Neopem

Approved Indications:

• Respiratory Tract Infections:
• Community-acquired pneumonia
• Acute exacerbations of chronic bronchitis
• Acute sinusitis
• Pharyngitis and tonsillitis caused by susceptible bacteria
• Urinary Tract Infections:
• Uncomplicated lower urinary tract infections
• Complicated urinary tract infections
• Skin and Soft Tissue Infections:
• Mild to moderate infections caused by susceptible organisms
• Gynecological Infections:
• Pelvic inflammatory disease (PID)
• Vaginal infections caused by susceptible bacteria

Important Off-label Uses:

• Mixed aerobic and anaerobic infections
• Prophylaxis in certain surgical interventions, particularly in urogenital and abdominal surgeries
• Infections caused by beta-lactamase producing multidrug-resistant pathogens where oral therapy is indicated
• Lower respiratory infections in patients with comorbidities or resistance to other beta-lactams

• Adults (18 years and older):
• Take 200 mg orally every 8 hours (three times daily) as the standard dose.
• For mild infections or dose adjustments, 150 mg every 8 hours may be used.
• Treatment duration typically ranges from 5 to 14 days, depending on the infection type and severity.
• Administer orally in tablet or capsule form.
• Pediatrics (under 18 years):
• Faropenem is not FDA-approved for children but may be used off-label under specialist supervision in some countries.
• Dosage is usually 10 to 15 mg/kg/day, divided into 2 or 3 doses.
• An oral suspension formulation (e.g., 50 mg/5 mL) may be available for easier dosing.
• Use only when clearly indicated and with close medical monitoring.
• Elderly:
• No routine dose adjustment required if renal function is normal.
• Renal Impairment:
• Mild to moderate impairment (creatinine clearance 30–50 mL/min): Usually no adjustment needed.
• Severe impairment (creatinine clearance <30 mL/min): Dose adjustment or increased dosing interval may be necessary; use with caution.
• Hepatic Impairment:
• No dose adjustment necessary.
• Administration Notes:
• Tablets or capsules should be swallowed whole with water.
• Can be taken with or without food.
• Ensure adherence to dosing intervals to maintain therapeutic drug levels.

Faropenem is an orally bioavailable penem-class beta-lactam antibiotic that inhibits bacterial cell wall synthesis. It binds with high affinity to several penicillin-binding proteins (PBPs), enzymes essential for cross-linking peptidoglycan strands during cell wall formation. This binding impairs the structural integrity of the bacterial cell wall, leading to osmotic instability and cell lysis. Faropenem exhibits broad-spectrum activity, effective against many Gram-positive and Gram-negative aerobic and anaerobic bacteria, and is resistant to hydrolysis by various beta-lactamases, including some extended-spectrum beta-lactamases (ESBLs).

• Absorption: Rapid and nearly complete oral absorption; bioavailability ~70%
• Distribution: Widely distributed into body tissues and fluids, including respiratory tract secretions; plasma protein binding approximately 80%
• Metabolism: Minimal hepatic metabolism; primarily excreted unchanged
• Elimination: Mainly renal excretion via glomerular filtration and tubular secretion
• Half-life: Approximately 1 hour in healthy adults
• Peak Plasma Concentration: Achieved within 1 to 2 hours post-dose
• Onset of Action: Therapeutic levels reached rapidly within 1 hour after administration

• Pregnancy:
• Faropenem has not been assigned an official FDA pregnancy category, but available data from animal studies have not shown teratogenic effects at therapeutic doses.
• There are no adequate and well-controlled studies in pregnant women.
• Use during pregnancy only if clearly needed, and if the potential benefit justifies the potential risk to the fetus.
• Caution is advised, especially during the first trimester.
• Lactation:
• Faropenem is excreted in small amounts into human breast milk.
• Although adverse effects in nursing infants have not been reported, the clinical significance is unknown.
• Use with caution during breastfeeding, particularly in neonates or premature infants.
• Consider temporary discontinuation of breastfeeding or use of an alternative antibiotic if prolonged therapy is required.
• General Recommendations:
• If used during pregnancy or lactation, monitor both mother and infant closely.
• Always consult a healthcare provider before using in pregnant or breastfeeding women.

• Primary: Beta-lactam antibiotic
• Subclass: Oral penem antibiotic (carbapenem analog)

• Known hypersensitivity to faropenem or any other beta-lactam antibiotics (penicillins, cephalosporins, carbapenems)
• History of severe hypersensitivity reactions (anaphylaxis, Stevens-Johnson syndrome) to beta-lactams
• Previous history of cholestatic jaundice or hepatic dysfunction attributed to faropenem

• Hypersensitivity reactions: Use with caution in patients with beta-lactam allergies due to possible cross-reactivity
• Monitor closely for signs of anaphylaxis and other allergic reactions during therapy
• Seizures: Rare cases reported, particularly in patients with CNS disorders or severe renal impairment
• Superinfection risk: Prolonged or repeated use may lead to overgrowth of non-susceptible organisms, including fungi
• Clostridioides difficile-associated diarrhea (CDAD): Consider in patients developing diarrhea during or after therapy; discontinue if CDAD suspected
• Renal function monitoring advised in patients with pre-existing impairment or receiving prolonged therapy

Common Adverse Effects:

• Gastrointestinal: nausea, diarrhea, abdominal discomfort, vomiting
• Dermatologic: rash, pruritus
• Neurological: headache, dizziness (less frequent)

Serious/Rare Adverse Effects:

• Severe allergic reactions including anaphylaxis, angioedema, and Stevens-Johnson syndrome (very rare)
• Hematologic abnormalities: eosinophilia, neutropenia (rare)
• Seizures, especially in predisposed individuals
• Clostridioides difficile-associated diarrhea or colitis

Onset: Side effects generally occur within the first days of therapy but may develop at any time.

• Drug-Drug:
• Probenecid may increase plasma levels of faropenem by inhibiting renal tubular secretion
• Concomitant use with bacteriostatic antibiotics (e.g., tetracyclines, macrolides) may reduce efficacy
• Drug-Food:
• No significant impact of food on absorption; can be taken with or without meals
• Drug-Alcohol:
• No known interactions; however, alcohol may worsen gastrointestinal side effects

Metabolism: Not significantly metabolized by cytochrome P450 enzymes, so low potential for CYP-mediated drug interactions.

• Faropenem increasingly recognized in international guidelines as an effective oral alternative for outpatient management of resistant community-acquired infections
• EMA and WHO acknowledge faropenem as a valuable oral carbapenem-class antibiotic, particularly in regions with high resistance prevalence
• Recent renal dosing guidelines refined to reduce toxicity risk in patients with severe renal impairment
• No new FDA black box warnings or major safety alerts have been issued recently

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture, heat, and direct light
• Keep tablets and capsules in tightly closed containers
• Do not freeze
• Keep out of reach of children
• No special reconstitution or refrigeration required for oral formulations