PLAZOMICIN
Background and Date of Approval
Plazomicin is an antibiotic indicated for serious bacterial infections, particularly those where conventional antibiotics have proven ineffective. It is a member of the aminoglycoside class of antimicrobials, commonly employed in difficult-to-treat bacterial infections. Plazomicin demonstrates activity against bacteria resistant to established antibiotics. The U.S. FDA approved plazomicin on 26 June 2018 following successful clinical trials designated CARE and EPIC. These studies demonstrated efficacy in treating complicated urinary tract infections and specific blood infections caused by resistant bacterial pathogens. This approval represented a therapeutic advance for infections unresponsive to standard treatments.
Uses
Plazomicin is approved by the FDA to treat: Complicated urinary tract infections (cUTIs), including serious kidney infections. Infections caused by certain tough bacteria that donât respond to other antibiotics, especially when other treatment options are not working or canât be used.
How is it administered?
This medicine is given as an injection directly into a vein (intravenous infusion), usually in a hospital setting under the supervision of a healthcare professional. It is typically administered once a day, and the duration of treatment depends on the severity and type of infection. The available strength is 500 mg per vial, and the exact dose is calculated based on the patient's body weight and kidney function. It is not available in tablet or oral form
Side Effects
Common side effects: Nausea Diarrhea Headache Dizziness Increased creatinine levels (a marker of kidney function) Serious side effects: Kidney damage (nephrotoxicity) Hearing loss or ringing in the ears (ototoxicity) Balance issues or vertigo Allergic reactions such as swelling, rash, or trouble breathing Anyone experiencing serious side effects should seek immediate medical help.
Warnings
Not recommended for patients with severe kidney impairment. Should not be used in combination with other drugs known to cause kidney or ear damage unless absolutely necessary. May interact with diuretics, certain antivirals, and chemotherapy drugs. Not advised for use in pregnant or breastfeeding women unless clearly needed. Close monitoring of kidney function and hearing is essential during treatment.
Precautions
Before starting treatment, itâs important to inform your doctor about any history of kidney problems, hearing issues, or previous allergic reactions to antibiotics. Since this drug is mainly cleared by the kidneys, people with reduced kidney function may require dose adjustments. Regular blood tests may be done to check for any harmful effects. Patients should stay well-hydrated and report any signs of hearing changes or balance issues immediately. Avoiding other medications that stress the kidneys or ears during treatment is also crucial.
Word of Advice
Plazomicin is administered by a healthcare provider in a clinical setting. Patients should attend all scheduled doses and follow-up appointments. Do not skip or stop treatment early, even if symptoms improve, as this can lead to incomplete recovery and increased resistance. Inform your doctor about any unusual symptoms during treatment. Avoid self-medicating or taking over-the-counter drugs without informing your healthcare team, especially painkillers such as ibuprofen that may affect kidney function.
References
https://go.drugbank.com/drugs/DB12615 https://zemdri.com/ https://www.sciencedirect.com/topics/medicine-and-dentistry/plazomicin https://www.mdpi.com/2075-1729/12/12/1949
Frequently Asked Questions
What is the drug Plazomicin used for?
Plazomicin is used to treat serious bacterial infections, especially complicated urinary tract infections and some bloodstream infections. It is helpful when other antibiotics donât work due to drug resistance. Doctors usually use it in hospital settings for severe cases.
Is Plazomicin available in India?
As of now, Plazomicin is not widely available in India and may not be stocked by most pharmacies. It might be accessible through special import or on a named-patient basis in select hospitals. Always check with a doctor or hospital pharmacy for availability.
Does Plazomicin cover Pseudomonas?
Plazomicin is not effective against Pseudomonas aeruginosa . For infections caused by Pseudomonas, other antibiotics like piperacillin-tazobactam or meropenem are usually preferred.
Is Plazomicin in pregnancy category?
Plazomicin is classified under Pregnancy Category D, which means it may harm the unborn baby if used during pregnancy. It should only be used when absolutely necessary and under strict medical supervision. Pregnant women should inform their doctor before starting this medicine.