Pepcid (famotidine)

In patients with renal impairment, doses and/or frequency of administration of famotidine can be modified in response to the degree of renal impairment. Adverse CNS effects have been reported in patients with moderate or severe renal insufficiency receiving famotidine, and modification of dosage and/or dosing interval may be used to avoid excess accumulation of the drug in such patients. In adults with moderate (creatinine clearances less than 50 mL/minute) or severe (creatinine clearances less than 10 mL/minute) renal impairment, the manufacturer states that dosage of famotidine may be reduced to half the usual dosage or the dosing interval may be prolonged to 36-48 hours as necessary according to the patient's clinical response. Some clinicians have recommended that one-half the usual adult dosage be administered in adults with creatinine clearances of 30-60 mL/minute per 1.48 m2 and that one-fourth the usual adult dosage be administered in those with creatinine clearances less than 30 mL/minute per 1.48 m2.

Based on the comparison of pharmacokinetic parameters of famotidine in adults and children, dosage adjustment also should be considered in children with moderate or severe renal impairment.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Reproduction studies in rats and rabbits using oral famotidine dosages up to 2 (approximately 2500 times the maximum human dosage) and 0.5 g/kg daily, respectively, or IV dosages up to 0.2 (approximately 250 times the maximum human dosage) and 0.1 g/kg daily, respectively, have not revealed evidence of harm to the fetus. Oral dosages of 2 g/kg daily inhibited weight gain in pregnant rats, and those of 0.5 and/or 2 g/kg daily on days 7-17 of gestation decreased fetal weight and delayed sternal ossification in the offspring. Decreased food intake and decreased weight gain also occurred in offspring of rats receiving these dosages from days 10-28 post partum. Death and locomotor dysfunction were observed in pregnant rats receiving IV famotidine dosages of 100 or 200 mg/kg daily. IV dosages of 100 or 200 mg/kg daily in rats have decreased pup body weight during the post-weaning period. Although no direct fetotoxic effects have been observed, sporadic abortions and decreases in fetal weight occurred secondary to substantial decreases in food intake in pregnant rabbits receiving oral dosages of 200 mg/kg (250 times the usual human dosage) or more daily. Decreased number of sacrocaudal vertebrae and delayed ossification have occurred in rabbits receiving oral famotidine dosages of 0.5 g/kg daily. There are no adequate and controlled studies to date using famotidine in pregnant women, and the drug should be used during pregnancy only when clearly needed. Women who are pregnant or nursing should seek the advice of a health professional before using famotidine for self-medication.

Famotidine is distributed into milk in humans and in animals. The drug has produced transient growth depression in the offspring of lactating rats receiving dosages at least 600 times the usual human dosage. Because of the potential for serious adverse reactions to famotidine in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

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