VALPROIC ACID solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Lannett Company, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 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, valproate should not be used to treat women with epilepsy or bipola

Produktbesonderheiten:

Valproic Acid Oral Solution USP is available as clear, cherry-red oral solution with artificial cherry flavor containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt, supplied as follows: NDC 0527-5250-70:  16 fl oz (473 mL) bottle STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

VALPROIC ACID- VALPROIC ACID SOLUTION
Lannett Company, Inc.
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MEDICATION GUIDE
Valproic Acid Oral Solution USP
(Val proe’ ik as’ id)
Read this Medication Guide before you start taking valproic acid 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?
Do not stop taking valproic acid without first talking to your
healthcare provider.
Stopping valproic acid suddenly can cause serious problems.
Valproic acid 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. Valproic acid may harm your unborn baby.
•
If you take valproic acid 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
taking any medicines and do
not have other risk factors.
•

Fachinformation

VALPROIC ACID- VALPROIC ACID SOLUTION
LANNETT COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROIC ACID SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR VALPROIC ACID.
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)
INDICATIONS AND USAGE
Valproic acid 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 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 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 cycle disorders (4, 5.6)
Prophylaxis of migraine headaches: Pregnant women, women of
childbearing potential not using effe