Doxepin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Depression As cap/soln: Initial: 75 mg/day, adjusted according to individual response. May increase up to 300 mg/day in severe cases. Doses up to 100 mg/day may be given as single dose at bedtime or in divided doses. Doses >100 mg should be given in 3 divided doses. Insomnia As tab: 3-6 mg once daily, taken within 30 minutes of bedtime and not within 3 hours of a meal. Max: 6 mg/day. Re-evaluate patient after 7-10 days if insomnia persists. Topical Pruritic skin disorders As 5% cream: Apply thinly to the affected area 3-4 times/day, with at least 3-4 hours interval between application, for up to 8 days. Max coverage area: <10% of BSA.
Administration
May be taken with or without food.
Contraindications
Mania, narrow-angle glaucoma, tendency to urinary retention. Severe liver impairment. Lactation. Concomitant use or within 14 days of discontinuing MAOIs.
Special Precautions
Patient with bipolar disorder; history of suicide-related events, epilepsy, risk factors of seizures (e.g. head trauma, brain damage, alcoholism), CV disease (e.g. recent MI, heart block, tachycardia, cardiac arrhythmia, conduction abnormalities), cerebrovascular disease, hypovolaemia, compromised respiratory function, sleep apnoea, decreased gastrointestinal motility, paralytic ileus, benign prostatic hyperplasia, xerostomia, visual problems, diabetes mellitus, hyperthyroidism. Patient undergoing elective surgery. Concomitant electroconvulsive therapy. Avoid abrupt withdrawal. Renal and mild to moderate hepatic impairment. Children and elderly. Pregnancy. CYP2D6 ultrarapid, intermediate and poor metabolisers. CYP2C19 ultrarapid, rapid and poor metabolisers. Patient Counselling This drug may cause drowsiness, if affected, do not drive or operate machinery. Topical: Avoid use of occlusive dressing. Monitoring Parameters Monitor ECG, heart rate and blood pressure in at risk patients; serum electrolytes (e.g. K, Na, magnesium), LFTs, blood glucose, weight and BMI at baseline, at periodic intervals and as clinically indicated. Closely monitor CNS status for signs of suicidal ideation, clinical worsening, and unusual behavioural changes especially at the start of therapy or when doses are increased or decreased; local skin reactions, excessive drowsiness or other systemic effects.
Adverse Reactions
Significant: Suicidal ideation and behaviour, precipitation of mania or hypomania, anticholinergic effects (e.g. constipation, dry mouth, blurred vision, urinary retention), CNS depression, bone fractures, mild pupillary dilation, orthostatic hypotension, QT prolongation, sleep-related activities (e.g. sleep-driving, cooking, eating or making phone calls while asleep), amnesia, hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), withdrawal symptoms, contact sensitisation (topical). Blood and lymphatic system disorders: Rarely, eosinophilia, purpura, leucopenia, agranulocytosis, thrombocytopenia. Cardiac disorders: Tachycardia. Endocrine disorders: Extrapyramidal symptoms. Gastrointestinal disorders: Nausea, vomiting, indigestion, diarrhoea, taste disturbances. General disorders and administration site conditions: Fatigue, weakness, chills, facial oedema; application site reactions (e.g. burning, or stinging sensation, irritation). Immune system disorders: Urticaria. Investigations: Weight gain, increased or decreased blood sugar levels. Metabolism and nutrition disorders: Anorexia. Nervous system disorders: Drowsiness, tremors, paraesthesia, headache, dizziness. Rarely, convulsions. Psychiatric disorders: Insomnia, nightmares, confusion, disorientation, agitation. Reproductive system and breast disorders: Testicular swelling, gynecomastia. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis. Skin and subcutaneous tissue disorders: Rash, sweating, pruritus, photosensitisation, alopecia. Vascular disorders: Flushing.
ROUTE(S) : Topical: B
ROUTE(S) : PO: C
Drug Interactions
Increased plasma concentrations with CYP2D6 inhibitors (e.g. quinidine, SSRIs). Increased risk of arrhythmias, hypo- or hypertension with anaesthetics, sympathomimetic agents (e.g. ephedrine, isoprenaline). May decrease antihypertensive effects of debrisoquine, bethanidine, guanethidine, clonidine. Increased rate of metabolism with barbiturates. Cimetidine may fluctuate steady-serum concentration of doxepin. May reduce effect of sublingual nitrates owing to dry mouth. Increased risk of severe hypoglycaemia with tolazamide.
ATC Classification
D04AX01 - doxepin
N06AA12 - doxepin ; Belongs to the class of non-selective monoamine reuptake inhibitors. Used in the management of depression.
Disclaimer: This information is independently developed by CIMS based on doxepin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in