Drug Catalog - Product Detail
Doxepin HCl Conc 10 MG/ML 120 ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 54838-0512-40 | SILARX | 120 | 10MG/ML | LIQUID |
PACKAGE FILES
Generic Name
DOXEPIN HYDROCHLORIDE
Substance Name
DOXEPIN HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA074721
Description
DESCRIPTION Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19 H 21 NO•HCl having a molecular weight of 315.84. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform. Doxepin hydrochloride oral solution is available as a concentrate for oral administration containing doxepin hydrochloride equivalent to 10 mg of doxepin per mL. It also contains the following inactive ingredients: glycerin; methylparaben; peppermint flavor; propylparaben; water. May contain hydrochloric acid and/or sodium hydroxide. Doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b , e ]oxepin-11(6 H )ylidene- N , N -dimethyl-, hydrochloride. structure of doxepin
How Supplied
HOW SUPPLIED Doxepin Hydrochloride Oral Solution USP (Concentrate) is available in 120 mL bottles (NDC 54838-512-40) with an accompanying dropper calibrated at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Each mL contains doxepin hydrochloride equivalent to 10 mg doxepin. Immediately prior to taking this medication, dilute each dose with approximately 120 mL (4 ounces) of water, whole or skimmed milk, or orange, grapefruit, tomato, prune or pineapple juice. Doxepin Hydrochloride Oral Solution USP (Concentrate) is not physically compatible with a number of carbonated beverages. For those patients requiring antidepressant therapy who are on methadone maintenance, Doxepin Hydrochloride Oral Solution USP (Concentrate) and methadone syrup can be mixed together with Gatorade ® , lemonade, orange juice, sugar water, Tang ® or water, but not with grape juice. Preparation and storage of bulk dilutions is not recommended. Recommended Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 10-1104 Rev. 03/20
Indications & Usage
INDICATIONS AND USAGE Doxepin is recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in pediatric patients under 12 years of age.
Dosage and Administration
DOSAGE AND ADMINISTRATION For most patients with illness of mild to moderate severity, a starting daily dose of 75 mg is recommended. Dosage may subsequently be increased or decreased at appropriate intervals and according to individual response. The usual optimum dose range is 75 mg/day to 150 mg/day. In more severely ill patients higher doses may be required with subsequent gradual increase to 300 mg/day if necessary. Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg/day. In patients with very mild symptomatology or emotional symptoms accompanying organic disease, lower doses may suffice. Some of these patients have been controlled on doses as low as 25 to 50 mg/day. The total daily dosage of doxepin may be given on a divided or once-a-day dosage schedule. If the once-a-day schedule is employed, the maximum recommended dose is 150 mg/day. This dose may be given at bedtime. Anti-anxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for two to three weeks.