See Supplemental Patient Information
- Misoprostol component of this drug is associated with abortion, premature birth, or birth defects when administered to pregnant women. Uterine rupture has occurred when misoprostol was administered in pregnant women to induce labor or abortion beyond the eighth week of pregnancy. Avoid use of this combination drug diclofenac/misoprostol in pregnant women [US Black Box Warning]
- Avoid using this combination drug in women of childbearing potential unless the patient requires NSAID and are at higher risk for developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID [US Black Box Warning]
- This combination drug is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [US Black Box Warning]
- Increased risk of serious and fatal cardiovascular thrombotic events, myocardial infarction, and stroke is associated with NSAIDs. Risk increases with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease are at higher risk [US Black Box Warning]
- Therapy is associated with onset of new hypertension or worsening of preexisting hypertension. Patients having thiazides or loop diuretics may exhibit impaired response to these therapies. Closely monitor blood pressure (BP) during the initiation of therapy and throughout the course of therapy
- Serious and fatal gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine have occurred. These events have occurred at any time during use and without warning symptoms [US Black Box Warning]. Concurrent use of oral corticosteroids or anticoagulants, longer duration of therapy, smoking, use of alcohol, older age, and poor general health status increases the risk of GI bleeding
- Administer lowest effective dose for the shortest duration possible to minimize the potential risk for an adverse CV and GI event in patients treated with an NSAID. Remain alert and also advise patients to maintain alertness for the development of CV events and GI ulcerations, bleeding even in the absence of previous CV and GI symptoms. Inform patients about the signs and/or symptoms of serious CV events and also about the measures required on occurrence of such events. Initiate additional evaluation and treatment on suspection of serious GI event. Discontinue therapy until a serious GI adverse event is ruled out. Consider alternate therapies that do not involve NSAIDs for high risk patients
- Prolong therapy of NSAID component is associated with renal papillary necrosis and other renal injury. Renal toxicity has occurred in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, with precipitation of overt renal decompensation may occur in such patients. Patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors, and the geriatrics are at highest risk. Discontinuation of therapy leads to recovery to the pretreatment state
- Therapy is not recommended in patients with advanced renal disease. On initiation of therapy closely monitor patient’s renal function
- Diclofenac component if this drug is associated with SGPT >3x the ULN. Elevations of one or more liver tests have occurred during therapy. Osteoarthritis patients are more susceptible to elevations in transaminases. Diclofenac component is also associated with drug-induced hepatotoxicity at any time during treatment. Even fatalities or liver transplantation have occurred. Severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure are reported on postmarketing surveillance
- Periodically monitor transaminases in patients receiving prolong therapy. Immediately discontinue therapy on persistent or worsening of abnormal liver tests, development of clinical signs and/or symptoms consistent with liver disease, or development of systemic manifestations
- Inform patients about the warning signs and symptoms of hepatotoxicity and also about essential appropriate measures on appearance of these signs and symptoms
- Anaphylactic reactions have occurred in patients. Avoid use in patients with the aspirin triad. Asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs are more susceptible. Provide emergency help when necessary
- Fatal serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN) have occurred. Inform patients about the signs and symptoms of serious skin manifestations and about discontinuing therapy on appearance of skin rash or any other sign of hypersensitivity
- Avoid use in late pregnancy as it may cause premature closure of the ductus arteriosus
- Avoid using as a substitute for corticosteroids or to treat corticosteroid insufficiency. The pharmacological activity of this combination drug in reducing fever and inflammation diminishes the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions
- Anemia has occurred in patients. Monitor hemoglobin or hematocrits in patients on prolong therapy if they exhibit any signs or symptoms of anemia. Alterations in platelet function have occurred. Carefully monitor patients with coagulation disorders or patients receiving anticoagulants
- Diclofenac component is associated with aseptic meningitis with fever and coma. Patients with systemic lupus and related connective tissue diseases are more susceptible. On occurrence of signs or symptoms of meningitis consider discontinuation of therapy
- Avoid use in patients with hepatic porphyria
Cautions: Use cautiously in:
- Renal impairment
- Hepatic impairment
- Hypertension
- Cardiovascular disease
- Risk of cardiac disease
- CHF
- Heart failure
- Fluid retention
- History of ulcer disease or GI bleeding
- Dehydration
- Inflammatory bowel disease
- Prolonged use
- Asthma
- Porphyria
- Use of corticosteroid
- Use of anticoagulant
- Coagulation disorder
- Concurrent diuretics
- Smokers
- Use of alcohol
- Concomitant use with potentially hepatotoxic drugs
- Debilitated patients
- Geriatrics
Supplemental Patient Information
- Inform patients about the abortifacient property and warn them to avoid giving the drug to others
- Advise patients to immediately inform their clinician if they become pregnant during therapy. Advise women of child bearing potential to use effective form of birth control measures while using this therapy
- Advise patients to immediately inform their clinician on appearance of hypersensitivity reactions
- Instruct them to strictly adhere to the directions given
Pregnancy Category:X
Breastfeeding: Diclofenac has a short half-life and little glucuronide metabolite formation. Most reviewers consider diclofenac to be acceptable during breastfeeding. Mispoprostol a prostaglandin E1 analogue appears normally in colostrum and milk. As low levels of misoprostol are excreted in breastmilk amounts ingested by the infant are small and are unexpected to cause any adverse effects in breastfed infants. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 February 2011). According to manufacturer's data diclofenac and misoprostol are excreted in human milk. Manufacturer recommends caution when this combination drug is administered to a nursing woman.
US Trade Name(s)
US Availability
diclofenac/misoprostol (generic)
Arthrotec (diclofenac/misoprostol)
Canadian Trade Name(s)
Canadian Availability
Arthrotec 50 (diclofenac/misoprostol)
Arthrotec 75 (diclofenac/misoprostol)
UK Trade Name(s)
UK Availability
Arthrotec 50 (diclofenac/misoprostol)
Arthrotec 75 (diclofenac/misoprostol)
Australian Trade Name(s)
Australian Availability
Arthrotec 50 (diclofenac/misoprostol)
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Arthrotec 75 75-200 MG-MCG TABS [Bottle] (PFIZER U.S.)
60 mg-mcg = $203.98
180 mg-mcg = $579.96 - Arthrotec 50 50-200 MG-MCG TABS [Bottle] (PFIZER U.S.)
60 mg-mcg = $199.98
180 mg-mcg = $579.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
