Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)
GAVIS Pharmaceuticals, LLC
METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE 10 mg
ORAL
PRESCRIPTION DRUG
Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults. Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for adults only. Therapy should not exceed 12 weeks in duration. The safety and effectiveness in pediatric patients have not been established. Do not use metoclopramide whenever stimulation of gastrointestinal motility may be dangerous such as in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may precipitate a hypertensive crisis, most likely due to release of catecholamines from the tumor. Such hyperte
Metoclopramide Hydrochloride Orally Disintegrating Tablets 5 mg strength are round, white to off-white, flat faced beveled edge tablet debossed with ‘N’ on one side and “581” on the other side; it is comprised of 5 mg metoclopramide (as 5.91 mg of metoclopramide hydrochloride). These are packaged in blister cards as follows: Box of 10 (10x10s) NDC 43386-581-30 Metoclopramide Hydrochloride Orally Disintegrating Tablets 10 mg are round, white to off-white, flat faced beveled edge tablet debossed with ‘N’ on one side and “580” on the other side; it is comprised of 10 mg metoclopramide (as 11.82 mg of metoclopramide hydrochloride). These are packaged in blister cards as follows: Box of 10 (10x10s) NDC 43386-580-30 Tablets should be stored at controlled room temperature, between 20°C and 25°C (68°F and 77°F).
Abbreviated New Drug Application
METOCLOPRAMIDE HYDROCHLORIDE - METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING GAVIS PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METOCLOPRAMIDE HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOCLOPRAMIDE HYDROCHLORIDE. METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING FOR ORAL USE. INITIAL U.S. APPROVAL: 1976 WARNING: TARDIVE DYSKINESIA _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ TREATMENT WITH METOCLOPRAMIDE CAN CAUSE TARDIVE DYSKINESIA, A SERIOUS MOVEMENT DISORDER THAT IS OFTEN IRREVERSIBLE. THE RISK OF DEVELOPING TARDIVE DYSKINESIA INCREASES WITH THE DURATION OF TREATMENT AND THE 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. INDICATIONS AND USAGE Metoclopramide Orally Disintegrating Tablets are a dopamine receptor antagonist indicated for: RELIEF OF SYMPTOMATIC GASTROESOPHAGEAL REFLUX: short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy (1.1) DIABETIC GASTROPARESIS (DIABETIC GASTRIC STASIS): the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis (gastric stasis) (1.2) Important Limitations: Therapy should not exceed 12 weeks in duration (1.3) Metoclopramide Hydrochloride Orally Disintegrating Tablets are recommended only for adults. The safety and effectiveness in pediatric patients have not been established (1.3) DOSAGE AND ADMINISTRATION GASTROESOPHAGEAL REFULX DISEASE: 10 mg to 15 mg dose up to four times daily at least 30 minutes before eating and at bedtime (2.2) DIABETIC GASTROPARESIS (DIABETIC GASTRIC STASIS): 10 mg dose four times daily at least 30 minutes befo Soma hati kamili