Convulex syrup 50mg/ml 100ml

Convulex /Convulex

Composition and release form

Convulex - capsules, soluble in the intestine: 1 caps. contains valproic acid 150, 300 and 500 mg, excipients: sorbitol (Karion 83); glycerin 85%; gelatin; titanium dioxide; iron oxide red E172; hydrochloric acid 25%; shellac; ferric oxide black E172; hypromellose phthalate; dibutyl phthalate;

in a blister strip package 10 pcs.; in a box of 10 packs (150 and 500 mg) or in a blister pack of 20 pcs.; in a box of 5 packs (300 mg).

Convulex - syrup for children:

100 ml contain valproic acid 4,338 g; excipients: sodium hydroxide; likazin 80/55; saccharin sodium; sodium cyclamate; methyl hydroxybenzoate; propyl hydroxybenzoate; sodium chloride; flavors of raspberry (9/372710) and peach (9/030307); purified water; in bottles of 100 ml, complete with a measuring syringe;

Convulex - drops for oral administration:

1 ml contains valproic acid 300 mg, excipients: purified water; in vials of 100 ml;

Convulex - pills of the prolonged action, coated: 1 tab. contains valproic acid 300 and 500 mg, excipients: citric acid monohydrate; ethyl cellulose; Eudragit RS30D; purified talc; colloidal anhydrous silicon; Magnesium stearate; Eudragit L30D; dibutyl phthalate; sodium carmellose; macrogol 6000; titanium dioxide; vanillin; simethicone;

in polyethylene bottles or dark glass bottles of 50 or 100 pcs.

pharmachologic effect

Convulex has antiepileptic, muscle relaxant, sedative effect.

Indications

Epilepsy of any genesis;

epileptic seizures (including generalized and partial, as well as against the background of organic brain diseases);

character and behavioral disorders associated with epilepsy;

febrile seizures in children;

manic-depressive syndrome with bipolar course, not amenable to treatment with lithium drugs or other drugs.

Contraindications

Hypersensitivity;

severe disorders of the liver and / or pancreas;

porphyria;

severe thrombocytopenia;

hemorrhagic diathesis;

pregnancy (I term);

breast-feeding;

Children up to 3 years (pills).

Side effects

In general, Convulex well tolerated by patients. Side effects are possible mainly when the level of the drug in plasma is higher than 100 mg / l or in combination therapy.

On the part of the digestive tract: nausea, vomiting, gastralgia, anorexia or increased appetite, diarrhea, hepatitis; rarely - constipation, pancreatitis, up to severe lesions with a fatal outcome (in the first 6 months of treatment, usually for 2-12 weeks).

From the side of the central nervous system: tremor; rarely - changes in behavior, mood, or mental state (depression, fatigue, hallucinations, aggressiveness, hyperactive condition, psychosis, unusual agitation, restlessness or irritability), ataxia, dizziness, drowsiness, headache, encephalopathy, dysarthria, stupor, consciousness coma

From the senses: diplopia, nystagmus, flickering "flies" before the eyes.

On the part of the blood-forming organs and the hemostatic system: anemia, leukopenia, thrombocytopenia, a decrease in the content of fibrinogen, platelet aggregation and blood clotting, accompanied by prolonged bleeding time, petechial hemorrhages, hemorrhages, hematomas, hemorrhage, etc.

On the part of metabolism: a decrease or increase in body weight.

Allergic reactions: skin rash, urticaria, angioedema, photosensitivity, Stevens-Johnson syndrome.

Laboratory indicators: hypercreatininemia, hyperammonemia, hyperbilirubinemia, a slight increase in the activity of “liver” transaminases, LDH (dose-dependent).

On the part of the endocrine system: dysmenorrhea, secondary amenorrhea, breast enlargement, galactorrhea.

Other: peripheral edema, hair loss (usually stopped after discontinuation of the drug).

Dosing and Administrations

Convulex accept inside.

Convulex capsules: not liquid, regardless of food, with a small amount of liquid, 2-3 times a day.

Syrup and drops Konvuleks: regardless of the food, with a small amount of liquid, 2-3 times a day.

Convulex tablets: without chewing, irrespective of food, with a small amount of liquid, 1-2 times a day.

For adults, the initial daily dose is 600 mg with a gradual increase in dose every 3 days until a clinical effect is achieved (the disappearance of seizures).

With monotherapy, the initial dose is 5-15 mg / kg / day, then the dose is gradually increased by 5-10 mg / kg per week.

The average daily dose is about 1000-2000 mg / day, i.e. 20-30 mg / kg. If necessary, increase the dose to 2500 mg / day.

The maximum dose - 30 mg / kg / day (can be increased with the possibility of organizing control over plasma concentration up to 60 mg / kg / day).

In combination therapy, 10–30 mg / kg / day, followed by an increase in dose of 5–10 mg / kg per week.

For children weighing more than 25 kg: the initial daily dose of 300 mg (regardless of body weight) can gradually increase until the clinical effect is achieved (disappearance of convulsive seizures) to 20-30 mg / kg per day. The initial dose for monotherapy is 5-15 mg / kg / day, then it is gradually increased by 5-10 mg / kg per week. The maximum dose of 30 mg / kg / day (can be increased with the possibility of organizing control over plasma concentration up to 60 mg / kg / day).

Children weighing 17-25 kg (tablets), 7.5-25 kg (capsules, syrup, drops): the average daily dose for monotherapy is 15-45 mg / kg, maximum - 50 mg / kg. With combined therapy - 30-100 mg / kg / day.

Storage conditions and shelf life

Store in a cool and dark place, protected from light and moisture, at a temperature not higher than 25 ° C. Shelf life - 5 years.