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Rifampin and Isoniazid Capsules
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Rifampin and Isoniazid Capsules

Shenyang Hongqi Pharmaceutical Co., Ltd. (abbreviated as: Hongqi Pharmaceutical) was established in 1964. Since the 1980s, it has focused on the development, production, sales and service of anti-tuberculosis drugs. After more than 30 years of unremitting efforts, it has provided more than 13 million tuberculosis patients. To provide high-quality medicines and services.
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Yifu Capsule Manual
  Please read the instructions carefully and use under the guidance of a doctor
 
【Drug Name】
Generic name: Yifu capsule
English name: Rifampin and Isoniazid Capsules
Chinese Pinyin: Yifu Jiaonang
【Ingredients】
This product is a compound preparation, and its components are: each capsule contains rifampicin (C 43 H 58 N 4 O 12 ) 0.15 g and isoniazid (C 6 H 7 N 3 O) 0.1 g.
【Properties】
This product is a capsule, the content of which is orange-red to dark red powder.
【Indications】
It is suitable for 4-month maintenance treatment of tuberculosis initial treatment and non-multidrug resistant tuberculosis patients.
【specification】
0.25g (C 43 H 58 N 4 O 12 0.15g and C 6 H 7 N 3 O 0.1g)
【Dosage】
This product is only suitable for adults weighing less than 50kg (not including 50kg). Common dosage for adults: oral administration, weight <50kg, oral administration of 0.45g rifampicin, 0.3g isoniazid, once a day. Take 30 minutes before meals or 2 hours after meals, the general course of treatment is 4 months. Or follow the doctor's advice.
【Adverse reactions】
1. Gastrointestinal reactions are the most common. After oral administration of this product, gastrointestinal reactions such as fear of eating, nausea, vomiting, upper abdominal discomfort, and diarrhea may occur.
2. Liver toxicity is the main adverse reaction of this product. In the first few weeks of the treatment course, a small number of patients may experience elevated serum aminotransferase, hepatomegaly and jaundice, and most of them are asymptomatic transient elevated serum aminotransferase. It can recover on its own during the course of treatment, and it is more likely to occur in the elderly, alcoholics, malnutrition, liver disease or other factors causing abnormal liver function. Adverse reactions include poor appetite, abnormal fatigue or weakness, nausea or vomiting (prodromal symptoms of liver toxicity) and dark urine, yellow eyes or skin (liver toxicity).
3. Allergic reactions including fever, pleomorphic rash, lymphadenopathy, vasculitis, purpura, asthma, anaphylactic shock, etc. "Flu-like syndrome" may occasionally occur after high-dose intermittent therapy, which manifests as chills, chills, fever, malaise, dyspnea, dizziness, lethargy and muscle pain, etc. The frequency of occurrence is obviously related to the size of the dose and the interval time. Acute hemolysis or renal failure may occasionally occur, and it is currently believed that the mechanism is an allergic reaction.
4. Nervous system toxicity: Peripheral neuritis is more common in patients with slow acetylation, and it is obviously related to the dose. More patients present with unstable gait, numbness, tingling, burning, or pain in hands and feet. Such reactions are more likely to occur in lead poisoning, arteriosclerosis, hyperthyroidism, diabetes, alcoholism, malnutrition, and pregnant women. Taking vitamin B610-50mg daily can prevent or relieve symptoms. Other adverse reactions such as excitement, euphoria, insomnia, loss of autonomy, toxic encephalopathy or toxic psychosis are rare. Serious toxic reactions such as optic neuritis and atrophy are occasionally reported.
5. The blood system may have neutropenia, eosinophilia, thrombocytopenia, methemoglobinemia, etc.
6. Others such as shortened prothrombin time, headache, dizziness, dry mouth, high blood pressure, vitamin B6 deficiency, hyperglycemia, metabolic acidosis, endocrine dysfunction, etc. occasionally reported.
【Taboo】
1. People who are allergic to isoniazid, rifampicin and rifamycin antibacterial drugs are forbidden.
2. Patients with severe liver dysfunction, biliary obstruction and pregnant women within 3 months are disabled.
【Precautions】
1. Use with caution in persons with alcoholism, mental illness, epilepsy, or liver damage. Use with caution in infants, pregnant women over 3 months and breastfeeding women.
2. Cross-allergic reactions. People who are allergic to ethionamide, pyrazinamide, niacin or other chemical structure-related drugs may also be allergic to this product.
3. Interference with diagnosis: It can cause direct antiglobulin test (Coombs test) to be positive; interfere with the determination of serum folic acid concentration and serum vitamin B12 concentration; it can cause false positives in the sulfobromide sodium test; it can interfere with the use of spectrophotometry The results of various urinalysis tests carried out due to changes in meter or color; can make blood urea nitrogen, serum alkaline phosphatase, serum alanine aminotransferase, aspartate aminotransferase, serum bilirubin, and serum urea nitrogen, serum alkaline phosphatase, serum alanine aminotransferase, aspartate aminotransferase, serum bilirubin and serum The result of uric acid concentration determination is increased; the ketone sulfate method for urine glucose determination can be a false positive reaction, but it does not affect the result of enzymatic determination.
4. Rifampicin can cause liver insufficiency. There are reports of deaths with jaundice in patients with original liver disease or when this product is taken with other hepatotoxic drugs. Therefore, patients with original liver disease can only be treated if there are clear indications. Use with caution. Observe the changes in liver function before and during treatment. Once liver damage occurs, stop the drug immediately.
5. Isoniazid is similar in structure to vitamin B6. When used in large doses, vitamin B6 can be excreted in urine, inhibiting decarboxylation of glutamate in the brain to γ-aminobutyric acid and causing convulsions. It can also cause peripheral nervous system Multiple lesions. Therefore, oral administration of 650-100 mg of vitamin B at the same time every day can help prevent or reduce symptoms of peripheral neuritis and (or) vitamin B6 deficiency. If you experience mild numbness or dizziness in your hands and feet, you can take vitamin B1 or B6. If you experience severe vomiting or hematemesis, the drug should be stopped immediately.
6. Rifampicin may cause a decrease in white blood cells and platelets, and cause bleeding and infection of the gums, and delayed wound healing. At this time, surgery such as tooth extraction should be avoided, and oral hygiene should be paid attention to. Care should be taken when brushing and flossing teeth until the blood picture returns to normal. During the medication, the surrounding blood should be checked regularly.
7. Hyperbilirubinemia is a mixed type of hepatocellularity and bile retention, which resolves spontaneously during medication in mild patients, and needs to be discontinued for observation in severe patients. Elevated blood bilirubin may also be the result of competition between rifampicin and bilirubin for excretion. Liver function changes should be closely monitored during the initial 2 to 3 months of treatment.
8. Patients with impaired liver function need to reduce the dose, and those with severe renal impairment need to reduce the dose.
9. This product is an anti-tuberculosis chemotherapy drug for the continued treatment. It is generally used for 4 months. The treatment should be maintained until the sputum tuberculosis bacteria becomes negative and the clinical symptoms are improved to the greatest extent.  10. If symptoms of optic neuritis occur during the course of treatment, an eye examination should be performed immediately and regular review.
11. Patients with slow acetylation are more likely to have adverse reactions, so a lower dose should be used.
12. After taking the medicine, urine, saliva, sputum, tears, sweat and other excrement can all be orange-red.
[Medicine for pregnant women and lactating women]
1. Both rifampicin and isoniazid can pass through the placenta, and animal experiments have confirmed that it can cause teratogenesis and stillbirth. Although there is no proven problem in humans, pregnant women should avoid using it. If it is indicated for use, the pros and cons must be fully weighed.
2. Both rifampicin and isoniazid can be secreted in breast milk. Although there is no problem in humans, the pros and cons should be fully weighed during breastfeeding. If medication is used, breastfeeding should be suspended.
【Children's Medication】
The safety of this product in children under 5 years of age has not been determined.
【Geriatric Medication】
The liver function of elderly patients has decreased, so the dosage should be reduced accordingly.
【medicine interactions】
1. Drinking alcohol can increase the incidence of liver toxicity of this product and increase the metabolism of this product. It is necessary to adjust the dose and closely observe whether the patient has liver toxicity.
2. The aminosalicylate can affect the absorption of this product, resulting in a decrease in the blood concentration of rifampicin; if it must be used in combination, the two should be taken at least 6 hours apart.
3. The combination of this product and ethionamide, pyrazinamide or other anti-tuberculosis drugs can aggravate its adverse reactions. Combined use with other hepatotoxic drugs can increase the liver toxicity of this product and should be avoided as much as possible.
4. Chlorophenazine can reduce the absorption of rifampicin, the peak time is delayed and the half-life is prolonged.
5. Combined use with miconazole or ketoconazole can reduce the plasma concentration of the latter two, so this product should not be combined with imidazoles.
6. Adrenocorticoids (glucocorticoids, mineralocorticoids), anticoagulants, aminophylline, theophylline, chloramphenicol, clofibrate, cyclosporine, verapamil (verapamil), and Carney, propafenone, trimethoprim, coumarin or indandione derivatives, oral hypoglycemic agents, corticotropin, dapsone, digitalis glycosides, disopyramide, quinidine, etc. When this product is used in combination, because rifampicin can induce liver microsomal enzyme activity, the efficacy of the above drugs can be weakened. Therefore, except for digoxin and dapsone, the dose of the above drugs should be adjusted before using this product and during the course of treatment. . When this product is combined with coumarin or indandione, the prothrombin time should be measured daily or regularly, and the dosage should be adjusted accordingly.
7. This product can promote the metabolism of estrogen or reduce its enterohepatic circulation, reduce the effect of oral contraceptives, and cause irregular menstruation, inter-menstrual bleeding and unplanned pregnancy. Therefore, patients should switch to other contraceptive methods when taking this product.
8. This product can induce liver microsomal enzymes, increase the metabolism of anti-tumor drugs dacarbazine and cyclophosphamide, form alkylated metabolites, and promote the reduction 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 sodium in the liver, so when the two are used together, the blood concentration of phenytoin sodium 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 a decrease in the blood concentration of mexiletine. Therefore, the latter two need to be adjusted when used in combination.
13. Probenecid can compete with rifampicin to be taken up by hepatocytes, increasing the blood concentration of rifampicin and causing toxic reactions. But the effect is unstable, so probenecid is usually not suitable to increase the blood concentration of this product.
14. Isoniazid is an antagonist of vitamin B6, which can increase the amount of vitamin B6 excreted by the kidneys, which may 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 combined with other neurotoxic drugs, so as not to increase neurotoxicity.
16. When combined with cycloserine, it can increase the adverse reactions of the central nervous system (such as dizziness or drowsiness). The dose should be adjusted and the signs of central nervous system toxicity should be closely observed, especially for patients who are engaged in tasks that require high sensitivity.    
17. This product can inhibit the metabolism of carbamazepine, increase the blood concentration, and cause toxic reactions; carbamazepine can induce the microsomal metabolism of isoniazid and increase the intermediate metabolites with hepatotoxicity.
18. When combined with acetaminophen, because isoniazid can induce hepatic cytochrome P450, the former increases the amount of toxic metabolites, which can increase liver toxicity and nephrotoxicity.
19. When combined with alfentanil, because isoniazid is a liver drug enzyme inhibitor, it can prolong the effect of alfentanil; combined with disulfiram can enhance the effect of the central nervous system, causing dizziness, uncoordinated movements, Irritability, insomnia, etc.; combined with enflurane can increase the formation of nephrotoxic inorganic fluoride metabolites.
20. Do not take ephedrine and belladonna at the same time to avoid adverse reactions.
21. Aluminum-containing antacids can delay and reduce the absorption of isoniazid after oral administration, and reduce the blood concentration. Avoid simultaneous use, or take this product at least 1 hour before oral antacids.
【Overdose】
1. The manifestations of drug overdose: oedema around the eyes or face, general itching, red man syndrome (skin mucous membranes and sclera are red or orange), convulsions, confusion, coma, etc. People with primary liver disease, alcoholics, or those taking other hepatotoxic drugs may cause death.
2. Treatment method of drug overdose:
(1) Stop the drug.
(2) Keep the airway unobstructed.
(3) Use short-acting barbiturates and vitamin B6 for intravenous administration. The dose of vitamin B6 is 1 mg of vitamin B6 per 1 mg of isoniazid. If the dose of isoniazid is unknown, vitamin B6 can be given every 30 minutes until the convulsions stop and the patient recovers awake. Following gastric lavage, gastric lavage should be performed within 2 to 3 hours after taking this product. After gastric lavage, activated carbon paste is given to absorb the residual product in the gastrointestinal tract; antiemetics should be given to patients with severe nausea and vomiting.
(4) Draw blood immediately to determine blood gas, electrolytes, urea nitrogen, blood sugar, etc.
(5) Immediately give sodium bicarbonate intravenously to correct metabolic acidosis, and repeat the administration as needed.
(6) Use osmotic diuretics and continue to use them after the clinical symptoms have improved to promote the excretion of this product and prevent the recurrence of symptoms of poisoning.
(7) Patients with severe poisoning should prepare blood as early as possible and prepare for hemodialysis. If hemodialysis is not possible, peritoneal dialysis can be performed, and diuretics should be used in combination. 
(8) For patients with severe liver damage for more than 24 to 48 hours, bile drainage may be considered to cut off the hepatoenteric circulation of rifampicin.
【Pharmacology and Toxicology】
This product is an anti-tuberculosis drug, a compound preparation of rifampicin and isoniazid. Rifampicin has a significant bactericidal effect on Mycobacterium tuberculosis and some non-tuberculous mycobacteria (including Mycobacterium leprae, etc.) both inside and outside the host cell. Isoniazid has a highly selective bactericidal effect on all types of Mycobacterium tuberculosis, has a strong effect on Mycobacterium tuberculosis in the growth and reproduction phase, and has a weak and slow effect on the quiescent phase. The combination of the two can enhance the antibacterial activity and reduce the production of resistant strains. 
Rifampicin binds firmly to the β subunit of DNA-dependent RNA polymerase, inhibits the synthesis of bacterial RNA and prevents the enzyme from connecting with DNA, thereby blocking the RNA transcription process and stopping the synthesis of DNA and protein. The mechanism of action of isoniazid may be to inhibit the synthesis of mycolic acid from sensitive bacteria and rupture the cell wall.
【Pharmacokinetics】
This product is well absorbed by oral administration, isoniazid reaches the peak plasma concentration (Cmax) 1 to 2 hours after taking the drug, and reaches the peak plasma concentration (Cmax) for rifampin within 1.5 to 4 hours. The peak plasma concentration (Cmax) of rifampicin after oral administration of 0.6g in adults is 7-9mg/L, and the peak plasma concentration (Cmax) of rifampicin in children 6 months to 5 years old is 11mg/L after oral administration of 10mg/kg. . After being absorbed, it is distributed in most tissues and fluids of the whole body, and can pass through the placenta. The protein binding rate of rifampicin is 80% to 91%, and the protein binding rate of isoniazid is only 0 to 10%. The blood elimination half-life (t1/2β) of rifampicin is 3 to 5 hours, which is shortened after multiple administrations, which is 2 to 3 hours; the blood elimination half-life of isoniazid (t1/2β) in fast-acetylated patients is 0.5 to 1.6 hours, the blood elimination half-life (t1/2β) of isoniazid in slow acetylation is 2 to 5 hours. In the liver, it is rapidly deacetylated by the action of self-induced microsomal oxidase. The metabolite of rifampicin, 25-desacetylrifampicin, has antibacterial activity, while the metabolite of isoniazid has no antibacterial activity.
Rifampicin is mainly excreted through the gall bladder and intestines, and can enter the enterohepatic circulation, but its deacetylated active metabolites have no enterohepatic circulation. 60%-65% of the dose is excreted through feces, and 6%-15% of the drug In the original form, 15% of the active metabolites are excreted through urine, and 7% are excreted as inactive 3-formyl derivatives, and can also be excreted through milk; 70% of the dose of isoniazid is excreted through the kidneys within 24 hours. Most of them are inactive metabolites, 93% of fast acetylation is excreted in urine as acetylation, and 63% of slow acetylation is excreted in milk, saliva, sputum and feces. Rifampicin cannot be cleared by hemodialysis or peritoneal dialysis. A considerable amount of isoniazid can be removed by hemodialysis and peritoneal dialysis.
The pharmacokinetic study of normal volunteers showed that the bioavailability of the two components of this product is similar whether they are taken at the same time in their respective doses or in a composite dosage form.
【Storage】
Shade, seal, and store in a dry place.
【package】
Aluminum-plastic blister packaging, 12 tablets/board; composite bag packaging, 5 panels/bag; carton packaging, 1 bag/box.
【Validity Period】
24 months
【Executive Standard】
"Chinese Pharmacopoeia" 2015 Edition Two
【Approval Number】
National Medicine Standard H21023354
【manufacturer】
Company Name: Shenyang Hongqi Pharmaceutical Co., Ltd.   
Production address: No. 6, Xinluo Street, Hunnan New District, Shenyang Postcode: 110179
Phone number: (024) 23786260 23786261  
Fax number: (024) 23786263
Website: www.hongqipharma.com
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