Ceclor 125mg / 5mL Suspension 60mL
IMPORTANT NOTICE:
For this product, a doctor's prescription is required. Please do not forget to attach a copy of your valid prescription(.jpeg, bmp, gif, jpg, jpeg, jpe, jif, jfif, jfi, png, wbmp, xbm, tiff format). After you have placed your order, our pharmacist will be in touch to confirm your order and validate your prescription. Please present the original copy of your prescription upon the arrival of your order.
An item like loose capsule/tablets, ampules, vials, and refrigerated items is not subject for merchandise return or exchange upon completing the purchase.
PRODUCT DETAILS | |
Brand Name | Ceclor |
Generic Name | Cefaclor |
Strength | 125mg/5ml 60ml |
Dosage Form | Oral Suspension |
Class Name | Cephalosporins |
Indication/Usage | Treatment of the following infections when caused by susceptible strains of the designated microorganisms: |
Otitis media caused by S. pneumoniae, H. influenzae, staphylococci, S. pyogenes (group A β-hemolytic streptococci and M. catarrhalis. | |
Lower respiratory tract infections, including pneumonia, caused by S. pneumoniae, H. influenzae, S. pyogenes (group A β-hemolytic streptococci), M. catarrhalis. | |
Upper respiratory tract infections, including pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic Streptococci) and M. catarrhalis. | |
Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Amoxicillin has been recommended by the American Heart Association as the standard regimen for the prophylaxis of bacterial endocarditis for dental, oral and upper respiratory tract procedures, with penicillin V a rational and acceptable alternative in the prophylaxis against α-hemolytic streptococcal bacteremia in this setting. Ceclor is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing its efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available at present. | |
Urinary tract infections, including pyelonephritis and cystitis caused by E. coli, P. mirabilis, Klebsiella spp, and coagulase-negative staphylococci. | |
Cefaclor has been found to be effective in both acute and chronic urinary tract infections. | |
Pneumonia caused by S. pneumoniae, H. influenzae (including β-lactamase-producing strains) and M. catarrhalis (including β-lactamase-producing strains). | |
Skin and skin structures infections caused by S. aureus (including β-lactamase-producing strains), S. pyogenes (group A β-hemolytic streptococci) and S. epidermidis (including β-lactamase-producing strains). | |
Uncomplicated lower urinary tract infections, including pyelonephritis, cystitis and asymptomatic bacteriuria caused by E. coli, P. mirabilis, Klebsiella spp (K. pneumoniae), S. saprophyticus and coagulase-negative staphylococci. | |
Sinusitis and gonococcal urethritis. | |
Appropriate culture, bacteriologic studies and susceptibility studies should be performed to determine susceptibility of the causative organisms to cefaclor. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly. | |
Dosage and Administration | Suspension: 125 mg/5 mL: Children 18 kg: 20 mg/kg/day (1 teaspoon 3 times a day); 9 kg: 20 mg/kg/day (½ teaspoon 3 times a day) or 40 mg/kg/day (1 teaspoon twice daily). |
Warning and Precautions | Warning |
Before therapy with Ceclor is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefaclor, cephalosporins, penicillins or other drugs. If Ceclor is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity, including anaphylaxis, among β-lactam antibiotics has been clearly documented. If an allergic reaction to cefaclor occurs, Ceclor should be discontinued and, if necessary, the patient should be treated with appropriate agents eg, pressor amines, epinephrine, antihistamines or corticosteroids and other emergency measures. | |
Antibiotics, including Ceclor, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs. | |
Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics (including macrolides, semisynthetic penicillins and cephalosporins); therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with the use of antibiotics. Such colitis may range in severity from mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken. | |
Precautions | |
General: Prolonged use of cefaclor may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. | |
Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. It should be recognized that a positive Coombs' test may be due to cefaclor eg, in hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition. | |
Ceclor should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefaclor in anuria is 2.3-2.8 hrs, dosage adjustments for patients with moderate or severe renal impairment are usually not required. Clinical experience with cefaclor under such conditions is limited: therefore, careful clinical observation and laboratory studies should be made. | |
Antibiotics, including cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. | |
Carcinogenicity, Mutagenicity & Impairment of Fertility: Studies have not been performed to determine potential for carcinogenicity or mutagenicity. Reproduction studies have revealed no evidence of impaired fertility. | |
Use in pregnancy: Reproduction studies have been performed in mice and rats at doses up to 12 times the maximum human dose and in ferrets given 3 times the maximum human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefaclor. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ceclor should be used during pregnancy only if clearly needed. | |
The effect of cefaclor on labor and delivery is unknown. | |
Use in lactation: No studies have been done with Ceclor DS. Small amounts of cefaclor have been detected in mother's milk following administration of single 500-mg doses. Average levels were 0.18, 0.2, 0.21 and 0.16 mcg/mL at 2, 3, 4 and 5 hrs, respectively. Trace amounts were detected at 1 hr. The effect on nursing infants is not known. Caution should be exercised when administered to a nursing woman. | |
Use in children: Safety and effectiveness for use in infants <1 month and children have not been established. | |
Contraindication | Hypersensitivity to cefaclor and other cephalosporins. |
Requires prescription? | Yes |
Storage Conditions | Store at temperatures not exceeding 30°C. Protect from light. The reconstituted suspensions will retain its potency for 14 days when kept in a refrigerator at 2-8°C. |
Manufacturer | Interphil Laboratories Inc. |
Regulatory Classification | Prescription Drug |