Suntopirol 25 Sun Pharma treats epilepsy (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Topiramate

Ingredient

Composition information	Content
Topiramate	25mg

Uses

indications

Suntopirol drugs are indicated in the following cases:

Single epilepsy: Suntopirol is indicated for initial treatment in patients from 10 years of age and older with partial convulsions or spasms - Shocking of the whole body.

Treatment of epilepsy support: Suntopirol is indicated in the support treatment in adults and children (from 2 - 16 years old) with partial convulsions or spasms - vibration of the whole body.

Migraine: Suntopirol is indicated for preventing migraine in adults. Biochemical and physiological studies on cultured neurons identify 3 characteristics that can contribute to the anti -epileptic effect of Topiramat.

The activity is repeated by the extended reducing of neuron that is blocked by Topiramat in a time -dependent type, resulting in a state -dependent sodium channel blocker. Topiramat increases the frequency at which Gabaa receptors are activated by G - Aminobutyry (GABA), and increases GABAA's ability to create chloride ion streams to neurons, showing that Topiramat increases the activity of inhibited neurological mediators.

This effect is not inhibited by Flumazenil, a antagonist with benzodiazepin and Topiramat nor increases the time of opening the channel, the difference between Topiramate and the Barbiturates is to adjust the GABAA receptor.

Because the anti -epileptic properties of Topiramat are completely different from the properties of benzodiazepin, Topiramat can be adjusted as an auxiliary group of the Gabaa receptor that is less sensitive to benzodiazepin.

In addition, Topiramat inhibits a few isenzymes of carbon dioxide. This pharmacological effect of Topiramat is much weaker than the effect of acetazolamid, is a familiar carbon dioxide inhibitor, and is not considered a major mechanism of Topiramat's anti -epileptic activity.

Research on animals, Topiramat has anti -convulsions in rats and rats in maximum electrical shock tests (MSE) and is effective in rodents that have epilepsy, including epilepsy and no muscle in spontaneous epilepsy (Ser) and tonic seizures and clones in mice due to the irritation of the nymph nodes and the glutinous anemia. Topiramat only has weak effects in the clonic inhibiting seizure due to the impact of the antagonistic substance of the Gabaa receptor is pentyleneterrazol.

Mouse research simultaneously used Topiramat and Carbamazepin or Phenobarbital shows that anti -convulsions are coat, while combined with phenytoin only shows that anti -convulsions have plus effects. In clinical trials, using Topiramat as a control assistance, there is no correlation between the concentration of Topiramat in plasma and the clinical effect of this drug. There is no evidence of human tolerance.

Dynamic pharmacokinetics

After taking the drug, Topiramat is quickly absorbed and reached the peak concentration in plasma after about 2 hours at the dose of 400 mg. The relative bioavailability of the drug is about 80% and the drug is not affected by food. The drug is linked to protein about 13 - 17% and the distribution of the drug is 0.55 - 0.80 l/kg for a single dose of 1200 mg. There is the influence of gender on distribution, in women with an integral distributed by about 50% compared to men. This is because the rate of obesity in female patients is higher.

Topiramat is not strongly metabolized (about 20%) in healthy volunteers. About 70% of the dose is eliminated in the form of unchanged by the kidneys. Topiramat is metabolized up to 50% in patients using simultaneously with anti -epileptic drugs that induce drug metabolic enzymes. Six metabolites, formed through hydroxylation, hydrolysis and glucuro - isolated complex, no metabolites are 5% greater than the dose.

The disposal time of the drug is 21 hours after using the dosage or multiple doses. Stable concentration state is achieved after 4-8 days in adult patients with normal kidney function.

The clearance of plasma and kidneys decreases in patients with renal function (CLCR ≤ 60 ml/min) and the clearance in plasma decreases at the end of the renal impairment. Time to achieve the balance state of the drug increases to 10-15 days in patients with medium and severe renal failure.

The clearance of the drug in plasma is constant in the elderly in case of no kidney disease.

The clearance of drugs in plasma decreases in patients with moderate and severe liver failure.

Before taking Suntopirol 25 Sun Pharma treats epilepsy (5 blisters x 10 tablets)

How to use

oral medication. Because the drug has a bitter taste, it is not allowed to break the pills.

Dosage

recommendations to start treatment with low doses then standard effectively to the effective dose based on clinical response.

Adults (from 17 years old)

The initial dose of Suntopirol is 50 mg/day/day, before going to bed for the first week and then increasing 50 or 100 mg after weeks until the dose is achieved effective, the dose is usually in the range of 200 - 400 mg/day, divided into 2 small doses for drinking. Many patients can meet well when using only 1 daily dose. Some special patients receive higher doses over 1600 mg/day.

Food does not affect Suntopirol.

There is no need to monitor topiramat concentration in plasma to optimize treatment with Suntopirol. Occasionally, the use of Suntopirol with Phenytoin may require adjusting the dose of Phenytoin to achieve the optimal clinical results. Add or reduce phenytoin and/or carbamazepin during treatment combined with Suntopirol may require adjusting the dose of Suntopirol.The recommended dose is applied to all adults, including the elderly, in case of no kidney disease.

Because Suntopirol is reversed by plasma by hemorrhage, an additional dose of Suntopirol is equivalent to about half of the daily dose should be used on the day of hemorrhage. The additional dose should be used at the beginning and when completed the process of hemorrhage. The additional doses may be different, based on the tools used for blood separation.

Lower initial dose, smaller increased dose, or longer dosage increase may be necessary if the patient cannot tolerate the drug according to the above regimen.

Patients with kidney failure or liver failure, the recommended dose is half the normal dose of adults.

Patients are children (2 - 16 years old)

initial dose as recommended as 25 mg in the evening for the first week. The dose will be increased every 1 to 2 weeks until the dose of 1-3 mg/kg/day (divided into 2 use), to achieve the best clinical response.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose?

Supporting treatment measures should be used appropriately. Hemorrhage is significantly effective in removing Topiramat from the body, but in the case of acute poisoning at a dose higher than 20 g in a patient, the hemorrhage is not necessary.

What to do when you forget a dose? However, if near the next dose time, skip the forgotten dose. Do not take double the dose to compensate for the forgotten dose.

Side Effects

When using Suntopirol, you may experience unwanted effects (ADR).

regularly

Loss of air conditioning, depression, concentration, confusion, dizziness, fatigue, abnormalities, drowsiness and difficulty in memory or memory.

Other side effects

Abdominal pain, anorexia, weakness, double vision, leukopenia, nausea, eyeball vibration, mental retardation, speech disorders, taste changes, visual disorders and weight loss. The risk of kidney stones increases, especially in patients.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Suntopirol drug is contraindicated in the following cases:

People who are sensitive to any component of the drug (excipients: Lactose Monohydrate, Cellulose Micro, Povidone (K - 30), Talc, Magnesi Stearat, Colloidal Anhydrous Silica, Sodium Starch Glycolate (pH 5.5 - 7.5), Hypromellose 2910 (E - 5 PREMIM), Microgol (6000), 6000), 6000) (Flakes form), titanium dioxid (anatase), iron oxid (red)).

Children under 2 years of age cannot use this medicine.

Be cautious when using

as well as other epilepsy medications, the discontinuation of treatment with topiramat or changing treatment through other anti -epileptic drugs should be made slowly, avoiding sudden changes will increase the frequency of epilepsy. As recommended, the dose should be reduced 100 mg/day after each week. In some patients, the suspension or change is done quickly without any difficulties.

Patients with medium and severe renal failure may need 10-15 days to achieve stable plasma concentrations compared to 4-8 days in patients with normal kidney function.

Topiramat should be used with caution in patients with liver or kidney failure, which is at risk of forming kidney stones, especially in patients who have been affected by kidney stones. Drink adequate water to reduce this risk.

The dangerous factor for kidney stones includes previous kidney stones, a family with a history of kidney stones or hypercalci.

Use Topiramat can cause drowsiness, fatigue, dizziness and difficulty focusing, especially in the first month of treatment. Patients should be advised to use carefully when driving and operating machinery or doing other jobs that require alertness until they recognize the side effects of Topiramat affecting intelligence and/or driving.

The ability to drive and operate machinery

Topiramat acts on the central nervous system and can cause off drowsiness, dizziness or similar symptoms. It can cause visual disorders and/or blurred vision. These side effects can endanger patients while driving and operating machinery.

There has been no official research on the effects of drugs on driving and operating machinery.

Pregnancy

like other anti -epileptic drugs, the development of selective toxicity in animals includes facial defects and defects in the limbs seen in the process of organizing the organ. Because there is no sufficient evidence and well -controlled studies in Topiramat in pregnant women, Topiramat is used for pregnant women only if the benefits are greater than the risk to the fetus.

breastfeeding period

Topiramat should be used cautiously in breastfeeding women. The drug is excreted in milk when studying in mice and hinders the development of the mouse's body. It is not known whether the drug is excreted through breast milk. The decision to breastfeed during medication should carefully consider the potential risks to children.

Drug interaction

There are many complex interactions between Topiramate and other anti -epileptic drugs and may increase toxicity without increasing anti -epileptic effect. These interactions can be changed and unpredictable and therefore should regularly monitor the drug concentration in plasma during combination treatment.

For example, in some patients using Phenytoin along with Topiramat, phenytoin plasma concentration increased by 25% and plasma concentrations of Topiramat decreased by 48%. These patients use phenytoin 2 times/day. Other patients have a change in phenytoin plasma concentrations.

When concurrent use of Valproic acid and Topiramat, the plasma concentration of Valproic acid increased by 11% and the plasma concentration of Topiramat decreased by 14%.

Serum digoxin concentration can be affected when using Digoxin and Topiramat.

Topiramat can inhibit the central nervous system as well as other side effects on awareness and mind - nerves. The central nervous system inhibitors can occur when used with alcohol or other central neurological inhibitors such as benzodiazepin, barbiturate, opiating copper, muscle -muscle relaxants, 3 -round antidepressants and some H1.

Topiramat can increase the Ethinyl estradiol's clearance and reduce the effectiveness of oral contraceptives or hormone replacement therapy.

Topiramat is a weak inhibitor of anhydrase carbonic enamel. Topiramate simultaneous use with other anhydrase carbonic inhibitors such as acetazolamid, methazolamid, dichlorphenamid can create a physiological environment that increases the risk of kidney stones.

Storage

Avoid light, store less than 30 ° C, in a dry place. Leave the drug from the vision and reach of children.

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