Trade Name: Meropenem

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Pharmaceuticals LLC

Presentation: INJECTION, POWDER, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 500 mg/20mL

Storage and handling

MEROPENEM Carbapenems [CS],Penem Antibacterial [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Meropenem (Meropenem) which is also known as Meropenem and Manufactured by Amneal Pharmaceuticals LLC. It is available in strength of 500 mg/20mL.

Meropenem (Meropenem) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Warnings and Precautions
  • Severe Cutaneous Adverse Reactions (5.2)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0 6/2018
  • Warnings and Precautions,
  • Severe Cutaneous Adverse Reactions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0 6/2018
  • Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of:
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenem for injection (I.V.) and other antibacterial drugs, meropenem for injection (I.V.) should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
  • Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). u00a0
  • Complicated intra-abdominal infections (adult and pediatric patients). u00a0
  • Bacterial meningitis (pediatric patients 3 months of age and older only). u00a0
  • Pediatric patients 3 months of age and older
  • Pediatric patients less than 3 months of age
  • 500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for complicated skin and skin structure infections (cSSSI) for adult patients. When treating infections caused by , a dose of 1 gram every 8 hours is recommended. u00a0
  • 1 gram every 8 hours by intravenous infusion over 15 minutes to 30 minutes for intra-abdominal infections for adult patients. u00a0
  • 1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL) over 3 minutes to 5 minutes for adult patients. u00a0
  • Dosage should be reduced in adult patients with renal impairment. u00a0
  • Single dose clear glass vials of meropenem for injection, USP (I.V.) containing 500 mg or 1 gram (as the trihydrate blended with anhydrous sodium carbonate for re-constitution) of sterile meropenem powder.
  • 500 mg Meropenem for Injection Vial n 1 gram Meropenem for Injection Vial u00a0
  • Meropenem for injection (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 beta (u03b2)-lactams.
  • Known hypersensitivity to product components or anaphylactic reactions to u03b2-lactams. n
  • No data
  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving u03b2-lactams. n
  • Severe cutaneous adverse reactions have been reported in patients receiving meropenem. ()
  • Seizures and other adverse CNS experiences have been reported during treatment. n n
  • Co-administration of meropenem with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. , n
  • Clostridium difficile
  • The following are discussed in greater detail in other sections of labeling:
  • Most common adverse reactions (2% or less) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash. n n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Co-administration of meropenem with probenecid inhibits renal excretion of meropenem and is therefore not recommended. n
  • The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. Antibacterial drugs other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. n n
  • No data
  • Renal Impairment: Dose adjustment is necessary, if creatinine clearance is 50 mL/min or less. , n
  • In mice and rats, large intravenous doses of meropenem (2,200 mg/kg to 4,000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities.
  • Intentional overdosing of meropenem is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. The largest dose of meropenem administered in clinical trials has been 2 grams given intravenously every 8 hours. At this dosage, no adverse pharmacological effects or increased safety risks have been observed.
  • Limited post-marketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in the Adverse Reactions section and are generally mild in severity and resolve on withdrawal or dose reduction. Consider symptomatic treatments. In individuals with normal renal function, rapid renal elimination takes place. Meropenem and its metabolite are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage.
  • Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic,u00a0carbapenem antibacterial for intravenous administration. It is (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. Its empirical formula is CHNOSu20223HO with a molecular weight of 437.52. Its structural formula is:
  • Meropenem, USP is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem, USP is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether.
  • When re-constituted as instructed, each 1 gram meropenem for injection, USP (I.V.) vial will deliver 1 gram of meropenem, USP and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg meropenem for injection, USP (I.V.) vial will deliver 500 mg meropenem, USP and 45.1 mg of sodium as sodium carbonate (1.96 mEq) n n .
  • No data
  • Carcinogenesis:
  • Carcinogenesis studies have not been performed.
  • Mutagenesis:
  • Genetic toxicity studies were performed with meropenem using the bacterial reverse mutation test, the Chinese hamster ovary HGPRT assay, cultured human lymphocytes cytogenic assay, and the mouse micronucleus test. There was no evidence of mutagenic potential found in any of these tests.
  • Impairment of Fertility:
  • In fertility studies, intravenous meropenem was administered to male rats beginning 11 weeks before mating and throughout mating and to female rats from 2 weeks before mating through Gestation Day 7 at doses of 240, 500, and 1000 mg/kg/day. There was no evidence of impaired fertility at doses up to 1000 mg/kg/day (on the basis of body surface area comparison, approximately 3.2 times to the MRHD of 1 gram every 8 hours).
  • No data
  • 1.u00a0u00a0 Cockcroft DW, MH Gault, 1976, Prediction of creatinine clearance from serum creatinine, Nephron., 16:31-41.
  • 2.u00a0u00a0 Kawamura S, AW Russell, SJ Freeman, and RA Siddall, 1992, Reproductive and Developmental Toxicity of Meropenem in Rats, Chemotherapy, 40:S238-250.
  • Meropenem for injection, USP (I.V.) is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. The dry powder should be stored at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • 500 mgn- 1 gram
  • u00a0
  • Manufactured for:
  • Amneal Pharmaceuticals LLC
  • Bridgewater, NJ 08807
  • Made in Taiwan
  • Rev. 08-2019-07
  • NDC 70121-1454-1
  • Meropenem for Injection USP (I.V.), 500 mg per vial
  • Rx only
  • Amneal Pharmaceuticalsu00a0LLC
  • u00a0
  • u00a0
  • NDC 70121-1454-7
  • Meropenem for Injection USP (I.V.), 500 mg per vial
  • Rx only
  • Amneal Pharmaceuticalsu00a0LLCNDC 70121-1453-1
  • Meropenem for Injection USP (I.V.), 1 g per vial
  • Rx only
  • Amneal Pharmaceuticalsu00a0LLC
  • Arrayn- Array
  • NDC 70121-1453-7
  • Meropenem for Injection USP (I.V.), 1 g per vial
  • Rx only
  • Amneal Pharmaceuticalsu00a0LLC
  • Arrayn- Array

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