Cephalexin

CEPHALEXIN — cephalexin for suspension
A-S Medication Solutions

1 INDICATIONS AND USAGE

1.1 Respiratory Tract Infections

Cephalexin for oral suspension is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.

1.2 Otitis Media

Cephalexin for oral suspension is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.

1.3 Skin and Skin Structure Infections

Cephalexin for oral suspension is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.

1.4 Bone Infections

Cephalexin for oral suspension is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.

1.5 Genitourinary Tract Infections

Cephalexin for oral suspension is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.

1.6 Usage

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 infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.

2 DOSAGE AND ADMINISTRATION

2.1 Adults and Pediatric Patients at Least 15 Years of Age

The usual dose of oral cephalexin is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days.

For more severe infections larger doses of oral cephalexin may be needed, up to 4 grams daily in two to four equally divided doses.

2.2 Pediatric Patients (over 1 year of age)

The recommended total daily dose of oral cephalexin for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses.

For the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in equally divided doses.

Cephalexin for oral suspension
Weight 10 kg (22 lb) 125mg/5mL ½ to 1 tsp q.i.d. 250mg/5mL ¼ to ½ tsp q.i.d.
20 kg (44 lb) 40 kg (88 lb) 1 to 2 tsp q.i.d. 2 to 4 tsp q.i.d. Or ½ to 1 tsp q.i.d. 1 to 2 tsp q.i.d.
Weight 10 kg (22 lb) 20 kg (44 lb) 125mg/5mL 1 to 2 tsp b.i.d. 2 to 4 tsp b.i.d. 250mg/5mL ½ to 1 tsp b.i.d. 1 to 2 tsp b.i.d.
40 kg (88 lb) 4 to 8 tsp b.i.d. 2 to 4 tsp b.i.d.

Directions for Mixing

125 mg per 5 mL (100 mL when mixed): Prepare suspension time at dispensing. Add to the bottle a total of 69 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 125 mg cephalexin in each 5 mL (teaspoonful).

125 mg per 5 mL (200 mL when mixed): Prepare suspension time at dispensing. Add to the bottle a total of 138 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 125 mg cephalexin in each 5 mL (teaspoonful).

250 mg per 5 mL (100 mL when mixed): Prepare suspension time at dispensing. Add to the bottle a total of 69 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 250 mg cephalexin in each 5 mL (teaspoonful).

250 mg per 5 mL (200 mL when mixed): Prepare suspension time at dispensing. Add to the bottle a total of 138 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 250 mg cephalexin in each 5 mL (teaspoonful).

* After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency.

2.3 Dosage Adjustments in Adult and Pediatric Patients at Least 15 Years of Age with Renal Impairment

Administer the following dosing regimens for cephalexin for oral suspension to patients with impaired renal function [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6) ].

Table 1. Recommended Dose Regimen for Patients with Renal Impairment
Renal function Dose regimen recommendation
Creatinine clearance 60 mL/min No dose adjustment
Creatinine clearance 30 to 59 mL/min No dose adjustment; maximum daily dose should not exceed 1 g
Creatinine clearance 15 to 29 mL/min 250 mg, every 8 hours or every 12 hours
Creatinine clearance 5 to 14 mL/min not yet on dialysis* 250 mg, every 24 hours
Creatinine clearance 1 to 4 mL/min not yet on dialysis* 250 mg, every 48 hours or every 60 hours

* There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

3 DOSAGE FORMS AND STRENGTHS

Cephalexin for oral suspension USP

125mg/5mL and 250 mg/5mL

4 CONTRAINDICATIONS

Cephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of cephalexin. Before therapy with cephalexin for oral suspension is instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy.

If an allergic reaction to cephalexin for oral suspension occurs, discontinue the drug and institute appropriate treatment.

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