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Helidac

Overdosage & Contraindications
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OVERDOSE

In case of an overdose, patients should contact a physician, poison control center, or emergency room. If all three components of this therapy are involved in an overdose, acute treatment should focus on the salicylate intoxication. There is neither a pharmacologic basis nor data suggesting an increased toxicity of the combination compared to individual components.

Bismuth Subsalicylate: The main concern of an acute bismuth subsalicylate (BSS) overdose focuses on the salicylate burden and not on bismuth, since less than 1% of the bismuth is normally absorbed. Each 262.4-mg tablet of BSS contains an amount of salicylate comparable to approximately 130 mg aspirin. Acute ingestion of less than 150 mg/kg of aspirin (i.e., less than one tablet of bismuth subsalicylate per kilogram of body weight) is not expected to lead to toxicity. Mild to moderate toxicity may result from the ingestion of 150 to 300 mg/kg, while severe toxicity may occur from ingestions over 300 mg/kg. Salicylate intoxication is well described in the literature and presents a complex clinical picture. Multiple respiratory and metabolic effects result in fluid, electrolyte, glucose, and acid-base disturbances. Initial symptoms of salicylate toxicity include hyperp-nea, nausea, vomiting, tinnitus, hyperpyrexia, lethargy, tachycardia, and confusion. In severe cases, these symptoms may progress to severe hyperpnea, convulsions, pulmonary or cerebral edema, respiratory failure, cardiovascular collapse, coma, and death.

Treatment: There is no specific antidote for salicylate poisoning. If there are no contraindications, vomiting should be induced as soon as possible with syrup of ipecac, or gastric lavage should be instituted, provided that no more than one hour has elapsed since ingestion. Activated charcoal and a cathartic may be administered as primary decontamination therapy in those cases where greater than one hour has elapsed since ingestion, or to further decontaminate the gastrointestinal tract in those who have already received ipecac or gastric lavage. Plasma salicylate levels may be useful; a common nomogram can be used to help predict the severity of intoxication. Supportive and symptomatic treatment should be provided, with emphasis on correcting fluid, electrolyte, blood glucose, and acid-base disturbances. (Note: An acidotic blood pH increases the un-ionized salicylate form, allowing more to reach the central nervous system.) Elimination may be enhanced by urinary alkalinization, hemodialysis, or hemop-erfusion. Since hemodialysis aids in correcting acid-base disturbances, this method may be preferred over hemoperfusion.

Metronidazole: Single oral doses of metronidazole, up to 19.5 g in adults, have been reported without resultant serious toxicity in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia.

Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day.

Treatment: There is no specific antidote for metronidazole overdose. Management of the patient should consist of symptomatic and supportive therapy. Metronidazole is dia-lyzable.

Tetracycline: The acute toxicity of tetracycline in overdose is not well established in the literature. Therapeutic and overdose quantities of tetracycline can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea.

Treatment: There is no specific antidote for tetracycline overdose. Management of the patient should consist of symptomatic and supportive therapy. Tetracycline is not dia-lyzable.

CONTRAINDICATIONS

This therapy is contraindicated in pregnant or nursing women, pediatric patients, in patients with renal or hepatic impairment, and in those with known hypersensitivity to bismuth subsalicylate, metronidazole or other nitroimidazole derivatives, or any of the tetracyclines. (See WARNINGS and PRECAUTIONS.) This product does not contain aspirin but should not be administered to those patients who have a known allergy to aspirin or salicylates.

Brand Name: Helidac
Generic Name: Bismuth Subsalicylate
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