Hibiotic tablets & suspension
broad spectrum bactericidal antibiotic
Composition :
– tablet 375 mg, 625 mg. 1000 mg (1 gm):
Each film coated tablet contains amoxycillin (trihydrate) 250 me, 500 mg or 875 mg in addition to clavulanic acid 125 mg as potassium salt
– Powder for oral suspension 230mg:
Each 5 ml after reconstitution contains amoxycillin (trihydrate) 200 mg in addition to clavulanic acid 30 mg as potassium salt
– Powder for oral suspension 460 mg:
Each 5 ml after reconstitution contains amoxycillin ((rihydrate) 400 mg in addition to clavulanic acid 60 mg as potassium salt.
– Powder for oral suspension 600 mg:
Each 5 ml after reconstitution contains amoxycillin (trihydrate) 600 mg in addition to clavulanic acid 42.9 mg as potassium salt.
Pharmacokinetic properties:
AmoXYCllhn and davulanic acid are well absorbed from the gastrointestinal tract after oral administration and are not affected by food intake.
Approximatety 90% of amoxycilhn appears in blood and 7CJl1o of amoxycillin and 4CJl1o of clavutanic acid are excreted unchanged in urine during the first 6 hours. Amoxyclllin diffuses readity into most body tissues and fluids.
Pharmacological properties :
Both Hibiotic@ tablets and Hibiotic N® suspension are antibacterial combination of amoxycillin and clavulanic acid as potassium salt. Amoxycillin is a semisynthetic penicillin with a broad spectrum bactericidal activity against several Gram positive and Gram negalive bacteria. Clavulanic acid generally acts as an irreversible, competitive Inhibitor of IS-Iactamases. Therefore, the administration of clavulanic acid with amoxycillin results in a synergistic bactericidal effect which exQands the spectrum of activity of amox cillin
against many strains of IS-Iactama pr uCln$ bacteria resislantlo amoxycillln
Hibiotic® tablets and Hibiotic suspension are stable in the presence of gaslnc secretions and are well absorbed after oral administration.
Antibacterial Activity :
Hibiotic® tablets and Hibiotic N® suspension are a potent bactericidal against a wide range of Gram positive and Gram negative bacteria, including IS-Iactamase producing organisms as well as different anaerobes:
– Aerobic Gram +ve & Gram-ve bacteria:
. Staphylococcal species • Streptococcal species • Haemophiluls influenzae
. Klebsiella species • Escherichia coli • Neisseria species
. Salmonella species • Moraxella catarrhalis • Shigella species
. Proteus mirabilis • Bordetella pertussis
– Anaerobic Gram +ve & Gram-ve bacteria:
. Clostridium species • Bacteroides fragilis • Peptococcus species
. Peptostreptococcus species
Indications :
– Acute or persistent or recurrent otitis media
– Upper respiratory tract infections, e.g.,acute or chronic sinusitis, recurrent tonsillits
– Lower respiratory tract infections, e.g., bronchitis, lobar and bronchopneumonia, lung abscess
– Skin and soft tissue infections e.g., abscesses, cellulitis, wound infections
– Genito=llrinaty tract infectlons e.g, stitis, urethritis
– Gynecological infections, e.g., pelvic infections, postpartum infections
– Dental infections, e.g., dental abscess
Dosage for oral administration:
Hibiofjc® tablets and Hibiotic N® suspension are not affected by food, so it can be taken with or after meals. Adult & 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:
2 months-2years: 2.5ml to 5ml Hibioti®N® 230 mg every 12 hours
2 – 6 years: 2.5ml to 5ml of Hibiotic N ~60 mg every 12 hours
6- 12 years: 7.5ml to lOml of Hibiotic N 460 mg every 12 hours
For persistent iM’d recurrent middle ear infections ( from 3 months and above)
use Hibiotic N 600mg suspension in a dose of 90mglkglday divided in 2 equal doses every 12 hours
N.B.:
Treatment with Hibiotic® should not exceed 14 days
Dose should be’adjusted in severe renal failure
Preparation of Hibiotic N® Suspension :
First shake the bottle to loosen the powder. Then add sterile water, shake well and fill up to the mark on the b~tt!e. Whlil\’ first reconstituted allow to stand for few seconds to ensure full dispers!on. Once reconstituted, H.blOtlt =peJTSton must be stored Irnrrefrigerator and userr- In 7 days. )hake well before taking
each dose.
Drug interactions:
Few drugs interactions may occur with Probencid and allopurinol.
As with other broad spectrum antibiotic, Hibiotic® may reduce the efficacy of oral contraceptives.
Use during pregnancy:
Both amoxyicillin and clavulanic acid are category B . HibiotiC® should not be used during pregnancy unless it is prescribed by the physician.
Use during lactation:
Although little amounts of Hibiotic® are excreted in milk, it could be used safely during lactation.
Adverse Effects :
Uncommon and may include nausea, vomitine, 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, hepatitis. and cholestatic jaundice which is usually reversible.
Precautions :
During prolonged therapy with HibiotiC® renal, hepatic and hematologic functions should be evaluated.
Contraindications :
Hypersensitivity to penicillins and/or clavulanic acid.
How SUpplied :
Hibiotic”l’ 1 000 mg (1 gm) Tablet: Strips of 8 film coated tablets in packs of 1 or 2 strips.
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 N® 600 mg Powder for oral suspension: Bottles of 80 ml after reconstitution with sterile water.
Hibiotic N® 460 mg Powder for oral suspension: Bottles of 60 ml after reconstitution with sterile water.
Hibiotic N® 230 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. SAE.
EJ-Obour City, Cairo, Egypt