YAFORT 500mg Cophavina medicine for local epilepsy (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Levetiracetam

Ingredient

Composition information	Content
Levetiracetam	500mg

Uses

indications

Yafort 500 mg Cophavina is indicated in the following cases:

Treatment of local seizures in adults and children over 1 month of age.

The mechanism of action of levetiracetam is not well known, but it seems different from the mechanisms of action of anti -epileptic drugs. In vitro and in vivo tests suggest that levetiracetam acts on Ca ++ concentrations in nerve cells. In addition, the drug also partially reverses the reduction of GABA and Glycine streams caused by induction with zinc and beta-carboline.

Moreover, in vitro studies show that levetiracetam is associated with a specific position in the brain tissue of rodents. This cohesive position is 2A protein in the synap bag, which is thought to be related to the broken bag and the release of neurotransmitters.

levetiracetam and related homosexual substances have a certain affinity to connect with 2A protein in Synap capsule, this corresponds to the anti -seizure protection activity of the drug in the study on the mouse model under the seizure under the sound stimulation. This discovery suggests that the interaction between levetiracetam and 2A protein in the synap bag can contribute to the anti -epileptic effect of the drug.

Pharmaceutical effect

Levetiracetam enhances the protection of anti -seizures in many models of local convulsions and the entire first -handedness on animals without the effect of convulsions. Initial metabolites are not active.

In humans, the drug works in both local and whole epilepsy (epilepsy/dramatic force -shaping force for light stimulation) that has affirmed the broad spectrum of the predecessor of the drug.

pharmacokinetics

absorption and distribution

Levetiracetam absorbs fast with the peak concentration after about 1 hour when using hungry gas. Oral bioavailability in the form of tablets reaches 100%. Food does not affect the absorption level but reduces the peak concentration (c) about 20% and slows down about 1.5 hours. The dynamic of linear drug is between 500 to 5000 mg. Stable state achieved after 2 days of using multi -dose regimen 2 times/day.

levetiracetam and metabolites associated with plasma proteins below 10%.

Metabolism

In humans, levetiracetam is almost less metabolic. The main metabolism (24% of the dose) is acetamide hydrolysis by enzyme and does not depend on any isomers of the cytochrome P450 liver enzyme. The metabolic substance of the drug has no biological activity on the animal model. There is no isomorphic conversion between levetiracetam and its metabolites.

Elimination

Semi -dumping time in adults is 7 ± 1 hour and is not affected by the dose, or repeated dose. About 66% of the levetiracetam dose is eliminated through the kidneys in the formless form. The whole body clearance is 0.96ml/min/kg and the renal clearance is 0.6ml/min/kg. Levetiracetam's clearance is correlated with creatinine clearance and decreased in patients with renal function.

levetiracetam eliminates glomerular filtration with the reabsorption of that part in the renal tubules.

Before taking YAFORT 500mg Cophavina medicine for local epilepsy (3 blisters x 10 tablets)

How to use

YAFORT film tablets must be taken with a sufficient amount of liquid and can be taken during or outside meals. The daily dose is divided equally for 2 drinks.

Dosage

adults and adolescents aged 16 and over

Starting dose: 1/2 capsules 2 times/day. After 2 weeks, increase the dose to the treatment dose: 1 capsule 2 times/day.

Depending on the clinical response, an additional dose of tablets can be increased 2 times/day after 2 weeks. Maximum dose: 3 capsules 2 times/day.

combined treatment:

adults (≥ 18 years old) and adolescents (12 to 17 years old) weighing 50 kg or more

Initial treatment dose: 1 capsule 2 times/day. This dose may start right from the beginning of treatment.

Depending on clinical response and drug tolerance, can increase to 3 tablets 2 times/day. Can be adjusted to increase or decrease by 1 tablet/time after every 2 to 4 weeks.

Elderly (65 years and older)

Should adjust the dose in the elderly with impaired renal function (see the item of patients with renal failure).

Children from 4 to 11 years old and adolescents (12 to 17 years old) weighs lighter 50 kg

Initial treatment dose: 10 mg/kg x 2 times/day.

Depending on clinical response and drug tolerance, the dose can be increased to 30 mg/kg x 2 times/day. Adjustment increases or decreases each time using drugs during the day not exceeding 10 mg/kg every 2 weeks. The drug is recommended to use low doses effectively.

Dosage for children from 50 kg or more is similar to the dose of adults.

Doctors should prescribe drugs and the content that best suits weight and dosage. Recommendation of dosage for children and adolescents:

weight

Starting dose: 10 mg/kg twice daily

Starting dose: 30 mg/kg twice daily

15 kg (1)

150 mg x 2 times/day

450 mg x 2 times/day

20 kg (1)

200 mg x 2 times/day

600 mg x 2 times/day

25 kg

250 mg x 2 times/day

750 mg x 2 times/day

from 50 kg (2)

500 mg x 2 times/day

1500 mg x 2 times/day

Dosage in children and adolescents 50 kg or more is similar to adult dose.

breastfeeding children and babies below 4 years

There is no enough data to recommend using levetiracetam for children under 4 years old.

Patients with renal failure

Daily dose is adjusted for each patient based on kidney function (creatinine clearance).

Group

Creatinine ml/min/1.73m clearance

Dosage and number of times used

Normal

1 - 3 capsules 2 times/day

50 - 79

1 - 2 capsules 2 times/day

Average

30 - 49

1/2 - 1 capsule 2 times/day

1/2 - 1 capsule 2 times/day (4)

(4) Additional dose recommends: 1/2 - 1 YAFORT tablet after the appraisal.

Patients with renal failure

Need to adjust the dose of levetiracetam is based on the level of renal failure due to levetiracetam clearance related to kidney function. This recommendation is based on a study in adults impaired kidney function.

Patients with liver failure

No dose adjustment for patients with hepatic impairment from mild to medium level. For patients with severe liver failure, creatinine clearance may not fully evaluate the degree of renal failure, so 50% of daily maintenance dose should be reduced when creatinine clearance is less than 70 m/min.

Treatment time

Yafort is a medication to treat chronic diseases. It is necessary to follow the therapy with YAFORT according to the doctor's instructions.

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

Sleep, agitation, quarrels, consciousness, respiratory failure and coma have been observed when overdose of levetiracetam.

Overdose

If an overdose is overdosed, gastrointestinal or causing. There is no specific antidote for levetiracetam. Overdose is mainly treated with symptoms and can be clinical. 60% Levetiracetam and 74% of the first metabolic substance are excluded by hemorrhage.

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

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Yafort 500 mg Cophavina 3x10, you may experience unwanted effects (ADR).

Unwanted effects are mainly reported including drowsiness, depression and dizziness.

Research in patients from 4 to 16 years old suffered from local seizures, the most unwanted effects were reported as drowsiness, hostile behavior, fear, emotional, agitation, anorexia, weakness and headache.

The safety of levetiracetam on children and adults is the same, except for unwanted effects on behavior and psychology that often appears in children rather than adults (38.6% compared to 18.6%). However, the risk is the same in children when compared to adults.

Research on adults and minors suffered from seizures (12 to 65 years old), the most unwanted effects were reported as headaches and drowsiness. The unwanted effect rate in patients with seizures is lower than local epilepsy (33.3% compared to 46.4%).

Research on adults and children (4 to 65 years old) with spontaneous epilepsy with spontaneous spasms of the whole of the whole primary and unwanted effects is reported as fatigue.

Common disorders and medical condition

Very common: weakness/fatigue.

Nervous system disorders

Very common: Sleep.

common: agitation, depression, unstable emotional, hostile behavior, insomnia, fear, personality disorders, abnormal thoughts.

Abdominal pain, diarrhea, indigestion, nausea, vomiting.

Pancreatitis.

Hepatitis, hepatitis, abnormalities in liver function test.

often occurs: anorexia, weight gain, increased risk of anorexia when used in combination with levetiracetam with topiramate.

weight loss.

often occurs: dizziness.

Eye disorders

common: Song, blurred vision.

Commits: muscle pain.

commonly: Trauma due to accident.

often occurs: infection, nasopharyngitis

Occurs: Coughing a lot.

common: thrombocytopenia, leukopenia, neutropenia, all blood reduction.

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

Yafort 500 mg Cophavina contraindicated in the following cases:

Hypersensitivity to levetiracetam, other substances of pyrrolidone or any ingredients of the drug.

Be cautious when using

According to the current clinical practice, if you have to stop treating with levetiracetam, you must gradually reduce the dose gradually (for example in adults: decrease 500 mg (1 tablet) twice a day per 2 or 4 weeks. In children, do not reduce the dose of more than 10 mg/kg twice a day per week).

Adjust the dose when using levetiracetam for patients with renal failure. For patients with severe liver failure, kidney function should be evaluated before choosing the dose.

It is necessary to advise patients to immediately notify any symptoms of depression and/or suicide intentions to the treating doctor.

The ability to drive and operate machinery

has not conducted research on the impact of the drug on the ability to drive and operate machinery, so be cautious for patients who perform jobs that require skills, for example: driving or operating machinery.

Pregnancy

If pregnant or suspected of being pregnant, notify your doctor. YAFORT should not be used during pregnancy except. Animal studies show that the drug has reproductive toxicity. The potential risks for people are unclear. The stop treatment of epilepsy can worsen the disease and can be harmful to the mother and the fetus.

breastfeeding period

levetiracetam is excreted through breast milk. Therefore, breastfeeding should not be breastfeeding.

Interactive drug

Please inform your doctor or pharmacist about the drugs you are or have taken recently, including non -prescription drugs.

levetiracetam can be taken during or outside meals. Do not use alcoholic foods or drinks during treatment with levetiracetam.

Data shows that Levetiracetam does not affect the serum concentration of current anti -epilepsy drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and these anti -epileptic drugs also do not affect the dynamic of levetiracetam.

Levetiracetam's clearance in children using anti -epileptic drugs irritated enamel is 22% higher than they do not use.

However, the dose adjustment is not recommended. Levetiracetam does not affect the plasma concentrations of carbamazepine, valproate, topiramate or lamotrigine. Probenecid (dose of 500 mg, 4 times daily), an excreted inhibitor at the renal tubules, showing the inhibition of the kidney removal mode of the initial metabolic substance but does not inhibit the kidney clearance of levetiracetam. However, the concentration of this metabolite remains low.

It is thought that other drugs excreted by active excretion through the renal tubules can also reduce the kidney clearance of metabolites. The effect of levetiracetam on probenecid has not been studied and also does not know the effect of levetiracetam on other active excreted drugs, such as non -anti -inflammatory drugs (NSAIDs), sulfonamide and methotrexate.

Levetiracetam dose 1 000 mg daily does not affect the pharmacokinetics of oral contraceptives (Ethinyl estradiol and levonorgestrel) and endocrine parameters (LH and Progesterone) are not changed. Levetiracetam dose 2 000mg daily does not affect pharmacokinetics of digoxin and warfarin, the time prothrombin is not changed. Concentrated with Digoxin drugs, oral contraceptives and warfarin does not affect levetiracetam pharmacology.

There is no data on the effects of antacids on the absorption of levetiracetam. The absorption level of levetiracetam is not affected by food but the absorption rate is slightly reduced. There is no data on drug interaction between levetiracetam and alcoholic beverages (Alcohol).

Storage

Leave a dry place, the temperature does not exceed 30 ° C, avoiding light.

Expiry date: 36 months from the date of manufacture. Do not use overdue drugs stated on the packaging.

Read the instructions carefully before use. This drug is only used as prescribed by a physician.

If you need more information, consult your doctor.

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