Linezolid Uses, Dosage, Side Effects & Warnings | DrugsAtlas
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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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