Contraindications
- Absolute
- known hypersensitivity to doxepin or other dibenzazepines or other ingredients of the drug
- acute intoxication with alcohol, sedatives, analgesics and other psychoactive drugs
- acute delirium tremens
- untreated closed angle glaucoma
- hypertrophy of the prostate with urine retention
- paralytic ileus
- Relative
- hypertrophy of the prostate without urine retention
- reduced function of the bone marrow
- organic brain disorders
- increased risk of seizures, preexisting epilepsy
- preexisting cardiac damage, particular some arrhythmias (e.g. sinoatrial blockage)
- Caution
- other forms of preexisting cardiac damage (other arrhythmias, insufficience)
- MAOIs of the irreversible type (tranylcypromine among others) : These drugs should normally be stopped at least 2 weeks before therapy with doxepin is started.
Children under 12 years of age should not be treated, because no sufficient clinical experience exists for this group of age.
Tricyclic antidepressant drugs, particularly when given in high doses, can induce sinus tachycardia, changes in conduction time, and arrhythmias. A few instances of unexpected death have been reported in patients with cardiovascular disorders. Myocardial infarction and stroke have also been reported with drugs of this class. Therefore, doxepin should be administered with extreme caution to patients with a history of cardiovascular disease, those with circulatory lability, and elderly patients. In such cases, treatment should be initiated with low doses with progressive increases only if required and tolerated, and the patients should be under close surveillance at all dosage levels.
Since tricyclic agents are known to reduce the seizure threshold, doxepin should be used with caution in patients with a history of convulsive disorders. Concurrent administration of ECT and doxepin may be hazardous and, therefore, such treatment should be limited to patients for whom it is essential.
Close supervision is required when doxepin is given to hyperthyroid patients or those receiving thyroid medication because of the possibility of cardiovascular toxicity. At doses above 150 mg/day, it may block the antihypertensive effect of guanethidine and related compounds.
Before initiation of treatment a complete and differentiated blood count should be taken. If any value is pathologic, the blood count should be monitored closely under therapy with doxepin. If values are normal, blood counts should be taken during therapy in regular intervals (recommended: weekly during first month of therapy, monthly during the next 2 months, every 3 months afterwards).
Liver-function studies should be performed periodically.
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