Imipramine Hydrochloride

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• IMIPRAMINE HYDROCHLORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• IMIPRAMINE HYDROCHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• DRUG INTERACTIONS
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• IMIPRAMINE HYDROCHLORIDE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• ANIMAL PHARMACOLOGY & OR TOXICOLOGY
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

IMIPRAMINE HYDROCHLORIDE DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

IMIPRAMINE HYDROCHLORIDE CONTRAINDICATIONS

WARNINGS

• ●

• ●patients with increased intraocular pressure, history of urinary retention, or history of narrow-angle glaucoma because of the drug's anticholinergic properties;

• ●hyperthyroid patients or those on thyroid medication because of the possibility of cardiovascular toxicity;

• ●patients with a history of seizure disorder because this drug has been shown to lower the seizure threshold;

• ●patients receiving guanethidine, clonidine, or similar agents, since imipramine may block the pharmacologic effects of these drugs;

• ●patients receiving methylphenidate hydrochloride. Since methylphenidate hydrochloride may inhibit the metabolism of imipramine hydrochloride, downward dosage adjustment of imipramine hydrochloride may be required when given concomitantly with methylphenidate hydrochloride.

• ●Imipramine may enhance the CNS depressant effects of alcohol. Therefore, it should be borne in mind that the dangers inherent in a suicide attempt or accidental overdosage with the drug may be increased for the patient who uses excessive amounts of alcohol. (SeePRECAUTIONS.)

PRECAUTIONS

DRUG INTERACTIONS

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

IMIPRAMINE HYDROCHLORIDE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

ANIMAL PHARMACOLOGY & OR TOXICOLOGY

SPL MEDGUIDE

• ●all risks and benefits of treatment with antidepressant medicines

• ●all treatment choices for depression or other serious mental illness

• ●What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

• ●Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

• ●Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

• ●Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• ●attempts to commit suicide

• ●new or worse depression

• ●new or worse anxiety

• ●feeling very agitated or restless

• ●panic attacks

• ●trouble sleeping (insomnia)

• ●new or worse irritability

• ●acting aggressive, being angry, or violent

• ●acting on dangerous impulses

• ●an extreme increase in activity and talking (mania)

• ●other unusual changes in behavior or mood

• ●What else do I need to know about antidepressant medicines?

• ●Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

• ●Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

• ●Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your health care provider.

• ●Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

• ●This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION