|ZOXIL 250 -||Gelatin capsules containing the equivalent of 250 mg Amoxycillin.|
|ZOXIL 500 -||Gelatin capsules containing the equivalent of 500 mg Amoxycillin.|
|ZOXIL S -||Powder for preparing a fruit-flavoured syrup. When reconstituted as directed, each 5 mL of the suspension contains the equivalent of 125 mg Amoxycillin. The powder contains 0,295% m/m sodium benzoate B.P. as a preservative.|
|ZOXIL SF -||Powder for preparing a fruit-flavoured syrup. When reconstituted as directed, each 5 mL of the suspension contains the equivalent of 250 mg Amoxycillin. The powder contains 0,295% m/m sodium benzoate B.P. as a preservative.|
|(i) Spectrum - Amoxycillin is a penicillinase-susceptible penicillin. Amoxycillin exhibits in vitro, bactericidal activity against a wide range of Gram-negative and Gram-positive organisms including:|
|Gram-positive bacteria:||Gram-negative bacteria:|
|Staphylococcus aureus (penicillin-sensitive) *||Neisseria gonorrhoeae *|
|Streptococcus pyogenes||Neisseria meningitidis|
|Streptococcus viridans *||Haemophilus influenzae **|
|Streptococcus faecalis *||Bordetella pertussis|
|Diplococcus pneumoniae *||Escherichia coli *|
|Corynebacterium-species *||Salmonella typhi|
|Clostridium species *||Salmonella species|
|Bacillus anthracis *||Shigella species|
|(ii) Bactericidal Action|
Amoxycillin exerts a rapid bactericidal activity at normal dosage levels against all susceptible organisms.
Amoxycillin is rapidly and well absorbed orally. A single 250 mg oral dose achieves an average peak serum level virtually equal to that achieved by IM injection viz. 5,3 micrograms/mL oral and 5,6 micrograms/mL IM. The peak serum level is achieved within 1,5 - 2 hours after oral and 15 minutes after IM or IV (18,2 micrograms/mL) administration.
After oral administration there is no significant difference between the peak serum levels in fasting and non-fasting subjects. The presence of food does not interfere with the absorption of Zoxil. Zoxil may, therefore, be taken with meals.
There is a linear/dose response in peak serum levels after both oral and parenteral administration.
(i) Sputum: The concentration of Amoxycillin in sputum does not decrease as occurs with ampicillin as purulence subsides.
(ii) Bile: Zoxil is present in bile obtained from a common bile duct drain of a healthy gall-bladder, however, biliary levels are lower when the gall-bladder is diseased and absent in the presence of biliary tract obstruction.
(iii) Urine: The average concentration of Zoxil in urine collected during the first six hours after 250 mg oral dose, is 580 mg/mL.
(i) Renal: Approximately 60% of an oral dose of Amoxycillin is excreted unchanged in the active form into the urine within six hours. Approximately 70%-80% of an intramuscular dose and 90% of an intravenous dose is excreted unchanged in the active form, into the urine within 12 hours.
(ii) Biliary: A variable percentage of Zoxil is excreted into the bile.
Even higher Zoxil serum levels may be achieved after oral administration to patients with normal renal function, by the simultaneous administration of a renal blocking agent such as probenecid. Probenecid should not be given in the presence of abnormal renal function. No data on the effect of probenecid on parenteral Amoxycillin are yet available.
|Upper respiratory tract infections||Lower respiratory tract infections|
|Otitis media||Typhoid Fever|
|Upper urinary tract infections||Lower urinary tract infections|
|Skin and soft tissue infections||Gastro-intestinal tract infections|
|Adults 250 mg (1 X 250 mg capsule or 5 mL of 250 mg/5 mL syrup) three times a day.|
|Children 2 - 10 years: 125 mg (5 mL of 125 mg/5 mL syrup) three times a day.|
|Children 6 months - 2 years: 125 mg (5 mL of 125 mg/5 mL syrup) three times a day.|
|Infants 0 - 6 months: 62,5 mg (2,5 mL of 125 mg/5 mL syrup) three times a day.|
|Premature infants 1,0 - 2,5 kg: 30,0 - 62,5 mg (quarter to half medicine measureful of 125 mg/5 mL syrup) once daily for the first 1 - 2 weeks depending on the size and maturity of the infant, thereafter dose may be given 2 - 3 times daily.|
|In severe infections these dosages may be increased.|
|NOTE:||(1) Patients with renal insufficiency may possibly require a reduced dose.|
|(2) During treatment with high doses of Zoxil, an adequate fluid intake and urinary output must be maintained. Indwelling catheters should be checked regularly for potency since at room temperature high urinary concentration of Zoxil may precipitate out of solution.|
|Gastro-intestinal tract infections||1 - 2 g||-||4 - 5 days|
|Acute typhoid fever||4 g
|Gonorrhoea||2 - 3 g||-||stat|
|Zoxil 250||- Dark Grey/Pink Opaque capsules overprinted "Zoxil 250" in white.|
|Zoxil 500||- Dark Grey/Pink Opaque capsules overprinted "Zoxil 500" in white.|
|Zoxil S||- Free-flowing, pink powder. Pink suspension.|
|Zoxil SF||- Free-flowing, pink powder. Pink suspension.|
|Zoxil 250||- Securitainers containing 15, 100 or 500 X 250 mg Amoxycillin capsules.|
|Zoxil 500||- Securitainers containing 15 or 100 X 500 mg Amoxycillin capsules.|
|Zoxil S||- Bottles containing powder for reconstitution to 100 mL of 125 mg/5 mL syrup.|
|Zoxil SF||- Bottles containing powder for reconstitution to 100 mL of 250 mg/5 mL syrup.|
|Zoxil 250||- 28/20.1.2/0124|
|Zoxil 500||- 28/20.1.2/0125|
|Zoxil S||- 28/20.1.2/0126|
|Zoxil SF||- 28/20.1.2/0127|