Indications Relief of signs and symptoms of osteoarthritis and adult rheumatoid arthritis; treatment of primary dysmenorrhea.

 Contraindications Asthma; urticaria; allergic-type reactions after taking aspirin or NSAIDs; sensitivity to valdecoxib.

 Route/Dosage

Osteoarthritis, Rheumatoid Arthritis

ADULTS: PO 10 mg once daily.

Primary Dysmenorrhea

ADULTS: PO 20 mg bid as needed.

 Interactions

ACE Inhibitors: Antihypertensive effect may be decreased. Aspirin: Risk of GI complications (eg, ulceration) may be increased. Dextromethorphan: Plasma levels may be reduced by valdecoxib, decreasing the pharmacologic effect. Fluconazole, Ketoconazole, Lithium: Plasma levels may be elevated by valdecoxib, increasing the pharmacologic and adverse effects. Loop Diuretics (eg, Furosemide): Diuretic effect may be decreased. Warfarin: Risk of bleeding may be increased.

 Lab Test Interferences None well documented.

 Adverse Reactions CARDIOVASCULAR: Hypertension; aneurysm; angina pectoris; arrhythmia; cardiomyopathy; CHF; coronary artery disorder; heart murmur; hypotension; generalized edema; bradycardia; palpitation; tachycardia; intermittent claudication; acquired hemagioma; varicose veins. CNS: Dizziness, headache; cerebrovascular disorder; hypertonia; hypoesthesia; migraine; neuralgia; neuropathy; paresthesia; tremor; twitching; vertigo; fatigue; anorexia; anxiety; increased appetite; confusion; depression; aggravated depression; insomnia; nervousness; morbid dreaming; somnolence. DERMATOLOGIC: Rash; cellulitis; contact dermatitis; acne; alopecia; dermatitis; fungal dermatitis; eczema; photosensitivity allergic reaction; pruritus; erythematous rash; maculopapular rash; psoriaform rash; dry skin; skin hypertrophy; skin ulceration; increased sweating; urticaria. EENT: Sinusitis; ear abnormality; earache; tinnitus; otitis media; blurred vision; cataract; conjunctivitis; eye pain; keratitis; abnormal vision. GI: Abdominal fullness; abdominal pain; diarrhea; dyspepsia; flatulence; nausea; abnormal stools; constipation; diverticulosis; dry mouth; duodenal ulcer; duodenitis; eructation; esophagitis; fecal incontinence; gastric ulcer; gastritis; gastroenteritis; gastroesophageal reflux; hematemesis; hematochezia; hemorrhoids; bleeding hemorrhoids; hiatal hernia; melena; stomatitis; increased stool frequency; tenesmus; tooth disorder; vomiting; taste perversion. GU: Amenorrhea; dysmenorrhea; leukorrhea; mastitis; menstrual disorder; menorrhagia; menstrual bloating; vaginal hemorrhage; impotence; prostatic disorder; genital moniliasis; albuminuria; cystitis; dysuria; hematuria; increased micturition frequency; pyuria; urinary incontinence; urinary tract infection. HEMATOLOGIC: Anemia; ecchymosis; epistaxis; hematoma NOS; thrombocytopenia; eosinophilia; leukopenia; leukocytosis; lymphadenopathy; lymphangitis; lymphopenia. HEPATIC: Abnormal hepatic function; hepatitis; increased ALT and AST. METABOLIC: Increased alkaline phosphatase, BUN, CPK, creatinine, and LDH; diabetes mellitus; glycosuria; gout; hypercholesterolemia; hyperglycemia; hyperkalemia; hyperlipemia; hyperuricemia; hypocalcemia; hypokalemia; increased thirst; decreased and increased weight; xerophthalmia. RESPIRATORY: Upper respiratory tract infection; abnormal breath sounds; bronchitis; bronchospasm; coughing; dyspnea; emphysema; laryngitis; pneumonia; pharyngitis; pleurisy; rhinitis. OTHER: Back pain; peripheral edema; flu-like symptoms; accidental injury; myalgia; goiter; allergic reaction; aggravated allergy; asthenia; chest pain; chills; cyst; face edema; fever; hot flushes; malaise; pain; periorbital swelling; peripheral pain; halitosis; arthralgia; accidental fracture; neck stiffness; osteoporosis; synovitis; tendonitis; breast neoplasm; lipoma; malignant ovarian cyst; herpes simplex; herpes zoster; fungal infection; soft tissue infection; viral infection; moniliasis.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. GI Effects: Serious GI toxicity (eg, ulceration, bleeding, perforation) can occur at any time, with or without warning symptoms. Anaphylaxis: Anaphylaxis may occur in patients without known exposure to valdecoxib; do not administer to patients with aspirin triad. Dehydration: Use with caution and rehydrate patient before use. Hepatic Disease: Use with caution in patients with mild to moderate hepatic impairment; avoid use in severe hepatic impairment. Renal Disease: Use with caution.

 Administration/Storage

• May administer each dose without regard to meals or antacids.
• Store tablets at controlled room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of GI bleeding or ulcers, “aspirin triad” (eg, asthma, rhinitis with or without nasal polyps), allergic reactions to aspirin or other NSAIDs, hypertension, CHF, edema, renal or hepatic impairment.
• Obtain baseline assessments of pain and ability to perform activities of daily living in patient with arthritis. Monitor periodically during therapy.
• Ensure that renal function has been assessed prior to initiating therapy and periodically during therapy in patient with renal impairment.
• Notify health care provider if indigestion, epigastric pain, unusual bleeding or bruising, or dark tarry stools occur.
• Monitor patient for GI, CNS, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Instruct patient to take exactly as prescribed.
• Advise patient that each dose may be taken without regard to food.
• Advise patient that dose is individualized based upon severity of symptoms and response to therapy.
• Advise patient to continue other arthritis medications as recommended by their health care provider.
• Caution patient to avoid smoking, alcohol, and aspirin-containing medications while taking this drug.
• Advise patient that if a dose is missed, take it as soon as possible, but if close to the next dose, do not double up and take the next dose as scheduled.
• Instruct patient to discontinue drug and notify health care provider if any of the following occur: persistent GI upset, skin rash, itching, black stools, weight gain, edema, changes in urine patterns, persistent nausea, “flu-like” symptoms, right upper abdominal pain, yellowing of skin or eyes, unexplained fatigue or lethargy.
• Advise patient to inform the health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Instruct patient not to take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up examinations and lab tests may be required to monitor therapy and to be sure and keep appointments.

–>

Indications for Drugs ::

 Action Inhibits inflammation, pain and fever, probably by inhibition of cyclooxygenase-2 (COX-2).

 Indications Relief of signs and symptoms of osteoarthritis and adult rheumatoid arthritis; treatment of primary dysmenorrhea.

 Contraindications Asthma; urticaria; allergic-type reactions after taking aspirin or NSAIDs; sensitivity to valdecoxib.

 Route/Dosage

Osteoarthritis, Rheumatoid Arthritis

ADULTS: PO 10 mg once daily.

Primary Dysmenorrhea

ADULTS: PO 20 mg bid as needed.

 Interactions

ACE Inhibitors: Antihypertensive effect may be decreased. Aspirin: Risk of GI complications (eg, ulceration) may be increased. Dextromethorphan: Plasma levels may be reduced by valdecoxib, decreasing the pharmacologic effect. Fluconazole, Ketoconazole, Lithium: Plasma levels may be elevated by valdecoxib, increasing the pharmacologic and adverse effects. Loop Diuretics (eg, Furosemide): Diuretic effect may be decreased. Warfarin: Risk of bleeding may be increased.

 Lab Test Interferences None well documented.

 Adverse Reactions CARDIOVASCULAR: Hypertension; aneurysm; angina pectoris; arrhythmia; cardiomyopathy; CHF; coronary artery disorder; heart murmur; hypotension; generalized edema; bradycardia; palpitation; tachycardia; intermittent claudication; acquired hemagioma; varicose veins. CNS: Dizziness, headache; cerebrovascular disorder; hypertonia; hypoesthesia; migraine; neuralgia; neuropathy; paresthesia; tremor; twitching; vertigo; fatigue; anorexia; anxiety; increased appetite; confusion; depression; aggravated depression; insomnia; nervousness; morbid dreaming; somnolence. DERMATOLOGIC: Rash; cellulitis; contact dermatitis; acne; alopecia; dermatitis; fungal dermatitis; eczema; photosensitivity allergic reaction; pruritus; erythematous rash; maculopapular rash; psoriaform rash; dry skin; skin hypertrophy; skin ulceration; increased sweating; urticaria. EENT: Sinusitis; ear abnormality; earache; tinnitus; otitis media; blurred vision; cataract; conjunctivitis; eye pain; keratitis; abnormal vision. GI: Abdominal fullness; abdominal pain; diarrhea; dyspepsia; flatulence; nausea; abnormal stools; constipation; diverticulosis; dry mouth; duodenal ulcer; duodenitis; eructation; esophagitis; fecal incontinence; gastric ulcer; gastritis; gastroenteritis; gastroesophageal reflux; hematemesis; hematochezia; hemorrhoids; bleeding hemorrhoids; hiatal hernia; melena; stomatitis; increased stool frequency; tenesmus; tooth disorder; vomiting; taste perversion. GU: Amenorrhea; dysmenorrhea; leukorrhea; mastitis; menstrual disorder; menorrhagia; menstrual bloating; vaginal hemorrhage; impotence; prostatic disorder; genital moniliasis; albuminuria; cystitis; dysuria; hematuria; increased micturition frequency; pyuria; urinary incontinence; urinary tract infection. HEMATOLOGIC: Anemia; ecchymosis; epistaxis; hematoma NOS; thrombocytopenia; eosinophilia; leukopenia; leukocytosis; lymphadenopathy; lymphangitis; lymphopenia. HEPATIC: Abnormal hepatic function; hepatitis; increased ALT and AST. METABOLIC: Increased alkaline phosphatase, BUN, CPK, creatinine, and LDH; diabetes mellitus; glycosuria; gout; hypercholesterolemia; hyperglycemia; hyperkalemia; hyperlipemia; hyperuricemia; hypocalcemia; hypokalemia; increased thirst; decreased and increased weight; xerophthalmia. RESPIRATORY: Upper respiratory tract infection; abnormal breath sounds; bronchitis; bronchospasm; coughing; dyspnea; emphysema; laryngitis; pneumonia; pharyngitis; pleurisy; rhinitis. OTHER: Back pain; peripheral edema; flu-like symptoms; accidental injury; myalgia; goiter; allergic reaction; aggravated allergy; asthenia; chest pain; chills; cyst; face edema; fever; hot flushes; malaise; pain; periorbital swelling; peripheral pain; halitosis; arthralgia; accidental fracture; neck stiffness; osteoporosis; synovitis; tendonitis; breast neoplasm; lipoma; malignant ovarian cyst; herpes simplex; herpes zoster; fungal infection; soft tissue infection; viral infection; moniliasis.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. GI Effects: Serious GI toxicity (eg, ulceration, bleeding, perforation) can occur at any time, with or without warning symptoms. Anaphylaxis: Anaphylaxis may occur in patients without known exposure to valdecoxib; do not administer to patients with aspirin triad. Dehydration: Use with caution and rehydrate patient before use. Hepatic Disease: Use with caution in patients with mild to moderate hepatic impairment; avoid use in severe hepatic impairment. Renal Disease: Use with caution.

 Administration/Storage

• May administer each dose without regard to meals or antacids.
• Store tablets at controlled room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of GI bleeding or ulcers, “aspirin triad” (eg, asthma, rhinitis with or without nasal polyps), allergic reactions to aspirin or other NSAIDs, hypertension, CHF, edema, renal or hepatic impairment.
• Obtain baseline assessments of pain and ability to perform activities of daily living in patient with arthritis. Monitor periodically during therapy.
• Ensure that renal function has been assessed prior to initiating therapy and periodically during therapy in patient with renal impairment.
• Notify health care provider if indigestion, epigastric pain, unusual bleeding or bruising, or dark tarry stools occur.
• Monitor patient for GI, CNS, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Instruct patient to take exactly as prescribed.
• Advise patient that each dose may be taken without regard to food.
• Advise patient that dose is individualized based upon severity of symptoms and response to therapy.
• Advise patient to continue other arthritis medications as recommended by their health care provider.
• Caution patient to avoid smoking, alcohol, and aspirin-containing medications while taking this drug.
• Advise patient that if a dose is missed, take it as soon as possible, but if close to the next dose, do not double up and take the next dose as scheduled.
• Instruct patient to discontinue drug and notify health care provider if any of the following occur: persistent GI upset, skin rash, itching, black stools, weight gain, edema, changes in urine patterns, persistent nausea, “flu-like” symptoms, right upper abdominal pain, yellowing of skin or eyes, unexplained fatigue or lethargy.
• Advise patient to inform the health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Instruct patient not to take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up examinations and lab tests may be required to monitor therapy and to be sure and keep appointments.

–>

Drug Dose ::

 Action Inhibits inflammation, pain and fever, probably by inhibition of cyclooxygenase-2 (COX-2).

 Indications Relief of signs and symptoms of osteoarthritis and adult rheumatoid arthritis; treatment of primary dysmenorrhea.

 Contraindications Asthma; urticaria; allergic-type reactions after taking aspirin or NSAIDs; sensitivity to valdecoxib.

 Route/Dosage

Osteoarthritis, Rheumatoid Arthritis

ADULTS: PO 10 mg once daily.

Primary Dysmenorrhea

ADULTS: PO 20 mg bid as needed.

 Interactions

ACE Inhibitors: Antihypertensive effect may be decreased. Aspirin: Risk of GI complications (eg, ulceration) may be increased. Dextromethorphan: Plasma levels may be reduced by valdecoxib, decreasing the pharmacologic effect. Fluconazole, Ketoconazole, Lithium: Plasma levels may be elevated by valdecoxib, increasing the pharmacologic and adverse effects. Loop Diuretics (eg, Furosemide): Diuretic effect may be decreased. Warfarin: Risk of bleeding may be increased.

 Lab Test Interferences None well documented.

 Adverse Reactions CARDIOVASCULAR: Hypertension; aneurysm; angina pectoris; arrhythmia; cardiomyopathy; CHF; coronary artery disorder; heart murmur; hypotension; generalized edema; bradycardia; palpitation; tachycardia; intermittent claudication; acquired hemagioma; varicose veins. CNS: Dizziness, headache; cerebrovascular disorder; hypertonia; hypoesthesia; migraine; neuralgia; neuropathy; paresthesia; tremor; twitching; vertigo; fatigue; anorexia; anxiety; increased appetite; confusion; depression; aggravated depression; insomnia; nervousness; morbid dreaming; somnolence. DERMATOLOGIC: Rash; cellulitis; contact dermatitis; acne; alopecia; dermatitis; fungal dermatitis; eczema; photosensitivity allergic reaction; pruritus; erythematous rash; maculopapular rash; psoriaform rash; dry skin; skin hypertrophy; skin ulceration; increased sweating; urticaria. EENT: Sinusitis; ear abnormality; earache; tinnitus; otitis media; blurred vision; cataract; conjunctivitis; eye pain; keratitis; abnormal vision. GI: Abdominal fullness; abdominal pain; diarrhea; dyspepsia; flatulence; nausea; abnormal stools; constipation; diverticulosis; dry mouth; duodenal ulcer; duodenitis; eructation; esophagitis; fecal incontinence; gastric ulcer; gastritis; gastroenteritis; gastroesophageal reflux; hematemesis; hematochezia; hemorrhoids; bleeding hemorrhoids; hiatal hernia; melena; stomatitis; increased stool frequency; tenesmus; tooth disorder; vomiting; taste perversion. GU: Amenorrhea; dysmenorrhea; leukorrhea; mastitis; menstrual disorder; menorrhagia; menstrual bloating; vaginal hemorrhage; impotence; prostatic disorder; genital moniliasis; albuminuria; cystitis; dysuria; hematuria; increased micturition frequency; pyuria; urinary incontinence; urinary tract infection. HEMATOLOGIC: Anemia; ecchymosis; epistaxis; hematoma NOS; thrombocytopenia; eosinophilia; leukopenia; leukocytosis; lymphadenopathy; lymphangitis; lymphopenia. HEPATIC: Abnormal hepatic function; hepatitis; increased ALT and AST. METABOLIC: Increased alkaline phosphatase, BUN, CPK, creatinine, and LDH; diabetes mellitus; glycosuria; gout; hypercholesterolemia; hyperglycemia; hyperkalemia; hyperlipemia; hyperuricemia; hypocalcemia; hypokalemia; increased thirst; decreased and increased weight; xerophthalmia. RESPIRATORY: Upper respiratory tract infection; abnormal breath sounds; bronchitis; bronchospasm; coughing; dyspnea; emphysema; laryngitis; pneumonia; pharyngitis; pleurisy; rhinitis. OTHER: Back pain; peripheral edema; flu-like symptoms; accidental injury; myalgia; goiter; allergic reaction; aggravated allergy; asthenia; chest pain; chills; cyst; face edema; fever; hot flushes; malaise; pain; periorbital swelling; peripheral pain; halitosis; arthralgia; accidental fracture; neck stiffness; osteoporosis; synovitis; tendonitis; breast neoplasm; lipoma; malignant ovarian cyst; herpes simplex; herpes zoster; fungal infection; soft tissue infection; viral infection; moniliasis.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. GI Effects: Serious GI toxicity (eg, ulceration, bleeding, perforation) can occur at any time, with or without warning symptoms. Anaphylaxis: Anaphylaxis may occur in patients without known exposure to valdecoxib; do not administer to patients with aspirin triad. Dehydration: Use with caution and rehydrate patient before use. Hepatic Disease: Use with caution in patients with mild to moderate hepatic impairment; avoid use in severe hepatic impairment. Renal Disease: Use with caution.

 Administration/Storage

• May administer each dose without regard to meals or antacids.
• Store tablets at controlled room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of GI bleeding or ulcers, “aspirin triad” (eg, asthma, rhinitis with or without nasal polyps), allergic reactions to aspirin or other NSAIDs, hypertension, CHF, edema, renal or hepatic impairment.
• Obtain baseline assessments of pain and ability to perform activities of daily living in patient with arthritis. Monitor periodically during therapy.
• Ensure that renal function has been assessed prior to initiating therapy and periodically during therapy in patient with renal impairment.
• Notify health care provider if indigestion, epigastric pain, unusual bleeding or bruising, or dark tarry stools occur.
• Monitor patient for GI, CNS, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Instruct patient to take exactly as prescribed.
• Advise patient that each dose may be taken without regard to food.
• Advise patient that dose is individualized based upon severity of symptoms and response to therapy.
• Advise patient to continue other arthritis medications as recommended by their health care provider.
• Caution patient to avoid smoking, alcohol, and aspirin-containing medications while taking this drug.
• Advise patient that if a dose is missed, take it as soon as possible, but if close to the next dose, do not double up and take the next dose as scheduled.
• Instruct patient to discontinue drug and notify health care provider if any of the following occur: persistent GI upset, skin rash, itching, black stools, weight gain, edema, changes in urine patterns, persistent nausea, “flu-like” symptoms, right upper abdominal pain, yellowing of skin or eyes, unexplained fatigue or lethargy.
• Advise patient to inform the health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Instruct patient not to take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up examinations and lab tests may be required to monitor therapy and to be sure and keep appointments.

–>

Contraindication ::

 Action Inhibits inflammation, pain and fever, probably by inhibition of cyclooxygenase-2 (COX-2).

 Indications Relief of signs and symptoms of osteoarthritis and adult rheumatoid arthritis; treatment of primary dysmenorrhea.

 Contraindications Asthma; urticaria; allergic-type reactions after taking aspirin or NSAIDs; sensitivity to valdecoxib.

 Route/Dosage

Osteoarthritis, Rheumatoid Arthritis

ADULTS: PO 10 mg once daily.

Primary Dysmenorrhea

ADULTS: PO 20 mg bid as needed.

 Interactions

ACE Inhibitors: Antihypertensive effect may be decreased. Aspirin: Risk of GI complications (eg, ulceration) may be increased. Dextromethorphan: Plasma levels may be reduced by valdecoxib, decreasing the pharmacologic effect. Fluconazole, Ketoconazole, Lithium: Plasma levels may be elevated by valdecoxib, increasing the pharmacologic and adverse effects. Loop Diuretics (eg, Furosemide): Diuretic effect may be decreased. Warfarin: Risk of bleeding may be increased.

 Lab Test Interferences None well documented.

 Adverse Reactions CARDIOVASCULAR: Hypertension; aneurysm; angina pectoris; arrhythmia; cardiomyopathy; CHF; coronary artery disorder; heart murmur; hypotension; generalized edema; bradycardia; palpitation; tachycardia; intermittent claudication; acquired hemagioma; varicose veins. CNS: Dizziness, headache; cerebrovascular disorder; hypertonia; hypoesthesia; migraine; neuralgia; neuropathy; paresthesia; tremor; twitching; vertigo; fatigue; anorexia; anxiety; increased appetite; confusion; depression; aggravated depression; insomnia; nervousness; morbid dreaming; somnolence. DERMATOLOGIC: Rash; cellulitis; contact dermatitis; acne; alopecia; dermatitis; fungal dermatitis; eczema; photosensitivity allergic reaction; pruritus; erythematous rash; maculopapular rash; psoriaform rash; dry skin; skin hypertrophy; skin ulceration; increased sweating; urticaria. EENT: Sinusitis; ear abnormality; earache; tinnitus; otitis media; blurred vision; cataract; conjunctivitis; eye pain; keratitis; abnormal vision. GI: Abdominal fullness; abdominal pain; diarrhea; dyspepsia; flatulence; nausea; abnormal stools; constipation; diverticulosis; dry mouth; duodenal ulcer; duodenitis; eructation; esophagitis; fecal incontinence; gastric ulcer; gastritis; gastroenteritis; gastroesophageal reflux; hematemesis; hematochezia; hemorrhoids; bleeding hemorrhoids; hiatal hernia; melena; stomatitis; increased stool frequency; tenesmus; tooth disorder; vomiting; taste perversion. GU: Amenorrhea; dysmenorrhea; leukorrhea; mastitis; menstrual disorder; menorrhagia; menstrual bloating; vaginal hemorrhage; impotence; prostatic disorder; genital moniliasis; albuminuria; cystitis; dysuria; hematuria; increased micturition frequency; pyuria; urinary incontinence; urinary tract infection. HEMATOLOGIC: Anemia; ecchymosis; epistaxis; hematoma NOS; thrombocytopenia; eosinophilia; leukopenia; leukocytosis; lymphadenopathy; lymphangitis; lymphopenia. HEPATIC: Abnormal hepatic function; hepatitis; increased ALT and AST. METABOLIC: Increased alkaline phosphatase, BUN, CPK, creatinine, and LDH; diabetes mellitus; glycosuria; gout; hypercholesterolemia; hyperglycemia; hyperkalemia; hyperlipemia; hyperuricemia; hypocalcemia; hypokalemia; increased thirst; decreased and increased weight; xerophthalmia. RESPIRATORY: Upper respiratory tract infection; abnormal breath sounds; bronchitis; bronchospasm; coughing; dyspnea; emphysema; laryngitis; pneumonia; pharyngitis; pleurisy; rhinitis. OTHER: Back pain; peripheral edema; flu-like symptoms; accidental injury; myalgia; goiter; allergic reaction; aggravated allergy; asthenia; chest pain; chills; cyst; face edema; fever; hot flushes; malaise; pain; periorbital swelling; peripheral pain; halitosis; arthralgia; accidental fracture; neck stiffness; osteoporosis; synovitis; tendonitis; breast neoplasm; lipoma; malignant ovarian cyst; herpes simplex; herpes zoster; fungal infection; soft tissue infection; viral infection; moniliasis.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. GI Effects: Serious GI toxicity (eg, ulceration, bleeding, perforation) can occur at any time, with or without warning symptoms. Anaphylaxis: Anaphylaxis may occur in patients without known exposure to valdecoxib; do not administer to patients with aspirin triad. Dehydration: Use with caution and rehydrate patient before use. Hepatic Disease: Use with caution in patients with mild to moderate hepatic impairment; avoid use in severe hepatic impairment. Renal Disease: Use with caution.

 Administration/Storage

• May administer each dose without regard to meals or antacids.
• Store tablets at controlled room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of GI bleeding or ulcers, “aspirin triad” (eg, asthma, rhinitis with or without nasal polyps), allergic reactions to aspirin or other NSAIDs, hypertension, CHF, edema, renal or hepatic impairment.
• Obtain baseline assessments of pain and ability to perform activities of daily living in patient with arthritis. Monitor periodically during therapy.
• Ensure that renal function has been assessed prior to initiating therapy and periodically during therapy in patient with renal impairment.
• Notify health care provider if indigestion, epigastric pain, unusual bleeding or bruising, or dark tarry stools occur.
• Monitor patient for GI, CNS, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Instruct patient to take exactly as prescribed.
• Advise patient that each dose may be taken without regard to food.
• Advise patient that dose is individualized based upon severity of symptoms and response to therapy.
• Advise patient to continue other arthritis medications as recommended by their health care provider.
• Caution patient to avoid smoking, alcohol, and aspirin-containing medications while taking this drug.
• Advise patient that if a dose is missed, take it as soon as possible, but if close to the next dose, do not double up and take the next dose as scheduled.
• Instruct patient to discontinue drug and notify health care provider if any of the following occur: persistent GI upset, skin rash, itching, black stools, weight gain, edema, changes in urine patterns, persistent nausea, “flu-like” symptoms, right upper abdominal pain, yellowing of skin or eyes, unexplained fatigue or lethargy.
• Advise patient to inform the health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Instruct patient not to take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up examinations and lab tests may be required to monitor therapy and to be sure and keep appointments.

–>

Drug Precautions ::

 Action Inhibits inflammation, pain and fever, probably by inhibition of cyclooxygenase-2 (COX-2).

 Indications Relief of signs and symptoms of osteoarthritis and adult rheumatoid arthritis; treatment of primary dysmenorrhea.

 Contraindications Asthma; urticaria; allergic-type reactions after taking aspirin or NSAIDs; sensitivity to valdecoxib.

 Route/Dosage

Osteoarthritis, Rheumatoid Arthritis

ADULTS: PO 10 mg once daily.

Primary Dysmenorrhea

ADULTS: PO 20 mg bid as needed.

 Interactions

ACE Inhibitors: Antihypertensive effect may be decreased. Aspirin: Risk of GI complications (eg, ulceration) may be increased. Dextromethorphan: Plasma levels may be reduced by valdecoxib, decreasing the pharmacologic effect. Fluconazole, Ketoconazole, Lithium: Plasma levels may be elevated by valdecoxib, increasing the pharmacologic and adverse effects. Loop Diuretics (eg, Furosemide): Diuretic effect may be decreased. Warfarin: Risk of bleeding may be increased.

 Lab Test Interferences None well documented.

 Adverse Reactions CARDIOVASCULAR: Hypertension; aneurysm; angina pectoris; arrhythmia; cardiomyopathy; CHF; coronary artery disorder; heart murmur; hypotension; generalized edema; bradycardia; palpitation; tachycardia; intermittent claudication; acquired hemagioma; varicose veins. CNS: Dizziness, headache; cerebrovascular disorder; hypertonia; hypoesthesia; migraine; neuralgia; neuropathy; paresthesia; tremor; twitching; vertigo; fatigue; anorexia; anxiety; increased appetite; confusion; depression; aggravated depression; insomnia; nervousness; morbid dreaming; somnolence. DERMATOLOGIC: Rash; cellulitis; contact dermatitis; acne; alopecia; dermatitis; fungal dermatitis; eczema; photosensitivity allergic reaction; pruritus; erythematous rash; maculopapular rash; psoriaform rash; dry skin; skin hypertrophy; skin ulceration; increased sweating; urticaria. EENT: Sinusitis; ear abnormality; earache; tinnitus; otitis media; blurred vision; cataract; conjunctivitis; eye pain; keratitis; abnormal vision. GI: Abdominal fullness; abdominal pain; diarrhea; dyspepsia; flatulence; nausea; abnormal stools; constipation; diverticulosis; dry mouth; duodenal ulcer; duodenitis; eructation; esophagitis; fecal incontinence; gastric ulcer; gastritis; gastroenteritis; gastroesophageal reflux; hematemesis; hematochezia; hemorrhoids; bleeding hemorrhoids; hiatal hernia; melena; stomatitis; increased stool frequency; tenesmus; tooth disorder; vomiting; taste perversion. GU: Amenorrhea; dysmenorrhea; leukorrhea; mastitis; menstrual disorder; menorrhagia; menstrual bloating; vaginal hemorrhage; impotence; prostatic disorder; genital moniliasis; albuminuria; cystitis; dysuria; hematuria; increased micturition frequency; pyuria; urinary incontinence; urinary tract infection. HEMATOLOGIC: Anemia; ecchymosis; epistaxis; hematoma NOS; thrombocytopenia; eosinophilia; leukopenia; leukocytosis; lymphadenopathy; lymphangitis; lymphopenia. HEPATIC: Abnormal hepatic function; hepatitis; increased ALT and AST. METABOLIC: Increased alkaline phosphatase, BUN, CPK, creatinine, and LDH; diabetes mellitus; glycosuria; gout; hypercholesterolemia; hyperglycemia; hyperkalemia; hyperlipemia; hyperuricemia; hypocalcemia; hypokalemia; increased thirst; decreased and increased weight; xerophthalmia. RESPIRATORY: Upper respiratory tract infection; abnormal breath sounds; bronchitis; bronchospasm; coughing; dyspnea; emphysema; laryngitis; pneumonia; pharyngitis; pleurisy; rhinitis. OTHER: Back pain; peripheral edema; flu-like symptoms; accidental injury; myalgia; goiter; allergic reaction; aggravated allergy; asthenia; chest pain; chills; cyst; face edema; fever; hot flushes; malaise; pain; periorbital swelling; peripheral pain; halitosis; arthralgia; accidental fracture; neck stiffness; osteoporosis; synovitis; tendonitis; breast neoplasm; lipoma; malignant ovarian cyst; herpes simplex; herpes zoster; fungal infection; soft tissue infection; viral infection; moniliasis.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. GI Effects: Serious GI toxicity (eg, ulceration, bleeding, perforation) can occur at any time, with or without warning symptoms. Anaphylaxis: Anaphylaxis may occur in patients without known exposure to valdecoxib; do not administer to patients with aspirin triad. Dehydration: Use with caution and rehydrate patient before use. Hepatic Disease: Use with caution in patients with mild to moderate hepatic impairment; avoid use in severe hepatic impairment. Renal Disease: Use with caution.

 Administration/Storage

• May administer each dose without regard to meals or antacids.
• Store tablets at controlled room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of GI bleeding or ulcers, “aspirin triad” (eg, asthma, rhinitis with or without nasal polyps), allergic reactions to aspirin or other NSAIDs, hypertension, CHF, edema, renal or hepatic impairment.
• Obtain baseline assessments of pain and ability to perform activities of daily living in patient with arthritis. Monitor periodically during therapy.
• Ensure that renal function has been assessed prior to initiating therapy and periodically during therapy in patient with renal impairment.
• Notify health care provider if indigestion, epigastric pain, unusual bleeding or bruising, or dark tarry stools occur.
• Monitor patient for GI, CNS, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Instruct patient to take exactly as prescribed.
• Advise patient that each dose may be taken without regard to food.
• Advise patient that dose is individualized based upon severity of symptoms and response to therapy.
• Advise patient to continue other arthritis medications as recommended by their health care provider.
• Caution patient to avoid smoking, alcohol, and aspirin-containing medications while taking this drug.
• Advise patient that if a dose is missed, take it as soon as possible, but if close to the next dose, do not double up and take the next dose as scheduled.
• Instruct patient to discontinue drug and notify health care provider if any of the following occur: persistent GI upset, skin rash, itching, black stools, weight gain, edema, changes in urine patterns, persistent nausea, “flu-like” symptoms, right upper abdominal pain, yellowing of skin or eyes, unexplained fatigue or lethargy.
• Advise patient to inform the health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Instruct patient not to take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up examinations and lab tests may be required to monitor therapy and to be sure and keep appointments.

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Drug Side Effects ::

 Action Inhibits inflammation, pain and fever, probably by inhibition of cyclooxygenase-2 (COX-2).

 Indications Relief of signs and symptoms of osteoarthritis and adult rheumatoid arthritis; treatment of primary dysmenorrhea.

 Contraindications Asthma; urticaria; allergic-type reactions after taking aspirin or NSAIDs; sensitivity to valdecoxib.

 Route/Dosage

Osteoarthritis, Rheumatoid Arthritis

ADULTS: PO 10 mg once daily.

Primary Dysmenorrhea

ADULTS: PO 20 mg bid as needed.

 Interactions

ACE Inhibitors: Antihypertensive effect may be decreased. Aspirin: Risk of GI complications (eg, ulceration) may be increased. Dextromethorphan: Plasma levels may be reduced by valdecoxib, decreasing the pharmacologic effect. Fluconazole, Ketoconazole, Lithium: Plasma levels may be elevated by valdecoxib, increasing the pharmacologic and adverse effects. Loop Diuretics (eg, Furosemide): Diuretic effect may be decreased. Warfarin: Risk of bleeding may be increased.

 Lab Test Interferences None well documented.

 Adverse Reactions CARDIOVASCULAR: Hypertension; aneurysm; angina pectoris; arrhythmia; cardiomyopathy; CHF; coronary artery disorder; heart murmur; hypotension; generalized edema; bradycardia; palpitation; tachycardia; intermittent claudication; acquired hemagioma; varicose veins. CNS: Dizziness, headache; cerebrovascular disorder; hypertonia; hypoesthesia; migraine; neuralgia; neuropathy; paresthesia; tremor; twitching; vertigo; fatigue; anorexia; anxiety; increased appetite; confusion; depression; aggravated depression; insomnia; nervousness; morbid dreaming; somnolence. DERMATOLOGIC: Rash; cellulitis; contact dermatitis; acne; alopecia; dermatitis; fungal dermatitis; eczema; photosensitivity allergic reaction; pruritus; erythematous rash; maculopapular rash; psoriaform rash; dry skin; skin hypertrophy; skin ulceration; increased sweating; urticaria. EENT: Sinusitis; ear abnormality; earache; tinnitus; otitis media; blurred vision; cataract; conjunctivitis; eye pain; keratitis; abnormal vision. GI: Abdominal fullness; abdominal pain; diarrhea; dyspepsia; flatulence; nausea; abnormal stools; constipation; diverticulosis; dry mouth; duodenal ulcer; duodenitis; eructation; esophagitis; fecal incontinence; gastric ulcer; gastritis; gastroenteritis; gastroesophageal reflux; hematemesis; hematochezia; hemorrhoids; bleeding hemorrhoids; hiatal hernia; melena; stomatitis; increased stool frequency; tenesmus; tooth disorder; vomiting; taste perversion. GU: Amenorrhea; dysmenorrhea; leukorrhea; mastitis; menstrual disorder; menorrhagia; menstrual bloating; vaginal hemorrhage; impotence; prostatic disorder; genital moniliasis; albuminuria; cystitis; dysuria; hematuria; increased micturition frequency; pyuria; urinary incontinence; urinary tract infection. HEMATOLOGIC: Anemia; ecchymosis; epistaxis; hematoma NOS; thrombocytopenia; eosinophilia; leukopenia; leukocytosis; lymphadenopathy; lymphangitis; lymphopenia. HEPATIC: Abnormal hepatic function; hepatitis; increased ALT and AST. METABOLIC: Increased alkaline phosphatase, BUN, CPK, creatinine, and LDH; diabetes mellitus; glycosuria; gout; hypercholesterolemia; hyperglycemia; hyperkalemia; hyperlipemia; hyperuricemia; hypocalcemia; hypokalemia; increased thirst; decreased and increased weight; xerophthalmia. RESPIRATORY: Upper respiratory tract infection; abnormal breath sounds; bronchitis; bronchospasm; coughing; dyspnea; emphysema; laryngitis; pneumonia; pharyngitis; pleurisy; rhinitis. OTHER: Back pain; peripheral edema; flu-like symptoms; accidental injury; myalgia; goiter; allergic reaction; aggravated allergy; asthenia; chest pain; chills; cyst; face edema; fever; hot flushes; malaise; pain; periorbital swelling; peripheral pain; halitosis; arthralgia; accidental fracture; neck stiffness; osteoporosis; synovitis; tendonitis; breast neoplasm; lipoma; malignant ovarian cyst; herpes simplex; herpes zoster; fungal infection; soft tissue infection; viral infection; moniliasis.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. GI Effects: Serious GI toxicity (eg, ulceration, bleeding, perforation) can occur at any time, with or without warning symptoms. Anaphylaxis: Anaphylaxis may occur in patients without known exposure to valdecoxib; do not administer to patients with aspirin triad. Dehydration: Use with caution and rehydrate patient before use. Hepatic Disease: Use with caution in patients with mild to moderate hepatic impairment; avoid use in severe hepatic impairment. Renal Disease: Use with caution.

 Administration/Storage

• May administer each dose without regard to meals or antacids.
• Store tablets at controlled room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of GI bleeding or ulcers, “aspirin triad” (eg, asthma, rhinitis with or without nasal polyps), allergic reactions to aspirin or other NSAIDs, hypertension, CHF, edema, renal or hepatic impairment.
• Obtain baseline assessments of pain and ability to perform activities of daily living in patient with arthritis. Monitor periodically during therapy.
• Ensure that renal function has been assessed prior to initiating therapy and periodically during therapy in patient with renal impairment.
• Notify health care provider if indigestion, epigastric pain, unusual bleeding or bruising, or dark tarry stools occur.
• Monitor patient for GI, CNS, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Instruct patient to take exactly as prescribed.
• Advise patient that each dose may be taken without regard to food.
• Advise patient that dose is individualized based upon severity of symptoms and response to therapy.
• Advise patient to continue other arthritis medications as recommended by their health care provider.
• Caution patient to avoid smoking, alcohol, and aspirin-containing medications while taking this drug.
• Advise patient that if a dose is missed, take it as soon as possible, but if close to the next dose, do not double up and take the next dose as scheduled.
• Instruct patient to discontinue drug and notify health care provider if any of the following occur: persistent GI upset, skin rash, itching, black stools, weight gain, edema, changes in urine patterns, persistent nausea, “flu-like” symptoms, right upper abdominal pain, yellowing of skin or eyes, unexplained fatigue or lethargy.
• Advise patient to inform the health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Instruct patient not to take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up examinations and lab tests may be required to monitor therapy and to be sure and keep appointments.

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Drug Mode of Action ::  

 Action Inhibits inflammation, pain and fever, probably by inhibition of cyclooxygenase-2 (COX-2).