Depakene (Valproic Acid)

Antiepileptic medication Depakene (valproic acid) is used as sole or adjunctive therapy in the treatment of simple or complex absence seizures, including petit mal, and is useful in primary generaliz (valproic acid) may also be used adjunctively in patients with multiple seizure types which include either absence or tonic-clonic seizures.

Simple absence is defined as a very brief clouding of the sensorium or loss of consciousness (lasting usually 2 to 15 seconds) accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.

Although the mechanism of Depakene (valproic acid) has not yet been established, the anticonvulsant activity of Depakene (valproic acid) may be related to increased brain concentrations of gamma-aminobutyric acid (GABA). The effect on the neuronal membrane is unknown.

General Precautions

Because of reports of thrombocytopenia and inhibition of platelet aggregation, platelet counts and bleeding time determination are recommended before instituting therapy and at periodic intervals. It is recommended that patients be monitored for platelet count prior to planned surgery. Clinical evidence of hemorrhage, bruising or a disorder of hemostasis/coagulation is an indication for reduction of dosage or withdrawal of therapy pending investigation. Hyperammonemia with or without lethargy or coma has been reported and may be present in the absence of abnormal liver function tests; if elevation occurs the Depakene antiepileptic medication (valproic acid) should be discontinued. Because Depakene antiepileptic medication (valproic acid) may interact with other antiepileptic drugs, periodic serum level determinations of concurrently administered antiepileptics are recommended during the early part of therapy (see Drug Interactions). There have been reports of breakthrough seizures occurring with the combination of valproic acid and phenytoin. Depakene antiepileptic medication (valproic acid) is partially eliminated in the urine as a ketone-containing metabolite which may lead to a false interpretation of the urine ketone test. There have been reports of altered thyroid function tests associated with valproic acid: The clinical significance of these is unknown. Depakene antiepileptic medication (valproic acid) may produce CNS depression, especially when combined with another CNS depressant such as alcohol. Occupational Hazards:
Patients should be advised not to engage in potentially hazardous occupations such as driving a car or operating dangerous machinery until it is known that they do not become drowsy from the drug. Drug Interactions:
Depakene antiepileptic medication (valproic acid) may potentiate the CNS depressant action of alcohol. There is evidence that Depakene antiepileptic medication (valproic acid) may cause an increase in serum phenobarbital levels by impairment of non-renal clearance. This phenomenon can result in severe CNS depression. The combination of Depakene antiepileptic medicationDEPAKENE (valproic acid)and phenobarbital has also been reported to produce CNS depression without significant elevations of barbiturate or DEPAKENE (valproic acid) serum levels. Patients receiving concomitant barbiturate therapy should be closely monitored for neurological toxicity. Serum barbiturate drug levels should be obtained, if possible, and the barbiturate dosage decreased, if indicated. Primidone is metabolized into a barbiturate, and therefore, may also be involved in a similar or identical interaction. There is conflicting evidence regarding the interaction of DEPAKENE (valproic acid) with phenytoin (see Precautions). It is not known if there is a change in unbound (free) phenytoin serum levels. The dose of phenytoin should be adjusted as required by the clinical situation. The concomitant use of Depakene antiepileptic medication (valproic acid) and clonazepam may produce absence status. Caution is recommended when Depakene antiepileptic medication (valproic acid) is administered with drugs affecting coagulation, e.g., ASA and warfarin (see Adverse Effects).

antiepileptic medication Depakene side effects are nausea, vomiting and indigestion. Since Depakene antiepileptic medication (valproic acid)has usually been used with other antiepileptics, in most cases it is not possible to determine whether the adverse reactions mentioned are due to Depakene side effects or to the side effects of the combination of drugs. Gastrointestinal: Nausea, vomiting and indigestion are the most commonly reported side effects at the initiation of therapy. These effects are usually transient and rarely require discontinuation of therapy. Diarrhea, abdominal cramps and constipation have also been reported. Anorexia with some weight loss and increased appetite with some weight gain have also been observed. CNS Effects: Sedative effects have been noted in patients receiving DEPAKENE (valproic acid) alone, but are found most often in patients on combination therapy. Sedation usually disappears upon reduction of other antiepileptic medication. Ataxia, headache, nystagmus, diplopia, asterixis, "spots before the eyes", tremor, dysarthria, dizziness and incoordination have been noted rarely. Rare cases of coma have been reported in patients receiving valproic acid alone or in conjunction with phenobarbital. Dermatologic: Transient increases in hair loss have been observed. Skin rash and petechiae have rarely been noted. Endocrine: There have been reports of irregular menses and secondary amenorrhea in patients receiving valproic acid. Abnormal thyroid function tests have been reported (see Precautions). Psychiatric: Emotional upset, depression, psychosis, aggression, hyperactivity and behavioural deterioration have been reported. Musculoskeletal: Weakness has been reported. Hematopoietic: Thrombocytopenia has been reported. DEPAKENE (valproic acid) inhibits the second phase of platelet aggregation (see Precautions). This may be reflected in altered bleeding time. Bruising, hematoma formation and frank hemorrhage have been reported. Relative lymphocytosis and hypofibrinogenemia have been noted. Leukopenia and eosinophilia have also been reported. Anemia and bone marrow suppression have been reported. Hepatic: Minor elevations of transaminases [(e.g. AST(SGOT) and ALT(SGPT)] and LDH are frequent and appear to be dose related. Occasionally, laboratory tests also show increases in serum bilirubin and abnormal changes in other liver function tests. These results may reflect potentially serious hepatotoxicity (see Warnings). Metabolic: Hyperammonemia (see Precautions). Hyperglycinemia has been reported and associated with a fatal outcome in a patient with pre-existing nonketotic hyperglycinemia. Pancreatic: There have been reports of acute pancreatitis occurring in association with valproic acid therapy. Other: Edema of the extremities has been reported.