metoclopramide hydrochloride
Drug Details
- Generic Name
- metoclopramide hydrochloride
- Brand Names
- Metoclopramide, metoclopramide hydrochloride
- Application Number
- ANDA072744
- Sponsor
- ATLANTIC BIOLOGICALS CORP.
- NDC Codes
- 6
- Dosage Forms
- SOLUTION, INJECTION, SOLUTION
- Routes
- ORAL, INTRAMUSCULAR, INTRAVENOUS
- Active Ingredients
- METOCLOPRAMIDE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Metoclopramide Orally Disintegrating Tablets is indicated in adults for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. Relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis). Limitations of Use : Metoclopramide Orally Disintegrating Tablets is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms and the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 )] Metoclopramide Orally Disintegrating Tablets is a dopamine-2 (D2) antagonist indicated in adults for: Treatment of symptomatic, documented gastroesophageal reflux disease (GERD) in adults with who fail to respond to conventional therapy. Relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis). Limitations of Use: Metoclopramide Orally Disintegrating Tablets is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms and the risk of methemoglobinemia in neonates. (1, 8.4 )