Topamax 25 Janssen Treatment of local epilepsy, migraine prevention (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Topiramate

Ingredient

Composition information	Content
Topiramate	25mg

Uses

Indications

Topamax 25mg drug are indicated in the following cases:

Single treatment for adults and children over 6 years old in the local seizure with or without epilepsy of the whole secondary epilepsy, and the spastic spastic epilepsy - the whole whole primary seizure.

Collaborate in the treatment of adults and children aged 2 and older suffering from local bleeding, attached or without epilepsy of the whole secondary epilepsy or spastic seizure - Scratching whole primary and in the treatment of epilepsy related to Lennox -Gastaut syndrome.

Topamax is indicated for preventive treatment migraine in adults after careful evaluation of other treatments.

Pharmacokic

Topiramat is classified as a monosaccharid that has been replaced with sulfamid. The active voltage is repeated by the extended reduction of neuron inhibited by Topiramat in a time -dependent -style manner, resulting in a sodium channel blocker depending on the state. Topiramat increases the frequency at which the GABA receptors are activated by Y-Aminobutyrate (GABA), and increases GABA's ability to create chloride ions into neurons, showing that Topiramat increases the activity of inhibited neurotransmitters.

pharmacokinetic

absorption:

Topiramat absorbs well and fast. Topiramat is not a strong touch substance for drug metabolic enzymes, not affected by meals, and no need to periodically check the concentration of topiramat in plasma.

Distribution:

About 13-17% Topiramat is connected to plasma proteins. The average apparent volume of the drug distribution is 0.08-0.55 l/kg when using a single dose from 100-1200 mg.

Metabolism:

Topiramat is not much metabolized (20%) in healthy volunteers. Topiramat is metabolized up to 50% in patients using simultaneously with anti -epileptic drugs that induce drug metabolic enzymes. The six metabolites, formed through hydroxylation, hydrolysis and complex glucuro, are isolated, qualitative from plasma, urine and fertilizer.

Era:

In humans, the main elimination path of Topiramat is constant and its metabolites are through the kidney. Plasma clearance is about 20 - 30ml/minute in human after drinking topiramat.

Before taking Topamax 25 Janssen Treatment of local epilepsy, migraine prevention (6 blisters x 10 tablets)

How to use

Topamax in the form of tablets, oral use. Recommendation when using Topamax tablets. You can drink topamax without caring for meals.

Dosage

Epilepsy - Coordination treatment

Adults: It is recommended to start at a dose of 25 to 50mg at night in a week. Then every week or two weeks, an additional dose of 25 to 50mg/day and divided into 2 drinks a day. The usual daily dose is 200 to 400mg, divided into twice. Some patients have been used at high doses of 1600 mg/day.

Children 2 years and older: Topamax's daily daily dose when combined treatment is recommended about 5 to 9mg/kg/day, divided into twice. The dose adjustment should be started by 25mg every night of the first week. Then, to achieve optimal clinical response, after every 1 or 2 weeks, the dose increases within 1 to 3mg/kg/day (divided into two drinks).

epilepsy - Unit of treatment

Adults: The dose adjustment should start at the dose of 25mg every night in a week. Then, every week or every two weeks, an additional dose of 25 or 50mg/day should be increased and divided into 2 drinks a day. The recommended starting dose is when single -therapy with topiramat in adults between 100 and 200mg/day is divided into 2 times and the maximum daily dose is recommended for 500mg/day divided into 2 times.

Children 6 years of age: Children from 6 years old should start at a dose of 0.5mg to 1mg/kg in the evening, in the first week. Then every 1 or 2 weeks, increasing the dose of about 0.5 to 1 mg/kg/day, divided into two drinks. The starting dose is recommended when single -therapy with Topiramat in children from 6 years old is from 100 to 400mg/day. Children have just diagnosed with local starting epilepsy, which has been used by doses of up to 500mg/day.

Migraine for adults: Topiramat's daily recommended daily dose in migraine prevention is 100mg/day, divided into 2 times. The dose adjustment should start at a dose of 25mg every night in a week. Then every week should increase by 25mg/day.

Renal failure: The recommendation of half of the starting dose and the maintenance dose in patients with end -stage renal impairment should be added half -dose Topamax daily used daily on dialysis days. Topamax dose added when dialysis should be divided at the beginning and at the end of the dialysis process.

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 overdose? Activated carbon has the ability to absorb Topiramat in vitro. Should use appropriate support measures. Dialysis is an effective way for Topiramat to remove the body. Patients should be fully rehydrated.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using topamax 25 mg , you may experience unwanted effects (ADR).

Rare, 1/10,000

Metabolic and nutritious disorders: hyper ammonia; Bright disease due to hyper ammonia.

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

Topamax 25 mg contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Preventive migraine prevention for pregnant women and women of reproductive age does not use appropriate contraception.

Precautions when using

Topamax drug stops: in patients with or without a history of convulsions, or epilepsy, must stop slowly Topamax. In cases where medical reasons should be forced to stop Topamax quickly, recommending appropriate monitoring.

Patients with renal impairment: Patients with renal impairment at an average or severe level may need 10 to 15 days for the concentration of drugs in plasma to achieve a stable state. Note that patients already know that kidney failure may need a longer time so that the concentration of the drug can reach the status of each dose.

Reduce: Reducing sweat and no sweat has been reported to be related to the use of Topiramat. Using water can reduce the risk of kidney stones, which may reduce the risk of adverse effects related to heat.

Disorders of depression: There is an increase in mood disorders and depression recorded during treatment with Topamax.

suicide or suicide intentions: Patients should be monitored the signs of suicide intentions and behaviors and should consider appropriate treatment. It is recommended that patients (and family members when necessary) should have medical advice immediately when there are signs of intentions and suicide behavior.

Kidney stones: Some patients, especially those who are likely to have kidney stones, may increase the risk of kidney stones and have symptoms and signs related to topiramat treatment.

Hepatic failure: People with liver failure, Topiramat should be used carefully, because the clearance of Topiramat may be reduced.

Nearly -closed -angle myopia and glocom: secondary closed -angle glaucoma related to Topiramat encountered in pediatric patients as well as in adults. Treatment includes Topamax stopping as quickly as possible under the decision of the treating doctor and lowering pressure by appropriate measures.

Visual defects: In clinical trials, most visual defect events can recover after stopping Topiramat. If visual problems occur at any time during the Topiramat treatment process, it is advisable to consider to stop taking the drug.

Metabolic acidosis: depends on each situation where appropriate reviews include serum levels of bicarbonate recommended when treated with topiramate. If metabolic acidosis appears and lasts, considering reducing the dose or may stop using Topiramat (decreasing dose).

Supplements with nutrients: may consider providing supplements or increased diet, if the patient lose weight while taking this medication.

Cognitive decline: There have been reports in literature about cognitive function impairment in adults when treating with Topiramat that had to request a decrease in dose or stop treatment.

Hyperactive hyperglycemia and enhancement: Hyperactive ammonia whether or not related to brain disease is reported when treated with Topiramat, especially when using Topiramat simultaneously with Valproic acid. In the majority of cases, enhancement of blood ammonia decreases when stopping treatment.

Lactose intolerance: Topamax tablets contain lactose. This drug should not be used in patients who are not able to tolerate lactose in rare genetic diseases, lactose deficiency or glucose-galactose absorption disorders.

The ability to drive and operate machinery

Topamax has a slight or medium impact on the ability to drive and operate machinery. Topamax works on the central nervous system, visual disorders can be dangerous to patients when driving or operating machinery.

Pregnancy

Other studies have shown that newborn babies who have exposed to topiramat are single -treatment therapy in the first 3 months of pregnancy may increase the risk of congenital defects and increase the risk of teratogenicity related to the use of anti -epileptic drugs in the combined treatment group compared to the single -treatment group. It is recommended that women of reproductive age should use appropriate contraception and selection of alternative therapies.

Breastfeeding period

Animal research has shown that Topiramat is excreted in milk. Because many drugs are excreted through breast milk, it is necessary to decide to stop/ avoid using topiramat or stop breastfeeding, depending on the importance of the drug for the mother.

Drug interaction

Other anti -epileptic drugs: In some patients, combining Topamax while being treated with phenytoin may increase the concentration of phenytoin in plasma. Phenytoin and carbamazepines reduce the plasma concentrations of Topamax.

Digoxin: In the single -dose study, the area under the curve (AUC) of the Digoxin concentration in serum decreased by 12% when used simultaneously with Topamax.

Central nervous system inhibitors: recommend Topamax is not used with alcohol or other central nervous system inhibitors.

Oral contraceptives: The ability to reduce the effectiveness of oral contraceptives and increase the risk of unexpected bleeding should be noted in patients who are taking oral contraceptives simultaneously with Topamax.

Lithium: On a healthy volunteer person, observing a system exposure with lithium when used with Topiramat 200 mg/day.

Rispendon: There are very little changes in pharmacokinetics of the entire activity (Risperidon and 9-Hydroxyrisperidon), and there is no change in the pharmacokinetics of 9-hydroxyrperidon.

hydrochlorothiazid (HCTZ): Clinical test results show that there is a decrease in serum potassium after taking Topiramat or HCTZ, more reductions when these two drugs are used at the same time.

metformin: plasma clearance when taking Topiramat decreases when used with metformin.

Pioglitazon/ Glybid: While treating Pioglitazon/ Glybid, adding topamax or vice versa, pay attention to monitor patients regularly to control diabetes.

The drugs that are likely to cause kidney stones: Topamax when used simultaneously with drugs that can cause kidney stones can increase the risk of kidney stones.

Valproic acid: When using Topiramat with Valproic acid in patients who are tolerated with each drug used alone, it is seen that there is a phenomenon of increased blood ammonia may have or do not accompany or//decrease in body temperature.

Storage

Store at temperatures not exceeding 30 ° C. Store in the original packaging. Do not store drugs mixed with food.

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