MEROXAN 1000mg  

Meropenem

Vial 1000 mg

Meropenem (Meroxan^®)

Description

Meropenem is a synthetic, broad – spectrum, carbapenem antibiotic for intravenous administration.

Clinical pharmacology

Meropenem is bactericidal in action, exerting its effect by inhibition of enzymes responsible for cell wall synthesis. Meropenem exerts its action by penetrating bacterial cells readily and interfering with the synthesis of vital cell wall components, which leads to cell death.

Antibacterial activity

Meropenem is a broad-spectrum carbapenem antibiotic. It is active against gram-positive and gram-negative bacteria. The bactericidal activity of Meropenem results from the inhibition of cell wall synthesis. Meropenem readily penetrates the cell wall of most gram-positive and gram-negaive bacteria to reach penicillin-binding-protein (PBP) targets.

Aerobic and facultative Gram-positive microorganisms:Enterococcus faecalis (excluding vancomycin-resistant isolates) Staphylococcus aureus ((beta)-lactamase and non-(beta)-lactamase producing, methicillin-susceptible isolates only) Streptococcus agalactiae ,Streptococcus pneumoniae (penicillin-susceptible isolaates only)

NOTE:    Penicillin-resistant isolates had meropenem MIC ₉₀ values of 1 or 2µg/mL, which is above the 0.12 µg/mL susceptible breakpoint for this species.

Aerobic and facultative Gram-negative microorganisms:Escherichia coli ,Haemophilus influenzae ((beta)-lactamase and non-(beta)-lactamase-producing),Klebsiella pneumoniae ,Neisseria meningitidis ,Pseudomonas aeruginosa, Proteus mirabilis

Aerobic and facultative Gram-positive microorganisms: Staphylococcus epidermidis ((beta)-lactamase and non-(beta)-lactamase-producing), methicillin-susceptible isolates only).

Aerobic and facultative Gram-negative microorganisms : Acinetobacter species,Aeromonas hydrophila ,Campylobacter jejuni ,Citrobacter diversus ,Citrobacter freundii ,Enterobacter cloacae ,Haemophilus influenzae (ampicillin-resistant, non-(beta)-lactamase producing isolates [BLNAR isolates]), Hafnia alvei ,Klebsiella oxytoca,Moraxella catarrhalis ((beta)-lactamase and non-(beta)-lactamase-producing isolates),Morganella morganii ,Pasteurella multocida, Proteus vulgaris, Salmonella species , Serratia marcescens, Shigella species , Yersinia enterocolitica

Anaerobic microorganisms :Bacteroides distasonis , Bacteroides ovatus , Bacteroides uniformis, Bacteroides ureolyticus , Bacteroides vulgatus , Clostridium difficile, Clostridium perfringens, Eubacterium lentum, Fusobacterium species , Prevotella bivia, Prevotella intermedia, Prevotella melaninogenica, Porphyromonas asaccharolytica , Propionibacterium acnes

Anaerobic microorganisms: Bacteroides fragilis, Bacteroides thetaiotaomicron, Peptostreptococcus species, Streptococcus pyogenes

Pharmacokinetics

Oral absorption -

Presystemic metabolism -

Plasma half – life 54.8 µg /ml

Range 0.5- 1.5 h

Volume of distribution 21 L

Plasma protein binding 2%

Indication

1- Skin and skin-structure infections.

2- Intra-abdominal infections.

3- Bacterial Meningitis.

4- Empiric therapy in febrile neutropenic patients

Contraindication

Meropenem is contraindicated in patients with known ypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to β- lactams.

Precaution

· While Meropenem possesses the characteristic low toxicity of the β-lactam group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.

· Prescribing Meropenem in the absence of a proven or stongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

· Seizures and other adverse CNS experiences have been reported during treatment with Meropenem I.V. these experiences have occurred most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) or with bacterial meningitis and / or compromised renal function. · Prolong use of Meropenem may result in overgrowth of nonsusceptible organisms.

Pregnancy

Pregnancy category B.

There are no adequate and well – controlled studies in pregnant women. Therefore Meropenem should be used during pregnancy only if clearly needed.

Breast feeding

It is not known whether this drug is excreted in human milk. Caution when Meropenem is administered to a breast-feeding woman.

Dosage

Usual adult dose

· Skin and skin structure infections: intravenous, 500 mg every 8 hours.

· Intra-abdominal infections: Intravenous 1 g every 8 hours.

Renal function impairment: dosage should be reduced in adult patients with creatinine clearance (Ccr) less than 51 ml/min

Note: Meropenem should be administered by intravenous (IV) infusion over approximately 15 to 30 minutes. Doses of 1 g may also be administered as an IV bolous injection (5 to 20 ml) over approximately 3 to 5 minutes.

Usual pediatric dose

Children 3 months of age and older:

Complicated SSSI: 10 mg / kg up to 500 mg every 8 hours

Intra-abdominal: 20 mg/kg up 1 g every 8 hours Meningitis: 40 mg/kg up to 2 g every 8 hours

Meropenem Dosage Schedule for Pediatric Patients with Healthy Renal Function
Type of infection	Dose (mg/kg)	Up to a maximum dose	Dosing interval
Complicated SSSI	10	500 mg	Every 8 hours
Intra-abdominal	20	1g	Every 8 hours
Meningitis	40	2g	© Copyright 2008 - daanapharmac.com | Powered By : [ PersianTools ]