Individual generic drug information

linezolid

Reference monograph

Part of registered formulation

LINEZOLID

Reference record: Linezolid
Source: BNF 80 (2020–2021)
Printed source pages: 627, 628
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Linezolid only.

Drug Action

Linezolid, an oxazolidinone antibacterial, is active against Gram-positive bacteria including meticillin- resistant Staphylococcus aureus (MRSA), and glycopeptide- resistant enterococci. Resistance to linezolid can develop with prolonged treatment or if the dose is less than that recommended. Linezolid is not active against common Gram-negative organisms; it must be given in combination with other antibacterials for mixed infections that also involve Gram-negative organisms.

Source page 627

Indications And Dose

Pneumonia (when other antibacterials e.g. a glycopetide, such as vancomycin, cannot be used) (initiated under specialist supervision) | Complicated skin and soft-tissue infections caused by Gram-positive bacteria, when other antibacterials cannot be used (initiated under specialist supervision) ▶BY MOUTH ▶Adult: 600 mg every 12 hours usually for 10–14 days (maximum duration of treatment 28 days) ▶BY INTRAVENOUS INFUSION ▶Adult: 600 mg every 12 hours Cellulitis (specialist use only) | Erysipelas (specialist use only) ▶BY MOUTH, OR BY INTRAVENOUS INFUSION ▶Adult: 600 mg every 12 hours Moderate diabetic foot infection (specialist use only) | Severe diabetic foot infection (specialist use only) | Leg ulcer infection (specialist use only) ▶BY MOUTH, OR BY INTRAVENOUS INFUSION ▶Adult: 600 mg every 12 hours

Source page 627

Cautions

Acute confusional states. bipolar depression. carcinoid tumour. elderly (increased risk of blood disorders). history of seizures. phaeochromocytoma. schizophrenia. thyrotoxicosis. uncontrolled hypertension CAUTIONS, FURTHER INFORMATION ▶Close observation Unless close observation and blood pressure monitoring possible, linezolid should be avoided in uncontrolled hypertension, phaeochromocytoma, Infection carcinoid tumour, thyrotoxicosis, bipolar depression, schizophrenia, or acute confusional states.

Source page 628

Prescribing And Dispensing Information

For choice of antibacterial therapy, see Diabetic foot infections, antibacterial therapy p. 533, Respiratory system infections, antibacterial therapy p. 538, Skin infections, antibacterial therapy p. 540.

Source page 628

Safety

Extracted information for Linezolid only.

Important Safety Information

CHM ADVICE (OPTIC NEUROPATHY) Severe optic neuropathy may occur rarely, particularly if linezolid is used for longer than 28 days. The CHM recommends that: . patients should be warned to report symptoms of visual impairment (including blurred vision, visual ﬁeld defect, changes in visual acuity and colour vision) immediately; . patients experiencing new visual symptoms (regardless of treatment duration) should be evaluated promptly, and referred to an ophthalmologist if necessary; . visual function should be monitored regularly if treatment is required for longer than 28 days. BLOOD DISORDERS Haematopoietic disorders (including thrombocytopenia, anaemia, leucopenia, and pancytopenia) have been reported in patients receiving linezolid. It is recommended that full blood counts are monitored weekly. Close monitoring is recommended in patients who: . receive treatment for more than 10–14 days; . have pre-existing myelosuppression; . are receiving drugs that may have adverse effects on haemoglobin, blood counts, or platelet function; . have severe renal impairment. If signiﬁcant myelosuppression occurs, treatment should be stopped unless it is considered essential, in which case intensive monitoring of blood counts and appropriate management should be implemented.

Source page 627

Interactions

→Appendix 1: linezolid

Source page 628

Side Effects

▶Common or very common Anaemia. constipation. diarrhoea. dizziness. gastrointestinal discomfort. headache. hypertension. increased risk of infection. insomnia. localised pain. nausea. skin reactions. taste altered. vomiting ▶Uncommon Arrhythmia. chills. dry mouth. eosinophilia. fatigue. gastritis. hyperhidrosis. hyponatraemia. leucopenia. neutropenia. oral disorders. pancreatitis. polyuria. renal failure. seizure. sensation abnormal. thirst. thrombocytopenia. thrombophlebitis. tinnitus. tongue discolouration. transient ischaemic attack. vision disorders. vulvovaginal disorder ▶Rare or very rare Antibiotic associated colitis. bone marrow disorders. tooth discolouration ▶Frequency not known Alopecia. angioedema. lactic acidosis. nerve disorders. serotonin syndrome. severe cutaneous adverse reactions (SCARs)

Source page 628

Pregnancy

Manufacturer advises use only if potential beneﬁt outweighs risk—no information available.

Source page 628

Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

Source page 628

Hepatic Impairment

Manufacturer advises caution in severe impairment (no information available).

Source page 628

Renal Impairment

Manufacturer advises metabolites may accumulate if eGFR less than 30 mL/minute/1.73 m2.

Source page 628

Monitoring Requirements

Monitor full blood count (including platelet count) weekly.

Source page 628

Dose and formulations

Extracted information for Linezolid only.

Directions For Administration

▶With intravenous use Infusion to be administered over 30–120 minutes.

Source page 628

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Infusion EXCIPIENTS: May contain Glucose ELECTROLYTES: May contain Sodium ▶Linezolid (Non-proprietary) Linezolid 2 mg per 1 ml Linezolid 600mg/300ml infusion bags | 10 bag P £445.00–£541.00 (Hospital only) ▶Zyvox (Pfizer Ltd) Linezolid 2 mg per 1 ml Zyvox 600mg/300ml infusion bags | 10 bag P £445.00 Oral suspension CAUTIONARY AND ADVISORY LABELS 9, 10 EXCIPIENTS: May contain Aspartame ▶Zyvox (Pfizer Ltd) Linezolid 20 mg per 1 ml Zyvox 100mg/5ml granules for oral suspension | 150 ml P £222.50 DT = £222.50 Tablet CAUTIONARY AND ADVISORY LABELS 9, 10 ▶Linezolid (Non-proprietary) Linezolid 600 mg Linezolid 600mg tablets | 10 tablet P £239.16 DT = £327.24 (Hospital only) | 10 tablet P £82.12–£445.00 DT = £327.24 ▶Zyvox (Pfizer Ltd) Linezolid 600 mg Zyvox 600mg tablets | 10 tablet P £445.00 DT = £327.24

Source page 628

Clinical care

Extracted information for Linezolid only.

Patient And Carer Advice

Patients should be advised to read the patient information leaﬂet given with linezolid.

Source page 628

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

600 mg every 12 hours usually for 10–14 days

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 627

Adults

First line only; read the complete Indications and dose section above.

600 mg every 12 hours

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 627

Adults

First line only; read the complete Indications and dose section above.

600 mg every 12 hours

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 627

Adults

First line only; read the complete Indications and dose section above.

600 mg every 12 hours

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 627

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

linezolid

Reference monograph

Part of registered formulation

LINEZOLID

Reference record: Linezolid
Source: BNF 80 (2020–2021)
Printed source pages: 627, 628
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Linezolid only.

Drug Action

Source page 627

Indications And Dose

Source page 627

Cautions

Source page 628

Prescribing And Dispensing Information

Source page 628

Safety

Extracted information for Linezolid only.

Important Safety Information

Source page 627

Interactions

→Appendix 1: linezolid

Source page 628

Side Effects

Source page 628

Pregnancy

Manufacturer advises use only if potential beneﬁt outweighs risk—no information available.

Source page 628

Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

Source page 628

Hepatic Impairment

Manufacturer advises caution in severe impairment (no information available).

Source page 628

Renal Impairment

Manufacturer advises metabolites may accumulate if eGFR less than 30 mL/minute/1.73 m2.

Source page 628

Monitoring Requirements

Monitor full blood count (including platelet count) weekly.

Source page 628

Dose and formulations

Extracted information for Linezolid only.

Directions For Administration

▶With intravenous use Infusion to be administered over 30–120 minutes.

Source page 628

Medicinal Forms

Source page 628

Clinical care

Extracted information for Linezolid only.

Patient And Carer Advice

Patients should be advised to read the patient information leaﬂet given with linezolid.

Source page 628

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

600 mg every 12 hours usually for 10–14 days

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 627

Adults

First line only; read the complete Indications and dose section above.

600 mg every 12 hours

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 627

Adults

First line only; read the complete Indications and dose section above.

600 mg every 12 hours

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 627

Adults

First line only; read the complete Indications and dose section above.

600 mg every 12 hours

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 627

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.