DESCRIPTION
id: E3AC7B54-0AD3-691D-0FF5-22D3AB766593
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Cephalexin, USP is a semisynthetic cephalosporin antibiotic 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:The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position.Each capsule for oral administration, contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1,439 µmol) of cephalexin.In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, edible printing ink with black iron oxide, FD&C Green No. 3, FD&C Yellow No. 6, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide.Also, the 500 mg strength capsule contains FD&C Blue No.1.After mixing, each 5 mL of Cephalexin for Oral Suspension will contain cephalexin monohydrate equivalent to 125 mg (360 µmol) or 250 mg (720 µmol) cephalexin. The suspensions also contain colloidal silicon dioxide, FD&C Red No. 40, sodium benzoate, strawberry flavor, sucrose and xanthan gum.
INDICATIONS AND USAGE
id: 7401DFB0-E99A-D494-CEB0-AFDDFBAE4CE5
displayName: INDICATIONS AND USAGE SECTION
FDA Article Code: 34067-9
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules and cephalexin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they 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.Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:Respiratory tract infections caused by S. pneumoniae and S. pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci and M. catarrhalisSkin and skin structure infections caused by staphylococci and/or streptococciBone infections caused by staphylococci and/or P. mirabilisGenitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniaeNote — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
CONTRAINDICATIONS
id: 899AEAB0-B81F-8D34-82C8-D022ECFF3821
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Cephalexin is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
WARNINGS
id: 2AD92284-D14C-69B7-C4AF-935C8A3A9644
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
BEFORE CEPHALEXIN THERAPY IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS AND PENICILLIN. CEPHALOSPORIN C DERIVATIVES SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS.SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to cephalexin.Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cephalexin, and may range from mild to life threatening. Therefore, it is important to consider this diagnosis in patients with diarrhea subsequent to the administration of antibacterial agents.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis.After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.Usage in Pregnancy — Safety of this product for use during pregnancy has not been established.
ADVERSE REACTIONS
id: 23F08A79-8035-FD74-2A2F-607BF3979101
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Gastrointestinal — Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported rarely. The most frequent side effect has been diarrhea. It was very rarely severe enough to warrant cessation of therapy. Dyspepsia, gastritis, and abdominal pain have also occurred. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.Hypersensitivity — Allergic reactions in the form of rash, urticaria, angioedema, and, rarely, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been observed. These reactions usually subsided upon discontinuation of the drug. In some of these reactions, supportive therapy may be necessary. Anaphylaxis has also been reported.Other reactions have included genital and anal pruritus, genital moniliasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported rarely. Eosinophilia, neutropenia, thrombocytopenia, and slight elevations in AST and ALT have been reported.
OVERDOSAGE
id: 7073CB30-571E-AF59-D81D-635E5678CFC5
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Signs and Symptoms — Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. If other symptoms are present, it is probably secondary to an underlying disease state, an allergic reaction, or toxicity due to ingestion of a second medication.Treatment — To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.Unless 5 to 10 times the normal dose of cephalexin has been ingested, gastrointestinal decontamination should not be necessary.Protect the patient’s airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient’s airway when employing gastric emptying or charcoal.Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin; however, it would be extremely unlikely that one of these procedures would be indicated.The oral median lethal dose of cephalexin in rats is 5,000 mg/kg.
DOSAGE AND ADMINISTRATION
id: D8FE24CA-9106-F57E-84E5-F9DFE3F32FEB
displayName: DOSAGE AND ADMINISTRATION SECTION
FDA Article Code: 34068-7
Cephalexin is administered orally.Adults— The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.Pediatric Patients — The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.
| Cephalexin Suspension |
| Weight |
125 mg/5 mL |
| 10 kg (22 lb) |
1/2 to 1 tsp q.i.d. |
| 20 kg (44 lb) |
1 to 2 tsp q.i.d. |
| 40 kg (88 lb) |
2 to 4 tsp q.i.d. |
| Weight |
250 mg/5 mL |
| 10 kg (22 lb) |
1/4 to 1/2 tsp q.i.d. |
| 20 kg (44 lb) |
1/2 to 1 tsp q.i.d. |
| 40 kg (88 lb) |
1 to 2 tsp q.i.d. |
| or |
| Weight |
125 mg/5 mL |
| 10 kg (22 lb) |
1 to 2 tsp q.i.d. |
| 20 kg (44 lb) |
2 to 4 tsp q.i.d. |
| 40 kg (88 lb) |
4 to 8 tsp q.i.d. |
| Weight |
250 mg/5 mL |
| 10 kg (22 lb) |
1/2 to 1 tsp b.i.d. |
| 20 kg (44 lb) |
1 to 2 tsp b.i.d. |
| 40 kg (88 lb) |
2 to 4 tsp b.i.d. |
In severe infections, the dosage may be doubled.In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.
HOW SUPPLIED
id: B69CD155-BC85-2C24-7A3C-85656EEA0716
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Cephalexin For Oral Suspension, USP is available in:The 125 mg per 5 mL oral suspension* is pink in color with a strawberry flavor and is available as follows:100 mL Bottles NDC 63304-958-01200 mL Bottles NDC 63304-958-02The 250 mg per 5 mL oral suspension* is pink in color with a strawberry flavor and is available as follows:100 mL Bottles NDC 63304-959-01200 mL Bottles NDC 63304-959-02* After mixing, store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed.Cephalexin Capsules, USP are available in:250 mg dark green and white, size 2, printed “RX656” on both cap and body.(28s) NDC 63304-656-27(100s) NDC 63304-656-01(500s) NDC 63304-656-05500 mg, dark green and light green, size 0, printed “RX657” on both cap and body.(28s) NDC 63304-657-27(100s) NDC 63304-657-01(500s) NDC 63304-657-05The bottle packages contain desiccant.Dispense in tight, light-resistant container.Store at 20 – 25° C (68 – 77° F). (See USP Controlled Room Temperature).
REFERENCES
id: D08E8C63-E5A5-1D98-1865-D4E3DA71D5EF
displayName: REFERENCES SECTION
FDA Article Code: 34093-5
1. National Committee for Clinical Laboratory Standards: Performance standards for antimicrobial disk susceptibility tests – 5th ed. Approved Standard NCCLS Document M2-A5, Vol 13, No 24, NCCLS, Villanova, PA 1993.2. National Committee for Clinical Laboratory Standards: Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically -3rd ed. Approved Standard NCCLS Document M7-A3, Vol 13, No 25, NCCLS, Villanova, PA 1993.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32216 USAby: Ranbaxy Laboratories LimitedNew Delhi, 110 019, IndiaJanuary 2007
