PREVACID NapraPAC

In case of a PREVACID NapraPAC 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.

Patients with a significant NAPROSYN overdose may have lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation, and/or vomiting. 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. Seizures have been reported with NAPROSYN use, but it is not clear whether these cases were drug-related.

Following an NSAID overdose, patients should be managed by supportive care. There are no specific antidotes. Hemodialysis does not decrease the plasma naproxen concentration because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in symptomatic patients seen within 4 hours of ingestion or following a large overdose. Forced diuresis, alkalinization of urine, or hemoperfusion is not likely to be useful due to high protein binding.

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. The oral LD50 (lethal dose 50 ¾ the amount of drug which causes the death of 50% of a group of animals) 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.

PREVACID

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/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 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 is contraindicated in patients who have experienced aspirin or NSAID-related asthma, urticaria, or allergic-type reactions. Severe, rarely fatal, anaphylactic reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS Aspirin-Sensitive Asthma).

PREVACID NapraPAC is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

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