Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)
Novel Laboratories, Inc.
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 (1x10) NDC 40032-581-31 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 (1x10) NDC 40032-580-31 Tablets should be stored at controlled room temperature, between 20°C and 25°C (68°F and 77°F).
Abbreviated New Drug Application
Novel Laboratories, Inc. ---------- SPL MEDGUIDE Medication Guide Metoclopramide Hydrochloride Orally Disintegrating Tablets Phenylketonurics: Phenylalanine is a component of aspartame. Each 5 mg and 10 mg Metoclopramide Hydrochloride Orally Disintegrating Tablets contains 4.7 mg of phenylalanine. Read the Medication Guide that comes with Metoclopramide Hydrochloride Orally Disintegrating Tablets before you take it and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as REGLAN tablets, REGLAN ODT, REGLAN injection or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of the information may be different. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about Metoclopramide Hydrochloride Orally Disintegrating Tablets? Metoclopramide Hydrochloride Orally Disintegrating 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 Metoclopramide Hydrochloride Orally Disintegrating Tablets. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking Metoclopramide Hydrochloride Orally Disintegrating Tablets. Your chances for getting tardive dyskinesia go up: • the longer you take Metoclopramide Hydrochloride Orally Disintegrating Tablets and the more Metoclopramide Hydrochloride Orally Disintegrating Tablets you take. You should not take Metoclopramide Hydrochloride Orally Disintegrating 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 doctor to know if you will get tardive dyskinesia if you take Metoclopramide Hydrochloride Orally Disintegrating Tablets. Call your Prečítajte si celý dokument
METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING NOVEL LABORATORIES, INC. ---------- 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. 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. (5.1) 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 Prečítajte si celý dokument