Meropenem Trihydrate Powder for Injection 0.5 g, each vial contains : Meropenem trihydrate buffered sodium carbonate sterile equivalent to Meropenem 0.5 g.
Meropenem Trihydrate is preparation of Meropenem trihydrate buffered sodium carbonate sterile (equivalent with Meropenem), which is available in 0.5 g and 1 g of sterile powder for injection in vial pack.
Meropenem Trihydrate is indicated for treatment of the following infections, in adults and children, caused by single or multiple bacteria sensitive to Meropenem :
- Pneumonias including nosocomial pneumonias; urinary tract infections; intra-abdominal infections; gynecological Infections e.g., endometritis; skin and skin structure infections; meningitis; septicaemia.
- Empiric treatment, for presumed infections in adult patients with febrile neutropenia, used as monotherapy or in combination with antiviral or antifungal agents.
Meropenem has proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections.
DOSAGE AND ADMINISTRATIONS :
- Recommended daily dosage :
- 500 mg IV every 8 hours in the treatment of pneumonia, urinary tract infections, gynaecological infections e.g., endometritis, skin and skin structure infections.
- 1 g IV every 8 hours in the treatment of nosocomial pneumonia, peritonitis, presumed infections in neutropenic patients and septicaemia.
- In meningitis, the recommended dosage is 2 g every 8 hours.
As with other antibiotics, particular caution is recommended in using Meropenem as monotherapy in critically ill patients with known or suspected 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 follows :
(Based on unit doses of 500 mg, 1 g)
|26 – 50||1 unit dose (500 mg or 1 g)||Every 12 hours|
|10 – 25||½ unit dose (250 mg or 500 mg)||Every 12 hours|
|< 10||½ unit dose (250 mg or 500 mg)||Every 24 hours|
Meropenem is cleared by haemodialysis. If continued treatment with Meropenem is necessary, it is recommended that the unit dose (based on the type and severity of infection) is administered at the completion of the haemodialysis procedure to restore therapeutically effective plasma concentrations.
- Adults with hepatic insufficiency :
No dosage adjustment is necessary in patients with hepatic insufficiency.
- Children > 3 months up to 12 years :
Recommended dose : 10 – 20 mg/kg every 8 hours depending on type and severity of infection, susceptibility of the pathogen(s) and the condition of the patient.
- Children > 50 kg body weight :
- Adult dosage should be used.
- Meningitis : Recommended dose : 40 mg/kg every 8 hours.
- There is no experience in children with renal impairment.
No dosage adjustment is required for elderly patients with normal renal function or creatinine clearance values > 50 ml/min.
Preparation of injection :
- Meropenem to be used for bolus IV injection should be reconstituted with Sterile water for injection (5 ml/250 mg Meropenem). This provides an approximate concentration of 50 mg/ml. Constituted solutions are clear, colourless or pale yellow.
- Meropenem for IV infusion may be directly constituted with compatible infusion fluid (50 – 200 ml).
- It is recommended that freshly prepared solutions of Meropenem are used whenever possible. Solutions of Meropenem should not be frozen.
- Meropenem can be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 – 30 minutes.
- Shake reconstituted solution before use.
- All vials are for single use only. Standard aseptic technique should be employed during constituted and administration.
- Reconstituted solution is stable on storage within 8 hours at temperatures below 25°C or 48 hours at refrigerator temperature (2 – 8)°C.
Accidental overdosage could occur during therapy, particularly in patients with renal impairment. Treatment of overdosage should be symptomatic. In normal individuals, rapid renal elimination will occur, while in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
Meropenem Trihydrate is contraindicated for patients who have demonstrated hypersensitivity to Meropenem.
WARNINGS AND PRECAUTIONS :
- Before initiating therapy with Meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to β-Lactam antibiotics. Meropenem should be used with caution in patients with such a history. If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken.
- Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
- As with other antibiotics, overgrowth of nonsusceptible organisms may occur, and therefore continuous monitoring of each patient is necessary.
- Pseudomembranous colitis has been reported on Meropenem may vary in severity from slight to life threatening. Therefore, antibiotics should be prescribed with care for individuals with a history of gastrointestinal complaints, particularly colitis. It is important to consider the diagnosis of pseudomembranous colitis in the case of patients who develop diarrhea in association with the use of Meropenem Trihydrate. Although studies indicate that a toxin produced by Clostridium difficile is one of the main causes antibiotic-associated colitis, other causes should be considered.
- The co-administration of Meropenem with potentially nephrotoxic drugs should be considered with caution.
- Effects on the ability to drive or operate machinery : No data are available, but it is not anticipated that Meropenem will affect the ability to drive and use machines.
- Use in pregnancy : Meropenem should not be used in pregnancy 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.
- Use in lactation : Meropenem should not be used in breastfeeding women unless the potential benefit justifies the potential risk to the baby.
- Use in children : Efficacy and tolerability in infants < 3 months have not been established; therefore, Meropenem is not recommended for use below this age.
DRUG INTERACTIONS :
- Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretions, with the effect of increasing the elimination half-life and plasma concentration of Meropenem. As the potency and duration of action of Meropenem doses without Probenecid are adequate, the co-administration of Probenecid with Meropenem is not recommended.
- Meropenem may reduce the serum Valproic acid levels.
ADVERSE REACTIONS :
- Local injection site reactions : inflammation, thrombophlebitis and pain at the site of injection.
- Systemic allergic reactions (hypersensitivity) : angioedema and manifestations of anaphylaxis.
- Skin : rash, pruritus and urticaria. Rarely severe skin reactions e.g., erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed.
- Gastrointestinal : abdominal pain, nausea, vomiting and diarrhoea. Pseudomembranous colitis has been reported.
- Blood : reversible thrombocythaemia, eosinophilia, thrombocytopenia, leucopenia and neutropenia (including very rare cases of agranulocytosis). A positive direct or indirect Coombs’ test may develop in some subjects. There have been reports of reduction in partial thromboplastin time.
- Liver function : increases in serum concentrations of bilirubin, transaminases, alkaline phosphatase and lactic dehydrogenase alone or in combination have been reported.
- Central nervous system : headache and paraesthesia. Infrequent convulsions have been reported although a causal relationship with Meropenem has not been established.
- Others : oral and vaginal candidiasis.
Meropenem Trihydrate Powder for Injection 0.5 g Box, 10 vials @ 0.5 g
Reg. No. GKL0602338444A1
STORE BELOW 30°C, PROTECT FROM LIGHT
Reconstituted solution is stable on storage within 8 hours at temperatures below 25°C or 48 hours at refrigerator temperature (2 – 8)°C.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia