Milnacipran hydrochloride

Milnacipran hydrochloride
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Black Box Warning

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete Boxed Warning. Milnacipran hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients

Overview

Milnacipran hydrochloride is a serotonin/norepinephrine reuptake inhibitor that is FDA approved for the treatment of fibromyalgia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Milnacipran hydrochloride indicated for the management of fibromyalgia.

• Dosage:

• Administer Savella in two divided doses per day.
• Based on efficacy and tolerability, dosing may be titrated according to the following schedule:

• Day 1: 12.5 mg once
• Days 2-3: 25 mg/day (12.5 mg twice daily)
• Days 4-7: 50 mg/day (25 mg twice daily)
• After Day 7: 100 mg/day (50 mg twice daily)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Milnacipran hydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Milnacipran hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Milnacipran hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Milnacipran hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Milnacipran hydrochloride in pediatric patients.

Contraindications

There is limited information regarding Milnacipran hydrochloride Contraindications in the drug label.

Warnings

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete Boxed Warning. Milnacipran hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients

There is limited information regarding Milnacipran hydrochloride Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Milnacipran hydrochloride Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Milnacipran hydrochloride Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Milnacipran hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Milnacipran hydrochloride in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Milnacipran hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Milnacipran hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Milnacipran hydrochloride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Milnacipran hydrochloride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Milnacipran hydrochloride in geriatric settings.

Gender

There is no FDA guidance on the use of Milnacipran hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Milnacipran hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Milnacipran hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Milnacipran hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Milnacipran hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Milnacipran hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Monitoring

There is limited information regarding Milnacipran hydrochloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Milnacipran hydrochloride and IV administrations.

Overdosage

There is limited information regarding Milnacipran hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Milnacipran hydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Milnacipran hydrochloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Milnacipran hydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Milnacipran hydrochloride Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Milnacipran hydrochloride Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Milnacipran hydrochloride Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Milnacipran hydrochloride Clinical Studies in the drug label.

How Supplied

There is limited information regarding Milnacipran hydrochloride How Supplied in the drug label.

Storage

There is limited information regarding Milnacipran hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Milnacipran hydrochloride Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Milnacipran hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Milnacipran hydrochloride Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Milnacipran hydrochloride Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.