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In the Chinese hamster ovary cell cytogenetic assay, fosinopril increased the frequency of chromosomal aberrations when tested without metabolic activation at a concentration that was toxic to the cells. However, there was no increase in chromosomal aberrations at lower drug concentrations without metabolic activation or at any concentration with metabolic activation. There were no adverse reproductive effects in male and female rats treated with 15 or 60 mg/kg daily. On a body weight basis, the high dose of 60 mg/kg is about 38 times the maximum recommended human dose. On a body surface area basis, this dose is 6 times the maximum recommended human dose. Discontinuations due to any clinical or laboratory adverse event were 4.1% and 1.1% in Monopril-treated and placebo-treated patients, respectively.
Monopril PrecautionsOn a body weight basis, the highest dose in mice and rats is about 250 times the maximum human dose of 80 mg, assuming a 50 kg subject. On a body surface area basis, in mice, this dose is 20 times the maximum human dose; in rats, this dose is 40 times the maximum human dose. Male rats given the highest dose level had a slightly higher incidence of mesentery/omentum lipomas. Neither fosinopril nor the active fosinoprilat was mutagenic in the Ames microbial mutagen test, the mouse lymphoma forward mutation assay, or a mitotic gene conversion assay. Fosinopril was also not genotoxic in a mouse micronucleus test in vivo and a mouse bone marrow cytogenetic assay in vivo. The most frequent reasons (0.4 to 0.9%) were headache, elevated transaminases, fatigue, cough diarrhea, and nausea and vomiting. Monopril Adverse ReactionsMonopril has been evaluated for safety in more than 2100 individuals in hypertension and heart failure trials, including approximately 530 patients treated for a year or more. In placebo-controlled clinical trials (688 Monopril-treated patients), the usual duration of therapy was two to three months. Discontinuations due to any clinical or laboratory adverse event, except for heart failure, were 8.0% and 7.5% in Monopril-treated and placebo-treated patients, respectively. Potential Adverse Effects Reported With Ace InhibitorsDuring clinical trials with any Monopril regimen, the incidence of adverse events in the elderly (greater than 65 years old) was similar to that seen in younger patients. Human overdoses of fosinopril have not been reported, but the most common manifestation of human fosinopril overdosage is likely to be hypotension. Laboratory determinations of serum levels of fosinoprilat and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of fosinopril overdose. No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of fosinopril and its metabolites. Oral doses of fosinopril at 2600 mg/kg in rats were associated with significant lethality. Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of fosinopril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Fosinoprilat is poorly removed from the body by both hemodialysis and peritoneal dialysis. Because the hypotensive effect of fosinopril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat fosinopril overdose by infusion of normal saline solution. No adverse clinical events were reported in 23 pediatric patients, age 6 months to 6 years, given a single 0.3 mg/kg oral dose of fosinopril. |
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