plazomicin

Contraindicated in:

Hypersensitivity to any aminoglycoside;
OB: Pregnancy.

Use Cautiously in:

Renal impairment (dose adjustments necessary; therapeutic drug monitoring useful in preventing nephrotoxicity and ototoxicity);
Hearing impairment;
Mitochondrial DNA variants in the 12S rRNA gene (MTRNR1) or maternal history of ototoxicity (↑ risk of ototoxicity);
Neuromuscular diseases such as myasthenia gravis (↑ risk of muscle weakness exacerbation);
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: ↑risk of renal impairment in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, hypotension

EENT: ototoxicity (vestibular and cochlear)

GI: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, nausea, vomiting

GU: nephrotoxicity

Neuro: headache

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

↑risk of nephrotoxicity when used with other nephrotoxic drugs.
↑risk of delayed recovery of neuromuscular function when used with neuromuscular blockers.

Availability ⬆ ⬇

Solution for injection: 50 mg/mL

Route/Dosage ⬆ ⬇

Estimate CCr with the Cockcroft-Gault formula using total body weight (TBW). For patients whose TBW is greater than their ideal body weight (IBW) by ≥25%, use IBW. Calculate dose using TBW. For patients whose TBW is greater than IBW by ≥25%, use adjusted body weight (IBW + 0.4 × [TBW-IBW]).
IV (Adults ): 15 mg/kg every 24 hr for 4–7 days.

Renal Impairment

IV (Adults ): CCr 30–59 mL/min: 10 mg/kg every 24 hr for 4–7 days; CCr 15–29 mL/min: 10 mg/kg every 48 hr for 4–7 days.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits protein synthesis in bacteria by binding to the 30S ribosome.

Therapeutic effects:

Bactericidal action (concentration-dependent).

Spectrum:

Active against gram-negative pathogens, including:
- Escherichia coli,
- Klebsiella pneumoniae,
- Proteus mirabilis,
- Enterobacter cloacae.

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacologic Classification: aminoglycosides

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Does not undergo metabolism. Primarily excreted by kidneys in urine (98% as unchanged drug).

Half-Life: 3.5 hr (↑ in renal impairment).

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	30 min	24 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose of plazomicin to patient. Emphasize importance of daily labs to prevent side effects.
Advise patient of the importance of drinking plenty of liquids.
Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reaction (rash, hives, itching, swelling of lips, difficulty breathing) or if diarrhea, abdominal cramping, fever, or bloody stools occur. Instruct patient not to treat with antidiarrheals without consulting health care professional.
Advise patient to notify health care professional if changes in hearing or balance or if new onset or changes in preexisting buzzing or roaring in ears occur, even if they occur after the completion of therapy.
Advise patient to report the signs of superinfection (black, furry overgrowth on the tongue; vaginal itching or discharge; loose or foul-smelling stools).
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during therapy. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

50909- HOVIONE FARMACINCIA, S.A.
- 50909-1704-
  - 50909-1704-1- 7 kg in 1 DRUM (50909-1704-1)

69097- Cipla USA Inc.
- 69097-820- Zemdri (plazomicin)
  - 69097-820-96- 10 VIAL in 1 CARTON (69097-820-96) / 10 mL in 1 VIAL (69097-820-37)

71045- Achaogen, Inc.
- 71045-010- Zemdri (plazomicin)
  - 71045-010-02- 10 VIAL in 1 CARTON (71045-010-02) / 10 mL in 1 VIAL (71045-010-01)

80735- Cipla Therapeutics Inc.
- 80735-820- Zemdri (plazomicin)
  - 80735-820-96- 10 VIAL in 1 CARTON (80735-820-96) / 10 mL in 1 VIAL (80735-820-37)

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Indications ⬇

Contraind./Precautions ⬆ ⬇