Toradol

Ketorolac is a prescription medication used for the short-term treatment (up to 5 days) of moderately severe pain following surgery. It is also used for back pain, cancer pain, and pain caused by kidney stones. Ketorolac ophthalmic solution is used to treat itchy eyes caused by allergies and swelling and redness (inflammation) that can occur after cataract surgery. 

Ketorolac belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

This medication comes in tablet, injectable (intravenous or intramuscular), nasal spray, and ophthalmic solution forms. Ketorolac ophthalmic solution can be taken for up to 2 weeks after cataract surgery.

The side effects you can expect depend upon which form you are taking. For instance, the ophthalmic solution may cause burning and stinging of the eyes and blurry vision. Ketorolac nasal spray may cause nasal pain and discomfort, tearing, runny nose and throat irritation.

Ketorolac tablets may cause drowsiness, dizziness and headache. Do not drive or operate heavy machinery until you know how it affects you.

Ketorolac is a prescription medication used for the short-term treatment (up to 5 days) of moderately severe pain following surgery. It is also used for back pain, cancer pain, and pain caused by kidney stones. Ketorolac ophthalmic solution is used to treat itchy eyes caused by allergies and swelling and redness (inflammation) that can occur after cataract surgery. 

Ketorolac may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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

The ketorolac dose your doctor recommends will be based on the condition being treated.

Ketorolac Tablet

The first oral (tablet) dose for adults under the age of 65 is 20 mg, followed by 10 mg every 4 to 6 hours, as needed. For patients over the age of 65, those who have kidney problems, and those who weigh less than 110 pounds, the usual recommended dose is 10 mg every 4 to 6 hours.

Maximum daily dose is 40 mg. Maximum length of therapy is 5 days.

Ketorolac Ophthalmic (Eye drops) Solution

The recommended dose of Acular LS (ketorolac 0.4%) is one drop 4 times a day in the operated eye as needed for pain and burning/stinging. May use up to 4 days after surgery.

The recommeded dose of Acuvail (ketorolac 0.45%) is one drop instilled into the affected eye twice daily beginning 1 day before cataract surgery, and continued through the first 2 weeks after surgery.

The recommended dose is one drop of Acular (ketorolac 0.5%) 4 times a day to the affected eye(s) for relief of eye itching due to allergies.

The recommended dose of Acular (ketorolac 0.5%) is one drop to the affected eye 4 times a day starting 24 hours after cataract surgery. May use for up to 2 weeks after cataract surgery.

Ketorolac Nasal Spray

The recommended dose is one spray into each nostril (two sprays total) every 6 to 8 hours. Ketorolac nasal spray should not be used more than 4 times daily.

For patients over the age of 65, those who have kidney problems, and those who weigh less than 110 pounds, the dosage may be one spray into one nostril every 6 to 8 hours.

WARNING

Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days) management of moderately severe acute pain that requires analgesia at the opioid level. It is NOT indicated for minor or chronic painful conditions. Ketorolac tromethamine is a potent NSAID analgesic, and its administration carries many risks. The resulting NSAID-related adverse events can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately. Increasing the dose of ketorolac tromethamine beyond the label recommendations will not provide better efficacy but will result in increasing the risk of developing serious adverse events.

Gastrointestinal Effects

• Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding, and/or perforation. 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.

Renal Effects

• 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.
• Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery, and is CONTRAINDICATED intra-operatively when hemostasis is critical because of the increased risk of bleeding.

Hypersensitivity

• Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of ketorolac tromethamine injection. Ketorolac tromethamine is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Intrathecal or Epidural Administration

• Ketorolac tromethamine is CONTRAINDICATED for intrathecal or epidural administration due to its alcohol content.

Labor, Delivery and Nursing

• The use of ketorolac tromethamine in labor and delivery is CONTRAINDICATED because it may adversely affect fetal circulation and the uterus.
• The use of ketorolac tromethamine is CONTRAINDICATED in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.

Concomitant Use with NSAIDs

• Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving ASA or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.

DOSAGE AND ADMINISTRATION

Ketorolac Tromethamine Tablets

• Ketorolac tromethamine tablets are indicated only as continuation therapy to ketorolac tromethamine injection, and the combined duration of use of ketorolac tromethamine injection and ketorolac tromethamine tablets is not to exceed 5 (five) days, because of the increased risk of serious adverse events.
• The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine injection  (maximum 120 mg).

Special Populations

• Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight, and for patients with moderately elevated serum creatinine. Doses of ketorolac tromethamine injection are not to exceed 60 mg (total dose per day) in these patients.

Serious side effects have been reported including:

• bleeding, ulcers, and gastrointestinal perforations (holes) as well as other potentially life-threatening stomach and intestinal problems. Contact your healthcare provider immediately if you experience any signs or symptoms of ulcers or bleeding, such as:
  • tarry, black stools
  • blood in urine
  • blood in stools
  • stomach pain
  • indigestion
  • vomiting blood
• kidney damage
• heart attacks and strokes. Contact your healthcare provider if you have:
  • chest pain
  • weakness
  • slurred speech
  • shortness of breath
• liver problems. Tell your doctor if you have:
  • nausea
  • upper stomach pain
  • extreme tiredness
  • yellowing of skin or whites of eyes
• edema (swelling) or congestive heart failure
• allergic reactions. Tell your doctor if you have:
  • rash
  • hives
  • difficulty breathing
  • swelling of the face or throat

Serious side effects have been reported with ketorolac ophthalmic solution including:

• Delayed healing. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Use of topical NSAIDs and topical steroids at the same time may increase the potential for healing problems.
• Hypersensitivity. There have been reports of asthma attacks or the worsening of asthma linked with the use of ketorolac ophthalmic solution in patients who have either a known hypersensitivity to aspirin/NSAID drugs or a past medical history of asthma.
• Increased Bleeding Time. There have been reports that NSAIDs applied to the eyes drugs may cause increased if also undergoing surgery. It is recommended that ketorolac ophthalmic solution be used with caution in those with known bleeding tendencies or who are receiving other medications that may increase bleeding time.
• Corneal Effects. Use of topical NSAIDs may result in keratitis, or inflammation of the clear tissue covering your eyes. This may be reduce your sight if not corrected. Immediately stop use of ketorolac ophthalmic solution if your vision changes and talk to your healthcare provider about these changes.
• Contact lens wear. Ketorolac ophthalmic solution should not be used while wearing contact lenses.

Ketorolac ophthalmic solution can cause blurry vision. Do not drive or operate heavy machinery until you know how ketorolac ophthalmic solution affects you.

Do not take ketorolac ophthalmic solution if you are allergic to ketorolac ophthalmic solution or to any of its ingredients.

Serious side effects have been reported. See the “Drug Precautions” section.

Common side effects of ketorolac tablets and injectable forms include:

• headache
• stomach pain
• nausea
• heartburn
• diarrhea
• drowsiness/dizziness
• swelling

Common side effects of ketorolac nasal spray include the side effects listed above as well as:

• nasal discomfort
• tearing
• throat irritation
• runny or stuffy nose

Common side effects of ketorolac ophthalmic solution include:

• burning and stinging of the eyes
• blurry vision

This is not a complete list of ketorolac side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• blood thinners such as warfarin (Coumadin, Jantoven)
• aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• dexamethasone (Decadron, Dexone)
• methylprednisolone (Medrol)
• prednisone (Deltasone)
• ACE inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinvil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace) and trandolapril (Mavik)
• antidepressants
• medications for anxiety or mental illness
• carbamazepine (Tegretol)
• phenytoin (Dilantin)
• methotrexate (Rheumatrex)
• sedatives
• sleeping pills
• tranquilizers

This is not a complete list of ketorolac drug interactions. Ask your doctor or pharmacist for more information.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Ketorolac passes into human milk. Because this medication may cause harm to the baby, ketorolac should not be used while nursing.

Ketorolac should only be used for a short-term (up to 5 days) to manage moderately severe acute pain.

Ketorolac is NOT indicated for minor or chronic painful conditions.

Ketorolac is a potent nonsteroidal anti-inflammatory drug (NSAID) analgesic, and it carries many risks.

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.