Approval Date:
Modification Date.
Cefadroxil Capsules InstructionsPlease read the instructions carefully and use under the guidance of your pharmacist
Cefadroxil is contraindicated in patients with hypersensitivity to cephalosporins and a history of penicillin anaphylaxis or immediate reaction
[Drug Name].
Generic Name: Cefadroxil Capsules
English Name: Cefalexin Capsules
Hanyu Pinyin: Toubao’anbian Jiaonang
[Ingredients
The main ingredient of this product is cefalexin.
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 white to slightly yellow powder or granule.
[Indications
It is indicated 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 0.125g
[Dosage].
Adult Dose: Take orally. Generally 250-500 mg once, 4 times a day, the highest dose is 4 g a day. patients with decompensated renal function should reduce the dose according to the degree of decompensation. 500mg every 12 hours in patients with mononeural cystitis, skin soft tissue infections and streptococcal pharyngitis.
Children’s dose: Oral. 25 to 50 mg/kg by body weight 4 times a day. 12.5 to 50 mg/kg orally every 12 hours for 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 prothrombin activity (see [Precautions])
Production of 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 is 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 antibacterial drugs.
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.
[Contraindications
It is contraindicated in patients with hypersensitivity to cephalosporins and a history of penicillin anaphylaxis or immediate reaction.
[Precautions
1. Hypersensitivity reactions
Hypersensitivity reactions have been reported with cefadroxil, including rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis relaxation disorder. 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-producing Clostridium 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, administration of 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 repeat infections occur during treatment, appropriate measures should be taken.
7. When the daily oral dose exceeds 4 g (cephalexin anhydrous), a switch to an injectable cephalosporin analog 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 have not been conducted in pregnant women. 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.
[For Children
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 did not identify 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].
Pharmacologic effects
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 in clinical infections against most strains of the following bacteria (see section [Indications]).
Gram-positive bacteria.
Staphylococcus aureus (methicillin-susceptible isolates only)
Streptococcus pneumoniae (penicillin-sensitive strains)
Gram-negative bacteria.
Escherichia coli
Haemophilus influenzae
Klebsiella pneumoniae
Mucoid Mucormycetes
Morphobacterium oddum
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 in male and female rats by oral administration (at 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 in pregnant rats given cefadroxil orally at doses of 250 or 500 mg/kg/day from day 15 of gestation to lactation (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. Peak blood concentrations were reached approximately 1 hour after administration of 250 mg, 500 mg, and 1 g of cefadroxil, with mean values of approximately 9, 18, and 32 µ g/ml, respectively. blood concentrations were still detectable 6 hours after dosing.
Distribution.
The plasma protein binding 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 in the urine via glomerular filtration and renal tubular secretion. 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 were approximately 1000, 2200, and 5000 mcg/ml after administration of 250 mg, 500 mg, and 1 g of cefadroxil, respectively.
[Storage] Store below 25°C.
[Packaging] Polyvinyl chloride/polyvinylidene chloride solid pharmaceutical laminate rigid tablets, pharmaceutical aluminum foil.
10 capsules/plate, 5 plates/box; 10 capsules/plate, 2 plates/box; 12 capsules/plate/box; 12 capsules/plate, 2 plates/box.
[Expiration date] 12 months
[Executive Standard
[Approval number]State Drug Administration H13020523
[Manufacturer
Company name: North China Pharmaceutical Hebei Huamin Pharmaceutical Co.
Production Address: No. 98, Hainan Road, Shijiazhuang Economic and Technological Development Zone
Postal code: 052165
Phone number: 4006511180
Fax number: (0311) 88152805
Website: www.ncpc.com.cn