KINBREX CAPSULES

PRODUCT INFORMATION

Name : Kinbrex Capsules

KINBREX CAPSULES

When given under fasting conditions celecoxib is absorbed reaching peak plasma concentrations after approximately 2-3 hours. Celecoxib exhibits linear and dose proportional pharmacokinetics over the therapeutic dose range. Plasma protein binding, which is concentration independent, is about 97% at therapeutic plasma concentrations and the drug is not preferentially bound to erythrocytes in the blood. Dosing with food (high fat meal) delays absorption resulting in a Tmax of about 4 hours and increases bioavailability by about 20%. Celecoxib is metabolised in the liver by hydroxylation, oxidation and some glucuronidation and in vitro and in vivo studies indicate that metabolism is mainly by cytochrome P450 CYP2C9. Pharmacological activity resides in the parent drug. The main metabolites found in the circulation have no detectable COX-1 or COX-2 inhibitory activity. Elimination of celecoxib is mostly by hepatic metabolism with less than 1 % of the dose excreted unchanged in urine. After multiple dosing elimination half life is 8-12 hours and the rate of clearance is about 500ml/min. With multiple dosing steady state plasma concentrations are reached before day 5. The intersubject variability on the main pharmacokinetic parameters (AUC, Cmax, elimination half-life) is about 30%. The mean steady state volume of distribution is about 500L/70kg in young healthy adults after a single 200mg dose indicating wide distribution of celecoxib into the tissues. Pre-clinical studies indicate that the drug crosses the blood/brain barrier.

SPECIFICATIONS

  • Each Hard gelatin capsule contains :- CELECOXIB 200 mg
  • Symptomatic treatment of inflammation and pain in osteoarthritis and rheumatoid arthritis. Treatment of pain post dental surgery.
  • Blister Pack of 10 x 10 Capsules (100 capsules) in a mono pack & 10 such packs in a Box.
  • PHARMACOLOGICAL CLASSIFICATION: A 3.1 Antirheumatics (anti-inflammatory agents)
  • Keep in a cool place protected from light. Keep out of reach of children.
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