Ketorolac Tromethamine 10 mg Tablet, Film Coated, 100-count
Other active recalls for Ketorolac Tromethamine (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ketorolac is used to relieve moderately severe pain, usually after surgery. Ketorolac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Read the full MedlinePlus article ↗- That's actually how ketorolac has to be used — the rules say treatment must always start with an injection, either into a vein or a muscle. The oral tablets are only for continuing...
- Why did my doctor give me a shot first instead of just pills?
- Ketorolac is actually quite hard on your stomach, kidneys, and cardiovascular system when used beyond 5 days — the risks of serious bleeding, ulcers, and other complications go up...
- Why can I only take this for 5 days? My pain might last longer than that.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ketorolac Tromethamine — tap one for details:
Ketorolac Tromethamine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII X7XJ6RM9Q2
A plant-derived cellulose processed into tiny crystals. It acts as a binder and filler to give the tablet or capsule structure and helps the medicine break apart properly in your stomach.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.166 | $16.59 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.7240 | $72.40 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.5547 | $55.47 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ketorolac Tromethamine 10 mg 00093-0314-01 | Teva | 100 tablets | $0.166 | — | Availability likely | — |
| Ketorolac Tromethamine 10 mg 00378-1134-01 | Mylan | 100 tablets | $0.166 | AB | Availability likely | — |
| Ketorolac Tromethamine 10 mg 00904-7303-04 | Major | 1 tablet | $0.166 | AB | Availability likely | — |
| Ketorolac Tromethamine 10 mg 27241-0316-01 | Ajanta | 100 tablets | $0.166 | AB | Availability likely | — |
| Ketorolac Tromethamine 10 mgthis 31722-0686-01 | Camber | 100 tablets | $0.166 | AB | Availability likely | — |
| Ketorolac Tromethamine 10 mg 43598-0139-01 | DR. | 100 tablets | $0.166 | AB | Availability likely | — |
| Ketorolac Tromethamine 10 mg 60687-0104-21 | American | 1 tablet | $0.166 | AB | Availability likely | — |
| Ketorolac Tromethamine 10 mg 62135-0811-60 | Chartwell | 60 tablets | $0.166 | AB | Availability likely | — |
| ketorolac tromethamine 10 mg 69292-0650-01 | Amici | 100 tablets | $0.166 | AB | Availability likely | — |
| Ketorolac Tromethamine 10 mg 69315-0260-01 | Leading | 100 tablets | $0.166 | AB | Availability likely | — |
| Ketorolac Tromethamine 10 mg 69452-0275-20 | Bionpharma | 100 tablets | $0.166 | AB | Availability likely | — |
| ketorolac tromethamine 10 mg 70710-1710-01 | Zydus | 100 tablets | $0.166 | AB | Availability likely | — |
| Ketorolac Tromethamine 10 mg 43063-0904-10 | PD-Rx | 10 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 50090-0601-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 50090-7265-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 50090-7453-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 50090-7638-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 50090-7695-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| ketorolac tromethamine 10 mg 50090-7808-00 | A-S | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 51407-0677-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 51655-0170-20 | Northwind | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 60760-0704-20 | St. | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 63187-0128-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 63629-2974-00 | Bryant | 3 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 66267-0418-20 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 66267-0832-04 | NuCare | 4 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 67296-2163-01 | Redpharm | 10 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 67296-2171-01 | Redpharm | 20 tablets | — | AB | FDA listed | — |
| ketorolac tromethamine 10 mg 67296-2230-01 | Redpharm | 10 tablets | — | AB | FDA listed | — |
| ketorolac tromethamine 10 mg 68071-2983-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| ketorolac tromethamine 10 mg 68071-3591-04 | NuCare | 4 tablets | — | AB | FDA listed | — |
| ketorolac tromethamine 10 mg 68788-4129-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 68788-8701-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 68788-8891-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 70518-0048-03 | REMEDYREPACK | 8 tablets | — | AB | Discontinued | — |
| Ketorolac Tromethamine 10 mg 70518-4161-01 | REMEDYREPACK | 20 tablets | — | AB | FDA listed | — |
| ketorolac tromethamine 10 mg 70518-4255-00 | REMEDYREPACK | 20 tablets | — | AB | FDA listed | — |
| ketorolac tromethamine 10 mg 70771-1747-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 71335-2136-00 | Bryant | 3 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 71335-2444-00 | Bryant | 3 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 71335-2658-00 | Bryant | 3 tablets | — | AB | FDA listed | — |
| ketorolac tromethamine 10 mg 71335-3084-00 | Bryant | 3 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 72189-0555-10 | Direct_Rx | 10 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 72684-0006-01 | ATNAHS | 100 tablets | — | — | FDA listed | — |
| Ketorolac Tromethamine 10 mg 72789-0437-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 76420-0032-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 80425-0139-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 80425-0267-01 | Advanced | 9 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 80425-0489-01 | Advanced | 9 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 82804-0248-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 82868-0020-15 | Northwind | 15 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 85766-0035-01 | Sportpharm | 100 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 87234-7695-01 | Injecta | 10 tablets | — | AB | FDA listed | — |
| Ketorolac Tromethamine 10 mg 87564-0018-10 | Amerisyn | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 31722-0686-01 You're viewing this | 100 TABLET, FILM COATED in 1 BOTTLE (31722-686-01) | 2022-08-25 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING Ketorolac tromethamine tablets, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine should not exceed 5 days. Ketorolac tromethamine tablets are not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions.
Increasing the dose of ketorolac tromethamine tablets beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events. GASTROINTESTINAL RISK ◾Ketorolac tromethamine, including ketorolac tromethamine tablets can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.
Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS ). CARDIOVASCULAR THROMBOTIC EVENTS ◾Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.
This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ). ◾Ketorolac tromethamine tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ). RENAL RISK ◾Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see WARNINGS ). RISK OF BLEEDING ◾Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ).
Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery. RISK DURING LABOR AND DELIVERY The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions. CONCOMITANT USE WITH NSAIDS ◾Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.
SPECIAL POPULATIONS Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (see DOSAGE AND ADMINISTRATION ) and for patients with moderately elevated serum creatinine (see WARNINGS ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets are indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.
Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine, and Ketorolac Tromethamine Tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS ). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablets therapy is not to exceed 5 days.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets are not to exceed 5 days.
In adults, the use of ketorolac tromethamine tablets are only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Patients age ≥65, renally impaired, and/or weight <50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Note: Oral formulation should not be given as an initial dose Use minimum effective dose for the individual patient Do not shorten dosing interval of 4 to 6 hours Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets are not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group: Table 4 Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age <17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not >40 mg/day Adult Age ≥65 years, renally impaired, and/or weight <50 kg 10 mg once, then 10 mg q4 to 6 hours prn not >40 mg/day
⛔ Contraindications ▾
CONTRAINDICATIONS (see also Boxed WARNING) Ketorolac tromethamine tablets are contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. Ketorolac tromethamine tablets are contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Ketorolac tromethamine tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions, and PRECAUTIONS: Preexisting Asthma ). Ketorolac tromethamine tablets are contraindicated as prophylactic analgesic before any major surgery. Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Ketorolac tromethamine tablets are contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see WARNINGS for correction of volume depletion). Ketorolac tromethamine tablets are contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. Ketorolac tromethamine tablets inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ).
Ketorolac tromethamine tablets are contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events. The concomitant use of ketorolac tromethamine and probenecid is contraindicated. The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.
⚠️ Warnings ▾
WARNINGS (see also Boxed WARNING) The total combined duration of use of ketorolac tromethamine tablets and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine tablets are not indicated for use in pediatric patients. The most serious risks associated with ketorolac tromethamine tablets are: Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation Ketorolac tromethamine is contraindicated in patients with previously documented peptic ulcers and/or GI bleeding.
Ketorolac tromethamine can cause serious gastrointestinal (GI) adverse events including bleeding, ulceration and perforation, of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with ketorolac tromethamine. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.
Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatment with, ketorolac tromethamine. Do not use ketorolac tromethamine for more than five days.
However, even short-term therapy is not without risk. In addition to past history of ulcer disease, other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids, or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of ketorolac tromethamine until a serious GI adverse event is ruled out.
For high risk patients, alternate therapies that do not involve NSAIDs should be considered. NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. Hemorrhage Because prostaglandins play an important role in hemostasis and NSAIDs affect platelet aggregation as well, use of ketorolac tromethamine in patients who have coagulation disorders should be undertaken very cautiously, and those patients should be carefully monitored.
Patients on therapeutic doses of anticoagulants (e.g., heparin or dicumarol derivatives) have an increased risk of bleeding complications if given ketorolac tromethamine concurrently; therefore, physicians should administer such concomitant therapy only extremely cautiously. The concurrent use of ketorolac tromethamine and therapy that affects hemostasis, including prophylactic low-dose heparin (2500 to 5000 units q12h), warfarin and dextrans have not been studied extensively, but may also be associated with an increased risk of bleeding.
Until data from such studies are available, physicians should carefully weigh the benefits against the risks and use such concomitant therapy in these patients only extremely cautiously. Patients receiving therapy that affects hemostasis should be monitored closely. In postmarketing experience, postoperative hematomas and other signs of wound bleeding have been reported in association with the peri-operative use of IV or IM dosing of ketorolac tromethamine.
Therefore, peri-operative use of ketorolac tromethamine should be avoided and postoperative use be undertaken with caution when hemostasis is critical (see PRECAUTIONS ). Renal Effec…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reaction rates increase with higher doses of ketorolac tromethamine tablets. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine tablets, such as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see Boxed WARNING, WARNINGS, PRECAUTIONS , and DOSAGE AND ADMINISTRATION ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine tablets are indicated, especially when the drug is used inappropriately.
In patients taking ketorolac tromethamine tablets or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: Gastrointestinal (GI) experiences including: abdominal pain* constipation/diarrhea dyspepsia* flatulence GI fullness GI ulcers (gastric/duodenal) gross bleeding/perforation heartburn nausea* stomatitis vomiting Other experiences: abnormal renal function anemia dizziness drowsiness edema elevated liver enzymes headaches* hypertension increased bleeding time injection site pain pruritus purpura rashes tinnitus sweating *Incidence greater than 10% Additional adverse experiences reported occasionally (<1% in patients taking ketorolac tromethamine tablets or other NSAIDs in clinical trials) include: Body as a Whole : fever, infections, sepsis Cardiovascular : congestive heart failure, palpitation, pallor, tachycardia, syncope Dermatologic : alopecia, photosensitivity, urticaria Gastrointestinal: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia Metabolic and Nutritional : weight change Nervous System : abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise Reproductive, female: infertility Respiratory: asthma, cough, dyspnea, pulmonary edema, rhinitis Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention Other rarely observed reactions (reported from postmarketing experience in patients taking ketorolac tromethamine tablets or other NSAIDs) are: Body as a Whole: angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema (see WARNINGS), myalgia Cardiovascular: arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitis Dermatologic: exfoliative dermatitis, erythema multiforme, Lyell’s syndrome, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis Gastrointestinal: acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) Hemic and Lymphatic: agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, postoperative wound hemorrhage (rarely requiring blood transfusion — see Boxed WARNING, WARNINGS , and PRECAUTIONS ) Metabolic and Nutritional: hyperglycemia, hyperkalemia, hyponatremia Nervous System: aseptic meningitis, convulsions, coma, psychosis Respiratory: bronchospasm, respiratory depression, pneumonia Special Senses: conjunctivitis Urogenital: flank pain with or without hematuria and/or azotemia, hemolytic uremic syndrome Postmarketing Surveillance Study A large postmarketing observational, nonrandomized study, involving approximately 10,000 patients receiving ketorolac tromethamineIV/IM, demonstrated that the risk of clinically serious gastrointestina…
🔄 Drug Interactions ▾
Drug Interactions Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac tromethamine tablets induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs. Warfarin, Digoxin, Salicylate, and Heparin The in vitro binding of warfarin to plasma proteins is only slightly reduced by ketorolac tromethamine (99.5% control vs 99.3%) when ketorolac plasma concentrations reach 5 to 10 mcg/mL.
Ketorolac does not alter digoxin protein binding. In vitro studies indicate that, at therapeutic concentrations of salicylate (300 mcg/mL), the binding of ketorolac was reduced from approximately 99.2% to 97.5%, representing a potential twofold increase in unbound ketorolac plasma levels. Therapeutic concentrations of digoxin, warfarin, ibuprofen, naproxen, piroxicam, acetaminophen, phenytoin and tolbutamide did not alter ketorolac tromethamine protein binding.
In a study involving 12 adult volunteers, ketorolac tromethamine tablets were coadministered with a single dose of 25 mg warfarin , causing no significant changes in pharmacokinetics or pharmacodynamics of warfarin. In another study, ketorolac tromethamine dosed IV or IM was given with two doses of 5000 U of heparin to 11 healthy volunteers, resulting in a mean template bleeding time of 6.4 minutes (3.2 to 11.4 min) compared to a mean of 6 minutes (3.4 to 7.5 min) for heparin alone and 5.1 minutes (3.5 to 8.5 min) for placebo.
Although these results do not indicate a significant interaction between ketorolac tromethamine tablets and warfarin or heparin, the administration of ketorolac tromethamine tablets to patients taking anticoagulants should be done extremely cautiously, and patients should be closely monitored (see WARNINGS and PRECAUTIONS : Hematologic Effect ). The effects of warfarin and NSAIDs, in general, on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than the users of either drug alone.
Aspirin When ketorolac tromethamine tablets are administered with aspirin, its protein binding is reduced, although the clearance of free ketorolac tromethamine tablets are not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ketorolac tromethamine and aspirin is not generally recommended because of the potential of increased adverse effects. Diuretics Clinical studies, as well as postmarketing observations, have shown that ketorolac tromethamine tablets can reduce the natriuretic effect of furosemide and thiazides in some patients.
This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS : Renal Effects ), as well as to assure diuretic efficacy. Probenecid Concomitant administration of ketorolac tromethamine tablets and probenecid resulted in decreased clearance and volume of distribution of ketorolac and significant increases in ketorolac plasma levels (total AUC increased approximately threefold from 5.4 to 17.8 mcg/h/mL) and terminal half-life increased approximately twofold from 6.6 to 15.1 hours.
Therefore, concomitant use of ketorolac tromethamine tablets and probenecid is contraindicated. Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%.
These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices.
This may indicate that they could enhance the toxicity of methotrex…
🤰 Pregnancy ▾
Pregnancy Risk Summary Use of NSAIDs, including ketorolac tromethamine tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of ketorolac tromethamine tablets use between about 20 and 30 weeks of gestation and avoid ketorolac tromethamine tablets use at about 30 weeks of gestation and later in pregnancy (see WARNINGS; Fetal Toxicity). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including ketorolac tromethamine tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. Animal reproduction studies have been performed during organogenesis using daily oral doses of ketorolac tromethamine at 3.6 mg/kg (0.37 times the human AUC) in rabbits and at 10 mg/kg (1 times the human AUC) in rats.
Results of these studies did not reveal evidence of teratogenicity to the fetus. However, animal reproduction studies are not always predictive of human response. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.
In animal studies, administration of prostaglandin synthesis inhibitors such as ketorolac tromethamine, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses.
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including ketorolac tromethamine tablets, can cause premature closure of the fetal ductus arteriosus (see WARNINGS; Fetal Toxicity). Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible.
If ketorolac tromethamine tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue ketorolac tromethamine tablets and follow up according to clinical practice (see WARNINGS; Fetal Toxicity). Data Human Data Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus.
Oligohydramnios/Neonatal Renal Impairment: Published studies and post-marketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. In many cases, but not all, the decrease in amniotic f…
🧒 Pediatric Use ▾
Pediatric Use Ketorolac tromethamine tablets are not indicated for use in pediatric patients. The safety and effectiveness of ketorolac tromethamine tablets in pediatric patients below the age of 17 have not been established.
🧓 Geriatric Use ▾
Geriatric Use (≥65 years of age) Because ketorolac tromethamine may be cleared more slowly by the elderly (see CLINICAL PHARMACOLOGY ) who are also more sensitive to the dose-related adverse effects of NSAIDs (see WARNINGS: Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation ), extreme caution, reduced dosages (see DOSAGE AND ADMINISTRATION ), and careful clinical monitoring must be used when treating the elderly with ketorolac tromethamine tablets.
🆘 Overdosage ▾
OVERDOSAGE Symptoms and Signs Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare.
Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Treatment Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes.
Emesis and/or activated charcoal (60 g to 100 g in adults, 1 g/kg to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large oral overdose (5 to 10 times the usual dose). Forced diuresis, alkalization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding. Single overdoses of taking ketorolac tromethamine tablets have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacodynamics Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity in animal models. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The biological activity of ketorolac tromethamine is associated with the S-form.
Ketorolac tromethamine possesses no sedative or anxiolytic properties. The peak analgesic effect of ketorolac tromethamine occurs within 2 to 3 hours and is not statistically significantly different over the recommended dosage range of ketorolac tromethamine. The greatest difference between large and small doses of ketorolac tromethamine is in the duration of analgesia.
Pharmacokinetics Ketorolac tromethamine is a racemic mixture of [-]S- and [+]R-enantiomeric forms, with the S-form having analgesic activity. Comparison of IV, IM and Oral Pharmacokinetics The pharmacokinetics of ketorolac tromethamine, following IV and IM doses of ketorolac tromethamine and oral doses of ketorolac tromethamine tablets, are compared in Table 1. In adults, the extent of bioavailability following administration of the ORAL form of ketorolac tromethamine and the IM form of ketorolac tromethamine was equal to that following an IV bolus.
Linear Kinetics In adults, following administration of single ORAL doses of ketorolac tromethamine tablets or IM or IV doses of ketorolac tromethamine in the recommended dosage ranges, the clearance of the racemate does not change. This implies that the pharmacokinetics of ketorolac tromethamine in adults, following single or multiple IM or IV doses of ketorolac tromethamine or recommended oral doses of ketorolac tromethamine tablets, are linear. At the higher recommended doses, there is a proportional increase in the concentrations of free and bound racemate.
Absorption Ketorolac tromethamine tablets are 100% absorbed after oral administration (see Table 1) . Oral administration of ketorolac tromethamine tablets after a high-fat meal resulted in decreased peak and delayed time-to-peak concentrations of ketorolac tromethamine by about 1 hour. Antacids did not affect the extent of absorption.
Distribution The mean apparent volume (Vβ) of ketorolac tromethamine following complete distribution was approximately 13 liters. This parameter was determined from single-dose data. The ketorolac tromethamine racemate has been shown to be highly protein bound (99%).
Nevertheless, plasma concentrations as high as 10 mcg/mL will only occupy approximately 5% of the albumin binding sites. Thus, the unbound fraction for each enantiomer will be constant over the therapeutic range. A decrease in serum albumin, however, will result in increased free drug concentrations.
Ketorolac tromethamine is excreted in human milk (see PRECAUTIONS: Nursing Mothers ). Metabolism Ketorolac tromethamine is largely metabolized in the liver. The metabolic products are hydroxylated and conjugated forms of the parent drug.
The products of metabolism, and some unchanged drug, are excreted in the urine. Excretion The principal route of elimination of ketorolac and its metabolites is renal. About 92% of a given dose is found in the urine, approximately 40% as metabolites and 60% as unchanged ketorolac.
Approximately 6% of a dose is excreted in the feces. A single-dose study with 10 mg ketorolac tromethamine tablets (n=9) demonstrated that the S-enantiomer is cleared approximately two times faster than the R-enantiomer and that the clearance was independent of the route of administration. This means that the ratio of S/R plasma concentrations decreases with time after each dose.
There is little or no inversion of the R- to S- form in humans. The clearance of the racemate in normal subjects, elderly individuals and in hepatically and renally impaired patients is outlined in Table 2 (see CLINICAL PHARMACOLOGY : Kinetics in Special Populations ). The half-life of the ketoro…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ketorolac Tromethamine Tablets, USP 10 mg are available as white to off-white colored, film-coated, round shaped, bevel edged biconvex tablets debossed with 'K' on one side and 'H' on other side. Bottles of 100 tablets NDC 31722-686-01 Storage Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Protect from light and excessive humidity. Keep this and all medications out of the reach of children. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 PHARMACEUTICALS, INC.
Manufactured by: HETEROTM Hetero Labs Limited Jeedimetla, Hyderabad - 500 055, India Revised: 08/2022 camberlogo
📋 Description ▾
DESCRIPTION Ketorolac tromethamine tablets, USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the chemical structure is: Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP. Ketorolac tromethamine, USP may exist in three crystal forms.
All forms are equally soluble in water. Ketorolac tromethamine, USP has a pKa of 7.8 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.4.
Its molecular formula is C 19 H 24 N 2 O 6 . Ketorolac tromethamine tablets, USP are available as round, white to off-white, film-coated, bevel edged biconvex tablets. Each tablet contains 10 mg ketorolac tromethamine, USP, the active ingredient, with added hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and lactose monohydrate.
The white film-coating contains hypromellose, polyethylene glycol and titanium dioxide. structure
💬 Information for Patients ▾
Information for Patients Ketorolac tromethamine tablets are a potent NSAID and may cause serious side effects such as gastrointestinal bleeding or kidney failure, which may result in hospitalization and even fatal outcome. Physicians, when prescribing ketorolac tromethamine, should inform their patients or their guardians of the potential risks of ketorolac tromethamine treatment (see Boxed WARNING , WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections), instruct patients to seek medical advice if they develop treatment-related adverse events, and advise patients not to give ketorolac tromethamine tablets to other family members and to discard any unused drug.
Remember that the total combined duration of use of ketorolac tromethamine tablets and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine tablets are not indicated for use in pediatric patients. Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.
Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. 1. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately (see WARNINGS).
2. Ketorolac tromethamine, like other NSAIDs, can cause GI discomfort and rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis.
Patients should be apprised of the importance of this follow-up (see WARNINGS , Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation). 3. Serious Skin Reactions, including DRESS Advise patients to stop taking ketorolac tromethamine tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible (see WARNINGS).
4. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur (see WARNINGS). 5.
Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians. 6. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms).
If these occur, patients should be instructed to stop therapy and seek immediate medical therapy. 7. Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat).
If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS). 8. Fetal Toxicity Inform pregnant women to avoid use of ketorolac tromethamine tablets and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus.
If treatment with ketorolac tromethamine tablets are needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours (see WARNINGS; Fetal Toxicity, PRECAUTIONS; Pregnancy).