Cefaclor Suspension
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Questions & Answers
Side Effects & Adverse Reactions
BEFORE THERAPY WITH CEFACLOR 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 THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.
IF AN ALLERGIC REACTION TO CEFACLOR OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Antibiotics, including cefaclor, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefaclor Capsules and Cefaclor for Oral Suspension, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.difficile.
C.difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C.difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who presents with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.difficile, and surgical evaluation should be instituted as clinically indicated.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes
Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus.
Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.
Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes
Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsules and Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor Capsules and Cefaclor for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
History
There is currently no drug history available for this drug.
Other Information
Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4S•H2O and the molecular weight is 385.82.
Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sicomet black oxide and titanium dioxide.
After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain citric acid, colloidal silicon dioxide, FD&C Red No. 40, flavor, simethicone emulsion, sodium benzoate, sodium citrate, sucrose, and xanthan gum.
Sources
Cefaclor Suspension Manufacturers
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Rebel Distributors Corp
![Cefaclor Suspension [Rebel Distributors Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cefaclor Suspension | Rebel Distributors Corp
Cefaclor is administered orally.
Adults –The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled.
Pediatric patients–The usual recommended daily dosage for children is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.
Cefaclor Suspension 20 mg/kg/day Weight 125 mg/5 mL 250 mg/5 mL 9 kg 1/2 tsp t.i.d. 18 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 40 mg/kg/day 9 kg 1 tsp t.i.d. ½ tsp t.i.d 18 kg 1 tsp t.i.d.B.I.D. Treatment Option–For the treatment of otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours.
Cefaclor Suspension 20 mg/kg/day (Pharyngitis) Weight 187 mg/5 mL 375 mg/5 mL 9 kg 1/2 tsp b.i.d. 18 kg 1 tsp b.i.d. 2 tsp b.i.d. 40 mg/kg/day (Otitis Media) 9 kg 1 tsp b.i.d. 1/2 tsp b.i.d. 18 kg 1 tsp b.i.d.Cefaclor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see PRECAUTIONS).
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.
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Carlsbad Technology, Inc.
Cefaclor Suspension | Kroger Company
• take every 4 to 6 hours, not more than 6 doses in 24 hoursadults and children 12 years of age and over
1 or 2 tablets
children 6 to under 12 years of age
1 tablet
children 4 to under 6 years of age
do not use unless directed by a doctor
children under 4 years of age
do not use
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Pack Pharmaceuticals, Llc
Cefaclor Suspension | Pack Pharmaceuticals, Llc
Cefaclor is administered orally.
Adults -- The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled.
Pediatric Patients -- The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.
Cefaclor Suspension 20 mg/kg/day Weight 125 mg/5 mL 250 mg/5 mL 9 kg 1/2 tsp t.i.d. 18 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 40 mg/kg/day 9 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 18 kg 1 tsp t.i.d.B.I.D. Treatment Option —For the treatment of otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours.
Cefaclor Suspension 20 mg/kg/day
(Pharyngitis) Weight 375 mg/5 mL 18 kg 1/2 tsp b.i.d. 40 mg/kg/day
(Otitis Media) 9 kg 1/2 tsp b.i.d. 18 kg 1 tsp b.i.d.Cefaclor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see PRECAUTIONS).
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.
Directions for Mixing:Add appropriate water volume as indicated in the following table in two portions to dry mixture in the bottle. Shake well after each addition.
Each 5 mL (Approx. one teaspoonful) will then contain Cefaclor USP monohydrate equivalent to 125 mg, 187 mg, 250 mg or 375 mg anhydrous cefaclor respectively as shown in the following table.
Oversize bottle provides extra space for shaking.
Cefaclor For Oral Suspension, USP Strength
Package Size (when mixed) Water Volume to Add Anhydrous Cefaclor/5 mL
(Approx. one teaspoonful) 125 mg/5 mL
150 mL 106 mL 125 mg 250 mg/5 mL 150 mL 106 mL 250 mg 375 mg/5 mL 100 mL 68 mL 375 mg -
Carlsbad Technology, Inc.
Cefaclor Suspension | Carlsbad Technology, Inc.
Cefaclor is administered orally.
Adults -- The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled.
Pediatric Patients -- The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.
Table 3: Cefaclor for Oral Suspension, USP 20 mg/kg/day Weight 125 mg/5 mL 250 mg/5 mL 9 kg 1/2 tsp t.i.d. 18 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 40 mg/kg/day 9 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 18 kg 1 tsp t.i.d.B.I.D. Treatment Option —For the treatment of otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours.
Table 4: Cefaclor for Oral Suspension, USP 20 mg/kg/day
(Pharyngitis) Weight 187 mg/5 mL 375 mg/5 mL 9 kg 1/2 tsp b.i.d. 18 kg 1 tsp b.i.d. 1/2 tsp b.i.d. 40 mg/kg/day
(Otitis Media) 9 kg 1 tsp b.i.d. 1/2 tsp b.i.d. 18 kg 1 tsp b.i.d.Cefaclor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see PRECAUTIONS).
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.
Directions for Mixing:Add appropriate water volume as indicated in the following table in two portions to dry mixture in the bottle. Shake well after each addition.
Each 5 mL (approximately one teaspoonful) will then contain Cefaclor, USP, monohydrate equivalent to 125 mg, 187 mg, 250 mg or 375 mg anhydrous cefaclor, respectively, as shown in the following table.
Oversize bottle provides extra space for shaking.
Table 5: Cefaclor For Oral Suspension, USP Strength
Package Size (when mixed) Water Volume to Add Anhydrous Cefaclor/5 mL
(approx. one teaspoonful) 125 mg/5 mL 75 mL 53 mL 125 mg 150 mL 106 mL 187 mg/5 mL 50 mL 35 mL 187 mg 100 mL 70 mL 250 mg/5 mL 75 mL 53 mL 250 mg 150 mL 106 mL 375 mg/5 mL 50 mL 34 mL 375 mg 100 mL 68 mL
![Cefaclor Suspension [Carlsbad Technology, Inc.]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
![Cefaclor Suspension [Pack Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ac5e34a9-994b-4611-aa41-3d1ed58a91c0&name=309bc345-79d1-4e7a-80fc-cfafd8e1010b-02.jpg)
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