VALPROIC ACID solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

ATLANTIC BIOLOGICALS CORP.

INN (mednarodno ime):

VALPROIC ACID

Sestava:

VALPROIC ACID 250 mg in 5 mL

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION. WARNINGS VALPROIC ACID SHOULD NOT BE ADMINISTERED TO PATIENTS WITH HEPATIC DISEASE OR SIGNIFICANT HEPATIC DYSFUNCTION. Valproic acid is contraindicated in patients with known hypersensitivity to the drug. Valproic acid is contraindicated in patients with known urea cycl

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

VALPROIC ACID- VALPROIC ACID SOLUTION
ATLANTIC BIOLOGICALS CORP.
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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 hap

Lastnosti izdelka

VALPROIC ACID- VALPROIC ACID SOLUTION
ATLANTIC BIOLOGICALS CORP.
----------
VALPROIC ACID ORAL SOLUTION, USP
RX ONLY
BOXED WARNING
HEPATOTOXICITY
HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS
RECEIVING VALPROIC ACID. EXPERIENCE HAS INDICATED THAT CHILDREN
UNDER THE AGE OF TWO YEARS ARE AT A CONSIDERABLY INCREASED RISK OF
DEVELOPING FATAL HEPATOTOXICITY, ESPECIALLY THOSE ON MULTIPLE
ANTICONVULSANTS, THOSE WITH CONGENITAL METABOLIC DISORDERS, THOSE
WITH SEVERE SEIZURE DISORDERS ACCOMPANIED BY MENTAL RETARDATION,
AND THOSE WITH ORGANIC BRAIN DISEASE. WHEN VALPROIC ACID PRODUCTS
ARE USED IN THIS PATIENT GROUP, THEY SHOULD BE USED WITH EXTREME
CAUTION AND AS A SOLE AGENT. THE BENEFITS OF THERAPY SHOULD BE
WEIGHED AGAINST THE RISKS. ABOVE THIS AGE GROUP, EXPERIENCE IN
EPILEPSY HAS INCIDENCE THAT THE INCIDENT OF FATAL HEPATOTOXICITY
DECREASES CONSIDERABLY IN PROGRESSIVELY OLDER PATIENT GROUPS.
THESE INCIDENTS USUALLY HAVE OCCURRED DURING THE FIRST SIX MONTHS OF
TREATMENT. SERIOUS OR FATAL HEPATOTOXICITY MAY BE PRECEDED BY NON-
SPECIFIC SYMPTOMS SUCH AS MALAISE, WEAKNESS, LETHARGY, FACIAL EDEMA,
ANOREXIA AND VOMITING. IN PATIENTS WITH EPILEPSY, A LOSS OF SEIZURE
CONTROL MAY ALSO OCCUR. PATIENTS SHOULD BE MONITORED CLOSELY FOR
APPEARANCE OF THESE SYMPTOMS. LIVER FUNCTION TESTS SHOULD BE
PERFORMED PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER,
ESPECIALLY DURING THE FIRST SIX MONTHS.
TERATOGENICITY
VALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE
DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF VALPROATE
PRODUCTS IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE
BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE
FETUS.
THIS IS ESPECIALLY IMPORTANT WHEN THE TREATMENT OF A SPONTANEOUSLY
REVERSIBLE CONDITION NOT ORDINARILY ASSOCIATED WITH PERMANENT
INJURY OR RISK OF DEATH (E.G., MIGRAINE) IS CONTEMPLATED. SEE
WARNINGS,
INFORMATION FOR PATIENTS.
A PATIENT INFORMATION LEAFLET DESCRIBING THE TERATOGENIC POTENTIAL OF
VALPROATE IS AVAILABLE FOR PATIENTS.
PANCREATITIS
CAS