Ethambutol Hydrochloride Capsules

1 Pharmacology This product is a synthetic antibacterial anti-tuberculosis drug. It has strong activity against bacteria in the growth and reproduction period, and almost no effect on bacteria in the dormant period. It has high antibacterial activity against various types of mycobacteria. There is no cross-resistance between Mycobacterium tuberculosis and this product and other drugs. The mechanism of action of this product has not been fully elucidated. It may be related to inhibiting the metabolism of sensitive bacteria, inhibiting the synthesis of RNA, interfering with the protein metabolism of Mycobacterium tuberculosis, and thus leading to bacterial death. 2 In large doses, it can cause cleft palate, brain exposure and spinal deformity in mouse experiments; it can cause mild cervical deformity in rat experiments; it can cause cyclops, short limbs and cleft palate in rabbit experiments.

Ethambutol hydrochloride, its chemical name is [2R, 2[S-(R*, R*)]-R]-()2,2-(1,2-ethylenediimino)-bis-1-butanol dihydrochloride

This product is in the form of capsules.

This product is suitable for the treatment of pulmonary tuberculosis and extrapulmonary tuberculosis caused by Mycobacterium tuberculosis in combination with other anti-tuberculosis drugs, and can also be used to treat atypical Mycobacterium tuberculosis infection.

It needs to be used in combination with other anti-tuberculosis drugs. 1 Initial treatment: Oral, 15 mg/kg per body weight, once a day; or 25-30 mg/kg once, up to 2.5 g, 3 times a week; or 50 mg/kg per body weight, up to 2.5 g twice a week. 2 Re-treatment: Oral, 25 mg/kg per body weight, once a day, for 60 consecutive days, followed by 15 mg/kg per body weight, once a day. 3 Atypical Mycobacterium tuberculosis infection: 15-25 mg/kg per body weight, once a day.

1. Common optic nerve damage, such as retrobulbar neuritis and damage to the central fibers of the optic nerve. This may be related to the decrease in the content of these metal elements caused by the chelation of this product with copper, zinc and other metal elements. The incidence of retrobulbar neuritis is about 0.8%, which is related to the dosage and course of treatment. It is prone to occur when taking the drug for a long time and the daily dose is greater than 25 mg/kg. The incidence rate is 1% at a daily dose of 15 mg/kg, 6% at 25 mg/kg, and increases to 15% at 35 mg/kg. It manifests as blurred vision, eye pain, red-green color blindness or decreased vision, and narrowed visual field. The above reactions can disappear on their own within weeks or months if discovered early and the drug is stopped in time, and permanent loss of visual function rarely occurs. 2. Rare chills, swollen and painful joints (especially the big toe, condyle, and knee joints), and a feeling of heat and tightness on the surface of the skin of the affected joints

People who are allergic to this product, patients with known optic neuritis, ethanol poisoning, and those under 13 years old should use it with caution.

Precautions for children: There is a lack of clinical data for children under 13 years old. Since it is difficult to monitor changes in vision in young children, this product should not be used in children under 13 years old; the dosage for children over 13 years old is the same as that for adults. Precautions for pregnancy and lactation: 1. Since this product can pass through the placenta, the fetal blood concentration is about 30% of the maternal blood concentration. Animal experiments show that this product can cause malformations. Although it has not been confirmed to be a problem in humans, pregnant women should still not use this product. If there is an indication for taking it, the pros and cons must be fully weighed. 2. This product can be secreted into breast milk, and the concentration is similar to the maternal blood concentration. Therefore, this product is prohibited for lactating women. If there is an indication for taking it, breastfeeding should be suspended. Precautions for the elderly: Elderly patients have physiological renal impairment, so the dosage should be adjusted according to renal function.

1 Aluminum salts, including DDI buffer, can reduce the absorption of this product. 2 The combination of this product with verapamil can reduce the absorption of the latter. 3 The combination with neurotoxic drugs can increase the neurotoxicity of this product, such as optic neuritis or peripheral neuritis. 4 The combination with ethionamide can increase the adverse reactions such as icteric hepatitis and optic neuritis.

Keep away from light, sealed and stored in a dry place.

0.25g

24 months

China Resources Double-Crane Pharmaceutical Co., Ltd.

• Founded in:

  1997-05-16

• Address:

  No. 1, Lize East 2nd Road, Wangjing, Chaoyang District, Beijing

• Tax NO.:

  91110000633796475U

• Registered Funds:

  1,038,836,522 yuan

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