Sodium Valproate

Each Tablet contains:
      Sodium valproate.................333/145mg

COMPOSITION :      Sodium valproate-200
     Each film coated tablet contains
     Sodium valproate I.P…….200 mg

     Sodium valproate-300
     Each film coated tablet contains
     Sodium valproate I.P……300 mg

     Sodium valproate-500
     Each film coated tablet contains
     Sodium valproate I.P……500 mg

     Sodium valproate CR-200
     Each film coated tablet contains
     Sodium valproate I.P……133.5 mg + Valproic acid
     USP 58 mg (Both together correspond to Sodium Valproate 200 mg)

     Sodium valproate CR-300
     Each film coated tablet contains
     Sodium valproate I.P……200 mg + Valproic acid
     USP 87 mg (Both together correspond to Sodium Valproate 300 mg)

     Sodium valproate CR-500
     Each film coated tablet contains
     Sodium valproate I.P……333 mg + Valproic acid
     USP 145 mg (Both together correspond to Sodium Valproate 500 mg)

DESCRIPTION  : Sodium valproate is the sodium salt of valproic acid and mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).

INDICATIONS :
Epilepsy
Sodium valproate 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.

Sodium valproate is also 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 that include absence seizures

Mania
Sodium valproate is indicated for the treatment of the manic episodes associated with bipolar disorder.

Migraine
Sodium valproate  is indicated for prophylaxis of migraine headaches.

DOSAGE AND ADMINISTRATION : Sodium valproate tablets are administered orally.

The recommended initial dose is 15 mg/kg/day increasing at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases. The maximum recommended dosage is 60 mg/kg/day. If the total daily dose exceeds 250 mg, it should be given in divided doses.

Antiepileptic drugs should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus and attendant hypoxia and threat to life. In epileptic patients previously receiving Sodium valproate therapy, Sodium valproate tablets should be initiated at the same daily dose and dosing schedule. After the patient is stabilized on Sodium valproate tablets, a dosing schedule of two or three times a day may be elected in selected patients

CONTRAINDICATIONS : Sodium valproate should not be administered to patients with hepatic disease or significant hepatic dysfunction. Sodium valproate is contraindicated in patients with known hypersensitivity to the drug

PRECAUTIONS : Hepatic failure resulting in fatalaties has occurred in patients receiving sodium valproate. 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 oedema, anorexia and vomiting. In patients with epilepsy, a loss of seizure control may also occur.

The benefits of the therapy should be weighed against the risks. Above this age group, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups. The drug should be discontinued immediately, in the presence of significant hepatic dysfunction suspected or apparent. In some cases, hepatic dysfunction has progressed in spite of discontinuation of drug.

SIDE EFFECT : The common adverse events reported during sodium valproate therapy include nausea, somnolence, dizziness, vomiting, asthenia, abdominal pain, dyspepsia, rash and mania.

PACKAGING INFORMATION :
Sodium valproate-200 Blister strip of 10’s
Sodium valproate-300 Blister strip of 10’s
Sodium valproate-500 Blister strip of 10’s

Sodium valproate CR-200 Blister strip of 10’s
Sodium valproate CR-300 Blister strip of 10’s
Sodium valproate CR-500 Blister strip of 10’s