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SINEQUAN (doxepin) 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 SINEQUAN (doxepin) include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that SINEQUAN (doxepin) is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, SINEQUAN (doxepin) is not recommended for use in children under 12 years of age.
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 - 50 mg/day.
The total daily dosage of SINEQUAN (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. The 150 mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment.
Anti-anxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for two to three weeks.
SINEQUAN is available as capsules containing doxepin HCl equivalent to:
10 mg - 100's..............................(NDC 0049-5340-66)
25 mg - 100's..............................(NDC 0049-5350-66)
50 mg - 100's..............................(NDC 0049-5360-66)
75 mg - 100's..............................(NDC 0049-5390-66)
100 mg - 100's.............................(NDC 0049-5380-66)
150 mg - 50's..............................(NDC 0049-5370-50)
SINEQUAN (doxepin) Oral Concentrate is available in 120 mL bottles (NDC 0049-5100-47) with an accompanying dropper calibrated at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Each mL contains doxepin HCl equivalent to 10 mg doxepin. Just prior to administration, SINEQUAN (doxepin) Oral Concentrate should be diluted with approximately 120 mL of water, whole or skimmed milk, or orange, grapefruit, tomato, prune or pineapple juice. SINEQUAN (doxepin) Oral Concentrate is not physically compatible with a number of carbonated beverages. For those patients requiring antidepressant therapy who are on methadone maintenance, SINEQUAN (doxepin) Oral 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.
Distributed by: Roerig Division of Pfizer Inc, NY, NY 10017. FDA Rev date: 02/08/2007
Last reviewed on RxList: 8/29/2007
This monograph has been modified to include the generic and brand name in many instances.
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