ARTHROTEC 75 200 MCG

What is ARTHROTEC 75?

ARTHROTEC 75 200 MCG contains MISOPROSTOL : 200 MCG DICLOFENAC SODIUM : 75 MG. It is listed in the Health Canada Drug Product Database under DIN 02229837, held by PFIZER CANADA ULC, supplied as TABLET (DELAYED-RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 12-Jan-2006. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is ARTHROTEC 75 used for?

ARTHROTEC (diclofenac sodium and misoprostol) is indicated for: • Acute and chronic use in the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ARTHROTEC, as a NSAID, does NOT treat clinical disease or prevent its progression. ARTHROTEC, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Use of ARTHROTEC should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events. In elderly patients, the dosage should be reduced to the lowest dose that will provide control of symptoms, adjusted when necessary, and closely supervised. The recommended daily oral dose of ARTHROTEC (diclofenac sodium plus misoprostol) for treating the signs and symptoms of rheumatoid arthritis and osteoarthritis is 100 mg administered as two divided doses (50 mg twice per day). The recommended maximum daily dose is 100 mg. ARTHROTEC should be taken immediately after a meal or with food or milk and the tablets should be swallowed whole. If a dose of ARTHROTEC is missed, the next dose should be taken at the regular time. The dose should not be doubled.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at 15 to 25°C and protect from heat and humidity. Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist. Keep out of reach and sight of children.

How is it supplied?

ARTHROTEC 50 tablets (diclofenac sodium plus misoprostol) are white to off-white, round biconvex tablets, engraved "SEARLE" over "1411" on one side, 4 x "A" around the circumference of the reverse side with a "50" in the middle. Each tablet has an enteric-coated core containing 50 mg diclofenac sodium, surrounded by an outer mantle containing 200 mcg misoprostol. Bottles of 250. ARTHROTEC 75 tablets are white to off-white, round and biconvex, engraved "SEARLE" over "1421" on one side, 4 x "A" around the circumference of the reverse side with a "75" in the middle. Each tablet has an enteric-coated core containing 75 mg diclofenac sodium, surrounded by an outer mantle containing 200 mcg misoprostol. Bottles of 250.

Contraindications

ARTHROTEC (diclofenac sodium plus misoprostol) is contraindicated in: • The peri-operative setting of coronary artery bypass graft surgery (CABG). • Women who are pregnant, or in whom pregnancy has not been excluded. Women of childbearing potential should be fully counseled about misoprostol's abortifacient potential and the importance of effective contraception (oral contraceptive or intrauterine device) and prevention of pregnancy while undergoing treatment. • Prolonged parturition. • Women who are breastfeeding. • Severe uncontrolled heart failure. • Known or suspected hypersensitivity to diclofenac sodium, misoprostol, other NSAIDs, or to any ingredient in the formulation. • History of asthma, urticaria, or allergic-type reactions after taking ASA or other NSAIDs. • Patients with active gastric / duodenal / peptic ulcer, active gastrointestinal bleeding, a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system. • Cerebrovascular bleeding or other bleeding disorders. • Inflammatory bowel disease. • Significant hepatic impairment or active liver disease. • Severely impaired or deteriorating renal function (creatinine clearance <30 mL/min or 0.5 mL/sec). • Known hyperkalemia. • Children and adolescents less than (18) years of age. • Diclofenac is contraindicated for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive side effects.

Warnings and precautions

Serious Warnings and Precautions: Risk of Cardiovascular (CV) Adverse Events: Diclofenac is associated with an increased risk of serious cardiovascular (CV) thrombotic events (such as myocardial infarction and stroke), which can be fatal. The increased risk is comparable to COX-2 inhibitors and high-dose ibuprofen. The risk may increase with dose and duration of treatment. Patients with CV disease or CV risk factors may be at greater risk. For patients with a high risk of developing an adverse CV event, other management strategies that do NOT include NSAIDs, particularly COX-2 inhibitors, ibuprofen and diclofenac, should be considered first. Treatment with ARTHROTEC is not recommended in patients with pre-existing cardiovascular disease (congestive heart failure NYHA -II-IV, ischemic heart disease, peripheral arterial disease) cerebrovascular disease, uncontrolled hypertension or patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking). Use of NSAIDs, such as ARTHROTEC, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure. Risk of Gastrointestinal (GI) Adverse Events: Use of NSAIDS, such as ARTHROTEC, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding). Risk in Pregnancy: ARTHROTEC is CONTRAINDICATED for use in women who are pregnant (all trimesters), or in whom pregnancy has not been excluded and in prolonged parturition. Misoprostol administration to pregnant women induces uterine contractions and is associated with abortion, premature birth, birth defects and fetal death. Serious skin reactions: Use of some NSAIDs, such as ARTHROTEC, have been associated with post-market cases of serious, fatal or otherwise life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), Drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN), generalized bullous fixed drug eruption (GBFDE), exfoliative dermatitis, and erythema multiforme. Patients appear to be at higher risk for these events early in the course of therapy, with the onset of cases usually occurring within the first month of treatment. These reactions may be reversible if the causative agent is discontinued and appropriate treatment instituted. Patients should be advised that they should discontinue their NSAID at the first appearance of a skin rash, mucosal lesions or any other sign of hypersensitivity, and contact their physician immediately for assessment and advice, including which therapies to discontinue. ARTHROTEC may cause sensitivity to sunlight. If patients experience any of these symptoms, they should discontinue their NSAID and contact their physician for assessment and advice, including which additional therapies to discontinue.

What can be used instead?

Other Canadian products sharing ATC code M01AB55 DICLOFENAC, COMBINATIONS. 6 of 12 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.