Fetzima Generic Name & Formulations
Legal Class
Rx
General Description
Levomilnacipran 20mg, 40mg, 80mg, 120mg; ext-rel caps.
Pharmacological Class
SNRI.
How Supplied
Caps 20mg—30; 40mg, 80mg, 120mg—30, 90; Titration Pack—1 (2 x 20mg + 26 x 40mg)
Manufacturer
Generic Availability
NO
Fetzima Indications
Indications
Major depressive disorder (MDD).
Limitations of Use
Not approved for the management of fibromyalgia; efficacy and safety have not been established.
Fetzima Dosage and Administration
Adult
Swallow whole. Initially 20mg once daily for 2 days, and then increase to 40mg once daily; may increase dose in 40mg increments at intervals of ≥2 days; max 120mg once daily. Renal impairment: moderate (CrCl 30–59mL/min): max 80mg once daily; severe (CrCl 15–29mL/min): max 40mg once daily. ESRD: not recommended. Concomitant strong CYP3A4 inhibitors: max 80mg once daily.
Children
<18yrs: not established.
Fetzima Contraindications
Contraindications
During or within 14 days of MAOIs. Initiating MAOIs during or within 7 days of levomilnacipran. Concomitant linezolid or IV methylene blue.
Fetzima Boxed Warnings
Boxed Warning
Suicidal thoughts and behaviors.
Fetzima Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thoughts and behavior in children and young adults; monitor for clinical worsening and unusual changes. Suicidal ideation. Screen for bipolar disorder. Monitor for serotonin syndrome; discontinue if occurs. Pre-existing hypertension, cardio- or cerebrovascular disease, or tachyarrhythmias. Monitor BP, HR prior to and during therapy; consider discontinuation or other treatment if elevation persists. Risk of bleeding. Angle-closure glaucoma. Obstructive urinary disorders. History of mania/hypomania. Seizure disorder. Renal impairment. Volume depleted. Hyponatremia (esp. elderly). Sexual dysfunction. Avoid abrupt cessation. Reevaluate periodically. Write ℞ for smallest practical amount. Pregnancy: see full labeling for effects on neonates in 3rd trimester. Nursing mothers: monitor infants.
Fetzima Pharmacokinetics
Elimination
Renal.
Fetzima Interactions
Interactions
See Contraindications. Allow at least 14 days after MAOI discontinuation before starting levomilnacipran; allow at least 7 days after discontinuing levomilnacipran before starting an MAOI. Increased risk of serotonin syndrome with other serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Increased risk of bleeding with concomitant NSAIDs, aspirin, warfarin, and others that affect coagulation. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, itraconazole, ritonavir); see Adult. Avoid alcohol. Caution with other CNS-active drugs, or drugs that can increase BP or HR.
Fetzima Adverse Reactions
Adverse Reactions
Nausea, constipation, vomiting, hyperhidrosis, heart rate increase, erectile dysfunction, tachycardia, palpitations; hypertension, urinary hesitation/retention (consider discontinuing if occurs).
Fetzima Clinical Trials
See Literature
Fetzima Note
Not Applicable
Fetzima Patient Counseling
See Literature
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