VALPROIC ACID solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Akorn

INN (Jina la Kimataifa):

VALPROIC ACID

Tungo:

VALPROIC ACID 250 mg in 5 mL

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Valproic acid 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 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 Precaution (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, valproate should not be used to treat women with epilepsy or bipolar disorder who

Bidhaa muhtasari:

Valproic Acid Oral Solution, USP is available as a raspberry flavored, reddish clear oral solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt in bottles of 16 ounces, 5 mL unit dose, and in 10 mL unit dose in trays of ten cups. Store at controlled room temperature 15 to 30°C (59 to 86°F).

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

VALPROIC ACID- VALPROIC ACID SOLUTION
Akorn
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MEDICATION GUIDE
Valproic Acid Oral Solution, USP
(val • pro • ic acid)
Revised 06/2022
Read this Medication Guide before you start taking Valproic Acid Oral
Solution, USP 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, USP?
Do not stop taking Valproic Acid Oral Solution, USP without first
talking to your healthcare provider.
Stopping Valproic Acid Oral Solution, USP suddenly can cause serious
problems.
Valproic Acid Oral Solution, USP 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
thefollowing 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, USP may harm your unborn baby.
2.
If you take Valproic Acid Oral Solution, USP 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.

Tabia za bidhaa

VALPROIC ACID- VALPROIC ACID SOLUTION
AKORN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROIC ACID ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VALPROIC ACID ORAL
SOLUTION.
VALPROIC ACID ORAL SOLUTION, USP
INITIAL U.S. APPROVAL: 1978
WARNINGS: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Valproic acid is an antiepileptic drug indicated for: (1)
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DOSAGE AND ADMINISTRATION
Valproic acid is intended for oral administration. (2.1) (2)
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DOSAGE FORMS AND STRENGTHS
Oral Solution: Equivalent of 250 mg valproic acid per 5 mL as the
sodium salt (3) (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
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)
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)
Hepatic disease or significant hepatic dysfunction (4, 5.1)
Known mitochondrial disorders caused by mutations in mitochondrial DNA
polymerase γ (POLG) (4,
5.1)
Suspected POLG-related disorder in children under two years of age (4,
5.1)
Known hypersensitivity to the drug (4, 5.12)
Urea