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First-line anti-tuberculosis drugs

Ethambutol hydrochloride tablets（0.25g）

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Ethambutol hydrochloride tablets（0.25g）

Shenyang Hongqi Pharmaceutical Co., Ltd. (abbreviated as: Hongqi Pharmaceutical) was established in 1964. Since the 1980s, it has focused on the development, production, sales and service of anti-tuberculosis drugs. After more than 30 years of unremitting efforts, it has provided more than 13 million tuberculosis patients. To provide high-quality medicines and services.

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Instructions for ethambutol hydrochloride tablets

Please read the instructions carefully and use under the guidance of a doctor

【Drug Name】

Generic name: ethambutol hydrochloride tablets

English name: Ethambutol Hydrochloride Tablets

Chinese Pinyin: Yansuan Yi'andingchun Pian

【Ingredients】

Chemical name: [2R,2[S-(R*, R*)]-R]-(+)2,2′-(1,2-ethylenediyldiimino)-bis-1-butanol Hydrochloride

Chemical Structure:

【Properties】

This product is a white piece.

[Indications] It is suitable for the treatment of tuberculosis caused by Mycobacterium tuberculosis in combination with other anti-tuberculosis drugs. It can also be used for the treatment of tuberculous meningitis and atypical mycobacterial infections.

【specification】

0.25g

【Dosage】

1. The usual dose for adults is combined with other anti-tuberculosis drugs. For the initial treatment of tuberculosis, take 15mg/kg once a day; or take 25-30mg/kg each time, up to 2.5g, 3 times a week; or 50mg/kg kg, up to 2.5g, 2 times a week. For retreatment of tuberculosis, take 25mg/kg of body weight once a day for 60 consecutive days, followed by 15mg/kg of body weight, once a day. For atypical mycobacterial infection, take 15~25mg/kg daily, once a meal.

2. The usual dosage for children is not suitable for children under 13 years old; the dosage for children over 13 years old is the same as that for adults.

【Adverse reactions】

1. The more frequent cases are blurred vision, eye pain, red-green blindness or vision loss, and reduced visual field (optic neuritis is likely to occur when the daily dose of 25mg/kg is based on body weight). The vision change can be unilateral or bilateral.

2. The less frequent ones are chills, joint swelling and pain (especially big toe, condyle, knee joint), and skin heating and tightness on the surface of the diseased joint (acute gout, hyperuricemia).

3. The rare cases are allergic reactions such as skin rash, fever, joint pain; or numbness, acupuncture sensation, burning pain or weakness of hands and feet (peripheral neuritis).

【Taboo】

The experiment has not been carried out and there is no reliable reference.

【Precautions】

1. Interference with diagnosis: taking this product can increase the measured value of blood uric acid concentration.

2. The following conditions should be used with caution: gout, optic neuritis, renal dysfunction.

3. Check during treatment:

(1) Eyes, visual field, vision, red and green discrimination, etc., should be checked once a day before and during the course of treatment, especially for patients with a long course of treatment and a daily dose of more than 15 mg/kg;

(2) Serum uric acid determination, because this product can increase the serum uric acid concentration, causing gout attacks. Therefore, it should be measured regularly during the course of treatment.

4. If gastrointestinal irritation occurs, ethambutol can be taken with food. Divided daily dose may not reach effective blood concentration, so the daily dose of this product should be taken once.

5. When ethambutol is used alone, bacteria can quickly develop drug resistance, so it must be used in combination with other anti-tuberculosis drugs. When this product is used in patients who have received anti-tuberculosis drugs, it should be used in combination with at least one drug.

6. In view of the fact that there is no practical method for measuring blood concentration, the dosage should be calculated based on the weight of the patient. In patients with impaired liver or kidney function, the blood concentration of this product may increase, and the half-life may be prolonged. Patients with impaired renal function need to reduce the dosage.

[Medicine for pregnant women and lactating women]

1. Ethambutol can penetrate the placenta, and the fetal blood concentration is about 30% of the mother's blood concentration. High doses of this product in mouse experiments can cause cleft palate, brain exposure and spinal deformities; high doses of this product in rats can cause mild cervical vertebra deformities; high doses of this product can cause cyclops, short limbs, and hare lips in rabbits And deformities such as cleft palate. Although it has not been confirmed in humans, pregnant women still need to fully weigh the pros and cons. The effect of this product and other drugs on the fetus is not clear.

2. Ethambutol can be distributed in breast milk, and the concentration is similar to the blood concentration. Although there is no problem in humans, the pros and cons of breastfeeding women must be weighed.

【Children's Medication】

There is still a lack of clinical data for children under 13 years of age. Because it is difficult to monitor changes in vision in young children, this product is not recommended for children under 13 years of age.

【Geriatric Medication】

The elderly are often accompanied by physiological decline in renal function, so the dosage should be adjusted according to renal function.

【medicine interactions】

1. Combined use with ethionamide can increase adverse reactions.

2. When used together with aluminum hydroxide, it can reduce the absorption of this product.

3. Combined use with neurotoxic drugs can increase the neurotoxicity of this product, such as optic neuritis or peripheral neuritis.

【Overdose】

The experiment has not been carried out and there is no reliable reference.

【Pharmacology and Toxicology】

This product is a synthetic antibacterial and antituberculosis drug. Its mechanism of action has not yet been fully elucidated. This product can penetrate into mycobacteria to interfere with the synthesis of RNA, thereby inhibiting the reproduction of bacteria. This product is only effective for mycobacteria during the growth and reproduction period. So far, no cross-resistance between this product and other anti-tuberculosis drugs has been found.

【Pharmacokinetics】

After oral administration, it is absorbed by the gastrointestinal tract from 75% to 80%. Widely distributed in body tissues and body fluids (except cerebrospinal fluid). The drug concentration in red blood cells is equal to or twice the plasma concentration, and can last for 24 hours; the drug concentration in kidney, lung, saliva and urine is higher; but the concentration in pleural fluid and ascites fluid is lower. This product cannot penetrate into normal meninges, but there may be traces in the cerebrospinal fluid of patients with tuberculous meningitis. Its volume of distribution is 1.6L/kg. The protein binding rate is about 20% to 30%. The plasma concentration can reach the peak after 2~4 hours of oral administration, and the half-life (Т1/2) is 3~4 hours, and it can be prolonged to 8 hours for patients with impaired renal function. Mainly metabolized by the liver, about 15% of the dose is metabolized into inactive metabolites. It is excreted by glomerular filtration and renal tubular secretion; about 80% is excreted within 24 hours after administration, at least 50% is excreted in its original form, and approximately 15% is inactive metabolites. Approximately 20% is excreted in the feces in its original form. The drug concentration in breast milk is approximately equivalent to the drug concentration in maternal blood. A considerable amount of ethambutol can be removed from the body through hemodialysis and peritoneal dialysis.

【Storage】

Shading, sealed and preserved.

【package】

Packed in plastic bottle, 100 tablets/bottle.

【Validity Period】

24 months

【Executive Standard】

"Chinese Pharmacopoeia" 2015 Edition Two

【Approval Number】

National Medicine Standard H21022349

【manufacturer】

Company Name: Shenyang Hongqi Pharmaceutical Co., Ltd.