Product Overview
[Drug Name]
Generic Name: Isoniazid Tablets
Trade Name: Yunpeng
English Name: Isoniazid Tablets
Chinese Pinyin: Yiyanjing Pian
[Ingredients]
The main ingredient of this product is isoniazid, whose chemical name is 4-pyridinecarboxylic acid hydrazide.
[Properties]
This product is a white tablet.
[Indications]
(1) Isoniazid is used in combination with other anti-tuberculosis drugs for the treatment of various types of tuberculosis, including tuberculous meningitis and other mycobacterial infections. (2) Isoniazid alone is suitable for the prevention of various types of tuberculosis: ① Family members or close contacts of patients who have recently been diagnosed with tuberculosis; ② Patients with a strong positive tuberculin purified protein derivative test (PPD) and chest X-ray examination consistent with non-progressive tuberculosis, negative sputum bacteria, and who have not received regular anti-tuberculosis treatment in the past; ③ Patients who are receiving immunosuppressants or long-term hormone treatment, patients with certain blood diseases or reticuloendothelial system diseases (such as leukemia, Hodgkin's disease), diabetes, uremia, silicosis or gastrectomy, and whose PPD test is positive; ④ Patients under 35 years old with a positive PPD test; ⑤ People who are known or suspected to be infected with HIV and whose PPD test is positive, or who have close contact with patients with active pulmonary tuberculosis.
[Usage and Dosage]
Oral prevention: Adults 0.3g (3 tablets) per day, taken at once; children 10mg/kg per day based on body weight, with a total daily dose not exceeding 0.3g (3 tablets), taken at once. Treatment: Adults, in combination with other anti-TB drugs, should receive an oral dose of 5 mg/kg daily, up to a maximum of 0.3 g (3 tablets), or 15 mg/kg daily, up to a maximum of 900 mg (9 tablets), 2-3 times per week. Children should receive 10-20 mg/kg daily, up to a maximum of 0.3 g (3 tablets) per day, taken at once. For children with severe TB (such as tuberculous meningitis), daily doses may be as high as 30 mg/kg (up to a maximum of 500 mg (5 tablets) per day), but caution should be exercised regarding liver damage and the development of peripheral neuritis.
[Adverse Reactions]
Common adverse reactions include unsteady gait or numbness, tingling, burning, or pain in the fingers (peripheral neuritis); dark urine, yellowing of the eyes or skin (hepatotoxicity, with an increased incidence in patients over 35 years of age); and loss of appetite, unusual fatigue or weakness, nausea, or vomiting (prodromal symptoms of hepatotoxicity). Rare cases may include blurred or decreased vision, with or without eye pain (optic neuritis); fever, rash, cytopenia, and gynecomastia. This product may occasionally cause convulsions due to neurotoxicity.
[Contraindications]
This product is contraindicated in patients with impaired liver function, mental illness, and epilepsy.
[Precautions]
1. Cross-sensitivity reactions. Patients allergic to ethionamide, pyrazinamide, niacin, or other chemically related drugs may also be allergic to this product. 2. Interference in diagnosis: Urine glucose determination using the copper sulfate method may produce a false-positive reaction, but this does not affect the results of enzyme-based assays. Isoniazid may increase serum bilirubin, alanine aminotransferase, and aspartate aminotransferase levels. 3. Use with caution in patients with a history of mental illness, epilepsy, or severe renal impairment. 4. If symptoms of optic neuritis occur during treatment, immediate eye examination and regular follow-up are recommended. 5. High doses of vitamin B6 can be used to counteract isoniazid poisoning.
[Use in Special Populations]
Precautions for Children:
Use strictly according to the pediatric dosage and instructions.
Precautions for Pregnancy and Lactation:
1. This drug can cross the placenta, resulting in higher fetal blood concentrations than maternal blood concentrations. Animal studies have shown that isoniazid can cause fetal death, but this has not been confirmed in humans. Therefore, the risks and benefits must be carefully considered when using this drug in pregnant women. The effects of isoniazid combined with other drugs on the fetus have not been elucidated. In addition, close observation for adverse reactions should be made when using this drug in neonates. 2. Isoniazid concentrations in breast milk can reach 12 mg/L, similar to blood concentrations. Although this has not been shown to be a problem in humans, the risks and benefits should be carefully considered when using this drug during breastfeeding. If used, breastfeeding should be discontinued.
Precautions for Elderly:
The incidence of hepatitis associated with this drug is higher in patients over 50 years of age.
[Drug Interactions]
1. Daily consumption of alcohol while taking isoniazid can predispose to hepatotoxicity induced by this drug and accelerate its metabolism. Therefore, the isoniazid dose should be adjusted and signs of hepatotoxicity should be closely monitored. Patients should be advised to avoid alcoholic beverages while taking this medication. 2. Aluminum-containing antacids can delay and reduce the absorption of isoniazid after oral administration, resulting in lower blood drug concentrations. Therefore, it is important to avoid taking both drugs simultaneously, or take isoniazid at least 1 hour before taking an oral antacid. 3. When anticoagulants (such as coumarin or indandione derivatives) are used simultaneously with isoniazid, the anticoagulant effect is enhanced due to the inhibition of the anticoagulant's enzyme metabolism. 4. When taken concurrently with cycloserine, adverse central nervous system reactions (such as dizziness or drowsiness) may be increased. Dosage adjustments should be made, and signs of central nervous system toxicity should be closely observed, especially for patients whose work requires high sensitivity. 5. The combined use of rifampicin and isoniazid can increase the risk of hepatotoxicity, especially in patients with pre-existing liver damage or those with rapid acetylation of isoniazid. Therefore, patients should be closely followed up for signs of hepatotoxicity during the first 3 months of treatment. 6. Isoniazid is a vitamin B6 antagonist and can increase renal excretion of vitamin B6, potentially leading to peripheral neuritis. Vitamin B6 requirements increase when taking isoniazid. 7. When used in combination with corticosteroids (especially prednisolone), isoniazid metabolism and excretion in the liver can be increased, leading to decreased blood concentrations and impacting efficacy. This is more pronounced in rapidly acetylated patients, so the dose should be adjusted appropriately. 8. When used in combination with alfentanil, isoniazid can prolong the effects of alfentanil, as it is a hepatic enzyme inhibitor. Combination with disulfiram can enhance its central nervous system effects, causing dizziness, incoordination, irritability, and insomnia. Combination with enflurane can increase the formation of nephrotoxic inorganic fluoride metabolites. 9. Combination with ethionamide or other anti-tuberculosis drugs can exacerbate the adverse reactions of these two drugs. Combination with other hepatotoxic drugs can increase the hepatotoxicity of this product and should be avoided as much as possible. 10. Isoniazid should not be used in combination with ketoconazole or miconazole, as it may decrease the blood concentrations of the latter drugs. 11. When used in combination with phenytoin or aminophylline, it may inhibit their hepatic metabolism, leading to increased blood concentrations of phenytoin or aminophylline. Therefore, when isoniazid is used sequentially or in combination with acetaminophen, the dosage of phenytoin or aminophylline should be adjusted appropriately. 12. When used in combination with acetaminophen, isoniazid can induce hepatic cytochrome P-450, increasing the amount of toxic metabolites formed by isoniazid, which may increase hepatotoxicity and nephrotoxicity. 13. When used concurrently with carbamazepine, isoniazid can inhibit its metabolism, increasing carbamazepine blood concentrations and causing toxic reactions. Carbamazepine can also induce isoniazid's microsomal metabolism, increasing the formation of hepatotoxic intermediate metabolites. 14. This product should not be used in combination with other neurotoxic drugs to avoid increasing neurotoxicity.
[Pharmacological Action]
This product is a synthetic antibacterial drug with bactericidal properties. It is effective only against mycobacteria, primarily those in their reproductive phase. 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.
[Storage]
Store in a dry, airtight container protected from light.
[Specification]
0.1g
[Packaging]
100 tablets/bottle.
[Expiration Period]
24 months
[Approval Number]
National Medicine Standard H34021587
[Manufacturer]
Company Name: Shanxi Yunpeng Pharmaceutical Co., Ltd.
