Merotic 1gm IV
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     Meropenem  1gm IV injection

 

Composition:

Merotic™1 gm IV injection: Each vial contains dry substance equivalent toMeropenemUSP1gmaccompanied bytwoampoulesof10mlWaterfor InjectionBP.

 

Pharmacology:

Meropenem is a carbapenem antibiotic for parenteral use that exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls with its high level of stability to all serine betalactamases and marked affinity for the Penicillin Binding Proteins (PBPs). The in-vitro antibacterial spectrum of meropenem includes the majority of clinically significant Gram-positive and Gram-negative, aerobic and anaerobic strains of bacteria.

 

Indication:

Pneumonia and Nosocomial Pneumonia

Urinary Tract Infections

Intra-abdominal Infections

Gynaecological Infections such as endometritis

Skin and Skin Structure Infections

Meningitis

Septicaemia

Empiric treatment for presumed infections in adult patients with febrile neutropenia

Other polymicrobial infections

 

Dosage and administration:

Adult

The dosage and duration of therapy shall be established depending on type and severity of infection and the condition of the patient.

The recommended daily dosage is as follows:-

In the treatment of pneumonia, UTI, gynecological infections such as endometritis, skin and skin structure infections- 500 mg IV every 8 hours

In the treatment of nosocomial pneumonia, peritonitis, presumed infections in neutropenic patients, septicaemia- 1 gm IV every 8 hours

In cystic fibrosis- doses upto 2 gm every 8 hours

In meningitis- 2 gm 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.

  Patients with impaired renal function

Dosage should be reduced in patients with creatinine clearance less than 51 ml/min, as scheduled below:

 

Creatinine clearance             Dose (Based on unit doses of                                  Frequency

(ml/min)                                   (500 mg, 1 gm, 2 gm)                           

25-50                                            1 unit doses                                                           every 12 hours

10-25                                          / unit dose                                                             every 12 hours

<1O                                              / unit dose                                                       every 24 hours

 

Patients with Hepatic Insufficiency

Nodosageadjustmentisnecessaryinpatientswithhepaticinsufficiency.

Elderly patients

No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.           

Children

Infantsunder3months:

Meropenemisnotrecommendedforinfantsunder3monthsold. Children over 3months:

  • Over3monthsto12years-10to20mg/kgevery8hours
  • Childrenover50kgweight,adultdosageshouldbeused
  • 4yearsto18yearswithsysticfibrosis-25to40mg/kgevery8hours
  • In meningitis- 40 mg/kg every 8hours

There is no experience in children with altered hepatic or renal function.

 

Contra-indication:

Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.

 

Adverse effect:

Serious adverse events are rare. The following adverse events may occur:

Inflammation,thrombophlebitis,painatthesiteofinjection,skinreactions like rash, pruritis, urticaria etc, abdominal pain, nausea, vomiting, diarrhoea, headache,paraesthesia.

 

Reconstitution procedure:

The content of one vial is to be dissolved in 20 ml water for injection for Merotic’” 1 gm IV injection. As the product dissolves, carbon dioxide is releasedandapositivepressuredevelops.Foreaseofusethefollowing techniques of reconstitution arerecommended.

 

Step 1:

Hold the vial in upright position.

Remove approximately 10 ml air from the vial

 

Step 2:

Add recommended volume of solvent slowly. Hold the syringe plunger tightly. After completion remove the needle. Shake to obtain a clear solution. As the antibiotic dissolves carbon dioxide is released causing frothing which clears quickly.

 

Step 3:

A high pressure inside the vial will be developed. Now, Depress the syringeplungerfullyandholdtheplungertightly.Insidetheneedletothe uprightvialuptotheneckandwithdrawapproximately10mlofgas.

 

Step 4:

Invert the vial. With a syringe plunger fully depressed, insert the needle keeping it within solution. The pressure aids withdraw of the soultion.

 

Step 5:

Bubble of carbon dioxide in syringe clears quickly on tapping. As these are carbon dioxide, smaller bubbles can be injected without ill effect.

Precaution:

As with all beta-lactam antibiotics, rare hypersensitivity reactions have been reported. Before initiating therapy with meropenem, carefulinquiry should be made concerning previous hypersensitivity reactions to beta- lactam antibiotics. If an allergic reaction to meropenem occurs, the drug shouldbediscontinued andappropriatemeasuresshouldbetaken.

Use in infection caused by methicillin resistant staphylococci is not recommended.

The co-administration of Meropenem with potentially nephrotoxic drugs should be considered with caution.

 

 

Pregnancy and lactation: 

 

Pregnancy

Animal studies have not shown any adverse effect on the developingfetus. Meropenem should not be used in pregnancy unless thepotential benefit justifies the potential risk to thefetus.

Lactation

Meropenemisdetectableatverylowconcentrationsinanimalbreastmilk. Merotic’”shouldnotbeusedinbreastfeedingwomenunlessthepotential benefit justifies the potential risk to thebaby.

 

Overdose:

Treatment of accidental overdosage should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove meropenem and its metabolite.

 

Storage:

Storeinacoolanddryplace.Itisrecommendedtousefreshly prepared solutionsofMerotic’” forIVinjectionandinfusion.Reconstitutedproduct should be used immediately and must be stored for no longer than 24 hours under refrigeration, only ifnecessary.

 

How supplied:

Merotic™ 1 gm IV injection: Each pack contains one vial of Meropenem USP 1 gm with two ampoules of 10 ml Water for injection BP, 20 ml disposablesyringeandasetofbutterflyneedle,alcoholpreppadandstrip bandage.

 

Manufactured By:

Rangs Pharmaceuticals Ltd.

Tejgaon, Dhaka, Bangladesh.

 

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