Meromax IV

MEROPENEM TRIHYDRATE

500 mg
1 g
Powder for I.V. Injection

ANTIBACTERIAL

Category:

Description

The Cathay Drug Co., Inc.

DESCRIPTION

Meropenem (Meromax IV) is a carbapenem beta-lactam antibacterial and a broad spectrum injectable antibiotic for intravenous administration.

FORMULATION

Each vial contains:

Meropenem (as trihydrate) equivalent to 500 mg anhydrous meropenem.

Meropenem  IV 1 g powder for Injection

Each vial contains:

Meropenem (as trihydrate)  equivalent to 1 g anhydrous meropenem.

CLINICAL PHARMACOLOGY

MECHANISM OF ACTION

Meropenem is bactericidal in action except against Listeria monocytogenes where it is bacteriostatic. The bactericidal activity of meropenem results from inhibition of bactericidal cell wall synthesis. Meropenem is highly resistant to hydrolysis by a variety of beta-lactamase (including penicillinases, cephalosporinases, and extended-spectrum beta-lactamases) but appears to be more susceptible to hydrolysis by metallo-beta-lactamases. Meropenem is stable to the renal enzyme (dehydropeptidase-1) and can therefore be given without an enzyme inhibitor. Meropenem has less seizure-inducing potential and can be used to treat central nervous system infection.

PHARMACOKINETICS

After intravenous injection of meropenem (0.5 and 1 g over 5 minutes, peak plasma concentrations of about 50 and 112 micrograms/mL respectively are attained. The same doses infused over 30 minutes produce peak plasma concentrations of 23 and 49 micrograms/mL, respectively.

Meropenem has a plasma elimination half-life of about 1 hour, this may be prolonged in patients with renal impairment and is also slightly prolonged in children. Meropenem is widely distributed into body tissues and fluids including the CSF and bile. It is about 2% bound to plasma proteins. It is more stable to renal dehydropeptidase-1 and is mainly excreted in the urine by tubular secretion and glomerular filtration. About 70% of a dose  is recovered unchanged in the urine over a 12-hour period and urinary concentrations above 10ug/mL are maintained for up to 5 hours after a 500 mg dose. Meropenem is reported to have one metabolite (IC1-213689), which is inactive and is excreted in the urine. Meropenem is removed by hemodialysis.

ANTIMICROBIAL SPECTRUM OF ACTIVITY

Meropenem (Meromax IV) has a broad spectrum of antibacterial activity and is active against many gram-positive and gram-negative bacteria and some anaerobic bacteria.

Meropenem (Meromax IV) is active in vitro and in clinical infections against:

Gram-postive aerobic and facultatively aerobic bacteria
·         Streptococcus Pneumoniae (penicillin-susceptible strains only)

·         Streptococcus pyogenes (group A beta-hemolytic streptococci)

·         Streptococcus agalactiae (group B streptococci)

·         Staphylococcus aureus (including beta-lactamase-producing strains, but not oxcacillin resistant [methicillin resistant] strains)

·         Enterococcus faecalis (not vancomycin-resistant strains)

·         Streptococcus viridans

·         Staphylococcus epidermidis (including beta-lactamases-producing strains, but not oxacillin-resistant strains)

Gram-negative aerobic and facultatively aerobic bacteria
·         Escherichia coli

·         Haemophilus influenzae (including beta-lactamases-producing strains)

·         Klebsiella pnemoniae

·         Neisseria meningitides

·         Proteus mirabilis

·         Pseudomonas aeruginosa

·         Acinetobacter

·         Aeromonas hydrophilia

·         Campylobacter jejuni

·         Citrobacter diversus

·         Citrobacter freundii

·         Enterobacter cloacae

·         Haemophilus influenzae (ampicillin-resistant, non-beta-lactamase-producing strains)

·         Havnia alvei

·         Klebsiella oxytoca

·         Moraxella catarrhalis(including beta-lactamase producing strains)

·         Morganella morganii

·         Pasteurella multocida

·         Proteus vulgaris

·         Salmonella

·         Shigella

·         Serratia marcescens

·         Yersinia enterolitica

Anaerobic bacteria
·         Bacteroides fragilis

·         Bacteroides thetaiotaomicron

·         Bacteroidesdistasonis

·         Bacteroides ovatus

·         Bacteroides uniformis

·         Bacteroides ureolyticus

·         Bacteroides vulgatus

·         Peptostreptococcus

·         Clostridium perfringes

·         Clostridium difficile

·         Eubacterium lentum

·         Fusobacterium

·         Prevotella bivia

·         Prevotella intermedia

·         Prevotella melaningogenica

·         Porphyromonas asaccharolytica

·         Propionibacterium acnes

INDICATIONS

Meropenem (Meromax IV) is used in the treatment of susceptible infections including:

  • Respiratory tract infections
  • Urinary tract infections
  • Skin infections
  • Meningitis
  • Septicaemia
  • Infections in immunocompromised patients

DOSAGE AND ADMINISTRATION

Administration

Meropenem (mexomax IV) is administered by IV injection or IV infusion.

Rate of administration

Meropenem (Meromax IV) is given by slow injection over 3 to 5 minutes or by infusion over 15 to 30 minutes.

Dosage

Meropenem (Meromax IV) recommended daily dosage is as follows:

Adults:

Usual adult dose: 500 mg to 1 g every 8 hours

Meningitis: increased to 2 g every 8 hours

Adult with cystic fibrosis: doses up to 2 g every 8 hours

Children

Children over 3 months of age and weighing less than 50 kg recommended dose: 10 to 20 mg/kg every 8 hours

Meningitis: increase to 40 mg/kg every 8 hours

Children with cystic fibrosis: dosess of 25 to 40 mg/kg every 8 hours.

Dosage for adults with renal impairment

Dosage of Meropenem (Meromax IV) should be reduced in patients with renal impairment. The following doses may be given based on creatinine clearance (CC):

  • CC 26 to 50 mL/min: the usual dose given every 12 hours
  • CC 10 to 25 mL/min: one-half the usual dose given every 12 hours
  • CC less than 10 mL/min: one-half the usual dose every 24 hours

Direction for reconstitution

Meropenem (Meromax IV) for intravenous injection should be reconstituted with sterile water for injections (5 mL per 250 mg Meropenem). This provides an approximate concentration of 50 mg/mL.

Meropenem (Meromax IV) for intravenous infusion may be reconstituted with compatible infusion fluids listed below (50 to 200 mL).

Storage, stability and compatibility

Meropenem (Meromax IV) is compatible with the following infusion fluids:

  • 9% Sodium Chloride solution
  • 5% or 10% Dextrose
  • 9% sodium chloride and 5% dextrose solution
  • 5% dextrose with 0.3% sodium chloride solution

Use freshly prepared solutions of Meropenem (Meromax IV) for IV injection and IV infusion.

Reconstituted product, constituted as described above. As shown below, the following diluents maintain satisfactory potency at room temperature (15-25°C) or under refrigeration (4°C).

Diluent Stability period at 15 -25°C Stability period at 4°C
Vial constituted with Sterile water for Injections for IV injection

 

Solutions (1-20 mg/mL) prepared with

·         0.9% sodium chloride

·         5% dextrose

·         5% dextrose and 0.3% sodium chloride

·         5% dextrose and 0.9% sodium chloride

·         10% dextrose

·         10% mannitol

·         2.5% mannitol

9 hours

 

 

 

 

11 hours

4 hours

4 hours

 

4 hours

 

3 hours

4 hours

5 hours

49 hours

 

 

 

 

49 hours

19 hours

19 hours

 

15 hours

 

9 hours

21 hours

21 hours

Incompatibilities

Meropenem (Meromax IV) should not be mixed with or added to other drugs.

CONTRAINDICATIONS

Patients who have shown hypersensitivity to Meropenem (Meromax IV).

WARNINGS

Pseudomembranous colitis

It is important to consider diagnosis in patients who develop diarrhea subsequent to the administration of antibacterial agents. Initiate appropriate therapeutic measures.

Superinfection

As with other broad-spectrum antibiotics, prolonged use of meropenem may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient is essential. If superinfection does occur during therapy, take appropriate measures.

Hypersensitivity reactions

Hypersensitivity reaction has been reported, as with all beta-lactam antibiotics. If hypersensitivity occurs, discontinue the drug and institute appropriate therapy.

Cross-hypersensitivity

Partial cross-allergenicity among beta-lactam antibiotics, including penicillins, cephalosporins, and other beta-lactams. Before initiating therapy with meropenem, make careful inquiry concerning previous hypersensitivity reactions to meropenem, cephalosporins, penicillins or other drugs.

PRECAUTIONS

  • Sensitivity to beta-lactam antibacterials, avoid if history of immediate hypersensitivity reaction
  • Hepatic impairment, monitor transaminase and bilirubin concentrations
  • Renal impairment
  • Pregnancy, in animal studies revealed no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, use of meropenem during pregnancy only if clearly needed.
  • It is not known whether meropenem is excreted in breast milk. Because many drugs are excreted in breast milk, use caution when administering to a nursing woman.

DRUG INTERACTIONS

  • Meropenem reduces plasma concentration of valproate.
  • Antibacterials that do not induce liver enzymes possibly reduce contraceptive effect of estrogens.
  • Excretion of meropenem is reduced by probenecid.

ADVERSE EFFECTS

Nausea, vomiting, diarrhea (antibiotic-associated colitis reported), abdominal pain; disturbance in liver function tests; thrombocytopenia (reduction in partial thromboplastin time reported), positive Coomb’s test, eosinophila, leucopenia, neutropenia; headache, paresthesia; hypersensitivity reactions including rash, pruritus, urticaria, angioedema, and anaphylaxis; convulsions; Stevens-Johnson syndrome and toxic epidermal necrolysis; local reactions including pain and thrombophlebitis at injection site.

OVERDOSAGE

Overdosing may occur if large doses are given to patients with reduced renal function. In the event of an overdose, discontinue meropenem and give general supportive treatment until renal elimination takes place. Meropenem and its metabolite are readily dialyzable and effectively removed by hemodialysis.

STORAGE CONDITION

Store at temperatures not exceeding 30°C. Do not freeze.

AVAILABILITY

Meropenem (Meromax IV) 500 mg Sterile Powder for Injection, I.V.: Type 1 clear glass vial, box of 1’s

Meropenem (Meromax IV) 1 g Sterile Powder for Injection, I.V.: Type 1 clear glass vial, box of 1’s

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