12.林可霉素

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48页(7517字)

【中文释文】:

赫司特林可霉素

〔成分〕

盐酸林可霉素

〔特点〕

林可霉素系供口服及非肠道使用的抗生素,化学上与任何已知的抗生素均无联系。按其治疗剂量给药,本品主要作为革兰阳性球菌(肠球菌除外)的抑菌剂。它具有很好进入骨组织的特点。

〔适应证〕

1.革兰阳性球菌引起的感染(葡萄球菌及产青霉素酶的菌株、链球菌及肺炎球菌);

2.骨及关节感染(骨髓炎、骨外伤事故后和骨外科手术后感染);

3.骨外科(骨缝合术、整形外科等)的感染;

4.中耳炎、鼻窦炎、乳突炎;

5.皮肤及结缔组织感染;

6.对青霉素过敏病人的呼吸道感染。

〔用法与用量〕

剂量决定于病原菌的敏感程度及感染的部位。

1.口服给药 本品最好于饭前或饭后1~2h服用。成人及14岁以上的青少年通常每6~8h服1粒胶囊。

一个月以上的婴儿,按30~60mg/(kg·d),分3~4个剂量服用。为此,将500mg胶囊打开,取所需药量与半流质食物或果汁共服。

2.肌肉及静脉注射 成人及14岁以上青少年通常用600~1200mg,每日2~3次。1个月以上的婴儿按10~20mg/(kg·d),分2~3个剂量给药。

3.静脉输注 剂量600~1200mg溶于250~500ml5%葡萄糖或0.9%氯化钠溶液中,在30~60min内输注完毕,间隔时间为8~12h。剂量间隔也可减至4h,剂量不变。

〔副作用〕

尤其在口服之后,已有软便和腹泻。严重和持续腹泻的病例也有报道,并且需要停药。也见有便中带血和粘液的急性结肠炎的个别病例。恶心、呕吐及直肠或阴道粘膜炎症状罕见。

在一些疾病中见有可逆性的白细胞减少或中性白细胞减少。因此建议在长期使用本品治疗时应检查血象。

在个别病例观察到肝功能化验异常(血清转氨酶及血胆红素增高)。尽管这些现象与林可霉素治疗之间的因果关系尚未肯定,但是建议长期用本品治疗时应进行肝功能化验。如果出现病理情况,应停药。

如有肾功能损害,应减少剂量。

非肠道给药后极少有过敏反应,若发生休克,必须立即进行急救。

让病人侧卧,保持气道畅道,也需要人工呼吸以及儿茶酚胺(肾上腺素,去甲肾上腺素,异丙肾上腺素),高剂量静脉注射类皮质激素并且连续静脉滴注。

妊娠及哺乳期只有在绝对必要时方可使用。初生儿在进一步弄清情况前不可使用本品治疗。

〔禁忌证与注意事项〕

如果有念珠菌感染的病人用林可霉素治疗时,需同时进行抗念珠菌感染治疗。

林克霉素治疗与肝功能紊乱之间没有因果关系,但在一些病例中发生胆汁和肝功异常,尤其转氨酶升高。此制剂不能用于对林可霉素和氯林可霉素过敏的病人。

对新生儿在进一步实践之前,不应该用林克霉素治疗。

〔包装〕

瓶装,每瓶500mg胶囊12粒,100粒及500粒;以及含600mg本品的安瓿5支及25支(每支2ml)。

医院用包装

〔生产厂家〕

德国赫司特制药公司

(附本品别名:林肯霉素、洁霉素、Lincomycin)

【外文释文】:

Lincomycin Hoechst

Composition

Lincomycin hydrochloride monohydrate

Properties

Lincomycin is an antibiotic for oral and parenteral use,chemically unrelated to any of the known antibiotics.In therapeutic doses it is bacteriostatic mainly against grampositive cocci(except enterococci).Lincomycin is noted for its good penetration into bone.

Indications

Infections caused by gram-positive cocci(staphylococci,also penicillinase-forming strains,streptococci,pneumococci):

Infections of bones and joints(ostenomyelitis,infections after accidental injuries involving bones and after bone surgery).

Prophylaxis of infections in bone surgery(osteosynthesis,plastic surgery etc.),

otitis media,sinusitis,mastoiditis,

infections of the skin and connective tissues,

respiratory tract infections in patients hypersensitive to penicillin.

Administration and dosage

The dosage is determined by the sensitivity of the pathogens and by the infection site.

Oral administration(capsules)

Cillimycin is best taken 1-2 hours before or after meals.In general,adults and adolescents over 14 years receive one capsule every 6-8 hours.

Children over 1 month of age receive 30-60 mg/kg body weight daily,divided into 3 or 4 single doses.For this purpose,a capsule with 500 mg,is opened and the required portion of the contents is administered in some pap or juice.

Intramuscular and intravenous injections

In general,adults and adolescents over 14 years receive 600-1 200 mg two or three times daily.

Children over 1 month of age receive 10-20 mg/kg body weight daily,divided into 2 or 3 single doses.

Intravenous infusion

At intervals of 8-12 hours,doses of 600-1200 mg are infused within 30-60 minutes,dissolved in 250-500 ml of a 5% glucose or of a 0.9% NaCl solution.The dosage intervals may be reduced to 4 hours,doses remaining the same.

Side effects

Soft stools may occur,especially after oral administration.Cases of severe and prolonged diarrhoea have been reported,which occasionally makes withdrawal of the drug necessary.Isolated cases of acute colitis associated with the passage of blood and mucus in the stools have been observed.

Nausea,vomiting and inflammation of rectal and vaginal mucosae occur in exceptional cases only.

In some cases,reversible leukopenia has been observed.Therefore it is advisable to check the blood picture during prolonged treatment.

Abnormalliver function tests(increases in serum transaminase and serum bilirubin)have occurred in isolated cases.Although a causal relationship between these phenomena and lincomycin treatement could not be established,it is advisable to carry out liver function tests in long-term treatment with this drug.In case of pathologic results,lincomycin should be discontinued.

In patients with impaired renal function,reduced doses are indicated(see prospectus).Hypersensibility reactions and anaphylaxis after parenteral administration are very rare.If shock occurs,immediate counermeasures are necessary.

The patient is placed on his side,airways must be kept patent,artificial respiration is indicated as well as catecholamines(epinephrine,norepinephrine,isoproterenol),high intravenous corticoid doses and continuous intravenous drip infusion.

Contraindications and precautions

If a patient with pre-existing monilial infection is treated with Cillimycin an anti-monilial therapy must be carried out concomitantly.

No causal relationship has been established between Cillimycin treatment and disorders of liver function,but jaundice and abnormal liver function tests,especially increased transaminase values,have been observed in some cases.

During pregnancy and lactation Cillimycin should be employed only if strictly indicated.

This preparation must not be used in patients with allergy to lincomycin and clindamycin.

Please note

Newborn infants should not be treated with lincomycin preparations,pending further experience.

Presentation

12 and 100 capsules of 500 mg

5 and 20 injection kits Manolette with 600 mg(2 ml)in Manoject

5 and 25 ampoules of 600 mg(2 ml)

Hospital packs

How to assemble the manolette in manoject

The all-glass Manolette is a syringe-ampoule ready for injection,with a ground glass cone for fitting the needle.

The rod-shaped plastic cover that protects the cone is pulled off and screwed with its threaded end into the rubber plunger of the Manolette.

Immediately prior to injection,the tip of the rubber-capped glass cone is snapped at the circular notch and pulled off together with the rubber cap.The needle is now fitted to the glass cone with a slight turn.After expelling the air in the usual way,the Manolette is ready for use.

Manufacturer

Hoechst AG.Frankfurt(Main)-Germany

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