"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
(Generic versions may still be available.)
(ketorolac tromethamine) Tablets
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.
- 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).
- 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 (see WARNINGS).
- TORADOL (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
- 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.
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).
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 C19H24N2O6.
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;
- swelling or rapid weight gain;
- urinating less than...
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 anti-inflammatory 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 previous heart attack), high blood pressure, liver disease, growths in the nose (nasal polyps), throat/stomach/intestinal problems (such as...
Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.
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