Depression Symptoms Treatment

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Drug Approvals

(British Approved Name Modified, rINNM)

INNs in main languages (French, Latin, Spanish):

Pharmacopoeias. In Europe.

European Pharmacopoeia, 6th ed. (Dosulepin Hydrochloride). A white or faintly yellow crystalline powder. It consists chiefly of the IT-isomer. Freely soluble in water, in alcohol, and in dichloromefhane. A 10% solution in water has a pH of 4.2 to 5.2. Protect from light.

Adverse Effects, Treatment, and Precautions

As for tricyclic antidepressants in general (see Amitriptyline).

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

Effects on the cardiovascular system. For reference to an increased risk of ischaemic heart disease in patients treated with dosulepin, see under Amitriptyline.

Overdosage. After an overdose of 1 g of dosulepin, the ECG of a 41-year-old man showed cardiac abnormalities mimicking an acute myocardial infarction. However, as cardiac enzymes did not confirm an ischaemic event, the abnormalities were thought to be due to either the quinidine-like effect of dosulepin or changes in potassium membrane permeability.

Porphyria. Dosulepin hydrochloride is considered to be unsafe in patients with porphyria because it has been shown to be porphyrinogenic in animals.

Interactions

For interactions associated with tricyclic antidepressants, see Amitriptyline.

Pharmacokinetics

Dosulepin hydrochloride is readily absorbed from the gastrointestinal tract, and extensively demefhylated by first-pass metabolism in the liver to its primary active metabolite, desmethyldothiepin (also termed northiaden). Paths of metabolism also include S-oxidation.

Dosulepin is excreted in the urine, mainly in the form of its metabolites small amounts are also excreted in the faeces. Elimination half-lives of about 14 to 24 and 23 to 46 hours have been reported for dosulepin and its metabolites, respectively.

Dosulepin is distributed into breast milk (see Breast Feeding under Precautions in Amitriptyline).

Uses and Administration

Dosulepin hydrochloride is a tricyclic antidepressant with actions and uses similar to those of amitriptyline. It is one of the more sedating tricyclics. In the UK, the MHRA suggests that the use of dosulepin for depression should be limited, because of the small margin of safety between the maximum therapeutic dose and potentially fatal overdose. It advises that treatment should only be started by a specialist-care prescriber, and that the quantity issued per prescription should be limited. In patients with increased risk factors for suicide at the start of treatment, during dose adjustment, and until improvement occurs, the MHRA suggests a maximum supply equivalent to 2 weeks of treatment with 75 mg daily.

In the treatment of depression, dosulepin hydrochloride is given in oral doses of 25 mg three times daily initially, gradually increased to 50 mg three times daily if necessary alternatively a single dose at night may be given. Higher doses of up to 225 mg daily have been given to severely depressed patients in hospital. The recommended initial dose for the elderly is 50 to 75 mg daily.

Dosulepin should be withdrawn gradually to reduce the risk of withdrawal symptoms.

Preparations

British Pharmacopoeia 2008: Dosulepin Capsules Dosulepin Tablets.

Proprietary Preparations

Australia:: Dothep Prothiaden

Belgium: Prothiaden

Czech Republic: Prothiaden

Denmark: Prothiaden

France: Prothiaden

Germany: Idom

Hong Kong: Prothiaden

India: Prothiaden

Irland: Dothep Prothiaden

Italy: Protiaden

Malaysia: Dothep Prothiaden

The Netherlands: Prothiaden

New Zealand: Dopress Prothiaden

Philippines: Prothiaden

Portugal: Protiadene

South Africa: Prothiaden Thaden

Singapore: Espin Prothiaden

Spain: Prothiaden

Switzerland: Protiaden

Thailand: Dopin Prothiaden

UK: Dothapax Prepadine Prothiaden

Multi-ingredient

Austria: Harmomed