TOFRANIL Sugar-coated tablet (2020)

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BOXED WARNING SECTION

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 ...

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure.

1. Description

Tofranil is supplied in tablet form for oral administration. Tofranil, imipramine hydrochloride USP, the original tricyclic antidepressant, is a member of the dibenzazepine group of compounds. It is designated ...

2. Clinical Pharmacology

The mechanism of action of Tofranil is not definitely known. However, it does not act primarily by stimulation of the central nervous system. The clinical effect is hypothesized as being due to potentiation ...

3. 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 ...

4. Contraindications

The concomitant use of monoamine oxidase inhibiting compounds is contraindicated. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. The potentiation of ...

5. Warnings

Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior ...

6. Precautions

Clinical Worsening and Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, ...

6.1. General

An ECG recording should be taken prior to the initiation of larger-than-usual doses of Tofranil and at appropriate intervals thereafter until steady state is achieved. (Patients with any evidence of cardiovascular ...

6.2. Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with imipramine hydrochloride and should counsel ...

6.4. Drug Interactions

Drugs Metabolized by P450 2D6 The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% ...

6.7. Pregnancy

Animal reproduction studies have yielded inconclusive results (see also ANIMAL PHARMACOLOGY & TOXICOLOGY). There have been no well-controlled studies conducted with pregnant women to determine ...

6.9. Nursing Mothers

Limited data suggest that Tofranil is likely to be excreted in human breast milk. As a general rule, a woman taking a drug should not nurse since the possibility exists that the drug may be excreted in ...

6.10. Pediatric Use

Safety and effectiveness in the pediatric population other than pediatric patients with nocturnal enuresis have not been established (see BOX WARNING and WARNINGS, Clinical Worsening and Suicide Risk ...

6.11. Geriatric Use

In the literature, there were four well-controlled, randomized, double-blind, parallel group comparison clinical studies done with Tofranil in the elderly population. There was a total number of 651 subjects ...

7. Adverse Reactions

Note: Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the tricyclic antidepressant ...

9. Overdosage

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic overdose. As the management is complex and changing, it is recommended ...

10. 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. ...

11. How Supplied

The three strengths of Tofranil (imipramine hydrochloride USP) are available as follows: Tablets 10 mg: triangular, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with on one side ...

13. Animal Pharmacology and/or Animal Toxicology

A. Acute Oral LD50 ranges are as follows: Rat 355 to 682 mg/kg Dog 100 to 215 mg/kg Depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular respiration ...