Pinnacle Cefalexin 500 mg Capsules

Cephalexin capsules are a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: 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. …

• 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
• Pediatric patients (over 1 year of age) Otitis media: 75 to 100 mg/kg in equally divided doses every 6 hours All other indications: 25 to 50 mg/kg given in equally divided doses In severe infections: 50 to 100 mg/kg may be administered in equally divided doses Duration of therapy ranges from 7 to 14 days depending on the infection type and severity
• Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min
• Adults and
• Pediatric Patients at Least 15 Years of Age The usual dose of oral cephalexin capsules 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 capsules may be needed, up to 4 grams daily in two to four equally divided doses
• Pediatric Patients (over 1 year of age) The recommended total daily dose of oral cephalexin capsules 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. …

250 mg capsules : Dark green opaque/white size “2” hard gelatin capsule filled with off white granular powder and imprinted with “A 42” on dark green opaque cap and “250 mg” on white body with black ink. …

• The safety and effectiveness of cephalexin
• Pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see Dosage and Administration ]

Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment
• Ask the patient about any previous hypersensitivity reactions to cephalexin, other beta-lactams (including cephalosporins) or other allergens Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued
• Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection
• If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider. …

• Cephalexin capsules are contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs
• Patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs

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 glucose in the urine. ( 7.3 ) 7.1 Metformin Administration of cephalexin with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin [see Clinical Pharmacology (12.3) ]. …

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 Coombs’ 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. …

The following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity reactions [see Warning and Precautions (5.1) ] Clostridium difficile -associated diarrhea [see Warnings and Precautions (5.2) ] Direct Coombs’ Test Seroconversion [see Warnings and Precautions (5.3) ] Seizure Potential [see Warnings and Precautions (5.4) ] Effect on Prothrombin Activity [see Warnings and Precautions (5.5) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.6) ] The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain . …

8.1 Pregnancy Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including cephalexin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . …

Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.