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Friday, October 3, 2014

Ketorolac

    

                   Ketorolac



Generic Name: ketorolac (KEE-toe-ROLE-ak)
Brand Name: Toradol
Ketorolac is only intended for short-term (up to 5 days) treatment of moderately severe pain. It should not be used to treat minor or long-term pain. Do not use more of ketorolac than prescribed. Do not use ketorolac to treat children.
Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take ketorolac for a long time. Do not use ketorolac right before or after coronary artery bypass graft (CABG).
Ketorolac may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Do not use ketorolac if:
  • you are allergic to ketorolac, aspirin, or any other NSAIDs (eg, ibuprofen, celecoxib)
  • you are taking aspirin or another NSAID (eg, ibuprofen, celecoxib)
  • you are breast-feeding or are in labor
  • you have recently had or will be having CABG
  • you have a stomach ulcer or a history of ulcers or severe stomach problems (eg, bleeding, perforation)
  • you have severe kidney problems or are at risk of kidney failure (eg, low blood volume, dehydrated)
  • you have bleeding in the brain (eg, stroke, aneurysm) or bleeding problems (eg, platelet disorder, hemophilia), or you are at risk of bleeding
Do not use ketorolac to prevent pain before any major surgery.

Ketorolac is used for:

The short-term (up to 5 days) treatment of moderately severe pain (usually after surgery), alone or in combination with other medicines.
Ketorolac is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes these symptoms.

Do NOT use ketorolac if:

  • you are allergic to any ingredient in ketorolac
  • you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin or an NSAID (eg, ibuprofen, naproxen, celecoxib)
  • you are taking pentoxifylline, probenecid, aspirin, or another NSAID (eg, ibuprofen, celecoxib)
  • you are in the last 3 months of pregnancy, are breast-feeding, or are in labor
  • you have recently had or will be having CABG or you have a stomach ulcer or a history of ulcers or severe stomach problems (eg, bleeding, perforation)
  • you have severe kidney problems or are at risk of kidney failure (eg, low blood volume, dehydrated)
  • you have bleeding in the brain (eg, stroke, aneurysm) or bleeding problems (eg, platelet disorder, hemophilia), or you are at risk of bleeding
  • you need to prevent pain before any major surgery
Contact your doctor or health care provider right away if any of these apply to you.

Before using ketorolac:

Some medical conditions may interact with ketorolac. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, Crohn disease)
  • if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
  • if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or you are at risk of any of these diseases
  • if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you smoke, drink alcohol, or have a history of alcohol abuse
Some MEDICINES MAY INTERACT with ketorolac. Tell your health care provider if you are taking any other medicines, especially any of the following:
  • Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), heparin and other blood thinners (eg, dalteparin), pentoxifylline, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of bleeding may be increased
  • Probenecid because it may increase the risk of ketorolac's side effects
  • Cyclosporine, lithium, metformin, methotrexate, oral NSAIDs (eg, ibuprofen), or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by ketorolac
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by ketorolac
This may not be a complete list of all interactions that may occur. Ask your health care provider if ketorolac may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Brand NameContainsDosage FormManufacturerPrice(Tk.)
ACUPAINKetorolac tromethamine 10mg/tabletTablet (film-coated)Beacon Pharmaceuticals Ltd.30s pack: 300.00 MRP
ACUPAINKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionBeacon Pharmaceuticals Ltd.30mg (1ml) amp x 5s pack: 275.00 MRP
ANALACKetorolac tromethamine 10mg/tabletTablet (film-coated)Ziska Pharmaceuticals Ltd.20s pack: 200.00 MRP
ANALACKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionZiska Pharmaceuticals Ltd.30mg (1ml) amp x 5s pack: 275.00 MRP
AROLAKKetorolac tromethamine 10mg/tabletTablet (film-coated)Ambee Pharmaceuticals Ltd.20s pack: 200.00 MRP
AROLAKKetorolac tromethamine 10mg/1ml ampoule & 30mg/1ml ampoulei.m/i.v InjectionAmbee Pharmaceuticals Ltd.10mg (1ml) amp x 5s pack: 150.00 MRP; 30mg (1ml) amp x 5s pack: 275.00 MRP
E-KETKetorolac tromethamine 10mg/tabletTablet (film-coated)Edruc Limited20s pack: 200.00 IP
E-KETKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionEdruc Limited30mg (1ml) amp x 5s pack: 250.00 MRP
EMODOLKetorolac tromethamine 10mg/tabletTablet (film-coated)Jayson Pharmaceuticals Ltd.20s pack: 200.00 IP
EMODOLKetorolac tromethamine 10mg/1ml ampoule & 30mg/1ml ampoulei.m/i.v InjectionJayson Pharmaceuticals Ltd.10mg (1ml) amp x 10s pack: 331.30 IP; 30mg (1ml) amp x 5s pack: 250.00 IP; 30mg (1ml) amp x 10s pack: 556.30 IP
ETOLACKetorolac tromethamine 10mg/tabletTablet (film-coated)Ibn Sina Pharmaceutical Ind. Ltd.20s pack: 200.00 MRP
ETOLACKetorolac tromethamine 10mg/1ml ampoule & 30mg/1ml ampoule & 60mg/2ml ampoulei.m/i.v InjectionIbn Sina Pharmaceutical Ind. Ltd.10mg (1ml) amp x 10s pack: 320.00 MRP; 30mg (1ml) amp x 10s pack: 550.00 MRP; 60mg (2ml) amp x 1s pack: 95.00 MRP
ETORACKetorolac tromethamine 10mg/tabletTablet (film-coated)Incepta Pharmaceuticals Ltd.30s pack: 300.00 MRP
ETORACKetorolac tromethamine 30mg/1ml ampoule & 60mg/1ml ampoulei.m/i.v InjectionIncepta Pharmaceuticals Ltd.30mg (1ml) amp x 1s pack: 55.00 MRP; 60mg (2ml) amp x 1s pack: 95.00 MRP
KELACKetorolac tromethamine 10mg/tabletTabletChemist Laboratories Ltd.20s pack: 160.00 MRP
KELACKetorolac tromethamine 10mg/1ml ampoule & 30mg/1ml ampoulei.m/i.v InjectionChemist Laboratories Ltd.10mg (1ml) amp x 5s pack: 125.00 MRP; 30mg (1ml) amp x 5s pack: 175.00 MRP
KENODOLKetorolac tromethamine 10mg/tabletTablet (film-coated)Rangs Pharmaceuticals Ltd.20s pack: 240.00 MRP
KENODOLKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionRangs Pharmaceuticals Ltd.30mg (1ml) amp x 6s pack: 300.00 MRP
KEROLACKetorolac tromethamine 10mg/tabletTablet (film-coated)Gaco Pharmaceuticals20s pack: 200.00 MRP
KETEKSKetorolac tromethamine 10mg/tabletTablet (film-coated)RAK Pharmaceuticals Pvt. Ltd.30s pack: 300.00 MRP


Brand NameContainsDosage FormManufacturerPrice(Tk.)
KETOBE 10Ketorolac tromethamine 10mg/tabletTablet (film-coated)Benham Pharmaceutical Ltd.30s pack: 298.20 MRP
KETOFLEXKetorolac tromethamine 10mg/tabletTablet (film-coated)Somatec Pharmaceutical Ltd.20s pack: 200.00 MRP
KETONICKetorolac tromethamine 10mg/tabletTablet (film-coated)Eskayef Bangladesh Ltd.20s pack: 200.00 MRP
KETONICKetorolac tromethamine 10mg/1ml ampoule & 30mg/1ml ampoulei.m/i.v InjectionEskayef Bangladesh Ltd.10mg (1ml) amp x 5s pack: 160.00 MRP; 30mg (1ml) amp x 5s pack: 275.00 MRP
KETORINKetorolac tromethamine 10mg/tabletTablet (film-coated)Orion Pharma Ltd.20s pack: 200.00 MRP
KETORINKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionOrion Pharma Ltd.30mg (1ml) amp x 5s pack: 250.00 MRP
KETROMINKetorolac tromethamine 10mg/tabletTablet (film-coated)Pacific Pharmaceuticals Ltd.20s pack: 200.00 MRP
KFLAMKetorolac tromethamine 10mg/tabletTablet (film-coated)Apex Pharmaceuticals Ltd.20s pack: 120.00 MRP
KFLAMKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionApex Pharmaceuticals Ltd.30mg (1ml) amp x 5s pack: 200.00 MRP
LOPADOLKetorolac tromethamine 10mg/tabletTablet (film-coated)Popular Pharmaceuticals Ltd.20s pack: 200.00 IP
LOPADOLKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionPopular Pharmaceuticals Ltd.30mg (1ml) amp x 5s pack: 250.00 IP
MINOLACKetorolac tromethamine 10mg/tabletTablet (film-coated)ACI Ltd.20s pack: 200.00 IP
MINOLACKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionACI Ltd.30mg (1ml) amp x 1s pack: 55.00 IP
OFPAINKetorolac tromethamine 10mg/tabletTablet (film-coated)Kemiko Pharmaceuticals Ltd.20s pack: 200.00 MRP
OFPAINKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionKemiko Pharmaceuticals Ltd.30mg (1ml) amp x 1s pack: 50.00 MRP
ORADOLKetorolac tromethamine 10mg/tabletTablet (film-coated)Aristopharma Ltd.20s pack: 200.00 MRP
ORADOLKetorolac tromethamine 30mg/1ml ampoule & 60mg/1ml ampoulei.m/i.v InjectionAristopharma Ltd.30mg (1ml) amp x 1s pack: 55.00 MRP; 60mg (2ml) amp x 1s pack: 95.00 MRP
ORCKetorolac tromethamine 10mg/tabletTablet (film-coated)Navana Pharmaceuticals Ltd.20s pack: 200.00 MRP
PAIRKetorolac tromethamine 10mg/tabletTablet (film-coated)Drug International Ltd.30s pack: 300.00 MRP
PAIR -30Ketorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionDrug International Ltd.30mg (1ml) amp x 5s pack: 250.00 MRP


PERILACKetorolac tromethamine 10mg/tabletTablet (film-coated)Bio Pharma Laboratories Ltd.20s pack: 200.00 MRP
PERILACKetorolac tromethamine 10mg/1ml ampoule & 30mg/1ml ampoulei.m/i.v InjectionBio Pharma Laboratories Ltd.10mg (1ml) amp x 5s pack: 150.00 MRP; 30mg (1ml) amp x 5s pack: 250.00 MRP
ROKET 10Ketorolac tromethamine 10mg/tabletTablet (film-coated)Globe Pharmaceuticals Ltd.20s pack: 200.00 MRP
ROKET 30Ketorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionGlobe Pharmaceuticals Ltd.30mg (1ml) amp x 5s pack: 250.00 MRP
ROLACKetorolac tromethamine 10mg/tabletTablet (film-coated)Renata Limited30s pack: 300.00 MRP
ROLACKetorolac tromethamine 10mg/1ml ampoule & 30mg/1ml ampoule & 60mg/2ml ampoulei.m/i.v InjectionRenata Limited10mg (1ml) amp x 1s pack: 32.00 MRP; 30mg (1ml) amp x 1s pack: 55.00 MRP; 60mg (2ml) amp x 2s pack: 190.00 MRP
ROTEKKetorolac tromethamine 10mg/tabletTablet (film-coated)Health Care Pharmaceuticals Ltd.20s pack: 200.00 MRP
ROTEKKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionHealth Care Pharmaceuticals Ltd.30mg (1ml) amp x 5s pack: 250.00 MRP
TODOLKetorolac tromethamine 10mg/tabletTablet (film-coated)Opsonin Pharma Limited30s pack: 300.00 MRP
TODOLKetorolac tromethamine 30mg/1ml ampoule & 60mg/1ml ampoulei.m/i.v InjectionOpsonin Pharma Limited30mg (1ml) amp x 5s pack: 280.00 MRP; 60mg (2ml) amp x 1s pack: 95.00 MRP
TOLECKetorolac tromethamine USP 10mg/tabletTablet (film-coated)Alco Pharma Ltd.20s pack: 200.00 MRP
TORADOLKetorolac tromethamine 10mg/tabletTablet (film-coated)Roche Bangladesh Pharmaceuticals Ltd.20s pack: 460.20 MRP
TORAXKetorolac tromethamine 10mg/1ml ampoule & 30mg/1ml ampoule & 60mg/2ml ampoulei.m/i.v InjectionSquare Pharmaceuticals Ltd.10mg (1ml) amp x 5s pack: 150.00 MRP; 30mg (1ml) amp x 5s pack: 275.00 MRP; 60mg (2ml) amp x 1s pack: 95.00 MRP
TORAX 10Ketorolac tromethamine 10mg/tabletTablet (film-coated)Square Pharmaceuticals Ltd.30s pack: 300.00 MRP
TOROLACKetorolac tromethamine 10mg/tabletTablet (film-coated)Silva Pharmaceuticals Ltd.20s pack: 200.00 MRP
WINOPKetorolac tromethamine 10mg/tabletTablet (film-coated)Acme Laboratories Ltd.20s pack: 200.00 MRP
WINOPKetorolac tromethamine 30mg/1ml ampoule & 60mg/1ml ampoulei.m/i.v InjectionAcme Laboratories Ltd.10mg (1ml) amp x 5s pack: 150.00 MRP; 30mg (1ml) amp x 1s pack: 50.00 MRP
XENOLAC-10Ketorolac tromethamine 10mg/tabletTablet (film-coated)Shamsul Alamin Pharmaceuticals Ltd.20s pack: 200.00 MRP
XIDOLOCKetorolac tromethamine 10mg/tabletTablet (film-coated)Beximco Pharmaceuticals Ltd.20s pack: 200.00 IP
ZEPACKetorolac tromethamine 10mg/tabletTablet (film-coated)Novartis (Bangladesh) Ltd.30s pack: 300.00 MRP


ZEPACKetorolac tromethamine 30mg/1ml ampoulei.m/i.v InjectionNovartis (Bangladesh) Ltd.30mg (1ml) amp x 5s pack: 300.00 MRP
ZEROPAINKetorolac tromethamine 10mg/tabletTablet (film-coated)Health Care Pharmaceuticals Ltd.20s pack: 240.00 MRP












For the Consumer

Applies to ketorolac: injectable, solution, tablet
Other dosage forms:
In addition to its needed effects, some unwanted effects may be caused by ketorolac. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking ketorolac:
More common
  • Swelling of face, fingers, lower legs, ankles, and/or feet
  • weight gain (unusual)
Less common
  • Bruising (not at place of injection)
  • high blood pressure
  • skin rash or itching
  • small, red spots on skin
  • sores, ulcers, or white spots on lips or in mouth
Rare
  • Abdominal or stomach pain, cramping, or burning that is severe
  • bleeding from the rectum or bloody or black, tarry stools
  • bloody or cloudy urine
  • blue lips and fingernails
  • blurred vision of other vision change
  • burning, red, tender, thick, scaly, or peeling skin
  • chest pain
  • convulsions
  • cough or hoarseness
  • dark urine
  • decrease in amount of urine that is sudden
  • fainting
  • fast, irregular, noisy, or troubled breathing
  • fever with severe headache, drowsiness, confusion, and stiff neck or back
  • fever with or without chills or sore throat
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • hearing loss
  • hives
  • increase in amount of urine or urinating often
  • light-colored stools
  • loss of appetite
  • low blood pressure
  • mood changes or unusual behavior
  • muscle cramps or pain
  • nausea, heartburn, or indigestion that is severe and continues
  • nosebleeds
  • pain in lower back and/or side
  • pain, tenderness, or swelling in the upper stomach area
  • painful or difficult urination
  • pale skin
  • puffiness or swelling of the eyelids or eyes
  • ringing or buzzing in ears
  • runny nose
  • severe restlessness
  • shortness of breath
  • swollen or painful glands
  • swollen tongue
  • thirst that continues
  • tightness in the chest with or without wheezing
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • yellow eyes or skin
Some of the side effects that can occur with ketorolac may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
More common
  • Abdominal or stomach pain (mild or moderate)
  • bruising at place of injection
  • diarrhea
  • dizziness
  • drowsiness
  • headache
  • indigestion
  • nausea
Less common or rare
  • Bloating or gas
  • burning or pain at place of injection
  • constipation
  • feeling of fullness in abdominal or stomach area
  • increased sweating
  • vomiting


For Healthcare Professionals

Applies to ketorolac: injectable solution, nasal spray, oral tablet

Renal

Acute renal failure has been reported with short-term use of ketorolac, even with moderate doses. Hyperkalemia often accompanies acute renal failure. Chronic ketorolac exposure may result in transient increases in BUN and creatinine in 2% to 3% of patients. Renal papillary necrosis has also been reported after chronic ketorolac exposure in some animal studies.

Patients with preexisting renal disease, congestive heart failure, hypovolemia, hepatic cirrhosis, nephrotic syndrome, or hypoalbuminemia are at increased risk for acute renal failure during ketorolac therapy as renal function in these conditions is dependent upon renal prostaglandin synthesis. Risk versus benefit should be carefully weighed in such patients.

In addition, ketorolac may have renal-metabolic effects such as salt and water retention, inhibition of diuretic action, and hyperkalemia due to suppression of the renin-angiotensin-aldosterone system. These effects are similar to those reported with other nonsteroidal anti-inflammatory agents.

Renal failure associated with hemolytic uremic syndrome developed in a 58-year-old female treated for arthralgias with oral ketorolac. After a total dose of 30 mg the patient developed vomiting and bloody diarrhea. Three days later, the patient again developed nausea, vomiting, oliguria, facial and peripheral edema, and hypertension. Hemolytic anemia, thrombocytopenia, elevated lactate dehydrogenase, decreased fibrinogen, and renal failure were noted on laboratory evaluation. Treatment consisted of furosemide and supportive care. Eight days later, all laboratory values were within normal limits and the patient was well.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.
Renal side effects have included acute renal failure and flank pain. Oliguria, nephritis, hyperkalemia, hematuria, proteinuria, and urinary frequency have also been reported. Ketorolac has also been implicated in a case of hemolytic uremic syndrome.

Gastrointestinal

As with other nonsteroidal anti-inflammatory agents, gastrointestinal complaints are common in patients on ketorolac therapy. While these effects are usually mild in nature, serious gastrointestinal effects are reported, including peptic and colonic ulceration and gastrointestinal bleeding and perforation. Serious gastrointestinal bleeding may not be preceded by symptoms. While experience is limited, there is some indication that the risk of serious gastrointestinal effects increases with prolonged treatment with ketorolac. Thus, ketorolac is only recommended for the short-term management of pain.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Ketorolac should be used with caution in these patients.
Gastrointestinal side effects have included gastrointestinal pain (13%), nausea (12%), dyspepsia (12%), diarrhea, constipation, flatulence, stomatitis, rectal bleeding, and melena. More serious effects include peptic ulceration (including giant gastric and duodenal ulcers), and gastrointestinal bleeding and perforation. GI bleeding increased with larger doses, therapy duration longer than 5 days, and older patients. Pancreatitis and exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease) has also been reported.

Hematologic

Hematologic side effects have included purpura, thrombocytopenia, epistaxis, inhibition of platelet aggregation, increased bleeding time, leukopenia, and eosinophilia.

Hepatic

Hepatic side effects have included borderline increases in liver function tests in up to 15% of patients in clinical trials. However, significant increases (three times normal values) occur in less than 1% of patients. Hepatitis, liver failure, and cholestatic jaundice have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included dyspnea, asthma, wheezing, and pulmonary edema.

Nervous system

Nervous system side effects have included headache (17%), somnolence or drowsiness (3% to 9%), dizziness (3% to 9%), convulsions, vertigo, tremors, hallucinations, and euphoria. In addition, paresthesias, stupor, and hyperkinesia are reported; causality is unknown.

Cardiovascular

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.
Cardiovascular side effects have included edema, palpitations, vasodilation, hypotension, syncope, and pallor. In addition, blood pressure may be elevated by ketorolac which may have clinical relevance in patients with comorbid illnesses.

Dermatologic

Dermatologic side effects have included rash, pruritus, and urticaria. Exfoliative dermatitis has also been reported.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis, bronchospasm, acute angioedema (including laryngeal and tongue edema), and fever. Lyell's syndrome, erythema multiforme, bullous reactions such Stevens-Johnson syndrome, and toxic epidermal necrolysis have also been reported.

Local

Local side effects associated with intramuscular injection of ketorolac include local pain, ecchymosis, bruising, hematoma, and tingling.

Ocular

Ocular side effects have included altered or blurred vision in less than 1% of patients.

Psychiatric

Psychiatric side effects have included depression, insomnia, abnormal dreams, and nervousness.

Other

Other side effects have included rare reports of tinnitus and hearing loss. Weight gain during long-term ketorolac therapy has also been reported.

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