If you are:
FDB Only When Necessary: NO FDA CATEGORY; CASE REPORTS SUGGEST MALFORMATIONS ASSOCIATED WITH USE
Precaution: AMOUNT EXCRETED MINIMAL; INSUFFICIENT DATA AVAIL FOR INFANT ADVERSE EFFECTS
An adult over 60:
management or monitoring precaution: Neuro/Psych-Anticholinergic effects may cause sedation, worsen cognitive impairment and increase fall risk. Cardiovascular-May cause orthostatic hypotension at higher doses. Gastrointestinal-May cause or worsen pre-existing constipation. Genitourinary-Best avoided in patients with urinary retention from any cause.
Giving Tofranil-PM to a child under 12:
Severe Precaution: Possible increased suicidal ideation and attempt with underlying major depression. No established safety and efficacy.