Sandoz Ketanol Forte 50mg 20 Tabs
Ketoprofen is rapidly absorbed from the gastrointestinal tract. Bioavailability after oral administration of 50 mg of ketoprofen is 90% and increases consistently with increasing dose.
Eating does not affect the total bioavailability (AUC) of ketoprofen, but reduces the rate of absorption. Ketoprofen is 99% bound to blood plasma proteins, mainly to the albumin fraction. The volume of distribution is 0.1-0.2 l/kg. After oral administration ketoprofen peak plasma concentration is reached after 1h.22 min.
In synovial fluid the concentration of ketoprofen reaches 50% of the plasma concentration (1.5 µg/ml); ketoprofen is slowly eliminated from synovial fluid – over 24 hours. It is metabolized in the liver, where it conjugates with glucuronic acid. About 75% of ketoprofen is excreted with urine, mainly as a conjugate with glucuronic acid.
Less than 10% is excreted unchanged in the feces. Ketoprofen does not cumulate in the tissues. The half-life of ketoprofen reaches 2 hours. In patients with renal failure ketoprofen is excreted slower and its half-life is prolonged by 1 hour. They also have a decreased clearance of ketoprofen.
In severe renal insufficiency a dose reduction is required. In patients with hepatic insufficiency, the concentration of ketoprofen in plasma is increased approximately 2-fold, which requires prescribing the lowest possible daily dose. Ketonal® forte has anti-inflammatory, analgesic and antipyretic effects.
The mechanism of action is associated with inhibition of the biosynthesis of prostaglandins and leukotrienes by inhibiting the activity of cyclooxygenase enzyme (cyclooxygenase-1 and cyclooxygenase-2) which catalyzes the synthesis of prostaglandins from arachidonic acid. Ketoprofen stabilizes the membranes of lysosomes and has anti-bradykinin activity.
Indications
1. Rheumatic diseases: rheumatoid arthritis seronegative spondyloarthritis (ankylosing spondyloarthritis, reactive arthritis) gout, pseudopodagra osteoarthritis extraarticular rheumatism (tendonitis, bursitis, capsulitis of the shoulder joint)
2. Pain syndrome: post-traumatic postoperative algodysmenorrhea pain in bone metastases in patients with cancer.
Composition
1 tablet contains:
Active substance:
ketoprofen – 100 mg.
Associates:
magnesium stearate,
colloidal silicon dioxide,
corn starch,
povidone,
talc,
lactose.
Coating composition:
Hypromellose, macrogol 400, indigo carmine (E132), titanium dioxide, talc, carnauba wax.
How to take, the dosage
Adults: the drug is prescribed 1-2 caps. 2-3 times per day, or 1 tablet. 2 times a day, or 1 sustained release tablet once a day.
The capsules and tablets should be taken with or immediately after a meal, without chewing, with plenty of water or milk (available in at least 100 ml).
The oral forms may be combined with the use of rectal suppositories or external dosage forms of Ketonal (cream, gel).
The maximum daily dose (including different dosage forms) is 200 mg.