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【中文品名】克拉霉素
【药效类别】抗微生物感染药>>抗生素类>>链霉菌属产物
【通用药名】CLARITHROMYCIN
【别 名】A-56268, Biaxin, Biaxin 250, Biaxin XL, Bremon, Centromicina, Claribid, Clarith, Cyllind, Klacid, Klaricid, Klasid, Lagur, Mabricoli, Macladin, Naxy, TE-031m Velcam, Zelcar
【化学名称】
(2R,3S,4S,5R,6R,8R,10R,11R,12S,13R)-5-(3,4,6-Trideoxy-3-dimethylamino-β-D-xylo-hexopyranosyloxy)-3-(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyloxy)-11,12-dihydroxy-6-methoxy-2,4,6,8,10,12-hexomethyl-9-oxopentadecan-13-olide
或 Erythromycin, 6-O-methyl-
【CA登记号】[81103-11-9]
【结 构 式】
【分 子 式】C38H69NO13
【分 子 量】747.95
【收录药典】JP14
【开发单位】雅培
【首次上市】1990年，意大利
【性 状】
【用 途】
一种对酸稳定的红霉素衍生物，用于鸟型结核分支杆菌综合征（罕见病用药地位）、清除幽门螺旋杆菌和用于儿童中耳炎
英文药名: Biaxin XL(Clarithromycin Extended Release Tablets)
中文药名: 克拉霉素缓释片
生产厂家: Abbott
药品说明
克拉霉素又名甲红霉素，是红霉素的衍生物，上世纪90年代初由日本大正公司开发成功，并以商品名Clarith注册。尔后，大正公司首先将其技术转让给美国雅培公司生产；1990年在爱尔兰、意大利上市，1991年10月获FDA批准定为IB类新药上市，商品名Biaxin，1993年以Klacid在中国香港上市，在欧洲和亚洲的商品名为克拉仙，目前已在全球50多个国家上市，市场用量稳步增长，并在临床中发挥了重要作用。克拉霉素及其片剂、胶囊已收载入中国药典2000年版（注：2005版药典收录在二部第232页），目前生产的剂型还有颗粒剂、分散片、缓释片、注射剂和干混悬剂。
克拉霉素具有高效、口服易于吸收，对酸稳定性好的特点，该药对革兰阳性菌的活性强，对酶稳定，在血清和肺组织中浓度高。临床证明体内活性是红霉素的6～10倍，是交沙霉素的14～35倍。并以改善生物利用度为特征，组织和细胞内分布极好、半衰期长，其不良反应发生率仅为3%，是用于治疗上呼吸道及下呼吸道和皮肤、软组织感染，已成为取代红霉素的大环内酯类抗生素品种。
此外，美国FDA已批准将克拉霉素与洛赛克合用，作为幽门螺旋杆菌引起的胃及十二指肠溃疡的治疗方案；该药也是治疗艾滋病患者感染的首选药物。
适应症
抗菌谱与红霉素相似，对胃酸稳定，对革兰阳性菌作用更强，对部分革兰阴性菌、链球菌属、支原体及衣原体等均有抗菌活性。对肺炎链球菌、化脓性链球菌、金葡菌、卡他莫拉菌、流感嗜血杆菌及肺炎支原体等有效。临床主用于支气管炎、肺炎、咽喉炎、扁桃体炎、支原体肺炎、皮肤及软组织感染、中耳炎、牙周炎、百日咳、猩红热。
用法用量
口服，成人，0.25g/次，2次/日；严重感染可增加至0.5g/次，2次/日，根据病情连续服用6～14日。儿童每日10mg～15mg/kg，分2～3次给予。
任何疑问，请遵医嘱！
副作用
1. 胃肠道反应有恶心、呕吐、胃部不适、腹胀，食欲不振及软便等，偶有转氨酶上升。
2. 对大环内酯类药物有过敏史者慎用。如出现皮疹等过敏症状时须停药。
3. 孕妇禁用，哺乳妇慎用。
规格
口服液：125mg/5 ml，250mg/5 ml。
片剂：250mg, 500mg/片。
缓释片：500mg/片。
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Biaxin XL
(clarithromycin)
How does Biaxin XL work? What will it do for me?
Clarithromycin belongs to the class of medications called macrolide antibiotics. It is used to treat infections caused by certain bacteria. It works by killing or stopping the growth of bacteria that can cause certain infections. Clarithromycin may be prescribed for people with bacterial throat infections, sinus infections, ear infections, lung infections such as chronic bronchitis exacerbation, pneumonia, and skin infections such as impetigo and cellulitis.
Clarithromycin may also be used to prevent and treat certain infections associated with human immunodeficiency virus (HIV) infection. Clarithromycin can be used in combination with other medications to kill H. Pylori, a bacteria known to cause ulcers in the digestive tract.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
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How should I use Biaxin XL?
Adults: The recommended adult dosing of clarithromycin tablets is 250 mg to 500 mg twice daily (every 12 hours) for 7 to 14 days, depending on the condition being treated.
The recommended adult dosing of the extended release form of clarithromycin is as follows 1,000 mg (2 tablets) once daily for 5 to 14 days, depending on the condition being treated.
Children: The recommended total daily dose for children is 15 mg per kilogram of body weight (to a maximum of 1,000 mg per day). This total daily dose should be divided in 2 and given 12 hours apart. Total treatment duration is usually 5 to 10 days, depending on the condition being treated.
If the child is receiving an oral suspension of clarithromycin, use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.
Clarithromycin tablets and clarithromycin suspension (given twice daily) may be taken with or without food. However taking this medication with food may cause less stomach upset.
The extended release tablets of clarithromycin must be taken with food. The tablets must be swallowed whole and not crushed or broken.
Finish all this medication, even if you have started to feel better.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is very important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store clarithromycin tablets at room temperature, protected it from light and moisture, and keep it out of the reach of children.
Store clarithromycin oral suspension at room temperature in tightly closed bottle and protected from light. Do not refrigerate. Any unused oral suspension should be thrown away after 14 days of reconstitution. Rinse dose measuring oral syringe between uses. Do not store the suspension in the syringe.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
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What form(s) does Biaxin XL come in?
Each oval, debossed, yellow, film-coated, extended-release tablet contains clarithromycin 500 mg. Nonmedicinal ingredients: cellulosic polymers, lactose monohydrate, magnesium stearate, propylene glycol, Quinoline Yellow Lake E104, sorbitan monooleate, talc, titanium dioxide, and vanillin. Tartrazine-free. HDPE bottles of 60.
Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.
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Who should NOT take Biaxin XL?
Clarithromycin should not be taken by anyone who:
is allergic to clarithromycin, erythromycin, other macrolide antibiotics, or to any of the ingredients of the medication
is taking astemizole, terfenadine, cisapride, pimozide, ergotamine, or dihydroergotamine
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What side effects are possible with Biaxin XL?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
change in sense of taste
diarrhea (mild)
headache
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
abdominal tenderness
fever
nausea and vomiting
severe abdominal or stomach cramps and pain
shortness of breath
skin rash and itching
unusual bleeding or bruising
watery and severe diarrhea, which may also be bloody:
yellow eyes or skin
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
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Are there any other precautions or warnings for Biaxin XL?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Allergy: Anyone who has had some form of allergy to a medication should be monitored by their doctor when taking clarithromycin. It should not be taken by anyone who is allergic to similar medications (e.g., azithromycin, erythromycin). If an allergic reaction to clarithromycin occurs, stop taking the medication and contact a doctor.
Diarrhea: This medication is associated a serious infection called Clostridium difficile associated diarrhea, caused by the bacteria C. difficile. This can occur as late as 2 months after your last dose of this medication. If you have loose, watery bowel movements that are green, foul-smelling, or bloody that may be accompanied by fever after taking clarithromycin, get medical attention as soon as possible.
Kidney disease: People with kidney disease should be monitored by their doctor while taking clarithromycin as they may experience increased side effects.
Liver disease: People with liver disease should be monitored by their doctor while taking clarithromycin as they may experience increased side effects.
Pregnancy: Clarithromycin should not be used during pregnancy except where no alternative therapy is appropriate. This applies particularly to the first 3 months of pregnancy.
Breast-feeding: Clarithromycin passes into breast milk. The safety of this medication for use while breast-feeding has not been established. If you are a breast-feeding mother and are taking clarithromycin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using clarithromycin oral suspension have not been established for children younger than 6 months of age. In cases of pneumonia, the use of clarithromycin oral suspension has not been studied for children younger than 3 years of age. The safety and effectiveness of using clarithromycin tablets have not been established for children under 12 years of age.
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What other drugs could interact with Biaxin XL?
There may be an interaction between clarithromycin and any of the following:
alprazolam
aminophylline
astemizole
atorvastatin
bromocriptine
buspirone
carbamazepine
cimetidine
cisapride
colchicine
cyclosporine
diazepam
digoxin
dihydroergotamine
disopyramide
divalproex
ergotamine
fluconazole
indinavir
lansoprazole
lovastatin
methylprednisolone
methysergide
midazolam
omeprazole
oxtriphylline
phenytoin
pimozide
rifabutin
rifampin
ritonavir
sildenafil
simvastatin
SSRIs (e.g., fluoxetine, paroxetine, sertraline)
tacrolimus
terfenadine
theophylline
triazolam
valproic acid
vinblastine
warfarin
zidovudine
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
stop taking one of the medications,
change one of the medications to another,
change how you are taking one or both of the medications, or
leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than the ones listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, decongestants, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. |
