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| UItracillin Pamphlet |
UItracillin vial (375, 750 & l500 mg)
Composition:
Each vial of Ultracillin 375 mg contains:Sulbactam (as sodium) 125 mg & Ampicillin (as sodium) 250 mg.
Each vial of Ultracillin 375 mg contains:Sulbactam (as sodium) 125 mg & Ampicillin (as sodium) 250 mg.
Each vial of Ultracillln 750 mg contains:Sulbactam (as sodium) 250 mg & Ampicillin (as sodium) 500 mg.
Each vial of Ultracillin 1500mg contains: Sulbactam (as sodium) 500 mg Ampicillin (as sodium)1000 mg
Properties:
Sulbactam is an irreversible inhibitor of most Important beta - lactamases, that occur In penicillin- resistant organisms. It exhibits synergistic effect with Penicillins and Cephalosporins.
Ampicilihi Is the bactericidal component of the combination, as It inhibits the biosynthesis of cell wall mucopeptide of many Gm +ve, Gm- ye aerobic and anaerobic bacteria.
Indications:
Ultracillin is indicated for infections caused by susceptible microorganisms as:
-Upperrespiratory tract Infections Including sinusitis, otitis media and tonsillitis.
- Lower respiratory tract infections including bacterial pneumonias and bronchitis.
- Urinary tract infections and pyelonephritls. ________
-Skin and soft tissue infections and gonococcal infections. ________
- Ultracillin 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 post-operative wound Infections.
Contraindications:
The use is contraindicated in individuals with a history of an allergic reaction to any of the Pen icillins.
Precautions & warnings:
-As with any antibiotic preparation, careful observation for signs of over growth of non susceptible organisms, Including fungi, is essential. If superinfection occur, the drug should be discontinued andlor appropriate therapy instituted.
OVERDOSAGE MAY CAUSE CONVULSIONS.
HYPERSENSITIVITY REACTIONS MAY OCCUR, SO HYPERSENSITIVITY TESTS SHOULD BE DONE PRIOR TO INJECTION.
Use during pregnancy & lactation:
Animal reproduction studies have revealed no evidence of impaired fertility or harm to the fetus due to use, however safety for use In human pregnancy has not been established.
Low concentrations ofAmpicillin and Sulbactam are excreted In the milk; therefore, caution should be exercised when the drug is administered to a nursing woman.
Drug Interactions:
- The concurrent administration ofAllopurinol and Ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients roceivingAmpicillin alone.
- Probenecid increases the blood level ofAmpicllin and Sulbactam
Adverse reactions:
-As with other parentral antibiotics, the principal side effect is pain at site of injection especially associated with l.M route.
- Most frequently observed side effects were diarrhea, nausea, vomiting, rash, itching and otherskin reactions.
- It is expected that the adverse reactions associated with use of Ampicillin may be occasionally observed.
Dosage and administration:
- Ultracillin can be administered by either intravenous or intramuscular routes, where It should be reconstituted with sterile water for injection or any compatible solution (At least 0.8 ml of diluent for each 375 mg of Ultracillin ) and allowed after reconstitution to stand to allow any foaming to dissipate to permit visual Inspection for complete dissolution.
- Adults : the dosage of Ultracillin is 1.5 -3 gm per day in divided doses every 6-8 hours,(Less severe infections may be treated on every 12 hours schedule). The dose should not exceed 4 gm I day.
For the prophylaxis of surgical infections, 1.5-3gm should be given at induction of anaesthesia. The dose maybe repeated 6-8 hourly. Administration is usually stopped after 24 hours, unless a therapeutic course is indicated.
- Children, infants and neonates: the dosage of Ultracillin for most infections is 150 mgI kg per day usually every 6 orB hours.
(In neonates during the first week of life dosing is usually every 12 hours).
N.B. In renal function impairment patients, the dose should be administered less frequently in accordance with usual practice forAmpicillin.
For l.V. administration:
Ultracillin should be reconstituted with sterile water for injection or 0.9 % Sodium Chloride and can be stored for up to B hours at 25° C or 48 hours at refregirator . The dose can be given by bolus Injection over a minimum of 3 minutes or can be
used in greater dilution either as bolus or as LV. infusion over 15 - 30 mInutes. ___________________
For I.M. administration:
Reconstitution can be done using sterile waterfor ,or Lidocaine hydrochloride 0.5%
Administration should be used within one hour of reconstitution.
Properties:
Sulbactam is an irreversible inhibitor of most Important beta - lactamases, that occur In penicillin- resistant organisms. It exhibits synergistic effect with Penicillins and Cephalosporins.
Ampicilihi Is the bactericidal component of the combination, as It inhibits the biosynthesis of cell wall mucopeptide of many Gm +ve, Gm- ye aerobic and anaerobic bacteria.
Indications:
Ultracillin is indicated for infections caused by susceptible microorganisms as:
-Upperrespiratory tract Infections Including sinusitis, otitis media and tonsillitis.
- Lower respiratory tract infections including bacterial pneumonias and bronchitis.
- Urinary tract infections and pyelonephritls. ________
-Skin and soft tissue infections and gonococcal infections. ________
- Ultracillin 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 post-operative wound Infections.
Contraindications:
The use is contraindicated in individuals with a history of an allergic reaction to any of the Pen icillins.
Precautions & warnings:
-As with any antibiotic preparation, careful observation for signs of over growth of non susceptible organisms, Including fungi, is essential. If superinfection occur, the drug should be discontinued andlor appropriate therapy instituted.
OVERDOSAGE MAY CAUSE CONVULSIONS.
HYPERSENSITIVITY REACTIONS MAY OCCUR, SO HYPERSENSITIVITY TESTS SHOULD BE DONE PRIOR TO INJECTION.
Use during pregnancy & lactation:
Animal reproduction studies have revealed no evidence of impaired fertility or harm to the fetus due to use, however safety for use In human pregnancy has not been established.
Low concentrations ofAmpicillin and Sulbactam are excreted In the milk; therefore, caution should be exercised when the drug is administered to a nursing woman.
Drug Interactions:
- The concurrent administration ofAllopurinol and Ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients roceivingAmpicillin alone.
- Probenecid increases the blood level ofAmpicllin and Sulbactam
Adverse reactions:
-As with other parentral antibiotics, the principal side effect is pain at site of injection especially associated with l.M route.
- Most frequently observed side effects were diarrhea, nausea, vomiting, rash, itching and otherskin reactions.
- It is expected that the adverse reactions associated with use of Ampicillin may be occasionally observed.
Dosage and administration:
- Ultracillin can be administered by either intravenous or intramuscular routes, where It should be reconstituted with sterile water for injection or any compatible solution (At least 0.8 ml of diluent for each 375 mg of Ultracillin ) and allowed after reconstitution to stand to allow any foaming to dissipate to permit visual Inspection for complete dissolution.
- Adults : the dosage of Ultracillin is 1.5 -3 gm per day in divided doses every 6-8 hours,(Less severe infections may be treated on every 12 hours schedule). The dose should not exceed 4 gm I day.
For the prophylaxis of surgical infections, 1.5-3gm should be given at induction of anaesthesia. The dose maybe repeated 6-8 hourly. Administration is usually stopped after 24 hours, unless a therapeutic course is indicated.
- Children, infants and neonates: the dosage of Ultracillin for most infections is 150 mgI kg per day usually every 6 orB hours.
(In neonates during the first week of life dosing is usually every 12 hours).
N.B. In renal function impairment patients, the dose should be administered less frequently in accordance with usual practice forAmpicillin.
For l.V. administration:
Ultracillin should be reconstituted with sterile water for injection or 0.9 % Sodium Chloride and can be stored for up to B hours at 25° C or 48 hours at refregirator . The dose can be given by bolus Injection over a minimum of 3 minutes or can be
used in greater dilution either as bolus or as LV. infusion over 15 - 30 mInutes. ___________________
For I.M. administration:
Reconstitution can be done using sterile waterfor ,or Lidocaine hydrochloride 0.5%
Administration should be used within one hour of reconstitution.
Presentation:
-Boxofonevial (375mg,75Omgorl500mg)
-Boxof50 viais(375mg,75Omgorl500mg).
Produced by
South Egypt Drug Industries Company
SEDICO
6 October City - Egypt
-Boxofonevial (375mg,75Omgorl500mg)
-Boxof50 viais(375mg,75Omgorl500mg).
Produced by
South Egypt Drug Industries Company
SEDICO
6 October City - Egypt
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