DIVALPROEX SODIUM tablet, film coated, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)

Предлага се от:

Mylan Pharmaceuticals Inc.

INN (Международно Name):

DIVALPROEX SODIUM

Композиция:

VALPROIC ACID 250 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies (

Каталог на резюме:

Divalproex Sodium Extended-Release Tablets, USP are available containing divalproex sodium, USP equivalent to 250 mg or 500 mg of valproic acid. The 250 mg tablets are white, film-coated, round, unscored tablets debossed with M over 177 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0472-01 bottles of 100 tablets NDC 0378-0472-05 bottles of 500 tablets The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with M 473 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0473-01 bottles of 100 tablets NDC 0378-0473-05 bottles of 500 tablets Recommended Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Medication Guide
Divalproex Sodium Extended-Release Tablets, USP
(dye val′ proe ex soe′ dee um)
What is the most important information I should know about divalproex
sodium extended-release tablets?
Do not stop divalproex sodium extended-release tablets without first
talking to a healthcare provider.
Stopping divalproex sodium extended-release tablets suddenly can cause
serious problems. Stopping a
seizure medicine suddenly in a patient who has epilepsy can cause
seizures that will not stop (status
epilepticus).
Divalproex sodium extended-release tablet can cause serious side
effects, including:
1.
Serious liver damage that can cause death, especially in children
younger than 2 years old and patients
with mitochondrial disorders. The risk of getting this serious liver
damage is more likely to happen
within the first 6 months of treatment.
Call your healthcare provider right away if you get any of the
following symptoms:
•
feeling very weak, tired, or uncomfortable (malaise)
•
swelling of your face
•
not feeling hungry
•
nausea or vomiting that does not go away
•
diarrhea
•
pain on the right side of your stomach (abdomen)
•
dark urine
•
yellowing of your skin or the whites of your eyes
•
loss of seizure control in people with epilepsy
In some cases, liver damage may continue even though the medicine is
stopped. Your healthcare
provider will do blood tests to check your liver before and during
treatment with divalproex
sodium extended-release tablets.
2.
Divalproex sodium extended-release tablets may harm your unborn baby.
•
If you take divalproex sodium extended-release tablets during
pregnancy for any medical
condition, your baby is at risk for serious birth defects that affect
the brain and spinal cord (such
as spina bifida or neural tube defects). These defects can begin in
the first month, even before
you know you are pregnant. Other birth defects that affect the
structures of the heart, head, arms,
legs, and the opening where the u

Данни за продукта

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS.
DIVALPROEX SODIUM EXTENDED-RELEASE_ _TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
WARNING: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
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INDICATIONS AND USAGE
Divalproex sodium extended-release tablets are indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
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DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg and 500 mg (3)
CONTRAINDICATIONS
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•
•
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HEPATOTOXICITY, INCLUDING FATALITIES, USUALLY DURING THE FIRST 6
MONTHS OF TREATMENT.
CHILDREN UNDER THE AGE OF TWO YEARS AND PATIENTS WITH MITOCHONDRIAL
DISORDERS ARE
AT HIGHER RISK. MONITOR PATIENTS CLOSELY, AND PERFORM SERUM LIVER
TESTING PRIOR TO
THERAPY AND AT FREQUENT INTERVALS THEREAFTER (5.1)
FETAL RISK, PARTICULARLY NEURAL TUBE DEFECTS, OTHER MAJOR
MALFORMATIONS, AND
DECREASED IQ (5.2, 5.3, 5.4)
PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES (5.5)
Acute treatment of manic or mixed episodes associated with bipolar
disorder, with or without
psychotic features (1.1)
Monotherapy and adjunctive therapy of complex partial seizures and
simple and complex absence
seizures; adjunctive therapy in patients with multiple seizure types
that include absence seizures (1.2)
Prophylaxis of migraine headaches (1.3)
Divalproex sodium extended-release tablets are intended for once-a-day
oral administration.
Divalproex sodium extended-release tablets should be swallowed whole
and should not be crushed or
chewed (2.1, 2.2).
Mania: Initial dose is 25 mg/kg/day, increasing as rapidly as possible
to achieve therapeutic response
or desired plasma level (2.1). The maximum recommended dosage is 60
mg/kg/day (2.1, 2.2).
Complex Partial Seizure