CAPRENEM

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Category
Carbapenem Antibiotic
Type
General Anaesthetic
Package
CAPRENEM® 0.5
Box of 1 vial @ 0.5 g.
Reg. No. : DKL 1032403844A1

CAPRENEM® 1
Box of 1 vial @ 1 g.
Reg. No. : DKL 1032403844B1
Composition
CAPRENEM® 0.5
Each vial contains:
Meropenem Trihydrate equivalent to 0.5 g of Anhydrous Meropenem.

CAPRENEM® 1
Each vial contains:
Meropenem Trihydrate equivalent to 1 g of Anhydrous Meropenem.
Indication
CAPRENEM® is indicated for treatment of the following infections caused by single or multiple bacteria sensitive to Meropenem:
- Pneumonia and Nosocomial Pneumonia
- Urinary Tract infections
- Intra-abdominal infections
- Gynecological infections, such as endometritis
- Skin and skin structure infections
- Meningitis
- Septicemia
- Empiric treatment for presumed infections in adults patients with febrile neutropenia, used as monotherapy or in combination with antiviral or antifungal agents.
CAPRENEM® is efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections. There is no experience in pediatric patients with neutropenia or primary or secondary immunodeficiency.
Dossage
The dosage and duration of therapy should be established depending on the type and severity of infection and the condition of the patient.
Adults :
- Pneumonia, UTI, gynecological infections such as endometritis, skin and skin structure infections: 500 mg i.v. 8 hourly.
- Nosocomial pneumonia, peritonitis, septicemia, presumed infections in neutropenic patients: 1 g i.v. 8 hourly.
- Meningitis: 2 g i.v. 8 hourly.
- As with other antibiotics, particular caution is recommended in using Meropenem as monotherapy in critically ill patients with known or suspected caused by Pseudomonas aeruginosa lower respiratory tract infection. Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infection.

Dosage schedule for adults with impaired renal function
Dosage should be reduced in patients with creatinine clearance < 51 mL/minute, as scheduled below :
Meropenem is cleared by hemodialysis. If continuous treatment with CAPRENEM® is necessary, it is recommended that the unit dose (based on the type and severity of infection) be administered at the completion of the hemodialysis procedure to restore therapeutically effective plasma concentrations.
There is no experience in the use of CAPRENEM® in patients under peritoneal dialysis.

Dosage in adults with hepatic insufficiency
No dosage adjustment is necessary in patients with hepatic insufficiency (see precautions).

Elderly patients
No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 mL/minute.

Children :
- Children > 3 months up to 12 years: recommended dose is 10 - 20 mg/kg body weight 8 hourly (depending on the type and severity of infection, susceptibility of the pathogen and the condition of the patient).
- Children > 50 kg body weight: adults dosage should be used.
- Meningitis: recommended dose is 40 mg/kg body weight 8 hourly.
- There is no experience in children with renal impairment.

Compatibilities and Stabilities :
- CAPRENEM® should not be mixed with or added to other drugs.
- CAPRENEM® is compatible with some infusion fluids as shown in the table of stability.
Precaution
- It should be used with cautions in patients with hypersensitivity to ?-lactam antibiotics. If an allergic reaction to Meropenem occurs, the drug should be discontinued.
- In patients with hepatic disease, serum hepatic levels should be monitored.
- It is not recommended for use in infections caused by methicillin resistant Staphylococci.
- It is important to consider the diagnosis of pseudomembran colitis in the case of patients who develop diarrhea in association with the use of CAPRENEM®. Although studies indicate that a toxin produced by Clostridium difficile is one of the main causes antibiotic-associated colitis, other causes should be considered.
- Caution should be given when CAPRENEM® is administered concomitantly with and potentially nephrotoxic drug.
- No data are available, but it should be anticipated that CAPRENEM® may affect the ability to drive and use machines.
- Pediatric use: Efficacy and tolerability in infants under 3 months have not been established, therefore CAPRENEM® is not recommended for use below 3 months infants. There is no experience in children with altered hepatic or renal function.
- Pregnancy and lactation: The safety of CAPRENEM® in pregnancy has not been evaluated. CAPRENEM® should not be used in pregnancy and lactation unless the potential benefit justifies the potential risk to the fetus. In every case, it should be used under the direct supervision of the physician.
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PELASCAP

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Category
Carbapenem Antibiotic
Type
General Anaesthetic
Package
Box of 1 vial @ 1 g.
Reg. No.: DKL1132405644A1

Composition
Each vial contains:
Imipenem Monohydrate equivalent to 500 mg of Anhydrous Imipenem.
Cilastatin Sodium equivalent to 500 mg of Cilastatin.
Inactive ingredient: Sodium Bicarbonate as a buffer.
Indication
PELASCAP® i.v. is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
- Lower respiratory tract infections.
- Urinary tract infections.
- Intra-abdominal infections.
- Gynecological infections.
- Bacterial septicemia.
- Bone and joint infections.
- Skin and skin structure infections.
- Endocarditis.
- PELASCAP® i.v. is also indicated for polymicrobial infections including those in which S. pneumoniae (pneumonia, septicemia), Group A ?-hemolytic Streptococcus (skin and skin structure infections), or nonpenicillinase-producing S. aureus is one of the causative organisms. However, monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin G.
PELASCAP® i.v. is not indicated for the treatment of central nervous system infections.
Dossage
The total daily dosage and route of administration of PELASCAP® i.v. should be based on the type or severity of infection, consideration of degree of susceptibility of the pathogen(s), renal function and body weight. Doses cited are based on a body weight of 70 kg. The total daily requirement should be given in equally divided doses.
The dosage of PELASCAP® i.v. contains 500 mg of Imipenem and 500 mg of Cilastatin.

Use in the elderly
Age does not usually affect the tolerability and efficacy of PELASCAP® i.v. The dosage should be determined by the severity of the infection, the susceptibility of the causative organism(s), the patient's clinical condition, and renal function.
INTRAVENOUS ADMINISTRATION: this formulation should not be used intramuscularly.

Adults (based on 70 kg body weight)
The usual adult daily dosage is 1 - 2 g of PELASCAP® i.v. administered in 3 - 4 equally divided doses (see chart below). In infections due to less sensitive organisms, the daily dose of PELASCAP® i.v. may be increased to a maximum dose of 50 mg/kg body weight/day (or not exceeding 4 g daily).

Usual adults intravenous dosage
Each 250 mg or 500 mg dose should be given by intravenous infusion over 20 - 30 minutes. Each 1000 mg dose should be infused over 40 - 60 minutes. In patients who develop nausea during infusion, the infusion rate may be slowed.

Prophylaxis use
For prophylaxis against post-surgical infections in adults, 1 g of PELASCAP® i.v. should be given intravenously on induction of anaesthesia and 1 g three hours later. For high risk surgery (i.e. colorectal surgery), two additional 0.5 g doses can be given at 8 and 16 hours after induction.


In patients with renal insufficiency
As in patients with normal renal function, dosing is based on the severity of infection. The maximum dosage for patients with various degrees of renal functional impairment is shown in the following table. Doses cited are based on a body weight of 70 kg. Proportional reduction in dose administered should be made for patients with lower body weight.

Pediatric dosage
Children over 40 kg body weight should receive adult doses with the maximum daily dose should not exceed 2 g.
Clinical data are insufficient to recommend an optimal dose for children under 3 months of age or infants and children with impaired renal function.
PELASCAP® i.v. is not recommended for the treatment of meningitis. If meningitis is suspected an appropriate antibiotic should be used.

Preparation of solution
Reconstituted solution is stable for 4 hours at room temperature (25 -30 C) or for 24 hours under refrigeration (2 -8 C). Discard any unused solution after these periods.
Precaution
- Pseudomembranous colitis, reported with virtually all antibiotics, can range from mild to life-threatening in severity. PELASCAP® i.v. should be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis. Treatment-related diarrhoea should always be considered as a pointer to this diagnosis. While studies indicate that a toxin of Clostridium difficile is one of the primary causes of antibiotic-asociated colitis, other causes should be considered.
- SIt should be used with caution in pregnant women and nursing mothers.
- Efficacy and tolerability in infants under three months of age have not yet to be established; therefore, PELASCAP® i.v. is not recommended for use below this age.
Patients with creatinine clearance of = 5 mL/min/1.73 m2 should not receive PELASCAP® i.v. unless hemodialysis is instituted within 48 hours.
- Caution should be exercised upon the partial cross-allergenicity between PELASCAP® i.v. and the other ?-lactam antibiotics, penicillins and cephalosporins.
- Severe reactions (anaphylactic shock) may occur in patients receiving therapy with ?-lactams.
- Before initiating therapy, careful inquiry should be made concerning previous hypersensitivity reactions to ?-lactam antibiotics. If an allergic reaction occurs, the drug should be discontinued and appropriate measures undertaken.
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