ÉNKORAT
Active material: Valproic Acid
When ATH: N03AG01
CCF: Anticonvulsants
When CSF: 02.05.05
Manufacturer: Sun Pharmaceutical Industries Ltd. (India)
DOSAGE FORM, COMPOSITION AND PACKING
Pills, enteric coated Pink colour, round, lenticular.
| 1 tab. | |
| sodium valproate | 200 mg |
Excipients: colloidal silicon dioxide, microcrystalline cellulose, corn starch, polyvinylpyrrolidone K30, calcium silicate, magnesium stearate, Talcum cleared, sodium starch glycolate (Type A), gipromelloza 2910, diʙutilftalat, methacrylic acid (Type C), Titanium dioxide, Ponceau 4R dye lacquer, Yellow dye “Sunset” (Sunset Yellow) FCF varnish.
10 PC. – strips of aluminum foil (10) – packs cardboard.
Pills, enteric coated Pink colour, round, lenticular.
| 1 tab. | |
| sodium valproate | 300 mg |
Excipients: colloidal silicon dioxide, microcrystalline cellulose, corn starch, polyvinylpyrrolidone K30, calcium silicate, magnesium stearate, Talcum cleared, sodium starch glycolate (Type A), gipromelloza 2910, diʙutilftalat, methacrylic acid (Type C), Titanium dioxide, Ponceau 4R dye lacquer, Yellow dye “Sunset” (Sunset Yellow) FCF varnish.
10 PC. – strips of aluminum foil (10) – packs cardboard.
Pharmacological action
Antiepileptics, It has a central muscle relaxant and sedative effect. The mechanism of action is associated with an increased content of GABA in the central nervous system (by inhibiting GABA-transferase, as well as a decrease GABA reuptake in the brain), thereby reducing anxiety and convulsive readiness motor areas of the brain. In others. hypothesis, It acts on portions of postsynaptic receptors, simulating or enhancing the inhibitory effect of GABA. Possible direct effect on the activity of the membrane due to the change in conductivity for K . It improves mood and mental state of the patients, It has antiarrhythmic activity.
Testimony
Epilepsy different genesis. Seizures (incl. generalized and partial seizures, and on the background of organic brain disease). Changes in the nature and behavior (due to epilepsy). Febrile seizures (children), children tick. Manic-depressive psychosis with bipolar course, is not amenable to treatment with drugs Li or other. PM. Specific Syndromes (Vesta, Lennox-Gastaut syndrome).
Contraindications
Hypersensitivity, hepatic failure, acute and chronic hepatitis, dysfunction of the pancreas, porphyria, gyemorragichyeskii diatyez, vыrazhennaya thrombocytopenia, pregnancy (I trimester), lactation, childhood (to 3 years, except for syrup).C care. Suppression of bone marrow hematopoiesis (leukopenia, thrombocytopenia, anemia), organic brain disease, liver and pancreas history; hypoproteinemia, mental retardation in children, congenital fermentopathy, renal failure, pregnancy.
Side effects
CNS: tremor; rarely – behavior changes, mood or mental state (depression, feeling tired, hallucinations, aggressiveness, hyperactive state, psychoses, unusual excitement, restlessness or irritability), ataxia, dizziness, drowsiness, headache, encephalopathy, dysarthria, enuresis, stupor, disturbance of consciousness, coma. From the senses: diplopia, nistagmo, twinkle “muşek” before your eyes. From the digestive system: nausea, vomiting, gastralgia, loss of appetite or increased appetite, diarrhea, hepatitis; rarely – constipation, pancreatitis, up to heavy defeats fatal (first 6 months of treatment, often on 2-12 Sun). From the side of hematopoiesis and hemostasis system: suppression of bone marrow hematopoiesis (anemia, leukopenia); thrombocytopenia, reduction of fibrinogen and platelet aggregation, leading to the development gipokoagulyatsii (accompanied by a prolongation of bleeding time, petechiae, bruises, gematomami, bleeding and others.). Metabolism: reduction or increase in body weight. Allergic reactions: skin rash, hives, angioedema, photosensitivity, malignant exudative erythema (Stevens-Johnson syndrome). Laboratory findings: giperkreatininemiя, ammoniemia, giperglicinemiя, giperʙiliruʙinemija, a slight increase in activity “Hepatic” transaminases, LDH (dose-dependent). On the part of the endocrine system: dysmenorrhoea, secondary amenorrhea, breast enlargement, galactorrhea. Other: peripheral edema, alopetsiya.Peredozirovka. Symptoms: nausea, vomiting, dizziness, diarrhea, respiratory dysfunction, hypomyotonia, giporefleksiя, mioz, coma. Treatment: gastric lavage (not later than 10-12 no), administration of activated charcoal, diurez, maintaining vital functions, hemodialysis.
Dosing and Administration
Inside, during a meal or immediately after a meal, without chewing, with a little water, 2-3 once a day. The syrup may be mixed with any liquid or added to a small amount of food. The initial dose of monotherapy for adults and children weighing more than 25 kg – 5-15 mg / kg / day, then the dose is gradually increased to 5-10 mg / kg / week. The maximum dose – 30 mg / kg / day (may be increased if possible Oversight plasma concentration up 60 mg / kg / day). In combination therapy in adults – 10-30 mg / kg / day with a consequent increase in dose 5-10 mg / kg / week. Children with body weight less than 25 kg of average daily dose in monotherapy – 15-45 mg / kg, maximum – 50 mg / kg. Depending on the age: newborn – 30 mg / kg, from 3 to 10 years – 30-40 mg / kg / day, to 1 year – in 2 admission, in older – in 3 admission. Combined therapy – 30-100 mg / kg / day. Children with body weight less than 20 kg should not apply controlled release tablet. In / jet, by 400-800 or mg / drip, calculated 25 mg / kg for 24, 36, 48 no. When deciding to go on / in the introduction of the first after oral administration is carried out at a dose of 0.5-1 mg / kg / hr via 4-6 hours after the last oral.
Cautions
During treatment expedient activity control “Hepatic” transaminases, bilirubin, peripheral blood, Blood Platelets, state of coagulation, amylase (every 3 Months, especially in combination with other. antiepileptic drugs). Patients, receiving al. antiepileptic drugs, transfer to valproic acid should be gradual, achieving a clinically effective dose through 2 Sun, chgo possible after the phasing out of others. antiepileptic drugs. Patients, untreated, etc.. antiepileptic drugs, clinically effective dose should be achieved through 1 Sun. The risk of side effects from the liver increased during the combined anticonvulsant therapy, as well as in children. Not allowed welcome drink, containing ethanol. Before surgery required blood count (incl. platelet count), determination of bleeding time, coagulation parameters. If you experience symptoms during treatment “Acute” abdomen before surgery is recommended to determine the level of amylase in the blood to avoid acute pancreatitis. During treatment should take into account the possible distortion of the results of urine tests for patients with diabetes (due to higher content of ketoproduktov), indicators of thyroid function. With the development of any acute serious side effects you should immediately discuss with your doctor about continuing or stopping treatment. To reduce the risk of diarrheal illness can receive antispasmodics and envelop drugs. Abrupt discontinuation of valproic acid may lead to more frequent seizures. During the period of treatment must be careful when driving and other lesson. potentially hazardous activities, require high concentration and speed of psychomotor reactions.
Cooperation
Valproic acid enhances the effects of, incl. side, others. antiepileptic drugs (phenytoin, lamotrigine), Antidepressants, antipsychotic drugs (neuroleptics), anxiolytics, ʙarʙituratov, MAO inhibitors, thymoleptics, ethanol. Adding valproate to clonazepam in rare cases can lead to increased severity of absence status. With simultaneous use of valproic acid with barbiturates or primidone marked increase in their concentration in plasma. Increases T1 / 2 of lamotrigine (inhibit liver enzymes, It slows down the metabolism of lamotrigine, whereby the T1 / 2 of its extended to 70 hours in adults and up 45-55 no – children). Reduces clearance of zidovudine by 38%, while its T1 / 2 is not changed. Tricyclic antidepressants, MAO inhibitors, antipsychotic drugs (neuroleptics) and etc. PM, lowering the threshold for seizure activity, reduce the effectiveness of valproic acid. In combination with salicylates has been increasing effects of valproic acid (the displacement of the connection with plasma proteins), enhances the effect of antiplatelet agents (ASK) and anticoagulants. In combination with pentobarbital, phenytoin, karʙamazepinom, mefloquine reduced the content of valproic acid in serum (accelerate metabolism). Felbamate increases the concentration of valproic acid in plasma 35-50% (require dose adjustment). With simultaneous use of valproic acid, ethanol, etc.. PM, CNS depressants (tricyclic antidepressants, MAO inhibitors and antipsychotic drugs), may increase CNS depression. Ethanol and other. hepatotoxic drugs increase the likelihood of developing liver damage. Valproic acid does not cause induction “Hepatic” enzymes, and does not reduce the effectiveness of oral contraceptives. Myelotoxic drugs – increasing the risk of suppression of bone marrow hematopoiesis.
