Cephalexin For Suspension
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Questions & Answers
Side Effects & Adverse Reactions
BEFORE CEPHALEXIN THERAPY IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS AND PENICILLIN. CEPHALOSPORIN C DERIVATIVES SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS.
SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.
There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to cephalexin.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cephalexin, and may range from mild to life threatening. Therefore, it is important to consider this diagnosis in patients with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis.
After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
Usage in Pregnancy – Safety of this product for use during pregnancy has not been established.
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
Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by S. pneumoniae and S. pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis.
Skin and skin structure infections caused by staphylococci and/or streptococci.
Bone infections caused by staphylococci and/or P. mirabilis.
Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae.
Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin for oral suspension and other antibacterial drugs, cephalexin 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
Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S • H2O and the molecular weight is 365.41.
Cephalexin has the following structural formula:
Sources
Cephalexin For Suspension Manufacturers
-
Lupin Pharmaceuticals, Inc.
![Cephalexin For Suspension [Lupin Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cephalexin For Suspension | Lupin Pharmaceuticals, Inc.
Cephalexin is administered orally.
Adults – The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients – The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
Cephalexin Suspension
Weight
125 mg/ 5 mL
10 kg (22 lb)
½to 1 tsp q.i.d.
20 kg (44 lb)
1 to 2 tsp q.i.d.
40 kg (88 lb)
2 to 4 tsp q.i.d.
Weight
250 mg/ 5 mL
10 kg (22 lb)
¼ to ½ tsp q.i.d.
20 kg (44 lb)
½ to 1 tsp q.i.d.
40 kg (88 lb)
1 to 2 tsp q.i.d.
or
Weight
125 mg/ 5 mL
10 kg (22 lb)
1 to 2 tsp b.i.d.
20 kg (44 lb)
2 to 4 tsp b.i.d.
40 kg (88 lb)
4 to 8 tsp b.i.d.
Weight
250 mg/ 5 mL
10 kg (22 lb)
½ to 1 tsp b.i.d.
20 kg (44 lb)
1 to 2 tsp b.i.d.
40 kg (88 lb)
2 to 4 tsp b.i.d.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
Directions for Mixing
For Cephalexin for Oral Suspension, USP 125 mg/5 mL:
Bottle size
Reconstitution directions
100 mL
Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition
200 mL
Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
For Cephalexin for Oral Suspension, USP 250 mg/5 mL:
Bottle size
Reconstitution directions
100 mL
Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
200 mL
Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
-
Aidarex Pharmaceuticals Llc
Cephalexin For Suspension | Aidarex Pharmaceuticals Llc
Cephalexin is administered orally.
Adults – The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients – The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
Cephalexin Suspension
Weight
125 mg/ 5 mL
10 kg (22 lb)
½to 1 tsp q.i.d.
20 kg (44 lb)
1 to 2 tsp q.i.d.
40 kg (88 lb)
2 to 4 tsp q.i.d.
Weight
250 mg/ 5 mL
10 kg (22 lb)
¼ to ½ tsp q.i.d.
20 kg (44 lb)
½ to 1 tsp q.i.d.
40 kg (88 lb)
1 to 2 tsp q.i.d.
or
Weight
125 mg/ 5 mL
10 kg (22 lb)
1 to 2 tsp b.i.d.
20 kg (44 lb)
2 to 4 tsp b.i.d.
40 kg (88 lb)
4 to 8 tsp b.i.d.
Weight
250 mg/ 5 mL
10 kg (22 lb)
½ to 1 tsp b.i.d.
20 kg (44 lb)
1 to 2 tsp b.i.d.
40 kg (88 lb)
2 to 4 tsp b.i.d.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
Directions for Mixing
For Cephalexin for Oral Suspension, USP 125 mg/5 mL:
Bottle size
Reconstitution directions
100 mL
Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition
200 mL
Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
For Cephalexin for Oral Suspension, USP 250 mg/5 mL:
Bottle size
Reconstitution directions
100 mL
Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
200 mL
Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
-
Preferred Pharmaceuticals, Inc.
Cephalexin For Suspension | Preferred Pharmaceuticals, Inc.
Cephalexin is administered orally.
Adults – The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.
Pediatric Patients – The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
Cephalexin Suspension
Weight
125 mg/ 5 mL
10 kg (22 lb)
½to 1 tsp q.i.d.
20 kg (44 lb)
1 to 2 tsp q.i.d.
40 kg (88 lb)
2 to 4 tsp q.i.d.
Weight
250 mg/ 5 mL
10 kg (22 lb)
¼ to ½ tsp q.i.d.
20 kg (44 lb)
½ to 1 tsp q.i.d.
40 kg (88 lb)
1 to 2 tsp q.i.d.
or
Weight
125 mg/ 5 mL
10 kg (22 lb)
1 to 2 tsp b.i.d.
20 kg (44 lb)
2 to 4 tsp b.i.d.
40 kg (88 lb)
4 to 8 tsp b.i.d.
Weight
250 mg/ 5 mL
10 kg (22 lb)
½ to 1 tsp b.i.d.
20 kg (44 lb)
1 to 2 tsp b.i.d.
40 kg (88 lb)
2 to 4 tsp b.i.d.
In severe infections, the dosage may be doubled.
In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
Directions for Mixing
For Cephalexin for Oral Suspension, USP 125 mg/5 mL:
Bottle size
Reconstitution directions
100 mL
Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition
200 mL
Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
For Cephalexin for Oral Suspension, USP 250 mg/5 mL:
Bottle size
Reconstitution directions
100 mL
Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
200 mL
Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
![Cephalexin For Suspension [Aidarex Pharmaceuticals Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fc538c6b-ddaf-4e09-ae8b-998e3065fa71&name=cephalexin-250mg_5ml-100ml-susp-lupin-2.jpg)
![Cephalexin For Suspension [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5dfec608-4a61-45d6-b535-42c4cb8a170c&name=96a6ddb4-acfe-4a1f-9316-285217ee5942-02.jpg)
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