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CELECOXIB Capsules (GREENSTONE LLC)

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CELECOXIB Capsules (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • ...
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1. INDICATIONS AND USAGE

Celecoxib is indicated

1.1 Osteoarthritis (OA)

For the management of the signs and symptoms of OA [...

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2. DOSAGE AND ADMINISTRATION

2.1 General Dosing Instructions

Carefully consider the potential benefits and risks of celecoxib and other treatment options before...

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3. DOSAGE FORMS AND STRENGTHS

Celecoxib capsules:

50 mg white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body.

100 mg white, with reverse printed white...

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4. CONTRAINDICATIONS

Celecoxib is contraindicated in the following patients:

  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to...
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5. WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Thrombotic Events

Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three...

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6. ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Cardiovascular Thrombotic Events [see

    6.1 Clinical...

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7. DRUG INTERACTIONS

See

...
Table 3: Clinically Significant Drug Interactions with Celecoxib
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8. USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Use of NSAIDs,...

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10. OVERDOSAGE

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care....

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11. DESCRIPTION

Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(...

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12. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Celecoxib has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of celecoxib...

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13. NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14. CLINICAL STUDIES

14.1 Osteoarthritis

Celecoxib has demonstrated significant reduction in joint pain compared to placebo. Celecoxib was evaluated for treatment of...

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16. HOW SUPPLIED/STORAGE AND HANDLING

Celecoxib 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as:

...
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Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

...

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