Breast-feeding. Careful monitoring of digoxin plasma concentration is required.Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%). • Metoclopramide 5 mg/ml Injection should not be used during the first three to four days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B). The injection is also used to prevent Do not use this medicine if you've ever had muscle movement problems after using metoclopramide or similar medicines, or if you've had a movement disorder called Before you take metoclopramide, tell your doctor if you have kidney or liver disease, congestive heart failure, high blood pressure, diabetes, Parkinson's disease, or a history of depression.Do not drink alcohol. Use dry hands and take care not to damage a tablet while pushing it out of the blister.Place the tablet in your mouth and allow it to dissolve, without chewing or swallowing it whole. Metoclopramide is a dopamine-receptor antagonist with a direct anti-emetic effect on the medullary chemoreceptor trigger zone.Metoclopramide is rapidly absorbed from the gastrointestinal tract and undergoes variable first-pass metabolism in the liver.Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney. A 77-week study was conducted in rats with oral metoclopramide doses up to 40 mg/kg/day (about six times the maximum recommended human dose on body surface area basis). 0121-1576-10 Metoclopramide, is a dopamine-2 receptor antagonist. Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS)To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine)Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible.
Careful monitoring of digoxin plasma concentration is required.Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. These reactions occur usually at the beginning of the treatment and can occur after a single administration. Treatment must be discontinued if clinical signs of tardive dyskinesia appear.Neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see section 4.8). 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). • Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting There are no specific antidotes for metoclopramide overdosage. In addition, metoclopramide, by producing a transient increase in plasma aldosterone, may increase the risk of fluid retention in patients with hepatic impairment Revised: 4/2018 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 metoclopramide. The mean elimination half-life in subjects with normal renal function was 5 to 6 hours. The resulting increase in metoclopramide blood concentrations increases the risk of adverse reactions. Active ingredient: metoclopramide. A healthcare provider will give the injection, usually during surgery, chemotherapy, or a medical procedure.Metoclopramide oral is taken for only 4 to 12 weeks.Metoclopramide is usually taken 30 minutes before meals and at bedtime, or only with meals that usually cause heartburn. It is commonly used to treat and prevent nausea and vomiting, to help with emptying of the stomach in people with delayed stomach emptying, and to help with gastroesophageal reflux disease.
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