DIVALPROEX SODIUM tablet, delayed release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

State of Florida DOH Central Pharmacy

INN (Nama Antarabangsa):

DIVALPROEX SODIUM

Komposisi:

VALPROIC ACID 250 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Divalproex sodium delayed-release tablets, USP are a valproate and are 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 continually reevaluate the l

Ringkasan produk:

Divalproex sodium delayed-release tablets USP are available as: Divalproex Sodium Delayed-Release Tablets USP, 125 mg  are pink-red colored, oval shaped enteric-coated tablets, imprinted with “D 84” on one side with black edible ink and plain on other side. Divalproex Sodium Delayed-Release Tablets USP, 250 mg are peach colored, oval shaped enteric-coated tablets, imprinted with “D 85”on one side with black edible ink and plain on other side. Divalproex Sodium Delayed-Release Tablets USP, 500 mg are pink colored, oval shaped enteric-coated tablets, imprinted with “D 86” on one side with black edible ink and plain on other side. They are supplied by State of Florida DOH Central Pharmacy as follows: 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].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

State of Florida DOH Central Pharmacy
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MEDICATION GUIDE
Divalproex Sodium Delayed-Release Tablets, USP
(dye val' proe ex soe' dee um)
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 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:
•
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 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. The most common birth
defects with divalproex
sodium delayed-release tablets 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 can happen.
•
Birth defects may occur even in children born to women who are

Ciri produk

DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, DELAYED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS,
USP.
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1983
WARNINGS: 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 fu