DESCRIPTION

CONTRAINDICATIONS AND WARNINGS

ARTHROTEC, because of the abortifacient property of the misoprostol component, is contraindicated in women who are pregnant. (See PRECAUTIONS). Reports, primarily from Brazil, of congenital anomalies and reports of fetal death subsequent to misuse of misoprostol alone, as an abortifacient, have been received. Patients must be advised of the abortifacient property and warned not to give the drug to others. ARTHROTEC should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. (See WARNINGS ). In such patients,
ARTHROTEC may be prescribed if the patient:

has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
is capable of complying with effective contraceptive measures.
has received both oral and written warnings of the hazards of misoprostol, the risk of    possible contraception failure, and the danger to other women of childbearing potential    should the drug be taken by mistake.
will begin ARTHROTEC only on the second or third day of the next normal menstrual period.

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ARTHROTEC is a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E 1 analog. ARTHROTEC oral tablets are white to off-white, round, biconvex and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (ARTHROTEC 50) or 75 mg (ARTHROTEC 75) diclofenac sodium surrounded by an outer mantle containing 200 mcg misoprostol.

Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are:

Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are:

C ₂₂ H ₃₈ O ₅ [M.W. = 382.54] (±) methyl 11(alpha), 16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate.

Inactive ingredients in ARTHROTEC include: colloidal silicon dioxide; crospovidone; hydrogenated castor oil; hydroxypropyl methylcellulose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone (polyvidone) K-30; sodium hydroxide; starch (corn); talc; triethyl citrate.