GENERIC NAME: Ketorolac BRAND NAME: Toradol CLASSIFICATION: Nonsteroidal anti-inflammatory agents, nonopioid analagesics DOSAGE: 30mg/amp1 amp

IM MECHANISM OF ACTION: - Inhibits prostaglandin synthesis, producing peripherally mediated analgesia - Also has antipyretic and anti-inflammatory properties. - Therapeutic effect:Decreased pain INDICATION: Short term management of pain (not to exceed 5 days total for all routes combined) CONTRAINDICATIONS: - Hypersensitivity - Cross-sensitivity with other NSAIDs may existPre- or perioperative use - Known alcohol intoleranceUse cautiously in: 1) History of GI bleeding 2) Renal impair-ment (dosage reduction may be required) 3) Cardiovascular disease SIDE EFFECTS/ ADVERSE EFFECTS: - CNS: 1) drowsiness 2) abnormal thinking 3) dizziness 4) euphoria 5) headache- RESP: 1) asthma 2) dyspnea - CV: 1) edema 2) pallor 3) vasodilation - GI: 1) GI Bleeding 2) abnormal taste 3) diarrhea 4) dry mouth 5) dyspepsia

6) GI pain 7) nausea - GU: 1) oliguria 2) renal toxicity 3) urinary frequency - DERM: 1) pruritis 2) purpura 3) sweating 4) urticaria - HEMAT: 1) prolonged bleeding time - LOCAL: 1) injection site pain - NEURO: 1) paresthesia - MISC: 1) allergic reaction, anaphylaxis NURSING IMPLICATIONS/RESPONSIBILITIES: - Patients who have asthma, aspirin-induced allergy, and nasal polyps are at increased risk for developing hypersensitivity reactions. Assess for rhinitis, asthma, and urticaria. - Assess pain (note type, location, and intensity) prior to and 1-2 hr following administration. - Ketorolac therapy should always be given initially by the IM or IV route. Oral therapy should be used only as a continuation of parenteral therapy. - Caution patient to avoid concurrent use of alcohol, aspirin, NSAIDs, acetaminophen, or other OTC medications without consulting health care professional. - Advise patient to consult if rash, itching, visual disturbances, tinnitus, weight gain, edema, black stools, persistent headche, or influenza-like syndromes (chills,fever,muscles aches, pain) occur. - Effectiveness of therapy can be demonstrated by decrease in severity of pain. Patients who do not respond to one NSAIDs may respond to another.

TORADOL (ketorolac tromethamine) Tablets

WARNING TORADOLORAL (ketorolac tromethamine), 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 TORADOLORAL and ketorolac tromethamine should not exceed 5 days. TORADOL (ketorolac tromethamine) ORAL is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of TORADOL (ketorolac tromethamine) ORAL 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 TORADOL (ketorolac tromethamine) 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, TORADOL (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 RISK

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke,
which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS and CLINICAL TRIALS).

TORADOL (ketorolac tromethamine) is CONTRAINDICATED for the treatment of peri-operative pain in the setting of
coronary artery bypass graft (CABG) surgery (seeWARNINGS). RENAL RISK

TORADOL (ketorolac tromethamine) is CONTRAINDICATED in patients with advanced renal impairment and in patients
at risk for renal failure due to volume depletion (seeWARNINGS). RISK OF BLEEDING

TORADOL (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). TORADOL (ketorolac tromethamine) is CONTRAINDICATED as prophylactic analgesic before any major surgery. RISK DURING LABOR AND DELIVERY

 The use of TORADOL (ketorolac tromethamine) in labor and delivery is contraindicated because it may adversely affect
fetal circulation and inhibit uterine contractions. The use of TORADOL (ketorolac tromethamine) is contraindicated in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates. CONCOMITANT USE WITH NSAIDS

TORADOL (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).

DRUG DESCRIPTION TORADOL (ketorolac tromethamine) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine 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 is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Its molecular formula is C 19H24N2O6. TORADOL (ketorolac tromethamine) ORAL is available as round, white, film-coated, red-printed tablets. Each tablet contains 10 mg ketorolac tromethamine, the active ingredient, with added lactose, magnesium stearate and microcrystalline cellulose. The white film-coating contains hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide. The tablets are printed with red ink that includes FD&C Red #40 Aluminum Lake as the colorant. There is a large T printed on both sides of the tablet, as well as the word TORADOL (ketorolac tromethamine) on one side, and the word ROCHE on the other.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF KETOROLAC (TORADOL, TORADOL IM, TORADOL IV/IM)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking ketorolac and seek medical attention or call your doctor at once if you have any of these serious side effects:

chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance; black, bloody, or tarry stools; coughing up blood or vomit that looks like coffee grounds; ...

Read All Potential Side Effects and See Pictures of Toradol

WHAT ARE THE PRECAUTIONS WHEN TAKING KETOROLAC TROMETHAMINE (TORADOL)?

Before taking ketorolac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other nonsteroidal antiinflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, blood disorders (such as anemia), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, growths in the nose (nasal polyps)

IMPORTANT WARNING:
Ketorolac is used for the short-term relief of moderately severe pain and should not be used for longer than 5 days, for mild pain, or for pain from chronic (long-term) conditions. 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 oral ketorolac. You must stop taking oral ketorolac on the fifth day after you received your first ketorolac injection. Talk to your doctor if you still have pain after 5 days or if your pain is not controlled with this medication. Ketorolac may cause serious side effects, especially when taken improperly. Take ketorolac exactly as directed. Do not take more of it or take it more often than prescribed by your doctor. People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as ketorolac may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke or 'ministroke;' if you smoke; and if you have or have ever had high cholesterol, high blood pressure, bleeding or clotting problems, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech. If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ketorolac. If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take ketorolac right before or right after the surgery. NSAIDs such as ketorolac may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking ketorolac. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin; or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Do not take aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) while you are taking ketorolac. Also tell your doctor if you have or have ever had ulcers or bleeding in your stomach or intestines. If you experience any of the following symptoms, stop taking ketorolac and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools. Ketorolac may cause kidney failure. Tell your doctor if you have kidney or liver disease, if you have had severe vomiting or diarrhea or think you may be dehydrated, and if you are taking angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); or diuretics ('water pills'). If you experience any of the following symptoms, stop taking ketorolac and call your doctor: swelling of the hands, arms, feet, ankles, or lower legs; unexplained weight gain; confusion; or seizures. Some people have severe allergic reactions to ketorolac. Tell your doctor if you are allergic to ketorolac, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn), or any other medications. Also tell your doctor if you have or have ever had asthma, especially if you also have frequent stuffed or runny nose or nasal

polyps (swelling of the lining of the nose). If you experience any of the following symptoms, stop taking ketorolac and call your doctor right away: rash; hives; itching; swelling of the eyes, face, throat, tongue, arms, hands, ankles, or lower legs; difficulty breathing or swallowing; or hoarseness. Do not breastfeed while you are taking ketorolac. Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to ketorolac. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ketorolac and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) to obtain the Medication Guide.

Why is this medication prescribed?

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.

How should this medicine be used?

Ketorolac comes as a tablet to take by mouth. It is usually taken every 4 to 6 hours on a schedule or as needed for pain. If you are taking ketorolac on a schedule, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Other uses for this medicine

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This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

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Before taking ketorolac,

do not take ketorolac if you are taking probenecid. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antidepressants; medications for anxiety or mental illness; medications for seizures such as carbamazepine (Tegretol) or phenytoin (Dilantin); methotrexate (Rheumatrex); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects. tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section or swelling of the hands, feet, ankles, or lower legs. tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or you plan to become pregnant. If you become pregnant while taking ketorolac, call your doctor.

talk to your doctor about the risks and benefits of taking ketorolac if you are 65 years of age or older. Older adults should not usually take ketorolac because it is not as safe as other medications that can be used to treat the same condition.

you should know that this medication may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you. talk to your doctor about the safe use of alcohol while taking this medication. Alcohol can make the side effects of ketorolac worse.

What special dietary instructions should I follow?

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Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

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If your doctor has told you to take ketorolac regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

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Ketorolac may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

headache dizziness drowsiness diarrhea constipation gas sores in the mouth sweating

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more ketorolac until you speak to your doctor.

fever blisters

yellowing of the skin or eyes excessive tiredness unusual bleeding or bruising lack of energy nausea loss of appetite pain in the upper right part of the stomach flu-like symptoms pale skin fast heartbeat cloudy, discolored, or bloody urine back pain difficult or painful urination

Ketorolac may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1800-332-1088].

What storage conditions are needed for this medicine?

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Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
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In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

nausea vomiting

stomach pain bloody, black, or tarry stools vomit that is bloody or looks like coffee grounds drowsiness slowed breathing or fast, shallow breathing coma (loss of consciousness for a period of time)

What other information should I know?

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Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names
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Toradol