Austrapen

Ampicillin (250mg) + Cloxacillin (250mg)
Price: Capsules (10's): ₹65 - ₹100, Dry Syrup (30ml): ₹55 - ₹85 (Approximate MRP)
Mfr: Aristo Pharmaceuticals Pvt. Ltd. | Form: Capsules, Dry Syrup

📋 Clinical Overview

Ampicillin (250mg) + Cloxacillin (250mg) is a fixed-dose combination of two beta-lactam antibiotics belonging to the penicillin class. Ampicillin is an aminopenicillin with a broad spectrum of activity against many Gram-positive and Gram-negative organisms but is susceptible to beta-lactamase degradation. Cloxacillin is a penicillinase-resistant penicillin (isoxazolyl penicillin) that is stable against staphylococcal beta-lactamase, providing coverage against penicillin-resistant staphylococci. This combination is designed to extend the antibacterial spectrum, particularly targeting infections where Staphylococcus aureus (including penicillinase-producing strains) is suspected alongside other susceptible organisms. It is bactericidal and acts by inhibiting bacterial cell wall synthesis.

💊 Dosage & Administration

Adult: One capsule (Ampicillin 250mg + Cloxacillin 250mg) every 6 hours. For severe infections, the dose may be increased to 2 capsules every 6 hours, as per physician advice. Must be taken on an empty stomach (1 hour before or 2 hours after food).

Note: ORAL: Swallow the capsule whole with a full glass of water. MUST be taken on an empty stomach: at least 1 hour before or 2 hours after meals to ensure adequate absorption. The course should be completed even if symptoms improve to prevent resistance and relapse.

⚠️ Contraindications

  • Known history of severe hypersensitivity (anaphylaxis, angioedema, urticaria) to any penicillin, beta-lactam antibiotic, or any component of the formulation
  • Patients with a history of penicillin-associated cholestatic jaundice/hepatic dysfunction

🔬 Mechanism of Action

Both ampicillin and cloxacillin are bactericidal beta-lactam antibiotics. They inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls by binding to and inactivating penicillin-binding proteins (PBPs). This inhibition leads to the activation of autolytic enzymes (autolysins) in the cell wall, resulting in cell lysis and death.

🤕 Side Effects

  • Diarrhea or loose stools
  • Nausea, vomiting
  • Abdominal discomfort
  • Oral or vaginal candidiasis (thrush)
  • Skin rash (often maculopapular and non-allergic)

🤰 Special Populations

Pregnancy: US FDA Pregnancy Category B. Both drugs cross the placenta. Studies have not shown a clear risk of major birth defects. Use during pregnancy only if clearly needed. Generally considered safe for use in pregnancy for treating susceptible infections.

Driving: Unlikely to affect the ability to drive or use machines. However, if the patient experiences dizziness or other CNS effects (rare), they should avoid these activities.

🔄 Drug Interactions

ProbenecidDecreases renal tubular secretion of penicillins, increasing and prolonging serum concentrations. Can be used therapeutically.Moderate
MethotrexateMay decrease renal clearance of methotrexate, increasing risk of methotrexate toxicity (myelosuppression, mucositis).Major
Oral ContraceptivesMay reduce efficacy of oral contraceptives due to altered gut flora and possibly other mechanisms. Advise use of a non-hormonal backup method.Moderate
WarfarinMay potentiate anticoagulant effect, increasing INR and risk of bleeding. Mechanism may involve alteration of gut flora reducing vitamin K production.Major
AllopurinolCo-administration with ampicillin increases the incidence of skin rash, especially in patients with hyperuricemia.Moderate
Aminoglycosides (e.g., Gentamicin)In vitro synergy against some organisms (e.g., Enterococci), but physical incompatibility if mixed in same IV line. Can be administered separately.Minor
Tetracyclines, Chloramphenicol, SulfonamidesBacteriostatic antibiotics may antagonize the bactericidal effect of penicillins. Avoid concurrent use unless clearly indicated.Moderate

🔁 Alternatives to Austrapen

Same composition (Ampicillin (250mg) + Cloxacillin (250mg)), different brands:

Ampiclox Kloxerate Bactoclav Megaclox