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Unictam

Broad spectrum antibiotic  

Unictam Tablet :
UNICTAM tablet is containing 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.
Unictam suspension :
Each 5 ml reconstituted suspension contains Sultamicillin 250 mg.
Unictam Vial :
Vials for IM/IV injection
3000 mg Vials, 1500 mg Vials, 750 mg Vials, 375 mg Vials.

Unictam Tablet :
 Carton box contains 2 (Al/ transparent(PVDC/PVC)strip, each one contains 6 film coated tablets.
Unictam suspension :
A bottle containing 3 g Sultamicillin + 2 Packs of purified water for reconstitution, 20 ml each, to yield 60 ml suspension of 250 mg / 5 ml sultamicillin. Shake the suspension well before use.
Unictam Vial :
- 3000 mg Vials  contain 1.000gm Sulbactam  sodium + 2.000 gm Ampicillin  sodium
+ two ampoules of  4 ml. sterile water of injection.
- 1500 mg Vials  contain.0.500gm Sulbactam  sodium + 1.000 gm Ampicillin  sodium
+ one ampoule of  5 ml. sterile water of injection.
- 750 mg Vials  contain 0.250gm Sulbactam  sodium + 0.500 gm Ampicillin  sodium
 + one ampoule of  2 ml. sterile water of injection.
- 375 mg Vials  contain 0.125gm Sulbactam  sodium + 0.250 gm Ampicillin  sodium
 + one ampoule of 2 ml. sterile water of injection.

Unictam Tablet :
The recommended dose of sultamicillin in adults(including elderly patients is 375 mg-750 mg twice daily. The dosage for most infections in children weighing less than 30 kg is sultamicillin 25-50 mg/kg/day in two 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. In both adult 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 gm(six 375 mg tablets). Concomitant probenecid 1.0 gm 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. In patients with severe impairment of renal function(creatinine clearance 30ml/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.
Unictam suspension :
- Children:
* Weighing less than 30 kg: 25-50 mg/kg/day in 2 divided doses depending on the severity of the infection.
* Weighing more than 30 kg: adult dose is administrated.
- In patients with severe renal impairment  (Creatinine Clearance < 30 ml/min.):
The dose should be reduced or the same dose  administered less frequently in accordance with usual practice for ampicillin.
Unictam Vial :
UNICTAM IM/IV can be administered by either intravenous or intramuscular routes. The following dilutions may be used:For intravenous administration UNICTAM  IM/IV should be reconstituted with sterile water for injection or any compatible solution and allowed to sand to allow any foaming to dissipate to permit visual inspection for complete dissolution. The dose can be given by bolus injection over a minimum of 3 minutes or can be used in greater dilutions either as a bolus or as an intravenous infusion over 15 - 30 minutes. UNICTAM  IM/IV may also be administered by deep intramuscular injection; if pain is experienced, 0.5% sterile solution for injection of lignocaine hydrochloride anhydrous may be used for reconstitution of the powder. The usual dosage of UNICTAM IM/IV is 1.5 g to 12 g per day in divided doses every 6 or 8 hours up to a maximum daily dosage of sulbactam of 4 g. Less severe infections may be treated on  every 12 hours schedule. The dosage of UNICTAM  IM/IV for most infections in children, infants and neonates is 150 mg/kg/day (corresponding to sulbactam 50 mg/kg/day and ampicillin 100 mg/kg/day). In children, infants and neonates dosing is usually every 6 or 8 hours in accordance with the usual practice for ampicillin. In neonates during the first week of life (especially preterms), dosing is usually every 12 hours. More or less frequent dosing may be indicated depending on the severity of the illness and the renal function of the patient. Treatment is usually continued until 48 hours after pyrexia and other  abnormal  signs have resolved. Treatment is normally given for 5 to 14 days, but the treatment period may be extended or additional ampicillin may be administered in severely ill cases. 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 UNICTAM IM/IV in such patients should be administered less frequently in accordance with the usual practice for ampicillin. In treating patients on restricted sodium intake, it should be noted that 1500 mg of UNICTAM  IM/IV contains approximately 115 mg (5 mmol) of sodium. For the prophylaxis of surgical infections, 1.5 - 3 g of UNICTAM  IM/IV should be given at induction of anesthesia, which allows sufficient time to achieve effective serum and tissue concentrations during the procedure. The dose may be repeated 6 - 8 hourly; administration is usually stopped 24 hours after the majority of surgical procedures, unless a therapeutic course of UNICTAM  IM/IV is indicated. In the treatment of uncomplicated gonorrhea, UNICTAM  IM/IV can be given as a single dose of 1.5 g. Concomitant probenecid 1.0 g orally should be administered in order to prolong plasma  concentrations of sulbactam and ampicillin.
Stability and Compatibility
Sulbactam sodium is compatible with most intravenous solutions but ampicillin sodium and hence UNICTAM IM/IV is less stable in solutions containing dextrose or other carbohydrates, and should not be mixed with blood products or protein hydrolysates. Ampicillin and hence UNICTAM IM/IV is incompatible with aminoglycosides and should not be physically mixed in the same container. The concentrated solution for intramuscular administration should be used within 1 hour of reconstitution. Time periods for use in different diluents  for intravenous  infusion are as follows:

Unictam Tablet :
UNICTAM tablet is indicated for infections caused by susceptible micro-organism.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 UNICTAM  IM/IV.
Unictam suspension :
Unictam is indicated for infections caused by susceptible microorganisms. 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.
  • Gonococcal infections.
  • Intra abdominal Infections.

Unictam oral forms may be also indicated in patients requiring Ampicillin/Sulbactam  therapy following treatment with parenteral forms.
Unictam Vial :
Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.

  • Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and  Acinetobacter calcoaceticus*.
  • Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*.

 

  • Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*, and Bacteroides spp.* (including B. fragilis*).

*Efficacy for this organism in this organ system was studied in fewer than 10 infections.

insert: 
Therapeutic Lines: 
Dosage Form: 

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