Producer: Merck Sharp & Dohme Corp. (Merck Sharp and Doum of the Building) USA
Code of automatic telephone exchange: M01AH02
Release form: Liquid dosage forms. Suspension.
General characteristics. Structure:
Active ingredient: 12,5 mg or 25 mg of a rofekoksib in 5 ml of suspension.
Pharmacodynamics. Highly specific inhibits ЦОГ−2, slows down formation of antiinflammatory prostaglandins. In therapeutic concentration at the person does not influence activity ЦОГ−1.
Pharmacokinetics. After intake bioavailability — more than 90% is well soaked up from a GIT. Linkng with proteins of plasma — about 90%. Cmax is reached in 2 h. Is exposed to biotransformation in a liver with formation of six inactive metabolites.
It is removed preferential by kidneys (72% in the form of inactive metabolites, less than 1% — in not changed look) and with excrements (14% in not changed look). Plasma clearance — about 120 ml/min.
Indications to use:
Route of administration and doses:
Osteoarthritis: an initial dose — 12,5 mg of 1 times a day, if necessary — 25 mg (the maximum daily dose).
Stopping of an acute pain and treatment of primary dysmenorrhea: an initial dose — 50 mg of 1 times a day, then — 25–50 mg of 1 times a day, the maximum daily dose — 50 mg.
Features of use:
Use during pregnancy. Contraindicated in the III trimester of pregnancy (perhaps premature fusion of Botallov Canal at a fruit). Perhaps in I and II trimesters of pregnancy if the expected effect of therapy at mother exceeds potential risk for a fruit (adequate and strictly controlled researches on use were not conducted). For the period of treatment it is necessary to stop breastfeeding.
With care apply at patients with the instruction on a peptic ulcer of a stomach and duodenum in the anamnesis, in the presence of hypostases, noncompensated heart failure, cirrhosis, at patients 65 years are more senior.
Against the background of the expressed renal or liver failure careful monitoring of function of kidneys/liver is necessary. At patients with dehydration carrying out a regidratation prior to treatment is desirable.
From urinogenital system: reversible depression of function of kidneys, including a renal failure.
Allergic reactions: Quincke's disease, itch, rash, small tortoiseshell.
Others: ≥ 2% — hypostasis of the lower extremities; ≥ 1% — increase in ALT and/or nuclear heating plant.
Interaction with other medicines:
Can increase concentration of a methotrexate in blood. At a concomitant use with warfarin the prothrombin time increases. Rifampicin reduces concentration in plasma by 50%.
Hypersensitivity, including to other NPVS.
It is not described.
List B. To store at a temperature not above 25 °C. A period of validity - 24 months.
According to the recipe
On 150 ml in bottles with a dosing spoon (spoon), on 1 bottle in a cardboard pack.