Cefalin Capsule

Cefalin Capsule

cefalexin

Manufacturer:

BIOFEMME, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Cefalexin monohydrate
Indications/Uses
Infections caused by susceptible microorganisms eg, skin & skin structure infections; bone & joint infections; GUT infections including acute prostatitis; resp tract infections including acute & chronic bronchitis & infected bronchiectasis; ENT infections including otitis media, mastoiditis, sinusitis, follicular tonsillitis, & pharyngitis; dental infections.
Dosage/Direction for Use
Adult 250 mg every 6 hr. Max: 4 g/day. Larger doses (up to 4 g daily) may be needed for more severe infections or those caused by less susceptible organisms. Streptococcal pharyngitis, skin & skin structure infections & uncomplicated cystitis 500 mg every 12 hr in patients >15 yr. Duration of treatment: 5-7 days (mild to moderate infections), 7-14 days (cystitis) & at least 10 days (β-hemolytic streptococcal infections). Renal impairment CrCl 11-40 mL/min 500 mg every 8-12 hr, 5-10 mL/min 250 mg every 12 hr, <5 mL/min 250 mg every 12-24 hr, intermittent dialysis patient Give additional 500 mg after each dialysis ie, total dosage of up to 1 g on that day.
Administration
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity to cephalosporins or penicillins.
Special Precautions
Hypersensitivity. Clostridium difficile-associated diarrhea & colitis. Seizures particularly in patients w/ impaired renal function in whom dosage was not reduced. Monitor prothrombin time in patients w/ renal or hepatic impairment, or poor nutritional state, those receiving protracted course of antibiotic therapy, & patients stabilized on anticoagulants. Periodic assessment of organ system functions including renal, hepatic, hematopoietic during prolonged therapy. Overgrowth of non-susceptible organisms including fungi in long term or repeated use. False +ve Coombs' test. False +ve glucose reaction in urine w/ Benedict's & Fehling's soln & Clinitest tab. May interfere w/ alkaline picrate assay for creatinine. Misleading quantitative determination of urinary protein excretion using strong acids. Renal impairment. Pregnancy & lactation.
Adverse Reactions
Abdominal cramp/pain, anorexia, Clostridium difficile-associated diarrhea & colitis, diarrhea, dyspepsia, gastritis, gastroenteritis, glossitis/stomatitis (eg, oral thrush), nausea, vomiting; anaphylaxis, angioedema, eosinophilia, erythema multiforme, fever, genital & anal pruritus, intertrigo, pruritus, rash (maculopapular erythematous, or morbilliform), serum sickness-like reactions, SJS, TEN, urticaria; decreased Hb &/or hematocrit, hemolytic anemia, reversible leukopenia; neutropenia, decreased platelets; +ve direct & indirect antiglobulin (Coombs') test results; thrombocytopenia; transient increases in BUN & serum creatinine conc; dysuria, reversible interstitial nephritis; nephrotoxicity, leukorrhea, pruritus vulvae, vag discharge, vulvo-vaginitis; transient increases in serum ALT, AST, & alkaline phosphatase conc; increased serum bilirubin; transient hepatitis & cholestatic jaundice; agitation, confusion, diplopia, dizziness, fatigue, headache, hallucinations, insomnia, malaise, paresthesia, somnolence, tremor, toxic paranoid reactions (rarely in patients w/ renal impairment); vertigo, tinnitus, hearing loss & behavioral changes in young childn; arthralgia, myalgia, arthritis, joint disorder, back pain, nuchal swelling, cardiac arrhythmia, vasodilatation, dyspnea, superinfection, elevated cholesterol.
Drug Interactions
Disulfiram-like reactions w/ alcohol. Prolonged serum conc w/ probenecid. May affect gut flora, leading to lower estrogen reabsorption & reduced efficacy of OCs. Increased Cmax & AUC & decreased renal clearance of metformin. May increase risk of nephrotoxicity w/ nephrotoxic drugs eg, aminoglycosides, colistin, polymyxin B, or vancomycin. May adversely affect renal function w/ potent diuretics (eg, furosemide). Additive or synergistic antibacterial activity w/ aminoglycosides & penicillins. Antagonism w/ chloramphenicol.
MIMS Class
Cephalosporins
ATC Classification
J01DB01 - cefalexin ; Belongs to the class of first-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Cefalin Capsule cap 250 mg
Packing/Price
50's (P29.7/cap)
Form
Cefalin Capsule cap 500 mg
Packing/Price
50's (P50.6/cap)
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