Elavil (Amitriptyline HCI)


Central nervous system agent


Antidepressant


Depression, insomnia.


(Adults) Initially 25 mg 3 times daily; or 50 to 100 mg at bedtime. Maintenance dose, 50 to 100 mg/day before or after meals.


Category NR


Drowsiness, somnolence, Constipation, urinary retention, blurry vision. May exacerbate schizophrenic or paranoid symptomatology.





Pregnancy Risk Categories defined:

A: Studies in pregnant women failed to show a risk to the fetus in the first trimester - with no evidence of risk in the later trimesters.

B: Animals studies indicate no adverse effect to the fetus, but there are no adequate, clinical studies in pregnant women.

C: Animal studies have shown an adverse effect on the fetus, but there are no adequate, clinical studies in humans. Despite potential risks, the drug may be useful in pregnant women.

D: There is evidence of risk to the human fetus, but the potential benefits of use in pregnant women may be acceptable, despite potential risks.

X: Studies in animals or humans show fetal abnormalities, or adverse reaction reports indicate evidence of fetal risk. Warning: the risks involved clearly outweigh any potential benefit from using the drug in pregnant women, regardless of trimester.

NR: Not rated (i.e., no information available at this time as to the potential risks or benefits).