Alvimopan capsules, 12 mg, are white to off-white, hard gelatin capsules printed with “2312 ” on body of the capsule. Alvimopan capsules are available as follows for hospital use only:
Carton containing 30 (6 x 5) unit-dose capsules NDC 0591-2312-15
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Recent Use of Opioids
Inform patients that they must disclose long-term or intermittent opioid pain therapy to their healthcare provider, including any use of opioids in the week prior to receiving alvimopan. Inform patients that recent use of opioids may make them more susceptible to adverse reactions to alvimopan, primarily those limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea).
Hospital Use Only
Inform patients that alvimopan capsules are available only through a program called the Alvimopan REMS Program under a REMS that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of alvimopan. Alvimopan capsules are for hospital use only for no more than 7 days after their bowel resection surgery.
Most Common Adverse Reaction
Inform patients that the most common adverse reaction with alvimopan in patients undergoing surgeries that include bowel resection is dyspepsia.
Brands listed are the trademarks of their respective owners.
Manufactured In India By:
Watson Pharma Private Ltd.
Verna, Salcette Goa 403 722 INDIA
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
Rev. A 1/2021
HOSPITAL USE ONLY
30 (6 x 5) unit-dose capsules
| ALVIMOPAN |
|Labeler — Actavis Pharma, Inc. (119723554)|
Revised: 01/2021 Actavis Pharma, Inc.
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