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 详细处方信息以本药内容附件PDF文件（201222917270134.pdf）的“原文Priscribing Information”为准
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部分中文卫非特处方资料（仅供参考）

卫非特Rifater
【分类】抗结核药

【别名】卫非特，利福平-异烟肼-吡嗪酰胺

【外文名】Rifater，Rifampin-Isoniazid-Pyrazimide

【成分】利福平，异烟肼，吡嗪酰胺

【适应症】结核病的短程化疗。

【用量用法】体重50kg或以上5片qd.体重40-49kg4片qd。体重30-39kg3片qd。连服二个月。

【禁忌】对本药成分过敏者。

【不良反应】过敏反应。胃肠道反应。肝肾功能损害。血小板及白血球减少，贫血，嗜酸性细胞增多。流感样综合症。月经不调。尿液、痰和眼泪变红色。多发性神经炎，大剂量可致惊厥，可增加癫痫发作的次数。活动性痛风。

【注意事项】肝肾功能损害、痛风、孕妇及哺乳妇女慎用。应同时服用维生素B6。

【药物相互作用】利福平可降低抗凝药、肾上腺皮质激素、环孢霉素、洋地黄制剂、奎尼丁、口服避孕药、口服降糖药、氨苯砜、麻醉和止痛药、巴比妥酸盐、安定、戊脉定、B-肾上腺素阻断剂、氯贝丁脂、孕激素、双异丙吡胺、茶碱、氯霉素、酮康唑和抗惊厥药的药效。与氯烷同时使用可增加肝脏毒性。异烟肼可增强苯妥英钠的作用。

【规格】片剂60片。

Rifater (rifampicin, isoniazid, pyrazinamide)
Main use：Tuberculosis
Active ingredient：Rifampicin, isoniazid, pyrazinamide
Manufacturer：Sanofi-Aventis
   
How does it work?
Rifater tablets contain three active ingredients, rifampicin, isoniazid and pyrazinamide. These are all antibiotics used to treat tuberculosis (TB). They work by killing the bacteria that cause the disease.

Rifampicin works by targeting and inactivating a bacterial enzyme called RNA-polymerase. The tuberculosis bacteria use RNA-polymerase to make essential proteins and to copy their own genetic information (DNA). Without this enzyme the bacteria cannot reproduce and they die.

The exact mechanism of action of isoniazid is unknown, but it is thought to prevent the tuberculosis bacteria from making substances called mycolic acids, which are needed to form the cell walls of the bacteria. It also seems to combine with an enzyme that interferes with the cell metabolism of the bacteria. As a result of the disruption in it's metabolism and without a cell wall, the bacteria die.

Pyrazinamide works in a different way to kill tuberculosis bacteria that have infected cells.

There are two stages in the treatment for tuberculosis. In the first two months treatment is aimed at killing as many bacteria as possible. Therefore several anti-TB drugs with different mechanisms of action are used at the same time. Rifater tablets are usually used together with another medicine called ethambutol for this first stage of treatment. Rifater and ethambutol are usually then stopped, and treatment continued with just rifampicin and isoniazid for a further four months to kill any remaining bacteria.

The bacteria that cause TB are difficult to treat. By using several medicines at the same time, the bacteria can be targeted in different ways and hence treatment is more likely to be effective than using a single medicine. In addition, using different medicines together makes it less likely that bacteria will develop resistance to the treatment.

What is it used for?
Treatment of tuberculosis.

Warning!
Each dose of this medicine should be taken at least 30 minutes before a meal or two hours after a meal to ensure it is fully absorbed from the gut.
It is important that you take each dose of this antibiotic regularly, as prescribed by your doctor. Unless your doctor tells you otherwise, it is also important that you finish the prescribed course of this antibiotic medicine, even if you feel better or it seems the infection has cleared up. Stopping the course early increases the chance that the infection will come back and that the bacteria will grow resistant to the antibiotic.
You will need to have a blood test to check your liver function before you start treatment with this medicine. If this test shows any existing problems with your liver, you will need to have regular blood tests to monitor your liver function throughout treatment with this medicine. All people taking this medicine should consult their doctor immediately if they experience any symptoms that may suggest a liver problem. These may include the development of jaundice (a yellow colouring to the skin and the whites of the eyes), persistent nausea and vomiting, abdominal pain, or feeling generally unwell.
You should avoid drinking large amounts of alcohol while you are taking this medicine, as this may increase the risk of side effects on the liver.
This medicine can sometimes cause inflammation of the bowel (colitis). For this reason, if you get diarrhoea that becomes severe or persistent or contains blood or mucus, either during or after taking this medicine, you should consult your doctor immediately.
This medicine may discolour your urine, saliva and tears a reddish/orange colour. This is normal and not harmful. It may also permanently stain soft contact lenses.
This medicine reduces the effectiveness of hormonal contraceptives such as the pill, patch or mini pill, and of emergency contraception (the morning after pill). You will need to use a different, non-hormonal, method of contraception to prevent pregnancy while you are taking this medicine, and for four to eight weeks after stopping treatment. Seek medical advice from your doctor. For more information see below.

Use with caution in
Children.
Elderly people.
Decreased kidney function.
Decreased liver function.
Slow liver metabolism (slow acetylator status).
Alcoholism.
Malnutrition.
Hereditary blood disorders called porphyrias.
Diabetes.
Epilepsy.
History of psychotic illness.
History of gout.
HIV infection.

Not to be used in
Jaundice.
Allergy to rifamycin antibiotics.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
The safety of this medicine for use during pregnancy has not been established. However, if rifampicin is used during the third trimester it may increase the risk of bleeding in the mother and baby after birth. This medicine should only be during pregnancy if considered essential by your doctor, and if the potential benefits to the mother outweigh any risks to the developing baby. Seek medical advice from your doctor.
Women who could get pregnant should be aware that this medicine reduces the effectiveness of hormonal contraceptives such as the pill, patch and mini pill, and of the morning after pill. For more information see the affect on other medicines section below, or ask your doctor for advice.
Rifampicin and pyrazinamide pass into breast milk in small amounts, but at normal doses are unlikely to be harmful to a nursing infant. However, isoniazid also passes into breast milk and may have adverse effects on a nursing infant. As a result this medicine should be used with caution in breastfeeding mothers, and only if the expected benefit to the mother is greater than any possible risk to the baby. Seek medical advice from your doctor. If you do breastfeed during treatment with this medicine, your doctor may prescribe pyridoxine (vitamin B6) supplements for you and the baby, to reduce the risk of side effects on the nerves.

Label warnings
Take this medication half to one hour before food.
Do not stop taking this medication except on your doctor's advice.
This medication may cause your urine to be coloured.

Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Reddish colouration of urine, saliva and tears.
Gut disturbances, such as nausea, vomiting, diarrhoea, abdominal discomfort.
Loss of appetite.
Inflammation of the nerves (neuritis), which may cause pins and needles sensations, muscle weakness or blurred vision. Your doctor may prescribe you pyridoxine (vitamin B6) supplements to help prevent this side effect. Tell your doctor straight away if you experience symptoms like these.
Headache.
Drowsiness.
Allergic skin rashes.
Flushing.
Itching.
Alteration in results of liver function tests.
Yellowing of the skin and eyes (jaundice).
Inflammation of the liver (hepatitis).
Inflammation of the bowel (colitis).
Decrease in the number of platelets in the blood (thrombocytopenia). Consult your doctor straight away if you get any unexplained purple spots or bruising on your skin during treatment.
Muscle weakness.
Fluid retention, causing swelling (oedema).
Menstrual disturbances.
Flu-like symptoms such as fever, chills, headache, dizziness and bone pain.
Shortness of breath.
Decrease in blood pressure.
Blood disorders.
Kidney failure.
Seizures (convulsions).
Gout.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

This medicine must not be used in combination with ritonavir and saquinavir (used for HIV infection), because there is an increased risk of side effects on the liver when rifampicin is used with these medicines.

Antacids (used to treat indigestion and heartburn) may reduce the absorption of this medicine from the gut. You should not take antacids at the same time of day as this medicine.

Rifampicin increases the activity of enzymes in the liver that break down various medicines. As a result, it can increase the removal of these medicines from the body, making them less effective. Medicines affected in this way by rifampicin include those listed below. If you are taking any of these your doctor may need to increase your dose after you start treatment with rifampicin, and subsequently decrease it again after your rifampicin treatment is finished.
Abacavir.
Anticoagulants such as warfarin and acenocoumarol. (People taking anticoagulants should have their blood clotting time (INR) monitored closely after starting and stopping treatment with rifampicin.)
Antidiabetic medicines taken by mouth, such as tolbutamide, gliclazide, glibenclamide, repaglinide, nateglinide, rosiglitazone. (People with type two diabetes treated with tablets should have their blood sugar checked regularly after starting and stopping treatment with rifampicin, and their dose of antidiabetic adjusted as necessary to control blood sugar.)
Aprepitant.
Aripiprazole.
Atovaquone.
Azole antifungals, eg itraconazole, voriconazole, posaconazole fluconazole, ketoconazole. (Ketoconazole may also lower the amount of rifampicin in the blood.)
Benzodiazepines, eg diazepam, midazolam, nitrazepam.
Beta blockers, eg atenolol.
Buspirone.
Calcium channel blockers, eg diltiazem, nifedipine, verapamil and possibly isradipine, nicardipine and nisoldipine.
Caspofungin.
Celecoxib.
Chloramphenicol.
Ciclosporin.
Clarithromycin.
Clozapine.
Corticosteroids, eg dexamethasone, fludrocortisone, hydrocortisone, prednisolone.
Co-trimoxazole. (This antibiotic may also increase the amount of rifampicin in the blood and so could increase the risk of side effects.)
Dapsone.
Diclofenac.
Digoxin.
Disopyramide.
Doxycycline.
Efavirenz.
Emergency contraception (the morning after pill). If you need emergency contraception while taking this medicine you should consult a doctor or family planning clinic. As the morning after pill is likely to be less effective while you are taking rifampicin, you may be prescribed a higher (unlicensed) dose, or advised to have a coil fitted as emergency contraception instead.
Eplerenone.
Etoricoxib.
Exemestane.
Ezetimibe.
Haloperidol.
Hormonal contraceptives, eg the pill, mini pill or patch. (A non-hormonal method of contraception, eg the coil or condoms, should be used to prevent pregnancy while taking rifampicin, and for four to eight weeks after finishing the treatment. This is because it can take this long for the liver enzymes to return to normal. Ask your doctor for advice.)
Hormone replacement therapy (HRT).
Imatinib.
Lamotrigine.
Losartan.
Mexiletine.
Mirtazapine.
Montelukast.
Mycophenolate.
Opioids such as methadone, codeine, fentanyl, morphine.
Phenytoin.
Praziquantel.
Propafenone.
Protease inhibitors for HIV infection, eg amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, saquinavir.
Quetiapine.
Quinidine.
Quinine.
Sirolimus.
Statins for lowering cholesterol, eg atorvastatin, fluvastatin, pravastatin, simvastatin.
Tacrolimus.
Tadalafil.
Telithromycin.
Terbinafine.
Theophylline.
Thyroid hormones, eg levothyroxine.
Toremifene.
Trimethoprim.
Zaleplon.
Zidovudine.
Zolpidem.
Zopiclone.

Isoniazid may prevent the breakdown by the liver of the medicines listed below, which may increase the amount of these medicines in the blood and hence the risk of their side effects.
Carbamazepine.
Ethosuximide.
Phenytoin.
Theophylline.

Pyrazinamide opposes the effect of the following medicines for treating gout:
allopurinol
probenecid
sulfinpyrazone.

Other medicines containing the same active ingredients
There are currently no other medicines available in the UK that contain this combination of active ingredients.

Rifinah contains just rifampicin and isoniazid.

Rifadin and Rimactane contain just rifampicin.

Isoniazid and pyrazinamide are also available on their own.

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 详细处方信息以本药内容附件PDF文件（201222917270134.pdf）的“原文Priscribing Information”为准
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