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 optic 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 optic neuritis is about 0.8%, which is related to the dosage and course of treatment. It is easy to occur when taking the drug for a long time and the daily dose is greater than 25mg/kg. The incidence rate is 1% at a daily dose of 15mg/kg, 6% at 25mg/kg, and 15% at 35mg/kg. It manifests as blurred vision, eye pain, red-green color blindness or decreased vision, and narrowed visual field. If the above reactions are discovered early and the drug is stopped in time, they will disappear on their own within weeks or months, and permanent loss of visual function rarely occurs. 2 Rare chills, joint swelling and pain (especially the big toe, condyle, and knee joints), and fever and tension on the surface of the affected joint skin (acute gout, hyperuricemia). Intestinal discomfort, nausea, vomiting, diarrhea, liver damage, peripheral neuritis (often manifested as numbness, tingling, burning pain or weakness in the hands and feet) and allergic reactions (often manifested as rash, itching, headache, fever, joint pain), etc.

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: Not yet clear. Precautions for pregnancy and lactation: Not yet clear. Precautions for the elderly: Elderly patients have reduced liver function and the dosage should be reduced as appropriate.

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

Yichang Humanwell Pharmaceutical Co., Ltd.

• Founded in:

  2001-08-08

• Address:

  No. 19, Dalian Road, Yichang Development Zone, Hubei Province

• Tax NO.:

  91420500730843405M

• Registered Funds:

  293,527,036 yuan

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