COMPOSITIONS :
Picyn® Powder for Injection 1500 mg, each vial contains : Ampicillin sodium equivalent to Ampicillin 1000 mg and Sulbactam sodium equivalent to Sulbactam 500 mg.
DESCRIPTIONS :
Picyn® contains Ampicillin sodium and Sulbactam sodium as active ingredients is available in powder for injection 750 mg and 1500 mg.
INDICATIONS :
Infections caused by susceptible microorganisms. Typical indications are upper and lower respiratory tract infections including sinusitis, otitis media and epiglottitis; bacterial pneumonia; urinary tract infections and pyelonephritis; intra-abdominal infections including peritonitis; cholecystitis; endometritis and pelvic cellulitis; bacterial septicemia; skin, soft tissue, bone and joint infections and gonococcal infections. Picyn® may also administered peri-operatively to reduce the incidence of post-operative wound infections in patients undergoing abdominal or pelvic surgery, in which peritoneal contamination may be present. In termination of pregnancy of caesarean section, Picyn® may be used prophylactically to reduce post-operative sepsis.
DOSAGE AND ADMINISTRATIONS :
Dosage :
- Usual dose :
1.5 – 12 g/day in divided doses every 6 – 8 hours up to a maximum daily dosage of Sulbactam of 4 g. Less severe infections may be treated on an every 12 hours schedule (see Table 1).
Table 1. Usual dose range
| Severity of infection | Daily dose of Picyn® (g) |
| Mild | 1.5 to 3 (0.5 + 1 to 1 + 2) |
| Moderate | Up to 6 (2 + 4) |
| Severe | Up to 12 (4 + 8) |
- Children, infants and neonates :
The dosage of Picyn® for most infections in children, infants and neonates is 150 mg/kgBW/day (corresponding to Sulbactam 50 mg/kgBW/day and Ampicillin 100 mg/kgBW/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 1st 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 – 14 days, but the treatment period may be extended or additional dose of Ampicillin may be administrated in severely ill cases.
- Patients with renal impairment :
In patients with severe impairment of renal function (creatinine clearance < 30 ml/minute), the elimination kinetics of Ampicillin and Sulbactam are affected and hence the plasma ratio of one to the other will remain constant. The dose of Picyn® in such patients should be administered less frequently in accordance with the usual practice for Ampicillin.
- Patients with restricted sodium intake :
In treating patients on restricted sodium intake, it should be noted that 1500 mg of Picyn® contains approximately 115 mg (5 mmol) of sodium.
- Prophylaxis of surgical infections :
For the prophylaxis of surgical infections, 1.5 – 3 g of Picyn® 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 Picyn® is indicated.
Administrations :
- Picyn® can be administered by either IV or IM routes.
- Method of reconstitution :
Picyn® should be reconstituted with Aqua pro Injection or any compatible solution and stand to allow any foaming to dissipate to permit visual inspection for complete dissolution. The following dilutions may be used (see Table 2).
Table 2. The dilutions may be used
| Total dosage (g) | Equivalent dosage of Ampicillin – Sulbactam | Package (vial) | Diluent volume (ml) | Maximum final concentration (mg/ml) |
| 0.75 | 0.5 – 0.25 | 10 ml | 1.6 | 250 – 125 |
| 1.50 | 1.0 – 0.5 | 10 ml | 3.2 | 250 – 125 |
Reconstituted solution is stable on storage within 1 hour at temperatures below 25ºC.
- Method of administration :
Intravenous (IV)
- IV bolus
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.
- IV infusion
The dose can be given as an IV infusion over 15 – 30 minutes.
After the initial reconstitution, add appropriate diluent to obtain a concentration in the range of 3 – 45 mg/ml, as shown in table below.
| Infusion volume (ml)
which can be used |
Maximum final concentration (mg/ml) | |
| 750 mg | 1500 mg | |
| 50 | 15 | 30 |
| 100 | 7.5 | 15 |
| 250 | 3 | 6 |
| 500 | – | 3 |
Time periods for use of IV infusion with different diluents are as follows can be seen in table 3.
Table 3. The dilution may be used for IV infusion
| Diluent | Concentration Ampicillin + Sulbactam
(mg/ml) |
Use periods (hours) |
| 25ºC | ||
| Sterile water for injection | Up to 45 | 8 |
| Isotonic Sodium chloride | Up to 45 | 8 |
| 5% Dextrose in water | 15 – 30
Up to 3 |
2
4 |
Intramuscular (IM)
Picyn® may also be administered by deep IM injection; if pain is experienced, 0.5% sterile solution for injection of Lidocaine HCl anhydrous may be used for reconstitution of the powder.
OVERDOSAGE :
Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of β-Lactams. Ampicillin may be removed from circulation by hemodialysis. The molecular weight, degree of protein binding and pharmacokinetics profile of Sulbactam suggest that this compound may also be removed by hemodialysis.
CONTRAINDICATIONS :
Individuals with a history of an allergic reaction to any of the Penicillins and Sulbactam.
WARNINGS AND PRECAUTIONS :
- Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on Penicillin therapy. These reactions are more likely 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 allergenic reaction occurs, the drug should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with Adrenaline, oxygen, IV steroid and airway management, including intubation, should be administered as indicated.
- As with any antibiotic preparation, constant observation for signs of overgrowth of non-susceptible organisms, including fungi, is essential. Should super infection occur, the drug should be discontinued and/or appropriate therapy instituted.
- As with any potent systemic agent, it is advisable to check periodically for organ system dysfunction during extended therapy; this includes renal, hepatic and hematopoietic systems. This is particularly important in neonates, especially when premature and other infants.
- Use in pregnancy and lactation :Animal reproduction studies have revealed no evidence of impaired fertility or harm to the fetus due to Ampicillin and Sulbactam. However, safety for use in pregnancy and lactation has not been established.
PRESENTATIONS :
Picyn® Powder for Injection 1500 mg Box, 1 vial @ 1500 mg Reg. No. DKL9602322644B1
STORAGE :
STORE BELOW 25ºC AND DRY PLACE, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
