国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)
Teva Pharmaceuticals USA, Inc.
METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE 5 mg
ORAL
PRESCRIPTION DRUG
Metoclopramide tablets are indicated for the: - Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. - Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use : 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) ]. Metoclopramide is contraindicated: - In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions ( 5.1, 5.2) ]. - When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation). - In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma cr
Each white, round, unscored, debossed “TV” on one side and “2204” on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 5 mg 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 metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 100 (NDC 0093-2203-01), 500 (NDC 0093-2203-05), and 1,000 (NDC 0093-2203-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Dispense in a tight, light-resistant container. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
Teva Pharmaceuticals USA, Inc. ---------- MEDICATION GUIDE Dispense with Medication Guide available at: www.tevausa.com/medguides Metoclopramide (met'' oh kloe' pra mide) Tablets Read this Medication Guide before you start taking metoclopramide tablets and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide injection, metoclopramide orally disintegrating tablets, or 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 metoclopramide tablets? 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 metoclopramide tablets. There is no treatment for tardive dyskinesia, but symptoms may decrease or go away over time after you stop taking metoclopramide tablets. Your chances for getting tardive dyskinesia increase: • the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You should not take metoclopramide 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 healthcare provider to know if you will get tardive dyskinesia if you take metoclopramide tablets. Call your healthcare provider right away if you get movements you cannot stop or control, such as: • lip smacking, chewing, or puckering up your mouth • frowning or scowling • sticking out your tongue • blinking and moving your eyes • shaking of your arms and legs See the section “What are the possible side effects of metoclopramide tablets?” for more information about side effects. What ar 阅读完整的文件
METOCLOPRAMIDE- METOCLOPRAMIDE TABLET TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METOCLOPRAMIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOCLOPRAMIDE TABLETS. METOCLOPRAMIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1979 WARNING: TARDIVE DYSKINESIA _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ METOCLOPRAMIDE CAN CAUSE TARDIVE DYSKINESIA (TD), A SERIOUS MOVEMENT DISORDER THAT IS OFTEN IRREVERSIBLE. THERE IS NO KNOWN TREATMENT FOR TD. THE RISK OF DEVELOPING TD INCREASES WITH DURATION OF TREATMENT AND TOTAL CUMULATIVE DOSAGE (5.1) DISCONTINUE METOCLOPRAMIDE IN PATIENTS WHO DEVELOP SIGNS OR SYMPTOMS OF TD (5.1) AVOID TREATMENT WITH METOCLOPRAMIDE FOR LONGER THAN 12 WEEKS BECAUSE OF THE RISK OF DEVELOPING TD WITH LONGER-TERM USE (5.1, 2.1, 2.2, 2.3) INDICATIONS AND USAGE Metoclopramide tablets are indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. (1) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. (1) Limitations of Use: 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) DOSAGE AND ADMINISTRATION Gastroesophageal Reflux (2.2) Administer metoclopramide continuously or intermittently: Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks. Intermittent: Single doses up to 20 mg prior to provoking situation. Acute and Recurrent Diabetic Gastroparesis (2.3) Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks Dosage Adjustment in Specific Populations (2.2, 2.3) For gastroesophageal reflux and acute and recurrent diabetic gastroparesis, see Full Prescribing Informa 阅读完整的文件