Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196, South Africa
ZYVOXID formulations are indicated for the treatment of patients with the following infections caused by susceptible strains of the designated micro-organisms (see PHARMACOLOGICAL ACTION). ZYVOXID is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy must be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected (see WARNINGS AND SPECIAL PRECAUTIONS).
Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteraemia.
Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), or Streptococcus pneumoniae (including multi-drug resistant S. pneumoniae (MDRSP) strains).
Complicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. ZYVOXID has not been studied in the treatment of decubitus ulcers.
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes.
Community-acquired pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant S. pneumoniae (MDRSP) strains), including cases with concurrent bacteraemia, or Staphylococcus aureus (methicillin-susceptible and -resistant strains).
Due to concern about inappropriate use of antibiotics leading to an increase in resistant organisms, prescribers should carefully consider alternatives before initiating treatment with ZYVOXID in the outpatient setting.
Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to linezolid. Therapy may be instituted empirically while awaiting results of these tests. Once these results become available, antimicrobial therapy should be adjusted accordingly.
ZYVOXID tablets, oral suspension or solution for infusion may be used as initial therapy. Patients who commence treatment on the parenteral formulation may be switched to either oral presentation when clinically indicated. In such circumstances, no dose adjustment is required as ZYVOXID has an oral bioavailability of approximately 100%.
The solution for infusion should be administered over a period of 30 to 120 minutes. The film coated tablets or oral suspension may be taken with or without food.
The recommended ZYVOXID dosage should be administered IV or orally as described in the tables below.
Adult and Adolescent (12 years and older) Patients:
| Infections (including those associated with concurrent bacteraemia) | Dosage and route of administration | Duration of treatment |
|---|---|---|
| Community-acquired pneumonia, including concurrent bacteraemia | 600 mg IV or orally every 12 hours | 10–14 consecutive days |
| Nosocomial pneumonia, including concurrent bacteraemia | ||
| Skin and soft tissue infections, including concurrent bacteraemia | 400 mg to 600 mg orally every 12 hours or 600 mg IV every 12 hours depending on clinical severity | |
| Enterococcal infections, including vancomycin-resistant infections, and those with concurrent bacteraemia | 600 mg IV or orally every 12 hours | 14–28 consecutive days |
Paediatric Patients (birth* through to 11 years):
| Infections (including those associated with concurrent bacteraemia) | Dosage and route of administration | Duration of treatment |
|---|---|---|
| Community-acquired pneumonia, including concurrent bacteraemia | 10 mg/kg IV or oralδ every 8 hours | 10–14 consecutive days |
| Nosocomial pneumonia, including concurrent bacteraemia | ||
| Skin and soft tissue infections, including concurrent bacteraemia | ||
| Enterococcal infections, including vancomycin-resistant infections, and those with concurrent bacteraemia | 10 mg/kg IV or oralδ every 8 hours | 14–28 consecutive days |
* Pre-term neonates less than 7 days of age (gestational age less than 34 weeks) have lower systemic ZYVOXID clearance values and larger AUC values than many full-term neonates and older infants. By day 7 of age, ZYVOXID clearance and AUC values are similar to those of full-term neonates and older infants.
δ Oral dosing using either ZYVOXID tablets or oral suspension
No dose adjustment is necessary.
No dose adjustment is required.
No dose adjustment is required. Due to the unknown clinical significance of higher exposure (up to 10 fold) to the two primary metabolites of ZYVOXID in patients with severe renal insufficiency, ZYVOXID should be used with special caution in these patients and only when the anticipated benefit is considered to outweigh the theoretical risk.
As approximately 30% of a ZYVOXID dose is removed during 3 hours of hemodialysis, ZYVOXID should be given after dialysis in patients receiving such treatment. The primary metabolites of ZYVOXID are removed to some extent by hemodialysis, but the concentrations of these metabolites are still very considerably higher following dialysis than those observed in patients with normal renal function or mild to moderate renal insufficiency.
Therefore, ZYVOXID should be used with special caution in patients with severe renal insufficiency who are undergoing dialysis and only when the anticipated benefit is considered to outweigh the theoretical risk.
To date, there is no experience of ZYVOXID administration to patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal failure (other than hemodialysis).
No dose adjustment is required. However, there are limited clinical data and it is recommended that ZYVOXID should be used in such patients only when the anticipated benefit is considered to outweigh the theoretical risk.
No cases of overdose have been reported. However, the following information may prove useful: Supportive care is advised together with maintenance of glomerular filtration. Approximately 30% of a ZYVOXID dose is removed during 3 hours of haemodialysis, but no data are available for the removal of ZYVOXID by peritoneal dialysis or haemoperfusion.
Tablets: Store at room temperature below 25°C. Tablets packed in HDPE bottles must be stored in a dry place and protected from light.
Infusion: Store at room temperature below 25°C. Infusion bags must be kept in overwrap until ready to use. Protect from light. Single-use infusion bags. Do not freeze. Discard any unused solution.
Granules for Suspension: Store at room temperature below 25°C.
Constituted Suspension: Store at room temperature below 25°C and use within 21 days.
ZYVOXID 400 mg Tablets: White HDPE bottles of 10 or 30 tablets or PVC/foil blisters of 10 or 30 tablets.
ZYVOXID 600 mg Tablets: White HDPE bottles of 10 or 30 tablets or PVC/foil blisters of 10 or 30 tablets.
ZYVOXID 200 mg/100 ml Solution for infusion: Single-use infusion bags packaged in a foil overwrap available in a pack size of 100 ml (200 mg linezolid).
ZYVOXID 600 mg/300 ml Solution for infusion: Single-use infusion bags packaged in a foil overwrap available in a pack size of 300 ml (600 mg linezolid).
ZYVOXID Granules for Suspension: Granules for suspension in 240 ml amber glass bottles. Once constituted, the volume of suspension is 150 ml.
ZYVOXID Solution for Infusion must be used immediately after the seal is first broken. ZYVOXID Solution for Infusion is supplied in single-use, ready-to-use infusion bags. Parenteral drug products should be inspected visually for particulate matter prior to administration. Check for minute leaks by firmly squeezing the bag. If leaks are detected, discard the solution, as sterility may be impaired.
Administer ZYVOXID Solution for Infusion over a period of 30 to 120 minutes. Do not use the intravenous infusion bag in series connections. Do not introduce additives into the intravenous solution. If ZYVOXID Solution for Infusion is to be given concomitantly with another drug, each drug should be given separately, in accordance with the recommended dosage and route of administration for each product.
Compatible infusion solutions: 0,9% Sodium Chloride Injection, 5% Dextrose Injection, Lactated Ringer’s Injection.
ZYVOXID Solution for Infusion is known to be physically incompatible with the following drugs: amphotericin B, chlorpromazine HCl, diazepam, pentamidine isethionate, phenytoin sodium, erythromycin lactobionate and trimethoprim-sulfamethoxazole.
ZYVOXID Solution for Infusion was chemically incompatible when combined with ceftriaxone sodium.
ZYVOXID Granules for Suspension is supplied as a powder/granule for constitution. Gently tap bottle to loosen powder. Add a total of 123 ml distilled water in two portions. After adding the first half, shake vigorously to wet all of the powder. Then add the second half of the water and shake vigorously to obtain a uniform suspension. After constitution, each 5 ml of the suspension contains 100 mg of linezolid.
Before using the constituted suspension, gently mix by inverting the bottle several times. Do not shake.
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