CELECOXIB capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)

제공처:

REMEDYREPACK INC.

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Celecoxib capsules are indicated For the management of the signs and symptoms of OA [ see Clinical Studies ( 14.1) ] For the management of the signs and symptoms of RA [ see Clinical Studies ( 14.2) ] For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies ( 14.3) ] For the management of the signs and symptoms of AS [ see Clinical Studies ( 14.4) ] For the management of acute pain in adults [ see Clinical Studies ( 14.5) ] For the management of primary dysmenorrhea [see Clinical Studies ( 14.5) ] Celecoxib capsules are 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 and Precautions ( 5.7, 5.9) ]. -   History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients [see Warnings and Precautions ( 5.7, 5.8)]. -   In the setting of CABG surgery [see Warnings and Precautions ( 5.1)]. -   In patients who have demonstrated allergic-type reactions to sulfonamides. Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward. Risk Summary Use of NSAIDs, including celecoxib capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including celecoxib capsules, in pregnant women starting at 30 weeks of gestation. There are no adequate and well-controlled studies of celecoxib capsules in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately 6 times the maximum recommended human dose (MRHD) of 200 mg twice daily. In addition, structural abnormalities (e.g., septal defects, ribs fused, sternebrae fused and sternebrae misshapen) were observed in rabbits given daily oral doses of celecoxib during the period of organogenesis at approximately 2 times the MRHD [see Data]. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and post-implantation loss. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. Clinical Considerations Labor or Delivery There are no studies on the effects of celecoxib capsules during labor or delivery. In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data The available data do not establish the presence or absence of developmental toxicity related to the use of celecoxib capsules. Animal Data Celecoxib at oral doses ≥150 mg/kg/day (approximately 2 times the human exposure at 200 mg twice daily as measured by AUC 0-24 ), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis. A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ≥30 mg/kg/day (approximately 6 times human exposure based on the AUC 0-24 at 200 mg twice daily for RA) throughout organogenesis. In rats, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses at oral doses ≥50 mg/kg/day (approximately 6 times human exposure based on the AUC 0-24 at 200 mg twice daily for RA). Celecoxib produced no evidence of delayed labor or parturition at oral doses up to 100 mg/kg in rats (approximately 7-fold human exposure as measured by the AUC 0-24 at 200 mg twice daily). The effects of celecoxib capsules on labor and delivery in pregnant women are unknown. Risk Summary Limited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of celecoxib in breast milk. The calculated average daily infant dose was 10 to 40 mcg/kg/day, less than 1% of the weight-based therapeutic dose for a two-year old-child. A report of two breastfed infants 17 and 22 months of age did not show any adverse events. Caution should be exercised when celecoxib capsules are administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for celecoxib capsules and any potential adverse effects on the breastfed infant from the celecoxib capsules or from the underlying maternal condition. Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including celecoxib capsules, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including celecoxib capsules, in women who have difficulties conceiving or who are undergoing investigation of infertility. Celecoxib capsules are 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 cardiovascular toxicity in children exposed to celecoxib capsules has not been evaluated and it is unknown if long-term risks may be similar to that seen in adults exposed to celecoxib capsules or other COX-2 selective and non-selective NSAIDs [see Boxed Warning, Warnings and Precautions ( 5.12), and Clinical Studies ( 14.3)]. The use of celecoxib in patients 2 years to 17 years of age with pauciarticular, polyarticular course JRA or in patients with systemic onset JRA was studied in a 12-week, double-blind, active controlled, pharmacokinetic, safety and efficacy study, with a 12-week open-label extension. Celecoxib has not been studied in patients under the age of 2 years, in patients with body weight less than 10 kg (22 lbs), and in patients with active systemic features. Patients with systemic onset JRA (without active systemic features) appear to be at risk for the development of abnormal coagulation laboratory tests. In some patients with systemic onset JRA, both celecoxib and naproxen were associated with mild prolongation of activated partial thromboplastin time (APTT) but not prothrombin time (PT). When NSAIDs including celecoxib are used in patients with systemic onset JRA, monitor patients for signs and symptoms of abnormal clotting or bleeding, due to the risk of disseminated intravascular coagulation. Patients with systemic onset JRA should be monitored for the development of abnormal coagulation tests [see Dosage and Administration ( 2.4), Warnings and Precautions ( 5.14), Adverse Reactions ( 6.1), Animal Toxicology ( 13.2), Clinical Studies ( 14.3)]. Alternative therapies for treatment of JRA should be considered in pediatric patients identified to be CYP2C9 poor metabolizers [see Poor Metabolizers of CYP2C9 substrates ( 8.8)]. 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 patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [ see Warnings and Precautions ( 5.1, 5.2, 5.3, 5.6, 5.13 )]. Of the total number of patients who received celecoxib capsules in pre-approval clinical trials, more than 3,300 were 65-74 years of age, while approximately 1,300 additional patients were 75 years and over. No substantial differences in effectiveness were observed between these subjects and younger subjects. In clinical studies comparing renal function as measured by the GFR, BUN and creatinine, and platelet function as measured by bleeding time and platelet aggregation, the results were not different between elderly and young volunteers. However, as with other NSAIDs, including those that selectively inhibit COX-2, there have been more spontaneous post-marketing reports of fatal GI events and acute renal failure in the elderly than in younger patients [see Warnings and Precautions ( 5.2, 5.6) ]. The daily recommended dose of celecoxib capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of celecoxib capsules in patients with severe hepatic impairment is not recommended [see Dosage and Administration ( 2.7) and Clinical Pharmacology ( 12.3)]. Celecoxib capsules is not recommended in patients with severe renal insufficiency [ see Warnings and Precautions   ( 5.6)   and Clinical Pharmacology ( 12.3 )].  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 substrates (such as warfarin, phenytoin) administer celecoxib capsules starting with half the lowest recommended dose. Alternative management should be considered in JRA patients identified to be CYP2C9 poor metabolizers [ see Dosage and Administration (2.7) and   Clinical Pharmacology (12.5) ].

제품 요약:

Celecoxib Capsules are available in the following strengths and configurations: Product Name Celecoxib Capsules 200 mg White to off white colored granules filled in size 1 hard gelatin white capsule axially printed with 'Cipla' on cap & '421' over '200 mg' on body in gold ink. NDC: 70518-2233-00 NDC: 70518-2233-01 NDC: 70518-2233-02 PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Storage: Store at 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

REMEDYREPACK INC.
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Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death .
This risk may happen early in
treatment and may increase :
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
"coronary artery bypass graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines :
•
anytime during use
•
without warming symptoms
•
that may cause death
•
o The risk of getting an ulcer or bleeding increases with :
•
o past history of stomach ulcers, or stomach or intestinal bleeding
with use
•
o of NSAIDs taking medicines called "corticosteroids", "antiplatelet
•
o drugs", "anticoagulants", "SSRIs" or "SNRIs"
•
o increasing doses of NSAIDs
•
o longer use of NSAIDs
•
o smoking
•
o drinking alcohol
•
o older age
•
o poor health
•
o advanced liver disease
•
o bleeding problems
•
NSAIDs should only be used :
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAID are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions
such as different types of arthritis, menstrual cramps, and other
types of short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare

제품 특성 요약

CELECOXIB- CELECOXIB CAPSULE
REMEDYREPACK INC.
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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
Warnings and Precautions (5.1, 5.4) 6/2018
Warnings and Precautions (5.2) 5/2019
INDICATIONS AND USAGE
Celecoxib 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 mg to 200 mg twice daily ( 2.3, 14.2)
JRA: 50 mg twice daily in patients 10 kg to 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