Lorazepam Schedule (India)

Schedule H

Lorazepam Routes

Oral, Intravenous (IV), Intramuscular (IM)

Lorazepam Formulations

Tablets: 0.5 mg, 1 mg, 2 mg

Injection: 2 mg/mL (1 mL ampoule), 2 mg/mL (2 mL ampoule)

Lorazepam Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Anxiety Disorders / Acute Anxiety Episodes

Parameter Recommendation

Starting dose 0.5–1 mg orally twice daily

Titration Increase by 0.5 mg per dose every 2–3 days as needed based on response and tolerability

Usual maintenance dose 2–4 mg/day in 2–3 divided doses

Maximum dose 10 mg/day

Clinical Notes:

Short-term use preferred (2–4 weeks); not for long-term anxiety management

SSRIs/SNRIs are first-line for chronic anxiety disorders

Elderly and debilitated patients: start at 0.5 mg once or twice daily

Taper gradually after prolonged use (>2 weeks)

Preoperative Sedation / Procedural Anxiolysis

Intramuscular Route:

Parameter Recommendation

Starting dose 0.05 mg/kg IM (usual adult dose: 2–4 mg)

Titration Not applicable (single pre-procedure dose)

Usual maintenance dose Not applicable

Maximum dose 4 mg per procedure

Timing: Administer 1–2 hours before procedure

Intravenous Route:

Parameter Recommendation

Starting dose 2 mg IV slowly over 2 minutes

Titration May give additional 1–2 mg if inadequate sedation

Usual maintenance dose Not applicable

Maximum dose 4 mg per procedure

Timing: Administer 15–20 minutes before procedure

Clinical Notes:

IV administration preferred for rapid onset

Dilute IV dose with equal volume of compatible diluent

Monitor respiratory status; resuscitation equipment must be available

Produces anterograde amnesia — beneficial for procedures

Status Epilepticus — Emergency Management

Parameter Recommendation

Starting dose 4 mg IV slowly at rate not exceeding 2 mg/min

Titration May repeat 4 mg IV after 10–15 minutes if seizures persist

Usual maintenance dose Not applicable (acute treatment only)

Maximum dose 8 mg total (two doses)

Clinical Notes:

First-line benzodiazepine for status epilepticus in many protocols

Must follow with longer-acting antiepileptic (phenytoin, levetiracetam, or valproate) for seizure prophylaxis

IM route (0.1 mg/kg, max 4 mg) may be used if IV access unavailable; onset slower

Monitor airway, breathing, and circulation continuously

Have flumazenil and ventilatory support available

Secondary Indications — Adults (Off-label, if any)

Alcohol Withdrawal Syndrome (AWS) Oral: 1–2 mg every 6–8 hours initially; IV: 2–4 mg every 4–6 hours in severe cases; taper based on CIWA-Ar score 5–7 days on taper OFF-LABEL; Specialist only AIIMS Deaddiction protocols; Indian psychiatry practice

Acute Catatonia 1–2 mg IM/IV; may repeat every 4–6 hours; oral 1–2 mg TDS for maintenance Until resolution; then taper OFF-LABEL; Specialist only Indian psychiatry practice; well-documented benzodiazepine-responsive condition

Acute Agitation in Psychiatric Emergencies 2 mg IM/IV; may repeat after 30–60 minutes if needed; max 4 mg in 2 hours Single episode OFF-LABEL; Specialist only Indian psychiatry emergency protocols

Chemotherapy-Induced Nausea and Vomiting (Anticipatory) 0.5–2 mg orally or IV before chemotherapy Per chemotherapy cycle OFF-LABEL; Specialist only Oncology practice; limited RCT evidence

Insomnia (short-term, anxiety-related) 0.5–2 mg at bedtime Maximum 2–4 weeks OFF-LABEL Use only when safer alternatives unsuitable

Lorazepam Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Status Epilepticus

Age/Weight Starting Dose Repeat Dose Maximum Total Dose

Infants 1–6 months 0.05 mg/kg IV slowly over 2 min May repeat once after 10–15 min 0.1 mg/kg

Children 6 months–5 years 0.05–0.1 mg/kg IV slowly May repeat once after 10–15 min 4 mg

Children 6–12 years 0.05–0.1 mg/kg IV slowly May repeat once after 10–15 min 4 mg

Adolescents >12 years 0.05–0.1 mg/kg IV (usual 2–4 mg) May repeat once after 10–15 min 8 mg

Clinical Notes:

Dilute IV dose and administer slowly over 2 minutes

IM route (0.05–0.1 mg/kg, max 4 mg) may be used if IV access unavailable

Follow with longer-acting antiepileptic drug

Monitor respiratory status closely; ventilatory support must be available

Higher risk of respiratory depression in young infants

Preoperative Sedation — Hospital/Specialist Only

Parameter Recommendation

Starting dose 0.02–0.05 mg/kg IV slowly over 2 minutes

Titration Not applicable

Usual maintenance dose Not applicable

Maximum dose 2 mg per procedure

Timing: Administer 30–60 minutes before procedure

Clinical Notes:

Not routinely used in neonates

Continuous cardiorespiratory monitoring mandatory

Anaesthetist supervision required

Safety Monitoring:

Continuous cardiorespiratory monitoring during and after parenteral administration

Monitor for excessive sedation, respiratory depression

Have airway management equipment and flumazenil available

Observe for paradoxical reactions (agitation, hyperactivity) — more common in children

Minimum Age: Not recommended in infants below 1 month of age except under specialist supervision in NICU/PICU settings.

Secondary Indications — Paediatrics (Off-label, if any)

Indication Dose Duration Label Status Evidence Basis

Acute anxiety before procedures 0.02–0.05 mg/kg orally or IV Single dose OFF-LABEL; Specialist only Paediatric anaesthesia practice

Lorazepam Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation

Severe impairment (eGFR <30) Use with caution; start at lower dose; risk of accumulation of glucuronide metabolite (inactive but may contribute to effects)

Haemodialysis Not significantly dialysed; no supplemental dose required

Peritoneal dialysis No supplemental dose required

Clinical Note: Lorazepam is preferred over many other benzodiazepines in renal impairment due to absence of active metabolites.

Lorazepam Hepatic adjustment

Severity	Recommendation
Mild impairment (Child-Pugh A) Start at lower end of dosing range (0.5 mg)	; titrate cautiously
Moderate impairment (Child-Pugh B)	Start at 50% of usual dose; increased sedation risk; monitor closely
Severe impairment (Child-Pugh C)	Avoid if possible; risk of precipitating or worsening hepatic encephalopathy; if essential, use lowest possible dose with specialist supervision
Clinical Note: Lorazepam is preferred over many other benzodiazepines in hepatic impairment as it undergoes glucuronidation (Phase II metabolism)	rather than oxidative metabolism, and has no active metabolites.

Lorazepam Contraindications

Known hypersensitivity to lorazepam, other benzodiazepines, or any excipient

Acute narrow-angle glaucoma (untreated)

Severe respiratory insufficiency (unless mechanically ventilated)

Severe sleep apnoea syndrome (untreated)

Myasthenia gravis (may worsen weakness)

Acute intoxication with alcohol, opioids, or other CNS depressants

Severe hepatic impairment with encephalopathy

Lorazepam Cautions

Elderly and debilitated patients — increased sensitivity

Chronic respiratory disease (COPD, bronchiectasis) — risk of respiratory depression

History of substance use disorder — high dependence potential

Depression or suicidal ideation — benzodiazepines may disinhibit; should not be sole therapy

Mild to moderate hepatic impairment

Cognitive impairment — may worsen confusion

History of paradoxical reactions to benzodiazepines

Concurrent use with opioids or other CNS depressants

Porphyria — may precipitate acute attack

Long-term use (>4 weeks) — risk of tolerance and dependence

Abrupt discontinuation after prolonged use — risk of withdrawal seizures

Lorazepam Pregnancy

Parameter Recommendation

Risk category High risk; avoid especially in 1st trimester and late 3rd trimester

Known risks First trimester: possible increased risk of congenital malformations (oral clefts — data inconsistent); Late pregnancy: neonatal sedation, hypotonia, respiratory depression, withdrawal ("floppy infant syndrome")

Preferred alternatives For chronic anxiety: SSRIs (sertraline), supportive therapy; For acute agitation: short-term only if essential

When it may be used Status epilepticus or life-threatening conditions where benefit outweighs risk; specialist supervision mandatory

Monitoring Fetal anomaly scan if exposed in 1st trimester; neonatal observation for sedation, respiratory depression, feeding difficulties, withdrawal symptoms (tremors, irritability)

Lorazepam Lactation

Parameter Recommendation

Compatibility Compatible with caution for short-term, low-dose use

Drug levels in milk Low to moderate; relative infant dose estimated at 2–8%

Preferred alternatives None clearly superior for acute anxiety; consider non-pharmacological approaches

Infant monitoring Monitor for sedation, poor feeding, hypotonia, inadequate weight gain

Recommendations Use lowest effective dose; short-term only; monotherapy preferred; consider timing breastfeeds to avoid peak drug levels (2–4 hours post-dose)

Lorazepam Elderly

Starting dose: 0.25–0.5 mg once or twice daily (half of usual adult dose)

Titration: Very slow; increase no more than 0.5 mg every 5–7 days

Usual maintenance dose: 0.5–2 mg/day in divided doses

Maximum dose: 2–4 mg/day (rarely exceed)

Extra risks:

Increased sensitivity to CNS effects

Higher risk of falls and hip fractures

Paradoxical agitation and confusion more common

Daytime sedation and cognitive impairment

Impaired driving ability

Respiratory depression (especially with comorbidities)

Association with increased dementia risk with long-term use

Recommendations:

Avoid long-term use for anxiety or insomnia

Consider non-benzodiazepine alternatives (SSRIs, buspirone, CBT)

Review need regularly; plan for discontinuation

Fall precautions essential

Lorazepam Major drug interactions

Interacting Drug/Class Mechanism/Effect Recommendation

Opioids (morphine, tramadol, codeine, fentanyl) Synergistic CNS and respiratory depression; risk of fatal overdose Avoid combination if possible; if essential, reduce doses of both and monitor respiratory status closely

Alcohol Synergistic CNS depression Avoid concomitant use; counsel patients

Clozapine Increased risk of severe hypotension, respiratory depression, cardiovascular collapse Avoid concomitant initiation; if essential, start with very low doses of both with close monitoring

Other CNS depressants (barbiturates, antipsychotics, sedating antihistamines) Additive CNS depression Reduce doses; monitor for excessive sedation

Valproate Decreased lorazepam clearance; increased levels Monitor for excessive sedation; may need to reduce lorazepam dose

Probenecid Inhibits glucuronidation; increases lorazepam levels and half-life Reduce lorazepam dose by 50%

Lorazepam Moderate drug interactions

Interacting Drug/Class Mechanism/Effect Recommendation

SSRIs (fluoxetine, sertraline) Additive sedation in some cases Monitor for sedation

Fluvoxamine May increase lorazepam levels Monitor for sedation

Antiepileptics (phenytoin, carbamazepine) No significant pharmacokinetic interaction Generally safe to combine

Antipsychotics (haloperidol, risperidone) Additive sedation Monitor; reduce doses if needed

Antihypertensives Additive hypotensive effect Monitor blood pressure

Oral contraceptives May increase lorazepam clearance Generally not clinically significant

Theophylline May reduce sedative effects (antagonism) Monitor clinical response

Aminophylline May reduce sedative effects Monitor clinical response

Lorazepam Common Adverse effects

Sedation / drowsiness

Dizziness

Fatigue

Muscle weakness

Ataxia (dose-dependent)

Confusion (especially in elderly)

Anterograde amnesia

Headache

Lorazepam Serious Adverse effects

Adverse Effect Notes

Respiratory depression Especially with IV use or concomitant opioids; requires immediate intervention

Paradoxical reactions Agitation, aggression, hostility; more common in elderly and children

Anaphylaxis / hypersensitivity Rare; discontinue immediately

Physical dependence and withdrawal syndrome With prolonged use; requires gradual taper

Severe CNS depression / coma Overdose or polydrug use; hospitalise immediately

Lorazepam Monitoring requirements

Phase Parameters

Baseline Respiratory rate, mental status, liver function (if prolonged use anticipated)

After initiation / parenteral use Sedation level, respiratory function, oxygen saturation

Long-term use Watch for dependency, withdrawal symptoms, cognitive effects

High-dose / prolonged therapy Hepatic function, mental status, fall risk assessment

Lorazepam Brands in India

Ativan® (Pfizer/Wyeth)

Larpose® (Intas)

Loratin® (Sun Pharma)

Lorazep® (Mankind)

Lopez® (Torrent)

Fixed-dose combinations uncommon; usually monotherapy.

Lorazepam Price range (INR)

Formulation	Approximate Price (per tablet)
Tablet 1 mg ₹3–₹7 per tablet
Injection 2 mg/mL (1 mL) ₹10–₹25 per ampoule

Prices vary across brands and states; not NPPA-controlled.

Lorazepam Clinical pearls

Lorazepam has no active metabolites, making it preferred over diazepam in hepatic dysfunction and elderly patients

Rapid IV onset makes it first-line for status epilepticus in many Indian tertiary centres

Taper slowly after use exceeding 2–4 weeks to prevent withdrawal seizures or rebound anxiety

Not appropriate for long-term anxiety management; transition to SSRIs for sustained therapy

Avoid co-prescribing with opioids due to synergistic respiratory depression risk

Always use lowest effective dose for shortest duration; reassess indication at each visit

IM absorption is reliable but slower than IV; reserve IM for settings without IV access

Lorazepam Tags

anxiolytic; benzodiazepine; status epilepticus; sedation; lorazepam; preoperative; NLEM; liver-safe benzodiazepine; alcohol withdrawal; IV/IM use

Lorazepam Version

RxIndia v1.0 — 20 Apr 2025

Lorazepam Reference

CDSCO product database

Indian Pharmacopoeia

API Textbook of Medicine

AIIMS Adult Treatment Guidelines

IAP Guidelines for Epilepsy and Status Epilepticus

NLEM India

Goodman & Gilman's Pharmacological Basis of Therapeutics

WHO EML (supportive for paediatric epilepsy indications)

RxIndia

The Drug Registry

Lorazepam