Augmentin ES 600 Powder for oral suspension preparation 75 ml

Augmentin ES 600 Powder for oral suspension preparation 75 ml

Composition:

Active Ingredients: Each 5 mL of prepared suspension contains
Amoxicillin (as trihydrate) — 600 mg (equivalent to 652.78 mg amoxicillin trihydrate) and
Clavulanic Acid (as potassium salt) — 42.9 mg (equivalent to 50.41 mg potassium clavulanate).
Excipients: 
Colloidal silicon dioxide, succinic acid, hypromellose, xanthan gum, strawberry flavor, aspartame, silicon dioxide.

Product Description:

• Augmentin ES is a broad-spectrum combined antibacterial medication consisting of a semi-synthetic penicillin antibiotic (amoxicillin) and a beta-lactamase inhibitor (clavulanic acid) in a 14:1 ratio.
• Its mechanism of action relies on the bactericidal inhibition of bacterial cell wall synthesis by amoxicillin.
• Clavulanic acid inactivates a wide spectrum of beta-lactamases, preventing the enzymatic degradation of amoxicillin and restoring its activity against beta-lactamase-producing bacterial strains.
• The medication is active against Gram-positive and Gram-negative aerobic and anaerobic bacteria (including golden staphylococcus, colon bacillus, Haemophilus influenzae, Klebsiella species, Moraxella catarrhalis, pneumococcus, pyogenic streptococcus, fecal enterococcus, Clostridium species, Peptostreptococcus species, Proteus species, Salmonella species, Shigella species, and Bacteroides fragilis).
• Clavulanic acid is less effective against class I chromosomal beta-lactamases produced by Pseudomonas aeruginosa, Serratia species, and Acinetobacter species.

Indications for Use:

• Treatment of bacterial infectious and inflammatory diseases in pediatric patients caused by susceptible microorganisms:
• Upper Respiratory Tract and ENT Infections: Acute otitis media (particularly caused by resistant strains of pneumococcus), recurrent tonsillitis, sinusitis.
• Lower Respiratory Tract Infections: Community-acquired pneumonia, bronchopneumonia, acute exacerbation of chronic bronchitis.
• Skin and Soft Tissue Infections: Erysipelas, impetigo, secondarily infected dermatoses, abscesses, phlegmons, wound infections.
• Urinary Tract Infections: Pyelonephritis, cystitis, urethritis.
• Bone and Joint Infections: Osteomyelitis.

Method of Administration and Dosage:

• Administered orally.
• To optimize absorption and minimize gastrointestinal side effects, it is recommended to take the medication at the start of a meal.
• Shake the bottle thoroughly before each use.
• Directions for Reconstitution: Add cooled boiled water to the powder in two portions, shaking vigorously each time until fully dissolved.
  The final volume of the prepared suspension should equal 75 mL.
• Pediatric Patients Aged 3 Months and Older:
• Recommended Dose: 90 mg/kg/day (calculated based on amoxicillin), divided into 2 doses (every 12 hours).
• Approximate Single Dose Volume (Twice Daily):
  Body weight 8 kg: 3.0 mL.
  Body weight 12 kg: 4.5 mL.
  Body weight 17 kg: 6.0 mL.
  Body weight 20 kg: 7.5 mL.
  Body weight 24 kg: 9.0 mL.
  Body weight 28 kg: 10.5 mL.
  Body weight 32 kg: 12.0 mL.
  Body weight 36 kg: 13.5 mL.
• Duration of Therapy: The standard treatment duration is up to 10 days.
• Treatment should not exceed 14 days without medical re-evaluation.

Contraindications:

• Hypersensitivity to amoxicillin, clavulanic acid, other penicillins, cephalosporins, or any excipients of the formulation.
• Infectious mononucleosis (high risk of developing a rubelliform skin rash).
• History of jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid therapy.
• Phenylketonuria (contains aspartame).
• Infants under 3 months of age.
• Moderate-to-severe renal impairment (creatinine clearance less than 30 mL/min).

Precautions:

• Administration with Food: Take at the start of meals to reduce gastrointestinal discomfort.
• Allergy Monitoring: Prior to initiating therapy, obtain a detailed history regarding previous hypersensitivity reactions to beta-lactam antibiotics. Discontinue immediately if an allergic reaction occurs.
• Laboratory Monitoring: During prolonged therapy, monitor hepatic, renal, and hematopoietic functions periodically.
• Risk of Superinfection: Extended use may result in the overgrowth of non-susceptible microorganisms or fungal pathogens (candidiasis).
• Diagnostic Testing: May cause false-positive results in urine glucose tests (enzymatic glucose oxidase methods are recommended).

Adverse Reactions / Side Effects:

• Infections: Frequently — mucocutaneous candidiasis.
• Gastrointestinal System: Frequently — diarrhea, nausea, vomiting; uncommonly — indigestion; very rarely — pseudomembranous and hemorrhagic colitis, tooth discoloration.
• Hepato-biliary System: Uncommonly — moderate elevation of liver enzymes (ALT/AST); very rarely — hepatitis, cholestatic jaundice.
• Allergic Reactions: Uncommonly — skin rash, pruritus, urticaria; very rarely — angioedema, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome.
• Hematopoietic System: Rarely — reversible leukopenia, thrombocytopenia; very rarely — agranulocytosis, hemolytic anemia, prolonged bleeding time.
• Nervous System: Uncommonly — dizziness, headache; very rarely — convulsions, hyperactivity, anxiety.
• Urinary System: Very rarely — interstitial nephritis, crystalluria, hematuria.

Pregnancy and Lactation:

Because this formulation is intended primarily for pediatric use, administration in adults is uncommon.
In cases where it is administered to adolescents or adults, use during pregnancy and lactation is permissible only when the expected benefit to the mother outweighs the potential risk to the fetus or child, strictly under medical supervision.

Storage Conditions:

Store the dry powder at a temperature not exceeding 30 °C in a dry place.
Store the reconstituted suspension in a refrigerator (between 2 °C and 8 °C) and use within 10 days.
Keep out of reach of children.

Packaging:

Cardboard box containing 1 bottle of powder for oral suspension (75 mL reconstituted volume), a dosing device (measuring spoon or syringe), and a patient information leaflet.