Doxepin oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of doxepin.
Drugs List
Therapeutic Indications
Uses
Symptoms of depressive illness especially if sedation required
Dosage
Optimum dosage depends on individual response and severity of condition.
Adults
Initial dosage should be 75mg daily. In more severely ill patients it may be necessary to administer a dose of up to 300mg daily in divided doses to obtain a response.
Dosage is usually within the range 25mg to 300mg daily. Doses up to 100mg may be given in once daily or in a divided schedule. If taken once per day, take at bedtime. If doses over 100mg are required they should be administered in three divided doses. Patients for whom insomnia is a troublesome symptom or if drowsiness is experienced as a side effect, dosage may be divided so that a higher proportion is administered in the evening.
It is often possible to reduce the dose for maintenance therapy once a satisfactory response has been obtained.
The optimal anti-depressant effect may not be evident for two to three weeks.
Elderly
Any increase in dose should be conducted under close supervision. Half the standard maintenance dose may be sufficient to produce a satisfactory clinical response.
Children
Children aged 12 to 18 years (unlicensed)
(See Dosage; Adult)
Contraindications
Children under 12 years
Within 2 weeks of discontinuing MAOIs
Acute porphyria
Breastfeeding
Glaucoma
Long QT syndrome
Mania
Severe hepatic disorder
Torsade de pointes
Urinary retention
Precautions and Warnings
Anaesthesia
Elderly
Family history of long QT syndrome
Patients under 25 years
Suicidal ideation
Benign prostatic hyperplasia
Cardiac arrhythmias
Cardiac conduction defects
Chronic constipation
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of mania
History of psychosis
History of torsade de pointes
Hyperthyroidism
Lactose intolerance
Phaeochromocytoma
Pregnancy
Raised intra-ocular pressure
Recent myocardial infarction
Renal impairment
Severe cardiac disorder
Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise patient drowsiness may affect ability to drive or operate machinery
Not all available products are licensed for all age groups
Reduce initial dose in the elderly
Some brands contain Sunset Yellow (E110) - can trigger allergic reactions
Some formulations contain amaranth (E123) - may cause allergic reactions
Some formulations contain lactose
Some formulations contain propylene glycol
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor serum electrolytes
Monitor the elderly for optimum dosing
Treatment of depression - monitor initially; may take 2-4 weeks to respond
Consider dose reduction or discontinuation if serotonin syndrome suspected
Do not withdraw this drug suddenly
Discontinue if patient enters a manic phase
Advise patient not to take St John's wort concurrently
Patient should avoid alcohol as effect may be potentiated
Advise patient/carers to report signs of suicide ideation or behaviour
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 self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm.
Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.
Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.
Pregnancy and Lactation
Pregnancy
Use doxepin with caution in pregnancy.
The manufacturer advises caution if doxepin is used during pregnancy. Animal studies have shown no teratogenic effects. Doxepin is known to cross the placenta however human data is limited and as such, a potential risk cannot be ruled out.
Lactation
Doxepin is contraindicated during breastfeeding.
Use of doxepin when breastfeeding is contraindicated by the manufacturer. Doxepin and it's active metabolite desmethyldoxepin are present in human breast milk at concentrations that could be as high as maternal levels (LactMed, 2022). Apnoea and drowsiness have been reported in nursing infants.
Side Effects
Aggravation of existing asthma
Agitation
Agranulocytosis
Alopecia
Aphthous stomatitis
Asthenia
Ataxia
Blood sugar changes
Blurred vision
Breast enlargement
Changes in libido
Chills
Confusion
Constipation
Convulsions
Decreased appetite
Diarrhoea
Disorientation
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Eosinophilia
Facial oedema
Fatigue
Flushing
Galactorrhoea
Gynaecomastia
Haemolytic anaemia
Hallucinations
Headache
Hyperhidrosis
Hyperpyrexia
Inappropriate secretion of antidiuretic hormone
Increased appetite
Increased risk of fractures
Indigestion
Insomnia
Jaundice
Leucopenia
Mania
Nausea
Nightmares
Numbness
Paraesthesia
Paranoid delusions
Photosensitivity
Postural hypotension
Prolongation of PR interval
Pruritus
Purpura
Rash
Suicidal tendencies
Tachycardia
Tardive dyskinesia
Testicular swelling
Thrombocytopenia
Tinnitus
Tremor
Urinary retention
Urticaria
Vomiting
Weight gain
Widened QRS complex
Withdrawal Symptoms and Signs
Withdrawal symptoms may occur within 5 days of treatment cessation. The risk of withdrawal symptoms is increased treatment is discontinued suddenly. When discontinuing doxepin, the dose should be reduced gradually over at least 4 weeks, or longer if withdrawal symptoms emerge (6 months in patients who have been on long-term maintenance treatment).
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last full review date: September 2022
Reference Sources
Summary of Product Characteristics: Doxepin 10mg Capsules. Morningside Healthcare Ltd. Revised October 2021.
Summary of Product Characteristics: Doxepin 25mg Capsules. Dexcel Pharma Ltd. Revised March 2021.
Summary of Product Characteristics: Doxepin 50mg Capsules. Dexcel Pharma Ltd. Revised March 2021.
Summary of Product Characteristics: Doxepin 25mg Capsules. Marlborough Pharmaceuticals Ltd. Revised June 2021.
Summary of Product Characteristics: Doxepin 50mg Capsules. Marlborough Pharmaceuticals Ltd. Revised June 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 September 2022
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Doxepin. Last revised: 18 April 2022
Last accessed: 06 September 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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