What is Ertapenem used for?

1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for Injection and other antibacterial drugs, Ertapenem for Injection should be used only 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, lo

How does Ertapenem work?

11 DESCRIPTION Ertapenem for Injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics.

What pharmaceutical form is Ertapenem available in?

Ertapenem: Proszek do sporządzania koncentratu roztworu do infuzji 1 g (dożylna)

Is Ertapenem OTC or prescription only?

Ertapenem requires a doctor's prescription.

What are the side effects of Ertapenem?

6 ADVERSE REACTIONS The following are described in greater detail in the Warnings and Precautions section. • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Seizure Potential [see Warnings and Precautions (5.2) ] • Interaction with Valproic Acid [see Warnings and Precautions (5.3) ] • Clostridium difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] • Caution with Intramuscular Administration [see Warnings and Precautions (5.5) ] • Devel

Who should NOT take Ertapenem?

4 CONTRAINDICATIONS • Ertapenem for Injection 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-lactams. • Due to the use of lidocaine HCl as a diluent, Ertapenem for Injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. • Known hypersensitivity to p

Does Ertapenem interact with other medications?

7 DRUG INTERACTIONS • Co-administration with probenecid inhibits the renal excretion of ertapenem and is therefore not recommended. ( 7.1 ) • The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. ( 5.2 , 7.2 ) 7.1 Probenecid Probenecid interferes with the active tubular

Can Ertapenem be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS • Renal Impairment: Dose adjustment is necessary, if creatinine clearance is ≤30 mL/min/1.73 m 2 . ( 2.4 , 8.6 , 12.3 ) 8.1 Pregnancy Risk Summary Available data from a small number of postmarketing cases with Ertapenem for Injection use in pregnancy are insufficient to inform any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies after intravenous administration of erta

How should Ertapenem be stored?

16.2 Storage and Handling Before reconstitution Do not store lyophilized powder above 25°C (77°F). Reconstituted and infusion solutions The reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection [see Dosage and Administration (2.7) ], may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used w

Who manufactures Ertapenem?

Sun Pharmaceutical Industries Europe B.V. (Holandia)

What ATC class does Ertapenem belong to?

Ertapenem: ATC J01DH03. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Ertapenem

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

⚠️ Warnings

Instructions for use: For single use only. Reconstituted solutions should be diluted in sodium chloride 9 mg/mL (0.9 %) solution immediately after preparation. Preparation for intravenous administration: ERTAPENEM must be reconstituted and then diluted prior to administration. Adults and adolescents (13 to 17 years of age) Reconstitution Reconstitute the contents of a 1 g vial of ERTAPENEM with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution to yield a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve (See section 6.4). Dilution For a 50 mL bag of diluent: For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 mL bag of sodium chloride 9 mg/mL (0.9 %) solution; or For a 50 mL vial of diluent: For a 1 g dose, withdraw 10 mL from a 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution and discard.‍‍‍‍‍ Transfer the contents of the reconstituted 1g vial of ERTAPENEM to the 50 mL vial of sodium chloride 9 mg/mL (0.9 %) solution. Infusion Infuse over a period of 30 minutes. Children (3 months to 12 years of age) Reconstitution Reconstitute the contents of a 1 g vial of ERTAPENEM with 10 mL of water for injection or sodium chloride 9 mg/mL (0.9 %) solution to yield a reconstituted solution of approximately 100 mg/mL. Shake well to dissolve. (See section 6.4). Dilution For a bag of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a bag of sodium chloride 9 mg/mL (0.9 %) solution for a final concentration of 20 mg/mL or less; or For a vial of diluent: Transfer a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) to a vial of sodium chloride 9 mg/mL (0.9 %) solution for a final concentration of 20 mg/mL or less. Infusion Infuse over a period of 30 minutes. Compatibility of ERTAPENEM with intravenous solutions containing heparin sodium and potassium chloride has been demonstrated. The reconstituted solutions should be inspected visually for particulate matter and discolouration prior to administration. Reconstituted solutions range from colourless to pale yellow. Variations of colour within this range do not affect potency. Any unused product or waste material should be disposed of in accordance with local requirements.

Ertapenem

User Reviews