Approved on.
Date of revision.
Cefadroxil Capsules Instructions
Please read the instructions carefully and use under the guidance of your physician
Contraindicated in patients with cephalosporin hypersensitivity and a history of penicillin anaphylaxis or immediate reaction
[Drug Name].
Generic Name: Cephalexin Capsules
English name: Cefalexin Capsules
Hanyu Pinyin: Toubao’anbian Jiaonang
[Ingredients
The main ingredient of this product is cephalexin.
Chemical name: (6R,7R)-3-methyl-7-[(R)-2-amino-2- phenylacetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
Chemical structure formula.
Molecular formula: C16H17N3O4S-H2O
Molecular weight: 365.41
[Properties
The content of this product is off-white or yellowish to yellow powder or granule.
[Indications
For acute tonsillitis, pharyngitis, sinusitis, bronchitis, pneumonia and other respiratory tract infections, otitis media, urinary tract infections and skin soft tissue infections caused by sensitive bacteria. This product is an oral preparation and should not be used for severe infections.
[Specifications
According to C16H17N3O4S (1) 0.125g (2) 0.25g
[dosage].
Adult Dose: Oral. Generally 250-500mg once, 4 times a day, the highest dose is 4g a day. patients with decompensated renal function should reduce the dose according to the degree of decompensated renal function. 500mg every 12 hours in patients with moniliasis, skin soft tissue infections and streptococcal pharyngitis.
Children’s dose: Oral. 25-50 mg/kg per day by body weight, 4 times a day. 12.5 to 50 mg/kg orally every 12 hours in patients with skin soft tissue infections and streptococcal pharyngitis.
[Adverse Reactions
The following serious adverse events are described in detail under [Precautions].
hypersensitivity reactions (see [Precautions])
Clostridium difficile associated diarrhea (see [Precautions])
Direct Coombs’test positive reaction (see [Precautions])
Epilepsy induction (see [Precautions])
Affects coagulant zymogen activity (see [Precautions])
Produces drug-resistant bacteria (see [Precautions])
Clinical trial experience
Because clinical trials are conducted under a variety of conditions, the incidence of adverse reactions observed in clinical trials of one drug cannot be directly compared with the incidence in clinical trials of another drug and may not reflect the actual observed incidence.
In clinical trials, the most common adverse reaction was diarrhea. Nausea, vomiting, dyspepsia, gastritis, and abdominal pain also occurred. As with penicillin and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported.
Other reactions include hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and increased vaginal discharge, dizziness, fatigue, headache, irritability, confusion, hallucinations, arthralgia, arthritis, and joint disease. Reversible interstitial nephritis, eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and mild elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported.
In addition to the above adverse reactions observed in patients treated with cefadroxil, the following adverse reactions and changes in other laboratory tests have been reported with cephalosporin-based antimicrobial agents.
Other adverse reactions: fever, colitis, aplastic anemia, hemorrhage, renal impairment, and toxic nephropathy.
Changes in laboratory tests: prolonged prothrombin time, elevated blood urea nitrogen (BUN), elevated creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), whole blood cytopenia, leukopenia, and granulocyte deficiency.
[Contraindicated].
It is contraindicated in patients with hypersensitivity to cephalosporins and a history of penicillin anaphylaxis or immediate reaction.
[Precautions].
1. Hypersensitivity reactions
Allergic reactions have been reported with cefadroxil, including rash, urticaria, angioedema, anaphylaxis, polymorphic erythema, Stevens-Johnson syndrome, or toxic epidermal necrolysis relaxation. Prior to treatment with this product, patients should be asked if there is a history of allergy to cefadroxil, other cephalosporins, penicillins, or other drugs. Up to 10% of penicillin-allergic patients develop cross-hypersensitivity reactions to beta-lactam antimicrobial drugs. If an allergic reaction to this product occurs, discontinue use immediately and take appropriate treatment.
2. Clostridium difficile-associated diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported with almost all antibacterial drug applications, including cefadroxil, and can range in severity from mild diarrhea to fatal colitis. Antibacterial drug therapy can cause alterations in the normal flora of the colon, leading to overgrowth of Clostridium difficile (C. difficile).
Toxin A and toxin B produced by Clostridium difficile are associated with the development of CDAD. Hypertoxin (hypertoxin)-producing C. difficile can lead to increased morbidity and mortality, and these infections may be difficult to treat with antimicrobial drugs and therefore may require colectomy. The possibility of CDAD must be considered in all patients who develop diarrhea after antibiotic use. A careful history is needed because CDAD has been reported after administration of antimicrobial therapy for more than 2 months.
If CDAD is suspected or confirmed, discontinuation of antibiotics that are not directed against Clostridium difficile needs to be considered. Appropriate fluid and electrolyte therapy, protein supplementation, antibiotics effective against C. difficile, and surgical evaluation must be given based on clinical indications.
3. Positive direct Coombs’ test response
Positive direct Coombs’ test reactions have been reported with all cephalosporin antibiotics, including cefadroxil. The use of cefadroxil has been reported to induce the production of acute intravascular hemolysis. If anemia occurs during or after treatment with this product, the presence of drug-induced hemolytic anemia needs to be diagnosed, the product discontinued, and appropriate therapy administered.
4. Induction of epilepsy
Many cephalosporin antibiotics can induce seizures, especially if the dose is not reduced in patients with renal impairment. If seizure symptoms occur, discontinue the product immediately. Anticonvulsant therapy may be given after diagnosis.
5. Prolonged prothrombin time
Cephalosporins may be associated with prolonged prothrombin time. Patients with renal or hepatic impairment, patients with poor nutritional status, patients on long-term antimicrobial therapy, and patients on anticoagulant therapy are at risk. Patients at risk need to be monitored for prothrombin time and treated as indicated.
6. Development of drug-resistant bacteria
Under diagnosed or not highly suspected bacterial infections, use of this product may not provide benefit to patients and may increase the risk of development of drug-resistant organisms.
Long-term use of this product may lead to overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If recurrent infections occur during treatment, appropriate measures should be taken.
7. When the daily oral dose exceeds 4 g (cephalexin anhydrous), a switch to injectable cephalosporins should be considered.
8. This product should be used with caution in patients with impaired renal function (creatinine clearance<30 ml/min with or without dialysis). Careful clinical observation and monitoring of renal function should be performed at the time of use, as the safe dose for such patients may be lower than the usual recommended dose and the application of this product is subject to dose reduction.
9. Interference with diagnosis: False-positive reactions to urine glucose (copper sulfate method) may occur with the use of this product.
[For pregnant and lactating women
Pregnant women
Adequate and well-controlled studies in pregnant women have not been conducted. Because animal reproduction studies are not fully predictive of human response, this product should be used during pregnancy only if it is clear that the benefits of treatment outweigh the risks.
In reproductive toxicity studies during organogenesis in mice and rats, oral administration of cefadroxil (at doses 0.6 and 1.2 times the maximum recommended human dose (MRHD) for body surface area) did not show damage to fetuses.
Lactating women
Cefadroxil is excreted in human milk. Use this product with caution in nursing women.
[Pediatric use
See [Dosage].
[For elderly patients
There were 701 subjects in 3 published clinical studies of cefadroxil, 433 (62%) of whom were 65 years of age and older. No overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between older and younger patients.
The product is largely excreted by the kidneys, and the risk of toxic reactions to this product may be greater in patients with impaired renal function. Because older patients are more likely to have reduced renal function, caution should be used when determining the dose (see [PRECAUTIONS]).
[Drug Interactions
Metformin
Cefadroxil, when combined with metformin, results in increased blood levels and decreased renal clearance of metformin. In healthy subjects, plasma Cmax and AUC of metformin increased by a mean of 34% and 24%, respectively, and renal clearance of metformin decreased by a mean of 14% when 500 mg of cefadroxil and metformin were given in a single dose. No data are available on the interaction of cefadroxil and metformin when administered in multiple doses.
When cefadroxil and metformin are administered concomitantly, patient status should be carefully monitored and the dose of metformin should be adjusted.
Probenecid
Probenecid has inhibitory effects on renal excretion of cefadroxil. Combined use of probenecid and cefadroxil is not recommended.
[Drug overdose
Symptoms of oral overdose can include nausea, vomiting, epigastric pain, diarrhea, and hematuria. In the case of an overdose, general supportive treatment measures are available.
Forced diuresis, peritoneal dialysis, hemodialysis, or activated charcoal hemoperfusion have not been determined to be beneficial for cefadroxil overdose.
[Pharmacologic Toxicology
Pharmacology
Mechanism: Cefadroxil is a bactericidal agent that acts by inhibiting bacterial cell wall synthesis.
Antibacterial activity: Cefadroxil has shown antibacterial activity in in vitro tests and clinical infections against most strains of the following bacteria (see [Indications] section).
Gram-positive bacteria.
Staphylococcus aureus (methicillin-susceptible isolates only)
Streptococcus pneumoniae (penicillin-susceptible strains)
Escherichia coli
Haemophilus influenzae
Klebsiella pneumoniae
Mucoid Mucormycetes
Aspergillus chimaera
Toxicological studies
Genotoxicity.
Tests have not been conducted to determine the potential mutagenicity of cefadroxil.
Reproductive Toxicity.
No effects on fertility and reproductive capacity were seen with transoral administration in male and female rats (doses up to 1.5 times the human dose in terms of body surface area). .
No adverse effects on embryonic development were seen in pregnant mice and rats given orally during organogenesis at doses of 250 or 500 mg/kg/day (on body surface area, approximately 0.6 and 1.2 times the MRHD), respectively.
In a perinatal toxicity study, no adverse effects on delivery, litter size, or offspring growth were seen with cefadroxil at doses of 250 or 500 mg/kg/day given orally to pregnant rats from day 15 of gestation until weaning (21 days after birth).
Carcinogenicity.
Lifetime animal studies have not been conducted to evaluate the potential carcinogenicity of cefadroxil.
[Pharmacokinetics].
Absorption.
Cefadroxil is acid-resistant and can be taken on an empty stomach or with a meal. After administration of 250 mg, 500 mg, and 1 g of cefadroxil, peak blood levels were reached at approximately 1 hour, with mean values of approximately 9, 18, and 32 mcg/ml, respectively. blood levels were still detectable 6 hours after administration.
Distribution.
The plasma protein binding rate of cefadroxil is 10% to 15%. It can enter the fetal blood circulation through the placenta, maternal amniotic fluid, and the drug can be secreted through breast milk after oral administration of cefadroxil by a lactating woman.
Excretion.
Cefadroxil is excreted via glomerular filtration and renal tubular secretion into the urine. Studies have shown that more than 90% of the drug is excreted in the urine in its original form within 8 hours. Peak urinary drug concentrations after administration of 250 mg, 500 mg and 1 g of cefadroxil were approximately 1000, 2200 and 5000 mcg/ml, respectively.
[Storage]Store below 25C.
[Expiration date] 18 months
[Approval number]0.125g (according to C16H17N3O4S sub>4S): State Pharmacopoeia H13020790;
[Marketing authorization holder
Marketing licensee: Shih Pharma Group Ouyi Pharmaceutical Co.
Registered Address: No. 88 Yangzi Road, Shijiazhuang Economic and Technological Development Zone
Postal code: 052165
Phone number: 0311-87886158
Fax number: 0311-87039126
[Producers]
Enterprise name: 石药集团欧意药业有限公司Production Address: No. 88 Yangzi Road, Shijiazhuang Economic and Technological Development Zone
Postal Code: 052165
Tel: 0311-87886158
Fax number: 0311-87039126
Website: http://www.ouyipharma.com