Aerogastol

What are the side effects you encounter while taking this medicine?
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Aerogastol uses

Aerogastol consists of Chlordiazepoxide, Metoclopramide, Simethicone.

Chlordiazepoxide:


WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

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

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

DESCRIPTION

Aerogastol (Chlordiazepoxide) combines in a single capsule formulation the antianxiety action of Aerogastol (Chlordiazepoxide) hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide.

Each Aerogastol (Chlordiazepoxide) capsule contains the active ingredients 5 mg Aerogastol (Chlordiazepoxide) hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients corn starch, lactose monohydrate, talc, methylparaben, propylparaben, potassium sorbate, D&C Yellow No. 10, FD&C Green No. 3, titanium dioxide, and gelatin.

Aerogastol (Chlordiazepoxide) hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds.

Aerogastol (Chlordiazepoxide) hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of Aerogastol (Chlordiazepoxide) hydrochloride is as follows:

Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is:

Chemical Structure Chemical Structure

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ANIMAL PHARMACOLOGY

Aerogastol hydrochloride has been studied extensively in many species of animals and these studies are suggestive of action on the limbic system of the brain, which recent evidence indicates is involved in emotional responses. Hostile monkeys were made tame by oral drug doses, which did not cause sedation. Aerogastol (Chlordiazepoxide) hydrochloride revealed a "taming-action with the elimination of fear and aggression”. The taming effect of Aerogastol (Chlordiazepoxide) hydrochloride was further demonstrated in rats made vicious by lesions in the septal area of the brain. The drug dosage which effectively blocked the vicious reaction was well below the dose which caused sedation in these animals.

The oral LD50 of single doses of Aerogastol (Chlordiazepoxide) hydrochloride, calculated according to the method of Miller and Tainter, is 720 ± 51 mg/kg as determined in mice observed over a period of 5 days following dosage.

Clidinium bromide is an effective anticholinergic agent with activity approximating that of atropine sulfate against acetylcholine-induced spasms in isolated intestinal strips. On oral administration in mice, it proved an effective antisialagogue in preventing pilocarpine-induced salivation. Spontaneous intestinal motility in both rats and dogs is reduced following oral dosing with 0.1 to 0.25 mg/kg. Potent cholinergic ganglionic blocking effects (vagal) were produced with intravenous usage in anesthetized dogs.

Oral doses of 2.5 mg/kg to dogs produced signs of nasal dryness and slight pupillary dilation. In two other species, monkeys and rabbits, doses of 5 mg/kg, po, given three times daily for 5 days did not produce apparent secretory or visual changes.

The oral LD50 of single doses of clidinium bromide is 860 ± 57 mg/kg as determined in mice observed over a period of 5 days following dosage; the calculations were made according to the method of Miller and Tainter.

Effects on Reproduction

Reproduction studies in rats fed Aerogastol (Chlordiazepoxide) hydrochloride, 10, 20 and 80 mg/kg daily, and bred through one or two matings showed no congenital anomalies, nor were there adverse effects on lactation of the dams or growth of the newborn. However, in another study at 100 mg/kg daily there was noted a significant decrease in the fertilization rate and a marked decrease in the viability and body weight of offspring which may be attributable to sedative activity, thus resulting in lack of interest in mating and lessened maternal nursing and care of the young. One neonate in each of the first and second matings in the rat reproduction study at the 100 mg/kg dose exhibited major skeletal defects. Further studies are in progress to determine the significance of these findings.

Two series of reproduction experiments with clidinium bromide were carried out in rats, employing dosages of 2.5 and 10 mg/kg daily in each experiment. In the first experiment, clidinium bromide was administered for a 9-week interval prior to mating; no untoward effect on fertilization or gestation was noted. The offspring were taken by caesarean section and did not show a significant incidence of congenital anomalies when compared to control animals. In the second experiment, adult animals were given clidinium bromide for 10 days prior to and through two mating cycles. No significant effects were observed on fertility, gestation, viability of offspring or lactation, as compared to control animals, nor was there a significant incidence of congenital anomalies in the offspring derived from these experiments.

A reproduction study of Aerogastol (Chlordiazepoxide) was carried out in rats through two successive matings. Oral daily doses were administered in two concentrations: 2.5 mg/kg Aerogastol (Chlordiazepoxide) hydrochloride with 1.25 mg/kg clidinium bromide or 25 mg/kg Aerogastol (Chlordiazepoxide) hydrochloride with 12.5 mg/kg clidinium bromide. In the first mating, no significant differences were noted between the control or the treated groups, with the exception of a slight decrease in the number of animals surviving during lactation among those receiving the highest dosage. As with all anticholinergic drugs, an inhibiting effect on lactation may occur. In the second mating, similar results were obtained except for a slight decrease in the number of pregnant females and in the percentage of offspring surviving until weaning. No congenital anomalies were observed in both matings in either the control or treated groups. Additional animal reproduction studies are in progress.

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INDICATIONS AND USAGE

Aerogastol (Chlordiazepoxide) is indicated to control emotional and somatic factors in gastrointestinal disorders. Aerogastol (Chlordiazepoxide) may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

CONTRAINDICATIONS

Aerogastol (Chlordiazepoxide) is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to Aerogastol (Chlordiazepoxide) hydrochloride and/or clidinium bromide.

WARNINGS

Concomitant use of benzodiazepines, including Aerogastol, 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 Aerogastol (Chlordiazepoxide) 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. Advise both patients and caregivers about the risks of respiratory depression and sedation when Aerogastol (Chlordiazepoxide) is used with opioids (see PRECAUTIONS ).

As in the case of other preparations containing CNS-acting drugs, patients receiving Aerogastol (Chlordiazepoxide) should be cautioned about possible combined effects with opioids, alcohol and other CNS depressants. For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.

Usage In Pregnancy

An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. 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 physicians about the desirability of discontinuing the drug.

As with all anticholinergic drugs, an inhibiting effect on lactation may occur.

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OVERDOSAGE

Manifestations of Aerogastol (Chlordiazepoxide) hydrochloride overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following Aerogastol (Chlordiazepoxide) hydrochloride overdosage.

While the signs and symptoms of Aerogastol (Chlordiazepoxide) overdosage may be produced by either of its components, usually such symptoms will be overshadowed by the anticholinergic actions of clidinium bromide. The symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation.

General supportive measures should be employed, along with immediate gastric lavage. Administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute. This may be repeated in 1 to 4 mg doses if arrhythmias, convulsions or deep coma recur. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol. Methylphenidate or caffeine and sodium benzoate may be given to combat CNS-depressive effects. Dialysis is of limited value. Should excitation occur, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines.

PRECAUTIONS

In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Aerogastol (Chlordiazepoxide) and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed - particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed.

Paradoxical reactions to Aerogastol (Chlordiazepoxide) hydrochloride, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Aerogastol (Chlordiazepoxide) therapy. The usual precautions are indicated when Aerogastol (Chlordiazepoxide) hydrochloride is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary. Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and Aerogastol (Chlordiazepoxide) hydrochloride.

Information for Patients

Inform patients and caregivers that potentially fatal additive effects may occur if Aerogastol (Chlordiazepoxide) is used with opioids or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider (see WARNINGS and PRECAUTIONS ).

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

Drug Interactions

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

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Aerogastol (Chlordiazepoxide). These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. Dosing in geriatric subjects should be initiated cautiously (no more than 2 capsules per day) and increased gradually if needed and tolerated. Aerogastol (Chlordiazepoxide) is contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction.

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ADVERSE REACTIONS

No side effects or manifestations not seen with either compound alone have been reported with the administration of Aerogastol (Chlordiazepoxide). However, since Aerogastol (Chlordiazepoxide) contains Aerogastol (Chlordiazepoxide) hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded.

When Aerogastol (Chlordiazepoxide) hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients - particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.

Other adverse reactions reported during therapy with Aerogastol (Chlordiazepoxide) hydrochloride include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after Aerogastol (Chlordiazepoxide) hydrochloride treatment.

Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with Aerogastol (Chlordiazepoxide) hydrochloride. When Aerogastol (Chlordiazepoxide) hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable.

Adverse effects reported with use of Aerogastol (Chlordiazepoxide) are those typical of anticholinergic agents, i.e., dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when Aerogastol (Chlordiazepoxide) therapy has been combined with other spasmolytic agents and/or a low residue diet.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG ABUSE AND DEPENDENCE

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of Aerogastol (Chlordiazepoxide). The more severe withdrawal symptoms have usually been limited to those patients who had 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 Aerogastol (Chlordiazepoxide) or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

DOSAGE AND ADMINISTRATION

Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Aerogastol varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.

Geriatric Dosing

Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Aerogastol (Chlordiazepoxide) capsules per day, to be increased gradually as needed and tolerated.

HOW SUPPLIED

Aerogastol (Chlordiazepoxide) is available in light green opaque capsules, each containing 5 mg Aerogastol (Chlordiazepoxide) hydrochloride and 2.5 mg clidinium bromide - bottles of 100 (NDC 0187-4100-10), with Aerogastol (Chlordiazepoxide) imprinted on the body of the capsule.

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).

Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF.

Manufactured by:

Valeant Pharmaceuticals International, Inc.

Steinbach, MB R5G 1Z7 Canada

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Aerogastol (Chlordiazepoxide) is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

9548900-20001220

Revised: 01/2017

Medication Guide

Aerogastol (Chlordiazepoxide) (lee braks)

(chlordiazepoxide HCl and clidinium bromide) capsules

What is the most important information I should know about Aerogastol (Chlordiazepoxide)?

  • Do not stop taking Aerogastol (Chlordiazepoxide) without first talking to your healthcare provider. Stopping Aerogastol (Chlordiazepoxide) suddenly can cause serious side effects.
  • Taking Aerogastol (Chlordiazepoxide) with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Aerogastol (Chlordiazepoxide) affects you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Aerogastol (Chlordiazepoxide) without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Aerogastol (Chlordiazepoxide) may make your sleepiness or dizziness much worse.
  • Aerogastol (Chlordiazepoxide) can cause abuse and dependence.
  • Do not stop taking Aerogastol (Chlordiazepoxide) all of a sudden. Stopping Aerogastol (Chlordiazepoxide) suddenly can cause seizures, shaking, stomach and muscle cramps, vomiting and sweating.
  • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

What is Aerogastol (Chlordiazepoxide)?

  • Aerogastol (Chlordiazepoxide) is a prescription medicine that is used with other therapies for the treatment of:
  • stomach (peptic) ulcers
  • irritable bowel syndrome (IBS)
  • inflammation of the colon called acute enterocolitis
  • Aerogastol (Chlordiazepoxide) contains the medicines Aerogastol (Chlordiazepoxide) HCl and clidinium bromide.
  • Aerogastol (Chlordiazepoxide) can be abused or lead to dependence. Keep Aerogastol (Chlordiazepoxide) in a safe place to prevent misuse and abuse. Selling or giving away Aerogastol (Chlordiazepoxide) may harm others. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • It is not known if Aerogastol (Chlordiazepoxide) is safe and effective in children.

Do not take Aerogastol (Chlordiazepoxide) if you:

  • have glaucoma
  • have an enlarged prostate
  • have a blockage of your bladder that causes problems with urination
  • are allergic to Aerogastol (Chlordiazepoxide) hydrochloride or clidinium bromide

Before you take Aerogastol (Chlordiazepoxide), tell your healthcare provider about all of your medical conditions, including if you:

  • have eye problems
  • have problems urinating or emptying your bladder
  • have coordination problems
  • have kidney or liver problems
  • have a history of depression, mental illness, or suicidal thoughts
  • have a history of drug or alcohol abuse or addiction
  • have bleeding problems
  • are pregnant or plan to become pregnant. Aerogastol (Chlordiazepoxide) may harm your unborn baby. Avoid taking Aerogastol (Chlordiazepoxide) during the first trimester of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment with Aerogastol (Chlordiazepoxide).
  • are breastfeeding or plan to breastfeed. Aerogastol (Chlordiazepoxide) may pass through your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Aerogastol (Chlordiazepoxide). Aerogastol (Chlordiazepoxide) may decrease the amount of breast milk your body makes.

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

Taking Aerogastol (Chlordiazepoxide) with certain other medicines can cause side effects or affect how well Aerogastol (Chlordiazepoxide) or the other medicines work.

Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

  • take a monoamine oxidase inhibitor (MAOI) medicine or an anti-psychotic medicine called phenothiazine.

How should I take Aerogastol (Chlordiazepoxide)?

  • Take Aerogastol (Chlordiazepoxide) exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your dose of Aerogastol (Chlordiazepoxide) if needed. Do not change your dose of Aerogastol (Chlordiazepoxide) or suddenly stop taking Aerogastol (Chlordiazepoxide) without talking with your healthcare provider.
  • If you take too much Aerogastol (Chlordiazepoxide), call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Aerogastol (Chlordiazepoxide)?

Aerogastol (Chlordiazepoxide) may cause serious side effects, including: See “What is the most important information I should know about Aerogastol (Chlordiazepoxide)?”

The most common side effects of Aerogastol (Chlordiazepoxide) include:

  • dry mouth
  • blurred vision
  • nausea
  • constipation
  • skin problems
  • swelling
  • irregular menstrual (periods) cycles
  • increase and decreased desire for sex (libido)
  • problems starting to urinate
  • drowsiness, coordination problems, and confusion may happen, especially in people who are elderly or weak

These are not all the possible side effects of Aerogastol (Chlordiazepoxide).

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 Aerogastol (Chlordiazepoxide)?

  • Store Aerogastol (Chlordiazepoxide) at room temperature 77°F (25°C).
  • Keep Aerogastol (Chlordiazepoxide) and all medicines out of the reach of children.

General information about the safe and effective use of Aerogastol (Chlordiazepoxide).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Aerogastol (Chlordiazepoxide) for a condition for which it was not prescribed. Do not give Aerogastol (Chlordiazepoxide) 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 Aerogastol (Chlordiazepoxide) that is written for health professionals.

What are the ingredients in Aerogastol (Chlordiazepoxide)?

Active ingredient: Aerogastol (Chlordiazepoxide) hydrochloride and clidinium bromide

Inactive ingredients: corn starch, lactose and talc. Gelatin capsule shells may contain methyl and propyl parabens and potassium sorbate, with the following dye systems: D&C Yellow No. 10 and either FD&C Blue No.1 or FD&C Green No. 3.

Manufactured in Canada by: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7 Canada

Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA

Aerogastol (Chlordiazepoxide) is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

For more information, go to www.valeant.com or contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576

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

Issued: 01/2017

NDC 0187-4100-10

Rx Only

Aerogastol (Chlordiazepoxide)®

(chlordiazepoxide HCl)

(clidinium bromide)

Each capsule

contains 5 mg

Aerogastol (Chlordiazepoxide)

HCl and 2.5 mg

clidinium bromide.

VALEANT

100 Capsules

Metoclopramide:


1 INDICATIONS AND USAGE

Aerogastol (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:

Aerogastol (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 ) ].

Aerogastol (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:

Aerogastol (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 Aerogastol (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 Aerogastol (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

Aerogastol 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 Aerogastol (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 Aerogastol (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 Aerogastol (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 Aerogastol (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 Aerogastol (Metoclopramide) tablets, consider starting therapy with Aerogastol (Metoclopramide) injection given intramuscularly or intravenously for up to 10 days injection). After patients are able to take oral therapy, switch to Aerogastol (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 Aerogastol (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

3 DOSAGE FORMS AND STRENGTHS

Tablets:

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

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

4 CONTRAINDICATIONS

Aerogastol (Metoclopramide) is contraindicated:

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

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 Aerogastol (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

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

Discontinue Aerogastol (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 Aerogastol (Metoclopramide) is withdrawn.

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

5.2 Other Extrapyramidal Symptoms

In addition to TD, Aerogastol 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 Aerogastol (Metoclopramide).

  • Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with Aerogastol (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 Aerogastol (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 Aerogastol (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 Aerogastol (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 Aerogastol (Metoclopramide). Avoid Aerogastol (Metoclopramide) in patients with Parkinson’s disease and other patients being treated with antiparkinsonian drugs due to potential exacerbation of symptoms. Avoid treatment with Aerogastol (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

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

5.5 Hypertension

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

5.6 Fluid Retention

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

5.7 Hyperprolactinemia

As with other dopamine D2 receptor antagonists, Aerogastol (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 Aerogastol (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

Aerogastol (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 Aerogastol (Metoclopramide) or the interacting drug, depending on the importance of the drug to the patient [see Drug Interactions (7.1)].

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

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

Table 3 displays the effects of other drugs on Aerogastol (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 Aerogastol (Metoclopramide); risk of exacerbation of extrapyramidal symptoms [see Clinical Pharmacology (12.3)].


Intervention


Reduce the Aerogastol (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 Aerogastol (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 Aerogastol (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 Aerogastol (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 Aerogastol on Other Drugs

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


Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations


Clinical Impact


Opposing effects of Aerogastol (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


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

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

Aerogastol (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 Aerogastol (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 Aerogastol (Metoclopramide) were observed.

8.2 Lactation

Risk Summary

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

Clinical Considerations

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

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

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

8.5 Geriatric Use

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

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

10 OVERDOSAGE

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

11 DESCRIPTION

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

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

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

Inactive Ingredients

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

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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

Aerogastol (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 Aerogastol (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 Aerogastol (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 Aerogastol (Metoclopramide).

Distribution

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

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

Effect of CYP2D6 Inhibitors on Aerogastol (Metoclopramide)

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


Parameter


Aerogastol (Metoclopramide) alone

(mean SD)


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

Aerogastol (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

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

Inform patients or their caregivers that Aerogastol (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

Aerogastol (Metoclopramide) TABLETS, USP

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


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

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

Your chances for getting tardive dyskinesia increase:

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


What are Aerogastol (Metoclopramide) tablets?

Aerogastol (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.

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


Do not take Aerogastol (Metoclopramide) tablets if you:

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

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

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

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

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

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

  • restlessness
  • drowsiness
  • tiredness
  • lack of energy

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

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

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

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


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

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


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

Active ingredient: Aerogastol (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

Aerogastol (Metoclopramide)

Tablets, USP

5mg

PHARMACIST: Dispense the accompanying

Medication Guide to each patient.

Rx only

100 TABLETS

TEVA

NDC 0093-2203-01

Aerogastol (Metoclopramide)

Tablets, USP

10 mg

PHARMACIST: Dispense the accompanying

Medication Guide to each patient.

Rx only

100 TABLETS

TEVA

Simethicone:


Active ingredient

Aerogastol (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, Aerogastol (Simethicone) emulsion, sorbitol, xanthan gum

Aerogastol 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.


Aerogastol 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.


Aerogastol 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.


Aerogastol 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.


Aerogastol 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."GAS-AID DROPS FOR INFANTS (SIMETHICONE) EMULSION [LEOSONS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Aerogastol?

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

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

One visitor reported doses

What is the dose of Aerogastol drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 11-50mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
11-50mg1
100.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

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

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