DIVALPROEX SODIUM tablet, delayed release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Upsher-Smith Laboratories, LLC

INN (International Name):

Divalproex Sodium

Sammensætning:

Valproic Acid 125 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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: Bottles of 100 with a child-resistant closure, NDC 0832-7122-11 NDC 0832-7122-15 Bottles of 500 250 mg (as valproic acid) tablets: Bottles of 100 with a child-resistant closure, NDC 0832-7123-11 NDC 0832-7123-15 Bottles of 500 NDC 0832-7123-01 Unit Dose Cartons of 100 500 mg (as valproic acid) tablets: Bottles of 100 with a child resistant closure, NDC 0832-7124-11 NDC 0832-7124-15 Bottles of 500 NDC 0832-7124-01 Unit Dose Cartons of 100 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.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
Upsher-Smith Laboratories, LLC
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MEDICATION GUIDE
Divalproex (di∙val∙pro∙ex) Sodium Delayed-Release Tablets, USP
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 a healthcare provider.
Stopping divalproex sodium delayed-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 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 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 delayed-
release tablets.
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 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

Produktets egenskaber

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
UPSHER-SMITH LABORATORIES, LLC
----------
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 plasma
level; see