Levomilnacipran

LEVOMILNACIPRAN

Manufacturer: Amneal Pharmaceuticals LLC

Score: 148.0

Quick Summary

Levomilnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) used for the treatment of major depressive disorder (MDD) in adults. The recommended dosage range is 40 mg to 120 mg once daily, with or without food. It is essential to monitor patients for clinical worsening and emergence of suicidal thoughts and behaviors, as well as other adverse reactions such as nausea, constipation, and increased heart rate. Special considerations are necessary for patients with renal impairment, pregnant or nursing women, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

Treatment of major depressive disorder (MDD) in adults
Selective serotonin and norepinephrine reuptake inhibitor (SNRI)

Important Safety Information

Warning

Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients

Contraindications

Hypersensitivity to levomilnacipran, milnacipran HCl, or any excipient in the formulation
Use of MAOIs intended to treat psychiatric disorders with levomilnacipran or within 7 days of stopping treatment with levomilnacipran

Adverse Reactions

Nausea
Constipation
Hyperhidrosis
Heart rate increased
Erectile dysfunction
Ejaculation disorder
Tachycardia
Vomiting
Palpitations

Dosing Recommendations

General Guidance

Reduce dose gradually whenever possible; maximum recommended dosage is 120 mg once daily

Major depressive disorder (MDD)

Adult Dose

20 mg once daily for 2 days, then increase to 40 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy
Use of levomilnacipran in the month before delivery may be associated with an increased risk of postpartum hemorrhage

Nursing Mothers

There are no available data on the presence of levomilnacipran in human milk
Infants exposed to levomilnacipran should be monitored for agitation, irritability, poor feeding, and poor weight gain

Pediatric Use

The safety and effectiveness of levomilnacipran have not been established in pediatric patients for the treatment of major depressive disorder (MDD)
Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients

Geriatric Use

No dose adjustment is recommended on the basis of age
SNRIs, including levomilnacipran, have been associated with cases of clinically significant hyponatremia in elderly patients