Tofranil is a tricyclic antidepressant with general pharmacological properties similar to those of structurally related tricyclic antidepressant drugs such as amitriptyline and doxepin.
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Imipramine, a tertiary amine, affects numerous neurotransmitter systems know to be involved in the etiology of depression, anxiety , ADD/ADHD, enuresis and numerous other mental and physical conditions. Imipramine is similar in structure to some muscle relaxants, and has a significant anelgisic effect and thus is very useful in some pain conditions.
The mechanisms of Imipramine's medicinal action all include, but are not limited to effects on; norepinephrine, serotonin, dopamine, epinephrine, opiates & ekephelinase, histamine and muscarine & acetylcholine.
Depression – For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
Childhood Enuresis – May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
Usual Adult Dose
Hospitalized Patients – Initially, 100 mg/day in divided doses gradually increased to 200 mg/day as required. If no response after two weeks, increase to 250 to 300 mg/day.
Outpatients – Initially, 75 mg/day increased to 150 mg/day. Dosages over 200 mg/day are not recommended. Maintenance, 50 to 150 mg/day.
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The safety of Tofranil in pregnancy has not been established. Neonates whose mothers had taken Tofranil up until delivery have shown symptoms such as dyspnea, lethargy, colic, irritability, hypotension or hypertension, tremor or spasms during the first few hours or days.
Therefore, Tofranil should not be administered to women of childbearing potential, particularly during the first trimester and the last 7 weeks of pregnancy, unless in the opinion of the physician the potential benefit to the patient outweighs the possible hazards to the fetus.
Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic overdose. Therefore, hospital monitoring is required as soon as possible.
Children have been reported to be more sensitive than adults to an acute overdosage of imipramine hydrochloride. An acute overdose of any amount in infants or young children, especially, must be considered serious and potentially fatal.
Children who relapse when the drug is discontinued do not always respond to a subsequent course of treatment.
Safety and effectiveness of Tofranil as temporary adjunctive treatment for nocturnal enuresis in children less than 5 years of age has not been established.