Cefalin Suspension/Drops

Cefalin Suspension/Drops

cefalexin

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Cefalexin monohydrate.
Description
Each mL suspension (oral drops) contains: Cefalexin (as monohydrate) 100 mg.
Each 5 mL (1 teaspoonful) suspension contains: Cefalexin (as monohydrate) 125 mg or 250 mg.
Action
Pharmacology: Pharmacodynamics: Cefalexin exerts its bactericidal activity by interfering with the synthesis of the bacterial cell wall. It binds to specific penicillin-binding proteins responsible for the synthesis of peptidoglycan, a heteropolymeric structure that gives the cell wall its mechanical stability. The final stage of peptidoglycan synthesis involves completion of the cross-linking of the terminal glycine residue of the pentaglycine bridge to the fourth residue of the pentapeptide. The transpeptidase that catalyzes this step is inhibited by cephalosporins. Thus, inhibition of the transpeptidase interrupts peptidoglycan synthesis, causing formation of defective cell walls and osmotically unstable spheroplasts and lysis of the bacteria.
Antimicrobial Spectrum of Activity: Cefalexin is usually active in vitro against the following microorganisms: (See Table 1.)

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Susceptible strains of Staphylococcus aureus, Streptococcus pneumoniae, group A β-hemolytic streptococci, or group B streptococci are usually inhibited in vitro by Cefalexin concentrations of 0.1 to 12 µg/mL.
Cefalexin is inactive against enterococci (e.g., Enterococcus faecalis), methicillin-resistant staphylococci, Bacteroides fragilis, Citrobacter, Enterobacter, Listeria monocytogenes, Proteus other than Proteus mirabilis, Providencia, Pseudomonas, Serratia, and Acinetobacter calcoaceticus.
Pharmacokinetics: Absorption: Cefalexin absorption in young children is delayed compared with adults and may be decreased up to 50% in neonates. Peak serum concentrations of the drug have been reported to occur within 3 hours in infants younger than 6 months, within 2 hours in children 9 to 12 months, and within 1 hour in older children.
Administration of Cefalexin with food results in peak serum concentrations that are slightly lower and are attained later, although the total amount of drug absorbed remains unchanged.
Elimination: Cefalexin's serum half-life is reported to be about 5 hours in neonates, and 2.5 hours in children 3 to 12 months old.
Cefalexin is excreted in the urine as unchanged drug via both glomerular filtration and tubular secretion. Approximately 70 to 90% of a single 250- or 500-mg oral dose is excreted within 8 to 12 hours in adults with normal renal function. Cefalexin concentrations of 0.2 mg/mL (range: 0.054 to 0.67) or 0.11 to 4 mg/mL have been reported in urine collected over a 6-hour period following a single 250- or 500-mg dose, respectively, in adults with normal renal function. Peak urine concentrations average about 2 mg/mL and occur 2 hours after a single 500 mg oral dose of Cefalexin.
Indications/Uses
Treatment of various infections caused by susceptible organisms, such as: Skin and skin structure infections caused by staphylococci and/or streptococci;
Bone infections caused by staphylococci and/or Proteus mirabilis;
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, streptococci, and Moraxella catarrhalis;
Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes.
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cefalexin in the subsequent prevention of rheumatic fever are not available at present.
Genitourinary tract infections caused by Escherichia coli, Proteus mirabilis and Klebsiella pneumoniae.
Dosage/Direction for Use
Recommended Pediatric Dose: Orally, 25 to 50 mg/kg body weight/day in four divided doses.
For severe infections and otitis media, the dose may be increased to 50 to 100 mg/kg body weight/day in four divided doses.
Or, as prescribed by a physician. (See Table 2.)

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Usual Duration of Treatment: (See Table 3.)

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Directions for Reconstitution: (See Table 4.)

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Overdosage
Symptoms of 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.
Unless 5 to 10 times the normal dose of Cefalexin has been ingested, gastrointestinal decontamination should not be necessary.
It is important to protect the patient's airway and support ventilation and perfusion during overdose. 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 Cefalexin; however, it would be extremely unlikely that one of these procedures would be indicated.
Contraindications
History of allergy to any ingredient in this product or other cephalosporins.
History of hypersensitivity to penicillins.
Special Precautions
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on Cephalosporin therapy. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be instituted. Pseudomembranous colitis has been reported with nearly all antibacterial agents including cephalosporins, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea after administration of antibacterial agents. If superinfection occurs during therapy, appropriate measures should be taken.
A false-positive Coombs' test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs' test may be due to the drug, e.g., Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition or in hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No human data available.
Renal insufficiency: In patients with impaired renal function, decreases in doses and/or frequency of administration of Cefalexin may be required and should be based on the degree of renal impairment, severity of infection, susceptibility of the causative organism, and serum concentrations of Cefalexin.
Use in Children: The safety and effectiveness of Cefalexin in children have been established and reported in various clinical trials.
Use In Pregnancy & Lactation
Use in Pregnancy: (Pregnancy Category B) Potential benefits should outweigh the potential risks.
Labor and Delivery: No data available.
Use in Lactation: Caution should be exercised when the drug is given to a breastfeeding woman.
Adverse Reactions
Hypersensitivity Reactions: Urticaria, pruritus, rash, fever and chills, reactions resembling serum sickness, eosinophilia, joint pain or inflammation, edema, erythema, genital and anal pruritus, angioedema, shock, hypotension, vasodilation, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, and exfoliative dermatitis have been reported. Anaphylaxis, including a few fatalities, has occurred rarely. Hypersensitivity reactions occur most frequently in patients with a history of allergy, particularly to penicillins.
Hematologic Effects: Positive direct and indirect antiglobulin (Coombs') test results have been reported. Non-immunologic positive Coombs' test results are most likely to occur in patients who have received large doses of Cefalexin or who have impaired renal function or hypoalbuminemia.
Other adverse hematologic effects of Cefalexin include rare, mild and transient neutropenia, thrombocytopenia, leukocytosis, granulocytosis, monocytosis, lymphocytopenia, basophilia, and reversible leukopenia.
Renal and Genitourinary Effects: Transient increases in BUN and serum creatinine concentrations, renal dysfunction, and toxic nephropathy.
Genitourinary effects reported with Cefalexin therapy include vaginitis, vaginal moniliasis, genital pruritus, and menstrual irregularities.
Hepatic Effects: Transient increases in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyl transferases (γ-glutamyl transpeptidase, GGT, GGTP), and alkaline phosphatase concentrations, increased serum concentrations of bilirubin and/or LDH, decreased serum albumin and/or total protein, hepatic dysfunction including cholestasis, have been reported with Cefalexin therapy.
Gastrointestinal Effects: Nausea, vomiting, diarrhea, abdominal pain, tenesmus, epigastric pain/dyspepsia, decreased appetite/anorexia, glossitis, flatulence, candidiasis, taste alteration, decreased salivation, and heartburn.
Rarely, antibiotic-associated pseudomembranous colitis, caused by toxin-producing Clostridia resistant to Cefalexin, has occurred during or following discontinuance of Cefalexin. Appropriate measures should be undertaken (i.e., sigmoidoscopy, appropriate bacteriologic studies, and treatment with fluid, electrolyte and protein supplementation) as needed. Antiperistaltic agents may prolong and/or worsen the condition and should be avoided if pseudomembranous colitis is suspected. If colitis is moderate to severe or is not relieved by discontinuance of the cephalosporin, appropriate anti-infective therapy should be administered. Isolation of the patient may be advisable. Other causes of colitis should be considered.
Other Adverse Effects: Other adverse effects reported with Cefalexin therapy include chest pain, pleural effusion, dyspnea or respiratory distress, cough, and rhinitis. Increased or decreased serum glucose concentration has also been reported.
Drug Interactions
No potentially hazardous interactions appear to have been reported. However, Cefalexin may share the interaction potential of other cephalosporins as with the following: Nephrotoxic Drugs: Concurrent use of nephrotoxic agents such as aminoglycosides, colistin, polymyxin B, or vancomycin may increase the risk of nephrotoxicity with some cephalosporins and probably should be avoided, if possible.
Other Anti-infective Agents: In vitro studies indicate that the antibacterial activity of cephalosporins may be additive or synergistic with aminoglycosides and penicillins against some organisms. Although some in vitro studies showed additive or synergistic antibacterial activity between Chloramphenicol and a cephalosporin, there is more recent in vitro evidence of antagonism between cephalosporins and Chloramphenicol against a variety of gram-negative and gram-positive bacteria, particularly when Chloramphenicol was added to the medium before the β -lactam. In addition, at least one case of in vivo antagonism has been reported in an infant with Salmonella meningitis. Therefore, it is recommended that combined therapy with Chloramphenicol and a cephalosporin be avoided, particularly when bactericidal activity is considered important.
Probenecid: Concomitant administration of oral Probenecid competitively inhibits tubular secretion resulting in higher and more prolonged serum concentrations of most cephalosporins.
Alcohol: Disulfiram-like reactions have occurred when alcohol was ingested within 48 to 72 hours after administration of β-lactam antibiotics that contain a tetrazolethiomethyl side chain. Therefore, ingestion of alcohol during and for 24 to 72 hours after administration of some cephalosporins should be avoided.
Storage
Store in a dry place at temperatures not more than 30°C. Protect from light.
MIMS Class
ATC Classification
J01DB01 - cefalexin ; Belongs to the class of first-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Oral susp 125 mg/5 mL (yellow powd for reconstitution into yellow, cherry-tutti-frutti) x 60 mL. 250 mg/5 mL (off-white to cream powder for reconstitution in to pink, tutti-frutti flavor) x 10 mL. Oral drops 100 mg/mL x 10 mL.
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