Drug Catalog - Product Detail
CEPHALEXIN ORAL SUSPENSION 250MG/5ML 200ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0441-02 | LUPIN PHARMACEUTICALS | 200 | 250MG/5ML | SUSPENSION |
PACKAGE FILES
Generic Name
CEPHALEXIN
Substance Name
CEPHALEXIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA065234
Description
11 DESCRIPTION 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 C 16 H 17 N 3 O 4 S • H 2 O and the molecular weight is 365.41. Cephalexin has the following structural formula: Cephalexin for oral suspension, USP is supplied in a multi-dose bottle as pink coloured 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 yield a pink coloured suspension with characteristic odour on constitution for the 125 mg/5 mL and 250 mg/5 mL strengths, respectively. The inactive ingredients in the cephalexin for oral suspension are colloidal silicon dioxide, FD&C Red No. 40, sodium benzoate, strawberry flavor, sucrose, xanthan gum. Image
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Cephalexin for Oral Suspension USP is a Pink coloured powder forming pink coloured suspension with characteristic odour on constitution for the 125mg/5mL and 250mg/5mL strength, respectively, supplied as follows: The 125 mg per 5 mL for oral suspension is available as follows: 100-mL Bottles NDC 68180-440-01 200-mL Bottles NDC 68180-440-02 The 250 mg per 5 mL for oral suspension is available as follows: 100-mL Bottles NDC 68180-441-01 200-mL Bottles NDC 68180-441-02 Directions for mixing are included elsewhere in the labeling [see Dosage and Administration ( 2.3 )] . Prior to mixing, store at 20°C to 25°C (68°F 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 [see Dosage and Administration ( 2.3 )] .
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 and 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.