CELEBREX - ei-intl.comei-intl.com/images/Celebrex_-_Product_Profile_Cards.pdf · CELEBREX (2 of 2)...
Transcript of CELEBREX - ei-intl.comei-intl.com/images/Celebrex_-_Product_Profile_Cards.pdf · CELEBREX (2 of 2)...
© 2002-2009. Pfizer Inc. CONFIDENTIAL—EDUCATIONAL AND TRAINING MATERIALS.DO NOT DETAIL OR DISTRIBUTE TO ANY THIRD PARTIES.
Pfizer Learning Systems Online CELEBREX — Product Profile Cards
celecoxib capsules/Pfizer Inc Chemical Class
Indications
Pharmacokinetics
Adverse Events
Contraindications
CELEBREX (1 of 2)
COX-2 specific inhibitor and member of NSAID group
Relief of the signs and symptoms of OA
Relief of the signs and symptoms of adult RA
Relief of signs and symptoms of ankylosing spondylitis
Management of acute pain in adults
Treatment of primary dysmenorrhea
To reduce number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care (eg, endoscopic surveillance, surgery)
T is approximately 3 hours
Metabolized in the liver and primarily eliminated in the urine and feces
Half-life is approximately 11 hours
Incidence >5% (any dose): headache, dyspepsia, upper respiratory tract infection, diarrhea
Patients with known hypersensitivity to celecoxib; patients who have demonstrated allergic-type reactions to sulfonamides; patients who have experienced asthma,
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urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery
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celecoxib capsules/Pfizer Inc Warnings
Precautions
Drug Interactions
Dosing
CELEBREX (2 of 2)
Black box warnings regarding increased risk of CV thrombotic events, MI, and stroke; GI risks such as bleeding ulceration, and perforation of stomach or intestines; and use following CABG surgery
Hypertension, congestive heart failure and edema, anaphylactoid reactions, advanced renal disease, skin reactions, and pregnancy
Include class labeling precautions regarding patients on corticosteroids, effects on inflammation, hepatic effects, hematologic effects, fluid retention and edema, preexisting asthma, and nursing mothers
Coadministration with drugs that inhibit P-450 enzyme 2C9 should be done with caution; potential for interaction with drugs metabolized by 2D6 enzyme
May interact with ACE inhibitors, furosemide, fluconazole, lithium, aspirin, and warfarin
OA: 200 mg/day (either QD or 100 mg BID)
RA: 100 mg to 200 mg BID
FAP: 400 mg BID to be taken with food
AS: 200 mg/day, single or divided (BID) doses; if no effect after 6 weeks, 400 mg/day may be worthwhile; if no effect after 6 weeks on 400 mg/day, a response is not likely
Acute pain and primary dysmenorrhea: 400 mg on first day followed by 200 mg if needed; 200 mg BID on subsequent days
Patients with moderate hepatic impairment: dose should be reduced by approximately 50%
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Cataflam : diclofenac potassium/Novartis Voltaren : diclofenac sodium /Novartis Voltaren -XR: diclofenac sodium/Novartis
Cataflam , Voltaren , and Voltaren -XR
(1 of 2)
In April 2005, the FDA requested that a black box warning on GI and potential CV risks be added to the package inserts of all NSAIDs. The product labeling for diclofenac has not yet been updated to include this additional safety information.
Chemical Class
Indications
Pharmacokinetics
Adverse Events
Member of the phenylacetic group of NSAIDs
Cataflam : relief of signs and symptoms of OA and RA; relief of mild to moderate pain; and treatment of primary dysmenorrhea
Voltaren : relief of signs and symptoms of OA and RA; acute and long-term relief of signs and symptoms of ankylosing spondylitis
Voltaren -XR: relief of signs and symptoms of OA and RA
T : Cataflam 1 hour, Voltaren 2.3 hours, Voltaren -XR 5.3 hours
Metabolized in the liver and eliminated in the urine and bile
some metabolites may have activity
Half-life is approximately 2 hours
Incidence 1% to 10%: GI effects, including abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/ perforation, heartburn, nausea, GI ulcers, and vomiting; abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headache, increased bleeding time, pruritus, rashes, and tinnitus
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Cataflam : diclofenac potassium/Novartis Voltaren : diclofenac sodium /Novartis Voltaren -XR: diclofenac sodium/Novartis
Cataflam , Voltaren , and Voltaren -XR
(2 of 2)
In April 2005, the FDA requested that a black box warning on GI and potential CV risks be added to the package inserts of all NSAIDs. The product labeling for diclofenac has not yet been updated to include this additional safety information.
Contraindications
Warnings
Precautions
Drug Interactions
Dosing
Patients with known hypersensitivity to diclofenac; patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
NSAID class warnings regarding risk of GI ulceration, bleeding, and perforation, anaphylactoid reactions, advanced renal disease, and pregnancy
Include precautions regarding patients on corticosteroids, effects on inflammation, fluid retention and edema, hepatic effects, hematologic effects, renal effects, preexisting asthma, and nursing mothers
May interact with aspirin, methotrexate, cyclosporine, ACE inhibitors, furosemide, lithium, and warfarin
OA: Cataflam 50 mg BID or TID, Voltaren 50 mg BID or TID or 75 mg BID, Voltaren -XR 100 mg QD
RA: Cataflam 50 mg TID or QID, Voltaren 50 mg TID or QID or 75 mg BID; Voltaren -XR 100 mg QD or 100 mg BID
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in rare patients if the benefits outweigh the clinical risks
Ankylosing spondylitis: Voltaren 25 mg QID (with extra 25 mg at night PRN)
Analgesia and primary dysmenorrhea: Cataflam 50 mg TID or, in some patients, initial dose of 100 mg followed by 50 mg doses
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Lortab Tablets, Lortab Elixir/UCB; Vicodin /Knoll Labs
Hydrocodone bitartrate and acetaminophen
(1 of 2)
In clinical practice, the pain associated with OA and RA is treated with a wide variety of agents, including opioid analgesics.
Chemical Class
Indications
Pharmacokinetics
Adverse Events
Contraindications
Hydrocodone: semisynthetic opioid analgesic
Acetaminophen: nonopioid nonsalicylate analgesic and antipyretic
Relief of moderate to moderately severe pain
Hydrocodone:
metabolized in liver and eliminated in urine
half-life is 3.5 to 4.1 hours
Acetaminophen:
metabolized in liver and eliminated in urine
half-life is 1.25 to 3 hours
Most frequently reported events include lightheadedness, dizziness, sedation, nausea, vomiting
Other events relate to the CNS, GI system, genitourinary system, respiratory depression, and dermatologic effects
Patients with hypersensitivity to hydrocodone or acetaminophen
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Warnings
Patients with respiratory depression; patients with head injury or increased intracranial pressure; patients with acute abdominal abnormalities
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Lortab Tablets, Lortab Elixir/UCB; Vicodin /Knoll Labs
Hydrocodone bitartrate and acetaminophen
(2 of 2)
In clinical practice, the pain associated with OA and RA is treated with a wide variety of agents, including opioid analgesics.
Precautions
Drug Interactions
Dosing
Special risk patients: elderly or debilitated, those with severe renal or hepatic impairment, hypothyroidism, Addison disease, and prostatic hypertrophy or urethral stricture
Suppresses cough reflex—caution when used postoperatively in patients with pulmonary disease
May impair mental and/or physical abilities required for potentially hazardous tasks, pregnancy, nursing mothers
May be habit-forming
May produce additive CNS depression with narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol); may enhance effects of MAO inhibitors or TCAs
Lortab :
2.5 mg hydrocodone/500 mg acetaminophen or 5 mg hydrocodone/500 mg acetaminophen: usual adult dose 1 or 2 tablets q 4 to 6 hours, not exceeding 8 tablets/day
7.5 mg hydrocodone/500 mg acetaminophen or 10 mg hydrocodone/500 mg acetaminophen: usual adult dose 1 tablet q 4 to 6 hours, not exceeding 6 tablets/day
elixir: usual dose 15 mL q 4 to 6 hours; not exceeding 6 doses/day
Vicodin :
2 tablets (5 mg hydrocodone/500 mg acetaminophen) q 4 to 6 hours as needed, up to 8 tablets/day
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Motrin , Motrin IB/McNeil Consumer Advil /Wyeth Consumer Healthcare
Ibuprofen (1 of 2)
In April 2005, the FDA requested that a black box warning on GI and potential CV risks be added to the package inserts of all NSAIDs. The product labeling for ibuprofen has not yet been updated to include this additional safety information.
Chemical Class
Indications
Pharmacokinetics
Adverse Events
Contraindications
Member of the propionic acid group of NSAIDs
Motrin : relief of signs and symptoms of OA, RA, and mild to moderate pain and treatment of primary dysmenorrhea
Motrin IB and Advil : temporary relief of headache, muscular aches, the minor pain of arthritis, toothache, backache, minor aches and pains associated with the common cold, the pain of menstrual cramps, and for reduction of fever
T within 1 to 2 hours
Half-life of about 2 hours
Eliminated in the urine
Incidence 3% to 9% (any dose): nausea, epigastric pain, heartburn, dizziness, rash
Patients with a history of reactions to any products containing ibuprofen; patients who have experienced asthma, rhinitis, and nasal polyps when taking aspirin or other NSAID/analgesic drugs
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Motrin , Motrin IB/McNeil Consumer Advil /Wyeth Consumer Healthcare
Ibuprofen (2 of 2)
In April 2005, the FDA requested that a black box warning on GI and potential CV risks be added to the package inserts of all NSAIDs. The product labeling for ibuprofen has not yet been updated to include this additional safety information.
Warnings
Precautions
Drug Interactions
Dosing
NSAID class warnings regarding risk of GI ulceration, bleeding, and perforation, anaphylactoid reactions, and advanced renal disease
Include NSAID class labeling precautions regarding renal effects, hepatic effects, hematologic effects, fluid retention, and pregnancy
Additional precautions include aseptic meningitis and visual disturbances
May interact with aspirin, coumarin-type anticoagulants, ACE inhibitors, furosemide, lithium, and methotrexate
Motrin in adults:
OA and RA: 300 mg QID, or 400 mg, 600 mg, or 800 mg TID or QID
primary dysmenorrhea: 400 mg q 4 hours
analgesia: 400 mg q 4 to 6 hours
Advil and Motrin IB : 200 mg q 4 to 6 hours
May be taken with food or milk for GI upset
Adults should not take ibuprofen for more than 10 days or for fever for more than 3 days unless directed by physician
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meloxicam/Boehringer Ingelheim Chemical Class
Indications
Pharmacokinetics
Adverse Events
Contraindications
Mobic (1 of 2)
Member of the enolic acid group of NSAIDs
Relief of the signs and symptoms of OA and RA
Relief of the signs and symptoms pauciarticular or polyarticular course juvenile RA in patients >2 years of age
T is 4 to 5 hours
Elimination is predominantly in the form of inactive metabolites and occurs in equal amounts in urine and feces
Half-life is approximately 15 to 20 hours
Incidence >5% (any dose): headache, diarrhea, dyspepsia, upper respiratory tract infection, urinary tract infection, nausea, influenza-like symptoms, arthralgia, pain
Patients with known hypersensitivity to meloxicam; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery
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meloxicam/Boehringer Ingelheim Warnings
Precautions
Drug Interactions
Dosing
Mobic (2 of 2)
Black box warnings regarding increased risk of CV thrombotic events, MI, and stroke; GI risks such as bleeding ulceration, and perforation of stomach or intestines; and use following CABG surgery
Anaphylactoid reactions, advanced renal disease, skin reactions, and pregnancy
Include class labeling precautions regarding patients on corticosteroids, effects on inflammation, hepatic effects, renal effects, hematologic effects, fluid retention and edema, preexisting asthma, and nursing mothers
May interact with ACE inhibitors, aspirin, furosemide, lithium, cimetidine, digoxin, warfarin, methotrexate, and cholestyramine
OA and RA: 7.5 mg QD, up to maximum of 15 mg/day, oral suspension or tablets
Juvenile RA: 0.125 mg/kg daily to a maximum of 7.5 mg/day, oral suspension
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Naproxen: Naprosyn , EC-Naprosyn /Roche; Naproxen Sodium: Aleve Tablets, Caplets, and Gelcaps/Bayer; Anaprox /Roche; Naprelan /Carnrick
Naproxen and Naproxen Sodium (1 of 3)
In April 2005, the FDA requested that a black box warning on GI and potential CV risks be added to the package inserts of all NSAIDs. The product labeling for naproxen has not yet been updated to include this additional safety information.
Chemical Class
Indications
Pharmacokinetics
Member of arylacetic group of NSAIDs
Naprosyn Tablets, Naprosyn Suspension, Anaprox Tablets, Anaprox DS Tablets: relief of signs and symptoms of OA, RA, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis, acute gout; management of pain and primary dysmenorrhea
Naprelan : OA, RA, ankylosing spondylitis, tendonitis, bursitis, acute gout, mild to moderate pain, and primary dysmenorrhea
EC-Naprosyn : relief of signs and symptoms of OA, RA, ankylosing spondylitis, juvenile arthritis
Aleve : temporary fever reducer; temporary relief of minor aches and pains due to common cold, headache, toothache, muscular ache, backache, menstrual cramps, and minor pain of arthritis
Naproxen sodium is more rapidly absorbed than naproxen
Half-life from 12 to 17 hours
Eliminated in the urine
Some dosage adjustment may be necessary in elderly persons
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Naproxen: Naprosyn , EC-Naprosyn /Roche; Naproxen Sodium: Aleve Tablets, Caplets, and Gelcaps/Bayer; Anaprox /Roche; Naprelan /Carnrick
Naproxen and Naproxen Sodium (2 of 3)
In April 2005, the FDA requested that a black box warning on GI and potential CV risks be added to the package inserts of all NSAIDs. The product labeling for naproxen has not yet been updated to include this additional safety information.
Adverse Events
Contraindications
Warnings
Precautions
Incidence 3% to 9% (any formulation): constipation, heartburn, abdominal pain, nausea, diarrhea, flu syndrome, headache, dizziness, drowsiness, itching (pruritus), skin rash, skin eruptions, ecchymoses, tinnitus, edema, dyspnea, pain (back), pain, infection, pharyngitis, rhinitis, sinusitis, urinary tract infection
Patients with allergic reactions to naproxen; patients who experience urticaria, hypotension, asthma, rhinitis, and nasal polyps after taking aspirin or other NSAIDs
Class warning for NSAIDs regarding risk of GI ulceration, bleeding, and perforation
Anaphylactoid reactions, especially in patients with asthma; use in patients with advanced kidney disease or late in pregnancy
Concomitant use with other products containing naproxen
Include class labeling precautions regarding patients on corticosteroids, effects on inflammation, hepatic effects, renal effects, hematologic effects, fluid retention and edema, preexisting asthma, and nursing mothers
Additional precaution on visual disturbances
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Naproxen: Naprosyn , EC-Naprosyn /Roche; Naproxen Sodium: Aleve Tablets, Caplets, and Gelcaps/Bayer; Anaprox /Roche; Naprelan /Carnrick
Naproxen and Naproxen Sodium (3 of 3)
In April 2005, the FDA requested that a black box warning on GI and potential CV risks be added to the package inserts of all NSAIDs. The product labeling for naproxen has not yet been updated to include this additional safety information.
Drug Interactions
Dosing
May interact with ACE inhibitors, hydantoins, sulfonamides or sulfonylurea, coumarin-type anticoagulants (eg, warfarin), aspirin, methotrexate, probenecid, furosemide, lithium, propranolol and other beta-blockers, and with EC-Naprosyn , H blockers, and intensive antacid therapy
OA, RA, and ankylosing spondylitis: Anaprox 275 mg BID; Naprosyn 250 mg, 375 mg, or 500 mg BID; Naprelan 750 mg or 1000 mg QD
Pain and dysmenorrhea: Anaprox 550 mg followed by 550 mg q 12 hours or 275 mg q 6 to 8 hours; Naprosyn 500 mg followed by 500 mg q 12 hours or 250 mg q 6 to 8 hours; Naprelan 1000 mg QD; Aleve 200 mg q 8 to 12 hours (for first dose, may take 400 mg within first hour)
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Tylox /Ortho-McNeil; Percocet /Endo Labs
Oxycodone and acetaminophen (1 of 2)
In clinical practice, the pain associated with OA and RA is treated with a wide variety of agents, including opioid analgesics.
Chemical Class
Indications
Pharmacokinetics
Adverse Events
Contraindications
Oxycodone: pure agonist opioid analgesic
Acetaminophen: nonopioid nonsalicylate analgesic and antipyretic
Relief of moderate to moderately severe pain
Oxycodone:
metabolized to several products, some of which have slight analgesic activity, and excreted primarily in the urine
half-life is 3.2 hours
Acetaminophen:
metabolized in liver and eliminated in urine
half-life is 1 to 4 hours
Most frequently observed events include lightheadedness, dizziness, sedation, nausea, vomiting
Other events include allergic reactions, euphoria, dysphoria, constipation, skin rash, pruritus; at higher doses, has most of the disadvantages of morphine, including respiratory depression
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Patients who are hypersensitive to oxycodone, acetaminophen, or any other component
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Tylox /Ortho-McNeil; Percocet /Endo Labs
Oxycodone and acetaminophen (2 of 2)
In clinical practice, the pain associated with OA and RA is treated with a wide variety of agents, including opioid analgesics.
Warnings
Precautions
Drug Interactions
Dosing
Tylox contains sodium metabisulfite, which may cause allergic-type reactions like anaphylactic symptoms or asthmatic episodes in certain patients
Potential for drug dependence (Class II)
Can produce morphine-type drug dependence and has potential for being abused
Patients with head injuries or increased intracranial pressure, or acute abdominal conditions
Special risk patients: elderly or debilitated, pediatric patients, those with severe hepatic or renal impairment, hypothyroidism, Addison disease, and prostatic hypertrophy or urethral stricture
May interact with other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol), and anticholinergics
Tylox : 1 tablet (5 mg oxycodone/500 mg acetaminophen) q 6 hours as needed
Percocet :
1 tablet q 6 hours as needed; available in tablets with the following oxycodone/acetaminophen ratios: 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/500 mg, 10 mg/650 mg
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daily dosage of acetaminophen should not exceed 4 grams
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oxycodone/Purdue Pharma
OxyContin (1 of 3)
In clinical practice, the pain associated with OA and RA is treated with a wide variety of agents, including opioid analgesics.
Chemical Class
Indications
Pharmacokinetics
Adverse Events
Contraindications
Pure agonist opioid analgesic
Management of moderate to severe pain where when a continuous, around-the-clock analgesic is needed for an extended period of time
Released at controlled rate over 12 hours
Metabolized to several products, some of which have slight analgesic activity, and excreted primarily in the urine
Half-life is 4.5 hours
Serious events are those associated with other opioids, including respiratory depression, apnea, respiratory arrest, circulatory depression (to an even lesser degree), hypotension, or shock
Other reported events >5%: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia
Patients with known hypersensitivity to oxycodone or in any situation where opioids are contraindicated; any patient with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), acute or severe bronchial asthma or hypercarbia; any patient who has or is
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suspected of having paralytic ileus
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oxycodone/Purdue Pharma
OxyContin (2 of 3)
In clinical practice, the pain associated with OA and RA is treated with a wide variety of agents, including opioid analgesics.
Warnings
Black box warnings:
OxyContin is an opioid agonist and a Schedule II controlled substance with abuse liability similar to morphine
Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit; this should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion
OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when continuous, around-the-clock analgesic is needed for an extended period of time
OxyContin Tablets are NOT intended for use as a prn analgesic
OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY; these tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids
OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED; TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE
Other warnings include interactions with alcohol, drug abuse and addiction, respiratory depression, head injury, and hypotensive effects
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oxycodone/Purdue Pharma
OxyContin (3 of 3)
In clinical practice, the pain associated with OA and RA is treated with a wide variety of agents, including opioid analgesics.
Precautions
Drug Interactions
Dosing
Patients may develop tolerance and physical dependence
Special precautions relating to 80 mg and 160 mg tablets: equivalent dosage and appropriate use
Acute alcoholism, adrenocortical insufficiency, CNS depression or coma, delirium, debilitation, ambulatory surgery, postoperative use, hyperthyroidism, prostatic hypertrophy or urethral stricture, toxic psychosis, pancreatic/biliary tract disease, tolerance and physical dependence, hepatic impairment, renal impairment, and pulmonary function impairment, pregnancy and nursing, pediatric use, geriatric use
May interact with other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative hypnotics, alcohol, other CNS depressants
May enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression
Opioid-naive patients: 10 mg or 20 mg q 12 hours
Patients currently on opioid therapy: calculate equivalent dose using conversion table supplied in labeling, then divide by 2 for the 12-hour dose
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oxycodone and aspirin/Endo Labs
Percodan (1 of 2)
In clinical practice, the pain associated with OA and RA is treated with a wide variety of agents, including opioid analgesics.
Chemical Class
Indications
Pharmacokinetics
Adverse Events
Contraindications
Oxycodone: pure agonist opioid analgesic
Aspirin: nonopioid NSAID; inhibits prostaglandin synthesis by COX-1 and COX-2
Management of moderate to moderately severe pain
Oxycodone:
detoxified in liver and eliminated primarily in urine
half-life is 3.2 hours
Aspirin:
metabolized in liver and excreted in the urine
half-life is 15 to 20 minutes for aspirin, 2 to 3 hours for salicylic acid
Most frequently observed events include: lightheadedness, dizziness, sedation, nausea, vomiting
Other events include euphoria, dysphoria, constipation, pruritus
Patients with known hypersensitivity to oxycodone or aspirin
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oxycodone and aspirin/Endo Labs
Percodan (2 of 2)
In clinical practice, the pain associated with OA and RA is treated with a wide variety of agents, including opioid analgesics.
Warnings
Precautions
Drug Interactions
Dosing
Potential for abuse and drug dependence
Respiratory depression, head injury and increased intracranial pressure, hypotensive effect, GI effects
other warnings on patients with peptic ulcer or coagulation abnormalities
Patients with head injury or increased intracranial pressure, acute abdominal conditions
Elevated hepatic enzymes, increased bleeding time, hemorrhage
Special risk patients: elderly or debilitated, those with CNS depression, severe renal or hepatic impairment, hypothyroidism, Addison disease, prostatic hypertrophy or urethral stricture, acute alcoholism, delirium, respiratory depression, and toxic psychosis
Pregnancy; tolerance and physical dependency
Oxycodone may have additive effects with other CNS depressants (including alcohol) and with skeletal muscle relaxants; aspirin may enhance effects of anticoagulants and inhibit effects of uricosuric agents
Usual adult dosage is one tablet oxycodone hydrochloride 4.5 mg, oxycodone terephthalate 0.38 mg, and aspirin 325 mgq 6 hours as needed
The maximum dose of aspirin should not exceed 4 grams per
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day
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codeine/acetaminophen/Ortho-McNeil Chemical Class
Indications
Pharmacokinetics
Adverse Events
Contraindications
Tylenol With Codeine Elixir, Tylenol With Codeine Tablets
(1 of 2)
Codeine is an opioid receptor agonist
Acetaminophen is a nonopioid nonsalicylate analgesic and antipyretic
Oral tablets: relief of mild to moderately severe pain
Oral elixir: relief of mild to moderate pain
Codeine:
metabolized mainly in liver; 10% converted to morphine
half-life is 2.5 to 3 hours
Acetaminophen:
metabolized in liver and eliminated in urine
half-life is approximately 1 to 4 hours
Most frequently observed reactions include lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting
Other events include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus
Contraindicated in patients who have experienced hypersensitivity to any component
®
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codeine/acetaminophen/Ortho-McNeil Warnings
Precautions
Drug Interactions
Dosing
Tylenol With Codeine Elixir, Tylenol With Codeine Tablets
(2 of 2)
Contains sodium metabisulfite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible patients; sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people
Include patients with head injury, increased intracranial pressure, and acute abdominal conditions
Special risk patients: elderly or debilitated, patients with severe renal or hepatic impairment, hypothyroidism, Addison's disease, and prostatic hypertrophy or urethral stricture
CNS depression may occur in patients taking other narcotic analgesics, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol); concurrent use of anticholinergics with codeine may produce paralytic ileus
Tablets
15 mg to 60 mg codeine plus 300 mg to 1000 mg acetaminophen q 4 hours; not to exceed 360 mg codeine and 4000 mg acetaminophen in 24 hours
pediatric use: 0.5 mg codeine/kg
Elixir (120 mg acetaminophen plus 12 mg codeine/5 mL)
7 to 12 years: 10 mL (2 tsp) TID or QID
3 to 6 years: 5 mL (1 tsp) TID or QID
adults: 15 mL (1 tbsp) q 4 hours, as needed
®
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tramadol hydrochloride tablets/Ortho-McNeil Chemical Class
Indications
Pharmacokinetics
Adverse Events
Contraindications
Ultram (1 of 2)
Centrally acting analgesic
Management of moderate to moderately severe pain in adults
T is 2 hours for tramadol and 3 hours for active metabolite M1
Metabolized mainly in the liver; production of M1 depends on P-450 enzyme 2D6; eliminated primarily in the urine
Half-life is 6.3 hours for tramadol and 7.4 hours for M1
Incidence >5%, up to 90 days: dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhea
Patients with known hypersensitivity to tramadol, or any other component of Ultram or opioids; cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs
max
®
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tramadol hydrochloride tablets/Ortho-McNeil Warnings
Precautions
Drug Interactions
Dosing
Ultram (2 of 2)
Bolded warning on seizure risk
reported in patients taking dose within recommended range; risk increased with doses increased above recommended range; increased risk in patients taking drugs that reduce seizure threshold (eg, antidepressants)
Other warnings on anaphylactoid reactions, respiratory depression, use with CNS depressants, increased head trauma or intracranial pressure, driving or operating machinery, withdrawal, physical dependence and abuse
Patients at risk for acute abdominal conditions or renal or hepatic disease
May interact with carbamazepine, quinidine, drugs that inhibit P-450 2D6 enzyme, cimetidine, MAO inhibitors, and rarely with digoxin and warfarin
Titration regimen in patients not requiring rapid onset of analgesic effects: 25 mg/day q AM up to 100 mg/day (25 mg QID)
After titration, or in patients who require rapid onset of analgesic effect: 50 mg to 100 mg as needed q 4 to 6 hours; total not to exceed 400 mg/day
Dosing adjustments for patients:
>75 years: not more than 300 mg/day in divided doses
with creatinine clearance <30 mL/min: dosing interval increased to 12 hours, with maximum daily dose of 200 mg
with cirrhosis: 50 mg q 12 hours
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