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Second-line anti-tuberculosis drugs

Protionamide Enteric-coated Tablets

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Protionamide Enteric-coated Tablets

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Instructions for Prothionamide Enteric-coated Tablets

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

【Drug Name】

Generic name: Prothionamide enteric-coated tablets

English name: Protionamide Enteric-coated Tablets

Chinese Pinyin: Bingliuyiyan'an Changrongpian

【Ingredients】

Chemical name: 2-Propylthioisonicotinamide

Chemical Structure:

【Properties】

This product is an enteric-coated tablet, after removing the coating, it appears yellow.

【Indications】

This product is only effective against mycobacteria. This product is used in combination with other anti-tuberculosis drugs for those who have failed to treat tuberculosis with first-line drugs (such as streptomycin, isoniazid, rifampicin and ethambutol).

【specification】

0.1g

【Dosage】

1. Common dosage for adults: Oral, combined with other anti-tuberculosis drugs, 250 mg once, 2 to 3 times a day.

2. Commonly used doses for children: Combine with other anti-tuberculosis drugs, orally 4-5 mg/kg according to body weight once, 3 times a day.

Not [ adverse reactions]

1. The higher incidence rate is: mental depression (central nervous system toxicity).

2. Less frequent ones include: unstable gait or numbness, acupuncture sensation, burning sensation, hand and foot pain (peripheral neuritis), mental confusion or other mental changes (central nervous system toxicity), yellow eyes or skin ( Jaundice, hepatitis).

3. The incidence rate is extremely low: blurred vision or vision loss, combined or not combined with eye pain (optic neuritis), menstrual disorders or cold fear, decreased libido (men), dry and rough skin, hypothyroidism, joint pain, Stiffness and swelling.

4. If the following conditions continue to occur: diarrhea, increased saliva, drooling, loss of appetite, metallic taste in the mouth, nausea, mouth pain, stomach pain, stomach upset, vomiting (gastrointestinal disorders, central nervous system toxicity) , Dizziness (including when getting up from lying or sitting position), lethargy, weakness (central nervous system toxicity).

【Taboo】

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

【Precautions】

1. Cross allergy, patients who are allergic to isoniazid, pyrazinamide, niacin or other drugs with similar chemical structures may be allergic to this product.

2. Interference with diagnosis: It can increase the measured value of alanine aminotransferase and aspartate aminotransferase.

3. Use with caution in the following situations: diabetes, severe liver function decline.

4. Tests must be performed during treatment: ①Alanine aminotransferase and aspartate aminotransferase are measured before medication and every 2 to 4 weeks during the course of treatment, but the increase in the above test values does not necessarily indicate the occurrence of clinical hepatitis, and may be in Recover during continued treatment; ② Eye examination, if vision loss or other symptoms of optic neuritis occur during treatment, eye examination should be performed immediately and regular review.

[Medicine for pregnant and lactating women]

Pregnant women are prohibited from taking it.

【Children's Medication】

Children under 12 years old should not take it.

【Medications for the Elderly】

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

【medicine interactions】

1. The same service with cycloserine can increase the incidence of central nervous system reactions, especially the symptoms of systemic convulsions. The dosage should be adjusted appropriately and the symptoms of central nervous system toxicity should be closely monitored.

2. The combination of this product and other anti-tuberculosis drugs may aggravate its adverse reactions.

3. This product is a vitamin B6 antagonist, which can increase renal excretion. Therefore, in patients treated with prothiasonamide, the requirement of vitamin B6 may increase.

【Overdose】

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

【Pharmacology and Toxicology】

This product is a derivative of isonicotinic acid, its mechanism of action is unknown, and it may inhibit peptide synthesis. The effect of this product on Mycobacterium tuberculosis depends on the concentration of the drug at the site of infection. At low concentration, it only has antibacterial effect, and high concentration has bactericidal effect. Inhibit the synthesis of mycolic acid from Mycobacterium tuberculosis. This product has partial cross-resistance with ethionamide.

【Pharmacokinetics】

It is rapidly absorbed by oral administration (more than 80%), widely distributed in the body fluid of the whole body, and the concentration in various tissues and in the cerebrospinal fluid is close to the blood concentration of the same period. This product can cross the placental barrier. The protein binding rate is about 10%. The blood concentration can reach the peak value 1~3 hours after taking the medicine, and the effective blood concentration can last for 6 hours, and the t1/2 is about 3 hours. Mainly metabolized in the liver. Excreted by the kidneys, 1% are the original form, 5% are active metabolites, and the rest are inactive metabolites.

【Storage】

Shading, sealed and preserved.

【package】

Packed in plastic bottle, 100 tablets/bottle.

【Validity Period】

36 months

【Executive Standard】

"Chinese Pharmacopoeia" 2015 Edition Two

【Approval Number】

National Medicine Standard H21022339

【manufacturer】

Company Name: Shenyang Hongqi Pharmaceutical Co., Ltd.