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| Drug Name: | ATENOLOL |
| Manufacturer: | Genpharm Inc. |
| Other Info: | See WARNINGS – Pregnancy and Fetal Injury. |
| Clinical Trials: | |
Atenolol Tablets USP are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality.
Treatment can be initiated as soon as the patient’s clinical condition allows.
(See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade.
As noted above, some subgroups (e.g.
elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.Atenolol Tablets USP are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure.
(See WARNINGS.)Atenolol is contraindicated in those patients with a history of hypersensitivity to atenolol or any of the drug product’s components.Atenolol can cause fetal harm when administered to a pregnant woman.
Atenolol crosses the placental barrier and appears in cord blood.
Administration of atenolol, starting in the second trimester of pregnancy, has been associated with the birth of infants that are small for gestational age.
No studies have been performed on the use of atenolol in the first trimester and the possibility of fetal injury cannot be excluded.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.Neonates born to mothers who are receiving atenolol at parturition or breast-feeding may be at risk for hypoglycemia and bradycardia.
Caution should be exercised when atenolol is administered during pregnancy or to a woman who is breast-feeding (See PRECAUTIONS, Nursing Mothers).Atenolol has been shown to produce a dose-related increase in embryo/fetal resorptions in rats at doses equal to or greater than 50 mg/kg/day or 25 or more times the maximum recommended human antihypertensive dose*.
Although similar effects were not seen in rabbits, the compound was not evaluated in rabbits at doses above 25 mg/kg/day or 12.5 times the maximum recommended human antihypertensive dose*.*Based on the maximum dose of 100 mg/day in a 50 kg patient.
NIH - Clinical Trials