Imipramine Pamoate 75 mg/1
Imipramine Pamoate · CAPSULE · Lupin Pharmaceuticals, Inc.
Imipramine Pamoate is a capsule containing imipramine pamoate at 75 mg/1, taken oral. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Imipramine Pamoate
- Generic Name
- Imipramine Pamoate
- NDC Code (Product)
68180-314- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 75 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090444
- Marketing Start
- 04/16/2010
Recall History
Lupin Pharmaceuticals Inc.
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION The following recommended dosages for imipramine pamoate should be modified as necessary by the clinical response and any evidence of intolerance. Initial Adult Dosage Outpatients: Therapy should be initiated at 75 mg/day. Dosage may be increased to 150 mg/day which is the dose level at which optimum response is usually obtained. If necessary, dosage may be increased to 200 mg/day. Dosage higher than 75 mg/day may also be administered on a once-a-day basis after the optimum dosage and tolerance have been determined. The daily dosage may be given at bedtime. In some patients it may be necessary to employ a divided-dose schedule. As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients. Hospitalized Patients: Therapy should be initiated at 100 to 150 mg/day and may be increased to 200 mg/day. If there is no response after two weeks, dosage should be increased to 250 to 300 mg/day. Dosage higher than 150 mg/day may also be administered on a once-a-day basis after the optimum dosage and tolerance have been determined. The daily dosage may be given at bedtime. In some patients it may be necessary…
Warnings
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 (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age …
Contraindications
CONTRAINDICATIONS Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with imipramine pamoate or within 14 days of stopping treatment with imipramine pamoate is contraindicated because of an increased risk of serotonin syndrome. The use of imipramine pamoate within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting imipramine pamoate in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION ). Myocardial Infarction The drug is contraindicated during the acute recovery period after a myocardial infarction. Hypersensitivity to Tricyclic Antidepressants Patients with a known hypersensitivity to this compound should not be given the drug. The possibility of cross-sensitivity to other dibenzazepine compounds should be kept in mind.
Adverse Reactions
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 drugs require that each of the reactions be considered when imipramine is administered. Cardiovascular: Orthostatic hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, ECG changes, precipitation of congestive heart failure, stroke. Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis. Neurological: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus. Anticholinergic: Dry mouth, and, rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract. Allergic: Skin rash, petechiae, urticaria, itching, photosensitization; e…
Frequently Asked Questions
What is Imipramine Pamoate used for?
Imipramine Pamoate contains Imipramine Pamoate. It is a capsule taken oral. Consult your doctor for specific uses.
Is Imipramine Pamoate a controlled substance?
Imipramine Pamoate is not classified as a controlled substance by the DEA.
What is the generic name for Imipramine Pamoate?
The generic name for Imipramine Pamoate is Imipramine Pamoate. There are no other listed brand versions of Imipramine Pamoate.
What is the NDC code for Imipramine Pamoate 75 mg/1?
The NDC (National Drug Code) for Imipramine Pamoate 75 mg/1 is 68180-314, listed by Lupin Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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