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LEADING PHARMA
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69315013401

imipramine hcl 25 mg tablet (generic tofranil)

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Dosage and Administration

Administration

Imipramine hydrochloride and imipramine pamoate are administered orally. Although imipramine hydrochloride has been administered in up to 4 divided doses throughout the day, it is long-acting and the entire oral daily dose may be administered at one time. Imipramine pamoate may also be used to administer the daily oral dose of imipramine, but it has no advantages over the hydrochloride. Administration of the entire daily dose at bedtime may reduce daytime sedation; patients who experience insomnia and stimulation may be given the entire daily dose in the morning.

Dosage

Dosage of imipramine salts is expressed in terms of imipramine hydrochloride.

Patients should be monitored for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustment. ()

Major Depressive Disorder

There is a wide range of oral dosage requirements, and dosage must be carefully individualized. Initial dosages of imipramine should be low and generally range from 75-100 mg daily, depending on the severity of the condition being treated. Dosage may be gradually adjusted to the level that produces maximal therapeutic effect with minimal toxicity and may range up to 300 mg daily. Hospitalized patients under close supervision may generally be given higher dosages than outpatients, and manufacturers state that dosages of greater than 200 mg daily are not recommended for outpatients. Geriatric patients should usually be given lower than average dosages. Manufacturers state that therapy should be initiated with 25-50 mg daily as imipramine hydrochloride (e.g., Tofranil) in these patients and that optimal dosage rarely exceeds 100 mg daily. If the daily dosage is established at 75 mg or more, imipramine pamoate (e.g., Tofranil PM) may be administered. Maximum antidepressant effects may not occur for 2 or more weeks after therapy is begun.

After symptoms are controlled, dosage should be gradually reduced to the lowest level that will maintain relief of symptoms. If maintenance therapy is necessary, manufacturers recommend an adult dosage of 50-150 mg daily. To avoid the possibility of precipitating withdrawal symptoms, imipramine should not be terminated abruptly in patients who have received high dosage for prolonged periods.

Functional Enuresis in Children

For the treatment of functional enuresis in children who are at least 6 years of age, the usual initial oral dosage of imipramine hydrochloride is 25 mg daily, administered 1 hour prior to bedtime. If a satisfactory response is not obtained within 1 week, dosage may be increased to 50 mg nightly for children younger than 12 years of age or 75 mg nightly for children 12 years of age and older. Dosages higher than 75 mg daily do not improve results and may increase the risk of adverse reactions. For children who are early-night bedwetters, better results may be obtained by administering 25 mg in midafternoon and again at bedtime. Dosage of imipramine hydrochloride for the treatment of functional enuresis in children should not exceed 2.5 mg/kg daily. Long-term effects of the drug in children have not been determined; therefore, after a satisfactory response has been maintained, imipramine hydrochloride should be gradually withdrawn. If dosage is gradually reduced after a favorable response of many weeks, relapses may be less frequent; children who relapse may not respond to subsequent treatment with imipramine. (See Cautions: Pediatric Precautions.)

Cautions

Imipramine shares the pharmacologic actions, uses, and toxic potentials of the tricyclic antidepressants, and the usual precautions of tricyclic antidepressant administration should be observed. Patients should be fully advised about the risks, especially suicidal thinking and behavior (suicidality), associated with tricyclic antidepressant therapy. For a complete discussion,

Although the clinical importance is not known, ECG changes have been reported in pediatric patients receiving twice the recommended maximum daily dosage.

Pediatric Precautions

Imipramine hydrochloride is used for the treatment of enuresis in children 6 years of age or older, but safety and efficacy of the drug for the treatment of this condition in younger children or for the treatment of any other condition in pediatric patients have not been established. The manufacturer of imipramine pamoate states that the drug should not be used in children of any age because of the high potency and risk of acute overdose.

The US Food and Drug Administration (FDA) has determined that antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders. However, FDA also states that depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide. Anyone considering the use of imipramine in a child or adolescent for any clinical use must therefore balance the potential risk of therapy with the clinical need. ( and Cautions: , in the Tricyclic Antidepressants General Statement 28:16.04.28.)

Pharmacokinetics

Absorption

In studies with radiolabeled imipramine, the drug was completely absorbed from the GI tract. Peak plasma concentrations of imipramine occur within 1-2 hours after oral administration and 30 minutes after IM administration (no longer commercially available in the US).

Distribution

Limited data indicate that imipramine and its active metabolite, desipramine, are distributed into milk in concentrations similar to those present in maternal plasma.

Elimination

The plasma half-life of imipramine ranges from 8-16 hours. Imipramine is metabolized via the same pathways as are other tricyclic antidepressants; desipramine, its N-monodemethylated metabolite, is pharmacologically active. Approximately 40% of a dose of imipramine is excreted in urine as inactive metabolites within 24 hours and 70% within 72 hours; small amounts are excreted in feces via biliary elimination.

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