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  • Name: Rifampicin Capsules(Ⅱ)
  • Add time: 2015-05-15
  • Views : 101

Ingredient
Chemical Name: 3 - {[(4-methyl-1-piperazinyl) imino] methyl} - rifamycin.
Chemical Structure:
[Character]
This product capsules, the contents of purple violaceum waxy solid.
Indications
1. This product is used in combination with other anti-TB drugs initial treatment and retreatment of various tuberculosis, including tuberculous meningitis treatment.
2. This product is used in combination with other drugs, leprosy, non-tuberculous mycobacterial infections.
3. The goods and vancomycin (intravenous) can be combined for methicillin-resistant Staphylococcus aureus infections caused serious. Rifampicin and erythromycin joint program for Legionella serious infections.
4. For asymptomatic carriers of Neisseria meningitidis to eliminate Neisseria meningitidis nasopharynx; but not for Neisseria meningitidis infection.
[Specification]
225mg (by C43H58N4O12 dollars)
Dosage
Oral.
Once 0.45g (2 tablets) once daily or as directed.
Adverse reactions
1. The most common gastrointestinal reactions, may occur after oral administration of anorexia, nausea, vomiting, abdominal discomfort, diarrhea and other gastrointestinal reactions, the rate was 1.7% to 4.0%, but can tolerate.
2. Liver toxicity based products major adverse reactions, the incidence of approximately 1%. In the course of the first few weeks, the small number of patients serum aminotransferase, hepatomegaly and jaundice, mostly asymptomatic serum aminotransferase a transient elevated, self-healing in the course of treatment, the elderly, alcoholics , malnutrition, liver disease, or other factors existing liver dysfunction are more likely to occur.
3. After the high-dose intermittent therapy allergy can occur even "flu-like syndrome", manifested as chills, chills, fever, malaise, difficulty breathing, dizziness, drowsiness and muscle pain, and dose size and frequency of intermittent time there significant relationship. It can occur even acute hemolysis or renal failure, now that the case of an allergic reaction which produces the mechanism.
4. other patients using this service, urine, saliva, sputum, tears, etc. may be in orange. Occasionally leukopenia, prothrombin time shortened, headache, dizziness, visual disorders.
Taboo
1. Disable the goods or rifamycin antimicrobial drug allergies.
2. severe liver failure, biliary obstruction, and within three months pregnancy.
[Precautions]
1. alcoholism, liver dysfunction caution. Baby, three months or more pregnant and lactating women with caution.
2. The diagnosis of interference: may cause direct antiglobulin test (Coombs test) positive; interference serum leaf
Acid concentrations were determined and serum vitamin B12 concentrations were measured result; make methyl bromide phthalocyanine sodium retention false positive test; the results can be carried out using a spectrophotometer or interference color change of the urinalysis tests; make the blood urea nitrogen, serum alkaline phosphatase, serum alanine aminotransferase, aspartate aminotransferase, bilirubin and serum measurement results of serum uric acid concentration increased.
3. Rifampicin can cause liver dysfunction, jaundice associated deaths have been reported with other hepatotoxic drugs when the same clothes in the original patients with liver disease or the goods and therefore the original liver disease, only in case there is a clear indication before caution, before the start of treatment, the treatment of close observation of changes in liver function, liver damage occur, immediate withdrawal.
4. Department of hyperbilirubinemia liver cells and bile retention of mixed type, medication in patients with mild self-limiting, weight are required to observe the withdrawal. Serum bilirubin may be the result of rifampicin compete with bilirubin excretion. Early treatment for 2 to 3 months, hepatic function should be closely monitored.
5. Therefore, this product must be combined with a single pathogen can rapidly develop resistance when rifampicin tuberculosis or other bacterial infections, and other drugs. Treatment may need to continue for 6 months to 2 years, or even years.
6. rifampicin may cause neutropenia and thrombocytopenia and bleeding gums and lead to infection, delayed wound healing and so on. You should avoid tooth extraction surgery, and pay attention to oral hygiene, brushing and flossing are required to carefully until the blood return to normal. Peripheral blood should be checked regularly during the treatment.
7. rifampicin should l hour before meals or after dinner two hours taking a single dose absorbed best fasting, because it affects the absorption of food.
8. Patients with liver dysfunction often need to reduce the dose, the daily dose ≤8mg / kg.
9. Renal dysfunction without reduction. There was no significant change in blood concentration reduced glomerular filtration rate in patients with or without urinary rifampicin.
10. After taking urine, saliva, sweat and other excretions could significantly orange. Interstitial nephritis may occur.
[Pregnant women and lactating women drug]
1. Rifampicin can cross the placenta, animal experiments have caused teratogenic. Although humans no teratogenic reports, but not enough data indicate that security can be used in pregnancy. 3 months or less during pregnancy. 3 months or more pregnant women with caution.
2. rifampicin by milk excretion, lactating women should fully weigh whether the medication after the decision.
Pediatric Use
This product in children under 5 years of application security has not been established. Baby caution.
[Geriatric medicine]
Elderly patients have decreased liver function, the dosage should reduce it.
Drug interactions
1. drinking can cause rifampicin increased incidence of liver toxicity, and increased metabolic rifampicin, the need to adjust the dose of rifampicin, and closely observe whether patients with liver toxicity appear.
2. aminosalicylates may affect the absorption of the product, resulting in reduced plasma concentrations; such as when applications must be united, the two take at least 6 hours.
3. The goods and isoniazid increased risk of liver toxicity, especially liver dysfunction and original fast acetylation of isoniazid patients.
4. rifampin and isoniazid amine B sulfur can be combined to aggravate the adverse reactions.
5. chlorophenol hydrochloride can reduce the absorption of rifampicin, the peak time delay and half-life.
6. rifampicin and miconazole or ketoconazole, after both can reduce blood concentration, so the product should not be combined with imidazole.
7. adrenocorticotropic hormone (glucocorticoid, mineralocorticoid), anticoagulants, aminophylline, theophylline, chloramphenicol, clofibrate, cyclosporine, verapamil (verapamil), duly Carney, propafenone, trimethoprim, or indandione coumarin derivatives, oral hypoglycemic agents, corticotropin, dapsone, digitalis glycosides, disopyramide, quinidine and When rifampin, as the latter induced hepatic microsomal enzyme activity, can weaken the efficacy of these drugs, so in addition to dapsone digoxin and outside, in front of the course of treatment with rifampicin and need to adjust the dose of these drugs . The goods and coumarin or indane ketones should be combined daily or periodically measuring prothrombin time, according to adjust the dose.
8. It can promote the metabolism of estrogen or reduce its enterohepatic circulation, reduce the role of oral contraceptives, resulting in irregular menstruation, menstrual bleeding between periods and unplanned pregnancy. Therefore, patients taking rifampicin peacetime, should use other contraceptive methods.
9. It can induce hepatic microsomal enzymes, increased antitumor dacarbazine (dacarbazine), cyclophosphamide metabolism, forming alkylated metabolites induce leukocyte reduced, and therefore the need to adjust the dose.
10. The goods and diazepam (Valium) combined to increase the elimination of the latter to reduce the plasma concentration, and therefore need to adjust the dose.
11. The product can increase phenytoin metabolism in the liver, so the two combined phenytoin plasma concentrations should be measured and adjust the dosage.
12. The product can increase levothyroxine degradation in the liver, so the dose of L-thyroxine should be increased when the two combined.
13. This product can also increase methadone, mexiletine metabolized in the liver, causing methadone withdrawal symptoms mexiletine plasma concentrations reduced, so after two in combination require dose adjustment.
14. probenecid can compete with the product uptake by liver cells, so that the product increased plasma concentration and toxic reactions. But instability in the action, it is usually not added with probenecid to increase the plasma concentration of this product.
Overdosage
1. than the amount of the performance:
Mental retardation; eye or facial edema; body itching; red man syndrome (skin and mucous membranes and sclera red or orange). With primary liver disease, alcoholism, or liver toxicity with taking other drugs that could cause death.
2. Treatment:
(1) withdrawal.
(2) gastric lavage, because patients often experience nausea, vomiting, should then vomiting; give activated charcoal paste after gastric lavage to absorb the remnants of rifampicin in the gastrointestinal tract; severe nausea and vomiting antiemetic agent.
(3) give intravenous fluids and diuretics to promote excretion of drugs.
(4) symptomatic and supportive therapy.
Pharmacology and Toxicology
Rifampin rifamycin class semi-synthetic broad-spectrum antibiotics, against a variety of pathogenic microorganisms have antibacterial activity. The drug against Mycobacterium tuberculosis and some non-tuberculous mycobacteria (including Mycobacterium leprae, etc.) has a significant bactericidal effect both inside and outside the host cell. Rifampicin aerobic Gram-positive bacteria with good antibacterial effect, including Staphylococcus aureus enzyme production strains and methicillin-resistant strains of Streptococcus pneumoniae, other Streptococcus, Enterococcus, Listeria, Bacillus anthracis, Clostridium perfringens, diphtheria, anaerobic bacteria and the like. Aerobic gram-negative bacteria such as Neisseria meningitidis, Haemophilus influenzae, Neisseria gonorrhoeae is also highly antibacterial activity. Rifampicin Legionella effect also good, Chlamydia trachomatis, lymphogranuloma venereum and psittacosis and other pathogens are specific inhibition.
Bacteria rifamycin class antibiotic cross-resistance. Rifampin and DNA-dependent RNA polymerase β subunit solid combination, inhibiting the synthesis of bacterial RNA, preventing the enzyme and DNA connection, thereby blocking the RNA transcription process, the synthetic DNA and protein stops.
Pharmacokinetics
Rifampicin is well absorbed orally, 1.5 to 4 hours after taking the plasma concentration reached its peak. After the adult oral 600mg peak plasma concentration (Cmax) of 7 ~ 9mg / L, 6 months to 5 years old children an oral 10mg / kg, peak plasma concentration (Cmax) of 11mg / L. This product is distributed in most tissues and body fluids well, including cerebrospinal fluid, when there is inflammation of the meninges increase in drug concentration in the cerebrospinal fluid; in saliva can achieve effective therapeutic concentrations; the product can pass through the placenta. The apparent volume of distribution (Vd) is 1.6L / kg. Protein binding rate of 80% to 91%. Medication after eating can reduce by 30% the absorption of drugs, the drug blood elimination half-life (t1 / 2β) of 3 to 5 hours, after repeated administration has been shortened, from 2 to 3 hours. This product may be self-induced liver microsomal oxidative enzymes rapidly deacetylation, become metabolites have antimicrobial activity 25- deacetylation rifampin, forming inactive metabolites excreted in the urine after hydrolysis.
This product is mainly excreted via the bile and gut, may enter the enterohepatic circulation, but its active metabolite deacetylation no enterohepatic circulation. 60% to 65% of the dose excreted by 6% to 15% of the drug to the prototype, 15% active metabolites excreted in the urine, 7% places no active 3-formyl derivative discharged. Also excreted through breast milk. Patients with renal dysfunction in this product is no accumulation; because of their role in induction of hepatic microsomal oxidase, taking rifampicin 6 to 10 days after its excretion rate increased; After high doses of biliary excretion due to saturation, the product of excretion may be delayed. Rifampin can not clear by hemodialysis or peritoneal dialysis.
[Storage]
Sealed and stored in a dry cool dark place (dark and not more than 20 ℃) ​​place.
[Packaging]
(1) blister packaging, 10 / plate; carton packaging, 6 board / box.
(2) blister packaging, 10 / plate; carton packaging, 3 plates / box.
(3) blister packaging, 10 / plate; carton packaging, a board / box.
[Validity]
Provisional 18 months
[Executive standard]
State Food and Drug Administration National Drug Standards WS-10001- (HD-1551) -2005-2011
Approval Number
Zhunzi H21023360
Manufacturer
Company Name: Shenyang Hongqi Pharmaceutical Co., Ltd.
Production Address: Shenyang Hunnan new network on the 6th Street Postcode: 110179
Phone Number: (024) 2,378,626,023,786,261 Fax: (024) 23786263

 

The above is for reference
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