CELEBREX Capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

G.D. Searle LLC Division of Pfizer Inc

Λέξεις κλειδιά

0025-1515 0025-1520 0025-1525 0025-1530

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1. Indications and Usage

CELEBREX is indicated: 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA) For the management of the signs and ...

2. Dosage and Administration

2.1 General Dosing Instructions Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dosage for the shortest ...

3. Dosage Forms and Strengths

CELEBREX (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 on blue ...

4. Contraindications

CELEBREX is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see Warnings ...

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 years duration have shown an increased risk of serious cardiovascular ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of CELEBREX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

See Table 3 for clinically significant drug interactions with celecoxib. Table 3. Clinically Significant Drug Interactions with Celecoxib: Drugs That Interfere with Hemostasis Clinical Impact: ...

8. Use in Specific Populations

8.8 Poor Metabolizers of CYP2C9 Substrates In patients who are known or suspected to be poor CYP2C9 metabolizers (i.e., CYP2C9*3/*3), based on genotype or previous history/experience with other CYP2C9 ...

8.1. Pregnancy

Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward. Risk Summary Use of NSAIDs, including CELEBREX, during the third trimester of pregnancy increases the risk of premature ...

8.2. Lactation

Risk Summary Limited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of CELEBREX in breast milk. The calculated average daily infant dose was 10 to 40 mcg/kg/day, ...

8.3. Females and Males of Reproductive Potential

Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including CELEBREX, may delay or prevent rupture of ovarian follicles, which has been associated with reversible ...

8.4. Pediatric Use

CELEBREX is approved for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis in patients 2 years and older. Safety and efficacy have not been studied beyond six months in children. The long-term ...

8.5. Geriatric Use

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly ...

8.6. Hepatic Impairment

The daily recommended dose of CELEBREX capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of CELEBREX in patients with severe hepatic impairment ...

8.7. Renal Impairment

CELEBREX is not recommended in patients with severe renal insufficiency [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)].

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. Gastrointestinal ...

11. Description

CELEBREX (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) ...

12.1. Mechanism of Action

Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. ...

12.2. Pharmacodynamics

Platelets In clinical trials using normal volunteers, CELEBREX at single doses up to 800 mg and multiple doses of 600 mg twice daily for up to 7 days duration (higher than recommended therapeutic doses) ...

12.3. Pharmacokinetics

Celecoxib exhibits dose-proportional increase in exposure after oral administration up to 200 mg twice daily and less than proportional increase at higher doses. It has extensive distribution and high ...

12.5. Pharmacogenomics

CYP2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as those homozygous for the CYP2C9*2 and CYP2C9*3 polymorphisms. Limited data from 4 published ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Celecoxib was not carcinogenic in Sprague-Dawley rats given oral doses up to 200 mg/kg for males and 10 mg/kg for females (approximately 2-to 4-times the human exposure as measured by the ...

13.2. Animal Toxicology and/or Pharmacology

An increase in the incidence of background findings of spermatocele with or without secondary changes such as epididymal hypospermia as well as minimal to slight dilation of the seminiferous tubules was ...

14. Clinical Studies

14.1 Osteoarthritis CELEBREX has demonstrated significant reduction in joint pain compared to placebo. CELEBREX was evaluated for treatment of the signs and the symptoms of OA of the knee and hip in placebo- ...

16.1. How Supplied

CELEBREX (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: NDC Number Size 0025-1515-01 ...

16.2. Storage and Handling

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information ...

BOXED WARNING SECTION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious ...