Approved date: January 29, 2007
Date of revision: October 1, 2010
November 30, 2015
Clozapine sheet instructions
Please read the instructions carefully and use them under the guidance of a physician.
Common name: clozapine tablets
English name: Clozapine Tablets
Pinyin: Lüdanping Pian
[Ingredients] The main component of this product is: clozapine. Its chemical name is: 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.
Molecular formula: C18H19ClN4
Molecular weight: 326.84
【Properties】 This product is light yellow.
[Indications] This product is not only effective for psychiatric positive symptoms, but also has a certain effect on negative symptoms. Applicable to all subtypes of acute and chronic schizophrenia, it has a good effect on illusion and youthfulness. It can also alleviate the emotional symptoms associated with schizophrenia (eg depression, guilt, anxiety). For patients who are ineffective or have poor efficacy with traditional antipsychotics, it may be effective to switch to this product. This product is also used to treat the excitement and illusion of mania or other psychotic disorders. Because it causes neutropenia, it is generally not the first choice.
[Usage and Dosage] Oral from a small dose, the first dose is 25mg (1 tablet), 2 to 3 times a day, gradually increasing slowly to the usual treatment amount of 200 ~ 400mg (8 ~ 16 tablets) a day, the high amount up to one 600mg (24 tablets). The maintenance amount is 100~200mg (4~8 pieces) per day.
[Adverse reactions] 1, strong sedative effect and anticholinergic adverse reactions, common dizziness, weakness, lethargy, sweating, salivation, nausea, vomiting, dry mouth, constipation, orthostatic hypotension, tachycardia.
2. Common appetite increases and weight gain.
3, can cause abnormal changes in the ECG. Can cause EEG changes or seizures.
4, can also cause blood sugar to increase.
5. Severe adverse reactions are agranulocytosis and secondary infection.
[Contraindications] Severe heart, liver, kidney disease, coma, convulsions, hypotension, epilepsy, glaucoma, myelosuppression or leukopenia are contraindicated. Disabled for allergic to this product.
1. Allergic rash and malignant syndrome should be discontinued immediately and treated accordingly.
2, the central nervous system inhibition state is used with caution. Patients with urinary retention should be used with caution.
3. During the first 3 months of treatment, the white blood cell count and classification should be checked every 1~2 weeks, and then checked regularly.
4. Regularly check liver function and ECG.
5, check blood sugar regularly to avoid diabetes or ketoacidosis.
6. It is not advisable to drive the vehicle, operate the machinery or work at height during the medication.
7. If there is fever of unknown origin during the medication, the medication should be suspended.
[Pregnant women and lactating women] Pregnant women are banned. Lactating women should stop breastfeeding during the use of this product.
[Child medication] Children under the age of 12 should not be used.
[Geriatric Use] Use with caution or with low doses.
1. This product can increase central inhibition with ethanol or other central nervous system inhibitors.
2. The combination of this product and antihypertensive drugs increases the risk of orthostatic hypotension.
3, this product combined with anticholinergic drugs can increase the anticholinergic effect.
4, this product and digoxin, heparin, phenytoin, warfarin can increase the bone marrow suppression.
5. This product is combined with lithium carbonate, which increases the risk of convulsions, malignant syndrome, confusion and dystonia.
6, this product combined with fluvoxamine, fluoxetine, paroxetine, sertraline and other antidepressants can increase plasma levels of clozapine and norclozapine.
7. The combination of this product and macrolide antibiotics can significantly increase the plasma clozapine concentration, and has been reported to induce seizures.
Symptoms of poisoning: The most common symptoms include convulsions, coma, tachycardia, hypotension, respiratory depression or failure, excessive salivation, and reports of epilepsy.
Treatment: Establish and maintain a smooth airway, prompt vomiting and gastric lavage, and give symptomatic treatment and supportive therapy according to the condition.
[Pharmacology and Toxicology] This product is a benzodiazepine antipsychotic. It has a strong blocking effect on the serotonin (5-HT2A) receptor and dopamine (DA1) receptor in the brain, and also blocks the dopamine (DA4) receptor, blocking the dopamine (DA2) receptor. The effect is weak, in addition to anticholinergic (M1), antihistamine (H1) and anti-α-adrenergic receptors, rarely extrapyramidal reaction, generally does not cause blood prolactin increased. It can directly inhibit the brain stem network upward activation system and has strong sedative and hypnotic effects.
[Pharmacokinetics] Oral absorption is fast and complete, and food has no effect on the rate and extent of absorption. After absorption, it is rapidly distributed to various tissues. The individual bioavailability varies greatly, with an average of about 50% to 60%. Over effect. The plasma peak concentration was reached 3.2 hours (1~4 hours) after administration, and the elimination half-life (t1/2β) averaged 9 hours (3.6~14.3 hours), the apparent volume of distribution (Vd) was 4.04~13.78L/kg, and the tissue binding rate was high. . Metabolized by the liver, 80% is present in the form of metabolites in urine and feces. The main metabolites are N-desmethylclozapine, N-oxide of clozapine and the like. In the case of the same dose and weight, the serum drug concentration of female patients is significantly higher than that of male patients. Smoking can accelerate the metabolism of this product, and the renal clearance rate and metabolism are significantly reduced in the elderly. This product can be secreted from milk and can pass the blood-brain barrier.
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
[Package] medicinal plastic bottles, 100 tablets per bottle.
[Validity Period] 24 months
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
[Approval No.] National Drug Standard H44021425
Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal code: 529331
Phone number: (0750) 2789348 400-8899-328 (National Service Phone)
Fax number: (0750) 2789348