Generic Tofranil

1. Denomination

Tofranil

2. Active Substance

Imipramine Hydrochloride

3. Indications for Use.

Imipramine is used in various depressive states, likewise in the depressions accompanied with a light retardation (slowdown of the rate of thoughts and speech), the depressions in elderly patients connected with sexual changes, depressive states in psychopaties and neuroses etc., also in alcoholic depressions.
Night bedwetting in children.

4. Action

By the nature of action Imipramine is an antidepressant with an accompanying stimulating performance.
The drug favors decrease of melancholy, mood improvement, onset of vigor and decrease of motional retardation, enhancement of psychic and general tonus of body. Favors healing of bedwetting in children against fright (but not against cold-related diseases).

5. Posology and Administration

Adults should take orally 25-50 mg 3-4 times/daily.
During 10-14 days a dose should be gradually increased up to 150-250 mg/daily, and when a clinical performance is attained it will be gradually decreased to a supporting one of 50-150 mg. In light depressions a dose rate is 75-150 mg/daily, a supporting one is 25-50 mg/daily.
Maximal oral doses: for adults out-patiently – up to 200 mg/daily, in hospital environment – up to 300 mg/daily; for elderly patients -  100 mg/daily; for children - 100 mg/daily.      
It is recommended to children up to 6 years of age orally, to children up to 12 years of age intramuscullarly.                                                                                                                                 In children of 6-12 years of in oral administration 10-30 mg/daily in 2 divided doses; more than 12 years of age - 25-50 mg/daily in divided doses, if needed and by taking into account tolerability a dose may be gradually increased. A therapeutic regimen is to be established individually.  In night bedwetting, a therapeutic regimen, depending on age, is to be from 5 to 75 mg once a day 1 hour before sleep.                                                                                                                                                      It just Imipramine Hydrochloride that is indicated for the treatment of night bedwetting in children.
For elderly patients it is ordered individually, and the treatment proceeds under doctor’s control.                                                                                                          

6. Counterindications

Hypersensitivity, ischemic disease of heart, tachycardia, stagnant heart failure, early post-infarction period, liver and kidneys failure, inclination to convulsions, schizophrenia, epilepsy, glaucoma, adenoma of prostate gland, atony of urine bladder, pregnancy, infancy under 2 years of age.

7. Should Be Taken with Precautions, if…

Caution should be taken in patients with low convulsions threshold; in severe diseases of liver and kidneys; in people with severe disorders of arterial tension, diabetes (correction of dosage regimen is needed).
In the period of treatment no alcoholic beverages should be taken.
For patients with suicidal tendencies a constant medical control is needed in the starting period of the therapy, likewise for children under 6 years of age and pregnant women.

8. Interface with Other Medications

If the drug is taken jointly with other medications there is a probability of emergence of adverse reactions, that is why during Imipramine therapy it is not recommended to take any other medications without doctor’s order.

9. Overdosing

Symptoms: dizziness, agitation, ataxia, convulsions, stupor, coma, dilatation of pupil, tachycardia, arrhythmia, life-threatening state in high venous tension, arterial hypotension, suppression of respiration, bluishness of separate parts of outer cover of the body, vomiting, fever.

10. Side Effects

Headache, dizziness, coordination disorders, sleep disorders, agitation, hallucinations, complete physical and emotional relaxation, tremor (more frequent of limbs and head), convulsions, disorders of speech, dry mouth, constipation, loss of arterial tension which is observed when a patient rises from sitting or lying position, retention of urination, indistinctness of vision, growth of lacteal glands, drop of libido, impotency, increase of the body mass, ultraviolet sensitivity, drop of hair, fever, high perspiration.

11. Pregnancy and Lactation

Imipramine should not be administered in the first 3 months of pregnancy; further on it may be ordered only in cases of acute necessity and under a strict doctor’s control. It is not recommended for use in the period of breastfeeding. In case of necessity breastfeeding should be ceased.

12. Driving

In the starting therapy period it is necessary to avoid driving of vehicles and fulfilling potentially hazardous works.

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