Caloket (Ketorolac Tromethamine)
Injectable NSAID for short-term postoperative pain management
Caloket is a non-steroidal anti-inflammatory drug (NSAID) containing ketorolac tromethamine. It is used in hospital settings for the short-term management of moderate to severe postoperative pain in adults and adolescents over 16 years. It is administered by healthcare professionals via intramuscular or intravenous injection. The maximum treatment duration is strictly limited to 2 days.
Quick Facts: Caloket
Key Takeaways
- Caloket is a potent injectable NSAID used only in hospitals for short-term postoperative pain relief, with a strict maximum treatment duration of 2 days.
- The maximum daily dose is 90 mg for adults under 65 and 60 mg for elderly patients or those with kidney problems.
- It must not be used in children under 16 years, during the third trimester of pregnancy, labor, delivery, or while breastfeeding.
- Major drug interactions exist with anticoagulants, other NSAIDs, corticosteroids, and SSRIs — always inform your medical team about all medications.
- Common side effects include drowsiness, headache, nausea, and stomach pain. Seek immediate medical help for signs of severe allergic reactions or skin reactions.
What Is Caloket and What Is It Used For?
Quick Answer: Caloket (ketorolac tromethamine) is a powerful non-steroidal anti-inflammatory drug (NSAID) administered by injection in hospital settings. It is used for the short-term treatment of moderate to severe pain after surgery in adults and adolescents aged 16 years and older.
Caloket belongs to the class of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). Its active substance, ketorolac tromethamine, works by inhibiting cyclooxygenase (COX) enzymes — specifically COX-1 and COX-2 — which are responsible for the production of prostaglandins, key mediators of pain and inflammation in the body. By blocking prostaglandin synthesis, ketorolac provides potent analgesic (pain-relieving), anti-inflammatory, and mild antipyretic (fever-reducing) effects.
What distinguishes ketorolac from many other NSAIDs is its exceptional analgesic potency when administered parenterally (by injection). Clinical studies have demonstrated that its pain-relieving effect is comparable to moderate doses of opioid analgesics such as morphine, making it an important tool in multimodal postoperative pain management. This opioid-sparing effect is particularly valuable because it allows healthcare teams to reduce the use of opioid medications, thereby minimizing opioid-related side effects such as respiratory depression, sedation, nausea, and the potential for dependence.
Caloket is formulated as a clear, yellowish solution in 1 ml glass ampoules, each containing 30 mg of ketorolac tromethamine per milliliter. The solution is designed for intramuscular injection, intravenous injection, or intravenous infusion. It is exclusively administered by healthcare professionals in a hospital or clinical setting — patients do not self-administer this medication.
The critical limitation of Caloket is its strict time restriction: the maximum duration of treatment by injection is 2 days, and treatment by infusion must not exceed 24 hours. This limitation is essential because the risk of serious adverse effects — particularly gastrointestinal bleeding, peptic ulceration, and renal impairment — increases significantly with prolonged use. This short-term restriction distinguishes ketorolac from most other NSAIDs, which may be prescribed for longer periods.
Caloket is approved within the European Economic Area and is marketed under the same name in Denmark, Finland (as Caloket 30 mg/ml), Norway, and Sweden. It is manufactured by EQL Pharma AB. While ketorolac tromethamine is also available under other brand names globally, the prescribing information and approved indications may vary by country and regulatory authority.
What Should You Know Before Taking Caloket?
Quick Answer: Caloket has numerous contraindications and precautions. It must not be used in patients with active gastrointestinal problems, severe kidney or liver disease, heart failure, bleeding disorders, or during the third trimester of pregnancy. Special caution is needed for elderly patients and those on anticoagulant therapy.
Contraindications
There are several absolute contraindications to the use of Caloket. Understanding these is critical for patient safety, as use in the presence of any of these conditions can lead to severe, potentially life-threatening complications.
- Are allergic to ketorolac tromethamine or any other ingredient in the formulation
- Are allergic to aspirin or other NSAIDs (including cross-sensitivity reactions such as asthma, rhinitis, or urticaria)
- Have active or a history of gastrointestinal ulceration, perforation, or bleeding
- Have severe liver disease (hepatic insufficiency)
- Have severe heart failure
- Have moderate to severe kidney disease
- Have abnormally low platelet count (thrombocytopenia)
- Have a bleeding disorder such as hemophilia or are at increased risk of bleeding
- Are taking anticoagulants (such as warfarin or heparin)
- Are taking other NSAIDs (including aspirin, ibuprofen, or diclofenac)
- Are taking lithium, probenecid, or pentoxifylline
- Have bronchospasm (airway muscle tightening causing wheezing)
- Have nasal polyps
- Are scheduled for epidural or spinal anesthesia (due to the ethanol content in Caloket)
- Are under 16 years of age
- Are in the third trimester of pregnancy, in labor, or during delivery
- Are breastfeeding
Ketorolac must not be used as a prophylactic analgesic before or during surgery due to the increased risk of bleeding related to its inhibition of platelet aggregation. Additionally, it is contraindicated in patients who are actively bleeding after surgery or who have been informed that they are at a higher risk of postoperative hemorrhage.
Warnings and Precautions
Even when Caloket is not strictly contraindicated, there are numerous situations requiring heightened caution and careful risk-benefit assessment by the treating physician.
Elderly patients: Older adults are more susceptible to adverse effects of NSAIDs, particularly gastrointestinal bleeding and renal impairment. The metabolism of ketorolac is delayed in elderly patients, and therefore a lower maximum dose (60 mg/day) is recommended. The lowest effective dose should always be used.
Gastrointestinal concerns: Patients with a history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) should be treated with particular caution, as NSAIDs can exacerbate these conditions. If symptoms of gastrointestinal bleeding or ulceration develop during treatment, Caloket must be discontinued immediately. Patients who have recently had gastrointestinal surgery should also inform their medical team, as ketorolac can occasionally impair intestinal wound healing.
Cardiovascular risk: Patients with heart disease, previous stroke, hypertension, diabetes, high cholesterol, or who smoke should be assessed carefully, as NSAIDs are associated with a slightly increased risk of cardiovascular thrombotic events.
Renal and hepatic function: Patients with any degree of kidney or liver impairment require dose adjustment and close monitoring. NSAIDs can further compromise renal function, particularly in patients who are dehydrated or have underlying kidney disease.
Skin reactions: In very rare cases, serious skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with NSAID use. Treatment should be stopped at the first appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity.
Anaphylaxis: Severe allergic reactions, including anaphylaxis, have occurred in patients with and without known prior hypersensitivity to ketorolac, aspirin, or other NSAIDs. Emergency resuscitation equipment should be available when administering this drug.
Pregnancy and Breastfeeding
Caloket is strictly contraindicated during the last three months of pregnancy, during labor and delivery, and while breastfeeding, as it can cause harm to both the mother and the child.
During the first and second trimesters of pregnancy, Caloket should only be used if absolutely necessary, and the dose should be as low and the duration of treatment as short as possible. Like other NSAIDs, ketorolac may make it more difficult to become pregnant by inhibiting ovulation. Women who are trying to conceive or undergoing fertility investigations should inform their healthcare provider.
Ketorolac is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, breastfeeding mothers must not receive Caloket.
If you are pregnant, planning a pregnancy, or breastfeeding, inform your medical team before receiving Caloket. The medication can affect fertility and is not safe during late pregnancy or while nursing.
How Does Caloket Interact with Other Drugs?
Quick Answer: Caloket has clinically significant interactions with many commonly used medications. The most dangerous combinations involve anticoagulants (greatly increased bleeding risk), other NSAIDs (additive gastrointestinal and renal toxicity), and lithium (increased lithium levels). Always disclose all medications to your healthcare team.
Drug interactions are a critical concern with ketorolac tromethamine due to its effects on platelet function, prostaglandin synthesis, and renal hemodynamics. The following interactions are well-documented and should be carefully considered by healthcare providers before prescribing Caloket.
Major Interactions
These combinations are contraindicated or should be strictly avoided due to the potential for serious, life-threatening adverse effects.
| Drug / Class | Interaction | Risk |
|---|---|---|
| Warfarin, Heparin, Clopidogrel | Ketorolac inhibits platelet aggregation; combined with anticoagulants, bleeding risk is greatly increased | Severe hemorrhage |
| Other NSAIDs (aspirin, ibuprofen, diclofenac) | Additive gastrointestinal toxicity and increased risk of renal impairment | GI bleeding, kidney failure |
| Lithium | NSAIDs reduce renal lithium clearance, leading to elevated serum lithium levels | Lithium toxicity |
| Methotrexate | NSAIDs reduce renal clearance of methotrexate, increasing its plasma concentration | Methotrexate toxicity |
| Probenecid | Probenecid significantly increases ketorolac plasma levels by reducing its renal clearance | Increased ketorolac toxicity |
| Pentoxifylline | Additive antiplatelet effects increase bleeding tendency | Increased bleeding risk |
Other Important Interactions
The following combinations require caution, close monitoring, and potentially dose adjustment. While not always absolutely contraindicated, they carry clinically significant risks.
| Drug / Class | Interaction | Recommendation |
|---|---|---|
| SSRIs (e.g., citalopram, sertraline) | SSRIs impair platelet function; combined with NSAIDs, gastrointestinal bleeding risk rises substantially | Avoid if possible; use gastroprotection |
| Corticosteroids (hydrocortisone, prednisolone, dexamethasone) | Corticosteroids increase the risk of gastrointestinal ulceration and bleeding when combined with NSAIDs | Avoid concurrent use where possible |
| ACE inhibitors (enalapril, cilazapril) | NSAIDs reduce the antihypertensive effect and may worsen renal function | Monitor blood pressure and renal function |
| Furosemide | NSAIDs reduce the diuretic and antihypertensive effect of furosemide | Monitor fluid balance and blood pressure |
| Digoxin | NSAIDs may increase serum digoxin levels | Monitor digoxin levels |
Caloket contains 96 mg of ethanol (alcohol) per 1 ml ampoule. While this amount is unlikely to affect adults, the alcohol content may alter the effect of other medications. This ethanol content is the reason why Caloket is contraindicated for patients receiving epidural or spinal anesthesia.
What Is the Correct Dosage of Caloket?
Quick Answer: The recommended starting dose is 10 mg, followed by 10–30 mg every 4–6 hours as needed. The maximum daily dose is 90 mg for adults under 65, and 60 mg for elderly patients or those with kidney problems. Treatment must not exceed 2 days.
Caloket is exclusively administered by qualified healthcare professionals in clinical settings. The dosage is individualized based on the severity of pain, the patient's age, weight, and renal function. Below are the specific dosing guidelines for each patient group.
Adults and Adolescents (16 Years and Older)
Standard Adult Dosing
- Initial dose: 10 mg via intramuscular (IM) or intravenous (IV) injection
- Subsequent doses: 10–30 mg every 4–6 hours as needed for pain control
- Maximum daily dose: 90 mg per day
- Maximum treatment duration: 2 days (injection); 24 hours (infusion)
When administered intramuscularly, ketorolac reaches peak plasma concentration within approximately 30–60 minutes, with the onset of analgesic effect typically occurring within 30 minutes. When given intravenously, the onset is faster. The duration of pain relief generally lasts 4–6 hours, though this may vary depending on the individual patient and the nature and severity of their postoperative pain.
Children
Caloket must not be administered to children or adolescents under 16 years of age. The safety and efficacy of ketorolac tromethamine in this age group have not been established.
Elderly Patients (Over 65 Years)
Elderly Dosing
- Dose: Lowest effective dose should be used
- Maximum daily dose: 60 mg per day
- Rationale: Ketorolac metabolism is delayed in elderly patients, resulting in prolonged drug exposure and increased risk of adverse effects
Elderly patients are at significantly greater risk of gastrointestinal bleeding, renal impairment, and cardiovascular events when taking NSAIDs. For this reason, the European Medicines Agency (EMA) and other regulatory authorities strongly recommend using the lowest effective dose for the shortest possible duration in older adults.
Patients with Kidney Problems
Renal Impairment Dosing
- Dose: Lowest effective dose should be used
- Maximum daily dose: 60 mg per day
- Note: Caloket is contraindicated in patients with moderate to severe renal impairment. Only patients with mild renal impairment may receive the drug, under careful supervision
Overdose
Because Caloket is administered by healthcare professionals in a controlled clinical environment, overdose is unlikely. However, if it does occur, symptoms may include abdominal pain, nausea, vomiting, hyperventilation, gastric ulceration, and renal dysfunction. These symptoms typically resolve after the drug is discontinued.
Severe overdose may lead to gastrointestinal hemorrhage and serious allergic reactions including skin rash, redness, and breathing difficulties. There is no specific antidote for ketorolac; treatment is supportive and symptomatic. Gastric decontamination (activated charcoal) may be considered if the overdose occurred recently. Hemodialysis does not significantly remove ketorolac from the bloodstream.
| Patient Group | Starting Dose | Max Daily Dose | Max Duration |
|---|---|---|---|
| Adults (16–64 years) | 10 mg IM/IV | 90 mg | 2 days |
| Elderly (≥65 years) | 10 mg IM/IV | 60 mg | 2 days |
| Renal impairment (mild) | 10 mg IM/IV | 60 mg | 2 days |
| Children (<16 years) | Not recommended | N/A | N/A |
What Are the Side Effects of Caloket?
Quick Answer: Common side effects of Caloket include drowsiness, headache, dizziness, nausea, stomach pain, and swelling. Serious but rare effects include severe allergic reactions (anaphylaxis), gastrointestinal bleeding, and severe skin reactions (Stevens-Johnson syndrome). Stop treatment and seek immediate medical attention for severe symptoms.
Like all NSAIDs, Caloket can cause side effects, although not everybody experiences them. The side effects are classified below by frequency according to the standard medical convention used by the European Medicines Agency (EMA). Understanding these frequencies helps patients and healthcare providers make informed decisions about risk versus benefit.
Stop treatment and tell your doctor or nurse immediately if you experience: difficulty breathing, swelling of the face, lips, tongue, or throat, severe skin rash with blistering, or signs of gastrointestinal bleeding (blood in stool, black tarry stools, vomiting blood).
Common
May affect up to 1 in 10 people
- Drowsiness
- Headache
- Dizziness
- Nausea
- Heartburn (dyspepsia)
- Stomach (abdominal) pain
- Diarrhea
- Sweating
- Swelling of hands, feet, or legs (edema)
Uncommon
May affect up to 1 in 100 people
- Psychological disturbance, depression, euphoria, difficulty concentrating
- Sleep disturbances, nervousness
- Sensory and taste disturbances
- Blurred vision
- Breathing difficulties (shortness of breath, wheezing, cough), nosebleeds
- Constipation, blood in stool, rectal bleeding, vomiting, dry mouth
- Abdominal bloating, flatulence
- Itching (pruritus), hives (urticaria), skin redness, purpura
- Muscle weakness or pain
- Increased urinary frequency, changes in urine volume
- Extreme fatigue, thirst
Rare
May affect up to 1 in 1,000 people
- Severe allergic reaction (anaphylaxis) with breathing difficulty, throat swelling, low blood pressure
- Severe skin reactions: toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS)
- Low platelet count (thrombocytopenia)
- Nightmares, hallucinations
- Seizures, involuntary muscle movements
- Hearing impairment
- Heart failure, high or low blood pressure
- Postoperative bleeding
- Gastrointestinal bleeding, intestinal inflammation
- Worsening of ulcerative colitis or Crohn's disease
- Kidney problems with protein or blood in urine
- Female infertility
Very Rare
May affect up to 1 in 10,000 people
- Angioedema (skin swelling), blistering of the skin
- Loss of appetite (anorexia)
- Abnormal blood electrolytes (high potassium, low sodium)
- Anxiety, psychotic reactions
- Tinnitus (ringing in the ears)
- Irregular, slow, or very fast heartbeat
- Bruising (hematoma), blood clot in an artery
- Esophageal inflammation, gastric ulcer, pancreatitis
- Severe liver inflammation (hepatitis), liver damage, liver failure
- Decreased urine output, pain at injection site, fever, chest pain
- Prolonged bleeding time, elevated liver and kidney function tests
Driving and Operating Machinery
Ketorolac may cause drowsiness, dizziness, and visual disturbances. Patients experiencing any of these effects should not drive, operate heavy machinery, or engage in activities requiring mental alertness until the effects have subsided. This is particularly relevant in the immediate postoperative period when the combined effects of anesthesia and analgesic medications may further impair cognitive and motor function.
How Should You Store Caloket?
Quick Answer: Caloket should be stored in its original packaging, protected from light, and kept out of the reach of children. Do not use the solution if particles are visible. Hospital pharmacies are responsible for proper storage in clinical settings.
Proper storage of Caloket is essential to ensure the medication remains safe and effective throughout its shelf life. While storage is primarily the responsibility of hospital pharmacies and healthcare facilities, patients and caregivers should be aware of the following guidelines:
- Keep out of sight and reach of children.
- Store the ampoule in its original outer carton to protect from light, as ketorolac solution is photosensitive.
- Do not use after the expiry date printed on the label (EXP). The expiry date refers to the last day of that month.
- Do not use if the solution appears cloudy or contains visible particles.
- Disposal: Unused medicine and waste should be disposed of in accordance with local pharmaceutical waste regulations.
Caloket is supplied as a clear, yellowish solution in 1 ml colorless glass ampoules, packaged in PVC trays within an outer carton. Each package contains 6 ampoules. No special temperature storage conditions are required beyond normal room temperature storage.
What Does Caloket Contain?
Quick Answer: Each 1 ml ampoule of Caloket contains 30 mg of ketorolac tromethamine as the active ingredient, along with ethanol, water for injections, sodium chloride, and sodium hydroxide (for pH adjustment).
Active Ingredient
The active substance is ketorolac tromethamine at a concentration of 30 mg per ml. Ketorolac tromethamine is the tromethamine salt of ketorolac, a member of the pyrrolizine group of non-steroidal anti-inflammatory drugs. The tromethamine salt form enhances the water solubility of the compound, making it suitable for parenteral (injectable) formulations.
Inactive Ingredients (Excipients)
- Ethanol — serves as a co-solvent (96 mg per ampoule, equivalent to approximately 3 ml of beer or 1 ml of wine)
- Water for injections — vehicle for the injectable solution
- Sodium chloride — tonicity adjusting agent to make the solution isotonic with blood
- Sodium hydroxide — pH adjustment agent
This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, making it essentially sodium-free. It contains 96 mg of ethanol (alcohol) per ampoule. The amount of alcohol is unlikely to have a noticeable effect on adults or adolescents. However, patients who are pregnant, breastfeeding, or have alcohol dependency should discuss this with their healthcare provider. The ethanol may also alter the effect of other medications.
Frequently Asked Questions About Caloket
Caloket (ketorolac tromethamine) is an injectable NSAID used for the short-term management of moderate to severe postoperative pain in adults and adolescents over 16 years. It is administered in hospital settings by healthcare professionals via intramuscular or intravenous injection. The maximum treatment duration is 2 days for injection and 24 hours for infusion.
Caloket is strictly limited to short-term use. The maximum treatment duration is 2 days for injections and 24 hours for infusion. This strict time limit is necessary to minimize the risk of serious side effects such as gastrointestinal bleeding, peptic ulceration, and kidney problems that are associated with prolonged NSAID use.
Common side effects (affecting up to 1 in 10 people) include drowsiness, headache, dizziness, nausea, heartburn, stomach pain, diarrhea, sweating, and swelling in the hands, feet, or legs (edema). Most of these side effects resolve after treatment is discontinued. You should seek immediate medical attention if you experience signs of a severe allergic reaction, severe skin reactions, or gastrointestinal bleeding.
Caloket is contraindicated during the last three months of pregnancy (third trimester), during labor and delivery, and while breastfeeding. If used during the first or second trimester, the dose should be as low and the treatment as short as possible. Caloket may also affect fertility. Women who are pregnant, planning pregnancy, or breastfeeding should always inform their healthcare provider.
Caloket has significant interactions with many commonly used medications. Major interactions include anticoagulants (warfarin, heparin, clopidogrel) which greatly increase bleeding risk, other NSAIDs which cause additive GI toxicity, lithium and methotrexate which reach toxic levels, and SSRIs which increase bleeding risk. It should never be combined with other NSAIDs including aspirin. Always tell your healthcare team about all medications you are currently taking.
For adults under 65 years with normal kidney function, the maximum daily dose is 90 mg. For patients aged 65 years and older, or those with mild kidney impairment, the maximum daily dose is reduced to 60 mg. The recommended starting dose is 10 mg, followed by 10–30 mg every 4–6 hours as needed. Caloket must not be used in children under 16 years.
References
- European Medicines Agency (EMA). Summary of Product Characteristics: Ketorolac tromethamine. EMA Product Information. Available at: www.ema.europa.eu.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: World Health Organization; 2023.
- Vadivelu N, Gowda AM, Urman RD, et al. Ketorolac tromethamine – routes and clinical implications. Pain Practice. 2015;15(2):175-193. doi:10.1111/papr.12198.
- De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesthesia & Analgesia. 2012;114(2):424-433. doi:10.1213/ANE.0b013e3182334d68.
- Forrest JB, Camu F, Greer IA, et al. Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. British Journal of Anaesthesia. 2002;88(2):227-233. doi:10.1093/bja/88.2.227.
- British National Formulary (BNF). Ketorolac tromethamine. NICE BNF. Available at: bnf.nice.org.uk.
- U.S. Food and Drug Administration (FDA). Ketorolac Tromethamine Injection Prescribing Information. FDA Approved Labeling. Available at: www.fda.gov.
- Macario A, Lipman AG. Ketorolac in the era of cyclo-oxygenase-2 selective nonsteroidal anti-inflammatory drugs: a systematic review of efficacy, side effects, and regulatory issues. Pain Medicine. 2001;2(4):336-351.
- Lee A, Cooper MG, Craig JC, Knight JF, Keneally JP. Effects of nonsteroidal anti-inflammatory drugs on postoperative renal function in adults with normal renal function. Cochrane Database of Systematic Reviews. 2007;(2):CD002765. doi:10.1002/14651858.CD002765.pub3.
- Lanas A, Chan FKL. Peptic ulcer disease. The Lancet. 2017;390(10094):613-624. doi:10.1016/S0140-6736(16)32404-7.
Editorial Team
Written by the iMedic Medical Editorial Team, comprising licensed physicians with expertise in clinical pharmacology, pain medicine, and perioperative care.
Reviewed by the iMedic Medical Review Board, an independent panel of specialists ensuring accuracy according to EMA, FDA, WHO, and BNF guidelines.
Evidence standard: All medical claims in this article are supported by Level 1A evidence (systematic reviews and meta-analyses of randomized controlled trials) where available, supplemented by regulatory authority prescribing information (EMA SmPC, FDA labeling, BNF). This article follows the GRADE evidence framework and has been reviewed for compliance with international medical reporting standards.
Conflict of interest: The iMedic editorial team has no financial relationships with pharmaceutical companies. This content is independently produced with no commercial funding or advertising.
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