Huether-50 Davipharm medicine treats epilepsy on start, prevention of migraine (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Topiramat

Ingredient

Composition information	Content
Topiramat	50mg

Uses

indications

Huether medicine - 50 Indications for treatment in the following cases:

Single treatment for patients from 2 years of age and older has local start -up seizures or seizures with spasms - Systemic convulsions. Gastaut.

The drug is also used to prevent migraine and alcoholic treatment. Although the exact impact mechanism of the drug is unknown, data from biochemical and physiological research has shown 4 characteristics that can contribute to the effectiveness of epilepsy and migraine of Topiramat. At the appropriate pharmacological concentration, Topiramate sodium channel blockers depend on voltage; enhance the activity of Y-Aminobutyric Acid (GABA) in some groups of the GABA-A receptor; Glutamate receptor resistance to AMPA/KINAT group; and inhibition of anhydrase carbon dicectrase (especially isoenzyme and CA-IV).

Pharmacokinetics

absorption

Topiramat is quickly absorbed with peak plasma concentrations reaching 2 hours after taking a dose of 400mg. The relative bioavailability of the tablet is 80% of the solution. The plasma concentration of Topiramat increases linearly and depends on the dose of 200 - 800 mg/day. Food does not affect the bioavailability of the drug.

Distribution

Topiramat passes through the placenta and is distributed into breast milk. About 15 - 41% Topiramat is associated with plasma proteins, with the ratio of bonding protein decreases as blood levels increase.

Elimination

Topiramat's average sale time is 21 hours after taking a dose or more dose. About 70% of the dose is excreted mainly in urine in the form of unchanged. Topiramat is not strongly metabolized: 6 metabolites have been determined, and no substance accounts for more than 5% of the dose. In patients with average renal failure (clearly 30 - 69 ml/minute creatinine) or severe renal failure (clearing creatinine ≥ 30 ml/minute), Topiramate's removal corresponds to 42 or 54%. However, Topiramat is also significantly absorbed in the renal tubules, so the clearinine clearance may not predict the Topiramat clearance. In the elderly with renal failure, the clearance of the drug also decreases. In patients with hemolysis, the clearance of Topiramat is 4-6 times faster than healthy people.

Hepatic failure: Although the mechanism is not well understood, Topiramat's clearance decreases in patients with liver failure.

Children: The change of Topiramat clearance has also been observed in children.

Before taking Huether-50 Davipharm medicine treats epilepsy on start, prevention of migraine (6 blisters x 10 tablets)

How to use

Huether - 50 oral medicine. Can drink topiramat without caring for meals.

Dosage

Topiramat dose must be carefully adjusted depending on the response and tolerance of each patient. Should start low doses and standard dose to achieve effective dose level.

epilepsy treatment:

Unit:

Adults: The recommended dose is 400 mg/day, divided into 2 times (morning - evening). The treatment process should follow the following dose schedule:

week 1: 25mg x 2 times/day.

week 2: 50mg x 2 times/day. Time/day.

weight

Total daily daily dose (mg/day) Maximum daily daily dose (mg/day) kg 200 300 KG 250 400 Low dose should start (25 - 50 mg/day), then gradually increase 25 - 50mg per week to the optimal dose, but not exceeding 400 mg/day.

Preventive migraine prevention:

recommended dose is 100 mg/day, divided into 2 times (morning - evening). The treatment process should follow the following dose schedule:

morning dose 2 25mg 25mg Gan:

Dosage should be reduced in patients with renal impairment: 50% of the dose reduction in patients with creatinine clearance below 70 ml/min. In patients with hemolysis, Topiramat clearance is 4-6 times faster than normal people. Topiramat should be considered after hemolysis.

Topiramat clearance decreases in patients with liver failure, but it is not necessary to adjust the dose.

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?

Symptoms:

Take 6 - 40g Topiramat has been reported in several patients. Signs and symptoms include: headache, excitement, drowsiness, sleep, fire transfer and hypokalemia. Clinical results are not serious. Every patient recovers.

A patient who taken around 96 - 110g Topiramat was admitted to the hospital in a coma for 20 - 24 hours, then recovered all after 3-4 days.

Treatment:

General support support and should try to remove the drug from the gastrointestinal tract by gastrointestinal or active carbon. Patients should be fully rehydrated.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 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

Because Topiramat is often used with other anti -epileptic drugs, it is difficult to confirm that the drug has an unwanted effect.

Support treatment - In adults:

Common: Sleep, dizziness, anxiety, loss of air conditioning, anorexia, fatigue, language disorders and problems related to language, mental slow mental, unusual vision, difficulty remembering, confusing, abnormal, double -looking, anorexia, nausea, weight loss, difficulty focus/ attention, body weakness, abdominal pain, temperament.

Unwanted effects occur with low frequency, but are considered to be related to drugs: not aware of the taste, excitement, cognitive issues, easy to touch, combining problems, abnormal gait, emotionlessness, mental disorders/ psychotic disorders, aggressive behaviors/ reactions, leukopen, kidney stones. There are some cases of turbulent thrombosis, although the cause related to drugs has not been set.

Supporting treatment - Children:

In double clinical trials, unwanted effects occur at a frequency> 5% and occur at a high percentage in patients with topiramate treatment rather than in the placebo group, including: Sleep, anorexia, anxiety, personality disorders, difficulty concentration/ attention, extreme reactions, vomiting, vomiting, vomiting, salivation, salivation Difficult to remember, hyperactivity, drowsiness, language disorders and issues related to language, paresthesia.

Unwanted effects that occur with low frequency, but are considered to be related to drugs: easy to touch, excitement, insensitivity, issues related to cognitive, mental mental movement, confusion, hallucinations, depression and leukemia.

Monotheraphy - all patients:

In double blind test, unwanted effects occur with a frequency of ≥ 10% in both placebo groups and only Topiramat includes: Perfect, headache, dizziness, fatigue, drowsiness, weight loss, nausea, and diarrhea. Symptoms when treating a monotherapy (monotherapy) are similar to supportive treatment.

Notify the physician with unwanted effects when using the drug.

Warnings

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

Contraindicated

Huether drugs - 50 contraindications in the following cases:

Hypersensitivity to any ingredients of the drug.

Hemorrhage hypercondreps, non-anion gap, metabolic acidosis (reduce serum bicarbonate levels below normal limits without chronic respiratory alkaline infection), have been reported when using Topiramat. This electrolyte imbalance usually occurs early in patients using Topiramat, although some cases may appear at any time. Metabolic acidosis has been observed in patients with low doses of 50 mg/day. The reason is due to the loss of bicarbonate in the kidney due to the inhibitory effect of topiramat on the carbon dioxide. The decrease in bicarbonate in serum is usually mild to moderate (4 MEQ/l average reduction when using a dose of 400 mg/day in adults and about 6 mg/kg/day in children), rarely, reducing plasma bicarbonate levels to less than 10 MEQ/l. Some manifestations of acute or chronic metabolic acidosis may include increased pulmonary ventilation, nonspecific symptoms such as fatigue and anorexia, or more serious sequelae including heart arrhythmia or drowsiness. Because chronic metabolic acidosis is untreated, it is likely to cause serious sequelae (such as an increase in the risk of kidney stones or calcium stains in the kidneys, the growth of bone and/or osteoporosis with an increased risk of fracture), the serum bicarbonate concentration must be monitored when starting and periodically during the Topiramate treatment. If metabolic acidosis occurs and prolonged, it is advisable to consider reducing the dose or stopping Topiramate (slowly reducing the dose). If you still decide to use Topiramat, you should treat this situation.

A syndrome consisting of acute myopia involved with a secondary angle of glaucoma was reported in several patients taking Topiramat. Symptoms include sudden vision loss and/or eye pain. Symptoms of eye include: nearsightedness, agricultural room, eye congestion (red eye) and increased internal pressure. Maybe or not to relax the pupils. The patient should immediately notify the doctor of eye symptoms such as blurred vision, visual disorders, eye pain during treatment. Treatment includes stopping Topiramat as quickly as possible with the approval of the treating doctor and taking appropriate measures.

oligohidrosis (reducing sweating and gaining body temperature), rarely stretched to the hospital, has been reported. Most cases are in children's patients, some cases have been reported after exposure to high environmental temperatures or strong exercise. Patients, especially children, Topiramat treatment should be closely monitored for reducing sweating and increasing body temperature, especially in hot weather. Should pay attention to compensate for enough water before and during exercise or when the weather is hot. Be careful when Topiramat is used with drugs that can cause body temperature disorders (such as anhydrase carbon inhibitors and drugs with anti -cholinergic activity).

In people with or without a history of seizures, epilepsy, anti -convulsions, including Topiramat, should gradually stop to reduce the possibility of seizures or increase the frequency of seizures. In case of fast stopping, it is recommended to take appropriate monitoring measures.

Epilepsy patients are taking anti -convulsions, including Topiramat, may have unexpected epilepsy. Therefore, patients who are taking Topiramat to treat epilepsy should be careful when doing things that can be dangerous when losing control (driving, operating machinery, swimming, high mountain climbing ...).

Based on current data, patients taking anti -convulsions drugs for any indications must be monitored about depression, suicide, abnormal thoughts in the mood or behavior.

Symptoms such as anxiety, excitement, hostile attitude, manic, mild manic can be a warning sign for suicide.

There has been reports on hyper ammonium and hepatic brain disease in patients using Topiramat (whether or not with Valproic acid). Patients with congenital abnormalities in metabolism or reduced liver mitochondrial activity may be at higher risk. If the patient has an unexplained sleep, vomiting, or mental change, the risk of hepatomal brain disease should be considered and measuring the concentration of ammonium in the blood.

There has been a report on the formation of kidney stones at about 1.5% of adult patients using Topiramat in clinical trials. In general, the rate of stone formation in men is higher than women.

It is unclear the exact mechanism of stone formation, possibly due to the inhibitory effect of Topiramat on the carbonic anhydrase. Patients should drink plenty of water to reduce this risk.

Safety and effectiveness of Topiramat in children under 2 years of age has not been established.

The effect of the drug on the ability to drive and operate machinery

Topiramat can cause drowsiness, dizziness, confusion, difficulty focusing, visual disorders. These unwanted effects can be dangerous for patients when driving or operating machinery, need to be cautious until the effects of the drug on each patient are understood.

Use drugs for women during pregnancy and lactation

Topiramat can be harmful to the fetus when used for pregnant women. Topiramat should only be used for pregnant women if the treatment benefits are higher than the risk of toxicity.

Data shows that Topiramat is distributed into breast milk at a concentration of about 10-20% of the mother's plasma concentrations. Due to the unclear effect of the drug on breastfeeding, cautious when taking the drug for nursing women.

Interactive drug

Metabolic drugs by liver enzyme: In vitro studies show that Topiramat inhibits CYP2C19 enzyme and CYP3A4 light touch. Therefore, pharmacokinetic interactions may occur with metabolic drugs by these enzymes (including anti -convulsions, central neurological inhibitors, oral contraceptives).

Amitriptylin: In healthy people, simultaneously use Topiramat (200 mg/day) and Amitriptylin (25 mg/day) increase CMAX and AUC of amitriptylin 12%. Therefore, be careful when adjusting the Topiramat dose.

Anti -seizure drugs: The plasma concentration of Topiramat decreases about 48% when used simultaneously Phenytoin and Topiramat. Phenytoin's plasma concentration increased by about 25% in some patients and basically did not change in the rest. Phenytoin does not affect the protein cohesion of Topiramat.

Simultaneous use of Carbamazepine and Topiramat reduces the plasma heat of Topiramat by 40%, but does not affect the plasma concentration of carbamazepine and its metabolites. Carbamazepin does not affect the protein cohesion of Topiramat.

Simultaneous use of Valproic and Topiramat acids affects the pharmacokinetics of both drugs (reducing the plasma concentrations of Topiramat 14% and 11% Valproic acid). In addition, it is also related to hyper ammonium with or not accompanied by hepatitis (see special note and cautious when used) and reduce body temperature. Topiramat or Valproic acid should be considered for body temperature.

Simultaneous use of Topiramat and Phenobarbital or Primidone reduces the plasma concentration of drugs used simultaneously. It is unclear the influence of phenobarbital or primidon on the pharmacokinetics of Topiramat.

Lamotrigin's

pharmacokinetics does not seem to affect simultaneously with Topiramat (400 mg/day), but the plasma concentration of Topiramat decreases about 13%.

Diabetes drugs: simultaneous use of Topiramat and Glybid (5 mg/day) in type 2 diabetics reduces concentration in stable state and Glyburid's AUC is 22 and 25%respectively. The pharmacokinetics of Topiramat in a stable state is not affected.

Simultaneous use of Topiramat and Pioglitazin in healthy patients with negligible AUC of Pioglitazon and CMAX constant. When starting to use the drug in diabetics, it is advisable to monitor appropriate blood sugar control. In drug interactive research in healthy people, CMAX and AUC of Metformin increased by 17 and 25% after use simultaneously with Topiramat. However, the time to 'reach the peak concentration of Metformin is not affected. Topiramat's oral clearance is reduced when used simultaneously with Metformin. It is unclear the importance of this interaction clinically. However, Topiramat can cause metabolic acidosis, one of the contraindications for Metformin.

Porture causes body temperature disorders: Increasing the risk of body temperature when Topiramat is used with drugs that can cause body temperature disorders (such as Anhydrase carbonic inhibitors and drugs with anti -cholinergic activity). Should be careful when coordinating.

ANHYDRASE CARBONDRASE: Topiramat is simultaneously used with carbon dioxide drugs (acetazolamid, Didorphenamid, Zonisamid) can increase risks or worsen metabolic acidosis and formed kidney stones.

Alcohol and central neurological inhibitors: Topiramat's simultaneous use with alcohol or central neurological inhibitors have not been clinically assessed. Because Topiramat has the ability to inhibit the central nervous system as well as unwanted effects on cognitive and/or nervous/kidneys, it is especially cautious when coordinated.

Digoxin: Digoxin's serum auc is reduced by about 12% when used with Topiramat in a single -dose study. However, it is unclear clinical importance.

dihydroergotamine: simultaneously use Topiramat 200 mg/day and single doses of dihydroergotamin (1mg of subcutaneous injection) in healthy people does not affect the pharmacokinetics of both drugs.

diltiazem: simultaneously use Topiramat and Diltiazem to reduce CMAX and AUC of Diltiazem 10 and 25%. CMAX and AUC of Topiramat increased 16 and 19%.

hydrodorothiazid: In a medical interactive study in healthy people, CMAX and AUC increased 27 and 29% after using more hydrochlorothiazid. Pharmacokinetics in the stable state of hydrochlorothiazid are not affected. It is unclear the importance of clinical interactions. It may be necessary to adjust the dose of Topiramat. In addition, both drugs show that reducing serum potassium concentration, and the degree of reduction is more when the two drugs are used simultaneously.

Lithi: Lithium pharmacokinetics are not affected when used with topiramat dose of 200 mg/day. When used with Topiramat 600 mg/ day, CMAX and AUC of Lithi increased by 27 and 26%. Therefore, lithium concentration should be monitored when used in high doses of topiramat.

Oral contraceptive pills: In a healthy pharmacokinetics study, the absorption of Ethinyl Estradiol and Norethindron is not affected in patients using Topiramat. However, the absorption of Ethinyl Estradiol is reduced in patients using Topiramat and Valproic acid. It is advisable to consider the possibility of contraception failed and increased the risk of bleeding.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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