CAMBIA 50 MG — DIN 02381680

What is CAMBIA?

CAMBIA 50 MG contains DICLOFENAC POTASSIUM : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02381680, held by ARALEZ PHARMACEUTICALS CANADA INC, supplied as POWDER FOR SOLUTION for ORAL administration. Health Canada currently lists it as marketed, status dated 08-Aug-2019. 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 CAMBIA used for?

CAMBIA (diclofenac potassium powder for oral solution) is indicated for acute treatment of migraine attacks with or without aura in adults 18 years and older. Efficacy and safety of CAMBIA beyond a single dose have not been studied. CAMBIA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic, basilar, or ophthalmoplegic migraine. Safety and efficacy have not been established for cluster headache which is present in an older, predominantly male population.

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

How is it administered?

Only one single dose sachet of CAMBIA is to be taken for the acute treatment of a migraine attack. The safety and efficacy of a second dose have not been studied. Empty the contents of one individual dose sachet into a cup containing 30 to 60 mL (1 to 2 ounce) of water; mix well. Ensure that the powder is completely dissolved before drinking. Drink the water-powder mixture immediately after re-constitution. Do NOT use liquids other than water. Taking CAMBIA with a meal may cause a delay in efficacy.

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

Contraindications

CAMBIA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. It is contraindicated in the perioperative pain setting of Coronary Artery Bypass Graft (CABG) surgery. It is contraindicated during the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition. It is contraindicated in women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants. It is contraindicated in patients with severe uncontrolled heart failure. It is contraindicated in patients with a history of asthma, urticaria, or allergic-type reactions after taking ASA or other NSAIDs (i.e. complete or partial syndrome of ASA-intolerance - rhinosinusitis, urticaria/angioedema, nasal polyps, asthma). It is contraindicated in patients with active gastric / duodenal / peptic ulcer, active GI bleeding. It is contraindicated in patients with cerebrovascular bleeding or other bleeding disorders. It is contraindicated in patients with inflammatory bowel disease. It is contraindicated in patients with severe liver impairment or active liver disease. It is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min or 0.5 mL/sec) or deteriorating renal disease. It is contraindicated in patients with known hyperkalemia. It is contraindicated in children and adolescents less than 18 years of age.

Warnings and precautions

Risk of Cardiovascular Adverse Events: Diclofenac is associated with an increased risk of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) that is comparable to COX-2 inhibitors and which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. To minimize the potential risk for an adverse CV event, CAMBIA should be used for the fewest number of days per month as needed, based on individual treatment goals. Treatment with CAMBIA 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, and caution should be exercised in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking). Risk of Gastrointestinal (GI) Adverse Events: Use of NSAIDs, such as CAMBIA is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding) which can be fatal. Elderly patients are at a greater risk. Risk in Pregnancy: CAMBIA is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition). Serious skin reactions: Use of some NSAIDs, such as CAMBIA, have been associated with rare post-market cases of serious, fatal or otherwise life-threatening skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and generalized bullous fixed drug eruption (GBFDE). 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.