Generic Name and Formulations:
Diclofenac potassium 50mg; per packet; buffered pwd for oral soln; anise and mint flavor; contains phenylalanine 25mg/packet.
Indications for CAMBIA:
Acute treatment of migraine with or without aura.
Limitations Of use:
Not indicated for prophylactic therapy. Safety and efficacy not established for cluster headache.
Use lowest effective dose for the shortest duration. ≥18yrs: Take on an empty stomach; mix 1 packet (50mg) with 30–60mL of water only and drink immediately. Not interchangeable with other forms of diclofenac.
<18yrs: not recommended.
Aspirin allergy. Coronary artery bypass graft surgery.
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. Medication overuse headache; may need detoxification. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation; Cat.D: ≥30 weeks gestation; avoid). Nursing mothers: not recommended.
Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Caution with other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics). May be affected by CYP2C9 inhibitors.
NSAID (benzeneacetic acid deriv.).
Nausea, dizziness; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, anaphylactic reactions, serious skin reactions (eg, SJS, TEN), anemia.