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Linezolid Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Antibacterial

Subclass

Oxazolidinone

Speciality

Infectious Diseases

Schedule (India)

Schedule H

Routes

Oral, Intravenous

Formulations

Tablets: 600 mg
Oral Suspension: 100 mg/5 mL (reconstitutable powder)
IV Infusion: 2 mg/mL (300 mL bag containing 600 mg)

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Complicated Skin and Soft Tissue Infections (cSSTI)

Parameter	Details
Route	Oral or IV
Starting dose	600 mg every 12 hours
Titration	Not applicable
Usual maintenance dose	600 mg every 12 hours
Maximum dose	600 mg per dose (1200 mg/day)
Duration	10–14 days

Clinical Notes:

Step-down to oral route once clinical stability established (100% oral bioavailability)
In diabetic foot infections, exclude osteomyelitis before finalizing duration
Obtain cultures before initiating therapy

2. Hospital-acquired Pneumonia / Community-acquired Pneumonia (HAP/CAP) — MRSA suspected or confirmed

Parameter	Details
Route	IV initially, step-down to oral
Starting dose	600 mg every 12 hours
Titration	Not applicable
Usual maintenance dose	600 mg every 12 hours
Maximum dose	600 mg per dose (1200 mg/day)
Duration	10–14 days (minimum 7 days)

Clinical Notes:

Confirm pathogen sensitivity with culture
Consider de-escalation if MRSA ruled out
IV-to-oral switch acceptable once afebrile and clinically improving

3. Vancomycin-Resistant Enterococcus faecium (VRE) Infections

Parameter	Details
Route	IV preferred initially
Starting dose	600 mg every 12 hours
Titration	Not applicable
Usual maintenance dose	600 mg every 12 hours
Maximum dose	600 mg per dose (1200 mg/day)
Duration	Individualised; typically ≥14 days

Clinical Notes:

Specialist use only (Infectious Diseases consultation recommended)
Limited clinical experience in India
Bacteriostatic agent; source control essential

Secondary Indications — Adults (Off-label)

Indication	Dose	Duration	Notes
MDR-TB / XDR-TB (as part of DR-TB regimen)	Starting dose: 600 mg once daily; Reduce to 300 mg once daily if toxicity develops	Up to 6–9 months as per NTEP guidelines	OFF-LABEL. Specialist only at DR-TB centres. Based on ICMR/NTEP DR-TB Management Module. Monitor for myelosuppression, neuropathy, lactic acidosis.

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications: cSSTI and HAP/CAP (including MRSA)

Age Group	Route	Starting Dose	Frequency	Maximum Dose	Duration
Neonates (<7 days)	IV	10 mg/kg	Every 12 hours	Do not exceed 600 mg/dose	10–14 days
Neonates (≥7 days) to <12 years	IV or Oral	10 mg/kg	Every 8 hours	Do not exceed 600 mg/dose	10–14 days
≥12 years	IV or Oral	600 mg	Every 12 hours	600 mg/dose	10–14 days

Safety Notes:

Titration: Not applicable
Avoid in neonates unless strictly indicated under neonatologist supervision
Monitor platelets and complete blood counts at least twice weekly
Not recommended below neonatal age except under specialist supervision

Secondary Indications — Paediatric Doses (Off-label)

Indication	Dose	Duration	Notes
MDR-TB (part of NTEP paediatric regimens)	10 mg/kg once daily	Case-specific; as per DR-TB centre protocol	OFF-LABEL. Specialist only. Monitor for myelosuppression and neuropathy. Based on NTEP paediatric DR-TB guidelines.

Renal Adjustments

No dose adjustment required in mild to severe renal impairment
Metabolites may accumulate with prolonged use (>14 days) in severe renal dysfunction — enhanced clinical monitoring recommended
Haemodialysis: Linezolid is partially removed; however, no routine supplemental post-dialysis dose is required. Administer dose after dialysis session if timing coincides

Hepatic adjustment

Contraindications

Known hypersensitivity to linezolid or any excipient
Concurrent use with irreversible monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuation
Uncontrolled hypertension
Phaeochromocytoma (unless adequately alpha-blocked)
Thyrotoxicosis
Concurrent use with directly-acting sympathomimetics (e.g., adrenaline, noradrenaline, dopamine) unless facilities for close BP monitoring available
Carcinoid syndrome

Cautions

Risk of serotonin syndrome when used with serotonergic agents (SSRIs, SNRIs, TCAs, tramadol, pethidine, buspirone, triptans) — use with extreme caution; avoid if possible
Myelosuppression risk increases significantly with therapy >14 days
Peripheral neuropathy and optic neuropathy — risk increases with therapy >28 days
Lactic acidosis — rare but serious; monitor in prolonged use
Pre-existing blood dyscrasias
Seizure history
Diabetes mellitus (risk of hypoglycaemia)

Pregnancy

Parameter	Details
Risk category	Not formally classified in India; limited human data
Safety statement	Use only if potential benefit clearly outweighs risk
Preferred alternatives	Vancomycin (if pathogen susceptible)
When may be used	Under specialist supervision when no safer alternative exists
Monitoring	Monitor maternal blood counts; fetal growth monitoring as clinically indicated

Lactation

Parameter	Details
Compatibility	Unknown; likely excreted in breast milk
Expected levels in milk	Unknown (presumed low to moderate)
Preferred alternatives	Vancomycin
Infant monitoring	Feeding pattern, diarrhoea, thrush, blood counts if prolonged exposure
Recommendation	Individualise decision; consider temporary cessation of breastfeeding during therapy if alternatives not feasible

Elderly

Parameter	Recommendation
Starting dose	600 mg every 12 hours (standard adult dose)
Titration	Not applicable
Additional risks	Increased susceptibility to myelosuppression, peripheral and optic neuropathy
Monitoring	CBC weekly; neurological assessment (vision, peripheral sensation)
Special considerations	Slower recovery from adverse effects; ensure adequate hydration

Major drug interactions

Drug/Class	Interaction	Management
MAO inhibitors (selegiline, phenelzine, tranylcypromine)	Hypertensive crisis; severe serotonergic effects	Contraindicated — avoid concurrent use; 2-week washout required
SSRIs (fluoxetine, sertraline, escitalopram)	Serotonin syndrome risk	Avoid combination; if essential, taper serotonergic drug, close monitoring, specialist oversight
SNRIs (venlafaxine, duloxetine)	Serotonin syndrome risk	Avoid combination if possible
Tramadol, pethidine, fentanyl	Serotonin syndrome; seizure risk	Avoid or use alternative analgesics
Direct sympathomimetics (adrenaline, dopamine, dobutamine)	Hypertensive crisis	Avoid or use with continuous BP monitoring in ICU setting
Indirect sympathomimetics (pseudoephedrine, phenylephrine)	Hypertensive crisis	Avoid concurrent use
Rifampicin	Reduces linezolid plasma levels by ~30%	Avoid if possible in DR-TB regimens; if unavoidable, monitor efficacy closely

Moderate drug interactions

Drug/Class	Interaction	Management
Warfarin	Possible INR elevation	Monitor INR more frequently; adjust warfarin dose as needed
Insulin / Oral hypoglycaemics	Hypoglycaemia risk (linezolid has intrinsic hypoglycaemic effect)	Monitor blood glucose closely
Tricyclic antidepressants	Serotonergic and adrenergic potentiation	Use with caution; monitor for toxicity
Triptans (sumatriptan)	Serotonin syndrome risk	Avoid concurrent use if possible
Phenytoin, carbamazepine	Variable interaction; monitor anticonvulsant levels	Clinical monitoring of seizure control
Beta-blockers	Enhanced hypotensive effect possible	Monitor blood pressure
Tyramine-rich foods	Mild pressor response possible (linezolid is weak, reversible MAOI)	Advise patients to avoid large amounts of aged cheese, fermented foods

Common Adverse effects

Nausea
Vomiting
Diarrhoea
Headache
Taste alteration (dysgeusia)
Insomnia
Anaemia (especially with use >2 weeks)
Thrombocytopenia (dose and duration related)

Serious Adverse effects

Adverse Effect	Clinical Notes
Myelosuppression (pancytopenia, severe thrombocytopenia)	Usually reversible on discontinuation; risk increases >14 days
Lactic acidosis	Rare but potentially fatal; presents with nausea, vomiting, abdominal pain, unexplained acidosis
Optic neuropathy	Risk with therapy >28 days; may cause permanent vision loss; discontinue immediately if visual symptoms
Peripheral neuropathy	Sensory predominantly; may be irreversible; monitor closely with prolonged use
Serotonin syndrome	Medical emergency; requires immediate discontinuation and supportive care
Hypoglycaemia	Particularly in diabetic patients; may be severe
Clostridioides difficile–associated diarrhoea	Consider in patients with diarrhoea during or after therapy

Monitoring requirements

Timing	Parameters
Baseline	CBC with platelets, renal function, liver function tests, blood glucose (in diabetics)
Weekly (if therapy >7 days)	CBC with platelets
Every 1–2 weeks (if therapy >28 days)	Neurological examination — visual acuity, colour vision, peripheral sensation
As clinically indicated	Serum lactate if unexplained acidosis, fatigue, or malaise develops
In DR-TB regimens	Monthly CBC, peripheral neuropathy assessment, blood glucose monitoring

Brands in India

Linox (Pfizer)
Lizolid (Cipla)
Lzin (Lupin)
Linezocrit (Sun Pharma)
Linid (Glenmark)
Linospan (Aristo)
Linezowin (Alkem)

Note: Fixed-dose combinations not standard; used as monotherapy in hospital-based MRSA protocols and DR-TB regimens

Price range (INR)

Formulation	Approximate Price
Tablet 600 mg	₹60–120 per tablet
IV Infusion 600 mg/300 mL	₹400–800 per bag

NPPA-controlled: Linezolid oral formulation listed under NLEM; price ceiling applicable
Government supply: Available through NTEP for DR-TB treatment and in government hospital pharmacies

Clinical pearls

Duration matters: Avoid use beyond 28 days unless absolutely essential — serious neuropathy and myelosuppression risk increases substantially
Oral bioavailability is 100%: Early step-down to oral route is pharmacokinetically equivalent and cost-effective
Platelet monitoring is mandatory: Check CBC before starting and weekly if therapy exceeds 7–10 days
Serotonergic drug screen: Always review medication list for SSRIs, SNRIs, tramadol before prescribing; taper serotonergic drugs if linezolid is essential
DR-TB use: Dose reduction to 300 mg once daily may be necessary if myelosuppression or neuropathy develops; coordinate with NTEP guidelines
Not for empirical use: Reserve for confirmed or strongly suspected MRSA/VRE infections; inappropriate use accelerates resistance

Version

RxIndia v1.1 — 08 May 2025

Reference

- CDSCO Drug Database
- National List of Essential Medicines (NLEM) 2022
- ICMR Guidelines for DR-TB Management 2021
- NTEP DR-TB Training Modules
- API Textbook of Medicine (Antibiotics chapter)
- AIIMS Antimicrobial Prescribing Guidelines 2023
- Indian Academy of Pediatrics (IAP) Antimicrobial Guidelines
- Harrison's Principles of Internal Medicine, 21st Edition
- Goodman & Gilman's The Pharmacological Basis of Therapeutics

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Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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