【中文名称】罗红霉素分散片
               
【产品英文名称】Roxithromycin Tablets for Oral Suspension

【功效主治】本品适用于化脓性链球菌引起的咽炎及扁桃体炎，敏感菌所致的鼻窦炎、中耳炎、急性支气管炎、慢性支气管炎急性发作，肺炎支原体或肺炎衣原体所致的肺炎；沙眼衣原体引起的尿道炎和宫颈炎；敏感细菌引起的皮肤软组织感染。        
   
【化学成分】罗红霉素。化学名称：9-{O-［（2-甲氧基乙氧基）-甲基］肟基}红霉素。     
   
【药理作用】本品为半合成的14元环大环内酯类抗生素。抗菌谱与抗菌作用基本上与红霉素相仿，对革兰阳性菌的作用较红霉素略差，对嗜肺军团菌的作用较红霉素强。对肺炎衣原体、肺炎支原体、溶脲脲原体的抗微生物作用与红霉素相仿或略强。本品可透过细菌细胞膜，在接近供体（“P”位）与细菌核糖体的50S亚基成可逆性结合，阻断了转移核糖核酸（t-RNA）结合至“P”位上，同时也阻断了多肽链自受位（“A”位）至“P”位的转移，因而细菌蛋白质合成受到抑制。

【药物相互作用】
1.不可与麦角胺、二氢麦角胺、溴隐亭、特非那定、酮康唑及西沙必利配伍。
2.对氨茶碱的代谢影响小，对卡马西平、华法林、雷尼替丁及其他制酸药基本无影响。
   
【不良反应】主要不良反应为腹痛、腹泻、恶心、呕吐等胃肠道反应，但发生率明显低于红霉素。偶见皮疹、皮肤瘙痒、头昏、头痛、肝功能异常（ALT及AST升高）、外周血细胞下降等。
【禁忌症】对本品、红霉素或其他大环内酯类药物过敏者禁用。
【用法用量】空腹口服，一般疗程为5～12日。成人一次150mg，一日2次；也可一次300mg，一日1次。儿童一次按体重2.5～5mg/kg，一日2次。     
【贮藏方法】密封，在干燥处保存。           
【注意事项】
1.肝功能不全者慎用。严重肝硬化者的半衰期延长至正常水平2倍以上，如确实需要使用，则一次给药150mg，一日1次。　　
2.轻度肾功能不全者不需作剂量调整，严重肾功能不全者给药时间延长一倍（一次给药150mg，一日1次）。　　
3.本品与红霉素存在交叉耐药性。　　
4.食物对本品的吸收有影响，进食后服药会减少吸收，与牛奶同服可增加吸收。　　
5.服用本品后可影响驾驶及机械操作能力。

【产品规格】50mg。

【批准文号】注册证号 H20070356

【生产企业】Sanofi-Aventis France 

Brand name: Rulide

Generic name: Roxithromycin

Rulide is used to treat infections in different parts of the body caused by bacteria.

Rulide is used to treat infections in different parts of the body caused by bacteria. For example:

acute pharyngitis (sore throat and discomfort when swallowing)

tonsillitis

sinusitis

acute bronchitis (infection of the bronchi causing coughing)

pneumonia (lung infection characterized by fever, malaise, headache)

skin and soft tissue infections

non gonoccocal urethritis

impetigo (bacterial infection causing sores on the skin)

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How to take Rulide

Swallow the tablets whole with a glass of water.

Rulide works best if you take it on an empty stomach.

The recommended adult dosage is 300mg per day, which may be taken according to one of the following alternative dosage regimens:

· One 300mg tablet once a day, or

· one 150mg tablet twice a day, or

· two 150mg tablets once a day.

However, depending on your condition and how you react to the medicine, your doctor may ask you to take a different dose.
The recommended dosage for children more than 40kg is one 150mg tablet twice daily.
The dosage of Rulide given to children is dependant on the child's weight.
Rulide D should be used for children less than 40kg in weight.

Side effects of Rulide

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Rulide.
It helps most people with bacterial infections, but it may have unwanted side effects in a few people.
Tell your doctor or pharmacist if you notice any of the following and they worry you:

· oral thrush - white, furry, sore tongue and mouth

· vaginal thrush - sore and itchy vagina and/or discharge

· nausea, vomiting, stomach pain, diarrhea, flatulence

· loss of appetite

· red and/or itchy skin

· headache, dizziness, ringing in the ears

· tiredness

· altered taste

These are mild side effects of this medicine and usually short-lived.
Tell your doctor or pharmacist immediately if you notice any of the following, particularly if they occur several weeks after stopping treatment with Rulide:

· Severe abdominal cramps or stomach cramps

· watery and severe diarrhea, which may also be bloody

· fever, in combination with one or both of the above.

These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention.

Precautions with Rulide

The serum half-life of Rulide is increased in patients with hepatic failure.
In severe hepatic insufficiency (e.g. hepatic cirrhosis with jaundice and/or ascites), the dose should be reduced by half i.e. Rulide 150mg once daily.
Effects on Driving and Use of Machines
Attention should be drawn to the possibility of dizzy sensations.
Use in Pregnancy and Breast Feeding
Safety of the fetus has not been established during pregnancy. However, studies in several animal species have not shown any teratogenic or foetotoxic action with doses up to 200mg/kg/day, or 40 times the human therapeutic dose.
Small amounts of Rulide are excreted in human breast milk (less than 0.05% of the dose ingested). Breast feeding or treatment of the mother should be stopped if required

Drug interactions with Rulide

Some medicines may interfere with the absorption of Rulide. These include:

· theophylline (Neulin, Austyn, Theo-dur), a medicine used to treat asthma

· some medicines for migraine headache such as ergotamine (Migral, Ergodryl, Cafergot) or dihydroergotamine (Dihydergot tablets)

· disopyramide (Rythmodan), a medicine to treat irregular heart rhythms

· terfenadine (Teldane) and astemizole (Hismanal), over the counter medicines used to treat allergies

· warfarin (Coumadin, Marevan), a medicine used to prevent blood clots

· digoxin (Lanoxin, Sigmaxin), a medicine used to treat heart failure

· midazolam (Hypnovel, Midazolam Sandoz), used to induce sleep before operations

· cyclosporin (Neoral, Cicoral, Cysporin, Sandimmun), a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system

· cisapride (Prepulsid), a medicine used to treat gastrointestinal problems

· pimozide (Orap), an antipsychotic medicine

These medicines may be affected by Rulide, or may affect how well it works. You may need to use different amounts of your medicine or take different medicines. Your doctor or pharmacist will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Rulide.

Missed dose of Rulide

If you miss a dose, take as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

Storage of Rulide

Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom. Keep away from children and pets.