Product Overview
[Drug name]
Generic name: Clindamycin Phosphate Vaginal Gel
Trade name: Xianju
English name: Clindamycin Phosphate Vaginal Gel
Pinyin: Kelinmeisu Linsuanzhi Yindaoningjiao
[Ingredients]
Clindamycin Phosphate
[Properties]
This product is a colorless or lavender gel
[Indications]
Various infectious diseases caused by sensitive bacteria, such as tonsillitis, suppurative otitis media, sinusitis, empyema, lung abscess, skin and soft tissue infection, acute bronchitis, intra-abdominal infection, female pelvic and genital infection.
[Usage and Dosage]
It is contraindicated for patients with a history of allergy to clindamycin or lincomycin.
[Adverse reactions]
1. Local reactions: After intramuscular injection, pain, nodules and sterile abscesses may occasionally occur at the injection site. Long-term intravenous infusion should pay attention to the occurrence of phlebitis. 2. Gastrointestinal reactions: Nausea, vomiting, abdominal pain and diarrhea are occasionally seen. 1-2% of patients may experience pseudomembranous colitis. 3. Allergic reaction: A small number of patients may experience drug-induced rash and occasionally exfoliative dermatitis. 4. It has basically no toxic reaction to the hematopoietic system, but may occasionally cause neutropenia, eosinophilia, thrombocytopenia, etc., which are generally mild and transient. 5. Transient elevation of alkaline phosphatase and serum transaminase, jaundice, and abnormal renal function may occur.
[Contraindications]
This product has cross-resistance with lincomycin and clindamycin, and is contraindicated for patients with a history of allergy to clindamycin or lincomycin.
[Precautions]
1. It has no cross-allergic reaction with penicillin and cephalosporin antibiotics, and can be used for patients who are allergic to penicillin. 2. It may be incompatible with ampicillin, phenytoin sodium, barbiturate hydrochloride, aminophylline, calcium gluconate and magnesium sulfate; it is antagonistic with erythromycin and should not be used together. 3. Patients with liver and kidney damage, gastrointestinal diseases such as ulcerative colitis, localized enteritis, and antibiotic-related enteritis should use this product with caution. 4. When using this product, attention should be paid to the possibility of pseudomembranous colitis. If pseudomembranous colitis occurs, first supplement water, electrolytes, and protein; then give metronidazole orally, 0.25g~0.5g, 3 times a day. If it is ineffective, then use vancomycin orally 0.125g~0.5g, 4 times a day for treatment. [Pregnant and lactating women] 1. There is no detailed research data at present, and no clear judgment can be made. Therefore, pregnant women should pay attention to the pros and cons when using this product. 2. It has been reported that when oral clindamycin 0.15g and intravenous clindamycin phosphate 0.6g are administered, the amount of drug in breast milk ranges from 0.7 to 3.8mcg/ml. Because clindamycin may cause adverse reactions in newborns, lactating women must stop using this product. [Children's use] It is not suitable for infants under one month old. Use with caution in children under 4 years old. When children (newborns to 16 years old) use this product, attention should be paid to monitoring liver and kidney function. [Use in elderly patients] 1. Pharmacokinetic studies of clindamycin have shown that there is no significant difference in pharmacokinetics between young patients with normal liver and kidney function and elderly patients after oral or intravenous clindamycin. 2. Clinical studies of clindamycin have not yet included a sufficient number of patients aged 65 and above, and it is currently difficult to determine whether the clinical response of the elderly is significantly different from that of young patients. However, clinical experience suggests that antibiotic-related colitis and diarrhea (caused by Clostridium difficile) occur more frequently in the elderly (>60 years old) and are more severe. Therefore, when elderly patients use this product, they should pay attention to careful observation or monitoring of diarrhea in these patients.
[Use in special populations]
Children's precautions: It is not suitable for infants under one month old. Use with caution in children under 4 years old. When children (newborns to 16 years old) use this product, attention should be paid to monitoring liver and kidney function.
Precautions during pregnancy and lactation: 1. There is currently no detailed research data, and a clear judgment cannot be made. Therefore, pregnant women should pay attention to the pros and cons when using this product. 2. It has been reported that when taking 0.15g of clindamycin orally or 0.6g of clindamycin phosphate intravenously, the amount of drug in breast milk ranges from 0.7 to 3.8mcg/ml. Because clindamycin may cause adverse reactions in newborns, breastfeeding women must stop using this product.
Precautions for the elderly: 1. Pharmacokinetic studies of clindamycin have shown that there is no significant difference in pharmacokinetics between young patients with normal liver and kidney function and elderly patients after oral or intravenous injection of clindamycin. 2. Clinical studies of clindamycin have not yet included a sufficient number of patients aged 65 and over, and it is currently difficult to determine whether the clinical response of the elderly is significantly different from that of young patients. However, clinical experience suggests that antibiotic-related colitis and diarrhea (caused by Clostridium difficile) occur more frequently in the elderly (60 years old) and are more severe. Therefore, when elderly patients use this product, they should pay attention to careful observation or monitoring of diarrhea in these patients.
[Drug Interactions]
1. Clindamycin has a neuromuscular blocking effect and may enhance the effect of other neuromuscular blockers. Therefore, patients who use these drugs should use clindamycin with caution. 2. It has been confirmed that the antagonism between clindamycin and erythromycin and chloramphenicol is clinically significant, and the two drugs should not be used at the same time. 3. This product may be incompatible with neomycin, kanamycin, ampicillin, phenytoin sodium, barbiturate hydrochloride, aminophylline, calcium gluconate and magnesium sulfate. 4. This product may aggravate the depression of the respiratory center when used in combination with opioid analgesics.
[Pharmacological action]
This drug is a chemical semi-synthetic clindamycin derivative. It has no antibacterial activity in vitro. It is rapidly hydrolyzed into clindamycin after entering the body and shows its pharmacological activity. Therefore, the antibacterial spectrum, antibacterial activity and therapeutic effect are the same as clindamycin, but its lipid solubility and permeability are better than clindamycin. It can be taken orally, intramuscularly or intravenously. Compared with lincomycin, it has 4-8 times stronger antibacterial effect, good absorption, high bone concentration, and good efficacy against anaerobic infections. This drug has strong antibacterial activity against Gram-positive cocci and anaerobic bacteria, including Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus (except carbonyl streptococcus), Streptococcus pneumoniae, Micrococcus among Gram-positive cocci, Clostridium, Bacteroides, Clostridium, Propionibacterium, Eubacterium, and Necrotic bacteria among anaerobic bacteria
[Storage] Shade from light and store in a sealed container. Expiration date 18 months.
[Specification] 5g:0.1g (calculated according to C18H33ClN2O5S)
[Packaging specification] 5g per tube * 1 tube/box
[Validity period] 24 months
[Approval number] National Medicine Standard H20080823
[Manufacturer] Enterprise name: Zhejiang Xianju Pharmaceutical Co., Ltd.
