Floxamo 500 mg + 500 mg 16 tablets

Floxamo 500 mg + 500 mg 16 tablets

Composition:
Each film-coated tablet contains:
Active ingredients:
- Amoxicillin trihydrate compacted 574 mg (equivalent to 500 mg amoxicillin anhydrous)
- Flucloxacillin sodium monohydrate compacted 544 mg (equivalent to 500 mg flucloxacillin anhydrous).
Inactive ingredients:
Prosolv H.D, Croscarmellose sodium, Magnesium stearate, Purified talc.
Film coat: Pharmacoat 603, Titanium dioxide, Glycerol, Talc, Brown color.
Description:
Floxamo is a broad-spectrum antibiotic combining two semi-synthetic penicillins:
Amoxicillin, a broad-spectrum penicillin, and Flucloxacillin, a penicillinase-resistant penicillin.
This combination provides bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including both penicillinase-producing and non-producing Staphylococci, Streptococci, H. influenzae, Neisseria spp., E. coli, Proteus mirabilis, and Salmonella.
Indications for Use:
Floxamo is indicated for the treatment of infections caused by susceptible organisms, including:
- Respiratory tract infections: bronchitis, pneumonia, empyema
- ENT infections: otitis media, sinusitis, tonsillitis, pharyngitis
- Gastrointestinal infections: enteritis, cholecystitis, typhoid, peritonitis, intra-abdominal abscesses
- Genitourinary infections: cystitis, pyelonephritis, prostatitis, gonorrhea, puerperal sepsis
- Skin and soft tissue infections: boils, abscesses, cellulitis, postoperative wound infections
- Bone infections: osteomyelitis
- Other infections: septicemia and endocarditis.
Dosage and Method of Administration:
Adults:
1000 mg (one tablet) every 8 hours.
Administer orally with water.
Reduce the dose in severe renal impairment.
Contraindications:
- Hypersensitivity to penicillins or any component of the formulation
- Severe renal impairment without dose adjustment.
Precautions:
- Adjust dose in renal impairment.
- Clostridioides difficile-associated diarrhea (CDAD) may occur.
- Severe cutaneous adverse reactions (SJS, TEN, DRESS, AGEP) have been reported.
- Concurrent use with coumarin anticoagulants may prolong bleeding time; dose adjustment may be required.
Side Effects:
Usually mild and transient: diarrhea, dyspepsia, skin rash.
Rare:
Clostridioides difficile-associated diarrhea, severe skin reactions (SJS, TEN, DRESS, AGEP).
Storage Conditions:
Store below 25°C in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing 2 blister strips of 8 film-coated tablets each, with a package insert.