Composition, form of production and packaging
The tablets covered with a film membrane of white color, round, biconcave, with a risk on both sides.
dexketoprofen trometamol 36.9 mg,
which corresponds to the content of dexketoprofen 25 mg
Excipients: microcrystalline cellulose - 141.2 mg, corn starch - 49.6 mg, sodium carboxymethyl starch (type A) - 27.1 mg, glyceryl palmitostearate - 5.2 mg.
The composition of the film shell: hypromellose - 1.34 mg, titanium dioxide (E171) - 0.36 mg, macrogol 6000 - 0.6 mg, propylene glycol - 0.42 mg.
10 pieces. - blisters (1) - cardboard boxes.
10 pieces. - blisters (3) - cardboard boxes.
10 pieces. - blisters (5) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
Non-steroidal anti-inflammatory drug. Has anti-inflammatory, analgesic and antipyretic effect. The mechanism of action of the drug is based on inhibition of the synthesis of prostaglandins due to inhibition of cyclooxygenase. Analgesic effect occurs 30 minutes after taking the drug, its duration is from 4 to 6 hours.
After taking the drug inside C max dexketoprofen in humans is achieved on average after 30 min (15-60 min).
Distribution and deduction
Binding to plasma proteins - 99%. The distribution time and T 1/2 of dexketoprofen are 0.35 and 1.65 h, respectively. The average V d is less than 0.25 l / kg. The main part of the drug is excreted in the urine in the form of metabolites (after glucuronation).
Pain syndrome of mild and moderate intensity in the following diseases and conditions:
- acute and chronic inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, spondyloarthritis, arthrosis, osteochondrosis);
The average recommended single dose is 12.5 mg (1/2 table) from 1 to 6 times / day every 4 to 6 hours as needed or 25 mg (1 tab.) 1 to 3 times / day every 8 hours.
The maximum daily dose is 75 mg (6 tablets).
In patients with impaired liver or kidney function, in elderly people , the drug should be taken at lower doses - not more than 50 mg / day.
The drug is not intended for long-term use: the duration of administration should not exceed 3-5 days.
On the part of the digestive system: heartburn, abdominal pain; rarely - erosive-ulcerative lesions of the gastrointestinal tract.
From the central nervous system and peripheral nervous system: headaches, dizziness, nervousness, sleep disturbance, paresthesia.
From the cardiovascular system: palpitation, increased blood pressure.
Allergic reactions: skin rash, bronchospasm.
Other: chills, swelling of the extremities, photosensitivity; rarely - a change in the pattern of peripheral blood, impaired renal function.
When used according to indications and in recommended doses, the drug is well tolerated.
- Stomach ulcer and duodenal ulcer;
- gastrointestinal bleeding;
- active bleeding of various origins;
- therapy with anticoagulants;
- Crohn's disease;
- nonspecific ulcerative colitis;
- bronchial asthma (including in the anamnesis);
- severe heart failure;
- severe renal failure;
severe hepatic impairment;
- lactation period;
- hypersensitivity to dexketoprofen or other NSAIDs.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy and lactation due to the lack of reliable clinical data to confirm the safety of its use.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in severe impairment of kidney function. In patients with impaired renal function , the drug should be taken at lower doses - not more than 50 mg / day.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is contraindicated in severe violations of liver function. In patients with impaired liver function , the drug should be taken at lower doses - not more than 50 mg / day.
Care should be taken when prescribing the drug to elderly patients, patients with allergic reactions, systemic connective tissue diseases and patients with hematopoiesis.
Patients should be informed that if side effects occur, and if there is no clinical effect within 3-5 days of treatment, it is necessary to inform the attending physician about it.
Special care is required with the simultaneous use of Dexalgin 25 with phenytoin, sulfonamides and preparations that reduce blood clotting.
Impact on the ability to drive vehicles and manage mechanisms
Since Dexalgin 25 may cause dizziness and drowsiness, caution should be given to patients who engage in potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
Treatment: gastric lavage; if necessary, symptomatic therapy.
The simultaneous use of Dexalgin 25 with other NSAIDs may increase the risk of side effects.
The simultaneous use of Dexalgin 25 with lithium preparations may increase the concentration of the latter in blood plasma.
Caution should be exercised when using NSAIDs less than 24 hours before or after the end of methotrexate therapy, as its blood level (and hence toxicity) may increase.
Individual cases of bleeding are described with simultaneous application of NSAIDs and anticoagulants.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light, inaccessible to children, at a temperature of no higher than 30 В° C. Shelf life - 2 years.