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DRUGS & SUPPLEMENTS
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What are the side effects you encounter while taking this medicine? |
Chlordiazepoxide:
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Safety and effectiveness in pediatric patients have not been established.
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.
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.
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.
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.
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.
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
Aerogastol (Chlordiazepoxide) (lee braks)
(chlordiazepoxide HCl and clidinium bromide) capsules
What is the most important information I should know about Aerogastol (Chlordiazepoxide)?
What is Aerogastol (Chlordiazepoxide)?
Do not take Aerogastol (Chlordiazepoxide) if you:
Before you take Aerogastol (Chlordiazepoxide), tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking 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:
How should I take Aerogastol (Chlordiazepoxide)?
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:
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)?
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:
Aerogastol (Metoclopramide) tablets are indicated for the:
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:
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)
Gastroesophageal Reflux
Acute and Recurrent Diabetic Gastroparesis (2.3)
Dosage Adjustment in Specific Populations (2.2, 2.3)
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)].
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 mg | |
Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.7)] | 5 mg four times daily (thirty minutes before each meal and at bedtime), or 10 mg taken three times daily | 30 mg |
CYP2D6 poor metabolizers [see Use in Specific Populations (8.9)] | ||
Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions (7.1)] | ||
Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) [see Use in Specific Populations (8.6)] | ||
Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations (8.6)] | 5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily | 20 mg |
The recommended adult dosage for the treatment of acute and recurrent diabetic gastroparesis is 10 mg four times daily for 2 to 8 weeks, depending on symptomatic response. Avoid 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 mg | |
Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.7)] | 5 mg four times daily (30 minutes before each meal and at bedtime) | 20 mg |
CYP2D6 poor metabolizers [see Use in Specific Populations (8.9)] | ||
Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions (7.1)] | ||
Moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Use in Specific Populations (8.6)] | ||
Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations (8.6)] | 5 mg twice daily | 10 mg |
Tablets:
Tablets: 5 mg and 10 mg Aerogastol (Metoclopramide) (3)
Aerogastol (Metoclopramide) is contraindicated:
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).
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).
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:
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.
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.
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.
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 ) ].
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)].
The following adverse reactions are described, or described in greater detail, in other sections of the labeling:
The following adverse reactions have been identified from clinical studies or postmarketing reports of 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
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
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 3 displays the effects of other drugs on 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 |
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 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. |
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.
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.
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)].
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)].
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)].
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.
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)].
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)].
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).
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.
Inactive Ingredients
Corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
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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.
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.
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 |
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.
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.
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:
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:
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:
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:
Aerogastol (Metoclopramide) tablets are not recommended for use in children. |
Do not take Aerogastol (Metoclopramide) tablets if you:
|
Before taking Aerogastol (Metoclopramide) tablets, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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:
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?
|
What should I avoid while taking Aerogastol (Metoclopramide) tablets?
|
What are the possible side effects of Aerogastol (Metoclopramide) tablets?
Call your healthcare provider and get medical help right away if you:
The most common side effects of Aerogastol (Metoclopramide) tablets include:
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?
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:
Aerogastol (Simethicone) 20 mg
Antigas
relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods
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.
age (yr) | weight (lb) | dose |
infants under2 | under 24 | 0.3 mL |
children over 2 | over 24 | 0.6 mL |
store at room temperature
benzoic acid, flavor, magnesium aluminum silicate, purified water, Aerogastol (Simethicone) emulsion, sorbitol, xanthan gum
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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The information was verified by Dr. Rachana Salvi, MD Pharmacology