Trade Names:Sinequan- Capsules 10 mg- Capsules 25 mg- Capsules 50 mg- Capsules 75 mg- Capsules 100 mg- Capsules 150 mg
Trade Names:Zonalon- Cream 5%Apo-Doxepin (Canada)
Moderately blocks reuptake of norepinephrine and weakly blocks reuptake of serotonin; also produces antihistaminic and anticholinergic activity.
T max is 2 to 8 days (steady-state).
Metabolized in the liver to desmethyldoxepin (active).
Urinary excretion; t ½ is 8 to 24 h (oral), 28 to 52 h (topical).
Treatment of psychoneurotic patients with depression and/or anxiety; depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol); depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly); psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders; moderate pruritus with atopic dermatitis or lichen simplex chronicus (topical).
Neurogenic pain, peptic ulcer disease.
Hypersensitivity to tricyclic antidepressants; use during acute recovery phase after MI; glaucoma; risk of urinary retention; concomitant use with MAOI; dibenzoxepines may produce cross-sensitivity.
PO Initial dose 75 mg/day, increasing as tolerated (max, 300 mg/day). May be given every day or on a divided dosage schedule. If given every day, the max recommended dose is 150 mg/day.For Mild Cases with Organic Diseases
PO 25 to 50 mg/day.PruritusAdults
Topical Apply thin film 4 times daily with at least 3 to 4 h between applications. Not recommended for more than 8 days.
Store capsules below 86°F.
CNS and respiratory depression may be potentiated.Cimetidine
May inhibit metabolism of doxepin, leading to increased concentrations.Clonidine
Concurrent use may lead to loss of BP control and possibly dangerous increases in BP.Guanethidine
Hypotensive action may be inhibited.MAOIs
Concurrent use may lead to severe seizures, hyperpyretic crisis, and fatal reactions. Generally, allow 7 to 10 days between discontinuation of 1 drug and start of another.SSRIs (eg, fluoxetine)
May increase serum concentrations of doxepin; effect may occur up to 5 wk after discontinuation of fluoxetine.Sympathomimetics (eg, dopamine, epinephrine)
Pressor response may increase or decrease; arrhythmias may occur.Type IC antiarrhythmics (eg, propafenone, flecainide)
May inhibit metabolism of doxepin, leading to increased concentrations.
None well documented.
Orthostatic hypotension; hypertension; fainting; tachycardia.
Dizziness; drowsiness; headache; confusion; weakness; tremors; convulsions; fatigue; disorientation; hallucinations; numbness; paresthesias; ataxia; extrapyramidal symptoms; tardive dyskinesia.
Skin rash; edema; photosensitization; pruritus.Topical use
Local burning or stinging; dry or tight skin.
Mydriasis; photophobia; blurred vision; tinnitus.
Nausea; constipation; dry mouth; paralytic ileus; vomiting; indigestion; taste perversion; diarrhea; anorexia; aphthous stomatitis.
Urinary retention; nocturia; altered libido; testicular swelling, gynecomastia (males); enlargement of breasts, galactorrhea (females).
Agranulocytosis; eosinophilia; purpura; thrombocytopenia; leukopenia.
Weight gain; syndrome of inappropriate secretion of antidiuretic hormone; raising or lowering of blood sugar levels.
Exacerbation of asthma.
Hyperthermia; alopecia; sweating; chills.
Category C (oral); Category B (topical).
Excreted in breast milk.
Not recommended for children younger than 12 yr of age.
Use drug with caution in patients with history of seizures, urinary retention, urethral spasm, angle-closure glaucoma or increased IOP, CV disorders, hyperthyroidism (or those receiving thyroid medication), hepatic or renal function impairment, schizophrenia, or paranoia.
The 150 mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment.
Use of cream can cause Type IV hypersensitivity reactions.
Use drug with caution in patients with suicidal tendencies; do not allow access to large quantities of drug.
For external use only; do not use ophthalmically, orally, or intravaginally. Because of absorption of drug, drowsiness often occurs.
If treatment is to be discontinued, or the dose reduced, gradually taper the dose and monitor patient for withdrawal symptoms. If significant withdrawal symptoms develop, reinstitute previous dosing schedule and attempt a less rapid tapering regimen after patient has stabilized.
Confusion, agitation, transient visual hallucinations, seizures, hyperactive reflexes, coma, cardiac arrhythmias, dilated pupils, hyperpyrexia, severe hypotension, CNS depression, ECG changes (QRS axis or width), disturbed concentration, stupor, drowsiness, muscle rigidity, vomiting, hypothermia.
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