Plazomicin

Plazomicin is a prescription medication used for the treatment of complicated urinary tract infections.

• Plazomicin is available under the following different brand names: Zemdri.

Common side effects of Plazomicin include:

• Nausea, 
• Vomiting, 
• Diarrhea, 
• Headache, and 
• Lightheadedness

Serious side effects of Plazomicin include:

• Hives, 
• Difficulty breathing, 
• Swelling of the face, lips, tongue, or throat, 
• Severe stomach pain, 
• Watery or bloody diarrhea (even if it occurs months after the last dose), 
• Dizziness, 
• Spinning sensation, 
• Lightheadedness, 
• Hearing loss, 
• Buzzing or roaring sound in the ears (during or after treatment), 
• Muscle weakness, 
• Little or no urination, 
• Swelling in the feet or ankles, 
• Tiredness, and 
• Shortness of breath

Rare side effects of Plazomicin include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, single-dose vial

• 500 mg/10 mL (50 mg/mL)
• Each vial contains plazomicin sulfate equivalent to 500 mg plazomicin free base.

Complicated Urinary Tract Infections

Adult dosage

• 15 mg/kg intravenous every 24 hours infused over 30 minutes.
• Duration of therapy should be guided by the severity of the infection and the patient’s clinical status for up to 7 days; the usual duration is 4-7 days.
• Appropriate oral therapy may be considered after 4-7 days of therapy to complete a total duration of 7-10 days (Intravenous plus oral); the maximum duration of therapy for cUTI is 7 days.

Sepsis

Adult dosage

• Pending FDA approval for acute bloodstream infections caused by multi-drug-resistant Enterobacteriaceae infections, including carbapenem-resistant Enterobacteriaceae.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Plazomicin has no noted severe interactions with any other drugs.
• Plazomicin has no noted serious interactions with any other drugs.
• Plazomicin has no noted moderate interactions with any other drugs.
• Plazomicin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Patients with known hypersensitivity to any aminoglycoside

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Plazomicin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Plazomicin?”

Cautions

• Also see Black Box Warnings
• Nephrotoxicity reported; most serum creatinine increases were above 1 mg/dL above baseline and reversible.
• Ototoxicity may occur.
• Aminoglycosides have been associated with exacerbation of muscle weakness in patients with underlying neuromuscular disorders or delayed recovery of neuromuscular function in patients receiving concomitant neuromuscular blocking agents.
• Fetal harm may occur when administered to a pregnant woman (see Pregnancy)
• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported in patients receiving aminoglycoside antibacterial drugs; discontinue treatment if an allergic reaction occurs
• Prescribing a drug in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
• Clostridium difficile-associated diarrhea
  • Clostridium difficile-associated diarrhea (CDAD) is reported for nearly all systemic antibacterial drugs and may range in severity from mild diarrhea to fatal colitis.
  • Antibacterial drug treatment alters the colon's normal flora and may permit overgrowth of C difficile; careful medical history is necessary.
  • If CDAD is suspected or confirmed, antibacterial drugs not directed against C difficile may need to be discontinued.

Pregnancy and Lactation

• Fetal harm may occur when administered to a pregnant woman.
• There are no available data on this drug in pregnant women to inform a drug-associated risk of adverse developmental outcomes.
• Lactation
  • There are no data on the presence of plazomicin in human milk, the effects on the breastfed infant, or the effects on milk production.
  • Plazomicin was detected in rat milk.
  • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for plazomicin and any potential adverse effects on the breastfed infant from plazomicin or the underlying maternal condition.