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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




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%




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:


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




Lortab Tablets, Lortab Elixir/UCB; Vicodin /Knoll Labs

Hydrocodone bitartrate and acetaminophen

(2 of 2)


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




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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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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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)


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:


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




Tylox /Ortho-McNeil; Percocet /Endo Labs

Oxycodone and acetaminophen (2 of 2)


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




oxycodone/Purdue Pharma

OxyContin (1 of 3)


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




suspected of having paralytic ileus





OxyContin (2 of 3)


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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OxyContin (3 of 3)


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




oxycodone and aspirin/Endo Labs

Percodan (1 of 2)


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




oxycodone and aspirin/Endo Labs

Percodan (2 of 2)


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




day




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:


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

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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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