gimoti
metoclopramide hydrochloride · by qol medcl
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~$1.37 /30
Overview
Metoclopramide Oral Solution USP is an orange-colored, vanilla-flavored, palatable, aromatic, sugar-free liquid for oral administration. Each 5 mL (teaspoonful) contains: Metoclopramide base (as the monohydrochloride monohydrate) 5 mg. Inactive ingredients: Citric Acid Anhydrous, FD&C Yellow No. 5 (tartrazine), FD&C Red No. 40, Glycerin, Methylparaben, Propylparaben, Purified Water, Sorbitol Solution 70%, Vanilla Flavor. Metoclopramide hydrochloride is a white, crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro- N -[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its molecular formula is C 14 H 22 ClN 3 O 2 •HCl•H 2 O, with a molecular weight of 354.3. Its structural formula is: Structural Formula
How to use
Therapy with metoclopramide oral solution should not exceed 12 weeks in duration. For the Relief of Symptomatic Gastroesophageal Reflux Administer from 10 mg to 15 mg metoclopramide orally up to 4 times daily 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE ). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose. Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using 4 times daily therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS ). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation. Therapy longer than 12 weeks has not been evaluated and cannot be recommended. For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis) Administer 10 mg of metoclopramide…
Side effects
In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency: CNS Effects Restlessness, drowsiness, fatigue, and lassitude occur in approximately 10% of patients receiving the most commonly prescribed dosage of 10 mg 4 times daily. (see PRECAUTIONS ). Insomnia, headache, confusion, dizziness or mental depression with suicidal ideation (see WARNINGS ) occur less frequently. The incidence of drowsiness is greater at higher doses. There are isolated reports of convulsive seizures without clearcut relationship to metoclopramide. Rarely, hallucinations have been reported. Extrapyramidal Reactions (EPS) Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and, rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine (see WARNINGS ). Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity,…
Warnings
Important safety information
WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia. See WARNINGS
Interactions
Drug Interactions The effects of metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers. The finding that metoclopramide releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors. Absorption of drugs from the stomach may be diminished (e.g. digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine). Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia. Because the action of metoclopramide will influence the delivery of food to the intestines and thus the rate of absorption, insulin dosage or timing of dosage may require adjustment.
Drug class
May treat
Dosage forms
SPRAY, METERED
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Frequently asked questions
- What is Gimoti?
- Metoclopramide Oral Solution USP is an orange-colored, vanilla-flavored, palatable, aromatic, sugar-free liquid for oral administration. Each 5 mL (teaspoonful) contains: Metoclopramide base (as the monohydrochloride monohydrate) 5 mg. Inactive ingredients: Citric Acid Anhydrous, FD&C Yellow No. 5 (tartrazine), FD&C Red No. 40, Glycerin, Methylparaben, Propylparaben, Purified Water, Sorbitol Solution 70%, Vanilla Flavor. Metoclopramide hydrochloride is a white, crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro- N -[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its molecular formula is C 14 H 22 ClN 3 O 2 •HCl•H 2 O, with a molecular weight of 354.3. Its structural formula is: Structural Formula
- What does Gimoti treat?
- Gimoti (Metoclopramide Hydrochloride) is indicated for gastroesophageal reflux, gastroparesis, postoperative nausea and vomiting, per its drug-label indications. This is general reference, not medical advice.
- How much does Gimoti cost?
- Gimoti has a typical acquisition cost of about $1.37 per unit, based on CMS NADAC data.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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