Cefalexin

Cephalexin

100MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons, 250MG BASE/5ML, 250MG BASE/5ML for suspensionÉtats-UnisCommercialiséAutorisé le 27 mars 1978

Contenu en anglais

Ouvrir dans le registreInterroger Osler

Indications

Cephalexin USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: 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 )

1.1Respiratory 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 .

1.2Otitis 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.

1.3Skin 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.

1.4Bone Infections Cephalexin

for oral suspension is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.

1.5Genitourinary 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.

Indications

( 1.6 )

1.1Respiratory 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 .

1.2Otitis Media Cephalexin

1.3Skin and Skin Structure Infections Cephalexin

1.4Bone Infections Cephalexin

for oral suspension is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.

1.5Genitourinary Tract Infections Cephalexin

Mises en garde et précautions d’emploi

Serious hypersensitivity (anaphylactic) reactions: Prior to use, inquire regarding history of hypersensitivity to beta-lactam antibacterial drugs. Discontinue the drug if signs or symptoms of an allergic reaction occur and institute supportive measures. ( 5.1 ) Clostridium difficile -associated diarrhea (CDAD): Evaluate if diarrhea occurs. ( 5.2 ) Direct Coomb's Test Seroconversion: If anemia develops during or after cephalexin therapy, evaluate for drug-induced hemolytic anemia.

( 5.3 ) Seizure Potential : Use lower dose in patients with renal impairment. ( 5.4 )

5.1Hypersensitivity Reactions

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 for oral suspension 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 for oral suspension occurs, discontinue the drug and institute appropriate treatment.

5.2 Clostridium difficile-Associated Diarrhea Clostridium 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.

5.3Direct Coombs’ Test Seroconversion

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.

5.4Seizure Potential

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 for oral suspension. Anticonvulsant therapy can be given if clinically indicated.

5.5Prolonged Prothrombin Time

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.

5.6Development of Drug-Resistant Bacteria

Prescribing cephalexin for oral suspension 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 for oral suspension 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.

Effets indésirables

The following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity reactions [ see Warning and Precautions ( 5.1 ) ] Clostridium 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 ) ] Effect on Prothrombin Activity [ 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.

6.1Clinical 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.

Conditionnement	Code	Statut
CEPHALEXIN EQ 250MG BASE/5ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDA062117-003	Discontinued
CEPHALEXIN EQ 100MG BASE/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDA062117-001	Discontinued
CEPHALEXIN EQ 125MG BASE/5ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDA062117-002	Discontinued
CEPHALEXIN EQ 125MG BASE/5ML	ANDA062986-001	Discontinued
CEPHALEXIN EQ 125MG BASE/5ML	ANDA065336-001	Prescription
CEPHALEXIN EQ 250MG BASE/5ML	ANDA065336-002	Prescription
CEPHALEXIN EQ 125MG BASE/5ML	ANDA062778-001	Discontinued
CEPHALEXIN EQ 250MG BASE/5ML	ANDA062777-001	Discontinued
CEPHALEXIN EQ 250MG BASE/5ML	ANDA062867-001	Discontinued
CEPHALEXIN EQ 125MG BASE/5ML	ANDA065081-001	Discontinued
CEPHALEXIN EQ 250MG BASE/5ML	ANDA065081-002	Discontinued
CEPHALEXIN EQ 250MG BASE/5ML	ANDA062768-001	Discontinued
CEPHALEXIN EQ 250MG BASE/5ML	ANDA065444-002	Discontinued
CEPHALEXIN EQ 125MG BASE/5ML	ANDA065444-001	Discontinued
CEPHALEXIN EQ 250MG BASE/5ML	ANDA062987-001	Discontinued
CEPHALEXIN EQ 250MG BASE/5ML	ANDA065326-002	Discontinued
CEPHALEXIN EQ 125MG BASE/5ML	ANDA065326-001	Discontinued
CEPHALEXIN EQ 125MG BASE/5ML	ANDA062767-001	Discontinued
CEPHALEXIN EQ 250MG BASE/5ML	ANDA062781-001	Discontinued
CEPHALEXIN EQ 125MG BASE/5ML	ANDA062873-001	Discontinued
CEPHALEXIN EQ 125MG BASE/5ML	ANDA210221-001	Prescription
CEPHALEXIN EQ 250MG BASE/5ML	ANDA210221-002	Prescription
CEPHALEXIN EQ 250MG BASE/5ML	ANDA065234-002	Prescription
CEPHALEXIN EQ 125MG BASE/5ML	ANDA065234-001	Prescription
CEPHALEXIN EQ 125MG BASE/5ML	ANDA062703-001	Prescription
CEPHALEXIN EQ 250MG BASE/5ML	ANDA062703-002	Prescription
CEPHALEXIN EQ 125MG BASE/5ML	ANDA062779-001	Discontinued

Cephalexin

Indications

1.1Respiratory Tract Infections Cephalexin

1.2Otitis Media Cephalexin

1.3Skin and Skin Structure Infections Cephalexin

1.4Bone Infections Cephalexin

1.5Genitourinary Tract Infections Cephalexin

Deux médicaments dans une même question ?

Cephalexin

Indications

1.1Respiratory Tract Infections Cephalexin

1.2Otitis Media Cephalexin

1.3Skin and Skin Structure Infections Cephalexin

1.4Bone Infections Cephalexin

1.5Genitourinary Tract Infections Cephalexin

Deux médicaments dans une même question ?

1.6Usage

Contre-indications

Mises en garde et précautions d’emploi

5.1Hypersensitivity Reactions

5.3Direct Coombs’ Test Seroconversion

5.4Seizure Potential

5.5Prolonged Prothrombin Time

5.6Development of Drug-Resistant Bacteria

Interactions

7.1Metformin Administration

7.2Probenecid

7.3Interaction with Laboratory or Diagnostic Testing

Grossesse et allaitement

8.1Pregnancy Pregnancy Category B

Effets indésirables

6.1Clinical Trials Experience

Dans d’autres pays

Conditionnements

Documents

Sources et licences

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