Topamax capsules 50mg, No. 60

epilepsy:

- as a means of monotherapy in adults and children over 2 years of age with epilepsy (including in patients with newly diagnosed epilepsy);

- as part of complex therapy: in adults and children over 2 years of age with partial or generalized tonic-clonic seizures, as well as for the treatment of seizures against the background of Lennox-Gastaut syndrome.

migraine:

- prevention of migraine attacks in adults. The use of TopamaxЃ for the treatment of acute migraine attacks has not been studied.

Inside, regardless of food intake.

To achieve optimal control of epileptic seizures in children and adult patients, it is recommended to start treatment with low doses of the drug, followed by gradual titration to the effective dose.

The capsules are intended for patients who have difficulty swallowing tablets (for example, children and the elderly). TopamaxЃ capsules should be carefully opened, mix the contents of the capsules with a small amount (about 1 teaspoon) of any soft food. This mixture should be swallowed immediately without chewing. Do not store the medicine mixed with food until the next dose.

TopamaxЃ capsules can be swallowed whole.

Partial or generalized tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome

Use in combination with other anticonvulsants in adult patients. The minimum effective dose is 200 mg / day. Usually the total daily dose ranges from 200 to 400 mg and is taken in 2 divided doses. Some patients may need to increase the daily dose to a maximum of 1600 mg of TopamaxЃ per day. It is recommended to start treatment with a low dose, followed by a gradual selection of the effective dose.

Dose selection begins with TopamaxЃ capsules at a dosage of 25-50 mg, prescribing the drug at night for 1 week. In the future, at weekly or fortnightly intervals, the dose can be increased by 25-50 mg and taken in 2 divided doses. When choosing a dose, it is necessary to be guided by the clinical effect. In some patients, the effect can be achieved by taking the drug once a day. To achieve the optimal effect of treatment with TopamaxЃ, it is not necessary to control its plasma concentration.

These dosage recommendations apply to all adult patients, including the elderly, in the absence of kidney disease (see 'Special instructions').

Combined anticonvulsant therapy in children over 2 years of age. The recommended total daily dose of TopamaxЃ as an adjunctive therapy is from 5 to 9 mg / kg and is taken in 2 divided doses. Dose selection should be started at 25 mg (or less, based on an initial dose of 1 to 3 mg / kg per day), given at night for 1 week. In the future, at weekly or bi-weekly intervals, the dose can be increased by 1-3 mg / kg and taken in 2 divided doses. When choosing a dose, it is necessary to be guided by the clinical effect. Dose selection begins with TopamaxЃ capsules at a dosage of 15 or 25 mg.

A daily dose of up to 30 mg / kg is usually well tolerated.

Epilepsy (including newly diagnosed epilepsy)

Monotherapy. General Provisions. When discontinuing concomitant anticonvulsants for topiramate monotherapy, consideration should be given to the possible effect of this step on seizure frequency. In cases where there is no need to abruptly cancel the concomitant anticonvulsant drug for safety reasons, it is recommended to reduce the dose gradually, by 1/3 every 2 weeks.

With the abolition of drugs that are inducers of liver enzymes, the concentration of topiramate in the blood will increase. In such situations, if there are clinical indications, the dose of TopamaxЃ can be reduced.

Monotherapy. Adults. At the beginning of treatment, the patient should take 25 mg of TopamaxЃ at bedtime for 1 week. Then the dose is increased at intervals of 1Ц2 weeks by 25 or 50 mg (the daily dose is divided into 2 doses). If the patient does not tolerate such a dose escalation regimen, then the intervals between dose increases can be increased or the dose increased more smoothly. When choosing a dose, it is necessary to be guided by the clinical effect.

The initial dose for monotherapy with topiramate in adults is 100 mg / day, and the maximum daily dose should not exceed 500 mg. Some patients with refractory forms of epilepsy tolerate topiramate monotherapy at doses up to 1000 mg / day. Dosing recommendations apply to all adults, including elderly patients without kidney disease.

Monotherapy. Children. Children over the age of 2 years in the first week of treatment should be given topiramate at a dose of 0.5-1 mg / kg at bedtime. Then the dose is increased at intervals of 1Ц2 weeks by 0.5Ц1 mg / kg / day (the daily dose is divided into 2 doses). If the child does not tolerate such a dose escalation regimen, then the dose can be increased more smoothly or the intervals between dose increases can be increased. The magnitude of the dose and the rate of its increase should be determined by the clinical outcome.

The recommended dose range for monotherapy with topiramate in children over 2 years of age is 100Ц400 mg / day. Children with recently diagnosed partial seizures can be given up to 500 mg / day.

Migraine

The recommended total daily dose of topiramate for the prevention of migraine attacks is 100 mg taken in 2 divided doses. At the beginning of treatment, the patient should take 25 mg of TopamaxЃ at bedtime for 1 week. Then the dose is increased with an interval of 1 week by 25 mg / day. If the patient does not tolerate such a dose escalation regimen, then the intervals between dose increases can be increased or the dose increased more smoothly. When choosing a dose, it is necessary to be guided by the clinical effect.

In some patients, a positive result is achieved with a daily dose of 50 mg topiramate. In clinical studies, patients received various daily doses of topiramate, but not more than 200 mg / day.

Special patient groups

Renal failure Patients with moderate or severe renal impairment may need dose reduction. It is recommended to use half of the recommended starting and maintenance dose.

Hemodialysis. Since topiramate is removed from the plasma during hemodialysis, an additional dose of TopamaxЃ should be prescribed on the days of hemodialysis, equal to approximately half the daily dose. The additional dose should be divided into two doses, taken at the beginning and after the end of the hemodialysis procedure. The additional dose may vary depending on the characteristics of the equipment used in the hemodialysis.

Liver failure. Topiramate should be used with caution in patients with hepatic impairment.

hypersensitivity to any component of the drug;

children under 2 years of age.

With care: renal and hepatic failure, nephrourolithiasis (including in the past and in the family history), hypercalciuria.