June 27, 2016
Recommended Topic Related To:

Asacol HD

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Asacol HD




Overdosage
Contraindications

OVERDOSE

There is no specific antidote for mesalamine overdose and treatment for suspected acute severe toxicity with Asacol HD should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fluid electrolyte imbalance, and maintenance of adequate renal function. Asacol HD is a pH dependent delayed-release product and this factor should be considered when treating a suspected overdose.

Single oral doses of 5000 mg/kg mesalamine suspension in mice (approximately 4.2 times the recommended human dose of Asacol HD based on body surface area), 4595 mg/kg in rats (approximately 7.8 times the recommended human dose of Asacol HD based on body surface area) and 3000 mg/kg in cynomolgus monkeys (approximately 10 times the recommended human dose of Asacol HD based on body surface area) were lethal.

CONTRAINDICATIONS

Asacol HD is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Asacol HD [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and DESCRIPTION].

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/25/2016

Overdosage
Contraindications

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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