Ketorolac – Comprehensive Patient Information
Basic Product Information
| International Non-Proprietary Name (INN) | Ketorolac trometamol |
| Common Australia Brand Names | - Toradol®
- Ketorolac-AFT®
- Acular® (eye drops)
|
| Anatomical Therapeutic Chemical (ATC) Code | M01AB15 |
| Available Forms and Strengths | - Tablet: 10 mg
- Solution for injection: 30 mg/mL, 60 mg/2 mL
- Eye drops: 0.5%
|
| Manufacturers (Australia-registered) | - Pfizer Australia
- AFT Pharmaceuticals
|
| Prescription Status | Schedule 4 (Prescription Only Medicine, S4, PBS-reimbursed for certain indications) |
Mechanism of Action
For Patients: Ketorolac belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking chemicals in your body called prostaglandins, which are responsible for pain and inflammation. This helps reduce discomfort, swelling, and fever.
For Healthcare Specialists: Ketorolac is a non-selective cyclo-oxygenase (COX-1 and COX-2) inhibitor. It suppresses prostaglandin synthesis by inhibiting the COX enzymes, providing potent analgesic and moderate anti-inflammatory effects. Its analgesic action is comparable to some opioids but without significant sedative or dependency risks.
Pharmacokinetics
| Absorption | Readily absorbed after oral, intramuscular, or intravenous administration; peak plasma concentration within 30–60 minutes (oral) and 10–30 minutes (IV/IM). |
| Metabolism | Primarily metabolised in the liver by hydroxylation and conjugation. |
| Elimination | Excreted mostly by the kidneys (approx. 90%). Elimination half-life is 5–6 hours in healthy adults, prolonged in the elderly or those with renal impairment. |
| Duration of Action | Analgesic duration 4–6 hours; dosing interval generally every 4–6 hours, not exceeding 5 days (oral). |
Use in Everyday Life & Best Practices
- Indications: Short-term management of moderate to severe pain, commonly after surgery, dental procedures, or acute musculoskeletal injuries.
- When & How to Take: Usually prescribed for 2–5 days. Discuss your pain management plan with your doctor before starting. Do not exceed the recommended dose or duration.
- English Practice Context: In Australia, longer-term use is avoided due to increased risk of gastrointestinal, kidney, and cardiovascular complications.
Tablets should be swallowed whole with a glass of water, ideally at the same times each day. Injection is administered by a healthcare professional in a hospital or GP clinic. Eye drops may be prescribed for postoperative eye pain and must not be ingested.
Dosing in the Morning vs Evening
- Morning Dosing: May help manage pain through the day; recommended if pain interferes with daily activities.
- Evening Dosing: Considered if pain is worse at night or disturbs sleep, but evening dosing may increase the risk of gastrointestinal symptoms overnight in some people.
- Tip: Take at regular intervals as prescribed (every 4–6 hours) and maintain consistency to keep pain under control.
Taking with Food or on an Empty Stomach
- Ketorolac may be taken with or without food. Taking with food, milk, or after meals may reduce the risk of stomach upset, which is more common with NSAIDs.
- English dietary habits (e.g., meals with moderate fat and dairy) pose no particular interaction. Avoid excessive alcohol and fried/greasy food while using Ketorolac.
Interaction Warnings
| Type | Interaction/Advice |
| Food | No major interactions, but take with food to minimise stomach upset. |
| Alcohol | Avoid – can increase risk of gastrointestinal bleeding and ulcers. |
| Other NSAIDs (e.g. ibuprofen) | Do not combine – increases risk of side effects. |
| Anticoagulants (e.g. warfarin, heparin) | Caution – increased risk of bleeding. |
| SSRIs, corticosteroids | May also increase risk of bleeding or ulcers. |
| Diuretics, ACE inhibitors | May affect kidney function, particularly in elderly or dehydrated patients. |
Indications
| Official (Registered) Uses | Off-Label Uses (Australia Guidelines) |
- Short-term management of moderate to severe acute pain requiring opioid-level analgesia (max 5 days oral, 2 days parenteral)
- Post-operative pain relief
- Eye pain and inflammation (ophthalmic solution)
| - Renal colic (in hospital)
- Musculoskeletal pain (not routinely recommended, specialist discretion)
|
Dosing According to Clinical Indication
| Indication | Route | Adult Dose | Paediatric Dose | Elderly/Impaired Renal Dose |
| Acute pain (post-op) | Oral | 10 mg every 4–6 h, max 40 mg per day, up to 5 days | Not recommended (limited data, consult specialist) | Lower dose: 10 mg every 6–8 h, max 20 mg per day |
| Severe acute pain | IM/IV | 10–30 mg every 4–6 h, up to 60–90 mg/day, max 2 days | Not recommended | 10–15 mg every 6 h, max 60 mg/day |
| Eye pain/inflammation | Eye drops | One drop 4 times daily into affected eye(s) | One drop 4 times daily; consult paediatric dosing | Same as adult |
Safety Profile and Side Effects
Like all medicines, Ketorolac can cause side effects. The risk is generally higher if used longer than recommended or in people with pre-existing conditions (e.g., ulcers, kidney disease). Always use for the shortest time possible.
| Common Side Effects (>1 in 100) | Rare but Serious Side Effects (<1 in 1,000) | Warnings |
- Stomach pain
- Indigestion, heartburn
- Headache
- Dizziness
- Nausea
| - Severe allergic reaction (anaphylaxis)
- Stomach/intestinal bleeding or ulcers
- Kidney dysfunction
- Severe skin rash
- Asthma attack (in at-risk individuals)
- Liver inflammation (hepatitis symptoms)
| - Avoid in pregnancy (especially last trimester), breastfeeding, peptic ulcer, severe kidney/liver disease.
- Do not use with other NSAIDs or if history of NSAID hypersensitivity.
- Seek immediate help for black stools, vomiting blood, severe allergic reaction, or persistent vomiting.
|
Guidelines for Proper Use
- Use for the shortest period necessary—generally not more than 5 days for tablets.
- Follow the dosing instructions exactly; never exceed the recommended daily maximum.
- Discuss all other medicines you take with your pharmacist; report any allergies or chronic conditions.
- If you miss a dose, take it as soon as possible, but skip it if next dose is soon—do not double dose.
- Do not drive or operate machinery if you feel dizzy or drowsy after taking Ketorolac.
- If you develop stomach pain, blood in stool, severe headache, swelling, or difficulty breathing, stop the medicine and seek urgent medical care.
- Store out of reach of children and in accordance with the packaging instructions (typically at room temperature, away from moisture).
Alternative Treatment Options
- Paracetamol: Widely used for mild-moderate pain, minimal gastrointestinal side effects, available non-prescription, but less effective than Ketorolac for moderate–severe pain.
- Other NSAIDs: Ibuprofen, diclofenac, and naproxen are available but may not match the analgesic potency for short-term, severe pain.
- Opioids (e.g., codeine, oxycodone): Considered for more severe pain where NSAIDs are contraindicated; higher risk of sedation, addiction, and constipation; prescription only.
- Combination therapy: Sometimes combined (by a doctor) for postoperative pain to reduce opioid requirements.
- Topical NSAIDs, local anaesthetics: Suitable for some mild/moderate conditions, lower systemic side effect risk.
Comparison Table:
| Alternative | Effective for | Advantages | Disadvantages |
| Paracetamol | Mild–moderate pain | Low GI/risk profile, OTC | Less effective for severe pain |
| Ibuprofen | Mild–moderate pain, inflammation | OTC, familiar | GI/kidney risk with prolonged use |
| Opioids | Severe pain | Potent, rapid action | Sedation, dependency, regulatory limits |
| Ketorolac | Short-term moderate–severe pain | Opioid-level relief without dependency; rapid | Strict duration limits, GI/renal risk |
Legal, Registration, and Reimbursement Status in Australia
- Registered with the Therapeutic Goods Administration (TGA)
- Prescription-Only Medicine: Schedule 4 (S4), cannot be bought over-the-counter
- Some forms reimbursed by the Pharmaceutical Benefits Scheme (PBS) when prescribed for specific indications (e.g., post-operative pain)
- Dispensed only by registered pharmacies upon presentation of a valid prescription
- Not suitable for repeat or public dispensing for chronic conditions
Latest Research and Clinical Guidance (2022–2025)
- A 2023 Australasian Anaesthesia review confirms Ketorolac’s role as a strong non-opioid analgesic for acute post-surgical pain, with recommendations to restrict use to under 5 days to reduce GI and renal risk (Smith et al., 2023, Med J Aust 218:229-235).
- Regardless of form, recent TGA advice emphasises avoiding Ketorolac in older adults and those with pre-existing kidney disease, underlining shorter course therapy.
- Multimodal regimens (Ketorolac + paracetamol) show benefit in opioid-sparing, though require monitoring for cumulative side effects (Australian Pain Society, 2024 Position Statement).
- Cochrane Review (2024) supports short-term, controlled use for postoperative analyses, especially where opioid minimisation is a priority.
Availability and Delivery
Ketorolac is generally available through most Australian pharmacies on prescription. Do not seek Ketorolac through unregistered sources or online shops without TGA verification.
| Common Pack Sizes | Indicative PBS Subsidised Price (2025) | Typical Pharmacy Delivery Time |
| 10 mg x 20 tablets (Toradol®) | $7–$12 (with prescription, PBS) | 1-2 days (Sydney, Melbourne, Brisbane) |
| 30 mg/mL x 5 ampoules (injection) | $15–$22 (private script) | 1-2 days (most cities), up to 4 days (regional) |
| 0.5% x 5 mL (Acular® eye drops) | $20–$27 | Same-day (major metro), 2–4 days (regional/remote) |
Frequently Asked Questions (FAQ)
- Can I buy Ketorolac over the counter?
No. In Australia, Ketorolac is only available with a doctor's prescription and must be dispensed by a pharmacist. - How long can I take Ketorolac for pain?
The maximum recommended duration for oral tablets is 5 days (usually much less for injections). Do not extend use without professional advice. - Can I drive or work while taking Ketorolac?
Most people can, but if you feel dizzy, sleepy, or unwell, avoid driving or operating machinery until symptoms resolve. - Is Ketorolac safe in pregnancy?
No. It should generally be avoided, especially in the third trimester due to risk of harm to both mother and baby. Discuss alternatives with your doctor. - What do I do if I forget a dose?
Take it as soon as you remember unless it's almost time for your next dose. Never double up or take extra doses to catch up.
