Expiration date: 07/2025
Composition
One tablet contains topiramate 25 or 100 mg
Excipients: lactose (milk sugar), pregelatinized corn starch, microcrystalline cellulose, sodium carboxymethyl starch, hypromellose (hydroxypropyl methylcellulose), magnesium stearate
Packaging
28 pcs.
pharmachologic effect
Toreal has an antiepileptic effect.
testimony
The partial or generalized tonic-clonic seizures as a monotherapy and in combination with other anticonvulsants, adjunctive therapy in the treatment of seizures associated with Lennox - Gastaut syndrome (adults and children), newly diagnosed epilepsy (in adults and children older than 2 years).
Contraindications
Hypersensitivity, pregnancy, breast-feeding, child up to 3 years.
Dosing and Administration
Toreal taken orally by swallowing the tablet whole without chewing, independent of meals. it is recommended to start treatment with low doses with a subsequent increase to the effective dose to the optimal control of seizures.
Adults:
The minimum effective dose of 200 mg / day. The usual daily dose of 200-400 mg (2 Hour). The maximum daily dose of 1600 mg. Treatment starts with 25-50 mg daily at bedtime for one week. Then increase the dose of 25-50 mg daily for 1-2 weeks, with a multiplicity of receiving two times a day. At intolerance of such a dosing regimen, the dose is increased by a smaller amount, or over large intervals. The dose and frequency of reception is adjusted depending on the clinical effect.
Children over 3 years:
The recommended daily dose is 5-9 Toreala mg / kg body weight, divided into 2 admission. Treatment started with a dose of 25 mg at bedtime for one week. the dose was then increased to 1.3 mg / kg / day for 1-2 weeks, with a multiplicity of receiving two times a day, to achieve optimal clinical effect.
Side effects
From the nervous system and sensory organs: fatigue, ataxia, impaired thinking and concentration, emotional lability, confusion, dizziness, paresthesia, hypoesthesia, lethargy, seldom - agitation, amnesia, aphasia, depression, diplopia and other visual impairment, conjunctivitis , nystagmus, speech disorder, perversion of taste sensations.
From the digestive tract: anorexia, gingivitis, nausea.
Other: weight loss, abdominal pain, chills, leukopenia, dyspnea, edema, epistaxis, nephrolithiasis, hematuria, pruritus, tinnitus, dysmenorrhea, weakening of libido, impotence.
special instructions
When receiving the drug for women is recommended to use adequate contraception. Topiramate, as well as other AEDs, it is recommended to cancel, gradually reducing the dose, in order to reduce the potential risk of increased frequency of seizures.
Renal impairment: Patients with moderate and severe strongly impaired renal function may need 10-15 days to reach the equilibrium state plasma concentrations as opposed to 4-8 days in patients with normal renal function. As with all patients, a gradual increase in dose should be administered in accordance with clinical outcomes (such as the control of seizures, frequency of side effects), given that patients with moderate or severe renal impairment may require a longer time to reach steady-state after each dose.
Overdose
Symptoms: convulsions, disturbance of consciousness up to coma, decreased blood pressure, severe metabolic acidosis, increased severity of side effects.
Treatment: gastric lavage, symptomatic therapy. An effective way to removing topiramate from the body - hemodialysis.
Storage conditions
In a dry, dark place at a temperature no higher than 25? C. Keep out of the reach of children.
Shelf life
2 years.
