Drug Catalog - Product Detail
DOXEPIN HCL ORAL SOLUTION SOL 10MG/ML 118ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 60432-0651-04 | MORTON GROVE PHARMACEUTICALS | 118 | 10MG/ML | LIQUID |
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Description
DESCRIPTION Doxepin Hydrochloride Oral Solution, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform. The solution is administered orally and contains doxepin hydrochloride equivalent to 10 mg doxepin per mL. Inactive Ingredients: citric acid anhydrous, glycerin, peppermint oil, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, and sorbitol solution. 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. C 19 H 21 NO∙HCl M.W. 316 image 1
How Supplied
HOW SUPPLIED Doxepin Hydrochloride Oral Solution, USP (Concentrate), a clear colorless liquid, is available in 4 fl oz (118 mL) containers, 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 (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 (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° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only Product No.: 8651 Manufactured For: Wockhardt USA, LLC Parsippany, NJ 07054 Manufactured By: Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053 28651 REV. 09-18 PHARMACIST - PATIENT MEDICATION GUIDE PROVIDED BELOW
Indications & Usage
INDICATIONS AND USAGE Doxepin hydrochloride oral solution is recommended for the 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. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride 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 hydrochloride 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.