---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（20125719120815.PDF）的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文克拉霉素处方资料（仅供参考）

克拉霉素Clarithromycin 
中文别名：克拉霉素、6-0-甲基红霉素A、6氧甲基红霉素、甲红霉素、甲氧基红霉素、克红霉素、克拉红霉素

英文别名：6-0-Methylerythromycin A、Claricid、Klaricid
 
药品类别：大环内酯类抗生素
 
药理药动
本品属 14元环大环内酯类抗生素。抗菌谱与红霉素、罗红霉素等相同，但对革兰阳性菌如链球菌属、肺炎球菌、葡萄球菌的抗菌作用略优，且对诱导产生的红霉素耐药菌株亦具一定抗菌活性。克拉霉素及其在体内的代谢产物对流感杆菌的抗菌作用增强。本品对淋球菌、李斯忒菌、空肠弯曲菌也有一定作用，而对嗜肺军团菌、肺炎支原体、沙眼衣原体、溶脲脲原体等的作用比红霉素为强，在近年开发的新品种中作用较突出， MIC90约 0.008～0.12mg/L。此外，对包柔螺旋体、鸟分枝杆菌、鼠弓形体等均具一定活性，且大多优于其他品种。
除对厌氧球菌具较强抗菌作用外，对脆弱类杆菌的作用优于红霉素等。
本品对金葡菌、化脓性链球菌、流感杆菌等的抗生素后效作用明显强于红霉素。
药动学
本品对胃酸稳定，口服吸收好。单剂顿服 100mg后2h达峰浓度，为0.35μg/ml；而顿服 1200mg后的峰浓度可达 3.97μg/ml。本品能迅速分布至各种组织中，肺组织中的药物浓度达 17.5μg/g；在扁桃体、鼻粘膜、皮肤中的浓度约为同期血药浓度的 2～6倍。药物在细胞内与细胞外的浓度之比为 16：4。蛋白结合率为 42％～70％。主要经粪及尿排泄。消除半减期为 2.6～4.4h。轻度肾功能不全者、或老年人、或轻度至中度肝功能不全者无需调整用药剂量。

适应症
主要用于敏感细菌所致的上、下呼吸道，包括扁桃体炎、咽喉炎、副窦炎、支气管炎、肺炎等、皮肤、软组织感染、脓疖、丹毒、毛囊炎、伤口感染等，疗效与其他大环内酯类相仿。本品也可用于沙眼衣原体或溶脲脲原体所致生殖泌尿系感染、艾滋病患者的非典型分支杆菌感染等。

用法用量
成人每 12h服 250mg，严重患者剂量可增至每 12h500mg；疗程据感染程度而定，一般为 7～14日。肌酐清除率低于 0.501ml/1.73平方米·秒者剂量减半。儿童剂量：每次 7.5mg/kg，每日 2次，最高剂量不超过每日 500mg。
[剂型与规格]片剂: 250mg/片。
[用法]轻症：每次 250mg，重症每次 500mg，均为 12小时 1次，疗程 7— 14日。12岁以上儿童按成人量。12岁以下儿童不应用此药。
[制剂]片剂：每片 250mg或 500mg

不良反应
可见恶心,胃灼热,腹痛腹泻,头痛.暂时性转氨酶升高,停药后可慧复.有胆汁性肝炎的个例.可能出现真菌或具抗药性细菌导致的严重感染,这时应停药,并作相应治疗.可发生过敏反应,轻者为药疹,荨麻疹,重者为过敏症.曾有短暂性中枢神经系统副作用的报告,如焦虑,头晕,失眠,幻觉,恶梦及意识模糊.
不良反应有腹泻(3％)、恶心(3％)、味觉改变(3％)、消化不良(2％)、腹痛或不适(2％)、头痛(2％)，一般程度较轻。尚可见 ALT、AST、LDH、碱性磷酸酶、胆红素升高(均＜1％)；白细胞减少(＜1％)、凝血酶原时间延长(1％)、BUN升高(4％)、血清肌研值升高(＜1％)等。
 
禁忌症
对大环内酯类药物过敏者,孕妇,哺乳妇女,严重肝肾功能低下者,心律失常,心动过缓,Q-T间期延长,缺铁性心脏病,充血性心力衰竭及水电解质紊乱者禁用或慎用.
本品主要在肝内代谢和排泄，因此肝功能不全者、严重肾功能不全者和 65岁以上老年人用药时需特别注意不良反应。
服药过量时可出现胃肠道功能紊乱和全身症状、可予洗胃及支持疗法。血透和腹膜透析都不能清除本品，故应从速排除尚未吸收的药物(如洗胃)，并给予对症治疗。
孕妇禁用(本品在动物胚胎中浓度为人血清的2—17倍)。哺乳妇慎用(宜暂停哺乳)。

药物相互作用
本品可干扰卡马西平代谢，使后者血药浓度明显增高，二者合用时应监测血药浓度，必要时调整用药剂量。与茶碱合用可使茶碱血浓度增高，但一般不必调整茶碱的剂量。
本品可使下列联合应用的药物血药浓度发生变化：地高辛(上升)、茶碱(上升)、口服抗凝血药(上升)、麦角胺或二氢麦角碱(上升)、三唑仑(上升)而显示更强的作用。对于卡马西平、环胞霉素、己巴比妥、苯妥英等也可有类似的阻滞代谢而使作用加强。
 
Klaricid (clarithromycin)
Main use：Bacterial infections
Active ingredient：Clarithromycin
 
How does it work?
Klaricid tablets, paediatric suspension, adult sachets and injection all contain the active ingredient clarithromycin, which is a type of medicine known as a macrolide antibiotic. It is used to treat infections caused by bacteria. (NB. Clarithromycin is also available without a brand name, ie as the generic medicine.)

Clarithromycin works by preventing bacteria from producing proteins that are essential to them. Without these proteins the bacteria cannot grow, replicate and increase in numbers. Clarithromycin doesn'’t directly kill the bacteria, but leaves them unable to increase in numbers. The remaining bacteria eventually die or are destroyed by the immune system. This treats the infection.

Clarithromycin is a broad-spectrum antibiotic that is active against a wide variety of bacteria that cause a wide variety of infections. Clarithromycin may be used to treat infections of the upper or lower airways, skin or soft tissue, or ears.

Clarithromycin is also used to eradicate a type of bacteria called Helicobacter pylori (H pylori) from the gut. The presence of these bacteria in the gut is associated with ulcers of the stomach and duodenum (an area of the intestine directly after the stomach). Eradicating H pylori from the gut allows ulcers to heal and also helps prevent them recurring. Clarithromycin is used in combination with a proton pump inhibitor such as lansoprazole or omeprazole and the antibiotics metronidazole or amoxicillin for this purpose (triple therapy). Proton pump inhibitors reduce the production of acid in the stomach and help create an environment in the stomach in which the antibiotic can work more effectively against the bacteria. They also help the ulcer to heal.

To make sure the bacteria causing an infection are susceptible to clarithromycin your doctor may take a tissue sample, for example a swab from the throat or skin, or a sputum sample.

What is it used for?
Bacterial infections of the lungs (chest or lower respiratory tract infections), eg bronchitis, pneumonia.
Bacterial infections of the nasal passages, sinuses or throat (upper respiratory tract infections) eg sinusitis, pharyngitis.
Bacterial infections of the skin or soft tissue, eg cellulitis, folliculitis or erysipelas.
Bacterial infections of the middle ear (otitis media).
Lyme disease.
Eradicating Helicobacter pylori bacteria from the gut in people with peptic ulcers.

How do I take it?
The dose of this medicine and how long it needs to be taken for depends on the type of infection you have and your age. Follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the packet of medicine.
Clarithromycin is usually taken twice a day (every 12 hours). It can be taken either with or without food.
Klaricid adult sachets contain granules that should be mixed with a small amount of water before taking.
Bottles of Klaricid paediatric suspension should be shaken before measuring out a dose. Only use the measuring spoon provided with the suspension. You should not use a regular teaspoon or tablespoon to take the medicine, as this will not give an accurate dose.
Unless your doctor tells you otherwise, it is 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.

Warning!
Broad-spectrum antibiotics 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.
All antibiotics can sometimes result in overgrowth of organisms that are not susceptible to the antibiotic, in particular fungi. You should let your doctor know if you think you have developed any other infections while you are taking this medicine, so that they can be treated appropriately.
Klaricid paediatric suspension can be stored at room temperature (below 30°C). Any suspension remaining after 14 days should be disposed of, preferably by returning it to your pharmacist.

Use with caution in
Decreased kidney function.
Decreased liver function.
People with an abnormal heart rhythm seen on a heart monitoring trace (ECG) as a 'prolonged QT interval', or people at risk of this (your doctor will know).

Not to be used in
People allergic to other macrolide-type antibiotics, eg erythromycin, azithromycin.
People taking astemizole, cisapride, pimozide, terfenadine or ergot derivatives, eg ergotamine, dihydroergotamine.
Klaricid tablets and adult sachets are not suitable for children under 12 years of age.
Klaricid adult sachets and Klaricid paediatric suspensions contain sucrose and are not suitable for people with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

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 during pregnancy has not been established. It should not be used in pregnant women unless the expected benefit to the mother is greater than any possible risk to the developing baby. Seek medical advice from your doctor.
This medicine passes into breast milk, but the effect on the nursing infant is unknown. It should not be used in breastfeeding women unless the expected benefit to the mother is greater than any possible risk to the nursing infant. Seek medical advice from your doctor.

Label warnings
Take at regular intervals. Complete the prescribed course unless otherwise directed.

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, it does not mean that all people using this medicine will experience that or any side effect.
Disturbances of the gut such as diarrhoea, nausea, vomiting, indigestion, abdominal pain.
Sore mouth or tongue.
Tongue or tooth discolouration.
Oral thrush (see warning section above).
Pins and needles sensations.
Headache.
Pain in the muscles or joints.
Disturbance of taste or smell.
Allergic skin reactions.
Dizziness.
Spinning sensation (vertigo).
Difficulty sleeping or bad dreams.
Confusion.
Reversible loss of hearing.
Inflammation of the large intestine (colitis) - see warning section above.
Low blood sugar (hypoglycaemia).
Liver or kidney disorders.
Abnormal heart beats (arrhythmias).

The side effects listed above may not include all of the side effects reported by the medicine'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.

Clarithromycin should not be taken by people who are taking any of the following medicines, because clarithromycin can raise the blood levels of these medicines, resulting in an increased risk of serious side effects:
astemizole
cisapride
dronedarone
eletriptan
eplerenone
ergot derivatives, eg ergotamine, dihydroergotamine or methysergide (used to treat migraine)
everolimus
ivabradine
mizolastine
pimozide
ranolazine
saquinavir
simvastatin
terfenadine.

Clarithromycin may reduce the breakdown of the medicines listed below. If the blood levels of these medicines are raised as a result, it may lead to an increased risk of their side effects. If you are taking one of these medicines and are prescribed clarithromycin you should let your doctor or pharmacist know if you experience any new or increased side effects:
alprazolam
aprepitant
bromocriptine
cabergoline
carbamazepine
ciclosporin
cilostazol
colchicine
digoxin
disopyramide
droperidol
etravirine
fesoterodine
itraconazole
maraviroc
methylprednisolone and possibly other corticosteroids
midazolam
nilotinib
pazopanib
phenytoin
quetiapine
reboxetine
repaglinide
rifabutin (increased risk of uveitis)
sildenafil
sirolimus
tacrolimus
tadalafil
theophylline
tolterodine
triazolam
vardenafil
verapamil
zopiclone.

Clarithromycin may also increase the blood levels and hence anti-blood-clotting effects of the anticoagulants nicoumalone and warfarin. As this may increase the risk of bleeding, people taking these combinations, particularly elderly people, may need more frequent monitoring of their blood clotting time (INR) so the dose of anticoagulant can be adjusted if necessary.

Clarithromycin may also increase the blood levels of cholesterol-lowering medicines called statins, eg atorvastatin and simvastatin. This may increase the risk of side effects on the muscles (myopathy) from these medicines. Combined use of simvastatin and clarithromycin should be avoided.

Clarithromycin may decrease the absorption of zidovudine from the gut. If you are taking both these medicines the clarithromycin should be taken at least two hours before or after the zidovudine to avoid the interaction. Ask your pharmacist for further advice.

There may be an increased risk of abnormal heart beats if clarithromycin is taken in combination with any of the following medicines:
anti-arrhythmic medicines (for an irregular heartbeat), eg amiodarone, disopyramide, quinidine
certain antimalarials, eg chloroquine, quinine, mefloquine, halofantrine
certain antipsychotics, eg chlorpromazine, thioridazine, fluphenazine, haloperidol.

Oral typhoid vaccine (Vivotif) should not be taken until at least three days after you have finished a course of this antibiotic, because the antibiotic could make this vaccine less effective.

In the past, women using hormonal contraception such as the pill or patch would be advised to use an extra method of contraception (eg condoms) while taking an antibiotic like this one and for seven days after finishing the course. However, this advice has now changed. You no longer need to use an extra method of contraception with the pill, patch or vaginal ring while you take a course of antibiotics. This change in advice comes because to date there is no evidence to prove that antibiotics (other than rifampicin or rifabutin) affect these contraceptives. This is the latest guidance from the Faculty of Sexual & Reproductive Healthcare.

However, if you are taking the contraceptive pill and experience vomiting or diarrhoea as a result of taking this antibiotic, you should follow the instructions for vomiting and diarrhoea described in the leaflet provided with your pills.

Ritonavir may increase the blood level of clarithromycin. This is not normally a problem, but if you have kidney problems and are taking ritonavir your doctor may prescribe you a lower than normal dose of clarithromycin.

Other medicines containing the same active ingredient
Klaricid XL 

Clarithromycin tablets, suspension and injection also available without a brand name, ie as the generic medicine.

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（20125719120815.PDF）的“原文Priscribing Information”为准
---------------------------------------------------------------