Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Marlborough Pharmaceuticals Ltd, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, UK
Symptoms of depressive illness in adults, especially where sedation is required.
The optimum oral dose depends on the severity of the condition and the individual patient’s response. The dose required may vary from 25-300mg daily. Doses up to 100mg daily may be given on a divided or once daily schedule. Should doses over 100mg daily be required, they should be administered in three divided doses daily. 100mg is the maximum dose recommended at any one time. This dose may be given at bedtime.
For the majority of patients with moderate or severe symptoms, it is recommended that treatment commences with an initial dose of 75mg daily. Many of these patients will respond satisfactorily at this dose level. For patients who do not, the dosage may be adjusted according to individual response. In more severely ill patients, it may be necessary to administer a dose of up to 300mg in divided doses daily, to obtain a clinical response.
In patients where insomnia is a troublesome symptom, it is recommended that the total daily dose be divided so that a higher proportion is given for the evening dose; similarly, if drowsiness is experienced as a side effect of treatment, Doxepin 25mg Capsules may be administered by this regimen or the dosage may be reduced. It is often possible, having once obtained a satisfactory therapeutic response, to reduce the dose for maintenance therapy.
The optimal anti-depressant effect may not be evident for two to three weeks.
The safety and efficacy in children under 18 years have not been established.
In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater susceptibility of elderly people to typical side effects of the drug.
Dosage reduction may be required in patients with hepatic impairment (see ‘Special warnings and special precautions for use’).
Dosage reduction may be required in patients with renal impairment (see ‘Special warnings and special precautions for use’).
Oral administration.
Mild: drowsiness, stupor, blurred vision, excessive dryness of mouth.
Severe: respiratory depression, hypotension, coma, convulsions, cardiac arrhythmias and tachycardias.
Also urinary retention (bladder atony), decreased gastrointestinal motility (paralytic ileus), hyperthermia (or hypothermia), hypertension, dilated pupils, hyperactive reflexes.
Deaths have been reported involving overdoses of doxepin. The reported cases involved doxepin alone and in combination with other drugs and/or alcohol.
Mild: observation and supportive therapy is all that is usually necessary.
Severe: medical management of severe doxepin overdosage consists of aggressive supportive therapy. If the patient is conscious, gastric lavage with appropriate precautions to prevent pulmonary aspiration should be performed even though doxepin is rapidly absorbed. The use of activated charcoal has been recommended, as has been continuous gastric lavage with saline for 24 hours or more. An adequate airway should be established in comatose patients and assisted ventilation used if necessary. ECG monitoring may be required for several days, since relapse after apparent recovery has been reported. Arrhythmias should be treated with the appropriate anti-arrhythmic agent. It has been reported that many of the cardiovascular and CNS symptoms of tricyclic anti-depressant poisoning in adults may be reversed by the slow intravenous administration of 1mg to 3mg of physostigmine salicylate.
Because physostigmine is rapidly metabolised, the dosage should be repeated as required. Convulsions may respond to standard anti-convulsant therapy. However, barbiturates may potentiate any respiratory depression. Dialysis and forced diuresis generally are not of value in the management of overdosage due to high tissue and protein binding of doxepin.
3 years.
Store below 25°C.
Doxepin 25mg Capsules are available as: Packs of 28 capsules. Aluminium/PVC blister strips; 2 rows of 7 capsules per strip, 2 strips in a carton box.
No special requirements.
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