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  • Name: Rifampin and Isoniazid Tablets
  • Add time: 2015-05-14
  • Views : 71

[Drug Name]
Generic Name:异福片
English name:Rifampin and Isoniazid Tablets
Pinyin:Yifu Pian
Ingredient
This product is compound, each containing rifampicin 0.3g, isoniazid 0.15g.
[Character]
This product is film-coated tablets, remove the coating, which was orange-red to dark red.
Indications
Suitable for all types of TB treatment.
[Specification]
0.45g (rifampin and isoniazid 0.3g 0.15g)
【Dosage】
30 minutes before eating or two hours after a meal taken, usually weighing more than 50 kg person, every two, once a day, continuous medication to bacterial overcast, clinical symptoms is eligible for the maximum degree of improvement so far. Or compliance.
【Adverse reactions】
Foreign clinical research data shows that:
Rifampicin: Rifampicin is well tolerated and rarely cause serious toxicity, adverse events daily or intermittently taking this might occur are:
* Minor, self-limiting skin reactions. Typically manifested as skin redness, itching with or without skin rash, serious skin allergic reactions are uncommon.
* Gastrointestinal reactions include loss of appetite, nausea, vomiting, abdominal discomfort and diarrhea. Rifampicin treatment had been reported to cause pseudomembranous colitis.
* Rifampicin can cause hepatitis, liver function should be monitored.
* Thrombocytopenia can occur, with or without purpura, usually intermittent treatment with rifampicin concerned, if purpura, immediate withdrawal, the purpura may disappear after continued treatment if purpura, has been reported to cause cerebral hemorrhage and even death ʱ??
Increased eosinophils, neutropenia, edema, muscle weakness and myopathy during rifampicin treatment also has small number of patients.
The following reaction often occurs in intermittent rifampicin during treatment, it may be associated with immune-related:
* Flu-like syndrome include fever, chills, headache, dizziness and other symptoms of the onset of pain, common in the first three to six months after the intermittent treatment. The frequency varies, if rifampicin dose <25mg / kg, administered once a week by intermittent incidence of up to 50%.
* Shortness of breath and wheezing.
* Blood pressure and shock.
* Acute hemolytic anemia.
* Acute renal failure, often by the acute tubular necrosis or acute interstitial nephritis caused.
Women receiving rifampicin-containing anti-TB drugs long-term treatment of occasional reports of menstrual disorders.
Rifampicin can cause urine, sweat, sputum and tears were red, the patient should be told in advance. Contact lenses may be permanently stained.
Isoniazid: Isoniazid therapy can be serious and sometimes fatal hepatitis. Polyneuritis isoniazid-related manifestations paresthesia, muscle weakness, tendon reflexes and the like. However, the above reaction is different blessing sheet with the recommended daily dose not often happen. Various hematological abnormalities include increased eosinophils, agranulocytosis, thrombocytopenia and anemia have occurred during isoniazid treatment. Gastrointestinal reactions include nausea, vomiting, and upper abdominal pain. Large doses of isoniazid can cause convulsions. There are other neurological toxicity toxic encephalopathy, optic neuritis and optic atrophy, memory impairment and toxic neuropathy. When conventional dose not common. We should keep in mind that use of this drug in patients with epilepsy have the possibility of increasing seizure frequency.
Taboo
Rifampin, isoniazid history of allergies were banned.
【Precautions】
1. This product Renyi Cheng parts can cause liver damage, during the medication should be careful to check liver function.
Rifampicin: in patients with impaired liver function only when using this service must be in, and should be careful medication under close medical monitoring, close monitoring of liver function especially ALT and AST, liver function should be checked before treatment and then during treatment every 2 to 4 weeks after the first, if signs of liver cell damage occurs, should immediately stop using rifampin.
In some cases, rifampin treatment early due to rifampicin and bilirubin excretion channel competition at the level of liver cells, can occur hyperbilirubinemia. Individual reports that bilirubin and / or moderately elevated transaminase interruption of treatment is not in itself an indication. However, duplicate detection levels were still. Should be combined with patient clinical situation consider withdrawal.
Because rifampicin intermittent treatment (administered less than 2 to 3 times a week) have the possibility of an immune response (see Adverse Reactions), should be closely monitored, and warned patients avoid intermittent medication.
Rifampicin induce liver enzymes including features γ- aminolevulinic acid synthase, useful rifampicin deterioration occurs porphyria reported cases.
Isoniazid: chronic liver disease or severe renal insufficiency should be monitored in patients taking isoniazid liver and kidney function, sometimes isoniazid treatment can be serious or even fatal drug-induced hepatitis, may also occur after several months of treatment. The risk of occurrence of hepatitis and age-related, and therefore, should be monitored for prodromal symptoms of hepatitis, such as fatigue, weakness, malaise, loss of appetite, nausea and vomiting. If these symptoms appear or detected signs of liver cell damage prompted, should be discontinued immediately due to medication can cause more serious liver damage.
2. Mental illness or epilepsy with caution.
Pregnant women and lactating women drug]
Rifampicin: in rodent experiments, large dose of rifampicin have teratogenic effects in pregnant women, clinical trials have not yet been associated with rifampicin.
The last few weeks of pregnancy using this service, can cause maternal postpartum hemorrhage, vitamin K can correct.
Isoniazid: It has been reported in rats and rabbits animal experiments, such as isoniazid during pregnancy can affect fetal development. While in mammals (mice, rats and rabbits) reproductive studies have not found isoniazid-related congenital abnormalities.
Rifampicin / isoniazid combination preparation different blessing sheet: medication unless it is considered significantly greater than the interests of patients may bring danger to the fetus only when used in pregnant women, Yin Lifu calm isoniazid through the placenta, and access to milk, therefore women receiving treatment of this product should stop breastfeeding. Unless the doctors think the benefits to the patient outweigh the potential risk to the infant.
Pediatric Use
There is currently a lack of detailed research data.
[Geriatric medicine]
There is currently a lack of detailed research data.
Drug interactions
Rifampicin: induce liver enzymes features include anti-clotting drugs can reduce, adrenocorticotropic hormone, cyclosporine, digitalis preparations, quinidine, oral contraceptives, oral hypoglycemic agents, dapsone, anesthesia active drugs and painkillers and other drugs. Rifampicin reduces while taking methadone, barbiturates, tranquilizers, verapamil, β-blockers, lipid-lowering, ethyl progesterone, disopyramide, mexiletine, theophylline, chloramphenicol and the anticonvulsant drug efficacy. As these drugs and rifampin same clothes, you may need to adjust the dose of these drugs. During rifampicin treatment recommended oral contraceptives women use other non-hormonal birth control method. Moreover, antacids affect the absorption of rifampicin.
Have reported that halothane (Halothane) and rifampicin with the service will increase the liver toxicity of the two drugs; ketoconazole with the goods when the same clothes, can reduce the blood concentration of the two, such as patients with drug indications, should be based on adjust the dose.
Rifampicin dose suppressed serum folate and vitamin B12 standard microbiological assay, a transient increase in BSP and serum bilirubin have been reported, therefore, should rifampicin in the early morning before the above experimental oral examination.
Isoniazid: phenytoin sodium excretion can be reduced, thereby enhancing their effects, the dose should be adjusted anti-seizure drugs, isoniazid associated with a higher incidence of drug-induced hepatitis may be associated with alcoholism (alcohol a day) related to the elderly or malnourished patients should be treated with isoniazid attention to the need vitamin B6.
Overdosage
If you overdose this product should immediately stopping the drug, gastric lavage, and symptomatic treatment measures (including hemodialysis).
Pharmacology and Toxicology
Pharmacological effects
This product is anti-TB drugs are isoniazid and rifampicin, the compound preparation thereof. Studies have demonstrated that isoniazid and rifampicin in therapeutic levels of intracellular and extracellular M. tuberculosis have antibacterial activity.
Mechanism of action: inhibition by rifampicin sensitive Mycobacterium tuberculosis RNA polymerase, particularly by interaction with the bacterial RNA polymerase reaches antibacterial effect, but no inhibitory effect on mammals. Mycobacterium tuberculosis Isoniazid ring by inhibiting fatty acid biosynthesis, and thus affect the synthesis of cell wall of M. tuberculosis.
Toxicology
There is no genetic compound of isoniazid and rifampicin, reproductive toxicity and carcinogenicity studies, toxicology each single agent can refer to the following related information.
Rifampicin:
Genetic Toxicity: Bacteria Drosophila or in mice not found this product has mutagenic effects; human lymphocyte chromosomal aberration test was negative, but during the whole blood cell cultures of this product, found an increase in chromosome breakage.
Reproductive toxicity: rodent study found that the goods in large doses have teratogenic effects.
Carcinogenicity: There is no long-term use of this product reported about people potentially carcinogenic, clinical reports have after a few patients taking this cancer grow faster, but its correlation with the drug has not been determined. People daily average of 2 to 10 times the dose given to the mice 60 weeks, the female animals can be observed increased incidence of liver cancer, but found no carcinogenic effects in male mice and other strains of mice or rabbits.
Others: A number of studies suggest that the goods on rabbits, rats, mice, guinea pigs and human potential immunosuppressive effects.
Isoniazid:
Genetic Toxicity: no report.
Reproductive toxicity: In pregnant rats and rabbits trials found that product can cause embryonic death.
Carcinogenicity: It has been reported, isoniazid can cause a variety of lung tumors in mice.
【Pharmacokinetics】
According to foreign research data presentation:
Rifampicin: rapid gastrointestinal absorption, in normal adults and children whose peak blood levels between individual differences, a dose of 10 mg per kg of body weight fasting oral, about 2 to 4 hours of peak blood concentration (10μg / ml) , such as with food may reduce its absorption.
Normal oral administration of 600 mg, the drug half life of about three hours, if oral 900 mg, the half-life increased to 5.1 hours, repeated administration, the half-life is shortened, the average is about 2 to 3 hours, oral administration of 600 mg per day, Drug renal failure patients with no significant increase in half-life, without making dose adjustments. When the same service with isoniazid, rifampicin half-life may be shortened.
After rifampicin absorption, rapidly excreted by the bile, and enterohepatic circulation produced. Rifampicin metabolized to acetyl metabolite, approximately 6 hours after rifampicin bile are almost desacetyl metabolite form. Its metabolites still have antibacterial activity, deacetylation can reduce the intestinal reabsorption, and conducive to the discharge. The product dose 30% from the urine, where 1/2 of the prototype.
This product is widely distributed in the body, after absorbing an effective concentration distribution in body organs and body fluids including cerebrospinal fluid, its protein binding rate of 80%, the majority of unbound drug is not ionized, freely diffuse into the tissue.
Isoniazid: 1 to 2 hours after oral administration reached peak blood concentrations within six hours plasma concentration decreased <50%. This product is rapidly distributed throughout the body after absorption of body fluids (cerebrospinal fluid, pleural effusion, and ascites), tissue, organs and excreta (saliva, sputum and faeces). It can be used through the placental barrier, but also into the milk, milk drug concentration and plasma concentration considerably. After 24 hours, 50% to 70% of the oral dose excreted by the urine.
Isoniazid major metabolic acetylation and hydrolysis to form. The body of isoniazid acetylation rate is controlled by the genes, about 50 percent of blacks and Europeans belong to slow metabolizers, most Asians belong to fast metabolizers. High dose of isoniazid adults, vitamin B6 deficiency can sometimes occur and may be phosphate isoniazid and pyridoxine competition off Tryptophanase due.
Pharmacokinetic study of healthy volunteers showed that pieces of two different blessing either in their respective constituent or in different doses while taking blessing sheet form taking its bioavailability similar.
Domestic research results are consistent with studies abroad.
[Storage]
Shading, sealed and stored in a dry place.
[Packaging]
Blister packaging, 15 / plate, composite film packaging, 2 plate / bag, carton packaging, 1 bag / box;
Blister packaging, 15 / plate, composite film packaging, 2 plate / bag, carton packaging, 2 bags / boxes.
[Validity]
24 months
[Executive standard]
"Chinese Pharmacopoeia" 2010 edition Third Supplement
【Approval Number】
Zhunzi H20103325
【manufacturer】
Company Name: Shenyang Hongqi Pharmaceutical Co., Ltd.
Production Address: Shenyang Hunnan New District envelope Street on the 6th
Postal Code: 110179
Telephone number: 024-23786260 23786261
Fax: 024-23786263

 

The above is for reference
If you have questions can contact the manufacturer