Flumox Suspension 250 mg/5 ml 100 ml

Flumox Suspension 250 mg/5 ml 100 ml

Composition:

Each 5 ml of reconstituted suspension contains:
Amoxicillin (as amoxicillin trihydrate) — 125 mg (equivalent to 143.47 mg).
Flucloxacillin (as flucloxacillin sodium monohydrate) — 125 mg (equivalent to 136.32 mg).

Product Description:

• Flumox is a broad-spectrum combination antibacterial agent containing amoxicillin (a broad-spectrum semisynthetic penicillin) and flucloxacillin (a penicillinase-resistant penicillin).
• Mechanism of Action: Exerts a bactericidal effect by inhibiting bacterial cell wall synthesis.
• Spectrum of Activity: Active against a wide range of gram-positive and gram-negative microorganisms, including strains of staphylococci (penicillinase-producing and non-penicillinase-producing), streptococci (pyogenic streptococcus, pneumococcus, fecal enterococcus), diphtheria bacillus, clostridia, anthrax bacillus, Haemophilus influenzae, Moraxella catarrhalis, gonococci, meningococci, Escherichia coli, Proteus mirabilis, Salmonella, pertussis bacillus, and Bacteroides melaninogenicus.
• Pharmacokinetics: Both components are well absorbed after oral administration, acid-stable, and achieve high therapeutic concentrations in tissues and body fluids.

Indications for Use:

• Respiratory Tract Infections: Bronchitis, pneumonia, empyema.
• Ear, Nose, and Throat (ENT) Infections: Otitis media, sinusitis, tonsillitis, pharyngitis.
• Gastrointestinal and Biliary Tract Infections: Enteritis, cholecystitis, typhoid and paratyphoid fever, peritonitis, intra-abdominal abscesses, biliary tract infections.
• Genitourinary Tract Infections: Cystitis, pyelonephritis, prostatitis, gonorrhea, puerperal sepsis.
• Skin and Soft Tissue Infections: Boils, carbuncles, abscesses, cellulitis, postoperative wound infections.
• Bone and Joint Infections: Osteomyelitis.
• Other Severe Systemic Infections: Septicemia, endocarditis.

Method of Administration and Dosage:

• Method of Administration: Oral use.
• Reconstitution: Shake the bottle to loosen powder before reconstitution.
  Add purified water up to the mark or in the volume specified on the package and shake well.
• Dosage Regimen:
  Adults: 250–500 mg every 8 hours (or 500 mg every 12 hours); doubled to 1 g every 8 hours for severe infections.
  Children under 10 years: 125–250 mg every 8 hours.
  Children weighing less than 40 kg: 20–40 mg/kg daily in divided doses every 8 hours, or 25–45 mg/kg daily in divided doses every 12 hours.
  Infants under 3 months: Maximum dose of 30 mg/kg daily in divided doses every 12 hours.
• Dose Adjustment: Dosage reduction is required in patients with severe renal impairment.

Contraindications:

Known hypersensitivity to amoxicillin, flucloxacillin, other penicillins, cephalosporins, or beta-lactam antibiotics.
Infectious mononucleosis and lymphatic leukemia (increased risk of skin rash).
History of hepatic dysfunction / cholestatic jaundice associated with flucloxacillin.

Precautions:

• Renal Impairment: Reduce dosage and increase dosing intervals in patients with severe renal impairment.
• Allergic Reactions: Use with caution in patients with allergic diathesis, bronchial asthma, or multiple allergies.
• Hepatic Function: Regular monitoring of liver function is recommended during prolonged therapy.
• Prolonged Use: May result in overgrowth of non-susceptible organisms and fungal superinfection.

Adverse Reactions / Side Effects:

• Gastrointestinal System: Nausea, vomiting, diarrhea, upset stomach, dyspepsia; rarely — pseudomembranous colitis.
• Allergic Reactions: Skin rash, urticaria, pruritus; rarely — angioedema, anaphylactic shock.
• Hepatic System: Transient elevation of liver enzymes; rare cases of cholestatic jaundice and hepatitis.
• Hematologic System: Reversible leukopenia, thrombocytopenia, eosinophilia.

Pregnancy and Lactation:

Pregnancy:
Use only when the expected benefit to the mother outweighs potential risks to the fetus (as prescribed by a physician).
Lactation Period:
Active ingredients are excreted in breast milk in small amounts.
If required during lactation, consider discontinuing breastfeeding or monitoring the infant carefully.

Storage Conditions:

Dry Powder: Store in a dry place protected from light at a temperature not exceeding 25°C.
Reconstituted Suspension: Store in a refrigerator (2–8°C) and use within 10 days.
Keep out of reach of children.

Packaging:

Dry powder for oral suspension (100 ml reconstituted volume) in a bottle.
1 bottle per carton box with package insert.