Product Overview
[Drug Name]
Generic Name: Pasiniazid Tablets
Trade Name: Para-aminosalicylic Acid Isoniazid Tablets
English Name: Pasiniazid Tablets
Chinese Pinyin: Dui’anjishuiyangsuan Yiyanjing Pion
[Ingredients]
The main ingredient of this product is para-aminosalicylic acid isoniazid.
[Properties]
This product is a light yellow tablet, yellow tablet, or film-coated tablet.
[Indications]
For the treatment of various types of pulmonary tuberculosis, endobronchial tuberculosis, and extrapulmonary tuberculosis in combination with other anti-tuberculosis drugs. It can also be used as a protective drug for tuberculosis-related surgery and to prevent tuberculosis infection and recurrence during long-term or high-dose corticosteroid or immunosuppressive therapy.
[Dosage and Administration]
1. Treatment: For use in combination with other anti-tuberculosis drugs.
Adults: 10-20 mg/kg per day based on body weight.
Children: The dose may be increased to 20-40 mg/kg per day based on body weight, taken as a single dose, as needed.
2. Prevention: 10-15 mg/kg daily, taken orally.
[Adverse Reactions]
Occasionally, adverse reactions such as dizziness, headache, insomnia, fever, rash, nausea, fatigue, jaundice, peripheral neuritis, optic neuritis, and hematocrit may occur.
[Contraindications]
1. Contraindicated in patients with mental illness or epilepsy. 2. Contraindicated in patients with severe liver dysfunction.
[Precautions]
1. This product should be taken continuously for at least three months. If no adverse reactions occur, it should not be discontinued midway. It can only be discontinued after clinically confirmed recovery.
2. Use with caution in pregnant women, patients with impaired liver and kidney function, and those with a history of mental illness, epilepsy, or brain trauma.
3. Liver function tests should be performed regularly during treatment. A few patients may experience transient elevations in aminotransferase levels during the first two months of treatment. Continued treatment with liver protection can restore aminotransferase levels to normal. If elevated levels persist, the drug should be discontinued. 4. If symptoms of optic neuritis occur during treatment, immediate eye examination and regular follow-up examinations are required.
5. Taking vitamin B6 with this medication can prevent and treat adverse neurological reactions such as peripheral neuritis.
6. Antacids, especially aluminum hydroxide, can inhibit the absorption of this drug and should not be taken together. 7. This drug may enhance the effects of coumarin anticoagulants, certain antiepileptic drugs, antihypertensive drugs, anticholinergics, and tricyclic antidepressants; caution is advised when using this drug together.
[Use in Special Populations]
Precautions for Children: This study has not been conducted and no reliable references are available.
Precautions for Pregnancy and Lactation: Use with caution in pregnant and lactating women.
Precautions for Elderly: This study has not been conducted and no reliable references are available.
[Drug Interactions]
Unknown.
[Pharmacological Actions]
1. This drug is a chemical compound of isoniazid (INH) and para-aminosalicylic acid (PAS). INH is primarily effective against mycobacteria during their reproductive stages. Its mechanism of action is not yet elucidated, but it may inhibit the synthesis of mycolic acid in sensitive bacteria, leading to cell wall disruption.
2. PAS effectively delays and blocks the acetylation process of INH in the body. Therefore, this product maintains a higher and longer-lasting INH concentration in the blood and reduces its toxicity to the liver. Clinically, after taking equal amounts of INH and this product, it was found that the INH blood concentration was only 0.03 mg/L after 12 hours, while this product was 2.6 mg/L; after 14 hours, the INH blood concentration was 0, while this product was still as high as 2 mg/L, which is twice the MIC. This not only enhances the bactericidal effect of the drug, but also delays the development of bacterial resistance.
3. Clinically, it has been confirmed that in combination with other anti-tuberculosis drugs, the anti-tuberculosis efficacy of this product is significantly better than that of INH, while the incidence of adverse reactions such as gastrointestinal reactions, liver damage and leukopenia is significantly lower than that of INH.
4. Animal studies have shown that this product has an anti-tuberculosis efficacy approximately five times that of INH in artificially infected mice. A daily dose of 10 mg/kg of this product significantly outperforms a physical mixture of INH (20 mg/kg daily) and PAS (200 mg/kg daily).
[Storage]
Store in a dry, light-proof, sealed container.
[Packaging Specifications]
100 capsules/box
[Expiry Date]
24 months
[Approval Number]
National Medicine Standard H20058553
[Manufacturer]
Guizhou Shenqi Pharmaceutical Co., Ltd.
