Cephalexin

CEPHALEXIN- cephalexin capsule
Northwind Pharmaceuticals

Highlights of Prescribing Information

These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES
CEPHALEXIN capsules, for oral use
Initial U.S. Approval: 1971
INDICATIONS AND USAGE
Cephalexin capsules are a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: (1)
Respiratory tract infection (1.1)
Otitis media (1.2)
Skin and skin structure infections (1.3)
Bone infections (1.4)
Genitourinary tract infections (1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) (1)
DOSAGE AND ADMINISTRATION
Adults and patients at least 15 years of age The usual dose is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered (2.1)
Pediatric patients (over 1 year of age)
Otitis media: 75 to 100 mg/kg in equally divided doses every 6 hours (2.2)
All other indications: 25 to 50 mg/kg given in equally divided doses (2.2)
In severe infections: 50 to 100 mg/kg may be administered in equally divided doses (2.2)
Duration of therapy ranges from 7 to 14 days depending on the infection type and severity. (2)
Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min. (2.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 250 mg and 500 mg (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. (4)
WARNINGS AND PRECAUTIONS
Serious hypersensitivity (anaphylactic) reactions: Prior to use, inquire regarding history of hypersensitivity to beta-lactam antibacterial drugs. Discontinue the drug if signs or symptoms of an allergic reaction occur and institute supportive measures. (5.1)
Clostridium difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs. (5.2)
Direct Coomb’s Test Seroconversion: If anemia develops during or after cephalexin therapy, evaluate for drug-induced hemolytic anemia. (5.3)
Seizure Potential: Use lower dose in patients with renal impairment. (5.4)
ADVERSE REACTIONS
The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. (6)
To report SUSPECTED ADVERSE REACTIONS, contact PROPHARMA at 866-562-4590 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)
DRUG INTERACTIONS
Metformin: increased metformin concentrations. Monitor for hypoglycemia. (7.1)
Probenecid — The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended. (7.2)
Administration of cephalexin may result in a false-positive reaction for glucose in the urine. (7.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2017


Please review the manufacturer’s complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80f6f146-a91c-4452-bc83-2e47c5671d91

Full Prescribing Information: Contents*


1. INDICATIONS AND USAGE
1.1 Respiratory Tract Infections
1.2 Otitis Media
1.3 Skin and Skin Structure Infections
1.4 Bone Infections
1.5 Genitourinary Tract Infections
1.6 Usage
2. DOSAGE AND ADMINISTRATION
2.1 Adults and Pediatric Patients At Least 15 years of age
2.2 Pediatric Patients (over 1 year of age)
2.3 Dosage Adjustments in Adult and Pediatric Patients At Least 15 years of Age with Renal Impairment
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Clostridium difficile-Associated Diarrhea
5.3 Direct Coombs’ Test Seroconversion
5.4 Seizure Potential
5.5 Prolonged Prothrombin Time
5.6 Development of Drug-Resistant Bacteria
6. ADVERSE REACTIONS
6.1 Clinical Trials Experience
7. DRUG INTERACTIONS
7.1 Metformin
7.2 Probenecid
7.3 Interaction with Laboratory or Diagnostic Testing
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
10. OVERDOSAGE
11. DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
15. REFERENCES
16. HOW SUPPLIED/STORAGE AND HANDLING
17. PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are not listed.
Please review the manufacturer’s complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80f6f146-a91c-4452-bc83-2e47c5671d91

Indications and Usage Section


1.1 Respiratory Tract Infections
Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin capsules are 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 capsules are 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 capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin capsules are 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 capsules and other antibacterial drugs, cephalexin capsules 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.

Please review the manufacturer’s complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80f6f146-a91c-4452-bc83-2e47c5671d91

Dosage and Administration Section


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.
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 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.


Please review the manufacturer’s complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80f6f146-a91c-4452-bc83-2e47c5671d91

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