英文药名: Biaxin(Clarithromycin Tablets)

中文药名: 克拉霉素片

生产厂家: Abbott

药品名称

英文药名: Biaxin, Clarithromycin
中文药名: 克拉霉素
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。

规格包装：

250mg*28 片
250mg*84 片
500mg*100 片
500mg*14 片
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250mg*40 片
500mg*40 片

Biaxin
Biaxin (Clarithromycin)

Pharmacological action

Semisynthetic antibiotic of group of macroleads. Inhibits synthesis of fibers in a microbic cell. Basically bacteriostatic an effect has.
It is active concerning Gram-positive bacteria: Streptococcus spp., Staphylococcus spp., Listeria monocytogenes, Corynebacterium spp.; Gram-negative bacteria: Helicobacter pylori, Haemophilus influenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Borrelia burgdorferi; anaerobic bacteria: Eubacterium spp., Peptococcus spp., Propionibacterium spp., Clostridium perfringens, Bacteroides melaninogenicus; intracellular microorganisms: Legionella pneumophila, Chlamydia trachomatis, Chlamydia pneumoniae, Ureaplasma urealyticum, Mycoplasma pneumoniae.
The preparation also is active concerning Toxoplasma gondii, Mycobacterium spp. (Except Mycobacterium tuberculosis).

Indications

Treatment of the infectious-inflammatory diseases caused by originators sensitive to a preparation, including:
- Infections of the top departments of respiratory tracts and ENTs-bodies;
- Infections of the bottom departments of respiratory tracts (an acute bronchitis, an exacerbation of a chronic bronchitis,atypical pneumonia);
- Infections of a skin and soft tissues;
- M.avium complex, M.kansasii, M.marinum, M.leprae and their preventive maintenance at patients AIDS;
- Helicobacter pylori at patients with a duodenum or stomach peptic ulcer (only as a part of the combined therapy);
- Other infectious-inflammatory diseases caused by microorganisms sensitive to a preparation.

Dosage regimen

To adults and children is more senior 12 years Biaxin prescribe in an average dose of 250 mg everyone 12 h.
At sinusitises, serious infections and at the diseases caused Haemophilus influenzae, the preparation is prescribed on 500 mg by everyone 12 h. The maximum daily dose - 2 Course of treatment - 8-14 days.
Helicobacter pylori at patients with a duodenum or stomach Biaxin peptic ulcer prescribe in a dose of 250-500 mg 2 times/24h as a part of the combined therapy. Course of treatment makes 7 days.
Tablets should not be broken. They should be swallowed entirely, washing down with a liquid small amount.
To children about 12 years a preparation are elderly prescribe in the form of suspension in doses from calculation of 15 mg/kg/sut in 2 receptions (through 12).
Course of treatment averages 7-14 days.
The single dose of a preparation should not exceed 500 mg. The maximum daily dose in pediatric practice - 1
For treatment and preventive maintenance of the widespread infection caused Mycobacterium avium complex, to adults and children is more senior 12 years prescribe a preparation in a dose of 500 mg everyone 12 h. The dose augmentation is If necessary possible. To children about 12 years are elderly prescribe a preparation in a dose from calculation of 15 mg/kg/24h, parted on 2 receptions (through 12). Treatment of the infection caused Mycobacterium avium complex, long.
The patient with disturbances of function of kidneys should be reduced a dose in 2 times or to double an interval between receptions.

Side effect

From the alimentary system: a nausea, vomiting, a diarrhoeia, an abdominal pain, a stomatitis, a glossitis; seldom - a pseudomembranous colitis (in case of serious and persistent diarrhoeia, a pseudomembranous colitis which can become perceptible in some cases, the preparation should be cancelled); on occasion - rising of activity of enzymes of a liver, a cholestatic icterus.
From party TSNS: giddiness, confusion of consciousness, feeling of pavor, a sleeplessness; dreadful dreamings, a headache.
Allergic reactions: an urticaria, anaphylactic reactions; very seldom - Stevens-Johnson's syndrome.
The other: time changes of gustatory sensations.
By-effects at the majority of patients are expressed slightly.

Contraindications

- Serious disturbances of function of a liver;
- A hepatitis (in the anamnesis);
- A porphyria;
- I trimester of pregnancy;
- A hypersensibility to Biaxin (Clarithromycin) and to other antibiotics from group of macroleads.

Pregnancy and lactemia

Application Biaxin (Clarithromycin) in I trimester of pregnancy is contraindicative.
Biaxin (Clarithromycin) Application in II and III trimesters of pregnancy is possible only when the expected advantage for mother exceeds potential risk for a foetus.
In need of application of a preparation in a lactemia it is necessary to stop thoracal feeding.

Special indicatings

At preparation appointment it is necessary to consider, that among antibiotics of group of macroleads there is a two-dimensional resistance.
Patients with disturbances of function of a liver of easy and average degree do not have necessity to reduce a preparation dose, if function of kidneys in norm. To patients with serious disturbances of function of kidneys the dose should be reduced.
Treatment by antibiotics changes normal flora of an intestine, development of the superinfection caused by refractory microorganisms therefore is possible.
The patient should be warned, that at a serious persistent diarrhoeia which can be caused a pseudomembranous colitis, he should address to the doctor.

Use in pediatrics

Now insufficiently given about efficiency and safety of application of a preparation at children about 6 months are elderly
Influence on ability to driving of motor transport and to management of mechanisms
The preparation does not render influence on rate of psychomotor reactions at a driving or work with mechanisms.

Overdosage

Symptoms: vomiting, an abdominal pain, a headache, confusion of consciousness.
Treatment: a gastric lavage, further spend symptomatic therapy.

Medicinal interaction

Biaxin (Clarithromycin) is metabolized in a liver and can inhibit activity of enzymes of system of cytochrome P450. At simultaneous Biaxin (Clarithromycin) application and other preparations metabolized with the assistance of specified enzymes, rising of concentration of these preparations in Serum and development of side-effects are possible.

Conditions and periods of storage

Tablets should be stored in the place protected from a moisture at temperature not above 25 C. The Period of validity - 3 years.