FLAMAR 400 Celecoxib 400mg Capsule 1's
RXDRUG-DR-XY44930-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
It is use for the treatment of rheumatoid arthritis and osteoarthritis. Used in the treatment of Familial adenomatous polyposis (FAP) as adjunct.
Dosage/Direction for Use
For OSTEOARTHRITIS the recommended dose is 200 mg daily given by mouth as a single dose or in 2 divided doses.
For RHEUMATOID ARTHRITIS the dose is 100 to 200 mg given twice daily.
In elderly patients and those of Afro-Carribbean origin treatment should be initiated at the lowest recommended dose.
In the treatment of PAIN and DYSMENORRHEA, an initial dose of 400 mg followed by an additional dose of 200 mg, if necessary, is recommended on the first day, thereafter the dose is 200 mg twice daily.
Treatment for FAP is 40 mg twice a day.
Doses for Osteoarthritis or Rheumatoid Arthritis ma be given with or without meals. But for Familial Adenomatous Polyposis, it should be taken with meals.
Or as prescribed by physician.
For RHEUMATOID ARTHRITIS the dose is 100 to 200 mg given twice daily.
In elderly patients and those of Afro-Carribbean origin treatment should be initiated at the lowest recommended dose.
In the treatment of PAIN and DYSMENORRHEA, an initial dose of 400 mg followed by an additional dose of 200 mg, if necessary, is recommended on the first day, thereafter the dose is 200 mg twice daily.
Treatment for FAP is 40 mg twice a day.
Doses for Osteoarthritis or Rheumatoid Arthritis ma be given with or without meals. But for Familial Adenomatous Polyposis, it should be taken with meals.
Or as prescribed by physician.
Administration
May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals, but doses for familial adenomatous polyposis must be given w/ meals.
Contraindications
It is contraindicated in patients with severe heart failure, inflammatory bowel disease and renal impairment associated with a creatinine clearance of less than 30 mL per minute.
It is also contraindicated in patients with asthma and urticaria.
Absolute Contraindication: Not to be given to those patients who have a history of: Stroke, Cerebrovascular Accident, CVA; Heart Attack, Myocardial Infarction; Coronary Artery Bypass Graft: CABG; Uncontrolled Hypertension; Congestive Heart Failure (CHF), NYHA II-IV.
It is also contraindicated in patients with asthma and urticaria.
Absolute Contraindication: Not to be given to those patients who have a history of: Stroke, Cerebrovascular Accident, CVA; Heart Attack, Myocardial Infarction; Coronary Artery Bypass Graft: CABG; Uncontrolled Hypertension; Congestive Heart Failure (CHF), NYHA II-IV.
Special Precautions
Celecoxib should not be used in patients with severe hepatic impairment. Therapy should be withdrawn if signs and symptoms of hepatic toxicity develops.
Celecoxib should not be given to patients with a history of hypersensitivity to sulfonamides.
Celecoxib should not be used in patients with liver dysfunction, impaired renal function, dehydration, anemia, pre-existing asthma and pregnant.
Celecoxib should not be given to patients with a history of hypersensitivity to sulfonamides.
Celecoxib should not be used in patients with liver dysfunction, impaired renal function, dehydration, anemia, pre-existing asthma and pregnant.
Adverse Reactions
Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, tooth disorder, and vomiting.
Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorders, and myocardial infarction.
Liver and Biliary system: Hepatic function, abnormal SGOT increased, and SGPT increased.
Psychiatric: Anorexia, anxiety, appetite increased, depression, nervousness, and somnolence.
Urinary System: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus, urinary incontinence, and urinary tract infection.
Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorders, and myocardial infarction.
Liver and Biliary system: Hepatic function, abnormal SGOT increased, and SGPT increased.
Psychiatric: Anorexia, anxiety, appetite increased, depression, nervousness, and somnolence.
Urinary System: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus, urinary incontinence, and urinary tract infection.
Drug Interactions
The metabolism of celecoxib is mediated mainly by the cytochrome P450 is isoenzyme CYP2C9. Concomitant administration of other drugs that inhibit or are metabolised by this isoenzyme may result in changes in the plasma concentration of celecoxib; co-administration of fluconazole has resulted in increased in plasma concentration of celecoxib. Celecoxib is an inhibitor of the isoenzyme CYP2D6 and the potential therefore exist for an effect on drugs metabolised by this enzyme.
Storage
Store at temperatures not exceeding 30°C. Protect from heat and moisture.
Action
Pharmacology: Mechanism of Action: Celecoxib is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities. The mechanism of action of celecoxib is believed to be due to the inhibition of prostaglandin synthesis, primarily via the inhibition of cyclo-oxygenase-2. Celecoxib does not inhibit the cyclo-oxygenase-1 isoenzyme.
Pharmacokinetics: Absorption: Peak plasma levels of celecoxib occur approximately 3 hours after an oral dose. Under fasting conditions, both peak plasma levels (Cmax) and area under the curve (AUC) are roughly dose proportional up to 200 mg twice a day; at higher doses, there are less than proportional increases in Cmax and AUC.
Pharmacokinetics: Absorption: Peak plasma levels of celecoxib occur approximately 3 hours after an oral dose. Under fasting conditions, both peak plasma levels (Cmax) and area under the curve (AUC) are roughly dose proportional up to 200 mg twice a day; at higher doses, there are less than proportional increases in Cmax and AUC.
MedsGo Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Features
Brand
Flamar 400
Full Details
Dosage Strength
400 mg
Drug Ingredients
- Celecoxib
Drug Packaging
Capsule 1's
Generic Name
Celecoxib
Dosage Form
Capsule
Registration Number
DR-XY44930
Drug Classification
Prescription Drug (RX)
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