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Nonsteroidal Anti-Inflammatories, Pain Killers
Orudis, Ketoprofen

This drug is also known as: Apo-Keto Apo-Keto-E Apo-Keto-SR Novo-Keto Novo-Keto-EC Nu-Ketoprofen Nu-Ketoprofen-E Orafen Orudis Orudis-E Orudis-SR Oruvail PMS-Ketoprofen PMS-Ketoprofen-E Rhodis Rhodis-EC Rhodis SR Rhovail OTC: Actron Orudis KT.

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Absorption, distribution and biotransfermation for Orudis(Ketoprofen): Med Safe: "Ketoprofen is rapidly and completely absorbed from the gastrointestinal tract. Maximal plasma levels are reached within 1.0 to 1.5 hours after administration. When ketoprofen is administered with food, the rate of absorption is slowed, resulting in delayed and reduced peak concentration (Cmax), however its total bioavailability is not altered. There is no accumulation on continued daily dosing.The drug is 99% bound to plasma protein. Ketoprofen diffuses into synovial fluid and in intraarticular, capsular, synovial and tendon tissues. Ketoprofen crosses the blood brain barrier and the placenta barrier. The plasma elimination half-life is approximately 2 hours. The volume of distribution is 6.7 ± 1.7 l. The biotransformation of ketoprofen is characterised by two main processes, hydroxylation and conjugation with glucuronic acid, the latter being the main pathway in man. Excretion of ketoprofen as unchanged drug is very low (less than 1%). Almost all administered ketoprofen is excreted as metabolites in the urine, of which 65 to 85% of administered dose is excreted as a glucuronide metabolite."
http://www.medsafe.govt.nz/Profs/Datasheet/o/Orudiscap.htm

General Information concerning Orudis (Ketoprofen): Medicine Net: "Brand names: Orudis, OruvailDrug class and mechanism: Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) effective in treating fever, pain, and inflammation in the body. As a group, NSAIDs are non-narcotic relievers of mild to moderate pain of many causes, including injury, menstrual cramps, arthritis, and other musculoskeletal conditions. Since the response to different NSAIDs varies from patient to patient, it is not unusual for a doctor to try different NSAIDs for any given condition. Prescription: yes; except for 12.5mg dose Generic Available: yes Preperations: capsules: 12.5mg, 25mg, 50mg, 75mg; Oruvail (extended-release capsules): 100mg, 150mg, 200mg"
http://www.focusonarthritis.com/script/main/Art.asp?li=ART&ArticleKey=799

Drug information database for Orudis (Ketoprofen): Nurses PDR: "Action/Kinetics: Possesses anti-inflammatory, antipyretic, and analgesic properties. Known to inhibit both prostaglandin and leukotriene synthesis, to have antibradykinin activity, and to stabilize lysosomal membranes. Onset: 15-30 min. Peak plasma levels: 0.5-2 hr. Duration: 4-6 hr. t1/2: 2-4 hr. t1/2, geriatrics: Approximately 5 hr. Is 99% bound to plasma proteins. Food does not alter the bioavailability; however, the rate of absorption is reduced. Uses: Rx: Acute or chronic rheumatoid arthritis and osteoarthritis (both capsules and sustained-release capsules). Primary dysmenorrhea. Analgesic for mild to moderate pain. OTC: Temporary relief of aches and pains associated with the common cold, toothache, headache, muscle aches, backache, menstrual cramps, reduction of fever, and minor pain of arthritis. Investigational: Juvenile rheumatoid arthritis, sunburn, prophylaxis of migraine, migraine due to menses."
http://www.nursespdr.com/members/database/ndrhtml/ketoprofen.html

Orudis (Ketoprofen) side effects: Health Square: "More common side effects may include: Abdominal pain, changes in kidney function, constipation, diarrhea, dreams, fluid retention, gas, headache, inability to sleep, indigestion, nausea, nervousness Less common or rare side effects may include: Allergic reaction, amnesia, anemia, asthma, belching, blood in the urine, bloody or black stools, change in taste, chills, confusion, congestive heart failure, coughing up blood, conjunctivitis (pinkeye), depression, difficult or labored breathing, dizziness, dry mouth, eye pain, facial swelling due to fluid retention, general feeling of illness, hair loss, hepatitis, high blood pressure, hives, impaired hearing, impotence, increase in appetite, increased salivation, infection, inflammation of the mouth, irregular or excessive menstrual bleeding, itching, jaundice (yellowing of the eyes and skin), kidney failure, liver problems, loosening of fingernails, loss of appetite, migraine, muscle pain, nasal inflammation, nosebleed, pain, peptic or intestinal ulcer, rapid heartbeat, rash, rectal bleeding, red or purple spots on the skin, ringing in the ears, sensitivity to light, skin discoloration, skin eruptions, skin inflammation and flaking, sleepiness, sore throat, stomach inflammation, sweating, swelling of the throat, thirst, throbbing heartbeat, tingling or pins and needles, vertigo, visual disturbances, vomiting, vomiting blood, weight gain or loss"
http://www.healthsquare.com/newrx/ORU1313.HTM

Overdose information for Orudis (Ketoprofen): Rx Med: "Symptoms And Treatment Of Overdose: Symptoms: Of 20 cases of overdosage (up to 5 000 mg) reported in Great Britain (5 children, 14 adolescents or young adults, and 1 elderly), only 4 had mild symptoms (vomiting in 3, drowsiness in 1 child). tag_Treatment Treatment: Administer gastric lavage or an emetic and treat symptomatically: compensate for dehydration, monitor urinary excretion and correct acidosis if present. The drug is dialyzable; therefore, hemodialysis may be useful to remove circulating drug and to assist in case of renal failure."
http://38.144.174.147/iissamples/issamples/InfoFrame.asp?Page=http://www.rxmed.com/RxMed/b.main/b2.pharmaceutical/b2.1.monographs/CPS-%20Monographs/CPS-%20(General%20Monographs-%20O)/ORUDIS.html&HostUrl=http://www.rxmed.com

Orudis (Ketoprofen)precautions: Inteli Health: "Over 60 Because of the potentially greater consequences of gastrointestinal side effects, the dose of NSAIDs for older patients, especially those over age 70, is often cut in half. Driving and Hazardous Work Do not drive or engage in hazardous work until you determine how the medicine affects you. Alcohol Avoid alcohol when using this medication because it increases the risk of stomach irritation. PregnancyDo not use ketoprofen while pregnant. Breast Feeding Ketoprofen passes into breast milk; avoid use while nursing. Infants and Children Ketoprofen may be used in exceptional circumstances; consult your doctor. Special Concerns Because NSAIDs can interfere with blood coagulation, this drug should be stopped at least 3 days prior to any surgery."
http://www.intelihealth.com/IH/ihtIH/WSIHW000/19689/11555/214028.html

Help lessen stomach upset while taking Orudis (Ketoprofen): A healthy Me: "Take ketoprofen with food, milk, or an antacid to lessen stomach upset. Remain upright (sitting or standing) for 15 to 30 minutes after each dose to prevent irritation of your esophagus (throat). Do not crush, chew, or break any extended-release forms of ketoprofen (e.g., Oruvail). Swallow them whole. Watch for bloody, black, or tarry stools or blood in your vomit. These symptoms could indicate damage to your gastrointestinal tract. If you drink more than three alcoholic beverages a day, ketoprofen may increase the risk of stomach bleeding. Symptoms of a ketoprofen overdose include nausea, vomiting, stomach pain, dizziness, drowsiness, headache, ringing in the ears, blurred vision, seizures, sweating, numbness or tingling, little or no urine production, and slow breathing."
http://www.ahealthyme.com/topic/topic100591234

Orudis (Ketoprofen) patient information: Personal MD: "Stomach upset is the most common side effect. If this persists or becomes severe, notify your doctor. Headache, heartburn, loss of appetite, lightheadedness, dizziness, bloating, constipation, diarrhea, drowsiness or nervousness may occur as your body adjusts to the medication. Notify your doctor if you develop persistent stomach pain, presence of black or bloody stools, rash, itching, edema (swelling of the feet or hands), vision changes or yellowing eyes and skin. This drug may rarely cause ringing in the ears/hearing loss. Infrequently, this medication may increase the skin's sensitivity to sunlight. If this happens to you, avoid prolonged sun exposure, wear protective clothing and use a sunscreen. Avoid sunlamps. If you notice other effects not listed above, contact your doctor or pharmacist."
http://www.personalmd.com/drgdb/8186.htm

Symptoms of an overdose of Orudis (Ketoprofen): Medline Plus: "body as a whole-unsteadiness, leg swelling (lower legs, ankles, and/or feet) convulsions, eyes, ears, nose, and throat, ringing in the ears, blurred vision, gastrointestinal, nausea and vomiting, diarrhea, stomach pain, possible loss of blood in the stomach and intestinal areas, nervous system, headache, agitation, incoherence (not understandable), confusion, coma, drowsinessHome treatment: The standard procedure is to induce emesis (vomiting) unless the patient is unconscious or experiencing convulsions. Before inducing emesis, contact Poison Control for verification.If instructed to induce emesis, the standard procedure is as follows: Give the usual dose of ipecac syrup: 15 milliliters (ml) or 1 TABLEspoonful for children and 30 ml (2 TABLEspoonsful) for an adult. Follow with 1/2 glass or 4 ounces (oz.) of water for children or 8 to 12 oz. of water for adults. Repeat 1 more time in 1/2 hour if emesis has not occurred."
U.S. National Library of Medicine
8600 Rockville Pike, Bethesda, MD 20894
custserv@nlm.nih.gov
http://www.nlm.nih.gov/medlineplus/ency/article/002661.htm

Comprehensive informations for Orudis (Ketoprofen): Wyeth Info: "CLINICAL TRIALS Rheumatoid Arthritis and Osteoarthritis The efficacy of ketoprofen has been demonstrated in patients with rheumatoid arthritis and osteoarthritis. Using standard assessments of therapeutic response, there were no detectable differences in effectiveness or in the incidence of adverse events in crossover comparison of Orudis and Oruvail. In other trials, ketoprofen demonstrated effectiveness comparable to aspirin, Ketoprofen, naproxen, piroxicam, diclofenac and indomethacin. In some of these studies there were more dropouts due to gastrointestinal side effects among patients on ketoprofen than among patients on other NSAIDs.In studies with patients with rheumatoid arthritis, ketoprofen was administered in combina-tionwith gold salts, antimalarials, low-dose methotrexate, d-penicillamine, and/or cortico-steroidswith results comparable to those seen with control nonsteroidal drugs.Management of PainThe effectiveness of Orudis as a general-purpose analgesic has been studied in standardpain models which have shown the effectiveness of doses of 25 to 150 mg. Doses of 25 mgwere superior to placebo. Doses larger than 25 mg generally could not be shown to be sig-nificantlymore effective, but there was a tendency toward faster onset and greater durationof action with 50 mg, and, in the case of dysmenorrhea, a significantly greater effect overallwith 75 mg. Doses greater than 50 to 75 mg did not have increased analgesic effect. Studiesin postoperative pain have shown that Orudis in doses of 25 to 100 mg was comparable to650 mg of acetaminophen with 60 mg of codeine, or 650 mg of acetaminophen with 10 mgof oxycodone. Ketoprofen tended to be somewhat slower in onset; peak pain relief wasabout the same and the duration of the effect tended to be 1 to 2 hours longer, particularly with the higher doses of ketoprofen."
http://www.wyethinfo.com/orudis.htm



Absorption, distribution and biotransfermation for Orudis(Ketoprofen): Med Safe: "Ketoprofen is rapidly and completely absorbed from the gastrointestinal tract. Maximal plasma levels are reached within 1.0 to 1.5 hours after administration. When ketoprofen is administered with food, the rate of absorption is slowed, resulting in delayed and reduced peak concentration (Cmax), however its total bioavailability is not altered. There is no accumulation on continued daily dosing.The drug is 99% bound to plasma protein. Ketoprofen diffuses into synovial fluid and in intraarticular, capsular, synovial and tendon tissues. Ketoprofen crosses the blood brain barrier and the placenta barrier. The plasma elimination half-life is approximately 2 hours. The volume of distribution is 6.7 ± 1.7 l. The biotransformation of ketoprofen is characterised by two main processes, hydroxylation and conjugation with glucuronic acid, the latter being the main pathway in man. Excretion of ketoprofen as unchanged drug is very low (less than 1%). Almost all administered ketoprofen is excreted as metabolites in the urine, of which 65 to 85% of administered dose is excreted as a glucuronide metabolite."
http://www.medsafe.govt.nz/Profs/Datasheet/o/Orudiscap.htm

General Information concerning Orudis (Ketoprofen): Medicine Net: "Brand names: Orudis, OruvailDrug class and mechanism: Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) effective in treating fever, pain, and inflammation in the body. As a group, NSAIDs are non-narcotic relievers of mild to moderate pain of many causes, including injury, menstrual cramps, arthritis, and other musculoskeletal conditions. Since the response to different NSAIDs varies from patient to patient, it is not unusual for a doctor to try different NSAIDs for any given condition. Prescription: yes; except for 12.5mg dose Generic Available: yes Preperations: capsules: 12.5mg, 25mg, 50mg, 75mg; Oruvail (extended-release capsules): 100mg, 150mg, 200mg"
http://www.focusonarthritis.com/script/main/Art.asp?li=ART&ArticleKey=799

Drug information database for Orudis (Ketoprofen): Nurses PDR: "Action/Kinetics: Possesses anti-inflammatory, antipyretic, and analgesic properties. Known to inhibit both prostaglandin and leukotriene synthesis, to have antibradykinin activity, and to stabilize lysosomal membranes. Onset: 15-30 min. Peak plasma levels: 0.5-2 hr. Duration: 4-6 hr. t1/2: 2-4 hr. t1/2, geriatrics: Approximately 5 hr. Is 99% bound to plasma proteins. Food does not alter the bioavailability; however, the rate of absorption is reduced. Uses: Rx: Acute or chronic rheumatoid arthritis and osteoarthritis (both capsules and sustained-release capsules). Primary dysmenorrhea. Analgesic for mild to moderate pain. OTC: Temporary relief of aches and pains associated with the common cold, toothache, headache, muscle aches, backache, menstrual cramps, reduction of fever, and minor pain of arthritis. Investigational: Juvenile rheumatoid arthritis, sunburn, prophylaxis of migraine, migraine due to menses."
http://www.nursespdr.com/members/database/ndrhtml/ketoprofen.html

Orudis (Ketoprofen) side effects: Health Square: "More common side effects may include: Abdominal pain, changes in kidney function, constipation, diarrhea, dreams, fluid retention, gas, headache, inability to sleep, indigestion, nausea, nervousness Less common or rare side effects may include: Allergic reaction, amnesia, anemia, asthma, belching, blood in the urine, bloody or black stools, change in taste, chills, confusion, congestive heart failure, coughing up blood, conjunctivitis (pinkeye), depression, difficult or labored breathing, dizziness, dry mouth, eye pain, facial swelling due to fluid retention, general feeling of illness, hair loss, hepatitis, high blood pressure, hives, impaired hearing, impotence, increase in appetite, increased salivation, infection, inflammation of the mouth, irregular or excessive menstrual bleeding, itching, jaundice (yellowing of the eyes and skin), kidney failure, liver problems, loosening of fingernails, loss of appetite, migraine, muscle pain, nasal inflammation, nosebleed, pain, peptic or intestinal ulcer, rapid heartbeat, rash, rectal bleeding, red or purple spots on the skin, ringing in the ears, sensitivity to light, skin discoloration, skin eruptions, skin inflammation and flaking, sleepiness, sore throat, stomach inflammation, sweating, swelling of the throat, thirst, throbbing heartbeat, tingling or pins and needles, vertigo, visual disturbances, vomiting, vomiting blood, weight gain or loss"
http://www.healthsquare.com/newrx/ORU1313.HTM

Overdose information for Orudis (Ketoprofen): Rx Med: "Symptoms And Treatment Of Overdose: Symptoms: Of 20 cases of overdosage (up to 5 000 mg) reported in Great Britain (5 children, 14 adolescents or young adults, and 1 elderly), only 4 had mild symptoms (vomiting in 3, drowsiness in 1 child). tag_Treatment Treatment: Administer gastric lavage or an emetic and treat symptomatically: compensate for dehydration, monitor urinary excretion and correct acidosis if present. The drug is dialyzable; therefore, hemodialysis may be useful to remove circulating drug and to assist in case of renal failure."
http://38.144.174.147/iissamples/issamples/InfoFrame.asp?Page=http://www.rxmed.com/RxMed/b.main/b2.pharmaceutical/b2.1.monographs/CPS-%20Monographs/CPS-%20(General%20Monographs-%20O)/ORUDIS.html&HostUrl=http://www.rxmed.com

Orudis (Ketoprofen)precautions: Inteli Health: "Over 60 Because of the potentially greater consequences of gastrointestinal side effects, the dose of NSAIDs for older patients, especially those over age 70, is often cut in half. Driving and Hazardous Work Do not drive or engage in hazardous work until you determine how the medicine affects you. Alcohol Avoid alcohol when using this medication because it increases the risk of stomach irritation. PregnancyDo not use ketoprofen while pregnant. Breast Feeding Ketoprofen passes into breast milk; avoid use while nursing. Infants and Children Ketoprofen may be used in exceptional circumstances; consult your doctor. Special Concerns Because NSAIDs can interfere with blood coagulation, this drug should be stopped at least 3 days prior to any surgery."
http://www.intelihealth.com/IH/ihtIH/WSIHW000/19689/11555/214028.html

Help lessen stomach upset while taking Orudis (Ketoprofen): A healthy Me: "Take ketoprofen with food, milk, or an antacid to lessen stomach upset. Remain upright (sitting or standing) for 15 to 30 minutes after each dose to prevent irritation of your esophagus (throat). Do not crush, chew, or break any extended-release forms of ketoprofen (e.g., Oruvail). Swallow them whole. Watch for bloody, black, or tarry stools or blood in your vomit. These symptoms could indicate damage to your gastrointestinal tract. If you drink more than three alcoholic beverages a day, ketoprofen may increase the risk of stomach bleeding. Symptoms of a ketoprofen overdose include nausea, vomiting, stomach pain, dizziness, drowsiness, headache, ringing in the ears, blurred vision, seizures, sweating, numbness or tingling, little or no urine production, and slow breathing."
http://www.ahealthyme.com/topic/topic100591234

Orudis (Ketoprofen) patient information: Personal MD: "Stomach upset is the most common side effect. If this persists or becomes severe, notify your doctor. Headache, heartburn, loss of appetite, lightheadedness, dizziness, bloating, constipation, diarrhea, drowsiness or nervousness may occur as your body adjusts to the medication. Notify your doctor if you develop persistent stomach pain, presence of black or bloody stools, rash, itching, edema (swelling of the feet or hands), vision changes or yellowing eyes and skin. This drug may rarely cause ringing in the ears/hearing loss. Infrequently, this medication may increase the skin's sensitivity to sunlight. If this happens to you, avoid prolonged sun exposure, wear protective clothing and use a sunscreen. Avoid sunlamps. If you notice other effects not listed above, contact your doctor or pharmacist."
http://www.personalmd.com/drgdb/8186.htm

Symptoms of an overdose of Orudis (Ketoprofen): Medline Plus: "body as a whole-unsteadiness, leg swelling (lower legs, ankles, and/or feet) convulsions, eyes, ears, nose, and throat, ringing in the ears, blurred vision, gastrointestinal, nausea and vomiting, diarrhea, stomach pain, possible loss of blood in the stomach and intestinal areas, nervous system, headache, agitation, incoherence (not understandable), confusion, coma, drowsinessHome treatment: The standard procedure is to induce emesis (vomiting) unless the patient is unconscious or experiencing convulsions. Before inducing emesis, contact Poison Control for verification.If instructed to induce emesis, the standard procedure is as follows: Give the usual dose of ipecac syrup: 15 milliliters (ml) or 1 TABLEspoonful for children and 30 ml (2 TABLEspoonsful) for an adult. Follow with 1/2 glass or 4 ounces (oz.) of water for children or 8 to 12 oz. of water for adults. Repeat 1 more time in 1/2 hour if emesis has not occurred."
U.S. National Library of Medicine
8600 Rockville Pike, Bethesda, MD 20894
custserv@nlm.nih.gov
http://www.nlm.nih.gov/medlineplus/ency/article/002661.htm

Comprehensive informations for Orudis (Ketoprofen): Wyeth Info: "CLINICAL TRIALS Rheumatoid Arthritis and Osteoarthritis The efficacy of ketoprofen has been demonstrated in patients with rheumatoid arthritis and osteoarthritis. Using standard assessments of therapeutic response, there were no detectable differences in effectiveness or in the incidence of adverse events in crossover comparison of Orudis and Oruvail. In other trials, ketoprofen demonstrated effectiveness comparable to aspirin, Ketoprofen, naproxen, piroxicam, diclofenac and indomethacin. In some of these studies there were more dropouts due to gastrointestinal side effects among patients on ketoprofen than among patients on other NSAIDs.In studies with patients with rheumatoid arthritis, ketoprofen was administered in combina-tionwith gold salts, antimalarials, low-dose methotrexate, d-penicillamine, and/or cortico-steroidswith results comparable to those seen with control nonsteroidal drugs.Management of PainThe effectiveness of Orudis as a general-purpose analgesic has been studied in standardpain models which have shown the effectiveness of doses of 25 to 150 mg. Doses of 25 mgwere superior to placebo. Doses larger than 25 mg generally could not be shown to be sig-nificantlymore effective, but there was a tendency toward faster onset and greater durationof action with 50 mg, and, in the case of dysmenorrhea, a significantly greater effect overallwith 75 mg. Doses greater than 50 to 75 mg did not have increased analgesic effect. Studiesin postoperative pain have shown that Orudis in doses of 25 to 100 mg was comparable to650 mg of acetaminophen with 60 mg of codeine, or 650 mg of acetaminophen with 10 mgof oxycodone. Ketoprofen tended to be somewhat slower in onset; peak pain relief wasabout the same and the duration of the effect tended to be 1 to 2 hours longer, particularly with the higher doses of ketoprofen."
http://www.wyethinfo.com/orudis.htm

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