Mesalamine: Package Insert and Label Information (Page 3 of 3)
16 HOW SUPPLIED/STORAGE AND HANDLING
Mesalamine extended-release capsules are available as light blue opaque hard gelatin capsules containing 0.375 g mesalamine in a light blue opaque gelatin capsule with the letters “G” and “M” imprinted on either side of a black band and are available in bottles of 120 capsules (NDC 70748-214-16).
Storage:
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Instruct patients:
- Swallow the capsules whole. Do not cut, break, crush or chew the capsules.
- Avoid co-administration of mesalamine extended-release capsules with antacids.
- Drink an adequate amount of fluids.
- Mesalamine extended-release capsules can be taken without regard to meals [see Dosage and Administration (2)].
Inform patients that mesalamine extended-release capsules may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their healthcare provider [see Warnings and Precautions (5.1), Drug Interactions (7.2)].
Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions
Inform patients of the signs and symptoms of hypersensitivity reactions. Instruct patients to stop taking mesalamine extended-release capsules and report to their healthcare provider if they experience new or worsening symptoms of Acute Intolerance Syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity [see Warnings and Precautions (5.2, 5.3)].
Hepatic Failure
Inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their healthcare provider if they experience such signs or symptoms [see Warnings and Precautions (5.4)].
Severe Cutaneous Adverse Reactions
Inform patients of the signs and symptoms of severe cutaneous adverse reactions. Instruct patients to stop taking mesalamine extended-release capsules and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity [see Warnings and Precautions (5.5)].
Photosensitivity
Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors [see Warnings and Precautions (5.6)].
Nephrolithiasis
Instruct patients to drink an adequate amount of fluids during treatment in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine) [see Warnings and Precautions (5.7)].
Patients with Phenylketonuria
Inform patients with phenylketonuria (PKU) or their caregivers that each mesalamine extended-release capsule contains aspartame equivalent to 0.56 mg of phenylalanine, so that the recommended adult dosing provides an equivalent of 2.24 mg of phenylalanine per day [see Warnings and Precautions (5.8)].
Blood Disorders
Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. Advise patients to complete all blood tests ordered by their healthcare provider [see Drug Interactions (7.3), Use in Specific Populations (8.5)].
Lupin Pharmaceuticals Inc.,
Baltimore, Maryland 21202
United States
Patented. See https://patents.salix.com/ for US patent information.
© 2021 Bausch Health Companies Inc. or its affiliates
9736202
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Rx only
MESALAMINE EXTENDED-RELEASE CAPSULES
0.375 g
120 Capsules
Lupin Pharmaceuticals Inc.,
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| Labeler — Lupin Pharmaceuticals, Inc. (089153071) |
Revised: 03/2022 Lupin Pharmaceuticals, Inc.
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