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SULTAMAT is indicated in the treatment of the following infections caused by the susceptible strains of bacteria indicated below: Upper respiratory tract infections : Sinusitis, otitis madia, pharyngitis, tonsillitis: Caused by the susceptible strains of: Haemophilus influenzae, Moraxella catarrhalis, Staphylococci, Streptococci, Klebsiella and Proteus spp. Lower respiratory tract infections:Bronchitis, pneumonia, acute exacerbations of chronic bronchitis: Caused by the susceptible strains of: Staphylococcus and Streptococcus spp. Haemophilus influenzae and H.parainfluenzae, Moraxella. Skin and skin structure infections: Caused by the following beta-lactamase-producing bacteria: Staphylococcus aureus, Esherichia coli, Klebsiella spp.( including K. Pneumoniae) Proteus mirabilis, Bacteroides fragilis, Enterobacter spp.. and Acinetobacter calcoaceticus. Intra-abdominal infections: Caused by the following beta- lactamase- producing bacteria: Escherichia coli, Klebsiella spp. (including K. Pneumoniae), Bacteroids spp. (including Bacteroides fragilis) and Enterobacter spp. Gynecological infections: Caused by the following beta-lactamase-producing bacteria: Escherichia coli, Bacteroides spp. ( including B.fragilis). Because of its ampicillin content, SULTAMAT can also be used for the tratment of infections caused by ampicillin-susceptible bacteria and where ampicillin treatment is indicated. Mixt infections caused by an ampicillin-susceptible bacteria and another microorganism which is sultamicillin- susceptible can be treated by the administration of SULTAMAT alone.


History of allergic reaction to any penicillins.

Adverse reactions:

Oral: Sultamicillin is generally well tolerated. The majority of side effects observed were of mild or moderate severity and were normally tolerated with continued treatment. Body As A Whole: Allergic reaction, anaphylactic shock and anaphylactoid reaction. Central and Peripheral Nervous: Dizziness. Gastrointestinal: The most frequently observed side effect was diarrhoea/loose stool. Nausea, vomiting, epigastric distress, melena and abdominal pain/cramps have been observed. As with other ampicillin-class antibiotics, enterocolitis and pseudomembranous colitis may rarely occur. Respiratory: Dyspnoea. Skin/Skin Structure: Rash and itching were infrequently observed, along with angioedema, dermatitis and urticaria. Miscellaneous: Drowsiness/sedation, fatigue/malaise and headache have been rarely observed. Adverse reactions associated with use of ampicillin alone may be observed with sultamicillin. Adverse reactions associated with the use of ampicillin and/or sulbactam/ampicillin IM/IV include: Central and Peripheral Nervous: Rare reports of convulsions. Gastrointestinal: Black hairy tongue, glossitis, stomatitis. Haematopoietic and Lymphatic: Anaemia, haemolytic anaemia, thrombocytopenia, thrombocytopenia purpura, eosinophilia, leukopenia, neutropenia, agranulocytosis, abnormal platelet aggregation. Liver/Biliary: Transient elevations of ALT (SGPT) and AST (SGOT) transaminases, bilirubinaemia, abnormal hepatic function and jaundice. Skin/Skin Structure: Rare reports of exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme and Stevens-Johnson syndrome. Urinary: Rare reports of interstitial nephritis. IM/IV: As with other parenteral antibiotics, the principal side effect observed is injection site pain, especially associated with the IM route of administration. A small number of patients may develop phlebitis after IV administration. Gastrointestinal: The most common were nausea, vomiting and diarrhoea. Skin/Skin Structure: The most common were rash, itching and other skin reactions. Haematopoietic and Lymphatic Systems: Anaemia, thrombocytopenia, eosinophilia and leukopenia have been reported during therapy with sulbactam sodium/ampicillin sodium. These reactions are reversible on discontinuation of therapy and are believed to be sensitivity reactions. Hepatic: Transient elevations of alanine and aspartic transaminases have been observed. It is expected that the adverse reactions associated with the use of ampicillin will be occasionally observed. Since infectious mononucleosis is viral in origin, ampicillin should not be used in the treatment. A high percentage of patients with mononucleosis who receive ampicillin develop a skin rash.


Allopurinol: The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. Anticoagulants: Penicillins can produce alterations in platelet aggregation and coagulation tests. These effects may be additive with anticoagulants. Bacteriostatic Drugs (Chloramphenicol, Erythromycin, Sulfonamides and Tetracyclines): Bacteriostatic drugs may interfere with the bactericidal effect of penicillins; it is best to avoid concurrent therapy. Estrogen-Containing Oral Contraceptives: There have been case reports of reduced oral contraceptive effectiveness in women taking ampicillin, resulting in unplanned pregnancy. Although the association is weak, patients should be given the option to use an alternate or additional method of contraception while taking ampicillin. Methotrexate: Concurrent use with penicillins has resulted in decreased clearance of methotrexate and a corresponding increase in methotrexate toxicity. Patients should be closely monitored. Leucovorin dosages may need to be increased and administered for longer periods of time. Probenecid: Probenecid decreases renal tubular secretion of ampicillin and sulbactam when used concurrently; this effect results in increased and prolonged serum concentrations, prolonged elimination half-life and increased risk of toxicity. Laboratory Test Interactions: False-positive glycosuria may be observed in urinalysis using Benedict reagent, Fehling’s reagent and Clinitest. Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol has been noted. This effect may also occur with sulbactam sodium/ampicillin sodium IM/IV.


Hypersensitivity. Overgrowth of nonsusceptible organism. Clostridium difficile-associated diarrhea (CDAD) must be considered in patients w/ diarrhea following antibiotic use. Check periodically for organ system dysfunction during prolonged therapy. Pregnancy & lactation. Neonates.



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