VALPROIC ACID solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

VALPROIC ACID (UNII: 614OI1Z5WI) (VALPROIC ACID - UNII:614OI1Z5WI)

可用日期:

Chartwell RX, LLC

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Valproic Acid Oral Solution, USP is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid oral solution is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. See Warnings and Precautions ( 5.1) for statement regarding fatal hepatic dysfunction. Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, v

產品總結:

Valproic Acid Oral Solution, USP is a clear pinkishred, cherry-flavored liquid containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt, supplied as follows: Bottles of 16 fl oz (473 mL) NDC 62135-196-47 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in the original container or a USP tight container.

授权状态:

Abbreviated New Drug Application

资料单张

Chartwell RX, LLC
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MEDICATION GUIDE
VALPROIC ACID (val proe’ ik as’id) ORAL SOLUTION, USP
Read this Medication Guide before you start taking valproic acid oral
solution 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 valproic
acid oral solution?
Do not stop taking valproic acid oral solution without first talking
to your healthcare provider.
Stopping valproic acid oral solution suddenly can cause serious
problems.
Valproic acid oral solution 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.
1.
Valproic acid oral solution may harm your unborn baby.
•
If you take valproic acid oral solution 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
urine comes out
(urethra) on the bottom of the penis can also happen. Decreased
hearing or hearing loss
can also happen.
•
Birth defects may occur even in children born to women who are not
taki

产品特点

VALPROIC ACID- VALPROIC ACID SOLUTION
CHARTWELL RX, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROIC ACID ORAL
SOLUTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR VALPROIC ACID
ORAL SOLUTION, USP.
VALPROIC ACID ORAL SOLUTION, USP
INITIAL U.S. APPROVAL: 1978
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)
RECENT MAJOR CHANGES
Boxed Warning, Fetal Risk 2/2019
Indications and Usage, Important Limitations ( 1.2) 2/2019
Contraindications ( 4) 2/2019
Warnings and Precautions, Use in Women of Childbearing
Potential ( 5.4) 2/2019
INDICATIONS AND USAGE
Valproic Acid Oral Solution, USP is indicated for:
Monotherapy and adjunctive therapy of complex partial seizures; sole
and adjunctive therapy of simple
and complex absence seizures; adjunctive therapy in patients with
multiple seizure types that include
absence seizures ( 1)
DOSAGE AND ADMINISTRATION
Valproic acid oral solution is intended for oral administration. (
2.1)
Simple and Complex Absence Seizures: Start at 10 to 15 mg/kg/day,
increasing at 1 week intervals by 5
to 10 mg/kg/week until seizure control or limiting side effects ( 2.1)
Safety of doses above 60 mg/kg/day is not established ( 2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Valproic Acid Oral Solution, USP: Equivalent of 250 mg valproic acid
per 5 mL as the sodium salt ( 3)
CONTRAINDICATIONS
Hepatic disease or significant hepatic dysfunction ( 4, 5.1)
Known mitochondrial disorders caused by mutations in