Date of approval.
Date of revision.
Cefadroxil Tablets Instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name]
Generic name: Cefadroxil Tablets
English name: Cefadroxil Tablets
Hanyu Pinyin: Toubaoqiang’anbian Pian
Ingredients
The main ingredient of this product is cefadroxil.
Chemical name: (6R, 7R)-3-methyl-7-[(R)-2-amino-2-(4-hydroxyphenyl)acetylamino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
Chemical structure formula.
Molecular formula: C16H17N3O5S-H2O
Molecular weight: 381.41
【Properties】.
This product is white or off-white tablet.
Indications】
This product can be used for the treatment of infections caused by sensitive bacteria in the following diseases.
1.Urinary tract infections: caused by Escherichia coli, Aspergillus chimaera and Klebsiella.
2, skin and skin tissue infections: caused by Staphylococcus and/or Streptococcus.
3, pharyngitis and/or tonsillitis: caused by Streptococcus pyogenes (group A beta-hemolytic streptococcus).
Note: Only intramuscular penicillin has been shown to be effective for the prophylaxis of rheumatic fever. Cefadroxil is generally effective against streptococcal infections of the oropharynx; however, there is no evidence to confirm the effectiveness of cefadroxil for the prophylaxis of secondary rheumatic fever.
Note: Culture and drug sensitivity testing should be performed prior to and during treatment. Renal function monitoring should be performed during administration of the drug.
To reduce the development of resistant bacteria and to maintain the efficacy of cefadroxil with other antibiotics, this product should be used only for the treatment or prevention of infections caused by proven or strongly suspected susceptible bacteria. If bacterial culture and drug sensitivity test results are available, treatment regimens should be selected or adjusted based on the test results. In the absence of the above data, empirical treatment regimens may be selected with reference to local epidemiology and pathogenic bacterial resistance.
Specification
According to C16H17N3O5S 0.5g
Dosage
This product is acid stable and can be taken orally before or after meals. Taking it with meals may help to reduce the occasional gastrointestinal discomfort caused by oral cephalosporins.
Adults.
Urinary tract infections: For simple urinary tract infections (e.g., cystitis), the usual dose is 1 to 2 g daily, taken as a single dose or in 2 divided doses. For other urinary tract infections, the usual dose is 2g daily in 2 divided doses.
Skin and skin tissue infections: the usual dose is 1g daily in a single dose or in 2 divided doses.
Pharyngitis and tonsillitis: For the treatment of pharyngitis and tonsillitis caused by group A beta-hemolytic streptococci, 1g daily in a single dose or in 2 divided doses for 10 days.
Children.
Urinary tract infection: the recommended dose is 30mg/kg daily in 2 divided doses (every 12 hours).
Pharyngitis, tonsillitis and impetigo: The recommended dose is 30mg/kg daily in a single dose or in 2 divided doses (every 12 hours). For the treatment of beta-hemolytic streptococcal infections, the drug should be taken continuously for at least 10 days.
Other skin and skin tissue infections: The recommended dose is 30 mg/kg daily in 2 divided doses (every 12 hours).
Patients with renal insufficiency.
In patients with renal insufficiency, the dose of this product should be adjusted according to creatinine clearance to prevent accumulation of the drug in the body. The following table shows the recommended dosing regimen. The starting dose for adults is 1000 mg and the maintenance dose is 500 mg (based on creatinine clearance [mL/min/1.73m2]) at the dosing intervals shown in the table below.
Creatinine clearance dosing interval 0-10 mL/min36 hours10-25 mL/min24 hours25-50 mL/min12 hoursPatients with creatinine clearance above 50 mL/min can be treated as normal renal function.
Adverse reactions
1.Gastrointestinal reactions
Symptoms of pseudomembranous enteritis may occur during or after treatment with antibiotics. Indigestion, nausea and vomiting have been reported rarely. Diarrhea has also been observed (see [Precautions]).
2. Hypersensitivity reactions
The occurrence of rash, urticaria, neurotic edema and pruritus has been observed, and these reactions generally resolve after discontinuation of the drug. Anaphylactic reactions have also been reported.
3.Other
Other reactions include abnormal liver function (including cholestasis and increased serum transaminases), genital pruritus, genital candidiasis, vaginitis, moderate transient neutropenia, and fever. Granulocyte deficiency, thrombocytopenia, atopic hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness, and arthralgia have been reported occasionally.
In addition to the adverse reactions observed above, other adverse reactions and laboratory test abnormalities reported with cephalosporins include: toxic epidermal necrolysis relaxation, abdominal pain, recurrent infections, renal insufficiency, nephrotoxicity, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs test, elevated urea nitrogen (BUN), elevated creatinine, elevated alkaline phosphatase, aspartate elevated AST, elevated ALT, elevated bilirubin, elevated lactate dehydrogenase (LDH), eosinophilia, allohemocytopenia, neutropenia.
Some cephalosporins have been found to trigger seizures, especially in patients with renal insufficiency without dose reduction (see [Dosage], [Drug Overdose]). If seizures occur as a result of the drug, the drug should be stopped immediately and anticonvulsants may be used if necessary.
Contraindication】
Contraindicated in patients with hypersensitivity to cephalosporins.
[Caution].
Warning.
1. Ask the patient about the history of allergy to this product, cephalosporins, penicillins and other drugs before applying this product. This product should be used with caution in the treatment of patients with penicillin allergy because cross-allergic reactions between β-lactam antibacterial drugs have been clearly reported and occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs with this product, discontinue the drug. Severe acute allergic reactions may require the use of epinephrine and other emergency measures according to clinical indications, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, antihypertensive drugs and keeping the airway open.
2. Almost all applications of antibacterial drugs (including this product) have been reported for Clostridium difficile-associated diarrhea (CDAD), the severity of which can range from mild diarrhea to fatal colitis. Antimicrobial therapy can cause alterations in the normal flora of the colon, leading to an overgrowth of C. difficile (C. diffile).
The production of toxin A and toxin B by C. difficile is associated with the development of CDAD. 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 as 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 hydration, electrolytes, and protein must be administered according to clinical indications, and antibiotics that are effective against C. difficile and surgical evaluation must be performed if necessary.
General considerations.
1. This product should be used with caution in patients with significant renal insufficiency (creatinine clearance less than 50 mL/min/1.73m2) (see [Dosage]). For patients with known or suspected renal insufficiency, careful clinical observation and appropriate laboratory tests are required before and during treatment with this product.
2. The use of this product may not be beneficial to the patient and may increase the risk of development of drug-resistant bacteria in the absence of a confirmed or not highly suspected bacterial infection or in the absence of indications for prophylaxis.
3. Long-term use of this product may lead to overgrowth of non-susceptible bacteria. Care should be taken to observe the patient’s condition and appropriate therapeutic measures need to be taken if overlapping infections occur during treatment.
4. This product should be used with caution in patients with a history of gastrointestinal disease, especially colitis.
Pregnant women and nursing mothers
Pregnancy
Reproduction studies have been conducted in mice and rats at 11 times the human dosage and no evidence was found that cefadroxil monohydrate causes impaired fertility or is harmful to the fetus. However, there have been no adequate and well-controlled studies in women during pregnancy. Because animal reproduction studies are not fully predictive of human response, this drug should be administered during pregnancy only when it is determined to be necessary.
Lactation
This product should be used with caution in women who are breastfeeding.
Pediatric use】.
See [Dosage and Administration].
Geriatric use
Cefadroxil was administered to approximately 650 patients in 3 foreign clinical trials for the treatment of urinary tract infections, of whom 28% were 60 years of age or older and 16% were 70 years of age or older. Approximately 1000 patients in 14 foreign clinical trials received cefadroxil for the treatment of skin and skin tissue infections, with 12% of patients 60 years of age and older and 4% of patients 70 years of age and older. In these clinical trials, there were no significant differences in safety between older and younger patients. In clinical studies of cefadroxil for the treatment of pharyngitis or tonsillitis, sufficient numbers of people aged 65 years and older were not included to determine differences in response between them and younger patients. Other reported clinical experiences with the use of cefadroxil have not identified differences between older and younger patients, but a higher sensitivity to this product in some older patients cannot be excluded.
The product is primarily excreted by the kidneys and dose adjustments should be made in patients with renal insufficiency (see [DOSAGE AND ADMINISTRATION]). Elderly patients are more likely to have decreased renal function. Careful dose selection is recommended and renal function should be monitored.
Drug interactions]
Positive Coombs’ test has been reported during treatment with cephalosporins. In hematological studies or transfusion cross-matching tests, anti-globulin tests on minors or Coombs’ tests on newborns whose mothers had taken cephalosporins before delivery, Coombs’ tests may be positive due to the drug.
Drug overdose
A study in children under 6 years of age showed that cephalosporin at doses below 250 mg/kg was not significantly abnormal and did not require special measures other than routine supportive treatment and observation. Gastric emptying is required if doses above 250 mg/kg are administered.
It has been reported that five anuric patients who took 1g of this product orally, on average about 63% of the drug was eliminated from the body in its original form after 6-8 hours of hemodialysis treatment.
Pharmacology and Toxicology
Pharmacological effects
Cefadroxil belongs to the cephalosporin class of antibiotics, and its mechanism of action is to produce bactericidal effect by inhibiting bacterial cell wall synthesis.
In vitro tests and clinical infection treatment have confirmed the activity of cefadroxil against the following microorganisms: β-hemolytic streptococci, staphylococci (including penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Acinetobacter chimaera, Klebsiella, and Catamorax.
Most Enterococcus faecalis are resistant to cefadroxil. Cefadroxil has no antibacterial activity against most Enterobacter spp., Morganella, Morgenella unusual, Pseudomonas aeruginosa and Fusobacterium.
Toxicological studies
Reproductive toxicity: No effects on fertility or fetuses were observed in mice and rats given doses of cefadroxil up to 11 times the human dose. However, no adequate and rigorous clinical studies have been conducted in pregnant women, and reproductive studies in animals do not fully predict the response in humans, and cefadroxil should be used in pregnant women only when clearly needed.
[Pharmacokinetics].
Cefadroxil is rapidly absorbed after oral administration of this product. The mean peak blood concentrations are about 16 and 28 μg/mL for a single dose of 500 mg and 1000 mg, respectively. 12 hours after oral administration, detection levels can still be reached. More than 90% of the drug was excreted in its original form via urine within 24 hours. A single oral dose of 500 mg results in a peak urinary drug concentration of approximately 1800 μg/mL. Increasing the dose administered usually increases the concentration of cefadroxil in the urine proportionally. With a single administration of 1000mg, the drug concentration in urine will be maintained above the minimum inhibitory concentration for up to 20 to 22 hours.
Storage】Store below 25℃.
Package】Polyvinyl chloride solid pharmaceutical hard tablets – pharmaceutical aluminum foil. 12 tablets/plate, 1 plate/box, 2 plates/box; 9 tablets/plate, 2 plates/box.
【Validity】 12 months
【Execution standard
【Approval number】
【Manufacturing enterprise】
Company Name: Shiyapharm Group Ouyi Pharmaceutical Co.
Address: No. 88 Yangzi Road, Shijiazhuang Economic and Technological Development Zone
Postal Code: 052165
Telephone number: 0311-87886158
Fax number: 0311-87039126
Website: http://www.ouyipharma.com