Composition:
Each 5 ml contains...............Sultamicillin 250 mg
Each tablet contains.............Sultamicillin 375 mg or 750 mg
Each Vial contains...............Sultamicillin 375,750 or 1500 mg

Properties:
Sultamicillin is a precursor of ampicillin.

The Ampicillin and Sulbactam:
► Sulbactam is an irreversible inhibitor of most important beta - lactamases, that occur in penicillin- resistant organisms.
Sulbactam exhibits synergistic effect with penicillins and cephalosporin's.
► Ampicillin is the bactericidal component of the combination, as it inhibits the biosynthesis of cell wall mucopeptide of many Gm +ve, Gm- ve aerobic and anaerobic bacteria.
Sultamicillin is well absorbed and diffuses readily into most tissues and fluids in the human body. Penetration into brain and spinal fluid is low except when meninges are inflamed, high concentrations of sulbactam and ampicillin.The are achieved in the blood, and both components have a half-life of one hour. Most of the sulbactam and ampicillin is excreted unchanged in the urine.

Indications:
Sultamicillin is indicated for infections caused by susceptible microorganisms e.g.:
► 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 injection is also used for intra-abdominal infections including peritonitis, cholecystitis, endometritis, pelvic Cellulitis,bacterial septicemia, and also pre - operatively to reduce the incidence of postoperative wound infections.

Endpoint excellent tolerability profile:

In over 2.250 patients treated with Ampicillin/Sulbactam,rate of discontinuation of treatment because of side effects was less than 1%.

The use of Ampicillin/Sulbactam (Ultracillin ) in patients with chronic liver disease revealed no changes in the blood chemistry tests.

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

Precautions:
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more expected to occur in individuals with a history of penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens.
As with any antibiotic preparation, constant observation for signs of over growth of non-susceptible organisms, including fungi, is essential. If super infection occur, the drug should be discontinued and/or appropriate therapy instituted.

Use during pregnancy and lactation: ► Animal reproduction studies have revealed no evidence of impaired fertility or harm to the fetus due to sultamicillin. However, safety for use in human pregnancy has not been established.
► Low concentrations of ampicillin and sulbactam are excreted in the milk; therefore, caution should be exercised when Sultamicillin is administered to a nursing woman.

Use in children:
The safety and effectiveness of sulbactam have been established for pediatric patients one year of age and older for skin and skin structure disorder infections; and have not been established for pediatric patients for intra-abdominal infection.

Drug Interactions:
Allopurinol and Ampicillin:
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. There are no data concerning concurrent administration of Sultamicillin and allopurinol.
Probenecid:
Probenecid decreases the renal tubular secretion of ampicillin and sulbactam and increases the blood level of ampicillin and sulbactam.

Adverse reactions:
Sultamicillin is generally well tolerated. The majority of side effects observed were of mild or moderate severity and were normally tolerated with continued treatment.
Gastrointestinal, the most frequently observed side effect was diarrhea/loose stool. Nausea, vomiting, epigastric distress, and abdominal pain/cramps have been observed.
Hypersensitivity reactions:
urticaria ,erythema multiform and exfoliate dermatitis.
It is expected that the adverse reactions associated with use of ampicillin may be occasionally observed.

Dosage and administration:
► Orally:
The recommended dose in adults.................................375-750 mg twice daily.
The dosage for most infections in children.................... weighing less then 30 kg is 25-50 mg/kg/day in 2 divided doses depending on the severity of the infection
In the treatment of gonorrhea.......................................a single dose of 2.25 gm (six 375 mg tablets) can be used.
► Injection:
Sultamicillin can be administered by either I.V or I.M routes, where it should be reconstituted with sterile water for injection or any compatible solution. The diluent's volume of each 375 mg is at least 0.8 ml.The dosage ranges from 1.5 to 3gm per day in divided doses every 6-8 hours. The dose should not exceed 4 gm / day. Less severe infections may be treated on every 12 hours schedule.
► For the prophylaxis of surgical infections:
1.5-3 gm should be given at induction of anesthesia. The dose may be repeated 6-8 hourly. Administration is usually stopped after 24 hours, unless a therapeutic course is indicated.

Storage after reconstitution:
After reconstitution, the solution should be allowed to stand to allow any foaming to dissipate in order to permit visual inspection for complete solubilization.
► For I.V. administration:
Reconstitution is only done with 0.9% sodium chloride, and can be stored for up to 8 hours at 25°C.
► For I.M. administration:
Reconstitution can be done using sterile water,or Lidocaine hydrochloride (0.5 or 2% ) and using only freshly prepared solution & administer within one hour after preparation.
N.B. In renal function impairment patients, the dose should be administered less frequently in accordance with usual practice for ampicillin.

Storage:
► Ultracillin sterile powder is to be stored at or below 30°C prior to reconstitution.
► Keep out of reach of children.

Packing:

Box of one Vial of 375 mg. Box of one Vial of 750 mg.	Bottle of 80 ml
Box of one Vial of 1500 mg.	Box of 12 tablets ( 375 mg ). Box of 6 tablets ( 750 mg)