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Ismo

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Ismo

Ismo

WARNINGS

Amplification of the vasodilatory effects of Ismo (isosorbide mononitrate) by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.

The benefits of isosorbide mononitrate in patients with acute myocardial infarction or congestive heart failure have not been established. Because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings. If isosorbide mononitrate is used in these conditions, careful clinical or hemo-dynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.

PRECAUTIONS

General

Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. The importance of these observations to the routine, clinical use of oral isosorbide mononitrate is not known.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No carcinogenic effects were observed in mice exposed to oral isosorbide mononitrate for 104 weeks at doses of up to 900 mg/kg/day (102 X the human exposure comparing body surface area). Rats treated with 900 mg/kg/day for 26 weeks (225 X the human exposure comparing body surface area) and 500 mg/kg/day for the remaining 95 to 111 weeks (males and females, respectively) showed no evidence of tumors. No mutagenic activity was seen in a variety of in vitro and in vivo assays. No adverse effects on fertility were observed when isosorbide mononitrate was administered to male and female rats at doses of up to 500 mg/kg/day (125 X the human exposure comparing body surface area).

Pregnancy Category C

Isosorbide mononitrate has been shown to be associated with stillbirths and neonatal death in rats receiving 500 mg/kg/day of isosorbide mononitrate (125 X the human exposure comparing body surface area). At 250 mg/kg/day, no adverse effects on reproduction and development were reported. In rats and rabbits receiving isosorbide mononitrate at up to 250 mg/kg/day, no developmental abnormalities, fetal abnormalities, or other effects upon reproductive performance were detected; these doses are larger than the maximum recommended human dose by factors between 70 (body-surface-area basis in rabbits) and 310 (body-weight basis, either species). In rats receiving 500 mg/kg/day, there were small but statistically significant increases in the rates of prolonged gestation, prolonged parturition, stillbirth, and neonatal death; and there were small but statistically significant decreases in birth weight, live litter size, and pup survival.

There are no adequate and well-controlled studies in pregnant women. Isosorbide mononitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether isosorbide mononitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosorbide mononitrate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of isosorbide mononitrate in pediatric patients have not been established.

Geriatric Use

Clinical studies of Ismo (isosorbide mononitrate) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, although age, renal, hepatic or cardiac dysfunction do not appear to have a clinically significant effect on the clearance of Ismo (isosorbide mononitrate) ®.

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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