Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)
Preferred Pharmaceuticals, Inc.
METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE 10 mg
ORAL
PRESCRIPTION DRUG
Metoclopramide tablets, USP are indicated for the: Limitations of Use: Metoclopramide tablets, USP 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 tablets are contraindicated: Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery [see Clinical Considerations]. In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) [see Data] . The estimated background risk of major b
Metoclopramide Tablets, USP: 10 mg - White, round, scored tablets in bottles of 30 NDC 68788-6791-3 Debossed: WPI on one side and 2229 on the other side. Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
METOCLOPRAMIDE HYDROCHLORIDE- metoclopramide hydrochloride tablet Preferred Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Metoclopramide (MET oh KLOE pra mide) Tablets, USP, Oral Use 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 are metoclopramide tablets? Me Belgenin tamamını okuyun
METOCLOPRAMIDE HYDROCHLORIDE- METOCLOPRAMIDE HYDROCHLORIDE TABLET PREFERRED PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METOCLOPRAMIDE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE TABLETS, USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1979 WARNING: TARDIVE DYSKINESIA _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • RECENT MAJOR CHANGES Boxed Warning 8/2017 Indications and Usage (1) 8/2017 Dosage and Administration, Dosage for Gastroesophageal Reflux (2.2) 8/2017 Dosage and Administration, Dosage for Acute and Recurrent Diabetic Gastroparesis (2.3) 8/2017 Contraindications (4) 8/2017 Warnings and Precautions, Tardive Dyskinesia (5.1) 8/2017 Warnings and Precautions, Other Extrapyramidal Symptoms (5.2) 8/2017 Warnings and Precautions, Neuroleptic Malignant Syndrome (5.3) 8/2017 Warnings and Precautions, Hyperprolactinemia (5.7) 8/2017 INDICATIONS AND USAGE Metoclopramide tablets, USP are indicated for the: Limitations of Use: Metoclopramide tablets, USP 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) • METOCLOPRAMIDE TABLETS 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 TABLETS IN PATIENTS WHO DEVELOP SIGNS OR SYMPTOMS OF TD (5.1) AVOID TREATMENT WITH METOCLOPRAMIDE TABLETS FOR LONGER THAN 12 WEEKS BECAUSE OF THE RISK OF DEVELOPING TD WITH LONGER-TERM USE (5.1, 2.1, 2.2, 2.3) 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 Belgenin tamamını okuyun