihypertensive medications of central action, beta-blockers, anticoagulants, cardiac glycosides.

    If you cancel the therapy dose should be reduced gradually. With the sudden cancellation of Faradil (Diazepam) after prolonged use may concern, excitement, tremors, convulsions. This medicine should be abolished in the development of paradoxical reactions (acute agitation, anxiety, sleep disturbances and hallucinations).

    After I.M. injection of Faradil (Diazepam) may increase the activity of CK in the blood plasma (which should be considered in the differential diagnosis of myocardial infarction).

    Avoid IA injection.

    Avoid alcohol during the period of treatment.

    Faradil (Diazepam) can cause slowing of psychomotor responses that should be considered for patients involved in potentially danger activities.

    Faradil (Diazepam) drug interactions

    When used Faradil (Diazepam) with drugs providing a depressing effect on the CNS (including with antipsychotics, sedatives, hypnotics, opioid analgesics, drugs for anesthesia), enhanced inhibitory effect on the central nervous system, the respiratory center, pronounced arterial hypotension.

    When used Faradil (Diazepam) with the tricyclic antidepressants (including amitriptyline) may be increasing of the CNS depressant effect, increasing concentrations of antidepressants and increased cholinergic action.

    Patients receiving long-term antihypertensive medications central action, beta-blockers, anticoagulants, cardiac glycosides, the extent and mechanisms of drug interactions are unpredictable.

    Simultaneous administration with muscle relaxants the action of muscle relaxants increases, also increases the risk of apnea.

    Co-administration with oral contraceptives may increase the effects of Faradil (Diazepam). The risk of breakthrough bleeding increases.

    Simultaneous administration with bupivacaine may increase the concentration of bupivacaine in blood plasma; with diclofenac - may increase dizziness; with isoniazid - a decrease of Faradil (Diazepam) elimination from the body.

    Drugs that cause induction of liver enzymes, including antiepileptic drugs (carbamazepine, phenytoin) may accelerate the elimination of Faradil (Diazepam).

    When this medicine used with caffeine decreases sedative and possibly anxiolytic action of Faradil (Diazepam).

    Simultaneous administration with with clozapine may be expressed as hypotension, respiratory depression, loss of consciousness; with levodopa - may suppress antiparkinsonian action; with lithium carbonate - described a case of coma, with metoprolol - possible decreased visual acuity, impairment of psychomotor reactions.

    Simultaneous administration with paracetamol may decrease excretion of Faradil (Diazepam) and its metabolite desmethyldiazepam; with risperidone - described the cases of NMS.

    Co-administration with rifampicin increased excretion of Faradil (Diazepam) is due to a significant increase in its metabolism under the influence of rifampicin.

    Theophylline at low doses changes a sedative effect of Faradil (Diazepam).

    In rare cases Faradil (Diazepam) inhibits the metabolism and increases the effect of phenytoin. Phenobarbital and phenytoin may accelerate the metabolism of Faradil (Diazepam).

    Fluvoxamine increases plasma concentrations and side effects of Faradil (Diazepam).

    Cimetidine, omeprazole, disulfiram may increase the intensity and duration of action of Faradil (Diazepam).

    Alcohol and alcohol containing drugs enhanced inhibitory effect on the central nervous system (mainly on the respiratory center) but can also occur syndrome of pathological intoxication.

    Faradil in case of emergency / overdose

    Symptoms: CNS depression of varying severity (from lethargy to coma): severe drowsiness, lethargy, weakness, decreased muscle tone, ataxia, prolonged confusion, depression of reflexes, coma; perhaps hypotension, respiratory depression.

    Treatment: induction of vomiting and the appointment of activated charcoal (if the patient is conscious), gastric lavage through a tube (if patient is unconscious), symptomatic therapy, monitor vital functions, liquids' intravenous injection (to increase urine output), if necessary - artificial ventilation. With the development of excitation barbiturates should not be used. In hospital conditions used a benzodiazepine receptor antagonist flumazenil as specific antidote. Hemodialysis is ineffective.

  • Metoclopramide:


    1 INDICATIONS AND USAGE

    Faradil (Metoclopramide) 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:

    Faradil (Metoclopramide) 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 ) ].

    Faradil (Metoclopramide) 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:

    Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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

    Faradil 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide); 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets, consider starting therapy with Faradil (Metoclopramide) injection given intramuscularly or intravenously for up to 10 days injection). After patients are able to take oral therapy, switch to Faradil (Metoclopramide) 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 Faradil (Metoclopramide); 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 Faradil (Metoclopramide): white, round, unscored, debossed “TV” on one side and “2204” on the other side.
    • 10 mg Faradil (Metoclopramide): white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side.

    Tablets: 5 mg and 10 mg Faradil (Metoclopramide) (3)

    4 CONTRAINDICATIONS

    Faradil (Metoclopramide) is contraindicated:

    • In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to Faradil (Metoclopramide) [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. Faradil (Metoclopramide) 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. Faradil (Metoclopramide) may increase the frequency and severity of seizures [see Adverse Reactions (6)].
    • In patients with hypersensitivity to Faradil (Metoclopramide). Reactions have included laryngeal and glossal angioedema and bronchospasm [see Adverse Reactions (6)].
    • History of TD or dystonic reaction to Faradil (Metoclopramide) (4)
    • When stimulation of gastrointestinal motility might be dangerous (4)
    • Pheochromocytoma, catecholamine-releasing paragangliomas (4)
    • Epilepsy (4)
    • Hypersensitivity to Faradil (Metoclopramide) (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 Faradil (Metoclopramide) 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

    Faradil (Metoclopramide) 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 Faradil (Metoclopramide) for longer than 12 weeks and reduce the dosage in elderly patients [see Dosage and Administration (2.2, 2.3)].

    Discontinue Faradil (Metoclopramide) 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 Faradil (Metoclopramide) is withdrawn.

    Faradil (Metoclopramide) 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. Faradil (Metoclopramide) is contraindicated in patients with a history of TD [see Contraindications (4)]. Avoid Faradil (Metoclopramide) in patients receiving other drugs that are likely to cause TD (e.g., antipsychotics).

    5.2 Other Extrapyramidal Symptoms

    In addition to TD, Faradil 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 Faradil (Metoclopramide).

    • Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with Faradil (Metoclopramide) 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 Faradil (Metoclopramide). 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide), more commonly within the first 6 months, but also after longer periods. Symptoms generally have subsided within 2 to 3 months after discontinuation of Faradil (Metoclopramide). Avoid Faradil (Metoclopramide) in patients with Parkinson’s disease and other patients being treated with antiparkinsonian drugs due to potential exacerbation of symptoms. Avoid treatment with Faradil (Metoclopramide) 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

    Faradil (Metoclopramide) may cause a potentially fatal symptom complex called neuroleptic malignant syndrome (NMS). NMS has been reported in association with Faradil (Metoclopramide) overdosage and concomitant treatment with another drug associated with NMS. Avoid Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil use in patients with a history of depression.

    5.5 Hypertension

    Faradil (Metoclopramide) may elevate blood pressure. In one study in hypertensive patients, intravenously administered Faradil (Metoclopramide) 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. Faradil (Metoclopramide) is contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas [see Contraindications (4)]. Discontinue Faradil (Metoclopramide) in any patient with a rapid rise in blood pressure.

    5.6 Fluid Retention

    Because Faradil 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 Faradil (Metoclopramide) if any of these adverse reactions occur.

    5.7 Hyperprolactinemia

    As with other dopamine D2 receptor antagonists, Faradil (Metoclopramide) 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 Faradil (Metoclopramide).

    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

    Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide). 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 Faradil (Metoclopramide) four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of Faradil (Metoclopramide) administration.

    Adverse reactions, especially those involving the nervous system, occurred after stopping Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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.

    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 Faradil (Metoclopramide)

    Table 3 displays the effects of other drugs on Faradil (Metoclopramide).


    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 Faradil (Metoclopramide); risk of exacerbation of extrapyramidal symptoms [see Clinical Pharmacology (12.3)].


    Intervention


    Reduce the Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide).


    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 Faradil (Metoclopramide) 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 Faradil on Other Drugs

    Table 4 displays the effects of Faradil (Metoclopramide) on other drugs.


    Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations


    Clinical Impact


    Opposing effects of Faradil (Metoclopramide) 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


    Faradil (Metoclopramide) 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 Faradil (Metoclopramide) on other drugs is variable. Increased gastrointestinal (GI) motility by Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil during pregnancy.

    There are potential risks to the neonate following exposure in utero to Faradil (Metoclopramide) during delivery [see Clinical Considerations]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of Faradil (Metoclopramide) 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

    Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) were observed.

    8.2 Lactation

    Risk Summary

    Limited published data report the presence of Faradil (Metoclopramide) in human milk in variable amounts. Breastfed infants exposed to Faradil (Metoclopramide) have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation [see Data]. Faradil (Metoclopramide) 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 Faradil (Metoclopramide) and any potential adverse effects on the breastfed child from Faradil (Metoclopramide) or from the underlying maternal condition.

    Clinical Considerations

    Monitor breastfeeding neonates because Faradil (Metoclopramide) 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 Faradil (Metoclopramide) received by the breastfed infant was less than 10% of the maternal weight-adjusted dose. In one study, the estimated daily amount of Faradil (Metoclopramide) 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

    Faradil 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 Faradil (Metoclopramide) in pediatric patients have not been established.

    Dystonias and other extrapyramidal symptoms associated with Faradil (Metoclopramide) 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 Faradil (Metoclopramide) use in neonates [see Use in Specific Populations (8.8)].

    8.5 Geriatric Use

    Faradil (Metoclopramide) 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 Faradil (Metoclopramide); therefore, consider a reduced dosage of Faradil (Metoclopramide) 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 Faradil 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) clearance (by approximately 50%) compared to patients with normal hepatic function. The resulting increase in Faradil (Metoclopramide) blood concentrations increases the risk of adverse reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B). Reduce Faradil (Metoclopramide) 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, Faradil (Metoclopramide), 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

    Faradil (Metoclopramide) is a substrate of CYP2D6. The elimination of Faradil (Metoclopramide) 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 Faradil (Metoclopramide) [see Clinical Pharmacology (12.3)]. Reduce the Faradil (Metoclopramide) dosage in patients who are poor CYP2D6 metabolizers [see Dosage and Administration (2.2, 2.3)].

    10 OVERDOSAGE

    Manifestations of Faradil (Metoclopramide) overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with Faradil (Metoclopramide) use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide).

    11 DESCRIPTION

    Faradil (Metoclopramide) hydrochloride, USP, the active ingredient of Faradil (Metoclopramide) tablets, is a dopamine-2 receptor antagonist. Faradil (Metoclopramide) 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

    Faradil (Metoclopramide) tablets are for oral administration. Faradil (Metoclopramide) tablets are available in 5 mg and 10 mg tablets.

    • Each Faradil (Metoclopramide) tablet, 5 mg contains 5 mg Faradil (Metoclopramide) (equivalent to 5.91 mg of Faradil (Metoclopramide) hydrochloride, USP).
    • Each Faradil (Metoclopramide) tablet, 10 mg contains 10 mg Faradil (Metoclopramide) (equivalent to 11.82 mg of Faradil (Metoclopramide) 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

    Faradil stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of Faradil (Metoclopramide) 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 Faradil (Metoclopramide) on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs.

    Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide).

    Distribution

    Faradil (Metoclopramide) 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: Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) on CYP2D6 Substrates

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

    Effect of CYP2D6 Inhibitors on Faradil (Metoclopramide)

    In healthy subjects, 20 mg of Faradil (Metoclopramide) 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 Faradil (Metoclopramide) and fluoxetine had a 40% and 90% increase in Faradil (Metoclopramide) Cmax and AUC0-∞, respectively, compared to patients who received Faradil (Metoclopramide) alone [see Drug Interactions (7.1)].


    Parameter


    Faradil (Metoclopramide) alone

    (mean SD)


    Faradil (Metoclopramide) 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 Faradil (Metoclopramide) doses up to 40 mg/kg/day (about six times the maximum recommended human dose on body surface area basis). Faradil (Metoclopramide) elevated prolactin levels and the elevation persisted during chronic administration. An increase in mammary neoplasms was found in rodents after chronic administration of Faradil (Metoclopramide) [see Warnings and Precautions (5.7)]. In a rat model for assessing the tumor promotion potential, a 2-week oral treatment with Faradil (Metoclopramide) 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

    Faradil (Metoclopramide) 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

    Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablet, USP contains Faradil (Metoclopramide) hydrochloride, USP equivalent to 5 mg Faradil (Metoclopramide). 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 Faradil (Metoclopramide) tablet, USP contains Faradil (Metoclopramide) hydrochloride, USP equivalent to 10 mg Faradil (Metoclopramide). 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 Faradil (Metoclopramide) can cause serious adverse reactions. Instruct patients to discontinue Faradil (Metoclopramide) 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 Faradil (Metoclopramide).

    Inform patients or their caregivers that Faradil (Metoclopramide) 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

    Faradil (Metoclopramide) TABLETS, USP

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


    Read this Medication Guide before you start taking Faradil (Metoclopramide) tablets and each time you get a refill. There may be new information. If you take another product that contains Faradil (Metoclopramide) (such as Faradil (Metoclopramide) injection, Faradil (Metoclopramide) orally disintegrating tablets, or Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets?

    Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets. There is no treatment for tardive dyskinesia, but symptoms may decrease or go away over time after you stop taking Faradil (Metoclopramide) tablets.

    Your chances for getting tardive dyskinesia increase:

    • the longer you take Faradil (Metoclopramide) tablets and the more Faradil (Metoclopramide) tablets you take. You should not take Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets?” for more information about side effects.


    What are Faradil (Metoclopramide) tablets?

    Faradil (Metoclopramide) 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.

    Faradil (Metoclopramide) tablets are not recommended for use in children.


    Do not take Faradil (Metoclopramide) tablets if you:

    • have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking Faradil (Metoclopramide) tablets or a medicine that works like Faradil (Metoclopramide) tablets.
    • have stomach or intestine problems that could get worse with Faradil (Metoclopramide) 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). Faradil (Metoclopramide) tablets can increase your chance for seizures and make them worse.
    • are allergic to Faradil (Metoclopramide). Faradil (Metoclopramide) tablets can cause serious allergic reactions. Stop taking Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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. Faradil (Metoclopramide) tablets may harm your unborn baby if taken during the end of pregnancy. Talk to your healthcare provider if you become pregnant while taking Faradil (Metoclopramide) tablets.
    • are breastfeeding or plan to breastfeed. Faradil (Metoclopramide) can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take Faradil (Metoclopramide) tablets or breastfeed.

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

    Faradil (Metoclopramide) tablets may affect the way other medicines work, and other medicines may affect how Faradil (Metoclopramide) 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 Faradil (Metoclopramide), such as Faradil (Metoclopramide) injection or Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets?

    • Take Faradil (Metoclopramide) tablets exactly as your healthcare provider tells you. Do not change your dose unless your healthcare provider tells you to.
    • Faradil (Metoclopramide) comes as a tablet you take by mouth.
    • You should not take Faradil (Metoclopramide) tablets for more than 12 weeks.
    • Take Faradil (Metoclopramide) tablets at least 30 minutes before each meal and at bedtime.
    • If you take too many Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets?

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

    What are the possible side effects of Faradil (Metoclopramide) tablets?

    • Tardive dyskinesia (abnormal muscle movements). See “What is the most important information I need to know about Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets have ended their own lives (suicide).
    • High blood pressure. Faradil (Metoclopramide) tablets can cause your blood pressure to increase.
    • Too much body water. People who have certain liver problems or heart failure and take Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets include:

    • restlessness
    • drowsiness
    • tiredness
    • lack of energy

    You may have more side effects the longer you take Faradil (Metoclopramide) tablets and the more Faradil (Metoclopramide) tablets you take.

    You may still have side effects after stopping Faradil (Metoclopramide) tablets. You may have symptoms from stopping Faradil (Metoclopramide) 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 Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets?

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

    Keep Faradil (Metoclopramide) tablets and all medicines out of the reach of children.


    General information about the safe and effective use of Faradil (Metoclopramide) tablets.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Faradil (Metoclopramide) tablets for a condition for which they were not prescribed. Do not give Faradil (Metoclopramide) 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 Faradil (Metoclopramide) tablets that is written for health professionals. For more information, call 1-888-838-2872.


    What are the ingredients in Faradil (Metoclopramide) tablets, USP?

    Active ingredient: Faradil (Metoclopramide) 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

    Faradil (Metoclopramide)

    Tablets, USP

    5mg

    PHARMACIST: Dispense the accompanying

    Medication Guide to each patient.

    Rx only

    100 TABLETS

    TEVA

    NDC 0093-2203-01

    Faradil (Metoclopramide)

    Tablets, USP

    10 mg

    PHARMACIST: Dispense the accompanying

    Medication Guide to each patient.

    Rx only

    100 TABLETS

    TEVA

    Simethicone:


    Active ingredient

    Faradil (Simethicone) 20 mg

    Purpose

    Antigas

    Uses

    relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

    Warnings

    When using this product

    do not exceed 12 doses per day

    Keep out of reach of children. In case of overdose get medical help or contact a poison control center immediately.

    Directions

    • shake well before using
    • all dosages may be repeated as needed, after meals and at bedtime
    • fill enclosed dropper to recommend dosage level
    • dispense liquid slowly into baby's mouth, toward the inner cheek
    • may mix with 1 oz. of cool water, infant formula or other suitable liquids
    • clean dropper after each use and close the bottle to maintain child resistance
    age (yr) weight (lb) dose
    infants under2 under 24 0.3 mL
    children over 2 over 24

    0.6 mL

    Other information

    store at room temperature

    Inactive ingredients

    benzoic acid, flavor, magnesium aluminum silicate, purified water, Faradil (Simethicone) emulsion, sorbitol, xanthan gum

    Faradil 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.


    Faradil 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.


    Faradil 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.


    Faradil 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.


    Faradil 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."METOCLOPRAMIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    2. Dailymed."DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    3. Dailymed."GAS-AID DROPS FOR INFANTS (SIMETHICONE) EMULSION [LEOSONS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

    Frequently asked Questions

    Can i drive or operate heavy machine after consuming Faradil?

    Depending on the reaction of the Faradil after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Faradil 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 Faradil 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 Faradil, 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 Faradil 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.

    Visitor reports

    Visitor reported useful

    No survey data has been collected yet

    Visitor reported side effects

    No survey data has been collected yet

    One visitor reported price estimates

    What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
    The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Faradil is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
    Visitors%
    Expensive1
    100.0%

    Visitor reported frequency of use

    No survey data has been collected yet

    Visitor reported doses

    No survey data has been collected yet

    Visitor reported time for results

    No survey data has been collected yet

    Visitor reported administration

    No survey data has been collected yet

    One visitor reported age

    Visitors%
    46-601
    100.0%

    Visitor reviews


    There are no reviews yet. Be the first to write one!


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

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