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Epival 250mg 30 tabs, Valproate Semisodium

Epival 250mg 30 tabs, Valproate Semisodium
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Epival 250mg 30 tabs, Valproate Semisodium


DESCRIPTION: Epival (divalproex sodium) is a compound of sodium valproate in a molar ratio of 1:1.

It is chemically related to valproic acid.

Epival is an anticonvulsant agent that is not chemically related to other drugs used to treat convulsive disorders. The mechanism by which anti Epival exerts its effects has not been established. It has been suggested that its activity is associated with increased levels of gamma-aminobutyric acid (GABA) in the brain. The effect on the neuronal membrane.

Because of their enteric coating, absorption is delayed Epival one hour after administration. Peak serum levels of valproate are approximately one to four hours after an oral dose of Epival.

A slight delay in the initial absorption occurs when the drug is administered with food, but this does not affect total absorption.

Not established a good correlation between daily dose, serum level and therapeutic effect. Valproate is rapidly distributed and linked the drug is mostly (90%) to human plasma proteins.

Because of their enteric coating, Epival may reduce the incidence of gastrointestinal irritant effects when compared valproate with valproic acid. Eliminating Epival and its metabolites are mainly carried out in the urine, and in lesser amounts in the faeces and the air expelled. Very few drugs metabolized is excreted in the urine. The drug is metabolized in the liver and is excreted as a glucuronide conjugate.


q Mania: Epival is indicated for manic episodes associated with bipolar disorder.

q Epilepsy: As monotherapy or combination therapy for simple or complex seizures, tonic-clonic (grand mal), absence seizures (petit mal), in patients with multiple seizure types.

CONTRAINDICATIONS: Epival not be given to patients with significant liver disease or dysfunction. Epival is contraindicated in patients with known hypersensitivity to the drug.



General: For the reports of platelet dysfunction and thrombocytopenia is recommended that platelet counts and bleeding time determination before initiating therapy and at periodic intervals. It is recommended platelet counts before surgery to patients receiving Epival. There have been reports of hyperammonemia with or without lethargy and coma, and may present with normal frame of liver function tests. If this happens Epival should be discontinued.

Since Epival may interact with anticonvulsant drugs administered together, it is recommended to make periodic determinations of serum anticonvulsant drugs during initiation of concomitant therapy (see Drug Interactions).

Patient Information: Because Epival can produce CNS depression, especially when combined with another CNS depressant (eg, alcohol), they should warn patients not to perform hazardous activities such as driving cars or operating machinery dangerous until you know whether the drug will make you drowsy.


Hepatotoxicity: The malfunctioning of the liver, including liver failure resulting in fatalities in patients receiving valproic acid and its derivatives. These fatalities occurred during the first six months of treatment with Epival. Experience has indicated that children under two years are at higher risk of fatal hepatotoxicity, especially if they are treated with various anticonvulsants.

There is also increased risk in patients with congenital metabolic disorders, mental retardation and severe convulsive disorders. Serious or fatal hepatotoxicity may be preceded by nonspecific symptoms such as loss of seizure control, malaise, weakness, apathy, anorexia and vomiting. It should perform liver function tests prior to therapy and at frequent intervals after the start, especially during the first six months.

Caution must be used when administering Epival in patients with previous history of liver disease. Patients with several unusual congenital disorders, patients with severe seizures accompanied with mental retardation and organic brain disease patients may be at special risk.

The drug should be discontinued immediately when suspected or proven liver disease. In some cases liver dysfunction has progressed, even if the drug is discontinued.

Pancreatitis: Exceptional cases of severe pancreatitis have been reported in children and adults treated with Epival. Although not required regular monitoring of pancreatic enzymes in patients taking Epival is important to note the presentation of nausea, vomiting and abdominal pain, as these may be early symptoms of pancreatitis that require prompt medical attention. If pancreatitis is diagnosed, the Epival should be suspended immediately.

Somnolence in the elderly: Studies have shown that elderly patients treated with Epival may experience drowsiness, especially in those with hypoalbuminemia, increased serum urea nitrogen and poor elimination of sodium valproate. In this group of patients should be monitored fluid intake and nutrition, the presence of dehydration, drowsiness and other adverse events. In addition, it is recommended to reduce the initial dose and increase the dose slowly Epival.

The dose reduction or discontinuation of Epival be considered in elderly patients with reduced intake of food or liquid and in patients with excessive sleepiness.

Use in Pregnancy: According to recent reports published in the medical literature, Epival may produce teratogenicity in offspring of women taking the drug during pregnancy.

The incidence of neural tube defects (spina bifida) in the fetus, may increase in mothers receiving valproate during the first trimester of pregnancy.

Although the data are more extensive with respect to trimethadione, paramethadione, phenytoin and phenobarbital, reports suggest a possible similar association with the use of other antiepileptic drugs.

The vast majority of mothers with anticonvulsant medication deliver healthy babies. Note that the anticonvulsant medication should not be discontinued in patients who are administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with hypoxia and threat for life. In individual cases where the severity and frequency of the seizure disorder are such that stopping the medication does not pose a serious threat to the patient, you can consider the suspension of the drug before and during pregnancy, although it can not be said with confidence that even hits children do not pose any risk to the developing embryo or fetus.

The prescribing physician must weigh these considerations in treating or counseling epileptic women who may become pregnant. Only antiepileptic drugs should be administered to women of childbearing potential is clearly demonstrated that they are essential to control seizures.

Studies in rats and women demonstrated placental transfer of Epival. During childbirth blood levels have been reported Epival, equal to or greater than the levels of the mother, in the umbilical cord of newborns. Animal studies have also shown teratogenicity. Epival tablets should be swallowed whole without chewing.

DRUG INTERACTIONS: Epival may potentiate the depressant activity of alcohol on the CNS. There is evidence that Epival may cause increase in the serum phenobarbital not impaired renal elimination.

This phenomenon may result in CNS depression. Reports indicate that the combination of phenobarbital Epival and CNS depression occurs without any significant increase in serum levels of barbiturates or valproate. All patients receiving concomitant barbiturate therapy should be monitored carefully for neurological toxicity, determine the serum barbiturate drug, if possible, and reduce the dose of barbiturates, if appropriate.

Primidone is metabolized to a barbiturate and therefore may also have similar or identical interaction. The concomitant use of valproic acid and clonazepam may produce absence status.

Caution is advised when Epival is administered with drugs that affect blood clotting, such as aspirin and warfarin, or antiretroviral drug zidovudine (AZT) (see Side Effects).

Simultaneous administration of amitriptyline or nortriptyline Epival, although rarely observed, may cause increased levels of these drugs and therefore must be considered the measurement of serum or reducing the dose, when administered in the presence of Epival.

Carcinogenesis and Mutagenesis: The study of the drug in animals is not sufficient to determine if you have carcinogenic potential. We have conducted studies Epival mutagenesis using bacterial and mammalian systems.

These studies have provided no evidence of mutagenic potential for Epival.

PREGNANCY: See Warnings.

Nursing Mothers: Epival is excreted in milk. It is unknown what effect would this have on the child. As a rule, the patient should not breastfeed while receiving Epival.

Fertility: Chronic toxicity studies in rats and dogs demonstrated reduced youth and adult spermatogenesis and testicular atrophy at doses greater than 350 mg / kg / day in rats and greater than 90 mg / kg / day in dogs.

The effect of Epival in the development of the testes and sperm production and fertility in humans.

SIDE EFFECTS: Because Epival is generally used with other anticonvulsant drugs, in most cases it is not possible to determine whether the following adverse reactions can be attributed solely to Epival or combination of drugs.

Gastrointestinal: The most commonly reported side effects at the initiation of therapy are nausea, vomiting and indigestion. These effects are usually transient and rarely require discontinuing treatment. They have reported nausea, vomiting, diarrhea, abdominal pain and constipation. Also anorexia with some weight loss and increased appetite with weight gain.

CNS: sedative effects have been noted in patients receiving valproate alone but occur most frequently in those receiving combination therapy. Sedation usually disappears by reducing other anticonvulsant medication. Rarely has noticed ataxia, headache, nystagmus, diplopia, "spots before eyes", tremor, dysarthria, dizziness, or incoordination. Have been noted in rare cases of coma patients also taking phenobarbital.

Dermatological: transient increases were observed for hair loss. Rarely have noticed rashes and petechiae.

Psychiatric been reported emotional distress, depression, psychosis, aggression, hyperactivity and behavioral deterioration.

Musculoskeletal: weakness has been reported.

Hematopoietic: Valproic acid inhibits the second phase of platelet aggregation (see Drug Interactions). This may be reflected in altered bleeding time. Has also been noted in isolated cases moderate relative lymphocytosis and thrombocytopenia. Leukopenia have been reported.

Hepatic: Small increases in transaminases (eg, SGOT and SGPT) and DHL are common and appear to be dose related. Occasionally, laboratory results include increases in serum bilirubin and abnormal changes in other liver function tests. These results may reflect potentially serious hepatotoxicity (see WARNINGS). There have been spontaneous reports of polycystic ovary disease. Not established cause-effect relationship.


Epilepsy: The recommended starting dose is 15 mg / kg / day, which may be increased at weekly intervals from 5 to 10 mg / kg / day to achieve the control of seizures. The maximum recommended dose is 60 mg / kg / day. At higher intakes of 250 mg is recommended total daily dose divided into two or three doses.

Manic disorders: In adults, the recommended starting dose is 750 mg in two or three takes. This dose may be increased up to the lowest dose that produces the best therapeutic effect. The maximum recommended dose is 60 mg / kg / day. The serum level should be between 50 and 125 mg / ml. Must be strictly monitored the initial dose in elderly patients.

OVERDOSE: Overdose can cause coma. Since Epival tablets are enteric layer, the benefits of gastric lavage or emesis vary the time of intake. General care should be applied with particular attention to maintaining adequate urine flow. It has been reported that naloxone reverses the CNS depressant effects. Since theoretically naloxone can reverse the antiepileptic effects Epival should be used with caution.
Drug Name: Epival
Comparative Brand: Epival
Active ingredient: Valproate semisodium
Presentation: Tablets
Concentration: 250g
Response time: No
Laboratory: Abbott, S. A. de CV
Bottle with 30 capsules
Manufactured in: Mexico

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