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ZHEJIANG JINHUA CONBA BIO-PHARM.CO.,LTD


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The product description

 [Ingredients]

Clindamycin hydrochloride is the active ingredient.

Chemical name: Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidine-

carboxamido)-1-thio-L-threo-α-D-galactoocto pyranoside monohydrochloride

Chemical structure:

Chemical formula: C18H33ClN2O5S.HCl

Molecular weight: 461.44

[Description]

This drug is hard capsule which contains clindamycin hydrochloride.

[Indications]

This drug is indicated in the treatment of the following infections due to susceptible strains of streptococci, staphylococci and anaerobic baterium: otitis media, nasosinusitis, suppurative tonsillitis, pneumonitis, skin and soft tissue infections. When used to treat infections of bone and articulus intra-abdominal infections, infections of the female pelvis, lung abscess, empyema, osteomyelitis, septicoemia, this drug may be taken alone or with other antiseptic drugs.

[Specification] Each capsule contains 0.15g of clindamycin.

[Dosage and administration]The capsule must be swallowed wholly.

For adults, the single dose is 0.15-0.3g (equivalent to 1 to 2 capsules). Take four times a day. Patients with severe infections may take a single dose of 0.45g (equivalent to 3 capsules). A child dosage (4 weeks of age and older ) is 8-16 mg/kg/day divided into three or four equal doses.

[Side effects]

1. Gastrointestinal reactions: the most common syndromes include nausea, abdominal pain, vomiting and diarrhea. Severe syndromes such as angina abdominalis, abdominal tenderness, serious diarrheawatery feces or bloody andmucoid fecesmay occur with fever, abnormal thirsty, or lassitude (pseudomembranous colitis). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment

2. Hypersensitivity reactions: generalized mild to moderate morbilliform like skin rashes are the most frequently reported adverse reactions.Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Rare instances of erythema multiforme and exfoliative dermatitis , and some resembling Stevens-Johnson syndrome have also been reported.

3. Abnormalities in liver or renal function have been observed during clindamycin therapy. Rare instances of neutropenia and eosinophilia have been reported.

[Contraindications]

Clindamycin hydrochloride capsule is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

[Precautions]

1. Patients sensitive to lincomycin, may be also sensitive to clindamycin.

2. Levels of alanine aminotranferase and aspartate aminotransferase in serum are increased after taking this drug. This may interfere to diagnosis

3. Patients with the following deseases should take caution to use the drug:

(1)Entero deseases such as ulcerative colitis, segmental enteriti, and related enteritis.

(2)Abnormality in liver function.

(3)Severe renal hypofunction.

(4)In cased of hemolytic streptococcal infections, treatment should continue for at least 10 days. This may avoid occurance of acute rheumatic fever.

5. During the treatment, bowel frequency should be carefully monitored. The administration should discontinue when an increase of the bowel frequency may cause diphtheritic enteritis.

6. The use of clindamycin may result in diphtheritic enteritis, appropriate measures should be taken as indicated by the clinical situation. It is very effective for mild cases to discontinue the drug alone, but in moderate to severe cases, consideration should be given to management with fluids and electrolytes. When patients’ illness is not controlled by the above measures, patients should take arilin orally (250-500mg arilin each time, take three times daily). If arilin is not effective, patients may choose vancomycin (an adult daily dose of 0.5-2.0g divided into three or four equal doses)

7. Patients with signs of renal hypofunction ( except severe hypofunction), are not requested to reduce clindamycin dose. When patients with signs of severe renal or liver hypofunction are taking this drug, drug concentration in their sera should be monitored.

8.This drug occasionally causes overgrowth of microorganism –particularly fungi, which is not sensitive to clindamycin hydrochloride. So caution should be taken to avoid dual infection.

[Use for pregnant women and nursing mothers] Animal experiments indicate that it has no toxicity and teratogenic action towards fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of the human reponse, this drug should be used during pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk, so nursing mothers should take caution to use it.

[Pediatric use]. Children under 1 month of age are prohibited to use it.

[Geriatric use]In clinical studies, no enough data about older patients are reported, it is not sure whether reaction of older patients to this drug is similar with that of younger patients. Volunteers with normal liver or renal function, including old or young, may take clindamycin by oral or vein administration. Difference of clinical significance between these two administrations is not known. Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When indicated in older patients with signs of diarrhea, they should be carefully monitored for change in bowel frequency.

[Overdosage] There are no specific antagonistic drugs. Patients are managed by symptomatic and supportive care following this drug overdose.

[Storage]Keep tightly closed.

[Package]Aluminum-plastic foil. 12 capsules/ box.

[Shelf life]24 months

[Standard] Chinese Pharmacopeia (2005 edition, part II)

[License No.]Guo Yao Zhun Zi H33021180

[Manufacturer]

Name: Zhejiang Jinhua CONBA Bio-pharm. Co., Ltd.

Address: 288 Jinqu road, Jinhua, Zhejiang province, China

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