Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 04 January 2017

Indication(s)

INDICATIONS AND USAGE Cephalexin for Oral Suspension USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.

Cephalexin for Oral Suspension USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cephalexin for Oral Suspension USP in the subsequent prevention of rheumatic fever are not available at present.)

Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae Note - Culture and susceptibility tests should be initiated prior to and during therapy.

Renal function studies should be performed when indicated.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for Oral Suspension USP and other antibacterial drugs, Cephalexin for Oral Suspension USP 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.

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Advisory information

contraindications
CONTRAINDICATIONS Cephalexin for Oral Suspension USP is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Special warnings and precautions

PRECAUTIONS General Prescribing Cephalexin for Oral Suspension USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected.

If an allergic reaction to Cephalexin for Oral Suspension USP occurs, the drug should be discontinued and the patient treated with the usual agents (e.g., epinephrine or other pressor amines, antihistamines, or corticosteroids).

Prolonged use of Cephalexin for Oral Suspension USP 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.

Positive direct Coombs ' tests have been reported during treatment with the cephalosporin antibiotics.

In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs ' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs ' test may be due to the drug.

Cephalexin for Oral Suspension USP should be administered with caution in the presence of markedly impaired renal function.

Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Cephalosporins may be associated with a fall in prothrombin activity.

Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy.

Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Information for Patients Patients should be counseled that antibacterial drugs including Cephalexin for Oral Suspension USP should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold).

When Cephalexin for Oral Suspension USP is prescribed to treat a bacterial infection, patients should be told 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 for Oral Suspension USP or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible.

Drug Interactions Metformin - 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.

Although not observed in this study, adverse effects could potentially arise from co-administration of cephalexin and metformin by inhibition of tubular secretion via organic cationic transporter systems.

Accordingly, careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin.

Probenecid - As with other?-lactams, the renal excretion of cephalexin is inhibited by probenecid.

Drug/Laboratory Test Interactions As a result of administration of Cephalexin for Oral Suspension USP, a false-positive reaction for glucose in the urine may occur.

This has been observed with Benedict 's and Fehling 's solutions and also with Clinitest® tablets.

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 mg/ m2.

Pregnancy Teratogenic effects - Pregnancy Category B - Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon mg/ m2, and have revealed no harm to the fetus.

There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers The excretion of cephalexin in human milk increased up to 4 hours after a 500-mg dose; the drug reached a maximum level of 4 mcg/mL, then decreased gradually, and had disappeared 8 hours after administration.

Caution should be exercised when Cephalexin for Oral Suspension USP is administered to a nursing woman.

Pediatric Use The safety and effectiveness of cephalexin for Oral Suspension USP in pediatric patients was established in clinical trials for the dosages described in the DOSAGE AND ADMINISTRATION section.

In these trials, pediatric patients may have received cephalexin for Oral Suspension.

Geriatric Use 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, but greater sensitivity of some older individuals can not be ruled out.

This drug is known to be 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, and it may be useful to monitor renal function (see PRECAUTIONS, General).

Adverse reactions

ADVERSE REACTIONS Gastrointestinal - Onset of pseudomembranous colitis may occur during or after antibacterial treatment.

(See WARNINGS.

) 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, hemolytic anemia, and slight elevations in AST and ALT have been reported.

In addition to the adverse reactions listed above that have been observed in patients treated with Cephalexin for Oral Suspension USP, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: Adverse Reactions - Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction and toxic nephropathy.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (See INDICATIONS AND USAGE and PRECAUTIONS, General).

If seizures associated with drug therapy should occur, the drug should be discontinued.

Anticonvulsant therapy can be given if clinically indicated.

Altered

Laboratory Tests - Prolonged prothrombin time, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated LDH, pancytopenia, leukopenia, and agranulocytosis.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Cephalexin for Oral Suspension USP 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 for Oral Suspension 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 for Oral 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 b.i.d. 20 kg (44 lb) 2 to 4 tsp b.i.d. 40 kg (88 lb) 4 to 8 tsp b.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?-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.

Pregnancy and lactation
Nursing Mothers The excretion of cephalexin in human milk increased up to 4 hours after a 500-mg dose; the drug reached a maximum level of 4 mcg/mL, then decreased gradually, and had disappeared 8 hours after administration. Caution should be exercised when Cephalexin for Oral Suspension USP is administered to a nursing woman.

Interactions

Drug Interactions Metformin - 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.

Although not observed in this study, adverse effects could potentially arise from co-administration of cephalexin and metformin by inhibition of tubular secretion via organic cationic transporter systems.

Accordingly, careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin.

Probenecid - As with other?-lactams, the renal excretion of cephalexin is inhibited by probenecid.

More information

Category Value
Authorisation number ANDA065444
Agency product number 5SFF1W6677
Orphan designation No
Product NDC 68289-009,68289-008
Date Last Revised 11-09-2009
Type HUMAN PRESCRIPTION DRUG
RXCUI 309113
Marketing authorisation holder Jazeera Pharmaceutical