Dosulepin Hydrochloride Azure 75 mg Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dosulepin hydrochloride

Available from:

Azure Pharmaceuticals Ltd

ATC code:

N06AA16

INN (International Name):

Dosulepin hydrochloride

Pharmaceutical form:

Coated tablet

Therapeutic area:

dosulepin

Authorization status:

Not marketed

Authorization date:

2023-04-14

Summary of Product characteristics

Health Products Regulatory Authority
14 April 2023
CRN00CDKP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dosulepin Hydrochloride Azure 75 mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 75 mg of dosulepin hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White circular, convex sugar-coated tablets plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dosulepin is indicated for the management of depression and associated
anxiety.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _The usual total daily dose is 75 mg to 150 mg in divided
doses or as a single night-time dose. Treatment should be
initiated at the lower dose. In certain circumstances, _e.g. _in
hospital use, dosages up to 225 mg daily have been used.
Suggested regimens: 25 or 50 mg three times daily or, alternatively,
75 or 150 mg as a single dose at night. Should the regimen
of 150 mg as a single night-time dose be adopted, it is better to give
a smaller dose for the first few days.
_Elderly: _
50 to 75 mg daily initially. As with any antidepressant, the initial
dose should be increased with caution under close
supervision. Half the normal adult dose may be sufficient to produce a
satisfactory clinical response.
_Children: _Not recommended.
Method of administration
For oral administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Dosulepin is contraindicated following recent myocardial infarction,
and in patients with any degree of heart block or other
cardiac arrhythmias. It is also contraindicated in mania, severe liver
disease, narrow angle glaucoma or other causes of
increased intraocular pressure.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It may be two to four weeks from the start of treatment before there
is an improvement in the patient's depression; the subject
should be monitored closely during this period. The anxiolytic