Drug Catalog - Product Detail
IMIPRAMINE HCL, USP TB 25MG 1000
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-1764-10 | SANDOZ | 1000 | 25MG | TABLET |
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Description
DESCRIPTION Imipramine hydrochloride, USP the original tricyclic antidepressant, is a member of the dibenzazepine group of compounds. It is designated 5-[3-(Dimethylamino) propyl]-10, 11-dihydro-5 H -dibenz [ b,f ]-azepine monohydrochloride. Structurally, it may be represented as follows: Imipramine hydrochloride, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Each tablet, for oral administration, contains 10 mg, 25 mg or 50 mg imipramine hydrochloride, USP. Inactive ingredients for 10 mg include: corn starch, D & C Yellow #10 Aluminum Lake, D & C Red #30 Aluminum Lake, hydroxypropyl cellulose, hypromellose, lactose (anhydrous), magnesium stearate, polyethylene glycol, povidone and titanium dioxide; for 25 mg: corn starch, D & C Yellow #10 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, lactose (anhydrous), magnesium stearate, polyethylene glycol, povidone and titanium dioxide; for 50 mg: corn starch, D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, FD & C Red #40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, lactose (anhydrous), magnesium stearate, polyethylene glycol, povidone and titanium dioxide. imipraminehydrochloridechemicalstructure
How Supplied
HOW SUPPLIED Imipramine hydrochloride tablets, USP for oral administration are available as: 10 mg: Round, film-coated, yellow tablets, debossed GG on one side and 41 on the reverse side, and supplied as: NDC 0781-1762-31 bottles of 30 NDC 0781-1762-01 bottles of 100 NDC 0781-1762-10 bottles of 1000 25 mg: Round, film-coated, beige tablets, debossed GG on one side and 47 on the reverse side, and supplied as: NDC 0781-1764-31 bottles of 30 NDC 0781-1764-01 bottles of 100 NDC 0781-1764-10 bottles of 1000 NDC 0781-1764-13 unit dose packages of 100 50 mg: Round, film-coated, green tablets, debossed GG on one side and 42 on the reverse side, and supplied as: NDC 0781-1766-31 bottles of 30 NDC 0781-1766-01 bottles of 100 NDC 0781-1766-10 bottles of 1000 NDC 0781-1766-13 unit dose packages of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.
Indications & Usage
INDICATIONS AND USAGE Depression For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
Dosage and Administration
DOSAGE AND ADMINISTRATION Depression Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission. Usual Adult Dose Hospitalized Patients Initially, 100 mg/day in divided doses gradually increased to 200 mg/day as required. If no response after two weeks, increase to 250 to 300 mg/day. Outpatients Initially, 75 mg/day increased to 150 mg/day. Dosages over 200 mg/day are not recommended. Maintenance, 50 to 150 mg/day. Adolescent and Geriatric Patients Initially, 30 to 40 mg/day; it is generally not necessary to exceed 100 mg/day. Childhood Enuresis Initially, an oral dose of 25 mg/day should be tried in children aged 6 and older. Medication should be given one hour before bedtime. If a satisfactory response does not occur within one week, increase the dose to 50 mg nightly in children under 12 years; children over 12 may receive up to 75 mg nightly. A daily dose greater than 75 mg does not enhance efficacy and tends to increase side effects. Evidence suggests that in early night bedwetters, the drug is more effective given earlier and in divided amounts, i.e., 25 mg in midafternoon, repeated at bedtime. Consideration should be given to instituting a drug free period following an adequate therapeutic trial with a favorable response. Dosage should be tapered off gradually rather than abruptly discontinued; this may reduce the tendency to relapse. Children who relapse when the drug is discontinued do not always respond to a subsequent course of treatment. A dose of 2.5 mg/kg/day should not be exceeded. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount. The safety and effectiveness of imipramine hydrochloride as temporary adjunctive therapy for nocturnal enuresis in children less than 6 years of age has not been established.