ZEMDRI Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Cipla USA Inc.

Λέξεις κλειδιά

69097-820

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BOXED WARNING SECTION

WARNING: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE and FETAL HARM Nephrotoxicity has been reported with ZEMDRI. The risk of nephrotoxicity is greater in patients with impaired renal ...

1. Indications and Usage

1.1 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis ZEMDRI is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTI), including ...

2. Dosage and Administration

2.1 Recommended Dosage The recommended dosage regimen of ZEMDRI is 15 mg/kg administered every 24 hours by intravenous (IV) infusion over 30 minutes in patients 18 years of age or older and with creatinine ...

3. Dosage Forms and Strengths

ZEMDRI injection 500 mg/10 mL (50 mg/mL) is a sterile, clear, colorless to yellow solution supplied in a single-dose vial. Each single-dose vial contains plazomicin sulfate equivalent to 500 mg plazomicin ...

4. Contraindications

ZEMDRI is contraindicated in patients with known hypersensitivity to any aminoglycoside [see Warnings and Precautions (5.5)].

5. Warnings and Precautions

5.1 Nephrotoxicity Nephrotoxicity has been reported with the use of ZEMDRI [see Adverse Reactions (6.1)]. Most serum creatinine increases were ≤1 mg/dL above baseline and reversible. In Trial ...

6. Adverse Reactions

The following important adverse reactions are discussed in greater detail in the Warnings and Precautions section: Nephrotoxicity [see Warnings and Precautions (5.1)] Ototoxicity [see Warnings ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly to rates in the clinical trials of another ...

8.1. Pregnancy

Risk Summary Aminoglycosides, including ZEMDRI, can cause fetal harm when administered to a pregnant woman. There are no available data on the use of ZEMDRI in pregnant women to inform a drug associated ...

8.2. Lactation

Risk Summary There are no data on the presence of ZEMDRI in human milk, the effects on the breastfed infant, or the effects on milk production. Plazomicin was detected in rat milk (see Data). ...

8.4. Pediatric Use

The safety and effectiveness of ZEMDRI in patients less than 18 years of age have not been established.

8.5. Geriatric Use

Of the 425 patients treated with ZEMDRI in Trials 1 and 2, 40% (170/425) were 65 years of age and older, including 17.2% (73/425) patients 75 years of age and older. In Trial 1, for ZEMDRI-treated patients ...

8.6. Renal Impairment

Plazomicin total body clearance was significantly decreased in patients with CLcr greater than or equal to 15 to less than 60 mL/min compared to patients with CLcr greater than or equal to 60 mL/min ...

10. Overdosage

In the event of overdosage, ZEMDRI should be discontinued and supportive care is advised. Maintenance of glomerular filtration and careful monitoring of renal function is recommended. Hemodialysis may ...

11. Description

ZEMDRI contains plazomicin sulfate, a semi-synthetic aminoglycoside antibacterial derived from sisomicin. The chemical name of plazomicin sulfate is (2"R,3"R,4"R,5"R ...

12.1. Mechanism of Action

ZEMDRI is an antibacterial drug [see Microbiology (12.4)].

12.2. Pharmacodynamics

The ratio of area under the plasma concentration-time curve to the minimum inhibitory concentration (AUC:MIC) for plazomicin has been shown to best correlate with efficacy in animal and in vitro models ...

12.3. Pharmacokinetics

The pharmacokinetic (PK) parameters of plazomicin are similar for single- and multiple-dose administration of ZEMDRI in healthy subjects. No appreciable accumulation of plazomicin was observed following ...

12.4. Microbiology

Mechanism of Action Plazomicin is an aminoglycoside that acts by binding to bacterial 30S ribosomal subunit, thereby inhibiting protein synthesis. Plazomicin has concentration-dependent bactericidal activity ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long term carcinogenicity studies in animals have not been conducted with plazomicin. Mutagenesis Plazomicin was negative for mutagenicity in an Ames test and did not induce chromosome aberrations ...

14. Clinical Studies

14.1 Complicated Urinary Tract Infections, Including Pyelonephritis A total of 609 adults hospitalized with cUTI (including pyelonephritis) were randomized in a multinational, double-blind, noninferiority ...

15. References

1. American Speech-Language-Hearing Association. (1994). Audiologic management of individuals receiving cochleotoxic drug therapy [Guidelines]. Available from www.asha.org/policy.

16.1. How Supplied

ZEMDRI injection 500 mg/10 mL (50 mg/mL) is supplied in single-dose, 10-mL vials fitted with flip-off seals with royal blue polypropylene buttons as a clear, colorless to yellow, sterile solution. Each ...

16.2. Storage and Handling

Store ZEMDRI injection 500 mg/10 mL (50 mg/mL) refrigerated at 2°C to 8°C (36°F to 46°F).

17. Patient Counseling Information

Nephrotoxicity Advise patients, their families, or caregivers that nephrotoxicity has been reported with ZEMDRI therapy. Counsel patients to follow their physicians directions regarding renal function ...