Balsalazide Disodium

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Overview

What is Balsalazide Disodium?

Each Balsalazide Disodium Capsule USP 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 (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2-carboxyethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is:

Molecular Weight: 437.31

Molecular Formula: CHNONa•2HO

Balsalazide disodium is a stable, odorless yellow to orange crystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents.

The inactive ingredients in Balsalazide Disodium Capsules USP are colloidal silicon dioxide and magnesium stearate. Additionally, the capsule shell contains FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, and titanium dioxide. The black monogramming ink contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze. The sodium content of each capsule is approximately 79 mg.

What does Balsalazide Disodium look like?

What are the available doses of Balsalazide Disodium?

Capsules: 750 mg ()

What should I talk to my health care provider before I take Balsalazide Disodium?

Renal Impairment: Use balsalazide with caution in patients with a history of renal disease. ()

Pediatric: Pediatric use information is protected by marketing exclusivity. ()

How should I use Balsalazide Disodium?

Balsalazide is indicated for the treatment of mildly to moderately active ulcerative colitis in adults. Safety and effectiveness of balsalazide beyond 12 weeks in adults has not been established.

For treatment of active ulcerative colitis in adult patients, the usual dose is three 750 mg balsalazide 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.

What interacts with Balsalazide Disodium?

Sorry No Records found

What are the warnings of Balsalazide Disodium?

Sorry No Records found

What are the precautions of Balsalazide Disodium?

Sorry No Records found

What are the side effects of Balsalazide Disodium?

Sorry No records found

What should I look out for while using Balsalazide Disodium?

Patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction.

What might happen if I take too much Balsalazide Disodium?

No case of overdose has occurred with balsalazide. A 3-year-old boy is reported to have ingested 2 g of another mesalamine product. He was treated with ipecac and activated charcoal with no adverse reactions.

If an overdose occurs with balsalazide, treatment should be supportive, with particular attention to correction of electrolyte abnormalities.

How should I store and handle Balsalazide Disodium?

Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [].Balsalazide Disodium Capsules USPThe 750 mg capsule is supplied as a light orange opaque capsule with “54 795” printed in black ink on cap and body, containing a yellow-orange powder.NDC 60429-952-28: Bottle of 280 CapsulesStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Balsalazide Disodium Capsules USPThe 750 mg capsule is supplied as a light orange opaque capsule with “54 795” printed in black ink on cap and body, containing a yellow-orange powder.NDC 60429-952-28: Bottle of 280 CapsulesStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Balsalazide Disodium Capsules USPThe 750 mg capsule is supplied as a light orange opaque capsule with “54 795” printed in black ink on cap and body, containing a yellow-orange powder.NDC 60429-952-28: Bottle of 280 CapsulesStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Balsalazide Disodium Capsules USPThe 750 mg capsule is supplied as a light orange opaque capsule with “54 795” printed in black ink on cap and body, containing a yellow-orange powder.NDC 60429-952-28: Bottle of 280 CapsulesStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Balsalazide Disodium Capsules USPThe 750 mg capsule is supplied as a light orange opaque capsule with “54 795” printed in black ink on cap and body, containing a yellow-orange powder.NDC 60429-952-28: Bottle of 280 CapsulesStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Balsalazide disodium is delivered intact to the colon where it is cleaved by bacterial azoreduction to release equimolar quantities of mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-ß-alanine carrier moiety. The carrier moiety released when balsalazide disodium is cleaved is only minimally absorbed and is largely inert.

The mechanism of action of 5-ASA is unknown, but appears to be local to the colonic mucosa rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.

Non-Clinical Toxicology

Patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction.

Drug Interactions

Studies to evaluate possible interactions between naltrexone hydrochloride and drugs other than opiates have not been performed. Consequently, caution is advised if the concomitant administration of naltrexone hydrochloride and other drugs is required.

The safety and efficacy of concomitant use of naltrexone hydrochloride and disulfiram is unknown, and the concomitant use of two potentially hepatotoxic medications is not ordinarily recommended unless the probable benefits outweigh the known risks.

Lethargy and somnolence have been reported following doses of naltrexone hydrochloride and thioridazine.

Patients taking naltrexone hydrochloride may not benefit from opioid containing medicines, such as cough and cold preparations, antidiarrheal preparations, and opioid analgesics. In an emergency situation when opioid analgesia must be administered to a patient receiving naltrexone hydrochloride, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged (see )

In the adult clinical trials, 3 out of 259 patients reported exacerbation of the symptoms of ulcerative colitis.

Observe patients closely for worsening of these symptoms while on treatment.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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