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PREVACID NapraPAC (lansoprazole)
In case of a PREVACID NapraPAC (lansoprazole) overdose, patients should contact a physician, poison control center, or emergency room. There are no data suggesting increased toxicity of the combination of NAPROSYN and PREVACID compared with the individual components. To avoid exceeding the recommended doses of naproxen, do not use other naproxen-containing products (including NAPROSYN, ANAPROX/ANAPROX-DS, ALEVE, or naproxen sodium) with PREVACID NapraPAC (lansoprazole) .
Symptoms and Signs
Significant naproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation, or vomiting. GI 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. A few patients have experienced convulsions, but it is not clear whether or not these were drug-related. It is not known what dose of the drug would be life threatening. The oral LD50 of the drug is 543 mg/kg in rats, 1234 mg/kg in mice, 4110 mg/kg in hamsters, and greater than 1000 mg/kg in dogs.
Patients should be managed by symptomatic and supportive care following a NSAID overdose. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g per 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. Forced diuresis, alkalinization of urine, or hemoperfusion may not be useful due to high protein binding.
PREVACID is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of PREVACID with no adverse reaction.
Oral PREVACID doses up to 5000 mg per kg in rats (approximately 1300 times the 30 mg human dose based on BSA) and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs.
PREVACID NapraPAC (lansoprazole) is contraindicated in patients with known severe hypersensitivity to any component of the formulations of PREVACID (lansoprazole), NAPROSYN (naproxen), or the over-the-counter products containing naproxen.
PREVACID NapraPAC (lansoprazole) is contraindicated in patients who have experienced aspirin- or NSAID-related asthma, urticaria, or allergic-type reactions. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS Preexisting Asthma).
Last reviewed on RxList: 12/19/2008
This monograph has been modified to include the generic and brand name in many instances.
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