Diclofenac Sodium and Misoprostol

DICLOFENAC SODIUM AND MISOPROSTOL- diclofenac sodium and misoprostol tablet, delayed release
BluePoint Laboratories

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

DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS CONTAIN DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION OF MISOPROSTOL TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY. DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS SHOULD NOT BE TAKEN BY PREGNANT WOMEN [see Contraindications (4) , Warnings and Precautions (5.10) , and Use in Specific Populations (8.1) ].

PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. Diclofenac sodium and misoprostol delayed-release tablets 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. In such patients, diclofenac sodium and misoprostol delayed-release tablets 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 diclofenac sodium and misoprostol delayed-release tablets only on the second or third day of the next normal menstrual period [see Use in Specific Populations (8.3) ].

Cardiovascular Thrombotic Events
● Nonsteroidal anti-inflammatory drugs (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 (5.1) ].
● Diclofenac sodium and misoprostol is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) , and Warnings and Precautions (5.1) ].

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 (5.2) ].

1 INDICATIONS AND USAGE

Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in 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 (5.2) ].

2 DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. 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 and misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of rheumatoid arthritis and osteoarthritis, the dosage is given below.

Diclofenac sodium and misoprostol delayed-release tablets are administered as diclofenac sodium and misoprostol delayed-release tablets (50 mg diclofenac sodium/0.2 mg misoprostol) or as diclofenac sodium and misoprostol delayed-release tablets (75 mg diclofenac sodium/0.2 mg misoprostol).

Note: See Special Dosing Considerations section below.

For osteoarthritis, the dosage for maximal GI mucosal protection is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg three times a day. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg two times a day or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg two times a day can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

OA

Diclofenac sodium

Misoprostol

regimen

(mg/day)

(mcg/day)

Diclofenac Sodium

three times a day

150

600

and Misoprostol

Delayed-Release

Tablets 50 mg/0.2 mg

two times a day

100

400

Diclofenac Sodium

two times a day

150

400

and Misoprostol

Delayed-Release

Tablets 75 mg/0.2 mg

For rheumatoid arthritis, the dosage is diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg three or four times a day. For patients who experience intolerance, diclofenac sodium and misoprostol delayed-release tablets 75 mg/0.2 mg two times a day or diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg two times a day can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium and misoprostol delayed-release tablets, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

RA

Diclofenac sodium

Misoprostol

regimen

(mg/day)

(mcg/day)

Diclofenac Sodium

four times a day

200

800

and Misoprostol

Delayed-Release

Tablets 50 mg/0.2 mg

three times a day

150

600

two times a day

100

400

Diclofenac Sodium

two times a day

150

400

and Misoprostol

Delayed-Release

Tablets 75 mg/0.2 mg

Special Dosing Considerations:

Diclofenac sodium and misoprostol delayed-release tablets contain misoprostol, which provides protection against gastric and duodenal ulcers [see Clinical Studies (14) ]. For gastric ulcer prevention, the 200 mcg four and three times a day regimens are therapeutically equivalent, but more protective than the two times a day regimen. For duodenal ulcer prevention, the four times a day regimen is more protective than the three or two times a day regimens. However, the four times a day regimen is less well tolerated than the three times a day regimen because of usually self-limited diarrhea related to the misoprostol dose [see Adverse Reactions (6.1) ] , and the two times a day regimen may be better tolerated than three times a day in some patients.

Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of diclofenac sodium and misoprostol delayed-release tablets. If clinically indicated, misoprostol co-therapy with diclofenac sodium and misoprostol delayed-release tablets, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

When concomitant use of CYP2C9 inhibitors is necessary, the total daily dose of diclofenac should not exceed the lowest recommended dose of diclofenac sodium and misoprostol delayed-release tablets 50 mg/0.2 mg two times a day.

For additional information, it may be helpful to refer to the package inserts for misoprostol and diclofenac.

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