Vero-Piroxicam - instructions for use, dose, side effects, contraindications

Excipients: calcium phosphate dihydrate, potato starch, magnesium stearate, hypromellose (methyloxypropylcellulose), titanium dioxide, talcum, povidone (polyvinylpyrrolidone), macrogol 4000 (polyethylene glycol 4000), dye azorubin (acid red).

Description:The tablets covered with a film cover of pink color, biconcave, round.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.02.A.A.07 Piroxicam

Pharmacodynamics:

NSAIDs have anti-inflammatory, analgesic, antiplatelet and antipyretic effects. The mechanism of action is due to oppression of the synthesis of prostaglandins due to nonselective inhibition of cyclooxygenases 1 and 2 (COX1 and COX2). The analgesic effect is manifested 30 minutes after oral intake, the anti-inflammatory effect comes to the end of 1 week of treatment. After a single dose, the effect is maintained for 24 hours.

Pharmacokinetics:

Well absorbed when taken orally. Food slows the rate of absorption, but does not affect the amount of absorption. Bioavailability is 100%. The connection with plasma proteins is 97%. The concentration in the plasma is proportional to the dose used, the time to reach a maximum concentration of -3-5 hours. After a single intake of 20 mg of piroxicam, the maximum concentration is 1.5-2 μg / ml, after a regular intake of 20 mg / day - 3-8 μg / ml. The equilibrium concentration is achieved after - 7-12 days.

It penetrates into the synovial fluid (40-50%), excreted in breast milk - 1-3%. Metabolised in the liver by hydroxylation of the pyridyl ring of the side chain, followed by conjugation with glucuronic acid and the formation of inactive metabolites. The isozyme CYP2C9 also participates in the metabolism. The half-life is 24-50 hours.It is excreted in the form of conjugates by the kidneys and to a lesser extent - through the intestines. In unchanged form, about 5% is deduced.

Indications:

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid and gouty arthritis, rheumatism, ankylosing spondylitis (Bechterew's disease), osteoarthritis.
Pain: sciatica, tendonitis, bursitis, arthralgia, neuralgia, myalgia, sciatica, post-traumatic and post-operative pain, accompanied by inflammation, tuberculosis.

Contraindications:

Hypersensitivity to any of the components of the drug, erosive-ulcerative lesions of the gastrointestinal tract (GASTROINTESTINAL TRACT) in the acute stage, gastrointestinal bleeding, anamnestic data on the bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs, expressed hepatic and / or renal failure, confirmed hyperkalemia, a period after aortocoronary bypass grafting, a violation of blood clotting (including hemophilia, lengthening bleeding time, propensity bleeding, hemorrhagic diathesis), pregnancy, lactation, children's age (14 years).

Carefully:

Bronchial asthma, anemia, chronic heart failure, arterial hypertension, coronary heart disease, cerebrovascular diseases, dyslipidemia, diabetes mellitus, peripheral arterial disease, smoking, hepatic and / or renal insufficiency, diverticulitis, erosive and ulcerative diseases of the digestive tract and gastrointestinal bleeding in the anamnesis , elderly age (over 65 years), postoperative period, with acute hepatic porphyria, dehydration, frequent alcohol use, sepsis, stomatitis.

Dosing and Administration:

Inside.

Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis: 20 mg in 1 reception.

In some cases, as a maintenance therapy, a sufficient dose is 10 mg per day. In rare cases, if necessary, the dose of piroxicam can be temporarily increased to 30 mg per day (at one time).

Juvenile rheumatoid arthritis: 15 mg / day with a body weight of 26-45 kg; 20 mg / day - with a body weight of more than 46 kg.

With exacerbation of gout: the initial dose is 40 mg once a day for the first 2 days, for the next 4-6 days - 40 mg per day in 1 or 2 doses.

Pain syndrome: in the first 1-2 days to 40 mg per day, once or twice. The maintenance dose for the next 1-3 days is 10-20 mg per day in 1 dose.

Feverish syndrome: 10-20 mg / day in a single dose. If necessary, 40 mg / day is prescribed in the first 2 days, followed by a lower dose.

The maximum daily dose of piroxicam for adults is 40 mg. The duration of therapy is determined by the attending physician.

Side effects:

From the digestive system: nausea, decreased appetite, abdominal pain, flatulence, constipation or diarrhea, erosive and ulcerative lesions of the gastrointestinal tract, bleeding and perforation of the gastrointestinal tract; impaired liver function, increased activity of "liver" transaminases; dry mouth, stomatitis.

From the nervous system: dizziness, headache, drowsiness, insomnia, depression, irritability, hallucinations, paresthesia, inhibition, mood change.

From the urinary system: renal dysfunction, interstitial nephritis, papillary necrosis, nephrotic syndrome.

On the part of the organs of hematopoiesis and the system of hemostasis: anemia (including aplastic anemia, hemolytic anemia), leukopenia, eosinophilia, thrombocytopenia, decreased hematocrit; thrombocytopenic purpura.

From the cardiovascular system: increase or decrease in blood pressure, rarely - palpitation, dyspnea.

Other: swelling of the legs and feet, sweating, increased urea levels in the blood; hypoglycemia.

Allergic reactions: skin rash, itching, facial swelling, larynx, bronchospasm, malignant exudative erythema (Stevens-Johnson syndrome), shock, photosensitivity; vasculitis, serum sickness.

Interaction:

With simultaneous application of Piroxicam and

glucocorticosteroids and / or other NSAIDs - increased risk of side effects from the gastrointestinal tract;

Acetylsalicylic acid and other antiplatelet agents, serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) increased risk of developing gastrointestinal bleeding;

phenobarbital - the level of piroxicam concentration in blood serum decreases;

cimetidine - the level of piroxicam concentration in blood serum can increase, which leads to an increase in the action of piroxicam;

phenytoin and / or lithium preparations, as well as potassium-sparing diuretics - it is possible to increase the concentration level in plasma of phenytoin, lithium and potassium;

diuretics and antihypertensive drugs - weaken the effect of the latter;

anticoagulants (warfarin) - it is necessary to conduct blood clotting control;

methotrexate - may lead to an increase in the concentration of methotrexate and to an increase in its toxic effect.

Special instructions:

Patients with gastrointestinal disorders, after extensive surgical interventions, in the elderly, patients with bronchial asthma or with chronic obstructive pulmonary disease in a history should monitor the cellular composition of the blood, kidney and liver function.

In women of reproductive age, the contraceptive effect of IUD can be reduced due to the influence of piroxicam on myometrium tone.

Recommendations for use in children under the age of 14 are currently not developed.

During treatment should be excluded from the use of ethanol.

To reduce the risk of developing adverse events, the minimum effective dose should be used with the minimum possible short course.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 10 mg or 20 mg.

Packaging:

For 10 tablets in a planar cell package. For 20 tablets in a can of lightproof glass. Each bank or 2 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

List B. In a dry, protected from light and out of reach of children, at a temperature of no higher than 25 ° C.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N001298 / 01

Date of registration:06.12.2007 / 16.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Information update date: & nbsp01.02.2017

Illustrated instructions

Instructions

Vero-Piroxicam (Vero-Piroxicam)