Doxepin tablet is indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. Doxepin capsule is recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol) Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). Psychotic depressive disorders with associated anxiety including involutional depression a and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, s matic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.Clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age.

Tricyclic & related anti-depressant drugs

The mechanism of action of doxepin is not definitely known. It a is not a central nervous system stimulant nor a monoamine oxidase inhibitor. The current uhypothesis is that the clinical effects are due, at least in part, to influences on the adrenergic activity at the synapses so that deactivation of norepinephrine by reuptake into the nerve terminals is prevented. Animal studies suggest that doxepin does not appreciably antagonize the antihypertensive action of guanethidine. In animal studies anticholinergic, anti serotonin and anti histamine effects on smooth muscle have been demonstrated. At higher than usual clinical doses norepinephrine response was potentiated in animals. This effect was not dem onstrated in humans. At clinical dosages up to 150 mg per day, doxepin can be given to man concomitantly with guanethidine and related com pounds without blocking the antihypertensive effect. At dosages above 150 mg per day blocking of the antihypertensive effect of these compounds has been re ported. Doxepin is virtually devoid of euphoria as a side effect. Char ac teristic of this type of com­pound, doxepin has not been dem ons tra ted to produce the physical tolerance or psycholog­ycal dependence associated with addictive compounds.

Methylphenidate may increase plasma doxepin levels. Potentially Fatal: Potentiates hypertensive action of sympathomimetics. Increased anticholinergic effects with MAOIs. Additive CNS effects with anticholinergics, CNS depressants and alcohol.

Doxepin is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other dibenzoxepines should be kept in mind. Doxepin is contraindicated in patients with glaucoma or a tendency to urinary retention. These disorders should be ruled out, particularly in older patients.

Sedation, fatigue, weakness, lethargy, Dry mouth, Constipation, Blurred vision, Headache, Agitation, Insomnia, Anxiety, Nausea, vomiting, Sweating, Confusion, extrapyramidal symptoms (EPS), dizziness, paresthesia, Orthostatic hypotension, ECG changes, tachycardia, Increased LFTs, Tinnitus, Sexual dysfunction, Rash, Seizure, Agranulocytosis, Thrombocytopenia, Eosinophilia.

Reproduction studies have been performed in rats, rabbits, monkeys and dogs and there was no evidence of harm to the animal fetus. The relevance to humans is not known. Since there is no experience in pregnant women who have received this drug, safety in pregnancy has not been established. There has been a report of apnea and drowsiness occurring in a nursing infant whose mother was taking doxepin.

Epilepsy, CV disease, pregnancy, history of urinary retention, glaucoma; gradual withdrawal. May impair ability to drive or operate machinery.

Store at 15-30°C.