Valdecoxib

Valdecoxib
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Black Box Warning

Serious Skin Reactions: See full prescribing information for complete Boxed Warning. Serious Skin Reactions: Serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving BEXTRA. Some of these reactions have resulted in death. Patients appear to be at higher risk for these events within the first 2 weeks of treatment, but these may occur at any time during treatment. The reported rate of these serious skin events appears to be greater for BEXTRA as compared to other COX-2 agents. BEXTRA should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Overview

Valdecoxib is a Cyclooxygenase-2 Inhibitor that is FDA approved for the treatment of osteoarthritis, adult rheumatoid arthritis and primary dysmenorrhea. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• For relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis.
• For the treatment of primary dysmenorrhea

Dosage

Osteoarthritis and Adult Rheumatoid Arthritis The recommended dose of BEXTRA Tablets for the relief of the signs and symptoms of arthritis is 10 mg once daily.

Primary Dysmenorrhea The recommended dose of BEXTRA Tablets for treatment of primary dysmenorrhea is 20 mg twice daily, as needed.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Valdecoxib in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Valdecoxib in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Valdecoxib in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Valdecoxib in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Valdecoxib in pediatric patients.

Contraindications

• BEXTRA should not be given to patients who have demonstrated allergic-type reactions to sulfonamides.

BEXTRA Tablets are contraindicated in patients with known hypersensitivity to valdecoxib. BEXTRA should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs are possible in such patients (see WARNINGS — ANAPHYLACTOID REACTIONS, and PRECAUTIONS — PREEXISTING ASTHMA).

BEXTRA is contraindicated for the treatment of post-operative pain immediately following coronary artery bypass graft (CABG) surgery and should not be used in this setting.

Warnings

Serious Skin Reactions: See full prescribing information for complete Boxed Warning. Serious Skin Reactions: Serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving BEXTRA. Some of these reactions have resulted in death. Patients appear to be at higher risk for these events within the first 2 weeks of treatment, but these may occur at any time during treatment. The reported rate of these serious skin events appears to be greater for BEXTRA as compared to other COX-2 agents. BEXTRA should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Valdecoxib in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Valdecoxib in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Valdecoxib in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Valdecoxib during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Valdecoxib with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Valdecoxib with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Valdecoxib with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Valdecoxib with respect to specific gender populations.

Race

There is no FDA guidance on the use of Valdecoxib with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Valdecoxib in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Valdecoxib in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Valdecoxib in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Valdecoxib in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Valdecoxib in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Valdecoxib in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Valdecoxib in the drug label.

Pharmacology

There is limited information regarding Valdecoxib Pharmacology in the drug label.

Mechanism of Action

Structure

File:Valdecoxib01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Valdecoxib in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Valdecoxib in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Valdecoxib in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Valdecoxib in the drug label.

How Supplied

Storage

There is limited information regarding Valdecoxib Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Valdecoxib in the drug label.

Precautions with Alcohol

• Alcohol-Valdecoxib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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