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Topamax Generic

Structure and Composition Topamax Generic

1 tablet, film coated, contains topiramate 25 or 100 mg in blister pack of 7 pcs., A stack of cardboard 4 blisters.

1 capsule - 15 or 25 mg in polyethylene vials at 28 and 60 pc., In box 1 bottle.

Pharmacological action

Blocks voltage-sodium channels, stabilizing neuronal membranes and inhibits the release of glutamic acid, which plays a key role in causing epileptic seizures.

Rapidly absorbed in the gastrointestinal tract; bioavailability independent of food intake. Plasma protein binding - 13-17%. The average volume of distribution - 0,55-0,8 l / kg (females - 50% of the values observed in males). Biotransformed to the formation of six inactive metabolites. Displayed in the kidneys. Plasma Cl - 20-30 ml / min. Pharmacokinetics is linear profile. In patients with normal renal function to achieve stable plasma concentrations may need from 4 to 8 days (in patients with severe renal impairment - 10-15 days). Cmax (after repeated oral administration of 100 mg 2 times a day) - 6.76 mg / ml. T1 / 2 (after receiving multiple doses of 50 and 100 mg 2 times a day) - 21 hours in patients with impaired renal plasma and renal clearance is reduced.


Partial or generalized tonic-clonic seizures as a monotherapy and in combination with other anticonvulsant drugs, complementary therapies in the treatment of seizures associated with Lennox-Gastaut syndrome (in adults and children) of newly diagnosed epilepsy (adults and children older than 2 years).


Topamax Generic


Dosing and Administration

Inside, regardless of the meal. Tablets should not be split. With difficulty swallowing tablets should be used capsule contents mixed with small amounts of any soft food and swallow immediately without chewing.

Monotherapy: adults - 25 mg at bedtime for 1 week, then increase the dose by 25-50 mg every 1-2 weeks and take in 2 divided doses, the recommended dose - 100-500 mg / day (for some patients with refractory forms of Epilepsy - up to 1000 mg / day) for children older than 2 years - 0,5-1 mg / kg at night, then increase the dose of 0,5-1 mg / kg / day at intervals of 1-2 weeks and receive 2 admission ; the recommended dose - 3-6 mg / kg / day (for children with newly diagnosed partial seizures - up to 500 mg / day).

In combination with other anticonvulsants: adults - 25-50 mg per night for 1 week, then increase the dose by 25-50 mg every 1-2 weeks and take in 2 divided doses, the minimum effective dose - 200 mg / day, maximum - 200-400 mg / day for children - 1-3 mg / kg / day at night for 1 week, then increase the dose of 1-3 mg / kg at intervals of 1-2 weeks and receive 2 admission; recommended daily dose - 5.9 mg / kg.
Application of pregnancy and breastfeeding

During pregnancy is possible if the expected effect of therapy outweighs the potential risk to the fetus. The period of treatment should stop breastfeeding.

Increases in plasma phenytoin reduces - digoxin. Phenytoin and carbamazepine reduces the content of topiramate in the blood. Weakens the effectiveness of oral contraceptives. The simultaneous use with drugs that predispose to nephrolithiasis, may increase the risk of kidney stones.

Treatment: cleanse the stomach by lavage or induce vomiting. In severe cases, may hemodialysis.
Precautionary measures

During hemodialysis the patient should be given an additional dose (approximately 1 / 2 daily dose) before and after the procedure. Repeal the drug should be gradually, to avoid the development syndrome "cancel" - reduce the dose to 100 mg at weekly intervals. In patients with increased risk of nephrolithiasis is recommended to adequately raise the volume of fluid intake. With careful use in patients with impaired liver function (due to a possible reduction in clearance of the drug). There may be cases of secondary angle-closure glaucoma in adults and children. Should not be used during the drivers of vehicles and people, a profession which is associated with increased concentration. Do not take Topamax with alcohol or drugs, depressing the central nervous system.

Side Effects
Topamax Generic

CNS: ataxia, impaired thinking and concentration, confusion, dizziness, weakness, drowsiness, paresthesia, rarely - excitement, amnesia, depression, diplopia, emotional lability, tremor, speech impairment, visual disturbances.

From the digestive tract: anorexia, nausea.

Other: nephrolithiasis, perversion of taste sensations, reduction of body weight.


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