Ketorolac

What is Ketorolac?

• Ketorolac (Acular; Toradol) is a pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) used to relieve moderately severe pain, usually after surgery.

Ketorolac

Ketorolac-tromethamine

Ketorolac ball-and-stick

What are the uses of this medicine?

• Ketorolac (Acular; Toradol) is used for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.

How does this medicine work?

• Ketorolac tromethamine belongs to the acetic acid class of NSAIDs similar to diclofenac and etodolac.
• Like other NSAIDs, ketorolac is a potent cyclo-oxygenase (Cox) inhibitor which blocks the formation of prostaglandins that are important in pain and inflammatory pathways.
• The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• previously demonstrated hypersensitivity to ketorolac tromethamine
• active peptic ulcer disease
• recent gastrointestinal bleeding or perforation
• a history of peptic ulcer disease or gastrointestinal bleeding
• as prophylactic analgesic before any major surgery
• has coronary artery bypass graft (CABG) surgery
• advanced renal impairment
• in labor and delivery
• confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding
• currently receiving aspirin or NSAIDs
• probenecid
• pentoxifylline

What drug interactions can this medicine cause?

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 any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)

aspirin

• oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos)
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft)
• serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR).
• Do not take aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• antidepressants
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka)
• angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT)
• beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, InnoPran)
• medications for anxiety or mental illness
• medications for seizures such as carbamazepine (Epitol, Tegretol, Teril, others) or phenytoin (Dilantin, Phenytek) methotrexae (Otrexup, Rasuvo, Trexall)
• sedatives
• sleeping pills
• tranquilizers

Is this medicine FDA approved?

• Ketorolac was approved in the United States in 1991 and current indications are limited to the short term management of moderately severe, acute pain.

How should this medicine be used?

Recommended dosage:

• The recommended dose is 60 mg intramuscularly or 30 mg intravenously initially, followed by 30 mg every 6 hours for up to 5 days. An oral form is available in 10 mg tablets for switching from the parenteral form and is given every 6 to 8 hours, but continuation beyond 5 days is not recommended.
• 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.

Administration:

• Ketorolac injection comes as a solution (liquid) to inject intramuscularly (into a muscle) or intravenously (into a vein).
• 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.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Ketorolac is available in parenteral and oral forms in multiple generic forms
• Ketorolac tromethamine tablets
• Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration

This medicine is available in fallowing brand namesː

• Acular; Toradol

What side effects can this medication cause?

The most common side effects of this medicine include:

• abdominal pain
• constipation/diarrhea
• dyspepsia
• flatulence
• GI fullness
• GI ulcers (gastric/duodenal)
• gross bleeding/perforation
• heartburn
• nausea
• stomatitis
• vomiting
• abnormal renal function
• anemia
• dizziness
• drowsiness
• edema
• elevated liver enzymes
• headaches
• hypertension
• increased bleeding time
• injection site pain
• pruritus
• purpura
• rashes
• tinnitus
• sweating

What special precautions should I follow?

• 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 healthcare provider immediately.
• 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.
• Advise patients to stop taking ketorolac tromethamine immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible.
• 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.
• 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.
• 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.
• Inform pregnant women to avoid use of ketorolac tromethamine 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 is 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.
• Ketorolac is generally given for a few days only, and has not been linked to instances of idiosyncratic drug induced liver disease in the published literature.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• lethargy
• drowsiness
• nausea
• vomiting
• epigastric pain
• Gastrointestinal bleeding
• Hypertension
• acute renal failure
• respiratory depression
• coma
• Anaphylactoid reactions

Treatment of overdosage:

• 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.

Can this medicine be used in pregnancy?

• Use of NSAIDs, including ketorolac, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Can this medicine be used in children?

• Ketorolac is not indicated for use in pediatric patients.
• The safety and effectiveness of ketorolac in pediatric patients below the age of 17 have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• KETOROLAC TROMETHAMINE

Inactive Ingredients:

• ANHYDROUS CITRIC ACID
• ALCOHOL
• SODIUM CHLORIDE
• WATER
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID

Who manufactures and distributes this medicine?

Ketorolac Tromethamine Injection: Manufactured by:

• Hikma Pharmaceuticals USA Inc.
• Berkeley Heights, NJ

Ketorolac tromethamine tablets: Manufactured For:

• Teva Pharmaceuticals
• Parsippany, NJ

What should I know about storage and disposal of this medication?

Ketorolac Tromethamine Injection:

• Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).

Ketorolac tromethamine tablets:

• Store at 20° to 25°C (68° to 77°F).
• 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.

Nonsteroidal Antiinflammatory Drugs (NSAIDs)

Acetaminophen, Celecoxib, Diclofenac, Diflunisal, Etodolac, Fenoprofen, Flurbiprofen, Ibuprofen, Indomethacin, Ketoprofen, Ketorolac, Mefenamic Acid, Meloxicam, Nabumetone, Naproxen, Nimesulide, Oxaprozin, Phenylbutazone, Piroxicam, Rofecoxib, Sulindac, Tolmetin

• Dailymed label info on Ketorolac
• FDA Ketorolac