Topamax
Topamax (Topiramate)Pharmacological action
Antiepileptic preparation. Zinci sulfas-replaced of monosaccharides Belongs to the class.
Antiepileptic activity of a preparation is caused by a number of its properties. Topamax (Topiramate) reduces frequency of occurrence of action potentials.
Indications
- Partial or generalised toniko-clonic attacks at adults and children (as monotherapy or in a combination with other anticonvulsants);
- The attacks bound to syndrome Lennoksa-Gasto, at adults and children (as an agent of additional therapy).
Dosage regimen
At Topamax (Topiramate) application as a part of the combined therapy with other anticonvulsant preparations at adult patients the minimum effective dose makes 200 mg/days the Average daily dose makes 200-400 mg, frequency rate of reception - 2 times/days Recommend to begin treatment with a dose of 1 times/24h of 25-50 mg for the night within 1 week. Further it is necessary to enlarge a dose by 25-50 mg with intervals in 1 or 2 weeks before selection of an effective dose. Frequency rate of reception - 2 times/days if necessary probably augmentation of a daily dose to maximum - 1600 mg. As criterion of selection of a dose the clinical effect serves. At some patients the effect is reached at reception of a preparation of 1 times/days
At Topamax (Topiramate) application as a part of the combined therapy with other anticonvulsant preparations at children the recommended total daily dose is more senior 2 years makes from 5 to 9 mg/kg and is accepted in 2 receptions. Dose selection begin about 25 mg/24h (or less, from calculation of mass of a body of 1-3 mg/kg a day), accept a preparation for the night within 1 week. Further with week or fortnight intervals the dose can be enlarged by 1-3 mg/kg and to accept a preparation in 2 receptions. At dose selection it is necessary to be guided by clinical effect. The daily dose to 30 mg/kg of mass of a body is well transferred.
Topamax (Topiramate) is possible to accept without dependence from food intake. Tablets should not be divided.
At application of Topamax preparation as a monotherapy agent it is necessary to consider possible influence of cancellation of accompanying anticonvulsant therapy on the control of frequency of attacks. In such situations in the presence of clinical indications Topamax dose can be reduced.
Adults in the beginning of carrying out of Topamax monotherapy should accept on 25 mg of 1 times/24h before a dream within 1 week. Then a dose raise with an interval in 1-2 weeks on 25-50 mg/24h (a daily dose divide into 2 receptions). At intolerance of such regimen of therapy, a dose raise on smaller size or through the big intervals. A dose select depending on clinical effect. The recommended dose makes 100 mg/24h, the maximum daily dose - 500 mg. In some cases at monotherapy refractory to treatment of an epilepsy the Topamax dose makes 1000 mg/days
To children is more senior 2 years at monotherapy in the first week of Topamax treatment prescribe in a dose of mass of a body of 0 mg/kg a day (a daily dose divide into 2 receptions). The size of a dose and rate of its rising are defined by clinical efficiency and shipping of therapy. On the average a dose raise with an interval in 1-2 weeks on 0 mg/kg/days the Recommended range of doses at Topamax monotherapy at children is more senior 2 years makes 3-6 mg/kg/days At recently diagnosed partial attacks a dose can make to 500 mg/days the Preparation accept 2 times/days
At appointment of a preparation as the patient with moderately or strongly expressed disturbances of function of kidneys it is necessary to consider, that 10-15 days can be necessary for achievement of an equilibrium condition at the given category of patients, unlike 4-8 days at patients with normal function of kidneys. As Topamax leaves from plasma at a hemodialysis, in days of its carrying out it is necessary to prescribe the additional dose of a preparation peer to half of a daily dose, in 2 receptions (before procedure).
To cancel a preparation follows gradually to reduce to a minimum possibility of rising of frequency of attacks. It is recommended to reduce a dose by 100 mg every week.
Side effect
From party TSNS and peripheric nervous system: often (especially in dose selection) - disturbance of concentration of attention, confusion of consciousness, giddiness, feeling of weariness, paresthesia, drowsiness, thinking disturbance; seldom - excitation, an amnesia, an anorexia, an aphasia, depression, emotional lability, speech disturbances, a diplopia, a nystagmus, sight disturbance, a food faddism.
From the alimentary system: on occasion - rising of indicators of functional hepatic assays (at the patients Topamax accepting in a combination with other medicinal preparations or as monotherapy), a hepatitis, hepatic insufficiency (at Topamax application simultaneously with carrying out of massive medicinal therapy).
The other: seldom - a nausea, a nephrolithiasis, reduction of mass of a body.
The profile of safety of a preparation is established on the basis of the analysis of data on application of a preparation for 1800 patients and healthy volunteers. Because Topamax was mainly used as a part of the combined therapy, to establish the exact reason of development of side-effects very difficult
Contraindications
- A hypersensibility to preparation components.
Pregnancy and lactemia
Adequate and strictly controllable clinical researches of safety of Topamax application at pregnancy it was not spent. Nevertheless, preparation application at pregnancy is possible only in that case when the prospective advantage for mother exceeds potential risk for a foetus.
Special indicatings
To cancel Topamax follows gradually to reduce to a minimum possibility of rising of frequency of attacks. At carrying out of clinical tests a preparation dose reduced by 100 mg once a week.
At Topamax application the risk of formation of stones in kidneys and occurrences of the symptoms bound to it (a renal colic, a pain in a side and in the field of a kidney), especially at patients with predisposition to a nephrolithiasis (formation of stones in the past, a nephrolithiasis in the family anamnesis, a hypercalcuria), and also against application of other preparations promoting development of a nephrolithiasis can raise. For reduction of risk of development of a nephrolithiasis it is necessary to enlarge volume of a consumed liquid.
If against reception of Topamax preparation at the patient the body mass it is necessary to correct a diet decreases.
The preparation is resolved to application for children is more senior 2 years.
Influence on ability to driving of motor transport and to management of mechanisms
With care it is necessary to prescribe a preparation to the patients who are engaged in potentially dangerous kinds of activity, demanding special attention and speed of psychomotor reactions since the preparation can cause drowsiness, giddiness.
Overdosage
Symptoms: intensifying of implications of the described by-effects is possible.
Treatment: a gastric lavage; if necessary spend symptomatic therapy. Application of the activated coal is not shown, since in experiments in vitro has been shown, that the activated coal does not adsorb Topamax. Effective way of Topamax deducing from an organism is the hemodialysis.
Conditions and periods of storage
The preparation should be stored in a dry place at temperature not above 25 C. The Period of validity - 3 years.
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