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

One tablet contains active substance piroxicam 10 mg and 20 mg; auxiliary substances: cellulose powder, sodium carboxymethyl-starch (sodium starch glycolate), potato starch, sodium lauryl sulfate, magnesium stearate, gelatin, titanium dioxide or gelatin, titanium dioxide, the dye is blue patented.

Description:Capsules № 3 with a body and a lid of white color (for a dosage of 10 mg); capsules No. 3 with a white body and a blue lid (for a dosage of 20 mg). The contents of the capsules are powder from white with a creamy shade of color to a cream color.

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

ATX: & nbsp

M.02.A.A.07 Piroxicam

Pharmacodynamics:Nonsteroidal anti-inflammatory drug, has anti-inflammatory, analgesic, antiplatelet and antipyretic effect. Non-selectively inhibits cyclooxygenase-1 (COX1) and cyclooxygenase-2 (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 the maximum concentration of the drug in the plasma (TCmax) is 3-5 hours. After a single dose of 20 mg, the maximum concentration of piroxicam in plasma (Cmax) is 1.5-2 μg / ml, after regular intake of 20 mg / day, 3-8 μg / ml. TCss - 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 pyridine ring of the side chain, followed by conjugation with glucuronic acid and the formation of inactive metabolites. In the metabolism, the isoenzyme CYP2C9 also participates.The half-life (T1 / 2) is 24-50 hours. It is excreted as conjugates by the kidneys and to a lesser extent through the intestine. In unchanged form - 5%.

Indications:

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis and gout, ankylosing spondylitis (Bechterew's disease), osteoarthritis.

Pain: sciatica, tendonitis, bursitis, arthralgia, neuralgia, myalgia, sciatica, post-traumatic and post-operative pain, accompanied by inflammation, tuberculosis.

It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:Hypersensitivity, erosive-ulcerative lesions of the gastrointestinal tract (in the stage of exacerbation); complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis); severe renal failure (creatinine clearance (CC) of less than 30 ml / min), active gastrointestinal bleeding, inflammatory disease of the gastrointestinal tract,progressive kidney disease, severe hepatic failure or active liver disease, condition after aorto-coronary artery bypass grafting (CABG); confirmed hyperkalemia, blood clotting disorders (including hemophilia, lengthening bleeding time, propensity to bleed, hemorrhagic diathesis); children's age (up to 14 years), pregnancy, lactation.

Carefully:Chronic heart failure, ischemic heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min, ulcerative lesions of the gastrointestinal tract in history, presence of N. poulori infection, prolonged use non-steroidal anti-inflammatory drugs, alcoholism, severe physical illness, age over 65, simultaneous intake of oral glucocorticoids (including prednisolone), anticoagulant in (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Dosing and Administration:

Inside. With rheumatoid arthritis, osteoarthritis and Bechterew's disease - 10-30 mg / day in 1 dose, for a long time.

In acute diseases of skeletal muscles - 40 mg / day for one or more doses for 2 days, for the next 7-10 days - 20 mg / day.

When treating a gout attack, the initial dose is 40 mg, once, for the first 2 days, then for 4-6 days - 40 mg once or 20 mg twice a day.

With algodismenosis, treatment should be started when the first symptoms appear in the initial dose of 40 mg / day in 1 or more doses for 2 days. In the next 1-3 days - 20 mg per 1 reception.

When juvenile rheumatoid arthritis is prescribed once a day: children over 14 years of age weigh more than 46 kg - 20 mg / day.

Side effects:

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

On the part of the urinary system: renal dysfunction, interstitial nephritis, papillary necrosis, nephrotic syndrome.

On the part of the digestive system: nausea, decreased appetite,abdominal pain, bloating, 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 side of hematopoiesis and hemostasis system: anemia, aplastic anemia, hemolytic anemia, leukopenia, eosinophilia, thrombocytopenia, decreased hematocrit level; hemorrhagic vasculitis (Schönlein-Henoch disease).

From the cardiovascular system: increased blood pressure, lower blood pressure, rarely - palpitation, dyspnea.

Other: swelling of the legs and feet, increased sweating, increased urea concentration; hypoglycemia.

Allergic reactions: skin rash, itching, swelling of the face, throat, bronchospasm, malignant erythema multiforme (Stevens-Johnson syndrome), shock, photosensitivity; vasculitis, serum sickness.

Overdose:

Symptoms: heartburn, indigestion, nausea, vomiting, drowsiness.

Treatment: gastric lavage, Activated carbon - 0.5 g / kg. Hemodialysis does not cause a decrease in the concentration of piroxicam in the blood plasma, due to the high degree of its binding to proteins.

Interaction:

Piroxicam displaces other medicines from the connection with blood proteins. Caution should be given with drugs that are strongly associated with blood plasma proteins (possibly competitive inhibition of binding of other drugs).

With caution appoint the drug simultaneously with indirect anticoagulants, tk. it is possible to intensify the anticoagulant action. Anticoagulants increase the risk of bleeding.

Against the background of other non-steroidal anti-inflammatory drugs and corticosteroids, the risk of ulcerogenic effect increases (danger of gastrointestinal bleeding), the risk of allergic reactions and side effects from the gastrointestinal tract increases, acetylsalicylic acid reduces the level of piroxicam in blood plasma to 80%.

Piroxicam increases the risk of hyperkalemia when combined with potassium-sparing diuretics and other potassium-containing drugs.

With the simultaneous use of pyroxicam with cimetidine, probenecid and sulfinpyrazone, the concentration of piroxicam in the blood increases.

With the simultaneous use of piroxicam with lithium preparations, an increase in the lithium content in serum is possible.

Phenobarbital can reduce the concentration of piroxicam in the blood plasma.

Piroxicam increases the concentration of phenytoin.

Piroxicam reduces the effectiveness of antihypertensive drugs, diuretics (due to fluid retention, sodium and potassium ions).

When piroxicam is used 24 hours before or after taking methotrexate, the concentration of the latter in the blood serum increases and its toxicity increases.

With the simultaneous use of piroxicam with sulfonamides, nalidixic acid, oral hypoglycemic drugs, triiodothyronine, cyclophosphamide, an increase in their concentration in the blood plasma is possible.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

Patients with impaired function of the gastrointestinal tract, after extensive surgical interventions, in the elderly, patients with bronchial asthma or with chronic obstructive pulmonary disease in a history should monitor hemoglobin in the blood (risk of bleeding), kidney and liver function.

In women, it is possible to reduce the contraceptive effect of IUD because of the influence of piroxicam on myometrium tone.

Recommendations for use in children are not currently developed.

During treatment should be excluded from the use of ethanol.

To reduce the risk of developing adverse events from the gastrointestinal tract, a 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 dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 10 mg, 20 mg.

Packaging:For 10 or 20 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered. For 1, 2, 3, 10 or 20 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

Store in a dry, protected from light place, at a temperature not exceeding 25 ^aboutFROM

Keep out of the reach of children!

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

Terms of leave from pharmacies:On prescription

Registration number:P N003827 / 01

Date of registration:05.11.2009

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp18.10.2015

Illustrated instructions

Instructions

Piroxicam-OBL (Piroxicam-OBL)