DIVALPROEX SODIUM tablet, delayed release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

REMEDYREPACK INC.

INN (Международно Name):

DIVALPROEX SODIUM

Композиция:

VALPROIC ACID 250 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 USP 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 USP 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 USP for extended periods should con

Каталог на резюме:

Divalproex sodium delayed-release tablets USP are supplied as: The 250 mg tablets are orange colored, oval shaped, biconvex coated tablets imprinted ‘797’ with black ink on one side and plain on the other side. NDC: 70518-0463-00 NDC: 70518-0463-01 NDC: 70518-0463-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Recommended Storage: 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]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Статус Оторизация:

Abbreviated New Drug Application

Листовка

REMEDYREPACK INC.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
Divalproex Sodium
(dye val’ proe ex soe’ dee um)
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.
2. Divalproex sodium delayed-release tablets may harm your unborn
baby.
•
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
3. Inflammation of your pancreas that can cause death.
Call your healthcare provider right away if you have any of these
symptoms:
•
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

Данни за продукта

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
REMEDYREPACK INC.
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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 is 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 plasma
level; see full prescribing information