Diclofenac Sodium And Misoprostol

• •
  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

  Pregnancy. Use of misoprostol, a component of diclofenac sodium/misoprostol, during pregnancy can result in maternal and fetal harm, including uterine rupture, abortion, premature birth, or birth defects

  [see Warnings and Precautions (5.1)and Use in Specific Populations (8.1)]

  ]

  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)]

  .

• •
  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

  Pregnancy. Use of misoprostol, a component of diclofenac sodium/misoprostol, during pregnancy can result in maternal and fetal harm, including uterine rupture, abortion, premature birth, or birth defects

  [see Warnings and Precautions (5.1)and Use in Specific Populations (8.1)]

  and Warnings and Precautions (5.2)]

  .

• •
  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)]

  .

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

• •Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• •Osteoarthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three times daily. A dosage of diclofenac higher than 150 mg/day is not recommended.
• •Rheumatoid Arthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three or four times daily A dosage of diclofenac higher than 200 mg/day is not recommended.
• •For dosage modifications due to intolerance, see the full Prescribing Information.

Delayed-release tablets:

• •
  50 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off‑white tablets imprinted with a “50” in the middle on one side and “G” and “0028” on the other.
• •75 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off‑white tablets imprinted with a “75” in the middle on one side and “G” and “0029” on the other.

• •
  Reversible Infertility
  : Consider withdrawal in women who have difficulties conceiving.
• •
  Geriatric Patients
  : Avoid use in patients with cardiovascular and/or renal risk factors.
• •
  Renal Impairment
  : Avoid use in patients with advanced renal disease.