Drug Catalog - Product Detail
BALSALAZIDE DISODIUM CP 750MG 280
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0750-02 | OCEANSIDE PHARMACEUTICALS | 280 | 750MG | CAPSULE |
PACKAGE FILES
Generic Name
BALSALAZIDE DISODIUM
Substance Name
BALSALAZIDE DISODIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA020610
Description
11 DESCRIPTION Each Balsalazide Disodium capsule contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug. Each capsule of Balsalazide Disodium (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2-carboxethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is: Molecular Weight: 437.32 Molecular Formula: C 17 H 13 N 3 O 6 Na 2 ●2H 2 O Balsalazide disodium is a stable, odorless orange to yellow microcrystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents. Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg. colazal-1
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Balsalazide Disodium Capsules are available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black. NDC 68682-750-02 Bottles of 280 capsules. 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].
Indications & Usage
1 INDICATIONS AND USAGE Balsalazide Disodium Capsule is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and effectiveness of Balsalazide Disodium Capsules beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established. • Balsalazide Disodium capsule is a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. ( 1 ) • Safety and effectiveness of Balsalazide Disodium capsule beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Adult dose is three 750 mg Balsalazide Disodium capsules 3 times a day (6.75 g/day) with or without food for 8 weeks. Some adult patients required treatment for up to 12 weeks. ( 2.1 ) • Pediatric dose is EITHER: ( 2.2 , 8.4 ) • Three 750 mg Balsalazide Disodium capsules 3 times a day (6.75 g/day) with or without food for 8 weeks. OR: 3. One 750 mg Balsalazide Disodium capsule 3 times a day (2.25 g/day) with or without food for up to 8 weeks. 4. Capsules may be swallowed whole or may be opened and sprinkled on applesauce, then chewed or swallowed immediately. ( 2.3 , 12.3 ) 2.1 Adult Dose For treatment of active ulcerative colitis in adult patients, the usual dose is three 750 mg Balsalazide Disodium capsules to be taken 3 times a day (6.75 g per day) for up to 8 weeks. Some patients in the adult clinical trials required treatment for up to 12 weeks. 2.2 Pediatric Dose For treatment of active ulcerative colitis in pediatric patients, aged 5 to 17 years, the usual dose is EITHER : • three 750 mg Balsalazide Disodium capsules 3 times a day (6.75 g per day) for up to 8 weeks; OR : • one 750 mg Balsalazide Disodium capsule 3 times a day (2.25 g per day) for up to 8 weeks. Use of Balsalazide Disodium capsules in the pediatric population for more than 8 weeks has not been evaluated in clinical trials. [See Clinical Studies (14) ] 2.3 Administration Alternatives Balsalazide Disodium capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on applesauce. The entire drug/applesauce mixture should be swallowed immediately; the contents may be chewed, if necessary, since contents of Balsalazide Disodium capsules are NOT coated beads/granules. Patients should be instructed not to store any drug/applesauce mixture for future use. If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient. Teeth and/or tongue staining may occur in some patients who use Balsalazide Disodium capsules in sprinkle form with food.