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Cilastatin

Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropep.

Prescription medicine Intravenous

How to use Cilastatin

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections. ( 1.1 ) Urinary tract infections. ( 1.2 ) Intra-abdominal infections. ( 1.3 ) Gynecologic infections. ( 1.4 ) Bacterial septicemia. ( 1.5 ) Bone and joint infections. ( 1.6 ) Skin and skin structure infections. ( 1.7 ) Endocarditis. …

How to take it and how often
  • The dosage of Imipenem and Cilastatin for Injection (I.V.) in adult patients should be based on suspected or confirmed pathogen susceptibility
  • For adult patients with normal renal function (creatinine clearance of greater than or equal to 90 mL/min), the recommended dosage regimens are: 500 mg every 6 hours OR 1,000 mg every 8 hours OR 1,000 mg every 6 hours
  • See full prescribing information for dosage recommendations
  • In pediatric patients
  • A reduction in dose must be made for a patient with a creatinine clearance of less than 90 mL/min
  • Patients with creatinine clearances of less than 15 mL/min should not receive Imipenem and Cilastatin for Injection (I.V.) unless hemodialysis is instituted within 48 hours
  • Reconstitute Imipenem and Cilastatin for Injection, USP (I.V.) vial with appropriate diluent and dilute the reconstituted suspension with an appropriate infusion solution before administering by intravenous infusion
  • Dosage
  • In Adults For Intravenous Injection Only The dosage of Imipenem and Cilastatin for Injection (I.V.) in adult patients should be based on suspected or confirmed pathogen susceptibility as shown in Table 1 below
  • The dosage recommendations for Imipenem and Cilastatin for Injection (I.V.) represent the quantity of imipenem to be administered
  • An equivalent amount of cilastatin is also present in the solution
  • These doses should be used for patients with creatinine clearance of greater than or equal to 90 mL/min. …
Strengths it comes in

For Injection Imipenem and Cilastatin for Injection (I.V.) is a sterile powder mixture for reconstitution in single-dose vials containing: 250 mg imipenem (anhydrous equivalent) and 250 mg cilastatin (free acid equivalent) 500 mg imipenem (anhydrous equivalent) and 500 mg cilastatin (free acid equivalent) For Injection: Imipenem and Cilastatin for Injection (I.V.) is a sterile powder mixture for r …

Children
  • Use of Imipenem and Cilastatin for Injection (I.V.)
  • In pediatric patients is supported by evidence from adequate and well-controlled trials of Imipenem and Cilastatin for Injection (I.V.)
  • In adults and clinical studies
  • In pediatric patients [see Dosage and Administration and Clinical Pharmacology ]
  • Imipenem and Cilastatin for Injection (I.V.) is not recommended
  • In pediatric patients with CNS infections because of the risk of seizures. …
Older adults

Of the approximately 3,600 subjects ≥ 18 years of age in clinical studies of Imipenem and Cilastatin for Injection (I.V.), including postmarketing studies, approximately 2,800 received Imipenem and Cilastatin for Injection (I.V.). Of the subjects who received Imipenem and Cilastatin for Injection (I.V.), data are available on approximately 800 subjects who were 65 and over, including approximately 300 subjects who were 75 and over. …

While you are taking it
  • Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment
  • They should report any previous hypersensitivity reactions to Imipenem and Cilastatin for Injection (I.V.), other carbapenems, beta-lactams or other allergens
  • Counsel patients that antibacterial drugs including Imipenem and Cilastatin for Injection (I.V.) should only be used to treat bacterial infections
  • They do not treat viral infections (e.g., the common cold). …
Talk to a doctor first if
  • Imipenem and Cilastatin for Injection (I.V.) is contraindicated in patients who have shown hypersensitivity to any component of this product
  • Known hypersensitivity to any component of Imipenem and Cilastatin for Injection (I.V.)
Medicines it may not mix with

Ganciclovir: Generalized seizures have been reported in patients who received ganciclovir. Do not co-administer unless benefit outweighs risk ( 7.1 ). Probenecid: Concomitant administration of Imipenem and Cilastatin for Injection (I.V.) and probenecid results in increases in the plasma level and half-life of imipenem. Concomitant administration is not recommended ( 7.2 ). Valproic acid/divalproex sodium: Concomitant use with Imipenem and Cilastatin for Injection (I.V.) is generally not recommended. Consider other antibacterial drugs to treat infections in patients whose seizures are well-controlled on valproic acid or divalproex sodium ( 5.3 , 7.3 ). …

Warnings

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. If an allergic reaction to Imipenem and Cilastatin for Injection (I.V.) occurs, discontinue the drug immediately ( 5.1 ). Seizure Potential: Seizures and other CNS adverse reactions, such as confusional states and myoclonic activity, have been reported during treatment with Imipenem and Cilastatin for Injection (I.V.). …

Possible side effects

The following serious adverse reactions 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 )] Increased Seizure Potential Due to Interaction with Valproic Acid [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4 )] Development of Drug-Resistant Bacteria [see Warnings and Precautions ( 5.5 )] The most frequently occurring adverse reactions (≥ 0.2%) in adults were phlebitis, nausea, diarrhea, vomiting, rash, pain injection site, fever, hypotension, seizures, erythema at injection …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary Available data from a small number of postmarketing cases with Imipenem and Cilastatin for Injection (I.V.) use in pregnancy are not sufficient to identify any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. …

If you take too much

In the case of overdosage, discontinue Imipenem and Cilastatin for Injection (I.V.), treat symptomatically, and institute supportive measures as required. Imipenem and Cilastatin for Injection (I.V.) is hemodialyzable.

How to store it

Before Reconstitution: Imipenem and Cilastatin for Injection, USP (I.V.) sterile powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2022-10-10.

Brands around the world

Products with Cilastatin as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

CilastatinCILASTATIN SODIUM 1 kg/kg · Powder · Shandong Anhong Pharmaceutical Co., Ltd.
NDC 49386-035Label
Cilastatin SodiumCILASTATIN SODIUM 1 kg/kg · Powder · Merck Sharp & Dohme Corp.
NDC 69806-0094Label
Imipenem And CilastatinIMIPENEM 500 mg/20mL, CILASTATIN SODIUM 500 mg/20mL · Injection, Powder, For Solution · Fresenius Kabi USA, LLC
NDC 63323-322Label
Imipenem And CilastatinIMIPENEM 500 mg/20mL, CILASTATIN SODIUM 500 mg/20mL · Injection, Powder, For Solution · Fresenius Kabi USA, LLC
NDC 63323-322Label
Imipenem And CilastatinIMIPENEM 500 mg/20mL, CILASTATIN SODIUM 500 mg/20mL · Injection, Powder, For Solution · Fresenius Kabi USA, LLC
NDC 63323-322Label

Nigeria (NAFDAC)

NAFDACBacqure Injection 500 mg 04-9478

Other countries: check your pack's registration number and we point you to your regulator.

Check your pack of Cilastatin

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3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

Questions about Cilastatin

What is Cilastatin used for?

Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections. ( 1.1 ) Urinary tract infections. ( 1.2 ) Intra-abdominal infections. ( 1.3 ) Gynecologic infections. ( 1.4 ) (From the official U.S. FDA label.)

How do I take Cilastatin?

Follow your prescription or the leaflet in your pack. The official label says: The dosage of Imipenem and Cilastatin for Injection (I.V.) in adult patients should be based on suspected or confirmed pathogen susceptibility ( 2.1 ). For adult patients with normal renal function (creatinine clearance of greater than or equal to 90 mL/min), the recommended dosage regimens are: 500 mg every 6 hours OR 1,000 mg every 8 hours OR 1,000 mg every 6 hours ( 2.1 ). S…

Do I need a prescription for Cilastatin?

Usually yes. Cilastatin is a prescription medicine in most countries. Rules differ by country.

What brands contain Cilastatin?

Cilastatin is sold under names such as Recarbrio, Primaxin, Imipenem And Cilastatin. Brand names differ between countries.

How can I check that my Cilastatin is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.