Cambia (Diclofenac Potassium for Oral Solution) Drug Information: Overdosage and Contraindications

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May 25, 2012

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What is a migraine headache?

A migraine headache is a form of vascular headache. Migraine headache is caused by vasodilatation (enlargement of blood vessels) that causes the release of chemicals from nerve fibers that coil around the large arteries of the brain. Enlargement of these blood vessels stretches the nerves that coil around them and causes the nerves to release chemicals. The chemicals cause inflammation, pain, and further enlargement of the artery. The increasing enlargement of the arteries magnifies the pain.

Migraine attacks commonly activate the sympathetic nervous system in the body. The sympathetic nervous system is often thought of as the part of the nervous system that controls primitive responses to stress and pain, the so-called "fight or flight" response, and this activation causes many of the symptoms associated with migraine attacks; for example, the increased sympathetic nervous activity in the intestine causes nausea, vomiting,...

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OVERDOSE

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

CONTRAINDICATIONS

CAMBIA (diclofenac potassium for oral solution) is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to diclofenac [see WARNINGS AND PRECAUTIONS].
CAMBIA (diclofenac potassium for oral solution) is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see WARNINGS AND PRECAUTIONS].
CAMBIA (diclofenac potassium for oral solution) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS].