DIVALPROEX SODIUM tablet, delayed release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

Divalproex Sodium (UNII: 644VL95AO6) (Valproic Acid - UNII:614OI1Z5WI)

Доступна з:

NCS HealthCare of KY, LLC dba Vangard Labs

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. 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. The efficacy of divalproex sodium delayed-release tablets was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)] . The safety and effectiveness of divalproex sodium delayed-release tablets for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual pat

Огляд продуктів:

Divalproex sodium delayed-release tablets, USP are supplied as 125 mg, 250 mg and 500 mg (as valproic acid) tablets for oral administration. The 125 mg (as valproic acid) tablets are rose-colored, enteric-coated, capsule-shaped, imprinted with "U-S 125". The 250 mg (as valproic acid) tablets are peach-colored, enteric-coated, capsule-shaped, imprinted with "U-S 250". The 500 mg (as valproic acid) tablets are light pink-colored, enteric-coated, capsule-shaped, imprinted with "U-S 500". 125 mg (as valproic acid) tablets: NDC 0615-8326-39 Blistercards of 30 250 mg (as valproic acid) tablets: NDC 0615-8327-39 Blistercards of 30 NDC 0615-8327-30 Unit Dose Boxes of 30 500 mg (as valproic acid) tablets: NDC 0615-8328-39 Blistercards of 30 NDC 0615-8328-30 Unit Dose Boxes of 30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
NCS HealthCare of KY, LLC dba Vangard Labs
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MEDICATION GUIDE
DIVALPROEX (di∙val∙pro∙ex) SODIUM DELAYED-RELEASE TABLETS, USP
Read this Medication Guide before you start taking divalproex sodium
delayed-release tablets 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 tablets?
Do not stop taking divalproex sodium delayed-release tablets without
first talking to your healthcare
provider.
Stopping divalproex sodium delayed-release tablets suddenly can cause
serious problems.
Divalproex sodium delayed-release tablets 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:
In some cases, liver damage may continue despite stopping the drug.
• 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
•
Divalproex sodium delayed-release tablets may harm your unborn baby.
• If you take divalproex sodium delayed-release tablets 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 u

Характеристики продукта

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM
DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS.
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1983
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 tablets are an anti-epileptic drug
indicated for:
Treatment of manic episodes associated with bipolar disorder (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)
DOSAGE AND ADMINISTRATION
Divalproex sodium delayed-release tablets are administered orally in
divided doses. Divalproex sodium
delayed-release tablets should be swallowed whole and should not be
crushed or chewed (2.1, 2.2).
Mania: Initial dose is 750 mg daily, 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 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 plasm