Acelex

• Respiratory Tract Infections:
  Treatment of pharyngitis, tonsillitis, bronchitis, and pneumonia caused by susceptible Gram-positive and Gram-negative bacteria.
• Skin and Soft Tissue Infections:
  Used for cellulitis, abscesses, wound infections, and impetigo caused by Staphylococcus aureus and Streptococcus species.
• Otitis Media:
  Acute middle ear infections caused by susceptible bacteria.
• Bone Infections:
  Osteomyelitis due to susceptible organisms.
• Urinary Tract Infections (Uncomplicated):
  Cystitis and pyelonephritis caused by susceptible E. coli and Proteus mirabilis.
• Dental Infections:
  For odontogenic infections caused by susceptible bacteria.
• Off-label Uses:
  Some clinicians use for prophylaxis in surgical procedures or certain Lyme disease cases.

Adults and Children ≥15 years:

• Typical Dose: 250 mg to 500 mg orally every 6 hours.
• Severe Infections: Up to 1 g every 6 hours.
• Duration: Usually 7 to 14 days depending on infection type.

Pediatrics (<15 years):

• Dose: 25 to 50 mg/kg/day divided into 3 or 4 doses.
• Maximum Dose: 4 g/day.

Renal Impairment:

• CrCl 10-29 mL/min: Administer every 12 hours.
• CrCl <10 mL/min: Administer every 24 hours.
• Dose adjustments required to prevent accumulation.

Administration:

• Oral capsules, tablets, or suspension.
• May be taken with or without food.

Cephalexin is a first-generation cephalosporin antibiotic that acts by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, blocking the final transpeptidation step of peptidoglycan synthesis. This inhibition weakens the cell wall, causing osmotic instability and cell lysis, which results in bacterial death. Cephalexin exhibits bactericidal activity primarily against Gram-positive cocci and some Gram-negative bacilli.

• Absorption:
  Rapid and well absorbed orally with approximately 90% bioavailability.
• Peak Plasma Concentration:
  Achieved within 1 hour after oral administration.
• Distribution:
  Widely distributed into most body tissues and fluids except cerebrospinal fluid.
• Protein Binding:
  Approximately 10-15%.
• Metabolism:
  Minimal hepatic metabolism.
• Elimination:
  Primarily excreted unchanged via renal tubular secretion.
• Half-life:
  About 0.5 to 1 hour in patients with normal renal function; prolonged in renal impairment.

• Pregnancy:
  FDA Category B — Animal studies have not demonstrated risk to the fetus, but adequate well-controlled studies in pregnant women are lacking.
• Lactation:
  Excreted in small amounts in breast milk; considered safe during breastfeeding with no reported adverse effects in infants.

• Antibiotic
• First-generation cephalosporin

• Known hypersensitivity to cephalexin, cephalosporins, or penicillins.
• History of severe allergic reactions (e.g., anaphylaxis) to β-lactam antibiotics.

• Hypersensitivity Reactions: May cause anaphylaxis or serious hypersensitivity; discontinue immediately if symptoms occur.
• Clostridioides difficile-associated Diarrhea: Monitor for severe persistent diarrhea.
• Renal Impairment: Adjust dose accordingly.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection.

Common:

• Gastrointestinal: Diarrhea, nausea, vomiting, abdominal pain.
• Dermatologic: Rash, pruritus, urticaria.
• Others: Headache, dizziness.

Rare/Serious:

• Anaphylaxis.
• Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Hematologic abnormalities such as eosinophilia, neutropenia.

• Probenecid: May increase cephalexin plasma concentrations by inhibiting renal tubular secretion.
• Oral Contraceptives: May reduce contraceptive efficacy; recommend alternative methods.
• Nephrotoxic Agents: Use caution with concurrent nephrotoxic drugs.
• No significant interactions involving CYP450 enzymes.

• No major recent changes in indications or safety warnings.
• Continued recommendation as first-line treatment for uncomplicated skin and soft tissue infections and UTIs.
• Emphasis on antibiotic stewardship to minimize resistance.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep tightly closed in original container.
• Do not freeze.
• Keep out of reach of children.