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Unasyn Oral

Sultamicillin

1. TRADE NAME OF MEDICINAL PRODUCT
UNASYN

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sultamicillin is a double ester in which ampicillin and the beta-lactamase inhibitor sulbactam are linked via a methylene group. Chemically Sultamicillin is the oxymethylpenicillinate sulphone ester of ampicillin and has a molecular weight of 594.7.

3. PHARMACEUTICAL FORM
Sultamicillin is available as film-coated tablets containing the tosylate salt equivalent to 375 mg sultamicillin which is a mutual prodrug of sulbactam and ampicillin yielding the equivalent of 147 mg sulbactam and 220 mg ampicillin.

Sultamicillin is also available as a powder for oral suspension containing sultamicillin base that after reconstitution with water provides 250 mg sultamicillin per 5 ml.

4. CLINICAL PARTICULARS
4.1 Therapeutic Indications

Sultamicillin is indicated for infections caused by susceptible micro-organisms. Typical indications are upper respiratory tract infections including sinusitis, otitis media and tonsillitis; lower respiratory tract infections including bacterial pneumonias and bronchitis; urinary tract infections and pyelonephritis; skin and soft tissue infections and gonococcal infections.

Sultamicillin may also be indicated in patients requiring sulbactam/ampicillin therapy following initial treatment with sulbactam/ampicillin IM/IV.

4.2 Posology and Method of Administration
The recommended dose of sultamicillin in adults (including elderly patients) is 375-750 mg orally twice daily.

In both adults and children treatment is usually continued until 48 hours after pyrexia and other abnormal signs have resolved. Treatment is normally given for 5-14 days, but the treatment period may be extended if necessary.

In the treatment of uncomplicated gonorrhoea, sultamicillin can be given as a single oral dose of 2.25 grams (six 375 mg tablets). Concomitant probenecid 1.0 gram should be administered in order to prolong plasma concentrations of sulbactam and ampicillin.

Cases of gonorrhoea with a suspected lesion of syphilis should have dark field examinations before receiving sultamicillin and monthly serological tests for a minimum of four months.

It is recommended that there be at least 10 days treatment for any infection caused by hemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.

Use in Children and Infants
The dosage for most infections in children weighing less than 30 kg is sultamicillin 25-50 mg/kg/day orally in 2 divided doses depending on the severity of the infection and the physician's judgement. For children weighing 30 kg or more the usual adult dose should be given.

Use in Patients with Renal Impairment
In patients with severe impairment of renal function (creatinine clearance ≤ 30 ml/min), the elimination kinetics of sulbactam and ampicillin are similarly affected and hence the plasma ratio of one to the other will remain constant. The dose of sultamicillin in such patients should be administered less frequently in accordance with usual practice for ampicillin.

4.3 Contraindications
The use of this product is contraindicated in individuals with a history of an allergic reaction to any of the penicillins.

4.4 Special Warning and Special Precautions for Use
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including sultamicillin. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before therapy with penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, the drug should be discontinued and the appropriate therapy instituted.

Serious anaphylactic reactions require immediate emergency treatment with adrenaline.

Oxygen, intravenous steroids, and airway management, including intubation, should be administered as indicated.

As with any antibiotic preparation, constant observation for signs of overgrowth of nonsusceptible organisms, including fungi, is essential. Should superinfection
occur, the drug should be discontinued and/or appropriate therapy instituted.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including sultamicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

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.

It is advisable to check periodically for organ system dysfunction during prolonged therapy; this includes renal, hepatic and hematopoietic systems.

The principal route of excretion of sulbactam and ampicillin following oral administration of sultamicillin is via the urine. Because renal function is not fully developed in neonates. this should be considered when using sultamicillin in neonates.

Tablets: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Powder for Oral Suspension: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other Medicaments and Other Forms of Interaction
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 reagent, and Clintest. 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.

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