Cephalexin Powder, For Suspension
FDA Label NDC 59651-322

Cephalexin for oral suspension is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes in adults and pediatric patients aged one year and older. 

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 in adults and pediatric patients aged one year and older.

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 in adults and pediatric patients aged one year and older.

Cephalexin for oral suspension is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis in adults and pediatric patients aged one year and older. 

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 in adults and pediatric patients aged one year and older.

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.

• The recommended dosage of oral cephalexin for oral suspension 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 for oral suspension may be needed, up to 4 grams daily in two to four equally divided doses.

• The recommended total daily dose of oral cephalexin for oral suspension 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.

See Table 1 for the dosage of cephalexin for oral suspension by weight for pediatric patients.

Table 1: Dosage by Weight of Cephalexin for Oral Suspension for Pediatric Patients

*teaspoon =tsp
Weight of Pediatric Patient	Cephalexin for Oral Suspension (125 mg/5mL)	Cephalexin for Oral Suspension (250 mg/5mL)
OPTION 1	Dosage	Dosage
10 kg	½ to 1 tsp* four times a day	¼ to ½ tsp four times a day
20 kg	1 to 2 tsp four times a day	½ to 1 tsp four times a day
40 kg	2 to 4 tsp four times a day	1 to 2 tsp four times a day
OPTION 2
10 kg	1 to 2 tsp two times a day	½ to 1 tsp two times a day
20 kg	2 to 4 tsp two times a day	1 to 2 tsp two times a day
40 kg	2 to 4 tsp two times a day	2 to 4 tsp two times a day

• 125 mg/5 mL (100 mL when mixed): Prepare suspension time at dispensing. Add to the bottle a total of 67 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/5 mL (200 mL when mixed): Prepare suspension time at dispensing. Add to the bottle a total of 134 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/5 mL (100 mL when mixed): Prepare suspension time at dispensing. Add to the bottle a total of 67 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/5 mL (200 mL when mixed): Prepare suspension time at dispensing. Add to the bottle a total of 134 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 the different concentrations and volumes of the suspension as described above, store in refrigerator. The suspension may be kept for 14 days without significant loss of potency.

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

See Table 2 for the dosage in adults and pediatric patients at least 15 years of age with renal impairment.

For Oral Suspension: 125 mg/5 mL or 250 mg/5 mL of cephalexin as an off-white to pale yellow colored powder for reconstitution in a multi-dose bottle that forms an off-white to light pink suspension with cherry flavor on constitution for each strength, respectively.

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

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 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 occurs, discontinue the drug and institute appropriate treatment.

Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cephalexin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. Acute intravascular hemolysis induced by cephalexin therapy has been reported. If anemia develops during or after cephalexin therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute appropriate therapy.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue cephalexin. Anticonvulsant therapy can be given if clinically indicated.

Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated.

Prescribing cephalexin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Prolonged use of cephalexin may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

The following serious events are described in greater detail in the Warning and Precautions section:

• Hypersensitivity Reactions [see Warning and Precautions (5.1)]
• Clostridioides 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)]
• Prolonged Prothrombin Time [see Warnings and Precautions (5.5)]
• Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.6)]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, the most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported.

Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (ALT) have been reported.

In addition to the adverse reactions listed above that have been observed in patients treated with cephalexin, the following adverse reactions and other altered laboratory tests have been reported for cephalosporin class antibacterial drugs:

Other Adverse Reactions: Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy.

Altered Laboratory Tests: Prolonged prothrombin time, increased blood urea nitrogen (BUN), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.

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)].

The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended.

A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict’s solution or Fehling’s solution.

Risk Summary

Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of cephalexin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups.

Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-times the maximum recommended human dose (MRHD) based on body surface area during organogenesis revealed no evidence of harm to the fetus (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

In animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500 mg/kg/day (approximately 0.6 and 1.2 times the MRHD) based on body surface area, respectively during the period of organogenesis showed no adverse effects on embryofetal development.

In a pre- and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or 500 mg/kg/day of cephalexin from Day 15 of pregnancy to litter Day 21 showed no adverse effects on parturition, litter size, or growth of offspring.

Risk Summary

Data from a published clinical lactation study report that cephalexin is present in human milk. The relative infant dose (RID) is considered to be <l% of the maternal weight adjusted dose. There are limited data on the effects of cephalexin on the breastfed child. There are no data on the effects of cephalexin on milk production.

The developmental health benefits of breastfeeding should be considered along with the mother's clinical need for cephalexin and any potential adverse effects on the breastfed child from cephalexin or from the underlying maternal condition.

The safety and effectiveness of cephalexin have been established in pediatric patients aged one year and older in clinical trials [see Indications and Usage (1.1 – 1.5)] for the dosages described in the dosage and administration section [see Dosage and Administration (2.1, 2.2)].

The safety and effectiveness of cephalexin have not been established in pediatric patients younger than one year old.

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.

This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see Warnings and Precautions (5.4)].

Cephalexin should be administered with careful monitoring in the presence of renal impairment (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies including renal function monitoring should be conducted because safe dosage may be lower than that usually recommended [see Dosage and Administration (2.3)]. Monitor patients longer for toxicity and drug interactions due to delayed clearance.

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.

Cephalexin for oral suspension, USP is a semisynthetic cephalosporin antibacterial drug 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:

Cephalexin-str.jpg (Cephalexin Str)

Cephalexin for oral suspension, USP is supplied in a multi-dose bottle as an off-white to pale yellow colored powder containing 125 mg/5 mL or 250 mg/5 mL of cephalexin for oral use following reconstitution with water. Freshly reconstituted solutions of cephalexin for oral suspension, USP yield an off-white to light pink suspension with cherry flavor for the 125 mg/5 mL and 250 mg/5 mL strengths, respectively. The inactive ingredients in the cephalexin for oral suspension, USP are art cherry flavor, FD&C Red No. 40, modified food starch, silicon dioxide, sodium benzoate, sucrose, xanthan gum. 

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

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 C_max 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.

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)

Streptococcus pyogenes

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.

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.

Cephalexin for oral suspension, USP is off-white to pale yellow colored powder that forms an off-white to light pink suspension with cherry flavor on constitution for the 125 mg/5 mL and 250 mg/5 mL strength, respectively, supplied as follows:

The 125 mg/5 mL for oral suspension  is available as follows:

• 100 mL Bottles                              NDC 59651-322-01
• 200 mL Bottles                              NDC 59651-322-02



The 250 mg/5 mL for oral suspension  is available as follows:



• 100 mL Bottles                              NDC 59651-323-01
• 200 mL Bottles                              NDC 59651-323-02



Directions for mixing are included elsewhere in the labeling [see Dosage and Administration (2.3)].

 

Store at 20^o to 25^oC (68^o to 77^oF) [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 [see Dosage and Administration (2.3)].

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

Patients should be counseled that antibacterial drugs including cephalexin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin is 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 or other antibacterial drugs in the future.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Issued: March 2026

NDC 59651-322-01

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)

AUROBINDO

Package Label- Principal Display Panel (125 mg per 5 mL)

NDC 59651-323-01

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)

AUROBINDO

Package Label- Principal Display Panel (125 mg per 5 mL)