Méropénem Actavis Uses

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What is Méropénem Actavis?

Méropénem Actavis injection is used to treat infections caused by bacteria. It works by killing the bacteria or preventing their growth. Méropénem Actavis will not work for colds, flu, or other virus infections.

Méropénem Actavis is to be given only by or under the direct supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Méropénem Actavis is used in certain patients with the following medical condition:

Méropénem Actavis indications

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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Méropénem Actavis I.V. and other antibacterial drugs, Méropénem Actavis 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.

Méropénem Actavis I.V. is useful as presumptive therapy in the indicated condition (e.g., intra-abdominal infections) prior to the identification of the causative organisms because of its broad spectrum of bactericidal activity.

For information regarding use in pediatric patients [seeIndications and Usage (1.1), (1.2), (1.3), Dosage and Administration (2.3), Adverse Reactions (6.1), andClinical Pharmacology (12.3)].

Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only)

Méropénem Actavis I.V. is indicated as a single agent therapy for the treatment of complicated skin and skin structure infections due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.

Intra-abdominal Infections (Adult and Pediatric Patients)

Méropénem Actavis I.V. is indicated as a single agent therapy for the treatment of 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 of Age and Older Only)

Méropénem Actavis I.V. is indicated as a single agent therapy for the treatment of bacterial meningitis caused by Streptococcus pneumoniae‡, Haemophilus influenzae, and Neisseria meningitidis.

‡ The efficacy of Méropénem Actavis as monotherapy in the treatment of meningitis caused by penicillin nonsusceptible isolates of Streptococcus pneumoniae has not been established.

Méropénem Actavis I.V. has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.

How should I use Méropénem Actavis?

Use Méropénem Actavis as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Méropénem Actavis.

Uses of Méropénem Actavis in details

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Use: Labeled Indications

Intra-abdominal infections: Treatment of complicated appendicitis and peritonitis in adult and pediatric patients caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Bacteroides thetaiotaomicron, and Peptostreptococcus species.

Meningitis, bacterial: Treatment of bacterial meningitis in pediatric patients 3 months and older caused by Haemophilus influenzae, Neisseria meningitidis, and penicillin-susceptible isolates of Streptococcus pneumoniae.

Skin and skin structure infection, complicated: Treatment of complicated skin and skin structure infections in adults and pediatric patients 3 months and older caused by Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), P. aeruginosa, E. coli, Proteus mirabilis, B. fragilis, and Peptostreptococcus species.

Off Label Uses

Anthrax

Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax, Méropénem Actavis is an effective and recommended agent for the treatment of anthrax meningitis and an effective and recommended alternative agent for systemic anthrax.

Bite wound infection, treatment, animal or human bite

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), Méropénem Actavis is an effective and recommended alternative agent for treatment of animal or human bite wounds.

Bloodstream infection (gram-negative bacteremia)

Based on the IDSA guidelines for the diagnosis and management of intravascular catheter-related infection, Méropénem Actavis is effective and recommended in the management of catheter-related bloodstream infection.

Clinical experience also suggests the utility of Méropénem Actavis for the treatment of bloodstream infection caused by gram-negative pathogens, including Pseudomonas aeruginosa.

Méropénem Actavis description

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The chemical name of Méropénem Actavis trihydrate is -Azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 3-[[5-[(dimethylamino)carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo, trihydrate, [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-.(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-carboxylic acid, trihydrate. The molecular formula of Méropénem Actavis trihydrate is C17H25N3O5S·3H2O and its CAS number is 119478-56-7.

DBL Méropénem Actavis for Injection is presented as a sterile white to pale yellow crystalline powder containing Méropénem Actavis trihydrate equivalent to Méropénem Actavis, 500 mg or 1 g, blended with sodium carbonate anhydrous. DBL Méropénem Actavis for Injection contains 208 mg sodium carbonate anhydrous and 90.2 mg of sodium for each gram of Méropénem Actavis (anhydrous potency). It contains no antimicrobial preservative and is for use in one patient on one occasion only..

Méropénem Actavis dosage

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Adults: The recommended dose of Méropénem Actavis injection of 500 mg is given every 8 hours for a skin and skin structure infections when treating infections caused by Pseudomonas aeruginosa, dose of 1 gram every 8 hours is recommended, and 1 gram given every 8 hours for intra-abdominal infections. Méropénem Actavis injection should be administered by intravenous infusion over approximately 15 to 30 minutes. Doses of 1 gram every 8 hours may also be administered as an intravenous bolus injection (5 to 20 mL) over approximately 3-5 minutes.

Renal Impairment: Dosage should be reduced in patients with creatinine clearance less than 51 mL/min.

When only serum creatinine is available, the following formula (Cockroft and Gault equation) may be used to estimate creatinine clearance.

There is inadequate information regarding the use of Méropénem Actavis in patients on hemodialysis. There is no experience with peritoneal dialysis.

Hepatic Impairment: No dosage adjustment is necessary in patients with impaired hepatic function.

Elderly: No dosage adjustment is required for elderly patients with creatinine clearance values above 50 mL/min.

Children: For pediatric patients from 3 months of age and older, the Méropénem Actavis injection, 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 infections, intra-abdominal or meningitis). Pediatric patients weighing over 50 kg should be administered Méropénem Actavis injection at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 g every hour for intra-abdominal infections and 2 g every 8 hours for meningitis. Méropénem Actavis injection, should be given as intravenous infusion over approximately 15 to 30 minutes or as an intravenous bolus injection (5 to 20 mL) infusion over approximately 3-5 minutes. There is limited safety data available to support the administration of a 40 mg/kg (up to a maximum of 2 g) bolus dose.

Méropénem Actavis interactions

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What other drugs will affect Méropénem Actavis?

Probenecid competes with Méropénem Actavis for active tubular secretion and thus, inhibits the renal excretion, with the effect of increasing the elimination t½ and plasma concentration of Méropénem Actavis. As the potency and duration of action of Méropénem Actavis dosed without probenecid are adequate, the co-administration of probenecid with Méropénem Actavis is not recommended.

The potential effect of the Méropénem Actavis on the protein-binding of other drugs or metabolism has not been studied. The protein-binding of Méropénem Actavis is low (approximately 2%) and therefore, no interactions with other compounds based on displacement from plasma proteins would be expected.

Méropénem Actavis may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients.

Méropénem Actavis has been administered concomitantly with other medications without adverse pharmacological interactions. However, no other specific data regarding potential drug interactions is available (apart from probenecid as mentioned above).

Incompatibilities: Méropénem Actavis should not be mixed with or added to other drugs. Méropénem Actavis is incompatible with the following infusion fluids: Sodium chloride solution 0.9%, glucose solution 5% or 10%, glucose 5% solution with sodium bicarbonate 0.02%, glucose 5% solution with sodium chloride 0.9%, glucose 5% with sodium chloride 0.225% solution, glucose 5% with potassium chloride 0.15% solution, Mannitol 2.5% or 10% solution.

Méropénem Actavis side effects

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What are the possible side effects of Méropénem Actavis?

Méropénem Actavis is generally well tolerated. In clinical trials, adverse events lead to cessation of treatment in <1% of patients. Serious adverse events are rare.

Common Events: Local IV Injection Site Reactions: Inflammation, thrombophlebitis, pain.

Gastrointestinal Disorders: Nausea, vomiting, diarrhea.

Hematologic: Reversible thrombocythemia.

Hepatic Function: Reversible increases in serum transaminases, bilirubin, alkaline phosphatase and lactic dehydrogenase alone or in combination have been reported.

Uncommon Events (<1%): Systemic Allergic Reactions: Systemic allergic reactions (hypersensitivity) may occur following administration of Méropénem Actavis. These reactions may include angioedema and manifestations of anaphylaxis.

Dermatologic: Rash, pruritus, urticaria, severe skin reactions eg, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been observed.

Gastrointestinal Disorders: Pseudomembranous colitis. Jaundice and hepatic failure have been reported but a causal link with Méropénem Actavis has not been established.

Blood and Lymphatic System Disorders: Eosinophilia, leukopenia, thrombocytopenia, neutropenia, agranulocytosis, hemolytic anemia has been observed very rarely. A positive direct or indirect Coombs' test may develop.

Cardiovascular: Cardiac failure has been reported but a causal link with Méropénem Actavis has not been established.

Central Nervous System: Headache, paresthesia. Delirium, hallucinations and convulsions have been reported but a causal link with Méropénem Actavis has not been established.

Respiratory: Pneumonia and respiratory failure have been reported but a causal link with Méropénem Actavis has not been established.

Body as a Whole: Fever and septicemia have been reported but a causal link with Méropénem Actavis has not been established.

Others:

Oral and vaginal candidiasis.

Méropénem Actavis contraindications

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What is the most important information I should know about Méropénem Actavis?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Méropénem Actavis, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Méropénem Actavis or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Active ingredient matches for Méropénem Actavis:

Meropenem in France.


List of Méropénem Actavis substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
MYRON tab 50's (Alarsin)$ 0.37
1 g x 1's (Intensicare (Nectar Lifesciences Ltd))$ 27.11
Necperonam 1000 mg Injection (Intensicare (Nectar Lifesciences Ltd))$ 0.02
Necperonam 1g VIAL / 1 (Intensicare (Nectar Lifesciences Ltd))$ 27.11
Necperonam 1g VIAL / 1 (Intensicare (Nectar Lifesciences Ltd))$ 27.11
Nemero 1000 mg Injection (Research Medicure Pvt. Ltd.)$ 0.01
Nemero 125 mg Injection (Research Medicure Pvt. Ltd.)$ 3.31
Nemero 500 mg Injection (Research Medicure Pvt. Ltd.)$ 6.02
Nemropen 1000 mg Injection (Bison Biotec Pvt Ltd)$ 0.02
1 g x 1's (H & Care)
250 mg x 1's (H & Care)
500 mg x 1's (H & Care)
Neumer 1g INJ / 1 (H & Care)
Neumer 250mg INJ / 1 (H & Care)
Neumer 500mg INJ / 1 (H & Care)
Neumer 1g INJ / 1 (H & Care)
Neumer 250mg INJ / 1 (H & Care)
Neumer 500mg INJ / 1 (H & Care)
Nexmoir 1g VIAL / 1 (Alna (H&I))$ 26.51
Nexmoir 125mg VIAL / 1 (Alna (H&I))$ 3.98
Nexmoir 250mg VIAL / 1 (Alna (H&I))$ 9.04
NUCYTIN NDD 1000MG INJECTION 1 vial / 1 injection each (Biocon)$ 34.34
Nucytin-NDD 1g POWD / 1 (Biocon)$ 34.34
Nuronem inj 1 g 1's (Sun Pharma)
Nuronem inj 500 mg 1's (Sun Pharma)
Omipenam 1000 mg Injection (Om Biotec)$ 0.02
Onmero 1g VIAL / 1 (Rishab Healthcare Pvt Ltd)
Onmero 500mg VIAL / 1 (Rishab Healthcare Pvt Ltd)
1 g x 1's (Rishab Healthcare Pvt Ltd)
500 mg x 1's (Rishab Healthcare Pvt Ltd)
Onmero 1000 mg Injection (Rishab Healthcare Pvt Ltd)$ 0.01
Injectable; Injection; Meropenem Trihydrate 25 mg / ml (Astrazeneca)
Injectable; Injection; Meropenem Trihydrate 50 mg / ml (Astrazeneca)
Injectable; Injection; Meropenem Trihydrate 25 mg / ml
Injectable; Injection; Meropenem Trihydrate 50 mg / ml
Injectable; Injection; Meropenem Trihydrate 500 mg

References

  1. DailyMed. "MEROPENEM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "meropenem". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "meropenem". http://www.drugbank.ca/drugs/DB00760 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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