FETZIMA levomilnacipran hydrochloride capsule extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

LEVOMILNACIPRAN HYDROCHLORIDE (UNII: 371U2ZK31U) (levomilnacipran - UNII:UGM0326TXX)

Dostępny od:

Avera McKennan Hospital

INN (International Nazwa):

LEVOMILNACIPRAN HYDROCHLORIDE

Skład:

levomilnacipran 40 mg

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

New Drug Application

Charakterystyka produktu

FETZIMA- LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FETZIMA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FETZIMA.
FETZIMA (LEVOMILNACIPRAN) EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009 (MILNACIPRAN)
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS (5.1).
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS
(5.1).
FETZIMA IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4).
RECENT MAJOR CHANGES
Contraindications - removed uncontrolled narrow-angle glaucoma (4)
07/2014
Warnings and Precautions - Angle Closure Glaucoma (5.6)
07/2014
INDICATIONS AND USAGE
FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of Major Depressive
Disorder (MDD) (1).
Limitation of Use: FETZIMA is not approved for the management of
fibromyalgia. The efficacy and safety of FETZIMA for
the management of fibromyalgia have not been established (1).
DOSAGE AND ADMINISTRATION
_Recommended dose:_ 40 mg to 120 mg once daily with or without food
(2.1).
Initiate dose at 20 mg once daily for 2 days and then increase to 40
mg once daily (2.1).
Based on efficacy and tolerability, increase dose in increments of 40
mg at intervals of 2 or more days (2.1).
The maximum recommended dose is 120 mg once daily (2.1).
Take capsules whole; do not open, chew or crush (2.1)
_Renal Impairment:_ Do not exceed 80 mg once daily for moderate
impairment. Do not exceed 40 mg once daily for
severe renal impairment (2.3).
_Discontinuation:_ Reduce dose gradually whenever possible (2.4)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 20 mg, 40 mg, 80 mg and 120 mg (3).
CONTRAINDICATIONS
_Hypersensitivity_ to levomilnacipran, milnacipran HCl, or any
excip