Approved on.
Date of revision.
Cefaclor Dry Suspension Instructions
Please read the instructions carefully and use under the guidance of your physician
Warning: contraindicated in patients with hypersensitivity to this product and other cephalosporins.
[Drug Name].
Generic name: Cefaclor dry mix suspension
English Name: Cefaclor for Suspension
Hanyu Pinyin: Toubaokeluo Ganhunxuanji
[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: C15 H14ClN3O4S-H2O
Molecular weight: 385.82
[Properties
This product is fine granules or powder; aromatic.
[Indications
This product is indicated for the treatment of infections caused by the following sensitive strains of bacteria:
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), and the American Heart Association recommends carboxymethylpenicillin (Amoxicillin) for the prevention of bacterial endocarditis due to dental, oral, and upper respiratory tract infections; in this regard, penicillin V is a reasonable choice for the prevention of alpha-hemolytic streptococcal infections. 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 β-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).
Sinusitis
Gonococcal urethritis
Appropriate tissue culture and susceptibility studies should be performed to determine the susceptibility of the causative organism to cefaclor.
[Specifications]
0.125g(byC15H14ClN3O4Scount)
[Dosage].
Orally. Adults: The usual adult dose is 0.25g every 8 hours. The dose for bronchitis and pneumonia is 0.25g once, three times daily. 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 dose of 4 g daily 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 3 g may be given in combination with propofol lg.
[Adverse reactions
Adverse reactions associated with cefaclor treatment include.
Allergic reactions: reported in about 1.5% of patients, including urticaria-like rash (1/100). Pruritus, urticaria, and positive Coombs test, all occurring at an incidence of less than 1/200.
Seropathy-like reactions have been reported with cefaclor. This reaction is characterized by polymorphic erythema, rash, and other skin manifestations with arthritis/arthralgia, with or without fever. Unlike typical serum sickness, it is rarely associated with lymphadenopathy and proteinuria, there are no circulating immune complexes, and there are no signs 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 cases in 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 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, rare in reports. 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.
Causal relationship is not clear.
Central nervous system side effects: hyperfunction, hypersensitivity, insomnia, confusion, hypertension, dizziness, hallucinations, and somnolence, which have been reported rarely.
Temporary outliers in clinical laboratory test results have been reported. Although the etiology is unknown, it is listed below as information to bring to the physician’s attention.
Hepatic side effects: slightly elevated AST (SGOT), ALT (SGPT), or alkaline phosphatase values (the latter in 1 of 40 cases). Abnormal liver function tests have been reported.
Hematopoietic system: As reported with other beta-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 (less than 1/500 in the latter) or abnormal urinalysis (less than 1/200 in the latter). Abnormal renal function tests have been reported.
Some cephalosporins can cause epilepsy, especially in patients with renal insufficiency and without dose reduction, and should be discontinued if seizures associated with drug therapy occur. Anticonvulsants may be given if clinically indicated.
[Contraindications
It is contraindicated in patients with hypersensitivity to this and other cephalosporins.
[Precautions
General precautions: Long-term use of cefaclor can result in 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.
Directly positive Coombs’ tests have been reported during treatment with cephalosporin-based 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 before 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 to 2.8 hours. For patients with moderate to severe renal impairment, the dose is usually unchanged. In this setting, clinical experience with cefaclor is limited, and careful clinical observation and laboratory studies should be performed.
Caution should be exercised with the use of antibiotics, including cephalosporins, in patients with a history of gastrointestinal disease (especially colitis).
Warnings: Before using cefaclor, be careful to determine if the patient has a previous allergy 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 anaphylaxis) has been clearly reported in the literature with beta-lactam antibiotics.
If an allergic reaction to cefaclor occurs, the drug should be discontinued immediately. If necessary, it should be treated with an appropriate medication (eg, pressoramide, antihistamines, or corticosteroids).
Antibiotics (including cefaclor) should be used with caution in patients who show 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, and in mild cases of pseudomembranous colitis, simply discontinuing the drug usually works, whereas in moderate to severe cases, appropriate therapeutic measures should be taken.
[For pregnant and lactating women
Dosing during pregnancy: Multiple reproduction studies were conducted in mice and rats at doses up to 12 times the human dosage and in 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 do not always predict the response in humans, this product should not be used during pregnancy unless it is 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 postdose, respectively, and traces of the drug 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 Dosage].
Pediatric Use: The efficacy and safety of this product in infants less than one month old 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, 40 mg/kg/day with a maximum dose of lg/day.
Cefaclor dry suspension
Children’s weight 20mg / kg / day 40mg / kg / day
9kg 1/2 sachet per dose, three times daily 1 sachet per dose, three times daily
18kg 1 sachet each time, three times a day 2 sachets each time, three times a day
[Geriatric use] None. See “Dosage and Administration”.
[Drug Interactions
Drug/Laboratory Interactions: Urinary glucose in patients taking cefaclor may show a false-positive reaction in tests using Benedict’s and Ferring’s solutions and using CLINITEST tablets instead of TES-TAPE (glucose enzyme test strips, Eli Lilly and Company).
Enhanced anticoagulation has been reported rarely when cefaclor and oral anticoagulants are given together. As with other beta-lactam antibiotics, transrenal excretion of cefaclor is inhibited by probenecid.
[Drug overdose].
Signs and symptoms: Toxicity syndromes that occur after an 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: When treating overdose syndromes, consider the potential for multiple drug overdoses, drug-drug interactions, and differences in patient pharmacokinetics.
Unless five times the normal amount of cefaclor has been taken. It is not necessary to remove the overdose from the gastrointestinal tract. 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 certain drugs that have been absorbed. Protect the patient’s airway when performing gastric emptying or giving activated charcoal.
Compulsory diuresis, peritoneal dialysis, hemodialysis, or activated charcoal hemoperfusion have not been shown to be beneficial for cefaclor overdose.
[Pharmacology and Toxicology
In vitro tests have shown that the effect of cephalosporins 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 was shown between cefaclor and methylpenicillin.
Pneumococci
Streptococcus pyogenes
Gram-negative aerobic bacteria.
Septic acid bacteria
Esherichia coli
Haemophilus influenzae, including strains that produce beta-lactamases and are resistant to ampicillin (ampicillin).
Klebsiella spp.
Katamora (Blenheimia)
Diphtherococcus gonorrhoeae
Amoeba oddis
Anaerobic bacteria.
Anaplasma spp. (except for Mycobacterium fragilis)
Black digestive cocci
Streptococcus pepticus spp.
Propionibacterium acnes
Note: Pseudomonas spp.; Calcium acetobacter; most enterococci; Enterobacter spp.; Morganella morganii; 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 Streptococcus faecalis) and Enterococcus faecalis (formerly Streptococcus faecalis)] are resistant to cefaclor and other cephalosporins. Cefaclor is inactive against most strains of Enterobacteriaceae, Serratia marcescens, Morganella spp, Proteus mirabilis, and Proteus mirabilis, as well as against Pseudomonas spp or Fusobacterium spp.
Triptogenicity (carcinogenicity, mutagenicity, and teratogenicity): No studies have been performed to determine the potential for carcinogenicity or mutagenicity, and multiple reproduction studies have shown no evidence of impairment of fertility.
[Pharmacokinetics].
Cefaclor is well absorbed after oral administration on an empty stomach. The total absorption rate was the same whether or not the product was taken with 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 for 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 in its original form via the kidneys in the urine, 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 its half-life by 25%-30%.
[Storage] Protect from light, seal, and store in a cool, dark (protected from light and not exceeding 20°C) dry place. .
[Package]
Polyester/Aluminum/Flow-through polypropylene pharmaceutical laminates,6bags/box;9bags/box;12bags/boxes.
[Expiration date] 12 months
[Executive Standard]
[approval number][approval number]H10940087
[manufacturer][manufacturer][manufacturer “font-family:Times New Roman”>
Marketing license holder: Hainan Xiangsheng Pharmaceutical Co.
Registered Address: No. 2, Yogu 3rd Road, Xiuying District, Haikou City, Hainan Province, China
Manufacturer: Hainan Xiangsheng Pharmaceutical Co.
Production Address: No. 15, Industrial Avenue, Laocheng Economic Development Zone, Hainan Province
Postal code: 571924
Phone number: 0898-66814532
Customer Service Hotline.
800-8289800 (Toll-free from landlines only.)
400-8877552 (can be dialed from mobile and landline phones, charged by local call.)
Fax number: 0898-67201188
Website: www.simcere.com