Lepigin 100 Danapha tablets treat chronic schizophrenia (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Clozapine

Ingredient

Composition information	Content
Clozapine	100mg

Uses

indications

Lepigin 100 drugs are indicated in the following cases:

Severe chronic schizophrenia treatment (progressing from at least 2 years) in the case of resistance (not clinically and socially relieved despite prescribing at least 2 high -dose neuroleptic drugs for at least 6 weeks); Or intolerant to the classical neuroleptic (serious side effects in the nervousness and causing disability, untreated by better dose adjustment or with conventional medications).

Pharmacokinus

Clozapin is a dibenzodiazepin drug, which has a strong mental impact, effective simultaneously on symptoms of emotion and depression.

Clozapin has characteristics that rarely cause extrasic effects and do not significantly increase blood prolactin.

Clozapin causes fast and strong sedation.

Clozapin is different from classical neurolysis: According to surveys on animals, clozapin does not cause evidence to remain in position and do not inhibit the behavior repeating the gesture, words like when treated with apomorphin. In addition to inhibiting the dopaminergic receptor (D1 as well as D2), Clozapin also has an antagonistic effect on the 5-HT2 receptor and has a strong anti-cholinergic effect and canceled noradrenalin.

Dynamic pharmacokinetics

After taking the drug, Clozapin is almost fully absorbed (90 - 95%), and is not affected by food.

Clozapin's peak plasma concentration is about 1-6 hours after drinking, strongly linked to plasma proteins (95%).

The absolute bioavailability of Clozapin is about 55%. Clozapin is metabolized in the liver, mainly oxidation and reduction of methyl at the position n.

The semi -cancellation time fluctuates, on average about 12 hours after the single dose. 50% of the active ingredient is excreted in the form of metabolites in urine and 40% are excreted through bile. The pharmacokinetic parameters change by individuals.

Before taking Lepigin 100 Danapha tablets treat chronic schizophrenia (10 blisters x 10 tablets)

How to use

oral medication.

Dosage

Following the instructions of the physician or the average dose:

Initial dose: 25 mg on the first day, then increase each step from 25 - 50 mg/day, to reach the dose of 300 mg/day on day 14 to 21. Divided into several times. More than the first use. 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 do

do when overdose? However, there are also cases of tolerance with a dose of over 4000 mg.

Symptoms

Enhance the effect of anti -cholinergic and sedative, convulsions, increased salivation, pupils, visual disorders, confusion, agitation, delusion, increased reflexes, coma, lower blood pressure, depravity, tachycardia, severe manifestations in the heart (arrhythmia, atrioventricular block, collecting suburb), respiratory failure.

Treatment

Bowel washing, then use activated carbon for the first 6 hours after detecting poisoning. Symptomatic treatment in specialized hospitals for at least 5 days (can react slowly). Monitor the signs of life, check the electrolyte and balance the acid. Do not use adrenalin and derivatives in the treatment of hypotension (can cause reverse effects of adrenalin).

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 use double the prescribed dose.

Side Effects

Unknown frequency

Blood and hematopoietic system: Loosy leukocytes, usually appears in the first 18 weeks. Can recover after treatment, sometimes death, leukocytes, eosinophilia.

cardiovascular: Hypotension (rarely causing vascular collapse with respiratory arrest or cardiac arrest); High blood pressure, transformed on electrocardiograms; Tachycardia, arrhythmia, perinodus and myocarditis (sometimes led to death). digestive: constipation, vomiting, vomiting, dry mouth. liver: liver disorders, transaminase increase and rarer than increased cholestase.

Urinary tract disorders or urinary retention, penis pain.

Eye: Eye regulatory disorders, glaucoma.

Neurological: Members transforming brain (nose - wave), reducing the threshold of epilepsy, epilepsy (rare), expression of the tower includes tremor, not sitting still and stiff.

Some other effects: increased salivation, drowsiness, weakness, malignant syndrome of neuroleptics, sudden death for unknown reasons, gaining weight.

Instructions on how to handle ADR

Notice immediately to the doctor the unwanted effects when using the drug.

Warnings

Contraindicated

Lepigin 100 contraindications in the following cases:

Too hypersensitivity to clozapin.

History of granulocytes or grain leukemia due to drugs or characteristic blood pathology.

Psychotic caused by alcohol and poisoning, poisoning, coma.

Severe liver, kidney or heart disease.

Glaucom closed angle.

Urine disorders due to prostate hypertrophy

Be cautious when using

because the drug can cause hematological disorders, it is important to note the following points:

Do not simultaneously use clozapin with measures that can reduce leukocytes (especially classical neurolysis or antidepressants).

Not used with slow neuroleptics (due to the inability to quickly remove the body in the case of granulocytosis).

Before starting with clozapin treatment, it is necessary to count the white blood cell formula to ensure that only patients with normal leukocytes can be taken. After the beginning of the treatment, it is necessary to count the white blood cell formula for 18 weeks, then at least once a month until the treatment is terminated. It is necessary to remind the patient to immediately notify the doctor at each medical examination if an infection or high fever.

In case of infection or if leukocytes below 3500/mm3, or a significant decrease compared to the original, immediately check the white blood cell formula. If the results of the leukocytes are below 3500/mm3 and/or neutrophils of neutrophils in the range of 1500 - 2000/mm3, the number of white blood cells and the neutrophils must be checked at least 2 times a week. If the white blood cell volume is lower than 3000/mm3 and/or if the neutrophilic white blood cell is below 1500/mm3, the treatment must be stopped immediately and stop permanently.

Despite stopping clozapin, if the number of white blood cells is absolutely lower than 2000/mm3 or neutral leukemia is lower than 1000/mm3, the patient must be transferred to a specialized hospital.

Cases of clozapine stops due to leukopenia according to the above standards, must not be used again.

Some other points need to be cautious:

In some patients with a history of epilepsy or cardiovascular, kidney or liver disorders, the initial dose must be lower and increase the dose slower.

In case of not severe liver disease, can be treated with clozapin but need clinical and subclinical monitoring regularly in liver function.

When using the drug may have posture hypotension, accompanied by fainting or not.

may have temporary fever, usually benign, mainly in the first 3 weeks of treatment. It may be accompanied by an increase in leukemia, and a fever may be a sign of a potential or neutrophilic hyperlike infection. If you have high fever, you can think of malignant syndrome of sedatives.

Elderly: Low initial dose (12.5 mg, taken 1 time in the first day) and increase the dose of 25 mg per day.

The ability to drive and operate machinery

Caution when used for driving and operating machinery because Clozapin is at risk of drowsiness, especially during the first treatment.

Pregnancy

There is no full research on humans, so it should not be used for pregnant women.

The period of breastfeeding

Survey on animals shows that the drug is excreted through breast milk, so it is not advisable to breastfeed during treatment.

Interactive drug

Not used simultaneously with medications causing leukopenia.

Do not coordinate

Alcohol: Increase sedative effects.

It should be noted when coordinating

Hematoplasty drugs: increase the effect of lowering blood pressure and can cause posture lowering.

Central nervous systems: Morphin derivatives (pain relief and cough), most antihistamine H1, Barbiturat, Benzodiazepine, Clonidin and drugs with them: Increased central depression, can cause severe consequences, especially drivers and operating machinery.

Be cautious in patients being treated or treated with recent benzodiazepine or other mental medications, due to increased risk of depravity that can cause respiratory arrest or cardiac arrest in some cases.

Move inhibitors: Increases hypotension and can cause posture lowering.

Atropine and drugs have the same effect as atropine (imipramine antidepressants, most H1 antihistamine drugs, anti -vibration anti -vibration drugs, anti -spasms have atropinic effect, disopyramide): Coordinate the alcoholic effects of atropine group that causes urinary truce, constipation, mouth dry.

wafarin and strongly linked drugs with plasma proteins: may change the concentration of plasma of other drugs or clozapin.

cimetidine: Increasing the concentration of clozapin in plasma with increased adverse effects.

Phenytoin and cytochrom P450 induction drugs: Reducing plasma clozapin tromg concentration, may cause mental symptoms.

Lithium and other neuroleptic drugs: may increase the risk of malignant syndrome of sedatives.

Adrenalin and derivative: can cause reverse effects on arterial blood pressure).

Storage

Leave the medicine in a dry place, avoid light, temperatures below 30 ° C.

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