Buy Asacol Online

Asacol HD (mesalamine)

THERAPEUTIC CLASS

5-aminosalicylic acid derivative

DEA CLASS

RX

INDICATIONS

Treatment of moderately active ulcerative colitis (UC) in adults.

ADULT DOSAGE

Ulcerative Colitis

Moderately Active:
Two 800mg tabs tid for 6 weeks

ADMINISTRATION

Oral route

Swallow tab whole; do not cut, break, or chew
Take with or without food

HOW SUPPLIED

Tab, Delayed-Release: 800mg

WARNINGS/PRECAUTIONS

Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure reported; evaluate renal function prior to therapy and periodically thereafter. Has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of UC. Exacerbation of symptoms of colitis reported; symptoms usually abate when therapy is discontinued. Patients with sulfasalazine hypersensitivity may have similar reaction to therapy. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) reported; caution with conditions that predispose to the development of myocarditis or pericarditis. Hepatic failure reported in patients with preexisting liver disease; caution with liver disease. Organic or functional obstruction in the upper GI tract may cause prolonged gastric retention of the drug, which could delay the release of mesalamine in the colon. Caution in elderly.

ADVERSE REACTIONS

Headache.

DRUG INTERACTIONS

Known nephrotoxic agents, including NSAIDs, may increase the risk of renal reactions. Azathioprine or 6-mercaptopurine may increase the risk for blood disorders.

PREGNANCY AND LACTATION

Category C, caution in nursing.

MECHANISM OF ACTION

5-aminosalicylic acid derivative; has not been established. Suspected to diminish inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

PHARMACOKINETICS

Absorption: Tmax=10-16 hrs (median), Cmax=5mcg/mL (mesalamine), 4.6mcg/mL (N-acetyl-5-aminosalicylic acid); AUCtau=20mcg•hr/mL (mesalamine), 25mcg•hr/mL (N-acetyl-5-aminosalicylic acid). Distribution: Found in breast milk; crosses placenta. Metabolism: Gut mucosal wall and liver via rapid acetylation; N-acetyl-5-aminosalicylic acid (metabolite). Elimination: Urine (N-acetyl-5-aminosalicylic acid); T1/2=12.6 hrs (mesalamine), 23.6 hrs (N-acetyl-5-aminosalicylic acid).

ASSESSMENT

Assess for hypersensitivity to sulfasalazine, salicylates, or aminosalicylates; conditions that predispose to the development of myocarditis or pericarditis; organic or functional obstruction in the upper GI tract; hepatic impairment; pregnancy/nursing status; and possible drug interactions. Evaluate renal function prior to initiation of therapy.

MONITORING

Monitor for acute intolerance syndrome, exacerbation of symptoms of colitis, myocarditis, pericarditis, hepatic failure, hypersensitivity reactions, and other adverse reactions. Perform periodic monitoring of renal function. Monitor blood cell counts in elderly patients.

PATIENT COUNSELING

Instruct to swallow tabs whole and not to break, cut, or chew tabs. Advise to d/c previous oral mesalamine therapy and follow dosing instructions if switching therapy. Instruct to contact physician if intact, partially intact, and/or tab shells are seen in stool repeatedly. Advise pregnant and breastfeeding women, or women of childbearing potential that the medication contains dibutyl phthalate, which is excreted in breast milk and could possibly cause fetal malformations. Instruct to leave any desiccant pouches present in the bottle.

STORAGE

20-25°C (68-77°F); excursions permitted 15-30°C (59-86°F). Protect from moisture.

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