Secret Paris Invisible Romantic Rose
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
Celecoxib capsules are indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)].
Celecoxib capsules are indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)].
Celecoxib capsules are indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)].
Celecoxib capsules are indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)].
Celecoxib capsules are indicated for the management of AP in adults [see Clinical Studies (14.5)].
Celecoxib capsules are indicated for the treatment of PD [see Clinical Studies (14.5)].
History
There is currently no drug history available for this drug.
Other Information
Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular formula is C17H14F3N3O2S, and the molecular weight is 381.37; the chemical structure is as follows:
Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, USP, together with inactive ingredients including: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.
In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, titanium dioxide and the following colorant agents:
50 mg – D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40
100 mg – D&C Red No. 28, FD&C Blue No. 1
200 mg – FD&C Blue No. 1, FD&C Red No. 3
400 mg – FD&C Green No. 3, FD&C Red No. 40
The imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.
Sources
Secret Paris Invisible Romantic Rose Manufacturers
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Procter & Gamble Manufacturing Company
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Secret Paris Invisible Romantic Rose | Mylan Pharmaceuticals Inc.
Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.
These doses can be given without regard to timing of meals.
2.1 OsteoarthritisFor relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.
2.2 Rheumatoid ArthritisFor relief of the signs and symptoms of RA the recommended oral dose is 100 mg to 200 mg twice daily.
2.3 Juvenile Rheumatoid ArthritisFor the relief of the signs and symptoms of JRA the recommended oral dose 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 capsule 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 to 8°C/ 35 to 45°F).
2.4 Ankylosing SpondylitisFor the management of the signs and symptoms of AS, the recommended dose of celecoxib capsules is 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.
2.5 Management of Acute Pain and Treatment of Primary DysmenorrheaThe recommended dose of celecoxib capsules 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.
2.6 Special Populations Hepatic InsufficiencyThe 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 in patients with severe hepatic impairment is not recommended [see Warnings and Precautions (5.5), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Poor Metabolizers of CYP2C9 SubstratesPatients 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) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e., CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers [see Use in Specific Populations (8.8), and Clinical Pharmacology (12.5)].
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