Isoniazid Tablets

This product is a synthetic antibacterial drug with bactericidal effect. It is only effective against mycobacteria, mainly bacteria in the growth and reproduction period. Its mechanism of action has not yet been elucidated, and it may inhibit the synthesis of mycolic acid of sensitive bacteria and cause cell wall rupture.

The main ingredient of this product is isoniazid.

This product is white or off-white tablets.

1. Isoniazid combined with other anti-tuberculosis drugs is suitable 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 recently diagnosed with tuberculosis; 2. Patients with a strong positive tuberculin purified protein derivative test (PPD) and a chest X-ray examination consistent with non-progressive tuberculosis, negative sputum bacteria, and no formal anti-tuberculosis treatment in the past; 3. Patients who are receiving immunosuppressants or long-term hormone therapy, certain blood diseases or reticuloendothelial system diseases (such as leukemia, Hodgkin's disease), diabetes, uremia, silicosis or gastrectomy, whose tuberculin purified protein derivative test is positive; 4. Patients under 35 years old with a positive tuberculin purified protein derivative test; 5. People who are known or suspected to be infected with HIV, whose tuberculin purified protein derivative test is positive, or who have close contact with patients with active pulmonary tuberculosis.

Oral. 1. Prevention: 0.3g (3 tablets) per day for adults. Take it all at once. 10mg/kg per day for children. The total daily dose should not exceed 0.3g (3 tablets). Take it all at once. 2. Treatment: In combination with other anti-tuberculosis drugs, adults can take 5mg/kg per day orally. The maximum dose is 0.3g (3 tablets). Or 15mg/kg per day. The maximum dose is 900mg (9 tablets). Take it 2-3 times a week. Children can take 10-20mg/kg per day. The maximum dose is 0.3g (3 tablets). Take it all at once. For some children with severe tuberculosis (such as tuberculous meningitis), the daily dose can be as high as 30mg/kg (maximum daily dose is 500mg). However, attention should be paid to the occurrence of liver damage and peripheral neuritis.

The patients with a higher incidence rate have unstable gait or numbness, tingling, burning or finger pain (peripheral neuritis); dark urine, yellowing of eyes or skin (hepatotoxicity: the incidence of hepatotoxicity increases in patients over 35 years old); poor appetite, abnormal fatigue or weakness, nausea or vomiting (prodromal symptoms of hepatotoxicity). The patients with a very low incidence rate have blurred vision or decreased vision, with or without eye pain (optic neuritis); fever, rash, hematocrit and male breast development. This product may occasionally cause convulsions due to neurotoxicity.

It is contraindicated for patients with abnormal liver function, mental illness and epilepsy.

Precautions for children: Use strictly according to the dosage and usage for children. Precautions for pregnancy and lactation: 1. This product can cross the placenta, resulting in a higher fetal blood concentration than the maternal blood concentration. Animal experiments have confirmed that isoniazid can cause stillbirth, but although it has not been confirmed in humans, pregnant women must fully weigh the pros and cons when using it. The effect of isoniazid on the fetus when combined with other drugs has not yet been clarified. In addition, adverse reactions should be closely observed when using the drug in newborns. 2. The concentration of isoniazid in breast milk can reach 12 mg/L, which is similar to the blood concentration; although it has not been confirmed to be a problem in humans, the pros and cons should still be fully weighed when used during lactation. If the drug is used, breastfeeding should be stopped. Precautions for the elderly: The incidence of hepatitis caused by this product is higher in patients over 50 years old.

1. Drinking alcohol every day while taking isoniazid can easily cause liver toxicity induced by this product and accelerate the metabolism of isoniazid. Therefore, the dosage of isoniazid needs to be adjusted and signs of liver toxicity need to be closely observed. Patients should be advised to avoid alcoholic beverages during medication. 2. Aluminum-containing antacids can delay and reduce the absorption of isoniazid after oral administration, reducing blood drug concentrations. Therefore, it is necessary to avoid taking both at the same time, or take isoniazid at least 1 hour before oral antacids. 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 enzyme metabolism of the anticoagulant. 4. When taken together with cycloserine, it can increase adverse reactions of the central nervous system (such as dizziness or drowsiness). The dosage needs to be adjusted and signs of central nervous system toxicity need to be closely observed, especially for patients who are engaged in work that requires high sensitivity. 5. When rifampicin is used in combination with isoniazid, the risk of hepatotoxicity may increase, especially in patients with existing liver damage or those who are fast acetylation of isoniazid. Therefore, close follow-up should be conducted during the first three months of treatment to detect signs of hepatotoxicity. 6. Isoniazid is an antagonist of vitamin B6 and can increase the amount of vitamin B6 excreted through the kidneys, which may lead to peripheral neuritis. The requirement for vitamin B6 increases when taking isoniazid. 7. When used in combination with adrenal cortical hormones (especially prednisolone), it can increase the metabolism and excretion of isoniazid in the liver, resulting in a decrease in the latter's blood concentration and affecting the efficacy. This is more significant in fast acetylation patients, so the dose should be adjusted appropriately. 8. When used in combination with alfentanil, isoniazid can prolong the effect of alfentanil because it is a liver enzyme inhibitor; when used in combination with disulfiram, it can enhance its central nervous system effects, causing dizziness, incoordination, irritability, insomnia, etc.; when used in combination with enflurane, it can increase the formation of inorganic fluorine metabolites with nephrotoxicity. 9. When used in combination with ethionamide or other anti-tuberculosis drugs, it can aggravate the adverse reactions of the latter two. When used in combination with other hepatotoxic drugs, it can increase the hepatotoxicity of this product, so it should be avoided as much as possible. 10. Isoniazid should not be used in combination with ketoconazole or miconazole, because it can reduce the blood concentration of the latter two. 11. When used in combination with phenytoin sodium or aminophylline, it can inhibit the metabolism of the two in the liver, resulting in an increase in the blood concentration of phenytoin sodium or aminophylline. Therefore, when isoniazid is used successively or in combination with the two, the dose of phenytoin sodium or aminophylline should be appropriately adjusted. 12. When used with acetaminophen, isoniazid can induce liver cytochrome P-450, increasing the amount of toxic metabolites formed by the former, which can increase liver toxicity and kidney toxicity. 13. When used simultaneously with carbamazepine, isoniazid can inhibit its metabolism, increase the blood concentration of carbamazepine, and cause toxic reactions; carbamazepine can induce isoniazid microsomal metabolism, forming an increase in intermediate metabolites with liver toxicity. 14. This product is not recommended for use with other neurotoxic drugs to avoid increasing neurotoxicity.

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

50mg

36 months