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Aminosalicylic Acid
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  • AHFS Monographs

Aminosalicylic Acid

Class: Antituberculosis Agents
VA Class: AM500
CAS Number: 65-49-6
Brands: Paser

Medically reviewed by Drugs.com on Jan 24, 2022. Written by ASHP.

Introduction

Antituberculosis agent; structural analog of aminobenzoic acid.

Uses for Aminosalicylic Acid

Tuberculosis

Treatment of active (clinical) tuberculosis (TB) in conjunction with other antituberculosis agents. Designated an orphan drug by the US FDA for this use.

Second-line agent used in treatment of drug-resistant TB caused by Mycobacterium tuberculosis known or presumed to be susceptible to aminosalicylic acid.

For initial treatment of active TB caused by drug-susceptible M. tuberculosis, recommended multiple-drug regimens consist of an initial intensive phase (2 months) and a continuation phase (4 or 7 months). Although the usual duration of treatment for drug-susceptible pulmonary and extrapulmonary TB (except disseminated infections and TB meningitis) is 6–9 months, ATS, CDC, and IDSA state that completion of treatment is determined more accurately by the total number of doses and should not be based solely on the duration of therapy. A longer duration of treatment (e.g., 12–24 months) usually is necessary for infections caused by drug-resistant M. tuberculosis.

Patients with treatment failure or drug-resistant M. tuberculosis, including multidrug-resistant (MDR) TB (resistant to both isoniazid and rifampin) or extensively drug-resistant (XDR) TB (resistant to both isoniazid and rifampin and also resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial such as capreomycin, kanamycin, or amikacin), should be referred to or managed in consultation with experts in the treatment of TB as identified by local or state health departments or CDC.

Ulcerative Colitis and Crohn's Disease

Has been used in the treatment of mild to moderate ulcerative colitis in patients intolerant of sulfasalazine. Also has been used in the treatment of Crohn's disease. Designated an orphan drug by the US FDA for use in these conditions.

Usually, 5-aminosalicylic acid analogs (e.g., balsalazide, mesalamine, olsalazine) are used in the management of ulcerative colitis or Crohn's disease; aminosalicylic acid is a 4-aminosalicyclic acid analog.

Aminosalicylic Acid Dosage and Administration

Administration

Oral Administration

Administer orally. Has been administered IV, but a parenteral preparation is not commercially available in the US.

The delayed-release granules (Paser) have an acid-resistant coating designed to protect against degradation in the stomach so that the drug is released gradually and high peak concentrations are avoided.

To protect the acid-resistant coating, administer the granules in food or drink with a pH <5. The granules can be sprinkled on applesauce or yogurt. Alternatively, they can be suspended in a fruit drink (e.g., orange, apple, tomato, grapefruit, grape, or cranberry juices, “fruit punch”); the granules will sink in the juice and must be resuspended by swirling. The granul...