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Doxepin | Sinequan is a medication used to treat major depressive disorder, anxiety disorders, chronic hives, and trouble sleeping.

Therapeutic Class

Tricyclic & related anti-depressant drugs

Pharmacology

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 hypothesis 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 antihistamine effects on smooth muscle have been demonstrated. At higher than usual clinical doses norepinephrine response was potentiated in animals.

This effect was not demonstrated in humans. At clinical dosages up to 150 mg per day, doxepin can be given to man concomitantly with guanethidine and related compounds without blocking the antihypertensive effect. At dosages above 150 mg per day blocking of the antihypertensive effect of these compounds has been reported.

Doxepin is virtually devoid of euphoria as a side effect. Characteristic of this type of com­pound, doxepin has not been demonstrated to produce the physical tolerance or psychological dependence associated with addictive compounds.

Dosage

Capsule:

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 increased 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 intended 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.

Tablet:

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

Administration

May be taken with or without food.

Interaction

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.

Contraindications

Doxepin is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other benzoxepines 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.

Side Effects

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.

Storage Conditions

Store at 15-30°C.