Question 1

What is Cilastatin?

Accepted Answer

Cilastatin is a dehydropeptidase inhibitor that is used exclusively in combination with the antibiotic imipenem. It works by blocking a specific enzyme in the kidneys that would otherwise break down the antibiotic. By preventing this metabolic process, cilastatin ensures the antibiotic remains active in the body for a longer period. This mechanism also helps to prevent potential kidney toxicity that can occur when the antibiotic is broken down.

Question 2

What is Cilastatin used for?

Accepted Answer

Cilastatin is used to treat the prevention of renal degradation of imipenem .

Question 3

How does Cilastatin work?

Accepted Answer

Mechanism of Action

Cilastatin is not an antibiotic and does not kill bacteria on its own. Its primary role is to protect specific antibiotics, such as imipenem, from being destroyed by the body's natural processes. It belongs to a group of drugs called dehydropeptidase inhibitors.

Protecting the Antibiotic

When certain antibiotics enter the kidneys, an enzyme called dehydropeptidase I quickly breaks them down. Cilastatin works by blocking this enzyme. By stopping this breakdown, cilastatin provides several benefits:

Increased Effectiveness: It allows the antibiotic to stay in the bloodstream and tissues at higher levels for a longer time.

Urinary Concentration: It ensures that higher levels of the active antibiotic reach the urine, which is helpful for treating urinary tract infections.

Kidney Protection: It may help reduce the risk of kidney irritation that can occur when the antibiotic is broken down into certain metabolites.

Because cilastatin has no antibacterial effect of its own, it is only administered in combination products to enhance the performance of the accompanying antibiotic medication.

Question 4

What are the active ingredients in Cilastatin?

Accepted Answer

The active ingredient in Cilastatin is cilastatin .

Question 5

What are the side effects of Cilastatin?

Accepted Answer

Common side effects of Cilastatin may include:

Nausea

Vomiting

Diarrhea

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Cilastatin?

Accepted Answer

Cilastatin belongs to the renal dehydropeptidase inhibitor drug class.

Question 7

What is the dosage of Cilastatin and how do I take it?

Accepted Answer

Administration Methods

Cilastatin is always used in combination with other medications. It is administered in the following ways:

Intravenous (IV) infusion: The medication is delivered slowly into a vein over a period of time.

Intramuscular (IM) injection: The medication is injected directly into a large muscle.

Frequency and Schedule

This medication is typically administered several times a day at regular intervals. When used in a hospital, healthcare providers will manage the timing of each dose. If you are using this medication at home, it is important to follow the specific schedule provided by your healthcare professional and to use the medication exactly as directed.

Missed Doses

If you miss a dose of this medication, contact your doctor or pharmacist immediately to receive instructions on when to schedule the next dose. Do not use extra medication to make up for a missed dose.

Completing the Course

It is essential to receive all scheduled doses for the full length of time prescribed by a doctor. Skipping doses or stopping the medication early, even if symptoms improve, may prevent the infection from being fully treated and could lead to the return of the infection.

Question 8

Is Cilastatin safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Information regarding the use of cilastatin during pregnancy is limited, as there are no adequate and well-controlled studies in humans. In animal studies where cilastatin was administered in combination with imipenem, some adverse effects on the fetus were observed at very high doses, though other studies showed no evidence of harm. Due to the lack of definitive human data, healthcare providers typically recommend using this medication during pregnancy only when the potential benefits justify the potential risks to the developing fetus.

Breastfeeding

It is not known whether cilastatin passes into human breast milk. However, imipenem, which is almost always administered with cilastatin, has been found in human milk. Because many drugs are excreted in breast milk, caution is advised. It is important for breastfeeding individuals to consult with their healthcare provider to weigh the benefits of treatment against any potential risks to the nursing infant.

Question 9

What forms and strengths does Cilastatin come in?

Accepted Answer

Available Forms

Cilastatin is not available as a standalone product. It is provided in combination with the antibiotic imipenem, and sometimes with relebactam, in the following forms:

Powder for Intravenous Infusion: This form is dissolved and administered into a vein.

Powder for Intramuscular Injection: This form is prepared for injection into a muscle.

These products are intended for use in a clinical setting and are administered by healthcare professionals.

Question 10

What is the FDA approval status of Cilastatin?

Accepted Answer

FDA Approval Status

Cilastatin is approved by the U.S. Food and Drug Administration (FDA) only as a component of combination drug products. It was first approved in 1985 for use with the antibiotic imipenem. It is also available in a three-drug combination that includes imipenem and the beta-lactamase inhibitor relebactam.

Approved Indications

The combination of imipenem and cilastatin is indicated for the treatment of serious infections caused by susceptible bacteria, including:

Lower respiratory tract infections

Urinary tract infections

Intra-abdominal infections

Gynecologic infections

Bacterial septicemia

Bone and joint infections

Skin and skin structure infections

Endocarditis

Cilastatin itself does not have antibacterial activity; it is included to prevent the breakdown of imipenem in the kidneys, which allows the antibiotic to reach higher levels in the body.

Regulatory Safety Information

There are currently no FDA boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) associated with cilastatin. Regulatory oversight focuses on its use within combination products, which are typically administered by intravenous or intramuscular injection in clinical settings.

Question 11

What should I know about Cilastatin and cost?

Accepted Answer

Cost Considerations

Cilastatin is not available as a standalone medication; it is always administered in combination with other drugs, such as imipenem or relebactam. Because these medications are typically given by injection or infusion in a hospital or clinic, the cost is often bundled with other medical services and supplies rather than being a separate retail pharmacy charge.

Factors Influencing Price

Generic Availability: Generic versions of imipenem and cilastatin are available, which may be less expensive than brand-name versions.

Insurance Coverage: Most health insurance plans, including Medicare and Medicaid, generally cover these injections when they are medically necessary. Out-of-pocket costs will depend on the specific plan's deductible and coinsurance rates.

Setting of Care: Costs can vary significantly between inpatient hospital stays and outpatient infusion centers.

Dosage and Duration: The total price is influenced by the specific dose required and the length of the treatment course.

Patients are encouraged to contact their insurance provider or the billing department of their healthcare facility for specific information regarding out-of-pocket costs.

Cilastatin

Medication Quick Facts

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

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