MESALAMINE (Page 4 of 4)

14 CLINICAL STUDIES

Two similar, randomized, double-blind, placebo-controlled, multi-center studies were conducted in a total of 562 adult patients in remission from ulcerative colitis. The study populations had a mean age of 46 years (11% age 65 years or older), were 53% female, and were primarily white (92%).

Ulcerative colitis disease activity was assessed using a modified Sutherland Disease Activity Index (DAI), which is a sum of four subscores based on stool frequency, rectal bleeding, mucosal appearance on endoscopy, and physician’s rating of disease activity. Each subscore can range from 0 to 3, for a total possible DAI score of 12.

At baseline, approximately 80% of patients had a total DAI score of 0 or 1. Patients were randomized 2:1 to receive either mesalamine 1.5 g or placebo once daily in the morning for six months. Patients were assessed at baseline, 1 month, 3 months, and 6 months in the clinic, with endoscopy performed at baseline, at end of study, or if clinical symptoms developed. Relapse was defined as a rectal bleeding subscale score of 1 or more and a mucosal appearance subscale score of 2 or more using the DAI. The analysis of the intent-to-treat population was a comparison of the proportions of patients who remained relapse-free at the end of six months of treatment. For the table below (Table 3) all patients who prematurely withdrew from the study for any reason were counted as relapses.

In both studies, the proportion of patients who remained relapse-free at six months was greater for mesalamine than for placebo.

Table 3: Percentage of Ulcerative Colitis Patients Relapse-Free* Through 6 Months in Mesalamine Maintenance Studies

Mesalamine 1.5 g once daily % (# no relapse/N) Placebo % (# no relapse/N) Difference (95% C.I.) P-value
Study 1 68% (143/209) 51% (49/96) 17% (5.5, 29.2) <0.001
Study 2 71% (117/164) 59% (55/93) 12% (0, 24.5) 0.046

*Relapse counted as rectal bleeding score ≥1 and mucosal appearance score ≥2, or premature withdrawal from study.

Examination of gender subgroups did not identify difference in response to mesalamine among these subgroups. There were too few elderly and too few African-American patients to adequately assess difference in effects in those populations.

The use of mesalamine for treating ulcerative colitis beyond six months has not been evaluated in controlled clinical trials.

16 HOW SUPPLIED/STORAGE AND HANDLING

Mesalamine extended-release capsules, USP are available as opaque light blue cap / opaque light blue body, hard gelatin capsules size ‘00’ having imprinting “A” on cap in black ink and “255” on body in black ink on either side of a black band filled with light grey to grey color granules and are supplied as follows:

Bottle of 120 capsules with child resistant closure, NDC 46708-724-35

Bottle of 1000 capsules, NDC 46708-724-91

Storage:

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Administration


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)].

Renal Impairment
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)].

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)].

Manufactured by:
Alembic Pharmaceuticals Limited
(Formulation Division)
Village Panelav, P. O. Tajpura, Near Baska,
Taluka-Halol, Panchmahal 389350, Gujarat, India.

Revised: 07/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46708-724-35

Mesalamine

Extended-Release

Capsules, USP

0.375 g

Rx only

120 Capsules

Alembic

120 capsules
(click image for full-size original)
MESALAMINE mesalamine capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-724
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE (MESALAMINE) MESALAMINE 0.375 g
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
SILICON DIOXIDE
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
TALC
TRIETHYL CITRATE
TITANIUM DIOXIDE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
SHELLAC
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color BLUE (opaque light blue cap) , BLUE (opaque light blue body) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code A;255
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-724-35 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:46708-724-91 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216967 11/03/2022
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-724)

Revised: 11/2022 Alembic Pharmaceuticals Limited

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