DIVALPROEX SODIUM tablet, film coated, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

American Health Packaging

INN (Tên quốc tế):

DIVALPROEX SODIUM

Thành phần:

VALPROIC ACID 250 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Divalproex sodium extended-release tablets are valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. 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. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed release tablets in this indication, and was confirmed in a 3 week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see

Tóm tắt sản phẩm:

Divalproex Sodium Extended-release Tablets USP, 250 mg are available as white to off-white, capsule-shaped, biconvex, film-coated tablets imprinted with "ZA47" on one side and the other side plain and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-310-01 Divalproex Sodium Extended-release Tablets USP, 500 mg are available as white to off-white, capsule-shaped, biconvex, film-coated tablets imprinted with "ZA48" on one side and the other side plain and are supplied as follows: Unit dose packages of 80 (10 x 8) NDC 68084‐415‐02 Unit dose packages of 100 (10 x 10) NDC 68084-415-01 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Maalox ® is the registered trademark of Novartis Consumer Health. Trisogel ® is the registered trademark of Eli Lilly Corporation. Titralac ® is the registered trademark of 3M Pharmaceuticals.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
American Health Packaging
----------
MEDICATION GUIDE
8231001/1222F
Divalproex Sodium (dye val’ proe ex soe’ dee um)
Extended-release Tablets, USP
Read this Medication Guide before you start taking divalproex sodium
extended-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 extended-release tablets?
Do not stop taking divalproex sodium extended-release tablets without
first talking to your healthcare
provider.
Stopping divalproex sodium extended-release tablets suddenly can cause
serious problems.
Divalproex sodium extended-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 extended-release tablets may harm your unborn
baby.
•
If you take divalproex sodium extended-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, le

Đặc tính sản phẩm

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS.
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
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 extended-release tablets are indicated for:
Acute treatment of manic or mixed episodes associated with bipolar
disorder, with or without psychotic
features (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 extended-release tablets are intended for once-a-day
oral administration.
Divalproex sodium extended-release tablets should be swallowed whole
and should not be crushed or
chewed (2.1, 2.2).
Mania: Initial dose is 25 mg/kg/day, 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 n