CELECOXIB

CELECOXIB- celecoxib capsule
RedPharm Drug, Inc.


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

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. [see Warnings and Precautions (5.1)]
Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. [see Contraindications (4) and Warnings and Precautions (5.1)

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. [see Warnings and Precautions (5.2) ]

HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES.
CELECOXIB capsules, for oral use
Initial U.S. Approval:1998

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.(5.1)
Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1)
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. (5.2)

RECENT MAJOR CHANGES

Boxed Warning 5/2016

Warnings and Precautions, Cardiovascular Thrombotic Events (5.1) 5/2016

Warnings and Precautions, Heart Failure and Edema (5.5) 5/2016

INDICATIONS AND USAGE

Celecoxib capsule is a non-steroidal anti-inflammatory drug indicated for:

Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)

DOSAGE AND ADMINISTRATION

Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2.1)
OA: 200 mg once daily or 100 mg twice daily (2.2, 14.1)
RA: 100 to 200 mg twice daily (2.3, 14.2)
JRA: 50 mg twice daily in patients 10-25 kg. 100 mg twice daily in patients more than 25 kg (2.4, 14.3)
AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit (2.5, 14.4)
AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed (2.6, 14.5)

Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). (2.7, 8.6, 12.3)

Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers, (2.7, 8.8, 12.3).

DOSAGE FORMS AND STRENGTHS

Celecoxib capsules: 50 mg, 100 mg, 200 mg and 400 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to celecoxib, or any components of the drug product or sulfonamides (4)
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
In the setting of CABG surgery (4)

WARNINGS AND PRECAUTIONS

Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop (5.3)
Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7)
Heart Failure and Edema : Avoid use of celecoxib capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5)
Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of celecoxib capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function (5.6)
Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs (5.7)
Exacerbation of Asthma Related to Aspirin Sensitivity : Celecoxib capsules is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
Serious Skin Reactions : Discontinue celecoxib capsules at first appearance of skin rash or other signs of hypersensitivity (5.9)
Premature Closure of Fetal Ductus Arteriosus : Avoid use in pregnant women starting at 30 weeks of gestation (5.10, 8.1)
Hematologic Toxicity : Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia (5.11, 7)

ADVERSE REACTIONS

Most common adverse reactions in arthritis trials (>2% and >placebo) are: abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd, at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs) : Monitor patients for bleeding who are concomitantly taking celecoxib capsules with drugs that interfere with hemostasis. Concomitant use of celecoxib capsules and analgesic doses of aspirin is not generally recommended (7)
ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers : Concomitant use with celecoxib capsules may diminish the antihypertensive effect of these drugs. Monitor blood pressure (7)
ACE Inhibitors and ARBs : Concomitant use with celecoxib capsules in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function (7)
Diuretics : NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects (7)
Digoxin : Concomitant use with celecoxib capsules can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels (7)

USE IN SPECIFIC POPULATIONS

Pregnancy : Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation (5.10,8.1)
Infertility : NSAIDs are associated with reversible infertility. Consider withdrawal of celecoxib capsules in women who have difficulties conceiving (8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 10/2016

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
1 INDICATIONS AND USAGE
1.1 Osteoarthritis (OA)
1.2 Rheumatoid Arthritis (RA)
1.3 Juvenile Rheumatoid Arthritis (JRA)
1.4 Ankylosing Spondylitis (AS)
1.5 Acute Pain (AP)
1.6 Primary Dysmenorrhea (PD)
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Instructions
2.2 Osteoarthritis
2.3 Rheumatoid Arthritis
2.4 Juvenile Rheumatoid Arthritis
2.5 Ankylosing Spondylitis
2.6 Management of Acute Pain and Treatment of Primary Dysmenorrhea
2.7 Special Populations
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular Thrombotic Events
5.2 Gastrointestinal Bleeding, Ulceration, and Perforation
5.3 Hepatotoxicity
5.4 Hypertension
5.5 Heart Failure and Edema
5.6 Renal Toxicity and Hyperkalemia
5.7 Anaphylactic Reactions
5.8 Exacerbation of Asthma Related to Aspirin Sensitivity
5.9 Serious Skin Reactions
5.10 Premature Closure of Fetal Ductus Arteriosus
5.11 Hematological Toxicity
5.12 Masking of Inflammation and Fever
5.13 Laboratory Monitoring
5.14 Disseminated Intravascular Coagulation (DIC)
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
8.8 Poor Metabolizers of CYP2C9 Substrates
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.5 Pharmacogenomics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology
14 CLINICAL STUDIES
14.1 Osteoarthritis
14.2 Rheumatoid Arthritis
14.3 Juvenile Rheumatoid Arthritis
14.4 Ankylosing Spondylitis
14.5 Analgesia, including Primary Dysmenorrhea
14.6 Special Studies
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

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