SAVELLA- milnacipran hydrochloride tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

milnacipran hydrochloride (UNII: RNZ43O5WW5) (milnacipran - UNII:G56VK1HF36)

Tilgængelig fra:

Physicians Total Care, Inc.

INN (International Name):

milnacipran hydrochloride

Sammensætning:

milnacipran hydrochloride 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Savella is indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)]. Concomitant use of Savella in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated. In patients receiving a serotonin reuptake inhibitor in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and have been started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. The effects of combined use of Savella and MAOIs have not been evaluated in humans. Therefore, it is recommended that Savella should not be used in combination wit

Produkt oversigt:

White, oval-shaped, film-coated tablets, debossed with "FL" on one side and "50" on the reverse 100-mg tablets: Pink, oval-shaped, film-coated tablets, debossed with "FL" on one side and "100" on the reverse Storage Store at 25°C (77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature].

Autorisation status:

New Drug Application

Indlægsseddel

SAVELLA - MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED
Physicians Total Care, Inc.
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MEDICATION GUIDE
Savella® (Sa-vel-la) Tablets
(milnacipran HCl)
Antidepressant Medicines, Depression and other serious Mental
Illnesses, and Suicidal
Thoughts or Actions
Savella is not used to treat depression, but it acts like medicines
that are used to treat depression
(antidepressants) and other psychiatric disorders.
Read the Medication Guide that comes with you or your family member's
antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts or
actions with antidepressant medicines.
Talk to your or your family member's healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults within the first few months of treatment.
2.
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts
and actions. Some people may have a particularly high risk of having
suicidal thoughts or actions.
These include people who have (or have a family history of) bipolar
illness (also called manic-
depressive illness) or suicidal thoughts or actions.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors,
thoughts, or feelings. This is very important when an antidepressant
medicine is started or
when the dose is changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare
provider between visits as ne

Produktets egenskaber

SAVELLA - MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAVELLA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SAVELLA.
SAVELLA® (MILNACIPRAN HCL) TABLETS
INITIAL U.S. APPROVAL: 2009
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL IDEATION, THINKING, AND BEHAVIOR IN
CHILDREN, ADOLESCENTS, AND YOUNG ADULTS
TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS. SAVELLA IS
NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (5.1).
INDICATIONS AND USAGE
Savella® is a selective serotonin and norepinephrine reuptake
inhibitor (SNRI) indicated for the management of
fibromyalgia (1).
Savella is not approved for use in pediatric patients (5.1).
DOSAGE AND ADMINISTRATION
Administer Savella in two divided doses per day (2.1).
Based on efficacy and tolerability, dosing may be titrated according
to the following schedule (2.1):
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)
Recommended dose is 100 mg/day (2.1).
May be increased to 200 mg/day based on individual patient response
(2.1).
Dose should be adjusted in patients with severe renal impairment
(2.2).
DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg, 25 mg, 50 mg, 100 mg (3)
CONTRAINDICATIONS
Use of monoamine oxidase inhibitors concomitantly or in close temporal
proximity (4.1).
Use in patients with uncontrolled narrow-angle glaucoma (4.2).
WARNINGS AND PRECAUTIONS
Suicidality: Monitor for worsening of depressive symptoms and suicide
risk (5.1).
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like
Reactions: Serotonin syndrome or NMS-like
reactions have been reported with SNRIs and SSRIs. Discontinue Savella
and initiate supportive treatment (5.2, 7).
Elevated blood pressure and heart rate: Cases ha