Drug Catalog - Product Detail
CELECOXIB CP 50MG 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65862-0907-60 | AUROBINDO PHARMA | 60 | 50MG | NA |
PACKAGE FILES
Generic Name
CELECOXIB
Substance Name
CELECOXIB
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA206827
Description
11. DESCRIPTION Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17 H 14 F 3 N 3 O 2 S, and it has the following chemical structure: Celecoxib is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is soluble to freely soluble in ethanol, soluble in methylene chloride and practically insoluble in water. The inactive ingredients in celecoxib capsules include: crospovidone, hydroxypropyl cellulose, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate. The empty hard gelatin capsule shells contain gelatin and titanium dioxide. The capsules are imprinted with edible ink containing propylene glycol and shellac. In addition, 50 mg capsules are imprinted with FD&C Red #40 aluminum lake and sodium hydroxide. 100 mg capsules are imprinted with FD & C Blue # 2 aluminum lake and strong ammonia solution. 200 mg capsules are imprinted with strong ammonia solution and yellow iron oxide. 400 mg capsules are imprinted with FD & C Blue # 2 aluminum lake, strong ammonia solution and yellow iron oxide. Chemical Structure
How Supplied
16. HOW SUPPLIED/STORAGE AND HANDLING Celecoxib Capsules, 50 mg are white cap/white body, size ‘5’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Z’ on the cap and ‘50’ on the body with red ink. Bottles of 60 NDC 65862-907-60 Bottles of 1,000 NDC 65862-907-99 Celecoxib Capsules, 100 mg are white cap/white body, size ‘4’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Y’ on the cap and ‘100’ on the body with blue ink. Bottles of 100 NDC 65862-908-01 Bottles of 500 NDC 65862-908-05 Bottles of 1,000 NDC 65862-908-99 Celecoxib Capsules, 200 mg are white cap/white body, size ‘2’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Y’ on the cap and ‘200’ on the body with gold ink. Bottles of 100 NDC 65862-909-01 Bottles of 500 NDC 65862-909-05 Bottles of 1,000 NDC 65862-909-99 Celecoxib Capsules, 400 mg are white cap/white body, size ‘0’ hard gelatin capsule filled with white to off-white granular powder, imprinted with ‘Z’ on the cap and ‘400’ on the body with green ink. Bottles of 60 NDC 65862-910-60 Bottles of 100 NDC 65862-910-01 Bottles of 500 NDC 65862-910-05 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1. INDICATIONS AND USAGE Celecoxib capsules are indicated Celecoxib is a nonsteroidal 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) 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 symptoms of RA [ see Clinical Studies (14.2) ]. 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies (14.3) ]. 1.4 Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS [ see Clinical Studies (14.4) ]. 1.5 Acute Pain For the management of acute pain in adults [ see Clinical Studies (14.5) ]. 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [ see Clinical Studies (14.5) ].
Dosage and Administration
2. 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 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 ). 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. These doses can be given without regard to timing of meals. 2.2 Osteoarthritis For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily. 2.3 Rheumatoid Arthritis For RA, the dosage is 100 mg to 200 mg twice daily. 2.4 Juvenile Rheumatoid Arthritis For JRA, the dosage for pediatric patients (age 2 years and older) is based on weight. For patients > 10 kg to < 25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily. For patients who have difficulty swallowing capsules, the contents of a celecoxib capsules can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2°C to 8°C/35°F to 45°F). 2.5 Ankylosing Spondylitis For AS, the dosage of celecoxib capsules are 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options. 2.6 Management of Acute Pain and Treatment of Primary Dysmenorrhea For management of Acute Pain and Treatment of Primary Dysmenorrhea, the dosage is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed. 2.7 Special Populations Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%. The use of celecoxib capsules in patients with severe hepatic impairment is not recommended [ see Warnings and Precautions (5.3) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] . Poor M etabolizers of CYP2C9 S ubstrates In adult patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin), initiate treatment with half of the lowest recommended dose. In patients with JRA who are known or suspected to be poor CYP2C9 metabolizers, consider using alternative treatments [ see Use in Specific populations (8.8) and Clinical Pharmacology (12.5) ].