Prescription Drug Information: Cephalexin (Page 3 of 3)

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4)].

12.3 Pharmacokinetics

Absorption: Cephalexin is acid stable and may be given without regard to meals. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL, respectively, were obtained at 1 hour. Serum levels were detectable 6 hours after administration (at a level of detection of 0.2 mcg/mL).

Distribution: Cephalexin is approximately 10% to 15% bound to plasma proteins.

Excretion: Cephalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations following the 250 mg, 500 mg, and 1 g doses were approximately 1000, 2200, and 5000 mcg/mL respectively.

Drug Interactions
In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean Cmax and AUC increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%. No information is available about the interaction of cephalexin and metformin following multiple doses of either drug.

12.4 Microbiology

Mechanism of Action

Cephalexin is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis.

Resistance

Methicillin-resistant staphylococci and most isolates of enterococci are resistant to cephalexin. Cephalexin is not active against most isolates of Enterobacter spp., Morganella morganii , and Proteus vulgaris. Cephalexin has no activity against Pseudomonas spp., or Acinetobacter calcoaceticus. Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibacterial drugs.

Antimicrobial Activity

Cephalexin has been shown to be active against most isolates of the following bacteria both in vitro and in clinical infections [see Indications and Usage ( 1)].

Gram-positive bacteria

Staphylococcus aureus (methicillin-susceptible isolates only) Streptococcus pneumoniae (penicillin-susceptible isolates)

Gram-negative bacteria

Escherichia coli

Haemophilus influenzae

Klebsiella pneumoniae

Moraxella catarrhalis

Proteus mirabilis

Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon body surface area.

16 HOW SUPPLIED/STORAGE AND HANDLING

Cephalexin Capsules USP

250 mg: Swedish orange body and gray cap imprinted “TEVA” on the cap and “3145” on the body, in bottles of 100 (NDC 0093-3145-01) and 500 (NDC 0093-3145-05).

500 mg: Swedish orange body and Swedish orange cap imprinted “TEVA” on the cap and “3147” on the body, in bottles of 100 (NDC 0093-3147-01) and 500 (NDC 0093-3147-05).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

Cephalexin for Oral Suspension* USP

(a cherry mixed fruit flavored formula)

125 mg/5 mL: bottles of 100 mL (NDC 0093-4175-73) and 200 mL (NDC 0093-4175-74).

250 mg/5 mL: bottles of 100 mL (NDC 0093-4177-73) and 200 mL (NDC 0093-4177-74).

Directions for mixing are included on the label.

Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Shake well before using. Keep tightly closed.

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

17 PATIENT COUNSELING INFORMATION

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 (5.1)

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.

Antibacterial Resistance

Counsel patients that antibacterial drugs including cephalexin capsules, and cephalexin for oral suspension, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin capsules, and cephalexin for oral suspension are prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cephalexin capsules, and cephalexin for oral suspension or other antibacterial drugs in the future.

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. V 12/2020

Package/Label Display Panel

NDC 0093-3145-01

Cephalexin

Capsules USP

250 mg

Rx only

100 CAPSULES

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-3147-01

Cephalexin

Capsules USP

500 mg

Rx only

100 CAPSULES

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-4175-73

Cephalexin

for Oral Suspension, USP

125 mg per 5 mL

when reconstituted according to directions.

Usual Pediatric Dose: 25 to 50 mg per kg a day in four

divided doses. For more severe infections, dose may be

doubled. See accompanying literature.

Rx only

FOR ORAL USE ONLY

100 mL (when mixed)

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-4177-73

Cephalexin

for Oral Suspension, USP

250 mg per 5 mL

when reconstituted according to directions.

Usual Pediatric Dose: 25 to 50 mg per kg a day in four

divided doses. For more severe infections, dose may be

doubled. See accompanying literature.

Rx only

FOR ORAL USE ONLY

100 mL (when mixed)

image
(click image for full-size original)
CEPHALEXIN
cephalexin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3145
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALEXIN (CEPHALEXIN ANHYDROUS) CEPHALEXIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
PROPYLENE GLYCOL
FERRIC OXIDE YELLOW
Product Characteristics
Color gray, orange (swedish orange) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code TEVA;3145
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3145-01 100 CAPSULE in 1 BOTTLE None
2 NDC:0093-3145-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062702 09/30/1990
CEPHALEXIN
cephalexin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3147
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALEXIN (CEPHALEXIN ANHYDROUS) CEPHALEXIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
PROPYLENE GLYCOL
Product Characteristics
Color orange (swedish orange) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code TEVA;3147
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3147-01 100 CAPSULE in 1 BOTTLE None
2 NDC:0093-3147-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062702 09/30/1990
CEPHALEXIN
cephalexin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-4175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALEXIN (CEPHALEXIN ANHYDROUS) CEPHALEXIN ANHYDROUS 125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
BENZYL ALCOHOL
MALTODEXTRIN
STARCH, CORN
SILICON DIOXIDE
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor CHERRY (cherry mixed fruit) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-4175-73 100 mL in 1 BOTTLE None
2 NDC:0093-4175-74 200 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062703 09/30/1990
CEPHALEXIN
cephalexin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-4177
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALEXIN (CEPHALEXIN ANHYDROUS) CEPHALEXIN ANHYDROUS 250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
BENZYL ALCOHOL
MALTODEXTRIN
STARCH, CORN
SILICON DIOXIDE
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor CHERRY (cherry mixed fruit) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-4177-73 100 mL in 1 BOTTLE None
2 NDC:0093-4177-74 200 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062703 09/30/1990
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2020 Teva Pharmaceuticals USA, Inc.

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