Piroxicam - instructions for use, doses, side effects, contraindications

Auxiliary substances (capsule 10 mg / 20 mg), microcrystalline cellulose (0.0100 g / 0.0200 g), wheat starch (0.0140 g / 0.0290 g), glycine (0.0075 g / 0.0150 g ), silicon dioxide colloidal (0.0010 g / 0.0015 g), talc (0.0015 g / 0.0025 g), magnesium stearate (0.0010 g / 0.0020 g).

Capsule shell: gelatin, titanium dioxide, indigo carmine Fd & C Blue 2 (10 mg capsules), yellow iron oxide (20 mg capsules), sunset yellow (20 mg capsules).

Description:

Hard gelatin capsules № 3 with a white body and blue cap (10 mg dosage) or body cream and orange lid (dosage 20 mg). The contents of the capsule - powder from white to creamy white, it is possible to form a cylindrical shape,easily breakable when touched.

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

ATX: & nbsp

M.02.A.A.07 Piroxicam

Pharmacodynamics:

Non-steroidal anti-inflammatory drug (NSAID), has anti-inflammatory, analgesic, and antipyretic effect. Non-selectively inhibits the activity of cyclooxygenase 1 and cyclooxygenase 2 (COX1 and COX2), inhibits the synthesis of prostaglandins in the inflammatory focus and central nervous system, suppresses the exudative and proliferative phase of inflammation. It inhibits the aggregation of neutrophils and the formation of superoxide anions in them, the migration of polymorphonuclear cells and monocytes to the focus of inflammation. Reduces the release of lysosomal enzymes from stimulated leukocytes. Reduces the pyrogenic effect of prostaglandins on the center of thermoregulation. Reduces the severity of the pain syndrome of average intensity, increasing the threshold of sensitivity to biological amines. The analgesic effect is manifested 30 minutes after oral administration. After a single dose, the effect persists for 24 hours. If the joint syndrome weakens or stops inflammation and pain at rest and whenmovement, reduces morning stiffness and swelling of the joints, contributes to an increase in the volume of movements. With primary dysmenorrhea (being an inhibitor of the synthesis of prostaglandins in the endometrium) weakens uterine contractions, preventing its ischemia and arresting the pain syndrome.

Pharmacokinetics:

When ingested, the drug is well absorbed from the gastrointestinal tract, the concentration in the plasma is proportional to the dose used, the maximum concentration in the plasma is achieved 3-5 hours after ingestion.

After a single dose of 20 mg of drug C_max - 1.5-2 μg / ml, after a regular intake of 20 mg / day - 3-8 μg / ml. Food slows the rate of absorption, but does not affect the amount of absorption. Bioavailability is almost 100%. The time to reach the equilibrium concentration is 7-12 days. It penetrates into the synovial fluid (40-50%), excreted in breast milk - 1-3%. Easily binds to blood plasma proteins (almost 98%). The half-life is 24-50 hours, with liver disease may be prolonged. The drug is metabolized in the liver by hydroxylating the side chain pyridine ring, followed by conjugation with glucuronic acid and the formation of inactive metabolites. 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:

Diseases of the musculoskeletal system: rheumatoid arthritis, osteoarthritis, spondylitis, sciatica, gout, tendovaginitis, bursitis, Bechterew's disease (spondyloarthritis ankylosing), back pain, neuralgia, myalgia, post traumatic pains and soft tissue inflammation; primary dysmenorrhea. The drug is intended for symptomatic therapy, reduces pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

in the period after aortocoronary shunting;
III trimester of pregnancy, the period of breastfeeding;
uncompensated heart failure;
hypersensitivity to the active substance or ancillary components;
anamnestic data on an attack of bronchial obstruction, rhinitis, hives after taking acetylsalicylic acid or other NSAIDs (complete or incomplete syndrome
intolerance to acetylsalicylic acid - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
erosive and ulcerative changes in the gastric mucosa or duodenum, active gastrointestinal bleeding;
inflammatory bowel disease;
cerebrovascular bleeding or other bleeding;
severe hepatic impairment or active liver disease;
severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease.
children's age till 18 years.

Carefully:

Ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min.

Anamnestic data on the development of gastrointestinal ulcer, the presence of Helicobacter pylori infection, advanced age, prolonged use of NSAIDs, frequent alcohol consumption, severe physical illness, concomitant therapy with the following drugs:

anticoagulants (for example, warfarin)
antiaggregants (eg, acetylsalicylic acid, clopidogrel)
oral glucocorticosteroids (for example, prednisolone)
selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

Dosing and Administration:

Duration of treatment and the dose applied is prescribed by the attending physician.

The drug is taken orally during a meal.

In diseases of the musculoskeletal system or joint diseases (rheumatoid arthritis, osteoarthritis, spondylitis) is taken 10-20 mg per day for 1 or 2 doses. If necessary, you can temporarily increase the dose to 30 mg per day, once or in divided doses, or reduce to 10 mg per day.

In acute diseases of the musculoskeletal system the first two days take 40 mg per day once or in several doses, and then within 1-2 weeks 20 mg per day.

With an acute attack of gout take 40 mg for 3-5 days.

Do not exceed the recommended daily dose, as this increases the risk of side effects.

With dysmenorrhea 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 to 3 days - 20 mg per 1 reception.

For posttraumatic pain the initial dose is 20 mg once a day. In some cases, you can increase the dose in the first 2 days - 40 mg once or in divided doses.

The maximum daily intake for adults should not exceed 40 mg.

Side effects:

The most frequently manifested by the digestive organs: pain in the epigastric region, belching, nausea, decreased appetite, vomiting, constipation or diarrhea, flatulence, erosive and ulcerative lesions of the gastrointestinal tract, bleeding organs of the gastrointestinal tract, which in exceptional cases can cause anemia, and perforation of the organs of the gastrointestinal tract, intestinal tract; dry mouth, stomatitis, liver dysfunction, increased activity of "liver" transaminases, an increase in the concentration of nitrogen in the plasma.

urinary system: renal dysfunction, interstitial nephritis, papillary necrosis, nephrotic syndrome, erythrocyturia, proteinuria, hyperkalemia, glomerulonephritis, nephrosis, increased urea and creatinine concentrations in plasma.

Central nervous system: dizziness, headache, tinnitus, drowsiness, less often - depression, insomnia, irritability, hallucinations, paresthesia, inhibition, mood change.

Hematopoiesis and hemostasis systems: anemia, including aplastic and hemolytic, leukopenia, eosinophilia, decreased hematocrit; rarely - thrombocytopenia, hemorrhage, thrombocytopenic purpura (Shenlen-Henoch disease).

The cardiovascular system: increase or decrease in blood pressure, signs of heart failure, rarely - palpitation, dyspnea.

Allergic reactions: skin rash, itching, dermatitis with slusheniem, erythema multiforme, Lyell's syndrome, bronchospasm, malignant exudative erythema (Stevens-Johnson syndrome), anaphylactic shock, photosensitivity, vasculitis, serum sickness, angioedema is possible.

Other: visual impairment, hyper - and hypoglycemia, edema of the shins and feet, increased sweating, increased or decreased body weight.

The frequency of the above disorders increases with an increase in the daily dose of the drug.

Overdose:

Symptoms: abdominal pain, nausea, vomiting, drowsiness, impaired vision, when taking very large doses - loss of consciousness, coma.

Treatment: Gastric lavage with the use of activated charcoal, antacids are used to slow the absorption. When severe poisoning the patient should be hospitalized. There is no specific antidote. Treatment is symptomatic.

Interaction:

With simultaneous application of Piroxicam and:

glucocorticosteroids and / or NSAIDs - there is an increased risk of side effects from the gastrointestinal tract, including bleeding;
phenobarbital - the level of piroxicam concentration in serum is reduced;
cimetidine, probenecid and sulfinpyrazone - the level of serum piroxicam concentration may increase, leading to an increased side effect of piroxicam;
phenytoin and / or lithium, and potassium-sparing diuretics and donators K + - can increase the level of concentration in plasma phenytoin, lithium, and potassium;
diuretics and antihypertensive drugs - the effect of the latter is weakened;
anticoagulants - blood coagulability should be monitored;
Acetylsalicylic acid - the level of piroxicam concentration in blood serum is reduced, the risk of development of erosive and ulcerative gastrointestinal lesions is increased;
selective serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) increases the risk of erosive and ulcerative gastrointestinal lesions;
methotrexate - may lead to an increase in the concentration of methotrexate and to an increase in its toxic effect.

Special instructions:

To prevent undesirable effects, the drug should only be used as directed by the doctor at the lowest effective dose, the minimum possible short course. Prolonged use of the drug in doses of more than 30 mg per day increases the risk of side effects (primarily from the gastrointestinal tract).

The simultaneous use of several non-steroidal anti-inflammatory drugs increases the risk of side effects, while the therapeutic effect does not improve.

Patients with impaired function of the gastrointestinal tract, after extensive surgical interventions, in the elderly, patients with bronchial asthma and chronic bronchial obstructive diseases in history, it is necessary to control the cellular composition of the blood, kidney and liver function.

If a peptic ulcer or bleeding occurs from the gastrointestinal tract, treatment should be discontinued, if the drug is absolutely necessary, then the treatment is carried out under the supervision of a physician.

If visual impairment occurs, a specialist consultation is necessary.

In women, the contraceptive effect of the intrauterine device may decrease, due to the effect of piroxicam on myometrium tone.

Recommendations for use in children are not currently developed.

During treatment should be excluded from the use of ethanol.

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

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 10 mg or 20 mg.

Packaging:

10 capsules in a PVC / aluminum foil blister. 2 blisters together with the instruction for use are placed in a cardboard box.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep the drug out of the reach of children.

Shelf life:

3 years

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N012690 / 01

Date of registration:16.05.2008

The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria

Manufacturer: & nbsp

SOPHARMA, AD Bulgaria

Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria

Information update date: & nbsp16.10.2015

Illustrated instructions

Instructions

Piroxicam (Piroxicam)