Arthrotec: Warnings

Diclofenac Sodium with Misoprostol  [Oral]

Arthrotec

Warning: Although the misoprostol component of this drug greatly reduces the risk of ulcers, the diclofenac component is nevertheless a NSAID, and there is a risk of gastrointestinal ulceration, bleeding, and perforation in patients treated chronically with NSAIDs, even in the absence of previous gastrointestinal tract symptoms. Because of the abortifacient properties of misoprostol, Arthrotec is contraindicated in pregnant women, and should never be given to a woman who is pregnant. Arthotec should also not be given to a woman of child-bearing age, unless the patient requires therapy with a NSAID, and the patient is at high risk of developing gastric or duodenal ulcers or complications of the ulcers associated with the use of an NSAID. In this case, the manufacturer of Arthrotec (Searle) has given guidelines for the prescription of Arthrotec: Use only if the patient: 1) Has had a negative pregnancy test within 2 weeks prior to initiating therapy. 2) Is capable of complying with contraceptive measures. 3) Has received both oral and written warnings of the risks involved with taking misoprostol, including the risk of possible contraception failure and the danger involved if Arthrotec is taken by mistake by other women of child-bearing potential. 4) Will begin Arthrotec only on the second or third day of the next normal menstrual period.

Precautions

• If you develop any visual disturbance during therapy, you should consult an ophthalmologist for ocular evaluation.
• Gastrointestinal (GI) ulcerations, bleeding, and perforation can occur at any time, with or without warning, in patients treated chronically with NSAIDs. If you feel any GI symptoms such as stomach pain, stop therapy and inform your physician immediately. However, you may develop a GI complication and have no symptoms. You are considered at high risk of having a serious adverse GI event if you are over 60 years of age or have a history of peptic ulcer disease, if you are using this drug in large doses or for longer than 3 months, if you are using 2 or more NSAIDs at the same time, or if you are also taking corticosteroids. Consult your physician.
• There exists the potential for increased bleeding time due to interference with clotting. Use caution if you have the tendency to bleed, or if you are taking medications that may prolong bleeding time.
• Mild to moderate renal impairment generally does not require dose adjustment. However, caution should be exercised because NSAIDs may further decrease renal function in some patients.
• NSAIDs may mask the symptoms of infection.

Infants and Children
This drug is not indicated for use in this age group.

Adults Over 60
Use with caution in this age group, as older patients are more likely to experience the drug's adverse reactions.

Drug Dependency
This drug is not expected to cause physical or psychological dependence.

Pregnancy Risk Category: X

Pregnancy Warnings
This drug causes fetal harm and is contraindicated in pregnant women. Do not use if you are pregnant or plan to become pregnant.

Nursing Mothers
Because of the risk of potential harm to the newborn, avoid using this drug while breastfeeding. If therapy is necessary, avoid breastfeeding while on this drug.

Prolonged Use
Prolonged use can cause gastrointestinal ulceration, bleeding, and perforation, as well as eye damage, weight gain, sore throat, fever, and reduced hearing. Consult your physician about regular examinations to check the eyes, liver function, and complete blood counts.

Discontinuing Therapy
No problems are expected.

Operating a Vehicle or Heavy Machinery
This drug may produce side effects that impair your mental alertness, such as drowsiness or vertigo. Avoid such activities if you feel these symptoms. Avoid consuming alcohol or other CNS depressants while taking this drug. They may intensify these side effects.

Sun Exposure
In rare cases, this drug may cause a photosensitivity reaction upon overexposure to the sun. If a rash or a bad case of sunburn occurs, call your physician.