DIVALPROEX SODIUM DELAYED RELEASE (SPRINKLE)- divalproex sodium capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Sandoz Inc.

ИНН (Международная Имя):

DIVALPROEX SODIUM

состав:

VALPROIC ACID 125 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Divalproex sodium delayed release capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed release capsules are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with

Обзор продуктов:

Divalproex Sodium Delayed Release Capsules (Sprinkle), for oral use 125 mg, are white opaque and blue, and are supplied in bottles of 100 (NDC 0781-2243-01). Recommended Storage: Store capsules below 77°F (25°C).

Статус Авторизация:

New Drug Application Authorized Generic

тонкая брошюра

DIVALPROEX SODIUM DELAYED RELEASE (SPRINKLE)- divalproex sodium
capsule
Sandoz Inc.
----------
MEDICATION GUIDE
DIVALPROEX SODIUM DELAYED RELEASE CAPSULES (SPRINKLE)
(dye val' proe ex soe' dee um)
Read this Medication Guide before you start taking divalproex sodium
delayed release capsules and each
time you get a refill. There may be new information. This information
does not take the place of talking to
your healthcare provider about your medical condition or treatment.
What is the most important information I should know about divalproex
sodium delayed release capsules?
Do not stop taking divalproex sodium delayed release capsules without
first talking to your healthcare
provider.
Stopping divalproex sodium delayed release capsules suddenly can cause
serious problems.
Divalproex sodium delayed release capsules can cause serious side
effects, including:
1. Serious liver damage that can cause death, especially in children
younger than 2 years old. 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:
•
nausea or vomiting that does not go away
•
loss of appetite
•
pain on the right side of your stomach (abdomen)
•
dark urine
•
swelling of your face
•
yellowing of your skin or the whites of your eyes
In some cases, liver damage may continue despite stopping the drug.
2. Divalproex sodium delayed release capsules may harm your unborn
baby.
•
If you take divalproex sodium delayed release capsules during
pregnancy for any medical condition,
your baby is at risk for serious birth defects that affect the brain
and spinal cord and are called spina
bifida or neural tube defects. These defects occur in 1 to 2 out of
every 100 babies born to mothers
who use this medicine during pregnancy. 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

Характеристики продукта

DIVALPROEX SODIUM DELAYED RELEASE (SPRINKLE)- DIVALPROEX
SODIUM CAPSULE
SANDOZ INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM
DELAYED RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DIVALPROEX SODIUM DELAYED RELEASE CAPSULES.
DIVALPROEX SODIUM DELAYED RELEASE CAPSULES (SPRINKLE), FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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)
INDICATIONS AND USAGE
Divalproex sodium delayed release capsules are an anti-epileptic drug
indicated for:
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)
DOSAGE AND ADMINISTRATION
Divalproex sodium delayed release capsules may be swallowed whole or
the contents may be sprinkled
on soft food. The drug/food mixture should be swallowed immediately
(avoid chewing) (2.2)
Safety of doses above 60 mg/kg/day is not established (2.1, 2.2)
Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1
week intervals by 5 to 10
mg/kg/day to achieve optimal clinical response; if response is not
satisfactory, check valproate plasma
level; see full prescribing information for conversion to monotherapy
(2.1)
Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week
intervals by 5 to 10 mg/kg/day until
seizure control or limiting side effects (2.1)
DOSAGE FORMS AND STRENGTHS
Ca