Hibiotic® – Broad Spectrum Bactericidal Antibiotic

Composition

Tablet 375 mg, 625 mg, 1000 mg (1gm): Each film coated tablet contains amoxycillin (trihydrate) 250 mg, 500mg or 875 mg in addition to clavulanic acid 125 mg as potassium salt.

Dry Syrup 156 mg: Each 5 ml after reconstitution contains amoxycilling (trihydrate) 125 mg in addition to clavulanic acid 31.25 mg as potassium salt.

Dry Syrup 312 mg: Each 5 ml after reconstitution contains amoxycilling (trihydrate) 250 mg in addition to clavulanic acid 62.50 mg as potassium salt.

Dry Syrup 228 mg: Each 5 ml after reconstitution contains amoxycilling (trihydrate) 200 mg in addition to clavulanic acid 28 mg as potassium salt.

Dry Syrup 457 mg: Each 5 ml after reconstitution contains amoxycilling (trihydrate) 400 mg in addition to clavulanic acid 57 mg as potassium salt.

Dry Syrup 600 mg: Each 5 ml after reconstitution contains amoxycilling (trihydrate) 600 mg in addition to clavulanic acid 42.9 mg as potassium salt.

Properties

Hibiotic® is an oral antibacterial combination of amoxycillin and clavulanic acid as potassium salt.

Amoxycilling is a semisynthetic penicilling with a broad spectrum bactericidal activity against several Gram positive and Gram negative bacteria.

Clavulanic acid generally acts as an irreversible, competitive inhibitor of ß-lactamases.

Therefore, the administration of clavulanic acid with amoxycilling results in a synergistic bactericidal effect which expands the spectrum of activity of amoxycilling against many strains of ß-lactamase producing bacteria resistant to amoxycillin alone.

Hibiotic® is stable in the presence of gastric secretions and is well absorbed after oral administration.

Antibacterial Activity

Hibiotic® is a potent bactericidal against a wide range of Gram positive and gram negative bacteria, including ß-lactamase producing organisms as well as some anaerobes, such as:

  • Staphylococcal species
  • Streptococcal species
  • Escherichia coli
  • Salmonella species
  • Shigella species
  • Clostridium species
  • Bacteroides fragilis
  • Haemophilus influenzae
  • Klebsiella species
  • Neisseria species
  • Moraxella catarrhalis
  • Proteus mirabilis
  • Bordetella pertussis

Indications

  1. Upper respiratory tract infections, e.g. acute or chronic sinusitis, tonsillitis and otitis media.
  2. Lower respiratory tract infections, e.g. bronchitis, bronchopneumonia and lung abscess Skin and soft tissue infections.
  3. Complicated and uncomplicated urinary tract infections.
  4. Gynecological infections, e.g. pelvic infections and septic abortion.
  5. Venereal infections, e.g. gonorrhea and chancroid.
  6. Dental infections, e.g., dental abscess.
  7. Other infections such as septicemia, osteomyelitis, peritonitis and postoperative infections

Dosage

Hibiotic® is not affected by food, so it can be taken with or after meals.

Adult and Children over 12 years:

Mild to moderate infections: One tablet 375 mg every 8 hours.

Severe infections: One tablet 1000 mg (1 gm) every 12 hours or one tablet 625 mg every 8 hours.

Children

  • 7-12 years: 5 ml (teaspoonful) 312 mg syrup every 8 hours.
  • 2-7 years: 5 ml (teaspoonful) 156 mg syrup every 8 hours.
  • 9 months-2 years: 2.5 ml (teaspoonful) 156 mg syrup every 8 hours.
  • 1 month-8 months: 0.3 ml/kg/dose of 156 mg syrup every 8 hours.

N.B. Dose could be doubled in children with severe infections.

Renal impairment patient

In renal impairment, the dose of Hibiotic® for adult must be modified as follows:

  • Mild Impairment (Creatinine clearance>30ml/min): No change in dosage.
  • Moderate Impairment (Creatinine clearance 10-30ml/min):  375mg or 625mg 12 hourly.
  • Severe Impairment (Creatinine clearance<10ml/min):  Not more than 375mg 12 hourly.

In children: Similar reduction in dosage should be made.

Preparation of Hibiotic® suspension

First shake the bottle to loosen the powder. Then add sterile water, shake well and fill up to the mark on the bottle.

When first reconstituted allow to stand for 5 minutes to ensure full dispersion.

Once reconstituted, Hibiotic® suspension must be stored in a refrigerator and used within 7 days. Shake well before taking each dose.

Adverse Effects

Uncommon and may include nausea, vomiting, abdominal discomfort or skin rash.

Other side effects which are very rare include erythema multiforme, Stevens-Johnson Syndrome, erythematous rashes associated with glandular fever, exfoliative dermatitis, pseudomembranous colitis and cholestatic jaundice which is usually reversible.

Precautions

During prolonged therapy with Hibiotic®, renal, hepatic and hematologic functions should be evaluated periodically.

Safe use of amoxycillin and clavulanate potassium during pregnancy has not been definitely established; therefore, the drug should be used during pregnancy only when necessary.

Contraindications

Hypersensitivity to penicillins and/or clavulanic acid.

How Supplied

  • Hibiotic® 1000 mg (1 gm) tablet: Strips of 8 film coated tablets in packs o f 1 strip.
  • Hibiotic® 625 mg Tablet: Strips of 10 film coated tablets in packs of 1 strip.
  • Hibiotic® 375 mg Tablet: Strips of 10 film coated tablets in packs of 1 strip.
  • Hibiotic® 312 mg Powder for oral suspension: Bottles of 60 ml after reconstitution with sterile water.
  • Hibiotic® 156 mg Powder for oral suspension: Bottles of 60 ml after reconstitution with sterile water.

Keep all medicaments out of reach of children

Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: J01CR02.


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