Isofuranamide Tablets

Anti-tuberculosis drugs are a combination of rifampicin, isoniazid and pyrazinamide. Rifampicin has a significant bactericidal effect on Mycobacterium tuberculosis and some non-tuberculous mycobacteria (including Mycobacterium leprae) both inside and outside the host cells.

This product is a compound preparation, each tablet contains the active ingredients rifampicin 0.12g, isoniazid 0.08g, and pyrazinamide 0.25g.

This product is a film-coated tablet, which appears orange-red to red after removing the coating.

It is suitable for the 2-month intensive treatment of patients with tuberculosis who are initially treated and have non-multi-drug-resistant tuberculosis.

Oral administration, 1 to 2 hours before meals, once a day. For patients weighing 30 to 39 kg, take 3 tablets at a time (containing 0.36 g rifampicin, 0.75 g pyrazinamide and 0.24 g isoniazid); for patients weighing 40 to 49 kg, take 4 tablets at a time (containing 0.48 g rifampicin, 1.0 g pyrazinamide and 0.32 g isoniazid); for patients weighing 50 kg and above, take 5 tablets at a time (containing 0.6 g rifampicin, 1.25 g pyrazinamide and 0.4 g isoniazid). The course of treatment is 2 months.

1. Digestive tract reactions are the most common. After oral administration of this product, gastrointestinal reactions such as loss of appetite, nausea, vomiting, upper abdominal discomfort, and diarrhea may occur. 2. Hepatotoxicity is the main adverse reaction of this product. In the first few weeks of treatment, a small number of patients may experience elevated serum aminotransferase, hepatomegaly, and jaundice. Most of them are transient asymptomatic elevations of serum aminotransferase, which can recover on their own during the course of treatment. It is more likely to occur in the elderly, alcoholics, malnourished people, people with pre-existing liver disease or other factors that cause abnormal liver function. Adverse reactions manifest as poor appetite, abnormal fatigue or weakness, nausea or vomiting (prodromal symptoms of hepatotoxicity) and dark urine, yellowing of eyes or skin (hepatotoxicity). 3. Allergic reactions include fever, polymorphic rash, lymphadenopathy, vasculitis, purpura, asthma, anaphylactic shock, etc. After high-dose intermittent therapy, "flu-like syndrome" may occasionally occur, manifested as chills, chills, fever, discomfort, dyspnea, dizziness, drowsiness, and muscle pain. The frequency of occurrence is significantly related to the dose and the interval time. Acute hemolysis or renal failure may occur occasionally, and its mechanism is currently believed to be an allergic reaction. 4 Nervous system toxicity: Peripheral neuritis is more common in slow acetylation and has a significant relationship with the dose. Many patients show unsteady gait, numbness, tingling, burning sensation or pain in the hands and feet. This reaction is more likely to occur in lead poisoning, arteriosclerosis, hyperthyroidism, diabetes, alcoholism, malnutrition and pregnant women. Taking 10-50 mg of vitamin B6 daily can prevent or relieve symptoms. Other toxic reactions such as excitement, euphoria, insomnia, loss of autonomy, toxic encephalopathy or toxic psychosis are rare, and severe toxic reactions such as optic neuritis and atrophy are occasionally reported. 5 The blood system may have neutropenia, eosinophilia, thrombocytopenia, anemia, methemoglobinemia, etc. 6 It can cause active gout and joint pain. 7Other symptoms such as shortened prothrombin time, headache, dizziness, dry mouth, hypertension, vitamin B6 deficiency, hyperglycemia, metabolic acidosis, and endocrine dysfunction have been occasionally reported.

1. Patients who are allergic to isoniazid, pyrazinamide, rifampicin and rifamycin antibiotics are contraindicated. 2. Patients with severe liver dysfunction, biliary obstruction, children and pregnant women under 3 months are contraindicated.

Precautions for children: It is recommended to take it according to the instructions under [Usage and Dosage]. Precautions for pregnancy and lactation: Rifampicin can cause malformations in rodents when used in large doses, and there are no controlled studies on pregnant women. Rifampicin used in the last few weeks of pregnancy can cause postpartum bleeding in mothers and infants, which can be corrected by giving vitamin K. There have been reports that the use of isoniazid in pregnant mice can cause embryonic death. However, there are no reports of congenital abnormalities caused by isoniazid. There are no controlled studies on pyrazinamide in pregnant women. It can be used in pregnant women after weighing the benefits against the potential risks to the fetus. Since both rifampicin and isoniazid can pass through the placenta into breast milk, breastfeeding should not be done unless the doctor believes that the benefits outweigh the potential risks to the baby. Precautions for the elderly: There is currently a lack of detailed research data.

1 Drinking alcohol can increase the incidence of hepatotoxicity of this product and increase the metabolism of this product. The dosage needs to be adjusted, and the patient should be closely observed for hepatotoxicity. 2 Para-aminosalicylate can affect the absorption of this product, resulting in a decrease in the blood concentration of rifampicin; if combined use is necessary, the interval between taking the two should be at least 6 hours. 3 The combination of this product with ethionamide or other anti-tuberculosis drugs can aggravate its adverse reactions. Combination with other hepatotoxic drugs can increase the hepatotoxicity of this product and should be avoided as much as possible. 4 Chlorophenazine can reduce the absorption of rifampicin, delay the peak time and prolong the half-life. 5 Combination with miconazole or ketoconazole can reduce the blood concentrations of the latter two, so this product should not be used in combination with imidazoles. 6. When adrenocortical hormones (glucocorticoids, mineralocorticoids), anticoagulants, aminophylline, theophylline, chloramphenicol, clofibrate, cyclosporine, verapamil (Isopamine), tocainide, propafenone, trimethoprim, coumarin or indandione derivatives, oral hypoglycemic drugs, corticotropin, dapsone, digitalis glycosides, disopyramide, quinidine, etc. are used in combination with this product, rifampicin can induce liver microsomal enzyme activity, which can weaken the efficacy of the above drugs. Therefore, except for digoxin and dapsone, the above drugs need to adjust the dosage before and during the treatment of this product. When this product is used in combination with coumarin or indandione, the prothrombin time should be measured daily or regularly to adjust the dosage accordingly. 7. This product can promote the metabolism of estrogen or reduce its enterohepatic circulation, reduce the effect of oral contraceptives, and lead to irregular menstruation, intermenstrual bleeding and unplanned pregnancy. Therefore, when patients take this product, they should use other contraceptive methods instead. 8 This product can induce liver microsomal enzymes, increase the metabolism of anti-tumor drugs dacarbazine and cyclophosphamide, form alkylated metabolites, and promote the decrease of white blood cells, so the dosage needs to be adjusted. 9 Combination with diazepam (Valium) can increase the elimination of the latter and reduce its blood concentration, so the dosage needs to be adjusted. 10 This product can increase the metabolism of phenytoin in the liver, so when the two are used together, the blood concentration of phenytoin should be measured and the dosage should be adjusted. 11 This product can increase the degradation of levothyroxine in the liver, so the dose of levothyroxine should be increased when the two are used together. 12 This product can also increase the metabolism of methadone and mexiletine in the liver, causing methadone withdrawal symptoms and reduced mexiletine blood concentration, so the latter two need to adjust the dose when used together. 13 Combination with probenecid can increase the blood concentration of rifampicin and pyrazinamide and produce toxic reactions. 14 Isoniazid is an antagonist of vitamin B6, which can increase the amount of vitamin B6 excreted through the kidneys and easily cause peripheral neuritis. Those who take vitamin B6 at the same time need to increase the dosage as appropriate. 15 This product should not be used in combination with other neurotoxic drugs to avoid increasing neurotoxicity. 16 When used in combination with cycloserine, it can increase adverse reactions of the central nervous system (such as dizziness or drowsiness). The dose needs to be adjusted and the signs of central nervous system toxicity need to be closely observed, especially for patients who are engaged in work that requires high sensitivity. 17 This product can inhibit the metabolism of carbamazepine, increase its blood concentration, and cause toxic reactions; carbamazepine can induce the microsomal metabolism of isoniazid, increasing the amount of hepatotoxic intermediate metabolites. 18 When used in combination with acetaminophen, because isoniazid can induce liver cytochrome P450, the amount of toxic metabolites formed by the former increases, which can increase liver toxicity and kidney toxicity. 19 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, its central nervous system effects can be enhanced, resulting in dizziness, incoordination, irritability, insomnia, etc.; when used in combination with enflurane, the formation of inorganic fluorine metabolites with nephrotoxicity can be increased. 20 Do not take it at the same time with ephedrine or belladonna to avoid or increase adverse reactions. 21 Aluminum-containing antacids can delay and reduce the absorption of isoniazid after oral administration, reducing blood drug concentrations. Avoid using them at the same time, or take this product at least 1 hour before taking oral antacids. 22 When used in combination with allopurinol, colchicine, and sulfinpyrazone, pyrazinamide can increase blood uric acid concentrations and reduce the effectiveness of the above drugs in treating gout. The dose should be adjusted to control hyperuricemia and gout.

Sealed, store in a dark and dry place.

0.45 g (C43H58N40120.12 g, C6H7N300.08 g and C5H5N300.25 g)

24 months

Chongqing Huapont Pharmaceutical Co., Ltd.

• Founded in:

  2012-06-26

• Address:

  No. 69, Renhe Xingguang Avenue, Yubei District, Chongqing

• Tax NO.:

  915000005992299001

• Registered Funds:

  450 million yuan

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