CONTRAINDICATIONS AND WARNINGS
ARTHROTEC® CONTAINS 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 (see also
PRECAUTIONS). ARTHROTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN (see
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.
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see
- ARTHROTEC is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see
NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events (see
ARTHROTEC (diclofenac sodium/misoprostol) is a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E1 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:
C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt.
Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are:
C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate.
Inactive ingredients in ARTHROTEC include: colloidal silicon dioxide; crospovidone; hydrogenated castor oil; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone (polyvidone) K-30; sodium hydroxide; starch (corn); talc; triethyl citrate.
Carefully consider the potential benefits and risks of ARTHROTEC and other treatment options before deciding to use ARTHROTEC. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
ARTHROTEC is 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. See
WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding and Perforation
for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.
Published Studies Related to Arthrotec (Diclofenac / Misoprostol)
Comparison of antinociceptive efficacy and gastroprotection between celecoxib and diclofenac plus misoprostol in rats. 
The present study was designed to assess the antinociceptive efficacy and gastroprotective activity of the mixture of diclofenac and misoprostol and its comparison with celecoxib in rats. The effect of diclofenac/misoprostol and celecoxib was assessed in the 1% formalin test... Considering the cardiovascular effects of COX-2 selective inhibitors, the combination of diclofenac and misoprostol could represent a safer and effective alternative for patients with pain.
Risk of hospitalization with peptic ulcer disease or gastrointestinal hemorrhage associated with nabumetone, Arthrotec, diclofenac, and naproxen in a population based cohort study. [2005.11]
OBJECTIVE: To identify the unbiased differences in the risk of hospitalization with peptic ulcer disease (PUD) or gastrointestinal (GI) hemorrhage among populations using 4 nonsteroidal antiinflammatory drugs (NSAID): nabumetone, Arthrotec, diclofenac plus a cytoprotective agent dispensed separately (diclo+coRx), and naproxen... CONCLUSION: Participants taking nabumetone and Arthrotec had significantly lower risk of hospitalization for PUD than those taking the other study drugs. Arthrotec was superior to nabumetone in a head to head comparison and especially when compared with the diclo+coRx and naproxen groups. No short term differences were seen in the rates of admission for GI hemorrhage. It appears that inherent gastroprotective strategies with Arthrotec and to a lesser extent with nabumetone do translate into decreased serious GI side effects at the population level in the short term.
Clinical Trials Related to Arthrotec (Diclofenac / Misoprostol)
Study to Evaluate the Incidence of Gastric Ulcers With PN 400 (Esomeprazole/Naproxen) Versus Diclofenac/Misoprostol in Subjects Who Are at High Risk for Developing NSAID-Associated Ulcers [Terminated]
This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6
months duration is designed to assess the efficacy, tolerability and safety of PN 400 versus
diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric
ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per
At least 20% of the subjects enrolled will be age 65 years and older.
Reports of Suspected Arthrotec (Diclofenac / Misoprostol) Side Effects
Drug Ineffective (21),
Drug Hypersensitivity (14),
Abdominal Pain Upper (11),
Fall (9), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Arthrotec has an overall score of 7. The effectiveness score is 6 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Arthrotec review by 51 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || arthritis|
|Dosage & duration:|| || 200 mg taken twice daily for the period of several years|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || I had less pain and less stiffness. |
|Side effects:|| || After a while the drug was less effective and I needed to take more. I started with one a day and had to mocve to two and sometiimes three a day.|
|Comments:|| || I went to the dr with pain in joints that started after getting lyme disease. I have had stomach problems with naprosyn. So he prescribed arthrotec. |
Page last updated: 2008-08-11