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Merokem I.V.
(meropenem) for Injection
FOR INTRAVENOUS USE ONLY
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Merokem I.V. (meropenem for injection) and other antibacterial drugs, MERREM I.V. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Each 500 mg MERREM I.V. vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq).
INDICATIONS
To reduce the development of drug-resistant bacteria and maintain the effectiveness of MERREM I.V. and other antibacterial drugs, MERREM I.V. should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
MERREM I.V. is indicated as single agent therapy for the treatment of the following infections when caused by susceptible isolates of the designated microorganisms:
Skin and Skin Structure Infections
Complicated skin and skin structure infections due to Staphylococcus aureus (β-lactamase and non-β- lactamase producing, methicillin susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (excluding vancomycin-resistant isolates), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.
Intra-abdominal Infections
Complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.
MERREM I.V. has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.MERREM I.V. is useful as presumptive therapy in the indicated condition (i.e., intra-abdominal infections) prior to the identification of the causative organisms because of its broad spectrum of bactericidal activity.
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DOSAGE AND ADMINISTRATION
Adults
The recommended dose of MERREM I.V. is 500 mg given every 8 hours for skin and skin structure infections and 1 g given every 8 hours for intra-abdominal infections. MERREM I.V. should be administered by intravenous infusion over approximately 15 to 30 minutes. Doses of 1 g may also be administered as an intravenous bolus injection (5 to 20 mL) over approximately 3-5 minutes.
Use in Elderly Patients
No dosage adjustment is required for elderly patients with creatinine clearance values above 50 mL/min.
Use in Pediatric Patients
For pediatric patients from 3 months of age and older, the MERREM I.V. dose is 10, 20 or 40 mg/kg every 8 hours (maximum dose is 2 g every 8 hours), depending on the type of infection (complicated skin and skin structure, intra-abdominal or meningitis). (See dosing table below.) Pediatric patients weighing over 50 kg should be administered MERREM I.V. at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 g every 8 hours for intra-abdominal infections and 2 g every 8 hours for meningitis. MERREM I.V. should be given as intravenous infusion over approximately 15 to 30 minutes or as an intravenous bolus injection (5 to 20 mL) over approximately 3-5 minutes.
WARNINGS
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH β- LACTAMS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.
THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE HYPERSENSITIVITY REACTIONS WHEN TREATED WITH ANOTHER β-LACTAM. BEFORE INITIATING THERAPY WITH MERREM I.V., CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OTHER β-LACTAMS, AND OTHER ALLERGENS. IF AN ALLERGIC REACTION TO MERREM I.V. OCCURS, DISCONTINUE THE DRUG IMMEDIATELY. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE, OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION. OTHER THERAPY MAY ALSO BE ADMINISTERED AS INDICATED.
CONTRAINDICATIONS
MERREM I.V. is contraindicated in patients with known hypersensitivity 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.
Presentation
Meterra Injection Each 2 ml Injection
Composition : 125mg, 250mg,500mg,1gm
MEROPENAM :- It is a synthetic Carbapenem Beta - Lactum Antibiotic. It has a potent bactericidal action against a broad spectrum of aerobic and anerobic bacteria.
Indication : Pneumonias, gynecological infections, skin and soft structure infections, meningitis, septicaemia and adult febrile neutropenia.
Dosage and administrations :- Administered as an intravenous injection over approkximately 5 minutes or by intravenous infusion over approximately 15-30 minutes with compatible infusion (50-200ml) fluid.
Adult :- Pneumonias, UTI, skin and skin structure infections :500mg 8hourly. Nosocomial Pneumonias, peritonitis, septicemia: 1g every 8hours. Meningitis : 2g every 8 hours
Contra-Indications :- Hypersensitivity to ingredients. Hypersensitivity to pencilins or other beta-lactam antibiotics.
Warning :
Special Precautions :-
Paediatrics :- Safety is not established in patient with neutropenia or primary/secondary immuno deficiency. Safety is not established in infants under 3 months of age.
Pregnancy :- Safety is not established
Lactation :- Safety is not established.
Elderly :- Safe for elderly with normal renal functions.
Side–effects :- Serious adverse effects are rare. Local IV injection site reaction, site reaction and neutrophilia. Headache, paresthesia, convulsions, oral and vaginal candidiasis.
Drug Interactions :- Nephrotoxic drugs, probenocid, sodium valproate etc.
Purity : Not less than 99%.
Your doctor has ordered meropenem, an antibiotic, to help treat your infection. The drug will be either injected into a large muscle (such as your buttock or hip) or added to an intravenous fluid that will drip through a needle or catheter placed in your vein for at least 15 minutes or more, one to three times a day.
Meropenem eliminates bacteria that cause many kinds of infections, including pneumonia and urinary tract, skin, bone, and stomach infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Your health care provider (doctor, nurse, or pharmacist) may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations. It is important to keep all appointments with your doctor and the laboratory. The length of treatment depends on how your infection and symptoms respond to the medication.
Side effects Return to top
Meropenem may cause side effects. Tell your health care provider if any of these symptoms are severe or do not go away:
* upset stomach
* diarrhea
* constipation
* dry mouth
* headache
If you experience any of the following symptoms, call your health care provider immediately:
* seizures
* fatigue and sleepiness
* dizziness
To reduce the development of drug-resistant bacteria and maintain the effectiveness of MERREM I.V. and other antibacterial drugs, MERREM I.V. should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
MERREM I.V. is indicated as single agent therapy for the treatment of the following infections when caused by susceptible isolates of the designated microorganisms:
USES: This medication is a carbapenem antibiotic (related to penicillin) used to treat a wide variety of bacterial infections (e.g., stomach/abdominal infections, meningitis).
HOW TO USE: This medication is given by vein (IV), generally every 8 hours, or as directed by your doctor. The length of therapy depends on your condition and response to treatment. You may be switched to an oral antibiotic when you are able to take medication by mouth. Antibiotics work best when the amount of medicine in your body is kept at a constant level. This is done by giving you the medication at evenly spaced intervals throughout the day and night. You should continue to use antibiotic medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, resulting in a relapse of the infection. Follow all instructions for proper mixing and dilution with the correct IV fluids. Consult your pharmacist. This medication should be checked visually for particles or discoloration before use. If present, do not use the liquid.
SIDE EFFECTS: Nausea, diarrhea, headache or pain/redness at the injection site may occur. If these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if you have any of these highly unlikely but very serious side effects: stomach pain, black/bloody stools, white patches in the mouth, fever, mental/mood changes, unusually fast/slow/irregular pulse, chest pain, seizures, change in amount of urine, yellowing eyes or skin. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
MEROSAN
Meropenem for Injection (500mg and 1g).
DESCRIPTION:
Meropenem for injection is a sterile, pyrogen-free, synthetic, ultra-broadspectrum, Carbapenem antibiotic for intravenous administration. It is Chemically (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1 azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate.
Meropenem penetrates well into most body fluids and tissues including cerebrospinal fluid, achieving concentrations matching or exceeding those required to inhibit most susceptible bacteria.
MECHANISM OF ACTION:
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-negative bacteria to reach penicillin- binding-protein (PBP) targets. Its strongest affinities are toward PBPs 2, 3 and 4 of Escherichia coli and Pseudomonas aeruginosa; and PBPs 1, 2 and 4 of Staphylococcus aureus.
Meropenem has significant stability to hydrolysis by beta-lactamases of most categories, both penicillinases and cephalosporinases produced by Gram-positive and Gram-negative bacteria. Meropenem has significant stability to hydrolysis by beta-lactamases of most categories, both penicillinases and cephalosporinases produced by Gram-positive (exept methicillin-resistant staphylococci (MRSA)) and Gram-negative bacteria. In vitro tests show meropenem to act synergistically with aminoglycoside antibiotics against some isolates of Pseudomonas aeruginosa.
INDICATIONS:
Skin and Skin Structure Infections: Complicated skin and skin structure infections due to Staphylococcus aureus (beta-lactamase and non-beta- lactamase producing, methicillin susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (excluding vancomycin-resistant isolates), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis , Bacteroides fragilis, and Peptostreptococcus species.
Intra-Abdominal Infections: Complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.
Bacterial Meningitis (Pediatric patients ≥ 3 months only): Bacterial meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase and non-beta-lactamase-producing isolates), and Neisseria meningitidis. Meropenem has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
DOSAGE AND ADMINISTRATION:
Route of Adminstration: For I.V. use only
MEROSAN is given intravenously as the trihydrate, but doses are expressed in terms of the amount of anhydrous meropenem. 1.14 g of meropenem trihydrate is approximately equivalent to 1 g of anhydrous meropenem. It is given by slow injection over 3 to 5 minutes or by infusion over 15 to 30 minutes in a usual adult dose of 0.5 to 1 g every 8 hours, increased to 2 g every 8 hours for meningitis; doses of up to 2 g every 8 hours have also been used in cystic fibrosis.
In Renal Impairment: Children over 3 months of age and weighing less than 50 kg may be given 10 to 20 mg/kg every 8 hours, increased to 40 mg/kg every 8 hours for meningitis. Dose of 25 to 40 mg/kg every 8 hours have been used in children with cystic fibrosis.
Direction For Reconstitution: MEROSAN is to be constituted using the volumes of diluent as shown below.
PREPARATION OF SOLUTIONS OF MEROPENEM:
For Intravenous Administration: Constitute 1 g Meropenem For Injection with 20 ml Sterile Water for Injection.
For Infusion: 1 g Meropenem For Injection may be directly constituted with a compatible diluent fluid.
Compatible Diluent Fluids:
- Sodium Chloride Injection 0.9%
- Dextrose Injection 5.0%
- Dextrose Injection 10.0%
- Dextrose and Sodium Chloride Injection 5.0% / 0.2%
- Dextrose and Sodium Chloride Injection 5.0% / 0.9%
- Potassium Chloride in Dextrose Injection 0.15% / 5.0%
- Sodium Carbonate in Dextrose Injection 0.02% / 5.0%
- Dextrose and Sodium Chloride Injection 2.5% / 0.45% Mannitol
- Mannitol Injection 2.5%
- Ringers Injection
- Ringers Lactate Injection
- Sodium Lactate Injection 1/6 N
- Sodium Bicarbonate Injection 5.0%
Adverse Effects: Meropenem may cause side effects such as thrombocythaemia, headache, nausea, vomiting, diarrhoea, abdominal pain, increase in serum transaminases, alkaline phosphatase, lactic dehydrogenase, skin rashes, pruritis, inflammation, pain at site of administration.
Contraindications: MEROSAN is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or Beta-lactamase inhibitors.
Indications :
Endocrine disorders, rheumatic disorders, colagen diseases, dermatological disorders, allergic states Opthalmic diseases, gastro-intestinal diseases, respiratory diseases, hematological disorders, neoplasms, edematous diseases
Fluid and Electrolyte Disturbances, Musculoskeletal- Steroid myopathy, Gastrointestinal-Peptic ulcer Dermatologic- Impaired wound healing, Neurological-Convulsions , Endocrine-Development of Cushingoid state
Methylprednisolone Sodium Succinate InjectionPrecautions :
CHF, HT, DM, epilepsy, elderly, gradual withdrawal, pregnancy, lactation, children and adolescent- irreversible growth retardation, postmenopausal women, glaucoma, corneal perforation, GI perforation, steroid myopathy
Contra-indications :
Serious infections except tuberculous meningitis and septic shock, benzyl alcohol C/I in infants
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