Generic
Levomilnacipran Hydrochloride
2 brands available in the market
At a glance
Levomilnacipran Hydrochloride is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults.
Description
The exact mechanism of the antidepressant action of levomilnacipran is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the CNS through inhibition of reuptake at serotonin and norepinephrine transporters. It binds with high affinity to the human serotonin (5-HT) and norepinephrine (NE) transporters and potently inhibits their reuptake. It lacks significant affinity for any other receptors, ion channels or transporters tested.
Indications
- Major Depressive Disorder (MDD) in adults
Therapeutic class
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Pharmacological class
SNRI
Pharmacology
Levomilnacipran inhibits serotonin and norepinephrine transporters, increasing their levels in the CNS, which produces antidepressant effects.
Mechanism of action
Improves symptoms of Major Depressive Disorder by inhibiting serotonin and norepinephrine reuptake.
Dosage
Adult Dose (Oral):
- Initial: 20 mg once daily (2 days), then 40 mg once daily
- May increase by 40 mg at intervals of 2 or more days if needed
- Maximum dose: 120 mg once daily
- Swallow capsules whole; do not open, chew or crush
- May be taken with or without food
Renal Impairment: Moderate: do not exceed 80 mg/day; Severe: do not exceed 40 mg/day
Administration
- Swallow capsules whole; do not open, chew or crush
- May be taken with or without food
- Take at the same time each day
Missed dose
If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
Side effects
Common Side Effects:
- Headache
- Nausea
- Constipation
- Insomnia
- Dizziness
- Dry mouth
- Hyperhidrosis
- Increased heart rate
- Increased blood pressure
Precautions & warnings
- Monitor for suicidal thoughts and behavior (adolescents and young adults)
- Monitor for serotonin syndrome
- Monitor blood pressure and heart rate
- Risk of angle-closure glaucoma
- Urinary hesitation or retention
- Activation of mania/hypomania
- Gradually reduce dose to avoid discontinuation syndrome
Contraindications
- Hypersensitivity to levomilnacipran, milnacipran HCl, or any excipients
- Coadministration with MAOIs or within 7 days (risk of serotonin syndrome)
Drug interactions
- Strong CYP3A4 inhibitors (ketoconazole): do not exceed 80 mg/day
Food interactions
Safety with alcohol is not known; consult your doctor.
Use in pregnancy
Use in Pregnancy: Third trimester use may increase risk of poor adaptation symptoms in the neonate (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability). Use only if clearly needed.
Use in lactation
Use in Lactation: Safety during breastfeeding has not been established; use with caution.
Pediatric use
Safety and effectiveness not established in pediatric patients; not approved for use in pediatric patients.
Geriatric use
No dose adjustment recommended based on age (exposure may be slightly higher); consider renal clearance.
Renal / hepatic impairment
Renal Impairment: Moderate: do not exceed 80 mg/day; Severe: do not exceed 40 mg/day; ESRD: not recommended.
Hepatic Impairment: Mild-severe: no dose adjustment recommended.
Overdose effects
No specific overdose information available; symptomatic and supportive measures should be employed.
Storage conditions
Store below 30°C, away from light and moisture; keep out of reach of children.
Chemical structure
Levomilnacipran Hydrochloride