Depression Symptoms Treatment

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Doxepin is authorised in the world under the following brand names: Adapin, Aponal, Curatin, Quitaxon, Sinequan, Triadapin, Zonalon.

Drug Approvals

(British Approved Name Modified, US Adopted Name, rINN)

International Nonproprietary Names (INNs) in main languages (French, Latin, and Spanish):

Pharmacopoeias. In China, Europe, and US.

European Pharmacopoeia, 6th ed. (Doxepin Hydrochloride). A white or almost white crystalline powder. Freely soluble in water, in alcohol, and in dichloromethane. Protect from light.

The United States Pharmacopeia 31, 2008 (Doxepin Hydrochloride). It consists of a mixture of Z-and E-isomers.

Adverse Effects, Treatment, and Precautions

As for tricyclic antidepressants in general (see Amitriptyline). Drowsiness and other systemic effects can also occur after topical application. In addition, local effects, most commonly burning and stinging, have been reported.

Breast feeding. For comments on the use of tricyclic antidepressants in breast feeding patients, see under Precautions for Amitriptyline.

Effects on the skin. Up to January 2002 the FDA was aware of 26 cases of allergic contact dermatitis associated with the use of doxepin 5% cream manifestations included eczema, urticaria, purpura, and papulovesicular lesions. Of the 20 cases where details were known, 13 occurred after use for more than the recommended 8 days. Patch testing was positive in the 21 cases where it was performed, supporting an allergic reaction rather than an exacerbation of the original condition.

Overdosage. An infant became difficult to arouse after the application of doxepin cream 5% to about 50% of her body-surface an entire 30-g tube of the cream was used in only 2 applications. The cream is not recommended for use in children.

Interactions

For interactions associated with tricyclic antidepressants, see Amitriptyline.

Pharmacokinetics

Doxepin is readily absorbed from the gastrointestinal tract after oral doses, and is extensively demethylated by first-pass metabolism in the liver, to its primary active metabolite, desmethyldoxepin. Doxepin is also absorbed through the skin after topical application. Paths of metabolism of both doxepin and desmethyldoxepin include hydroxylation and N-oxidation. Doxepin is excreted in the urine, mainly in the form of its metabolites, either free or in conjugated form. Doxepin and desmethyldoxepin are widely distributed throughout the body the plasma protein binding of doxepin is about 76%. Doxepin has been estimated to have a plasma elimination half-life ranging from 8 to 24 hours, which may be considerably extended in over-dosage that of desmethyldoxepin is longer. Doxepin crosses the blood-brain barrier and the placenta. It is distributed into breast milk (see Breast Feeding under Precautions in Amitriptyline).

Uses and Administration

Doxepin is a dibenzoxepine tricyclic antidepressant with actions and uses similar to those of amitriptyline. It has moderate antimuscarinic and marked sedative properties and has serotonin reuptake inhibitor activity.

In the treatment of depression doxepin is given orally as the hydrochloride although doses are expressed in terms of the base doxepin hydrochloride 84.8 mg is equivalent to about 75 mg of doxepin. The initial dose is 75 mg daily, gradually adjusted according to response. Doses of up to 300 mg daily may be required in severely depressed patients mildly affected patients may respond to as little as 25 to 50 mg daily. Daily doses up to 100 mg may be given in divided doses or as a single dose at bedtime. If the total daily dose exceeds 100 mg, it should be given in 3 divided doses, although the largest portion, up to a maximum of 100 mg, may be given at bedtime. In the USA, the maximum single dose is 150 mg. A suggested starting dose in the elderly is 10 to 50 mg daily.

Doxepin hydrochloride has also been given by intramuscular or intravenous injection. Doxepin should be withdrawn gradually to reduce the risk of withdrawal symptoms. Doxepin has histamine H₁ and H₂-antagonist activity and is used topically in a cream containing 5% of the hydrochloride for the short-term (up to 8 days) relief of moderate pruritus associated with various types of dermatitis (see below).

Headache. Tricyclic antidepressants can be effective in the management of some types of headache.

Insomnia. Doxepin is under investigation in the management of insomnia. Low oral doses of 1 to 6 mg at night are being studied.

Skin disorders. Tricyclic antidepressants have a wide range of pharmacological activity and some drugs in this group have notable antihistaminic actions. Doxepin in particular has very potent antihistaminic activity. It has been shown to be an effective oral alternative to conventional antihistamines in the treatment of chronic urticaria and to be an effective oral treatment for idiopathic cold urticaria. In the case of cold urticaria doxepin may act by inhibiting release of a platelet-activating factor-like lipid. For an overview of the possible treatments for the various urticarias, including mention of the use of doxepin. Like standard antihistamines doxepin has also been used topically for the relief of pruritus associated with various types of allergic and inflammatory skin disorders’ although some authorities remain to be convinced of its efficacy. Topical application of doxepin can also produce contact dermatitis (see Effects on the Skin, above) and drowsiness and other systemic effects.

Preparations

British Pharmacopoeia 2008: Doxepin Capsules

The United States Pharmacopeia 31, 2008: Doxepin Hydrochloride Capsules Doxepin Hydrochloride Oral Solution.

Proprietary Preparations

Australia:: Deptran Sinequan

Austria: Sinequan

Belgium: Sinequan

Canada: Sinequan Zonalon

Denmark: Sinequan

Finland: Doxal

France: Quitaxon

Germany: Aponal Doneurin Doxe Doxepia espadox Mareen Sinquan

Greece: Sinequan

Hong Kong: Qualiquan Sinequan

India: Spectra

Indonesia: Sagalon

Ireland: Sinequan Xepin

Israel: Gilex

Mexico: Sinequan

The Netherlands: Sinequan

Norway: Sinequan

New Zealand: Anten

Poland: Sinequan

Spain: Sinequan

Switzerland: Sinquane

Thailand: Sinequan

UK: Sinepin Sinequan Xepin

USA: Prudoxin Sinequan Zonalon