Finished product reference
Meropenem
Injection, Powder, for Solution · Parenteral · 500 mg
- List code
- 3283
What it is and how it works
Mechanism of Action Meropenem is an antibacterial drug [ see Microbiology ].
Indications
Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 4. Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). 5. Complicated intra-abdominal infections (adult and pediatric patients). 6. Bacterial meningitis (pediatric patients 3 months of age and older only). 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.
Dosage and administration (summary)
5. 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 Pseudomonas aeruginosa , a dose of 1 gram every 8 hours is recommended 6. 1 gram every 8 hours by intravenous infusion over 15 minutes to 30 minutes for intra-abdominal infections for adult patients. 7. 1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL) over 3 minutes to 5 minutes for adult patients. 8. Dosage should be reduced in adult patients with renal impairment.
Contraindications
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 (β)-lactams. 2. Known hypersensitivity to product components or anaphylactic reactions to β-lactams.
Warnings and precautions
7. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. 8. Severe cutaneous adverse reactions have been reported in patients receiving Meropenem for injection (I.V.). 9. Seizures and other adverse CNS experiences have been reported during treatment. ( Error! Hyperlink reference not valid. ) 10. Co-administration of Meropenem for injection (I.V.) with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. ( 5.4 , 7.2 ) 11.
Pregnancy
Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with meropenem in pregnant women.
Storage and supply
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 20º to 25ºC (68º to 77ºF) .
Source: Meropenem (Meropenem) — US FDA prescribing information, 2024-11-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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