CEPHALEXIN 250MG/5ML 200ML ORAL SUSPENSION
Generic: Cephalexin
CEPHALEXIN 250MG/5ML 200ML ORAL SUSPENSION
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Identification
Cephalexin
cephalexin
Lupin Pharmaceuticals, Inc.
HUMAN PRESCRIPTION DRUG
Administration
FOR SUSPENSION
ORAL
ANDA065234
Active Ingredients
| Ingredient | Strength |
|---|---|
| CEPHALEXIN | 250 mg/5mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
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Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Cephalexin USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria in adults and pediatric patients aged one year and older: 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 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 bacteria. ( 1.6 ) 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 in adults and pediatric patients aged one year and older. 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 in adults and pediatric patients aged one year and older. 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 in adults and pediatric patients aged one year and older. 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 in adults and pediatric patients aged one year and older . 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 in adults and pediatric patients aged one year and older . 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.
Dosage & Administration
2 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 ) See full prescribing information directions for mixing cephalexin for oral suspension ( 2.3 ) Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min. ( 2.4 ) 2.1 Recommended Dosage for Adults and Pediatric Patients at Least 15 Years of Age The recommended dosage 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 Recommended Dosage for 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. 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 2.3 Direction for Mixing cephalexin for oral susapension 125 mg/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/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/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/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, 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. 2.4 Dosage 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 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. Table 2. Recommended Cephalexin Dosage for Adult Patients and Pediatric Patients (at Least 15 Years of Age) with Renal Impairment Renal function (Creatinine clearance) Dosage recommendation Greater than or equal to 60 mL/min No dosage adjustment 30 mL/min to 59 mL/min No dosage adjustment; maximum daily dose should not exceed 1 g 15 mL/min to 29 mL/min 250 mg, every 8 hours or every 12 hours 5 mL/min to 14 mL/min not yet on dialysis * 250 mg, every 24 hours 1 mL/min 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.
Adverse Reactions
6 ADVERSE REACTIONS 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 )] The most common adverse reactions associated with cephalexin for oral suspension include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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.
Information for Patients
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 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. Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States Manufactured by: Lupin Limited Mandideep 462046 India Revised: May 2026 ID: 284100 Image 02
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.