Doxepin Hydrochloride - Doxepin Hydrochloride capsule prescribing information
Suicidality and Antidepressant Drugs
- Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin hydrochloride capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
- Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Doxepin hydrochloride capsule is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk , Precautions: Information for Patients , and Precautions: Pediatric Use )
INDICATIONS AND USAGE
Doxepin hydrochloride capsule 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 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 to 50 mg/day.
The total daily dosage of doxepin hydrochloride capsules 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.
CONTRAINDICATIONS
Doxepin hydrochloride is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other dibenzoxepines should be kept in mind.
Doxepin hydrochloride is contraindicated in patients with glaucoma or a tendency to urinary retention. These disorders should be ruled out, particularly in older patients.
ADVERSE REACTIONS
NOTE: Some of the adverse reactions noted below have not been specifically reported with doxepin hydrochloride capsule use. However, due to the close pharmacological similarities among the tricyclics, the reactions should be considered when prescribing doxepin hydrochloride.
Anticholinergic Effects
Dry mouth, blurred vision, constipation, and urinary retention have been reported. If they do not subside with continued therapy, or become severe, it may be necessary to reduce the dosage.
Central Nervous System Effects
Drowsiness is the most commonly noticed side effect. This tends to disappear as therapy is continued. Other infrequently reported CNS side effects are confusion, disorientation, hallucinations, numbness, paresthesias, ataxia, extrapyramidal symptoms, seizures, tardive dyskinesia, and tremor.
Cardiovascular
Cardiovascular effects including hypotension, hypertension, and tachycardia have been reported occasionally.
Allergic
Skin rash, edema, photosensitization, and pruritus have occasionally occurred.
Hematologic
Eosinophilia has been reported in a few patients. There have been occasional reports of bone marrow depression manifesting as agranulocytosis, leukopenia, thrombocytopenia, and purpura.
Gastrointestinal
Nausea, vomiting, indigestion, taste disturbances, diarrhea, anorexia, and aphthous stomatitis have been reported. (See Anticholinergic Effects .)
Endocrine
Raised or lowered libido, testicular swelling, gynecomastia in males, enlargement of breasts and galactorrhea in the female, raising or lowering of blood sugar levels, and syndrome of inappropriate antidiuretic hormone secretion have been reported with tricyclic administration
Other
Dizziness, tinnitus, weight gain, sweating, chills, fatigue, weakness, flushing, jaundice, alopecia, headache, exacerbation of asthma, angle closure glaucoma, mydriasis and hyperpyrexia (in association with chlorpromazine) have been occasionally observed as adverse effects.
Withdrawal Symptoms
The possibility of development of withdrawal symptoms upon abrupt cessation of treatment after prolonged doxepin hydrochloride administration should be borne in mind. These are not indicative of addiction and gradual withdrawal of medication should not cause these symptoms.
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 NOHCl having a molecular weight of 316. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform.
Inert ingredients for the capsule formulations are: microcrystalline cellulose, partially pregelatinized starch (corn), colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate, capsule moisture, elemental iron and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3.
The imprinting ink contains iron oxide black, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, N-Butyl Alcohol and shellac glaze.
It meets USP Dissolution Test 3.
HOW SUPPLIED
Doxepin hydrochloride capsules, USP are available containing doxepin equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg.
The 10 mg capsule is a #4 capsule with a buff opaque cap and buff opaque body imprinted with "Є529" in black ink on both the cap and body filled with white powder. They are available as follows:
10 mg– 100 count (NDC 24658-793-01)
10 mg– 1000 count (NDC 24658-793-10)
The 25 mg capsule is a #3 capsule with an ivory opaque cap and white opaque body imprinted with "Є530" in black ink on both the cap and body filled with white powder. They are available as follows:
25 mg– 100 count (NDC 24658-794-01)
25 mg– 1000 count (NDC 24658-794-10)
The 50 mg capsule is a #2 capsule with an ivory opaque cap and ivory opaque body imprinted with "Є531" in black ink on both the cap and body filled with white powder. They are available as follows:
50 mg– 100 count (NDC 24658-795-01)
50 mg– 1000 count (NDC 24658-795-10)
The 75 mg capsule is a #2 capsule with a bright light green opaque cap and bright light green opaque body imprinted with "Є532" in black ink on both the cap and body filled with white powder. They are available as follows:
75 mg– 100 count (NDC 24658-796-01)
75 mg– 1000 count (NDC 24658-796-10)
The 100 mg capsule is a #1 capsule with a bright light green opaque cap and white opaque body imprinted with "Є533" in black ink on both the cap and body filled with white powder. They are available as follows:
100 mg– 100 count (NDC 24658-797-01)
100 mg– 500 count (NDC 24658-797-05)
100 mg– 1000 count (NDC 24658-797-10)
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required.
Dispense with Medication Guide available at: www.puracaplabs.com/medguide/Doxepin-Hydrochloride-Capsule.pdf
Distributed by:
PuraCap Laboratories, LLC
DBA Blu Pharmaceuticals
Greenvale, NY 11548
Rev. 12-2022-00
MF529BLUREV12/22
LN0011
