Date of approval.
Date of revision.
Cefaclor Granules Instructions
Please read the instructions carefully and use under the guidance of a physician.
Warnings: Contraindicated for those who are allergic to this product and other cephalosporins.
Drug Name]
Generic name: Cefaclor Granules
English name: Cefaclor Granules
Hanyu Pinyin: Toubaokeluo Keli
Ingredients
The main ingredient of this product is cefaclor.
Chemical name: (6R,7R)-7-[(R)-2-amino-2-phenylacetamido]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate
Chemical structure formula.
Molecular formula: C15H14ClN3O4S-H2O
Molecular weight: 385.82
【Properties】.
This product is granule; aromatic gas.
Indications]
This product is indicated for the treatment of infections caused by the following sensitive strains of bacteria.
Otitis media: caused by S. pneumoniae, Haemophilus influenzae, Staphylococcus, Streptococcus pyogenes (group A beta-hemolytic streptococcus) and Catamorax.
Lower respiratory tract infections (including pneumonia): caused by S. pneumoniae, Haemophilus influenzae, Streptococcus pyogenes (group A beta-hemolytic streptococcus) and Catamorax.
Upper respiratory tract infections (including pharyngitis and tonsillitis): caused by Streptococcus pyogenes (group A beta-hemolytic streptococci) and Catamorax.
Note: Penicillin is commonly used for the treatment and prevention of streptococcal infections (including prevention of rheumatic fever). The American Heart Association recommends carboxymethylpenicillin (Amoxicillin) for the prevention of bacterial endocarditis caused by dental, oral, and upper respiratory tract infections, and in this regard, for the prevention of alpha-hemolytic streptococcal infections, penicillin V is a reasonable choice. Generally speaking cefaclor is effective for the eradication of streptococci in the nasopharynx, however, there are no significant data confirming the efficacy of cefaclor for the prevention of secondary rheumatic fever or bacterial endocarditis. A minimum 10-day therapeutic dose of cefaclor should be given for the treatment of beta-hemolytic streptococcal infections.
Urinary tract infections (including pyelonephritis and cystitis): caused by Escherichia coli, Aspergillus chimaera, Klebsiella spp. and coagulase-negative staphylococci.
Note: Cefaclor is effective in both acute and chronic urinary tract infections.
Skin and skin tissue infections: caused by Staphylococcus aureus and Streptococcus pyogenes (group A beta-hemolytic streptococci).
Sinus infections
Gonococcal urethritis
Appropriate tissue culture and susceptibility studies should be performed to determine the susceptibility of pathogenic bacteria to cefaclor.
Specification
0.125g (based on C15H14ClN3O4S)
Dosage and Administration
Take orally.
Adults: The usual adult dose is 0.25g every 8 hours. The dose for bronchitis and pneumonia is 0.25g once, three times a day. The recommended dose for sinusitis is 0.25g once, three times a day for 10 days. The dose may be doubled for more severe infections (e.g., pneumonia) or infections caused by slightly less sensitive bacteria. A daily dose of 4g has been used safely in normal subjects for 28 days, but the total daily dose should not be exceeded.
For the treatment of acute gonococcal urethritis in men and women, a single dose of 3g may be given in combination with propofol 1g.
[Adverse reactions].
Adverse reactions associated with cefaclor treatment include
Allergic reactions: According to reports, about 1.5% of patients, including urticaria-like rash (1/100). Pruritus, urticaria and positive Coombs test, all occurring at an incidence of 1/200 or less.
A serum sickness-like reaction has been reported with cefaclor. This reaction is characterized by the appearance of polymorphic erythema, rash and other skin manifestations with arthritis/arthralgia, with or without fever. It differs from typical serum sickness in that it is rarely associated with lymphadenopathy and proteinuria, there are no immune complexes entering the circulation, and there is no sign of sequelae of the reaction. In-depth studies are being conducted and the serum sickness-like reactions appear to be due to allergy, often occurring during or while entering a second course of cefaclor. Such reactions have been reported to occur more frequently in children than in adults, with an overall incidence of 1 case (0.5%) in 200 cases in one centralized trial and 2 cases (0.024%) in 8346 cases in total clinical trials [0.055% in children across clinical trials and 1 case (0.003%) in 38,000 automatic reports of side effects]. Signs and syndromes that appear a few days after the start of treatment subside a few days after stopping treatment. Such reactions occasionally result in hospitalization of patients, but the length of stay is usually short (mean length of stay is 2-3 days according to post-marketing surveillance studies). In those patients requiring hospitalization, their syndrome at the time of admission ranged from mild to severe, with a greater incidence of severe reactions in children. Antihistamines and glucocorticoids appeared to enhance the remission of signs and syndromes. No serious sequelae have been reported. More severe allergic reactions (including Stevens-Johnson syndrome, toxic epithelial necrolysis, and anaphylaxis) have been reported rarely and may occur more frequently in patients with a history of penicillin allergy.
Gastrointestinal syndrome: The incidence is approximately 2.5%, including diarrhea (1 of 70 cases). Nausea and vomiting have been reported.
Pseudomembranous colitis syndrome, which may occur during or after antibiotic therapy. Pseudomembranous colitis has been reported following the administration of large amounts of broad-spectrum antibiotics. Transient hepatitis, rarely reported. Biliary depression jaundice has been reported.
Other treatment-related side effects include eosinophilia (1 in 50 cases). Genital pruritus or vaginitis (less than 1 in 100 cases), thrombocytopenia, and interstitial nephritis have been reported. Candidiasis has been reported.
Causality is not clear.
Central nervous system side effects: hyperfunction, hypersensitivity, insomnia, confusion, hypertension, dizziness, hallucinations and drowsiness, which have been reported rarely.
Temporary outliers in clinical laboratory test results have been reported. Although the etiology is unknown, the following information is provided as a reminder to physicians.
Liver side effects: slightly elevated AST (SGOT), ALT (SGPT) or alkaline phosphatase values (the latter in 1 out of 40 cases). Abnormal liver function tests have been reported.
Hematopoietic system: As reported with other β-lactam antibiotics, this product can cause transient lymphocytosis and leukopenia. Rarely, it causes hemolytic anemia, repletion anemia. Granulocyte deficiency, neutropenia, eosinophilia, and angioedema have been reported.
Renal: Slightly elevated BUN or serum creatinine levels (the latter in less than 1 in 500) or abnormal urinalysis (in less than 1 in 200). Abnormal renal function tests have been reported.
Certain cephalosporins can cause epilepsy, especially in patients with renal insufficiency and without dose reduction, and should be discontinued if seizures related to drug therapy occur. If clinically necessary, anticonvulsants may be given.
Contraindications】It is contraindicated for those who are allergic to this product and other cephalosporins.
Precautions】
General precautions: Long-term use of cefaclor can lead to a proliferation of insensitive strains of bacteria. Therefore, careful observation of the patient is essential. If a secondary infection occurs during treatment, appropriate measures must be taken.
A direct positive Coombs’ test has been reported during treatment with cephalosporin antibiotics. A direct positive Coombs’ test has been reported during treatment with cefaclor. It is important to recognize that a positive Coombs’ test may be drug-related, for example, in hematologic studies or during cross-matching of blood for transfusion (when an antiglobulin test is performed) or in newborns whose mothers have taken cephalosporins prior to delivery.
Cefaclor should be used with caution in the presence of severe renal insufficiency because the half-life of cefaclor in anuric patients is 2.3-2.8 hours. For patients with moderate to severe renal impairment, the dose is usually unchanged. Clinical experience with cefaclor in this setting is limited, and careful clinical observation and laboratory studies should therefore be performed.
Use antibiotics (including cephalosporins) with caution in patients with a history of gastrointestinal disease (especially colitis).
WARNING: Before using cefaclor, take care to determine whether the patient has previously been allergic to cefaclor or other cephalosporins, penicillin, or other drugs. Use caution if this product is used in patients with penicillin allergy, as cross-sensitization (including anaphylactic reactions) has been clearly reported in the literature for beta-lactam antibiotics.
If an allergic reaction to cefaclor occurs, the drug should be discontinued immediately. If necessary, it should be treated with appropriate medication (e.g., pressurized amines, antihistamines, or corticosteroids).
Antibiotics (including cefaclor) should be used with caution in patients showing some type of allergy (especially to drugs).
Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics (including macrolide antibiotics, semisynthetic penicillins, and cephalosporins). Therefore, it is important to consider this diagnosis if diarrhea occurs in a patient on antibiotics. The degree of this colitis varies from mild to life-threatening. For mild cases of pseudomembranous colitis, simply discontinuing the drug usually works, while for moderate to severe cases, appropriate therapeutic measures should be taken.
[For pregnant and lactating women].
Administration during pregnancy: Reproduction studies have been conducted on mice and rats at doses up to 12 times the human dosage and on ferrets at three times the maximum human dosage. The results do not show any evidence that cefaclor impairs fertility or endangers the fetus. However, there are no appropriate, well-controlled clinical studies in pregnant women. Because animal reproduction studies are not always predictive of human response, the product should not be used during pregnancy unless urgently needed.
Delivery: The effect of cefaclor on delivery is not known.
Nursing Mothers: Small amounts of cefaclor were measured in breast milk after a single oral dose of 500 mg in nursing women, with mean levels of 0.18, 0.20, 0.21, and 0.16 mg/L at 2, 3, 4, and 5 hours post-dose, respectively, and traces of the drug were measured at hour 1. The effect of this product on breast-fed infants is unknown. Cefaclor should be administered with caution to nursing women.
[Pediatric Use].
Pediatric Use: The efficacy and safety of this product in infants within one month has not been established.
The usual daily dose for children is 20 mg/kg/day with water every 8 hours. The dose for bronchitis and pneumonia is 20 mg/kg/day every 8 hours. In more severe infections (otitis media) and infections caused by slightly less sensitive bacteria, 40mg/kg/day with a maximum dose of 1g/day.
Children 20mg/kg/day 40mg/kg/day 9kg 1/2 sachets each time, 1 sachet three times a day, 1 sachet three times a day 18kg 1 sachet each time, 2 sachets three times a day, 3 times a day [for elderly].
Refer to “Dosage and Administration”.
Drug Interactions]
Drug/Laboratory Interactions: In tests using Benedict’s and Ferring’s solutions and CLINITEST tablets instead of TES-TAPE (glucose enzyme test strips, Eli Lilly and Company, USA), urinary glucose in patients taking cefaclor may show a false positive reaction.
Increased anticoagulation when cefaclor and oral anticoagulants are given together has been reported rarely. As with other beta-lactam antibiotics, the renal excretion of cefaclor is inhibited by probenecid.
Drug Overdose
Signs and symptoms: Toxicity syndromes following overdose of cefaclor include: nausea, vomiting, epigastric discomfort and diarrhea, with the severity of epigastric discomfort and diarrhea being dose dependent. If other syndromes are present, they may be secondary to a pre-existing condition, an allergic reaction, or other toxic effects.
Treatment: In the treatment of overdose syndrome, the possibility of multiple drug overdoses, drug-drug interactions, and differences in patient pharmacokinetics should be considered.
Unless five times the normal amount of cefaclor has been taken, it is not necessary to clear the gastrointestinal tract of the overdose drug. Take care to protect the patient’s airway and maintain ventilation and perfusion. Carefully monitor and maintain the patient’s vital signs, blood gases, and serum electrolytes within acceptable limits. Administration of activated charcoal reduces drug absorption through the gastrointestinal tract, and activated charcoal is more effective than vomiting and lavage in many cases. Consider giving activated charcoal instead of gastric emptying or in addition to gastric emptying. Multiple administrations of activated charcoal may accelerate the elimination of some already absorbed drugs. Protect the patient’s airway when performing gastric evacuation or giving activated charcoal.
Compulsory diuresis, peritoneal dialysis, hemodialysis, or activated charcoal hemoperfusion have not been shown to be beneficial for cefaclor overdose.
[Pharmacological Toxicology].
In vitro tests have shown that the effect of cephalosporin on bacteria lies in the inhibition of bacterial cell wall synthesis. In vitro studies have shown that most of the following bacteria are susceptible to cefaclor, but the clinical efficacy for infections outside the “indications” is not known.
Gram-positive aerobic bacteria.
Staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains (by in vitro assay). Cross-resistance has been shown between cefaclor and methotrexate penicillin.
Pneumococci
Streptococcus pyogenes
Gram-negative aerobic bacteria.
Bifidobacterium septicum
Escherichia coli
Haemophilus influenzae, including strains that produce β-lactamases and are resistant to ampicillin (ampicillin).
Klebsiella spp.
Cataplasma (Blenheim’s cocci)
Dictyococcus gonorrhoeae
Aspergillus chimaericus
Anaerobic bacteria.
Bacteroidetes spp. (except Bacteroides fragilis)
Black peptococci
Streptococcus digestiveis spp.
Propionibacterium acnes
Note: Pseudomonas spp.; Calcium acetate immobilis; most enterococci; Enterobacter spp.; Morganella spp.; Aspergillus reesei; β-lactamase-negative, ampicillin-resistant Haemophilus influenzae; indole-positive Aspergillus and Serratia spp. are resistant to cefaclor.
Note: Staphylococci resistant to methicillin and most enterococcal strains [Enterococcus faecalis (formerly known as Streptococcus faecalis) and Enterococcus faecalis (formerly known as Streptococcus faecalis)] are resistant to cefaclor and other cephalosporins. Cefaclor is inactive against most strains of Enterobacter spp., Serratia spp., Morganella spp., Proteus mirabilis, and Proteus mirabilis, as well as against Pseudomonas spp. or Fusobacterium spp.
Tricariogenicity (carcinogenicity, mutagenicity and teratogenicity): No studies have been conducted to determine the potential for carcinogenicity or mutagenicity, and multiple reproduction studies have shown no evidence of impaired fertility.
Pharmacokinetics]
Cefaclor is well absorbed after oral administration on an empty stomach. The total absorption rate is the same whether the product is taken with or without food. However, when the product is taken with food, the peak concentration achieved is 50-75% of that observed in fasting individuals and is usually delayed by 45-60 minutes. The mean serum peak concentrations obtained within 30-60 minutes after administration of 250 mg, 500 mg and lg to fasting individuals were approximately 7, 13 and 23 mg/L, respectively. Within 8 hours, approximately 60-85% of the drug is excreted from the urine in its original form via the kidneys, with the majority of the drug excreted within 2 hours of administration. The half-life of the drug in normal human serum is 0.6-0.9 hours. In patients with impaired renal function, the serum half-life of cefaclor is slightly prolonged, and in patients with completely impaired renal function, the plasma half-life of the original drug is 2.3-2.8 hours. The route of excretion has not been measured in patients with severely impaired renal function. Hemodialysis shortens the half-life by 25%-30%.
[Storage].
Store in a cool, dark (away from light and not more than 20℃) dry place under shade and seal.
Package】
Polyester/aluminum/polyethylene pharmaceutical compound film packaging, 6 bags/box, 10 bags/box, 12 bags/box, 18 bags/box.
Expiration date】 18 months
Execution Standard
【Approval number】
State Drug Certificate H20113083
[Drug marketing license holder
Name
Name: Disha Pharmaceutical Group Co.
Registered Address: No. 1-4, Qingdao South Road, Weihai Jingji District
Postal Code: 264205
Contact: (0631) 5920760
Fax
Fax：（0631）5923070 5923072
Web
Address: http://www.disha.com.cn
Manufacturer
Company name: Disha Pharmaceutical Group Co.
Production Address: No.1 Baoyuan Road, Mountainside Town, Weihai Economic and Technological Development Zone
Postal Code: 264205
Contact: (0631) 5920760
Fax
Fax：（0631）5923070 5923072
Web
Address: http://www.disha.com.cn