Hibiotic tablets & suspension
broad spectrum bactericidal antibiotic
– 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.
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
– 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.
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
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
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.
During prolonged therapy with HibiotiC® renal, hepatic and hematologic functions should be evaluated.
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
AMOUN PHARMACEUTICAL CO. SAE.
EJ-Obour City, Cairo, Egypt