Diclofenac Sodium and Misoprostol

DICLOFENAC SODIUM AND MISOPROSTOL- diclofenac sodium and misoprostol tablet, film coated
Greenstone LLC

WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS

Uterine Rupture, Abortion, Premature Birth, and Birth Defects

Administration of misoprostol, a component of diclofenac sodium/misoprostol, to pregnant women can cause uterine rupture, abortion, premature birth, or birth defects. Uterine rupture has occurred when misoprostol was administered in pregnant women to induce labor or an abortion [see Warnings and Precautions (5.1)and Use in Specific Populations (8.1)].
Diclofenac sodium/misoprostol is contraindicated in pregnancy [see Contraindications (4)] and not recommended in women of childbearing potential. Patients must be advised of the abortifacient property and warned not to give the drug to others [see Warnings and Precautions (5.1)].
If diclofenac sodium/misoprostol is prescribed, verify the pregnancy status of females of reproductive potential prior to initiation of treatment and advise them to use effective contraception during treatment [see Use in Specific Populations (8.3)].

Cardiovascular Thrombotic Events

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.2)].
Diclofenac sodium/misoprostol is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.2)].
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.3)].

1 INDICATIONS AND USAGE

Diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3)].

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage Information

Carefully consider the potential benefits and risks of diclofenac sodium/misoprostol and other treatment options before deciding to use diclofenac sodium/misoprostol. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
After observing the response to initial therapy with diclofenac sodium/misoprostol, the dose and frequency should be adjusted to suit an individual patient’s needs.
Diclofenac sodium/misoprostol is not recommended for patients who would not receive the appropriate dosage of both active ingredients.
Diclofenac sodium/misoprostol, a fixed combination product, is administered as diclofenac sodium/misoprostol 50 (50 mg diclofenac sodium and 200 mcg misoprostol) or as diclofenac sodium/misoprostol 75 (75 mg diclofenac sodium and 200 mcg misoprostol).

2.2 Recommended Dosage in Patients with Osteoarthritis

The recommended dosage for the treatment of osteoarthritis for maximal GI mucosal protection is diclofenac sodium/misoprostol 50 three times a day. For patients who experience intolerance, diclofenac sodium/misoprostol 75 two times a day or diclofenac sodium/misoprostol 50 two times a day can be used, but these dosages are less effective in preventing ulcers. A daily dosage of diclofenac sodium greater than 150 mg/day is not recommended. Daily doses of the components delivered with these regimens are as follows:

*
For patients who experience intolerance; these dosages are less effective in preventing ulcers

Osteoarthritis

Regimen

Diclofenac sodium (mg/day)

Misoprostol (mcg/day)

Diclofenac sodium/misoprostol 50

three times a day

two times a day *

150

100

600

400

Diclofenac sodium/misoprostol 75

two times a day *

150

400

2.3 Recommended Dosage in Patients with Rheumatoid Arthritis

The recommended dosage for the treatment of rheumatoid arthritis is diclofenac sodium/misoprostol 50 three or four times a day. For patients who experience intolerance, diclofenac sodium/misoprostol 75 two times a day or diclofenac sodium/misoprostol 50 two times a day can be used, but are less effective in preventing ulcers. A daily dosage of diclofenac sodium greater than 200 mg/day is not recommended. Daily doses of the components delivered with these regimens are as follows:

*
For patients who experience intolerance; these dosages are less effective in preventing ulcers

Rheumatoid Arthritis

Regimen

Diclofenac sodium (mg/day)

Misoprostol (mcg/day)

Diclofenac sodium/misoprostol 50

four times a day

three times a day

two times a day *

200

150

100

800

600

400

Diclofenac sodium/misoprostol 75

two times a day *

150

400

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