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.
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.
For most patients with illness of mild to moderate se verity, a starting daily dose of 75 mg is recommended. Dos age may subsequently be in creased or decreased at appropriate intervals and according to individual response. The usual optimum dose range is 75 mg/day to 150 mg/day. In more severely ill patients higher doses may be required with subsequent gradual increase to 300 mg/day if necessary.
Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg/day. In patients with very mild symptomatology or emotional symptoms accompanying organic disease, lower doses may suffice. Some of these patients have been controlled on doses as low as 25 to 50 mg/day. The total daily dosage of doxepin (as the hydrochloride) may be given on a divided or once a day dosage schedule. If the once a day schedule is employed the maximum recommended dose is 150 mg/day. This dose may be given at bedtime. The 150 mg capsule strength is in tended for maintenance therapy only and is not recommended for initiation of treatment. Antianxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for 2 to 3 weeks.
Initial dose: 6 mg, once daily for adults and 3 mg, once daily for the elderly. Take within 30 minutes of bedtime. Total daily dose should not exceed 6 mg. Should not be taken within 3 hours of a meal
May be taken with or without food.
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.
Pregnancy & Lactation
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.
Precautions & Warnings
Epilepsy, CV disease, pregnancy, history of urinary retention, glaucoma; gradual withdrawal. May impair ability to drive or operate machinery.
Tricyclic & related anti-depressant drugs
Store at 15-30°C.
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