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Product description
Approved date: January 29, 2007
Date of revision: October 1, 2010
November 30, 2015
Cefaclor particle instruction
Please read the instructions carefully and use them under the guidance of a physician.
【Drug Name】
Common name: Cefaclor particles
English name: Cefaclor Granules
Pinyin: Toubaokeluo Keli
[Ingredients] The main ingredient of this product is: cefaclor. Its chemical name is: (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.
Molecular formula: C15H14ClN3O4S·H2O
Molecular weight: 385.82
【Properties】 This product is soluble particles or suspended particles; gas aroma.
[Indications] This product is mainly suitable for respiratory system, urinary system, otolaryngology and skin and soft tissue infections caused by sensitive bacteria.
[Specifications] 0.125g according to C15H14ClN3O4S
【Dosage】
This product is suitable for oral administration after fasting. Add this product to an appropriate amount (20 ~ 30ml) of hot water, and completely dissolve it after shaking.
Adults usually use 0.25g (2 bags) once a day, 3 times a day. The dose may be doubled in case of severe infection, but the total amount per day does not exceed 4g (32 bags), or as directed by your doctor.
Pediatrics are usually given in 20mg/kg per day, divided into 3 times. The serious infection can be increased to 40mg/kg, but the total amount per day does not exceed 1g (8 bags).
【Adverse reactions】
1. The adverse reactions associated with cefaclor treatment are as follows:
Allergic reactions: According to reports, it accounts for about 1.5% of patients, including urticaria-like rash (1/100). The itching, urticaria and Coomb test were positive, and the incidence was below 1/200.
It has been reported that the use of cefaclor can cause a serum-like reaction. This response is characterized by pleomorphic erythema, rash, and other skin manifestations of arthritis/arthritis, with or without fever. Unlike typical serum diseases, it is rarely associated with lymphadenopathy and proteinuria, no immune complexes that enter the circulation, and no signs of sequelae. Intensive research is being conducted, and the serum-like response appears to be due to allergies, often occurring during the second course of cefaclor or during the second course of treatment. It has been reported that children are more likely to have such reactions than adults, with a total incidence of one in 200 patients (0.5%) in a concentration trial and 2 (0.024%) in a total of 8346 clinical trials [in each The incidence of children in the second clinical trial was 0.055%, and in the report of side effects, 1 in 38,000 (0.003%)], the signs and syndromes that appeared several days after the start of treatment disappeared a few days after stopping treatment. This type of response occasionally causes the patient to be hospitalized, but the length of hospital stay is usually very short (the average hospital stay is 2 to 3 days according to post-marketing surveillance studies). Among these patients requiring hospitalization, the syndromes ranged from mild to severe at admission, and the incidence of serious reactions was higher in children. Antihistamines and glucocorticoids appear to be used to relieve symptoms and no serious sequelae have been reported.
More severe allergic reactions (including Steverns Johnson syndrome, toxic epithelial necrolysis and allergies) are rarely reported, and patients with a history of penicillin allergy may have more frequent allergic reactions.
Gastrointestinal symptoms: incidence rate of about 2.5%, soft stool, stomach discomfort, loss of appetite, nausea, vomiting, belching, including diarrhea (1 of 70 cases).
Pseudomembranous colitis: may occur during or after antibiotic treatment. Temporary hepatitis and cholestasis of jaundice are rare reported.
Other treatment-related side effects include: eosinophilia (1 in 50), genital itching or vaginitis (less than 1 in 100), thrombocytopenia or reversible interstitial nephritis is rare.
2. It is not yet certain whether the adverse reactions associated with cefaclor are:
Central nervous system: increased activity, nervousness, insomnia, mental confusion, high blood pressure, dizziness, hallucinations and lethargy are rare reports.
It has been reported that clinical laboratory test results can have transient abnormal values. Although the cause is unknown, it is listed below as a message for the attention of physicians.
Liver: AST, ALT, or alkaline phosphatase values are slightly elevated (1 of 40 in the latter).
Hematopoietic system: As reported for other β-lactam antibiotics, this product can cause transient lymphocytosis and leukopenia. Rarely causes hemolytic anemia. Aplastic anemia, agranulocytosis and possibly clinically significant reversible neutropenia.
Kidney: BUN or serum creatinine levels are slightly elevated (the latter is less than 1 in 500) or abnormal urine analysis, such as proteinuria, tubular urine, etc. (less than 1 in 200).
Some cephalosporins can cause epilepsy and should be discontinued. If clinically necessary, anticonvulsants can be given.
[Contraindications] Disabled for allergic to cefaclor and other cephalosporins.
【Precautions】
1. Before using cefaclor, care should be taken to determine if the patient has previously been allergic to cefaclor or other cephalosporins, penicillin or other drugs. If this product is used in patients who are allergic to penicillin, it should be noted because the literature clearly reports the presence of cross-allergic reactions in β-lactam antibiotics.
If an allergic reaction to cefaclor occurs, stop taking it immediately. If necessary, first aid measures should be used, including oxygen inhalation, intravenous antihistamines and epinephrine, and tracheal intubation.
Antibiotics (including cefaclor) should be used with caution in patients with previous types of allergies (especially for drugs).
2. Cefaclor should be used with caution in the presence of severe renal insufficiency, as cefaclor has a half-life of 2.3 to 2.8 hours in patients with anuria. For patients with moderate to severe renal impairment, the dose is usually constant. However, the clinical experience of applying cefaclor in this case is limited, so careful clinical observation and laboratory examination should be performed.
3. It has been reported that virtually all broad-spectrum antibiotics (including macrolide antibiotics, semisynthetic penicillins, and cephalosporins) produce pseudomembranous colitis. Therefore, if a patient with antibiotics develops diarrhea, it is important to consider this diagnosis. The extent may range from mild to life-threatening. For cases of mild pseudomembranous colitis, usually only need to stop the drug to work, for moderate to severe cases, appropriate treatment should be taken.
For patients with a history of gastrointestinal disease (especially colitis), use broad-spectrum antibiotics (including cephalosporins) with caution.
4. General precautions: Long-term use of cefaclor will cause insensitive strains to multiply. Therefore, careful observation of the patient is necessary. If a double infection occurs during treatment, appropriate measures must be taken.
5. It has been reported that the direct Coombs test was positive during cephalosporin antibiotic treatment. For example, in a hematological examination or in a secondary cross-matching process of blood transfusion (when an antiglobulin test is performed) or a cousin test of a newborn who has taken cephalosporin before delivery, the positive result is Both may be related to drugs.
6. Interference with laboratory test indicators: copper sulfate urine test can be false positive, but the glucose enzyme test method is not affected; serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and blood urea Nitrogen can be elevated; there is a false increase in serum and urine creatinine values measured by the Jaffe reaction.
7. This product should be taken orally on an empty stomach, because food can delay its absorption. Milk does not affect the absorption of this product.
8. This product should be placed out of reach of children.
[Pregnant women and lactating women]
Pregnant women: Multiple reproduction studies in mice and rats, the dose is up to 12 times the amount of humans, and the dose of white peony is three times the maximum dose. The results indicate that there is no evidence that cefaclor harms fertility or endangers the fetus. However, there are no adequately controlled clinical studies for pregnant women. Because animal reproduction research does not fully predict the body's response, it is not appropriate for pregnant women to use this product unless it is necessary.
Childbirth: The effect of cefaclor on childbirth is unclear.
Lactating women: A small amount of cefaclor can be measured in breast milk after oral administration of cefaclor 500 mg once daily. The average levels at 2, 3, 4 and 5 hours after service are 0.18, 0.20, 0.21 and 0.16 mg, respectively. /L, a trace amount of drug was measured at the 1st hour. The effect of this product on infants and young children is unknown. It is prudent to apply cefaclor to lactating women.
[Children's medication] The efficacy and safety of this product for infants within one month has not been established.
[Geriatric Use] According to the literature, compared with healthy adult subjects under 45 years old, healthy elderly subjects (over 65 years old) taking 750mg cefaclor alone, 40-50% of patients have high AUC, and 20% The patient has a low renal clearance rate. These differences are mainly caused by age-related renal functional diseases. In clinical studies, when elderly patients are taken at recommended doses in adults, the clinical efficacy and safety are similar to those of adult patients, and the doses administered in elderly patients are not different. Therefore, unless the elderly patient is weak, malnourished or severely impaired renal function, it is generally not necessary to adjust the dose.
【medicine interactions】
1. Antacid: When using this product within 1 hour of using aluminum hydroxide or magnesium hydroxide, the absorption of this product will be reduced. H2 receptor antagonists do not alter the extent and rate of absorption of this product.
2. Probenecid: Probenecid can reduce the renal excretion rate of this product.
3. Warfarin: When this product is used in combination with warfarin, it is rarely reported clinically that prothrombin time is prolonged, with or without bleeding. At present, there is no special research to explore the role of this.
4. Strong diuretics such as furosemide, etalic acid, and bumetanide, and antineoplastic drugs such as carbophyllum, streptozotocin, and aminoglycoside antibiotics may increase nephrotoxicity when combined with this product.
5. Clavulanic acid enhances the antibacterial activity of this product against certain Gram-negative bacilli that are resistant to this product by producing beta lactamase.
6. Laboratory tests: The use of this product can lead to false positive reactions of glucose in the urine. When the test is carried out in Benedict, s and Fehling, s solution, this phenomenon also occurs in patients who use cephalosporin and also on Clinitest tablets.
【Drug overdose】
Toxic symptoms after taking an excess of cefaclor include: nausea, vomiting, upper abdominal discomfort and diarrhea, and the severity of upper abdominal discomfort and diarrhea is dose related. If there are other symptoms, it may be secondary to the original disease, allergic reaction or other poisoning effects.
In the treatment of drug overdose, the possibility of multiple drug overdose, drug interactions, and individual differences in patient pharmacokinetics should be considered.
Except for five times the normal dose of cefaclor, it is not necessary to remove excess drug from the gastrointestinal tract. Pay attention to protect the patient's airway and maintain ventilation and perfusion. The patient's vital signs, blood gas and serum electrolytes are closely monitored and maintained within an acceptable range. By giving activated carbon, the absorption of the drug through the gastrointestinal tract can be reduced, and activated carbon is more effective than vomiting and lavage in many cases. Consider using activated carbon instead of gastric emptying, or add activated carbon in addition to gastric emptying. Multiple doses of activated carbon may accelerate the elimination of certain absorbed drugs. Care should be taken to protect the patient's airway when performing gastric emptying or treatment with activated carbon.
Mandatory catheterization, peritoneal dialysis, hemodialysis or carbon perfusion have not been shown to be beneficial for the excess of cefaclor.
【Pharmacology and Toxicology】
Pharmacological action
Cefaclor is a second-generation cephalosporin, an oral semi-synthetic antibiotic, which has a broad-spectrum antibacterial effect. Its mechanism of action is the same as that of other cephalosporins, and it mainly achieves bactericidal action by inhibiting the synthesis of cell walls. This product is stable to certain bacteria's β-lactamase, so some β-lactamase-producing microorganisms may be sensitive to this product.
In vitro and clinical studies have confirmed that this product has antibacterial activity against most of the following microorganisms:
Gram-positive bacteria: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae; this product is not effective against staphylococcus methicillin.
Gram-negative bacteria: Haemophilus influenzae (only for strains not producing β-lactamase), Moraxella catarrhalis (including strains producing β-lactamase).
Toxicological research
There are no studies on the genotoxicity, carcinogenicity and effects on fertility of this product. The results of reproductive toxicity test in mice, rats and ferrets showed that there was no obvious toxicity when the dose was 3 to 5 times higher than the recommended maximum dose (calculated by body surface area), but it was not completely due to animal testing. The results of clinical medications are predicted, so pregnant women can only take this product when they really need it.
[Pharmacokinetics] Cefaclor is well absorbed on an empty stomach, and the total absorption is the same regardless of whether it is taken with food. However, when taken with food, the peak concentration reached is 50-70% of the peak concentration observed after taking the fasting, and usually takes 45 to 60 minutes to appear. After taking cefaclor 250mg, 500mg and 1000mg for 30~60 minutes, the blood concentration peaks were 7mg/L, 13mg/L and 25mg/L respectively. Within 8 hours after taking the drug, the peak concentration of urine drug was 500mg/ L, 900 mg/L and 1900 mg/L. Cefaclor is widely distributed in the body, and can reach an effective concentration in the middle ear pus, and also in saliva and tears. The serum protein binding rate is low, about 25%. About 15% of the dose is metabolized in the body. Within 8 hours, about 60-85% of the drug is excreted from the urine by the kidney. The concentration in the urine is high, and a small amount is excreted from the bile. Most of the drugs are taken for 2 hours. Discharged inside. The half-life of cefaclor in normal people is 0.6 to 0.9 hours. For patients with impaired renal function, the serum half-life of cefaclor is slightly longer. For patients with severely impaired renal function, the route of excretion of this product has not been measured, and hemodialysis can shorten the half-life by 25-50%. For elderly healthy people with normal serum creatinine value (greater than 65 years old), it is known that they have higher plasma drug concentration peaks and AUC values, which is considered to be caused by age-related decline in renal function, but it is not obvious. Clinical features. Therefore, it is not necessary to adjust the dose for elderly people with normal serum creatinine values.
[Storage] Shading, sealing, and storing in a cool place (cool and dark (not exceeding 20 ° C).
[Packing] aluminum-plastic composite bag, 6 bags per box; 8 bags per box; 12 bags per box.
[Validity Period] tentatively 24 months
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
[Approval No.] National Drug Standard H20059922
【manufacturer】
Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
Production address: Guangdong Province
No. 66, Pidi Avenue, Yueshan Town, Kaiping City
Postal code: 529331
Phone number: 0750-2789348 2783621
400-8899-328 (National Service Phone)
Fax number: 0750-2789348
Website: http://www.basikshuttle.com
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