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Stadloric 200
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Stadloric 200 contains celecoxib that acts as an anti-inflammatory, analgesic, and antipyretic agent, is indicated in treatment and relief the signs and symptoms of pain, osteoarthritis, dysmenorrhoea.

Pack size Box of 30 capsules, 60 capsules, 100 capsules.
Shelf-life 24 months
Composition Celecoxib
Dosage forms and strengths Hard gelatin capsule: 200 mg
Product code :

PRESCRIBING INFORMATION

Indications:

  • Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA).
  • Relief the signs and symptoms of juvenile idiopathic arthritis (JIA) in patients ≥ 2 years of age weighing ≥ 10 kg.
  • Relief the signs and symptoms of ankylosing spondylitis.
  • Management of acute pain.
  • Treatment of primary dysmenorrhoea.

Dosage:

Adults:

  • Symptomatic treatment of osteoarthritis (OA): 200 mg as a single dose or as 100 mg twice daily.
  • Symptomatic treatment of rheumatoid arthritis (RA): 100 mg or 200 mg twice daily.
  • Ankylosing spondylitis (AS): 200 mg as a single dose or 100 mg twice daily, a total daily dose can be 400 mg.
  • Management of acute pain; treatment of primary dysmenorrhoea: Initial dose is 400 mg, followed by an additional 200 mg dose, if needed on the rst day. On subsequent days, 200 mg twice daily as needed.

Children 2 years of age and older: Juvenile idiopathic arthritis (JIA)

  • Children weighing 10 – 25 kg: 50 mg, twice daily.
  • Children weighing > 25 kg: 100 mg, twice daily.

CYP2C9 poor metabolisers: Consider reducing the dose to half the lowest recommended dose.

Co-administration with fluconazole: A half the recommended dose.

Usage:

Stadloric 200 is orally administered with or without food.

For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce, rice gruel, yogurt or mashed banana. To do so, the entire capsule contents must be carefully emptied onto a level teaspoon of room temperature applesauce, rice gruel, yogurt or mashed banana and should be ingested immediately with water.

 

Patients with known hypersensitivity to celecoxib, any components of the drug product.

Patients with demonstrated allergic-type reactions to sulfonamides.

Patients with experienced of asthma, urticaria, or other allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs including COX-2 inhibitors.

In the setting of coronary artery bypass graft (CABG) surgery.

Risk of cardiovascular thrombotic events.

Common: Bronchitis, sinusitis, upper respiratory tract infection, urinary tract infection; headache; insomnia; dizziness; hypertension, myocardial infarction, angina pectoris; cough, dyspnoea; vomiting, abdominal pain, diarrhea, dyspepsia, atulence; pruritus, rash; oedema peripheral; muscle spasms; nephrolithiasis; nephrolithiasis; blood creatinine increased, prostatic specic antigen increased, weight increased.

Treatment with Stadloric 200 should be at the lowest effective daily dose for the shortest duration possible. The cardiovascular thrombotic risk has been observed most consistently at higher doses. Physicians should assess periodically appearance of cardiovascular adverse events, even in the absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and seek physicians immediately if these symptoms occur.

Anti-platelet therapies should not be discontinued while using Stadloric 200.

Stadloric 200 should be used with caution in patients with: Hypertension; compromised cardiac function, pre-existing edema, or those taking diuretic treatment or otherwise at risk of hypovolemia; pre-existing congestive heart failure or hypertension; elderly, cardiovascular disease, using concomitant aspirin, glucocorticoids, or other NSAIDs, using alcohol or patients with a prior history of, or active, GI disease; dehydration; impaired renal/liver function, heart failure; systemic onset JIA.

Anticoagulation/INR should be monitored in patients taking a warfarin/coumarin type anticoagulant after initiating treatment with Stadloric 200 or changing the dose.

The concomitant use of Stadloric 200 and a non-aspirin NSAID should be avoided.

Stadloric 200 should be discontinued at the rst appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Stadloric 200.

Consider withdrawal of NSAIDs, including celecoxib, in women who have difficulties conceiving or who are undergoing investigation of infertility. Celecoxib should be avoided during the third trimester of pregnancy. Celecoxib should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. A decision should be made whether to discontinue nursing or discontinue the drug.

Patients should be aware of how they react to drug before driving or operating machinery.