SAVELLA- milnacipran hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

milnacipran hydrochloride

Composition:

milnacipran hydrochloride 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

12.5-mg tablets: Blue, round, film-coated tablets, debossed with "F" on one side and "L" on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:       NDC 0456-1512-63 25-mg tablets: White, round, film-coated tablets, debossed with "FL" on one side and "25" on the reverse Bottles of 60:               NDC 0456-1525-60 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets: White, oval-shaped, film-coated tablets, debossed with "FL" on one side and "50" on the reverse Bottles of 60:               NDC 0456-1550-60 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets: Pink, oval-shaped, film-coated tablets, debossed with "FL" on one side and "100" on the reverse Bottles of 60:               NDC 0456-1510-60 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack: 4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 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].

Authorization status:

New Drug Application

Patient Information leaflet

SAVELLA- MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
----------
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 hea

Summary of Product characteristics

SAVELLA- MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
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 bl