Toradol

• Ketorolac is a member of a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) that are used for treating inflammation and pain. Other drugs in this class include ibuprofen (Motrin) and naproxen (Naprosyn, Aleve), but ketorolac is more effective than other NSAIDs in reducing pain from both inflammatory and non-inflammatory causes. Ketorolac reduces the production of prostaglandins, chemicals that cells of the immune system make that cause the redness, fever, and pain of inflammation and that also are believed to be important in the production of non-inflammatory pain. It does this by blocking the enzymes that cells use to make prostaglandins (cyclooxygenase 1 and 2). As a result, pain as well as inflammation and its signs and symptoms, redness, swelling, fever, and pain, are reduced.
• The FDA approved ketorolac in November 1989.

>10%

Headache (17%)

Somnolence (3-14%)

Dyspepsia (12-13%)

GI pain (12-13%)

Nausea (12-13%)

1-10%

Diarrhea (3-9%)

Dizziness (3-9%)

Pruritus (3-9%)

Edema (1-3%)

Increased blood urea nitrogen (BUN) (3%)

Constipation (<3%)

Purpura (<3%)

Increased serum creatinine (2%)

Drowsiness (6%)

Hypertension (4%)

<1%

Abnormal thinking

Anaphylaxis

Blurred vision

Bronchospasm

Cholestatic jaundice

Depression

Difficulty in concentration

Dysgeusia

Euphoria

Hemolytic-uremic syndrome

Hepatitis

Hyperkalemia

Hyponatremia

Hypotension

Increased liver function test values

Insomnia

Laryngeal/lingual edema

Liver failure

Melena

Nervousness

Oliguria

Pallor

Peptic ulcer

Rash

Rectal bleeding

Stomatitis

Urinary frequency

Urinary retention

Vasodilation

Carefully consider the potential benefits and risks of TORADOL (ketorolac tromethamine) and other treatment options before deciding to use TORADOL (ketorolac tromethamine) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Acute Pain in Adult Patients

TORADOL (ketorolac tromethamine) ORAL is 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 TORADOL (ketorolac tromethamine) ORAL is to be used only as continuation treatment, if necessary.

The total combined duration of use of TORADOL (ketorolac tromethamine) ORAL 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 TORADOL (ketorolac tromethamine) ORAL therapy is not to exceed 5 days.

• Cheshire Pharm. Systems

• Compumed Pharmaceuticals, Inc.

• Roche Pharmaceuticals

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ketorolac falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Take ketorolac exactly as prescribed. Follow the directions on your prescription label carefully.

Oral Ketorolac

You will receive your first doses of ketorolac by intravenous (into a vein) or intramuscular (into a muscle) injection in a hospital or medical office. After that, your doctor may choose to continue your treatment with ketorolac tablets. Stop taking ketorolac tablets on the fifth day after you received your first ketorolac injection.

It is usually taken every 4 to 6 hours with a full glass of water.

Ketorolac Nasal Spray

The nasal spray is a liquid to be sprayed in the nostrils. 

It is usually used 3 or 4 times daily (every 6 to 8 hours) as needed for up to 5 days.

Ketorolac nasal spray can be taken on an empty stomach. If it causes upset stomach, try taking it with food.

If it irritates your throat, try sipping on water after using this medication.

Each bottle contains a one-day supply of medication. Throw away the bottle within 24 hours of using the first dose, even if the bottle still contains some medication.

Activate the pump before using each bottle for the first time. Hold the bottle away from your body, and press down on the flange 5 times. Read the instruction guide that comes with ketorolac nasal spray, and ask your healthcare provider or pharmacist if you have any questions.

Be careful not to get the medication in your eyes. If you do get ketorolac nasal spray in your eye, wash out the eye with water or sterile saline solution and call your doctor if irritation lasts longer than an hour.

Ketorolac Ophthalmic Solution

This medication comes in an ophthalmic (eye) solution form and is applied to the affected eye 4 times a day.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time.

• Store at room temperature.
• Protect from light.
• Keep this and all medicines out of the reach of children.

Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac is not a narcotic and is not habit-forming. It will not cause physical or mental dependence, as narcotics can. However, ketorolac is sometimes used together with a narcotic to provide better pain relief than either medicine used alone.

Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the dose of ketorolac and with the length of treatment. Therefore, ketorolac should not be used for more than 5 days. Before using this medicine, you should discuss with your doctor the good that this medicine can do as well as the risks of using it.

Ketorolac is available only with your doctor's prescription.

ToradolORAL 10 mg tablets are round, white, film-coated, red printed tablets. There is a large T printed on both sides of the tablet, with Toradol on one side, and ROCHE on the other, available in bottles of 100 tablets (NDC 0004-0273-01).

Storage

Store bottles at 15° to 30°C (59° to 86°F).

Package Insert Revised: March 2013

Toradol (ketorolac) is a nonsteroidal anti-inflammatory drug (NSAID). Ketorolac works by reducing hormones that cause inflammation and pain in the body.

Toradol is used short-term (5 days or less) to treat moderate to severe pain.

Toradol may also be used for purposes not listed in this medication guide.

Ask your doctor before using Toradol if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• lithium;

• methotrexate;

• heparin or warfarin (Coumadin, Jantoven);

• antipsychotic medicine;

• heart or blood pressure medication, including a diuretic or "water pill";

• seizure medicine (carbamazepine, phenytoin); or

• steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with ketorolac, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.