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Sodium valproate syrup :
Each 5 ml of syrup contains Sodium Valproate BP 200 mg.
Description
Sodium Valproate, the active ingredient of Sodium valproate is
endowed with anti-epileptic activity against a variety of
seizures. The mechanism by which Sodium Valproate exerts its
anti-epileptic effects has not been established. However, it has
been suggested that its activity is related to increased brain
levels of gamma-aminobutyric acid (GABA).
Indications
Sodium valproate is indicated for the treatment of all types
of epilepsy, e.g. Partial seizures, Absence seizures (petit mal),
Generalized tonic-clonic seizures (grand mal), Myoclonic seizures,
Atonic seizures, Mixed seizures that include absence attack,
Prophylaxis of febrile convulsion, Prophylaxis of post-traumatic
epilepsy.
Dosage
and Administration
Age group Dosage & Administration
Adults Initially 600 mg daily given in 2 divided doses, preferably
after food, increasing by 200 mg/day at 3-day intervals to a
maximum of
2.5 g daily in divided doses until control of seizure is achieved.
Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily).
Children Initially 20 mg/kg daily in divided doses, may be
increased
(up to 20 kg)provided plasma concentrations monitored (above 40
mg/kg daily also monitor clinical chemistry and hematological
parameters).
Children Initially 400 mg daily in divided doses increased until
control
(0ver 20 kg)(usually in the range of 20-30 mg/kg daily); Maximum
35 mg/kg daily.
Side effects
The most common side effects are anorexia, nausea and
vomiting. However, these side effects are minimized with the use
of enteric coated tablets. Effects on the CNS include sedation,
ataxia and tremor. These symptoms occur infrequently and usually
respond to a decrease in doses. Rash, alopecia and stimulation of
appetite have been observed occasionally. Sodium Valproate has
several effects on hepatic function of which elevation of liver
enzymes in plasma is observed in up to 40% of patients and often
occurs asymptomatically during the first few months of therapy.
Rarely a fulminate hepatitis that may be fatal may develop.
Children below 2 years of age with other medical conditions and
those being treated with multiple antiepileptic agents are
specially prone to suffer from hepatic injury, acute pancreatitis
and hyperammonemia have also been frequently associated with the
use of Sodium Valproate.
Contraindications
Sodium Valproate is contraindicated to patients who have known
hypersensitivity to the drug and liver dysfunction. Care should be
exercised when prescribing Sodium Valproate in women of child
bearing age.
Precautions
Liver functions should be monitored before therapy and during
first 6 months especially in patients most at risk, No undue
potential for bleeding before starting and before major surgery
must be ensured, Care should be taken in renal impairment,
pregnancy, breast-feeding and systemic lupus erythematosus. Sodium
Valproate is partially eliminated in the urine as a ketone
metabolite, which may lead to a false interpretation of the urine
ketone test. Sudden withdrawal of therapy should be avoided.
Use in Pregnancy & Lactation
Sodium Valproate crosses the placenta and in humans, exposure
to valproate in the first trimester has been associated with
neural tube defects such as anencephaly and spina bifida in
newborn.
Pregnant women treated with Sodium valproate should be offered to
estimate serum a-fetoprotein. Sodium valproate is excreted in
breast milk. However, breast-feeding by a mother taking Sodium
valproate probably causes no risk to the child.
Drug Interactions
Sodium Valproate appears to act as a non specific inhibitor of
drug metabolism. Drugs to which it interacts most significantly
are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.
Commercial pack
Sodium valproate syrup : Bottle containing 100 ml of Sodium
Valproate syrup.
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