"The US Food and Drug Administration (FDA) has approved 5-aminolevulinic acid (ALA; Ameluz, Biofrontera) gel in combination with the activating BF-RhodoLED photodynamic therapy (PDT) lamp for treatment of patients with actinic keratosis ("...
Severe:Respiratory depression, hypotension, coma, convulsions, cardiac arrhythmias and tachycardias. Also, urinary retention (bladder atony), decreased gastrointestinal motility (paralytic ileus), hyperthermia (or hypothermia), hypertension, dilated pupils, hyperactive reflexes.
Management and Treatment
Mild: Observation and supportive therapy is all that is usually necessary. It may be necessary to reduce the percent of body surface area treated or the frequency of application or apply a thinner layer of cream.
Severe: Medical management of severe doxepin overdosage consists of aggressive supportive therapy. The area covered with doxepin HCI cream should be thoroughly washed. An adequate airway should be established in comatose patients and assisted ventilation used if necessary. EKG monitoring may be required for several days, because relapse after apparent recovery has been reported with oral doxepin HCI. Arrhythmias should be treated with the appropriate antiarrhythmic agent. It has been reported that many of the cardiovascular and CNS symptoms of tricyclic antidepressant poisoning in adults may be reversed by the slow intravenous administration of 1 mg to 3 mg of physostigmine salicylate. Because physostigmine is rapidly metabolized, the dosage should be repeated as required. Convulsions may respond to standard anticonvulsant therapy; however, barbiturates may potentiate any respiratory depression. Dialysis and forced diuresis generally are not of value in the management of overdosage due to high tissue and protein binding of doxepin HCI.
Because doxepin HCI has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical PRUDOXIN (doxepin) Cream application, the use of PRUDOXIN (doxepin) Cream is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention.
PRUDOXIN (doxepin) Cream is contraindicated in individuals who have shown previous sensitivity to any of its components.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/21/2008
Additional Prudoxin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.