The toxic dose of ARTHROTEC has not been determined. However, signs of overdosage from the components of the product have been described.
Clinical signs that may suggest diclofenac sodium overdose include GI complaints, confusion, drowsiness, or general hypotonia. Reports of overdosage with diclofenac cover 66 cases. In approximately one-half of these reports of overdosage, concomitant medications were also taken. The highest dose of diclofenac was 5.0 g in a 17-year-old man who suffered loss of consciousness, increased intracranial pressure, and aspiration pneumonitis, and died 2 days after overdose. A 24year-old woman who took 4.0 g and the 28-and 42-year-old women, each of whom took 3.75 g, did not develop any clinically significant signs or symptoms. However, there was a report of a 17year-old woman who experienced vomiting and drowsiness after an overdose of 2.37 g of diclofenac.
Animal studies show a wide range of susceptibilities to acute overdosage, with primates being more resistant to acute toxicity than rodents (LD50 in mg/kg: rats, 55; dogs, 500; monkeys, 3200).
The toxic dose of misoprostol in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of GI discomfort being reported. In animals, the acute toxic effects are diarrhea, GI lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia.
Symptoms of overdosage with ARTHROTEC should be treated with supportive therapy. In case of acute overdosage, gastric lavage is recommended. Induced diuresis may be beneficial because diclofenac sodium and misoprostol metabolites are excreted in the urine. The effect of dialysis or hemoperfusion on the elimination of diclofenac sodium (99% protein bound) and misoprostol acid remains unproven. The use of oral activated charcoal may help to reduce the absorption of diclofenac sodium and misoprostol.
See BOXED CONTRAINDICATIONS AND WARNINGS related to misoprostol. ARTHROTEC should not be taken by pregnant women.
ARTHROTEC is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins. ARTHROTEC should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to diclofenac sodium have been reported in such patients (see WARNINGS-Anaphylactic Reactions, and PRECAUTIONS-Preexisting Asthma).
Last reviewed on RxList: 9/22/2014
This monograph has been modified to include the generic and brand name in many instances.
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