Schedule H

Oral, Intramuscular, Intravenous, Ophthalmic

• Tablets: 10 mg

• Injection: 30 mg/mL in 1 mL and 2 mL ampoules (IM/IV)

• Ophthalmic solution: 0.4%, 0.5% (5 mL bottles)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Short-term Management of Moderate to Severe Acute Pain (Including Post-operative Pain)

Route: IM / IV

Parameter Adults <65 years (Normal Renal Function) Adults ≥65 years OR Renal Impairment

Starting dose 30 mg IM or IV single dose 15 mg IM or IV single dose

Titration Not applicable Not applicable

Usual maintenance dose 30 mg every 6 hours 15 mg every 6 hours

Maximum dose 120 mg/day 60 mg/day

Route: Oral (only as continuation after parenteral therapy)

Parameter Adults <65 years Adults ≥65 years OR Renal Impairment

Starting dose 10 mg orally 10 mg orally

Titration Not applicable Not applicable

Usual maintenance dose 10 mg every 4–6 hours 10 mg every 6–8 hours

Maximum dose 40 mg/day 40 mg/day

Clinical Notes:

• Total combined duration of parenteral + oral therapy: NOT to exceed 5 days

• Do not use concurrently with other NSAIDs or high-dose aspirin

• Reserve for moderate-to-severe pain where opioid-sparing is desired

• Oral therapy is only for continuation after parenteral initiation; do not start with oral route

1. Post-operative Ocular Inflammation or Pain (Ophthalmic)

Route: Topical ophthalmic

Parameter Dosing

Starting dose 1 drop of 0.4% or 0.5% solution into affected eye(s)

Titration Not applicable

Usual maintenance dose 1 drop four times daily

Maximum dose 1 drop four times daily

Duration Up to 2 weeks post-operatively

Clinical Notes:

• Commonly used after cataract surgery, LASIK, or corneal refractive procedures

• May delay corneal healing; use with caution in patients with epithelial defects

Secondary Indications — Adults (Off-label)

Indication Dose Duration Setting Evidence Basis

Renal colic pain — OFF-LABEL 30 mg IV or IM once; may repeat every 6 hours if required Single dose or up to 24–48 hours Emergency/Specialist only Indian emergency practice; supported by RCTs

Acute migraine attack — OFF-LABEL 30 mg IM single dose One-time use Specialist only International RCTs; Indian neurologist practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indication: Short-term Post-operative Pain Management (Children ≥2 years)

Route: IM / IV — Hospital setting only under specialist supervision

Parameter Children <50 kg Children ≥50 kg

Starting dose 0.5 mg/kg IM or IV 15–30 mg IM or IV

Titration Not applicable Not applicable

Usual maintenance dose 0.5–1 mg/kg every 6 hours 15–30 mg every 6 hours

Maximum dose 60 mg/day 90 mg/day

Maximum duration 2 days (preferably); up to 5 days max 2 days (preferably); up to 5 days max

Clinical Notes:

• Oral ketorolac is generally not recommended in paediatrics

• Not recommended in children below 2 years of age except under specialist supervision due to lack of safety data

• Monitor hydration status and renal function closely

Secondary Indications — Paediatrics (Off-label)

Not routinely recommended. Any off-label use restricted to anaesthetist or paediatric pain specialist only.

Mild impairment (CrCl 50–80 mL/min) Use lower end of dose range; maximum 60 mg/day

Moderate impairment (CrCl 30–50 mL/min) Maximum 60 mg/day; monitor renal function closely

Severe impairment (CrCl <30 mL/min) Contraindicated

Volume depletion / Dehydration Contraindicated until corrected

Haemodialysis Not significantly dialyzed; avoid use

• Active peptic ulcer disease or gastrointestinal bleeding

• History of GI perforation or bleeding with prior NSAID use

• Advanced renal impairment (CrCl <30 mL/min or serum creatinine >160 μmol/L)

• Severe hepatic impairment

• Known hypersensitivity to ketorolac, aspirin, or other NSAIDs

• History of NSAID-induced asthma, urticaria, or angioedema

• Active or recent intracranial haemorrhage

• High risk of bleeding (including haemorrhagic diathesis, concurrent anticoagulation at therapeutic doses)

• Concurrent use with other NSAIDs (including aspirin at analgesic doses)

• Perioperative use in coronary artery bypass graft (CABG) surgery

• Labour, delivery, or breastfeeding (systemic forms)

• Hypovolaemia or dehydration

• Elderly patients (increased risk of GI bleeding and renal impairment)

• Hypertension (may worsen BP control)

• Heart failure or fluid retention

• Concurrent antiplatelet agents (increased bleeding risk)

• Concurrent corticosteroid therapy (increased GI ulceration risk)

• Asthma (non-NSAID-sensitive)

• Coagulation disorders

• Post-operative patients with significant blood loss

• Ophthalmic use: may delay corneal healing; avoid in epithelial defects

Aspect Recommendation

Overall safety Not recommended, especially in third trimester

First/Second trimester Use only if clearly necessary and no safer alternative

Third trimester Contraindicated — risk of premature closure of ductus arteriosus, oligohydramnios, prolonged labour

Preferred alternative Paracetamol

Monitoring if exposed Fetal renal function (amniotic fluid volume), ductus arteriosus patency

Aspect Recommendation

Systemic forms Not recommended — excreted in breast milk

Ophthalmic forms Acceptable — negligible systemic absorption

Drug levels in milk Low but potentially harmful

Preferred alternative Paracetamol, ibuprofen (limited short-term use)

Infant monitoring GI symptoms (vomiting, diarrhoea), feeding behaviour

Parameter Recommendation

Starting dose (IM/IV) 15 mg single dose

Maximum daily dose 60 mg/day

Titration Slower; extend dosing interval to every 6–8 hours

Special risks Increased GI bleeding, acute kidney injury, fluid retention, cardiovascular events

Monitoring Renal function, BP, signs of GI bleeding

Duration Limit to shortest effective duration; maximum 5 days

Drug/Class Interaction Management

Anticoagulants (warfarin, heparin, DOACs) Significantly increased bleeding risk Avoid combination; if essential, monitor INR/bleeding closely

Other NSAIDs (ibuprofen, diclofenac, aspirin >325 mg) Additive GI and renal toxicity Contraindicated

Methotrexate Decreased renal clearance of methotrexate → toxicity Avoid or reduce methotrexate dose; monitor levels

Lithium Increased plasma lithium levels → toxicity Monitor lithium levels; may need dose reduction

Probenecid Increased ketorolac levels; prolonged half-life Avoid combination

Pentoxifylline Increased bleeding risk Avoid combination

Drug/Class Interaction Management

ACE inhibitors / ARBs Reduced antihypertensive effect; increased risk of AKI Monitor BP and renal function; ensure adequate hydration

Diuretics (loop, thiazide) Reduced diuretic efficacy; increased nephrotoxicity risk Monitor renal function, fluid status

SSRIs / SNRIs Additive GI bleeding risk Consider gastroprotection

Corticosteroids Increased GI ulceration risk Add gastroprotection (PPI)

Antihypertensives (all classes) Attenuated BP control Monitor BP regularly

Cyclosporine Additive nephrotoxicity Monitor renal function closely

• Nausea, dyspepsia, abdominal discomfort

• Headache

• Dizziness, drowsiness

• Injection site pain (IM administration)

• Peripheral oedema

• Transient elevation in blood pressure

• Pruritus

Adverse Effect Notes

Peptic ulceration, GI bleeding, perforation May be fatal; can occur without warning symptoms

Acute kidney injury Especially in elderly, dehydrated, or those on ACE inhibitors/ARBs

Hypersensitivity reactions Anaphylaxis, angioedema, bronchospasm

Stevens-Johnson Syndrome / Toxic epidermal necrolysis Rare; discontinue immediately

Hepatotoxicity Elevated transaminases; rarely fulminant hepatic failure

Serious haemorrhage Post-operative bleeding, wound haematoma

Cardiovascular thrombotic events MI, stroke — especially with prolonged use

Aseptic meningitis Rare

→ Discontinue immediately if signs of serious GI, renal, hepatic, or hypersensitivity reactions occur

After initiation BP, urine output, signs of GI bleeding, renal function (after 1–2 doses in high-risk patients)

During therapy Daily assessment for GI symptoms, bleeding, fluid retention

Long-term Not applicable — maximum duration 5 days

• Ketorol® (Dr. Reddy's)

• Ketanov® (Ranbaxy/Sun Pharma)

• Toradol®

• Dolokind-K® (Mankind)

• Ketoflam®

• Acular® (ophthalmic — Allergan)

• Acular LS® (ophthalmic 0.4%)

• Multiple generic preparations available

Note: Not listed under NLEM 2022; prices vary across brands and are not NPPA-controlled.

• Strict 5-day limit: Combined parenteral + oral duration must not exceed 5 days due to high risk of GI bleeding and renal injury

• Not for chronic pain: Ketorolac is exclusively for short-term acute pain management; never prescribe for chronic conditions

• Excellent opioid-sparing agent: Useful in multimodal analgesia protocols to reduce opioid requirements post-operatively

• Renal vigilance: Ensure adequate hydration before and during therapy; avoid in any patient with suspected volume depletion

• Pre-operative caution: Avoid if significant bleeding risk anticipated; may impair haemostasis

• Ophthalmic use: Widely used post-cataract and refractive surgery; does not cause pupillary constriction unlike miotics

• Always screen: Ask about GI bleed history, NSAID allergy, asthma, and renal status before prescribing

NSAID; acute pain; post-operative pain; injectable analgesic; short-term use; ophthalmic NSAID; renal-risk; GI-bleeding risk; opioid-sparing; ketorolac; India formulary

RxIndia v1.1 — 04 Jun 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia

• AIIMS Drug Formulary

• API Textbook of Medicine

• NLEM 2022 (not listed)

• ICMR procedural analgesia protocols

• RCTs and meta-analyses for off-label indications (renal colic, migraine)

• Indian ophthalmology specialist practice protocols

• Goodman & Gilman's The Pharmacological Basis of Therapeutics