Each Film-Coated Tablet contains: Sultamicillin (as tosylate) 375 mg and 750 mg.
Sultamicillin is a double ester in which ampicillin and the β-lactamase inhibitor sulbactam are linked via methylene group. Chemically, sultamicillin is the oxymethylpenicillin sulphone ester of ampicillin.
Pharmacology: Pharmacokinetics: Following oral administration in humans, sultamicillin is hydrolyzed during absorption to provide sulbactam and ampicillin. Elimination half-lives 0.75 and 1 hour for sulbactam and ampicillin respectively in healthy volunteers, with 50-75% of each agent excreted in the urine unchanged. Elimination half-life are increased in the elderly and in patients with renal dysfunction. Probenecid decreases the renal tubular secretion of both ampicillin and sulbactam. Concurrent use of probenecid with sultamicillin results in increased and prolonged blood levels.
Microbiology: Sultamicillin is effective against wide range of gram-positive bacteria including: Staphylococcus aureus and epidermis (including penicillin-resistant and some methicillin resistant strains); Branhamelia catarrhalis; anaerobes including Bacteroides fragilis and related species, Escherichia coli; Klebsiella species, Proteus species, (both indole-positive and indole-negative); Enterobacter species; Morganella morganii; Citrobacter species; Neisseria meningitides and Neisseria gonorrhea.
Sultamicillin is used in the treatment of infections where β-lactamase producing organisms including uncomplicated gonorrhea, otitis media and respiratory tract and urinary tract infections.
Usual adult dose: One 375 mg FCT every 12 hours.
For more severe infections: One 750 mg FCT every 12 hours.
For severe soft tissue infections: 2.25 g or one 750 mg FCT TID.
The use of this product is contraindicated in individuals with history of an allergic reaction to any penicillins.
As with antibiotic preparation, constant observation of signs of over-growth of nonsusceptible organisms, including fungi is essential. Should be discontinued and/or appropriate therapy instituted.
It is advisable to check periodically for organ system dysfunction during prolonged therapy, this includes renal, hepatic and hematopoietic systems.
Use in Pregnancy: Animal reproduction studies have revealed no evidence of impaired fertility or harm to the fetus due to sultamicillin is administered to nursing woman.
Use in Pregnancy: Animal reproduction studies have revealed no evidence of impaired fertility or harm to the fetus due to sultamicillin is administered to nursing woman.
Sultamicillin is generally well tolerated. The majorities of side effects observed were of mild or moderate severity and were normally tolerated with continued treatment.
Gastrointestinal: the most frequent observed side effects was diarrhea/loose stool. Nausea, vomiting, epigastric distress and abdominal pain/cramps have been observed. As with other ampicillin-class antibiotics, enterocolitis and pseudomembranous colitis rarely may occur.
Skin/Skin Structures: rash and itching were infrequently observed.
Miscellaneous: drowsiness/sedation, fatigue and headache have been rarely observed.
Probenecid decreases the renal tubular secretion and sulbactam. Concurrent use of probenecid with Sultamicillin may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving both drug as compared to patients receiving ampicillin alone.
Store at temperatures not exceeding 30°C.
J01CR04 - sultamicillin ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Zunamyn tab 375 mg
100's (P25/tab)
Zunamyn tab 750 mg
50's (P58/tab)
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