77．罗华密新
出处：按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第431页（4238字）
【中文释文】：
(螺旋霉素)片剂
〔罗华密新〕
螺旋霉素。
〔包装〕
每盒16片装，每片1500000U。每盒20片，每片750000U。
〔抗菌谱〕
1．敏感菌 链球菌属、脑膜炎球菌、淋球菌、百日咳杆菌、白喉杆菌、单核细胞增生李斯特菌、梭菌属、肺炎支原体、砂眼衣原体、嗜肺军团菌属、密螺旋体属、钩端螺旋体属、弯曲菌属、鼠弓形体。
2．一般性敏感菌 流感嗜血杆菌、脆弱拟杆菌、霍乱弧菌、金黄色葡萄球菌。
耐药菌(最低抑菌浓度为4μg／ml) 肠杆菌科，假单胞菌属。
〔适应证〕
根据对螺旋霉素的抗菌活性，药代动力学特点及临床疗效的研究，并与其他种类抗生素进行比较，得出结论，对上述敏感菌的抗菌疗效确定，特别适用于：
1．耳鼻喉科 鼻炎、鼻窦炎、扁桃体炎、蜂窝织炎、耳炎、乳腺炎、颊口部感染。
2．呼吸系统 咽炎、支气管炎、肺炎、肺脓肿。
3．皮肤病
4．泌尿系统 衣原体感染、前列腺感染、淋病。
5．骨科 骨髓炎。
6．寄生虫感染 弓形体病，隐孢子虫病。
7．预防脑膜炎
〔注意事项〕
肾功能不全者无需调整剂量。孕妇使用安全。哺乳期产妇忌用。
〔配伍禁忌〕
迄今尚未发现存在配伍禁忌，特别是与茶碱类，麦角碱类无配伍禁忌。
〔副作用〕
轻微的胃肠不适，如恶心、腹泻。药物过敏者罕见，一旦发现，则停止用药。
〔剂量〕
成人：每日6片(每片750000U)分2或3次服用(即4500000U／d)。由于罗华密新的副作用及不良反应轻微，剂量可遵医嘱增加到6000000U／d。
儿童：依照体重，遵医嘱服用。
〔生产厂家〕
法国安东尼罗纳-普朗克公司。
【外文释文】：
Rovamycine
Spiramycin．
Presentation
1．5MIU tablets，16 tablets box．
0．75MIU tablets，20 tabiets box．
Spiramycin is a macrolide antibiotic，with a 16 membered ring nucleus．
Antimicrobial Spectrum
Species usually sensitive：streptococci(group A，Str．mitis，Str．sanguis，pneumococci)，meningococci，goncocci，Bordetella pertussis，Corynebacterim diphtheriae，Listeria monocytogenes，Clostridium，Mycoplasma pneumoniae，Chlamydia trachomatis，Legionella pneumophila，treponemas，leptospiras，Campylobacter，Toxoplasma gondii；
Species with inconstant sensitivity：Haemophilus influenzae，Bacteroides fragilis，Vibrio cholerae，Staphylococcus aureus；
Resistant species(MIC＞4μg／ml)：Enterobacteriaceae，Pseudomonas．When consistant sensitivity of strains is not established for a given species，only an in vitro study of the strain involved allows to confirm whether it is sensitive，intermediate or resistant．
Indications
They derive from the antimicrobial activity and from the pharmacokinetic features of spiramycin．
They are based on the results of the clinical studies performed with the drug and its position amongst the currently available antimicrobial agents．They are restricted to the infections caused by the above-mentioned susceptible organisms，especially：
ENT sphere
Rhinitis，sinusitis，tonsilitis，phlegmon，otitis，mastitis，bucco-dental infections．
Pulmonary sphere
Pharyngitis，bronchitis，pneumonia，abscess．
Dermatology
Urogenital tract
Chlamydial infections，prostatic infections，gonorrhoeas．
Orthopaedics
Osteomyelytis．
Parasitic infections
Toxoplasmosis，cryptosporidiosis．
Prevention of meningitis．
Precautions
Dosage adjustment is not necessary in case of renal impairment．
Spiramycin can be administered to pregnant women but should be discontinued in case of lactation．
Drug interactions
No drug interaction has been reported so far，especially with theophylline and derivatives of ergot alkaloids．
Adverse reactions
Gastrointestinal disturbances，such as nausea and diarrhoea；rare cases of hypersensitivity that require interruption of treament．
Dosage
Adults：6 tablets(each 0．75MIU)a day in 2 or 3 intakes(i．e．4．5MIU)．Due to the excellent tolerance of spiramycin，this dosage can be increased，according to the doctor’s prescription，to 6MIU／day．
Children
The dosage should be adapted in accordance to the doctor’s prescription，in relation to the child’s weight．
Further information is available from RPS DOMA．
Manufacturer
RPS DOMA，20 avenue Raymond Aron，92165 Antony Cedex，France