Levpiram 500mg Danapha tablets treat local starting epilepsy (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Levetiracetam

Ingredient

Composition information	Content
Levetiracetam	500mg

Uses

indications

Levpiram drugs are indicated in the following cases:

Levetiracetam is indicated that the treatment in the local start -up epilepsy has or without mucous secondary chemistry in patients who have just diagnosed epilepsy aged 16 and older. Myoclonic Epileepsy). Levetiracetam's anti -epileptic activity is evaluated on animals.

Intro and in vivo research research shows that levetiracetam has the ability to inhibit epilepsy without affecting sensitive neurons. Levetiracetam inhibits synchronously with epilepsy.

levetiracetam at 10 MCM concentration without affinity associated with the receptor of benzodiazepin, gaba, glycin or receptors of N - methyl - d - aspartat.

On In vitro, Levetiracetam does not interact with the sodium channel depending on the voltage or Calci Type T, Levetiracetam is also not related to the impact of neurotransmitters of the Gabaergic system. However, in Vitro also explained that Levetiracetam penetrates into the brain easily, and prevents epilepsy due to electric shock, due to chemical seizures including inhibitors that synthesize neurotransmitters of Gabaergic system, Glycin channel and partial inhibition of Calci N channel in neurosus.

Saturated and selected cohesion position on the brain tissue in the mouse has been described for levetiracetam.

Experiment shows that this connection position is in the protein in the SYNAP SV2A bag, which is related to the cellular cycle. Although the cohesion between levetiracetam and protein in Sinap SV2A bag is unclear, levetiracetam and related substances show that the affinity with SV2A protein is related to the potential for anti -convulsions in mouse. The interaction between levetiracetam and protein SV2A may contribute to explaining the anti -epileptic mechanism of levetiracetam.

Pharmacokinetics

absorption

After drinking, Levetiracetam is quickly absorbed with peaks in plasma achieved after 1 hour. Food does not affect the absorption of the drug but reduces cmax by 20% and extends TMAX to 1.5 hours.

Distribution

levetiracetam binds to protein less than 10%.

Metabolism

The pathway is mainly metabolized by acetamid hydropive enzymes, forming carboxylic acid metabolites. Not affected by cytochrom P450.

Elimination

Levetiracetam waste sale time in plasma does not depend on the dose and average in the range of 6 - 8 hours.

About 66% of the dose is eliminated through the kidneys in constant form.

Before taking Levpiram 500mg Danapha tablets treat local starting epilepsy (5 blisters x 10 tablets)

How to use

Take oral use.

The drug must be taken with a sufficient amount of water and can be taken during or outside the meal.

The daily dose is divided equally for 2 drinks.

Dosage

Single treatment

Adults and adolescents from 16 years old

The starting dose is 250 mg twice daily and increases to 500 mg twice a day after 2 weeks. This dose can still continue to increase to 250 mg twice a day for every 2 weeks depending on the clinical response. The maximum dose is 1500 mg twice daily.

combined treatment

Adults (≥ 18 years old) and adolescents (12 - 17 years old) weighing 50 kg or more

The starting dose is 500 mg, taken 2 times/day. This dose may start from the first day of treatment.

Based on clinical response and drug tolerance can increase the dose to 1500 mg, 2 times daily. Adjust the dose increases or decreases to 500 mg, 2 times daily for a period of 2-4 weeks.

Elderly (from 65 years of age)

Adjusting the dose in the elderly based on kidney function (see the patient item of kidney failure).

Children from 4 - 11 years old and adolescence (12 - 17 years old) weighing less than 50 kg

Initial treatment dose is 10 mg/kg, 2 times/day.

Based on clinical response and drug tolerance can increase the dose up to 30 mg/kg, 2 times/day. Adjusting the dose increases or decreases should not exceed 10 mg/kg 2 times/day for every 2 weeks. The drug is recommended to use the lowest treatment dose possible.

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

The doctor will choose the form of medicine and the content that best suits weight and dosage.

recommended dose for children and adolescents:

weight

Initial dose: 10 mg/kg twice daily

Maximum dose: 30 mg/kg twice daily

From 25 kg

250 mg twice daily.

750 mg twice daily.

500 mg twice daily.

1500 mg twice daily.

infants and children under 4 years old or children under 25 kg

Do not use levetiracetam for children below 4 years old because they do not have enough data to prove the safety of the drug and the effectiveness of treatment.

Patients with renal failure

Daily dose is adjusted based on the kidney function according to the table below. To use this table, it is necessary to calculate creatinine clearance (CLCR) ml/min.

Dose adjustment for patients with renal function.

group

Creatinine clearance (ml/min/1.73m2)

Dosage and frequency

Normal

500 to 1500mg x 2 times daily.

50 - 79

500 to 1000mg x 2 times daily.

Average

30 - 49

250 to 750mg x 2 times daily.

250 to 500mg x 2 times daily.

500 to 1000mg x 1 time daily (2).

(2): Additional dose is 250 - 500 mg after the appraisal.

Patients with liver failure

No need to adjust the dose of levpiram for patients with hepatic impairment from mild to medium level. For patients with severe liver failure, creatinine clearance may not fully assess the level of renal failure. Therefore, it is recommended to reduce the daily daily dose when creatinine clearance is below 70 ml/min.

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.

Overdose

If an overdose of the stomach may be overdose, or increase vomiting. There is no specific antidote for levetiracetam. Overdose management mainly treat symptoms and can be accumulated. The appraisal effect is 60% for levetiracetam and 74% for the first metabolites.

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. Note that it should not be used double the prescribed dose.

Side Effects

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

Very often happens

Common disorders: weakness, fatigue.

Nervous system disorders: Drowsiness.

Nervous disorders: Memory loss, loss of air conditioning, convulsions, dizziness, headache, tremor, balance disorders, centralized disorders, memory impairment.

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

Gastrointestinal disorders: abdominal pain, diarrhea, indigestion, nausea, vomiting.

Liver disorders: Hepatitis, hepatitis, bat often in liver function test.

Metabolic and nutrition disorders: Anorexia, weight gain. The risk of anorexia increases higher when used in combination with levetiracetam with topiramat.

Disorders of ear and vestibular: Stunned.

Eye disorders: Song Thi, blurred vision.

Disorders of musculoskeletal and connective tissue: muscle pain.

Trauma, toxicity and complications due to procedures: Trauma due to accident.

Infections and parasites: infections, nasopharyngitis.

Respiratory disorders, chest and mediastinum: Coughing a lot.

Skin and subcutaneous disorders: rash, eczema, itching, hair loss - hair. In some cases, hair loss - hair will recover when stopping levetiracetam.

Blood disorders and lymphocytes: platelets.

In addition, the following side effects have been recorded in the reports after the drug is marketed. The data is not enough to support the estimated new incidence in the community.

Blood and lymphatic disorders: leukopenia, neutropenia, hypoglycemia (with bone marrow inhibitors determined in some cases).

Mental disorders: abnormal behavior, anger, anxiety, confusion, hallucinations, mental disorders, suicide, seeking suicide and suicide.

Disorders of the nervous system: There is an abnormal feeling.

Skin and tissue disorders: Hair loss, in some cases of observation, recovery when stopping levetiracetam.

Digestive disorders: pancreatitis.

Hepatitis disorders: hepatitis, liver failure.

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

Levpiram drug is contraindicated in the following cases:

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

Be cautious when using

levetiracetam is only used for adults and children over 4 years old. Need to adjust the dose for patients with renal failure.

For patients with severe liver - kidney failure, adjust the dose according to the kidney function assessment.

Do not stop the drug suddenly due to the risk of increasing seizures. When you want to stop levetiracetam oral, it is necessary to stop slowly by reducing the dose 1 g every 2 weeks.

The ability to drive and operate machinery

There is no research on the impact of the drug on the driver, operating machinery and people working on high. Because sensitivity per individual may vary, some patients may be sleepy or have symptoms related to the central nervous system, especially at the time of starting treatment or after increasing the dose. Therefore, be careful for patients when performing jobs that require skills, for example: Driving, operating machinery. It is recommended that patients should not drive or operate machinery until it is sure that their ability to perform these activities is not affected by the drug.

Pregnancy

If pregnant or suspected of being pregnant, notify your doctor.

Do not use levetiracetam during pregnancy unless necessary. Animal studies show that the drug has reproductive toxicity. The potential risks for people are unclear. The stop treatment of epilepsy can make the disease worse and can be harmful to the mother and the fetus.

breastfeeding period

levetiracetam is excreted through breast milk. Therefore, breastfeeding should not be breastfeeding when using deduction when really necessary.

Drug interaction

levetiracetam 1000 mg daily does not affect the pharmacokinetics of oral contraceptives (Ethinyl estradiol and levonorgestrel) and endocrine parameters (LH and Progesterone) are not changed. Levetiracetam 2000 mg daily does not affect pharmacokinetics of digoxin, warfarin and thrombin time is not changed. The sharing of Digoxin drugs, oral contraceptives and warfarin does not affect the pharmacokinetics of levetiracetam.The data has shown that levetiracetam does not affect the plasma concentrations of other epilepsy drugs (phenytoin, carbamazepin, valproic acid, phenobarbital, lamotrigin, gabapentin and primidon) and other anti -epileptic drugs also do not affect the dynamics of levetiracetam.

Storage

Leave the medicine in a dry place, avoid light, the temperature does not exceed 30 ° C.

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