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DOXEPIN is a brand name for Doxepin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Symptoms of depressive illness in adults, especially where sedation is required.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology:
The optimum oral dose depends on the severity of the condition and the individual patient’s response. The dose required may vary from 25-300 mg daily. Doses up to 100 mg daily may be given on a divided or once daily schedule. Should doses over 100 mg daily be required, they should be administered in three divided doses daily.
100 mg 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 75 mg 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 300 mg 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 25 mg 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. Paediatric population The safety and efficacy in children under 18 years have not been established.
Elderly 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.
Hepatic impairment:
Dosage reduction may be required in patients with hepatic impairment (see ‘Special warnings and special precautions for use’). Renal impairment Dosage reduction may be required in patients with renal impairment (see ‘Special warnings and special precautions for use’).
Method of administration:
Oral administration.
Frequency is defined as: very common (≥ 1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Note:
Some of the side-effects noted below have not been specifically reported with Doxepin 25 mg Capsules. However, due to the close pharmacological similarities amongst the tricyclics, the reactions should be considered when prescribing Doxepin 25 mg Capsules.
System Organ Class Adverse Reaction Frequency Blood and lymphatic system disorders Eosinophilia, agranulocytosis, leucopoenia, thrombocytopenia, purpura, haemolytic anaemia Rare Endocrine disorders Inappropriate anti-diuretic hormone secretion, gynaecomastia Rare Metabolism and nutrition Appetite decreased Not known Hallucinations RarePsychiatric disorders Insomnia, nightmares, mania, paranoid delusions, confusion, disorientation, agitation, suicidal ideation, suicidal behaviour Not known Renal and urinary disorders Urinary retention Rare Breast enlargement, galactorrhoea RareReproductive system and breast disorders Testicular swelling, libido increased or decreased Not known Drowsiness Common Ataxia, convulsions Rare Nervous system disorders Tardive dyskinesia, dizziness, headache, dysgeusia, numbness, paraesthesia, tremor Not known Ear and labyrinth disorders Tinnitus Rare Eye disorders Blurred vision Not known Cardiac disorders Tachycardia Not known System Organ Class Adverse Reaction Frequency Dry mouth, constipation Common Nausea, vomiting, indigestion, diarrhoea, Not known Gastrointestinal disorders Aphthous ulcer Not known Hepatobiliary disorders Jaundice Rare Electrocardiogram QRS complex prolonged, Electrocardiogram PR prolongation RareInvestigations Blood sugar increased, blood sugar decreased, Weight increased Not known Respiratory, thoracic and mediastinal conditions Asthma Not known Skin rash, facial oedema, photosensitivity, pruritus, urticaria UncommonSkin and subcutaneous tissue disorders Alopecia Not known Musculoskeletal and connective tissue disorders Bone Fracture Not known Vascular disorders Postural hypotension, flushing Not known General disorders and administration site conditions Chills, fatigue, asthenia, hyperpyrexia, hyperhidrosis Not known Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebo- controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared with placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
The once-a-day dosage regimen of Doxepin 25 mg Capsules in patients with intercurrent illness or patients taking other medications should be carefully adjusted. This is especially important in patients receiving other medications with anti-cholinergic effects.
The use of Doxepin 25 mg Capsules on a once-a-day dosage regimen in geriatric patients should be adjusted carefully on the basis of the patient’s condition. The elderly are particularly liable to experience toxic effects, especially agitation, confusion and postural hypotension.
Doxepin is contra-indicated in individuals who have shown hypersensitivity to tricyclic antidepressants (TCAs), doxepin, or any of the inactive ingredients. Doxepin is also contra-indicated in patients with mania, severe liver disease, lactation, glaucoma, tendency to urinary retention.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Doxepin in United Kingdom.
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The initial dose should be increased with caution under close supervision. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response. Patients should be warned that drowsiness may occur with the use of Doxepin 25 mg Capsules.
Patients should also be cautioned that their response to alcohol may be potentiated. Although Doxepin 25 mg Capsules carry less risk than other tricyclic anti- depressants, caution should be observed in the treatment of patients with severe cardiovascular disease, including patients with heart block, cardiac arrhythmia and those who have experienced a recent myocardial infarction.
5). If concomitant treatment of buprenorphine/ opioids is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. Hepatic/renal impairment Use with caution in patients with hepatic and/or renal impairment.
Patients with epilepsy Use with caution in patients with a history of epilepsy. Since suicide is an inherent risk in any depressed patient until significant improvement has occurred, patients should be closely supervised during early therapy.
Patients with benign prostatic hyperplasia may experience an increase in associated urinary retention (see ‘Undesirable effects’).
Excipients:
Doxepin 25 mg Capsules contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.