Topiramin (topiramate) coated tablets 25 mg. №60 vial

Description

Topiramin (topiramate) coated tablets 25 mg. №60 vial

Composition

active substance: topiramate;

1 tablet contains topiramate 25 mg or 100 mg or 200 mg;

Excipients: copovidone, lactose monohydrate, sodium starch glycolate (type A), magnesium stearate, colloidal silicon dioxide;

• composition of Opadry shell II white (for a dosage of 25 mg): hydroxypropylmethylcellulose, titanium dioxide (E 171), polydextrose, triethyl citrate, polyethylene glycol;
• the composition of the shell Opadry II yellow (for a dosage of 100 mg): polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide yellow (E 172);
• the composition of the shell Opadry II pink (for a dosage of 200 mg): polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide red (E 172).

Dosage form

Coated tablets.

Basic physical and chemical properties:

• 25 mg tablets: white, round, coated, imprinted with “T” on one side and imprinted “25” on the other;
• 100 mg tablets: yellow, round, coated, imprinted with “T” on one side and imprinted “100” on the other;
• 200 mg tablets: dark pink, round, coated, imprinted with a “T” on one side and imprinted with “200” on the other.

Pharmacotherapeutic group

Antiepileptics. Other antiepileptic drugs. Topiramate.
ATX code N03A X11.

Pharmacological properties

This pharmaceutical agent is included in the group of antiepileptic drugs.
Its main component, topiramate, belongs to sulfamate-substituted monosaccharides.

Electrophysiological and biochemical studies were carried out, which established that topiramate has three mechanisms of drug action, which make it possible to realize its antiepileptic effects.
This substance is primarily capable of blocking sodium channels and suppressing the appearance of repetitive exposure potentials.
Also, thanks to topiramate, certain receptors are activated with the help of g-aminobutyrate, due to which these receptors are stimulated to produce a stream of chloride ions up to neurons. As a consequence, inhibitory neurotransmitters activate their effects.
Finally, topiramate is able to inhibit the activation of certain receptors for glutamate amino acids.
The indicated properties of topiramate are dose-dependent.
In addition to the listed effects, topiramate helps to inhibit the activity of certain isoenzymes of the enzyme carbonic anhydrase, which is encoded in humans using the CA4 gene.
It should be noted that topiramate is less effective than acetazolamide (a carbonic anhydrase inhibitor).

Indications

Topiramin used for the treatment of epilepsy, both in monotherapy and in combination (with partial, generalized tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome).
Also used to prevent the development of migraine attacks (in adults).

Contraindications

The drug Topiramin in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
It is contraindicated to use in pediatrics until the age of 6 years. From 2 years old it can be used as part of combination therapy.

Application during pregnancy and lactation

This drug Topiramin is contraindicated in the treatment of pregnant women.
If it is necessary to administer the drug during breastfeeding, then lactation should be suspended for the duration of treatment.

Method of administration and dosage

This drug Topiramin is used in the minimum effective dosage, it is taken once a day, before going to bed, or 2 times a day (at doses over 25 mg per day).
In monotherapy, treatment begins with minimal dosages (25 mg per day in children, 100 mg in adults), with a gradual increase in dosage (if necessary) by 25-50 mg per week.
If necessary, end treatment – interruption of admission is also made by gradually reducing the dosage (by 100 mg per week).
It is taken orally, the effect does not depend on food intake. The maximum recommended dose Topiramin per day is 500 mg, with a refractory form – up to 1 thousand mg. The maximum allowable daily dose is 1600 mg.
The maximum daily dose for children is calculated at the rate of 5 to 9 mg per 1 kg of patient weight, per day. The initial dose is 0.5-1 mg per 1 kg, increases by the same amount per week and is brought to 3-6 mg per 1 kg of body weight. As with adults, it can be taken once a day.
In renal diseases, the dose is reduced by 50%.
When used in combination therapy, the initial dosage is the same as that used in monotherapy. The usual recommended dose per day is 200 mg, on average, 200-400 mg per day is taken (no more than 1,000 mg).
Migraines are treated with an average dosage of 100 mg per day, with an initial dose of 25 mg per day.

Overdose

Overdose can cause:

• convulsions, drowsiness, dizziness, agitation / depression;
• disorders of speech, vision, thinking, coordination of movements;
• diplopia, lethargy, stupor;
• arterial hypotension, metabolic acidosis.

Urgent gastric lavage, symptomatic therapy, hemodialysis, and increased fluid intake are recommended.

Side effects

In some cases, there may be some side effects in the form of:

• nervousness, dizziness, headache, speech disorders, vision, thinking, coordination of movements, as well as ataxia, fatigue;
• anorexia, nystagmus, paresthesia, depression;
• in children – personality disorders, salivation, hyperkinesia, disturbances in taste, emotional lability, apathy, psychosis, aggression, in rare cases – suicidal thoughts, hallucinations;
• decrease in the depth of the anterior chamber of the eye, eye hyperemia, increased intraocular pressure, diplopia, mydriasis;
• dyspepsia, nausea, diarrhea, abdominal pain, dry lips, hepatitis, liver failure;
• weight loss, asthenia, nephrolithiasis, oligohydrosis (in children), metabolic acidosis, fever;
• erythema multiforme, pemphigus, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• leukopenia, neutropenia;
• thromboembolism (isolated cases).