Piroxicam

Piroxicam – non-steroidal anti-inflammatory drug (NPVS), the analgeziruyushchy, febrifugal and suppressing development inflammatory process of action.

Form of release and structure

• Tablets, coated (on 20 pieces in packagings planimetric cell, on 1 packaging in a cardboard pack);
• Capsules: No. 3, gelatinous firm; a dosage of 0,01 g – the white case and a blue lid, a dosage of 0,02 g – the cream case and an orange lid; capsule contents – powder from creamy-white till white color, are allowed formation of the cylindrical form which is easily breaking up at a touch (on 10 pieces in blisters from PVC / aluminum foil, on 2 blisters in a cardboard pack);
• Suppositories rectal: puleobrazny, chartreuse color, the mramornost is allowed (on 5 pieces in the blister, on 2 blisters in a cardboard pack);
• Gel for external use of 0,5% and 1%: transparent, from chartreuse till light yellow color, with an ethanol smell, existence of vials of air and opalescence is allowed (on 30, 50 or 100 g in aluminum tubas, on 1 tuba in a cardboard pack).

Structure of 1 tablet:

• Active ingredient: piroxicam – 0,01 or 0,02 g;
• Auxiliary components: calcium phosphate disubstituted, magnesium stearate, sodium lauryl sulfate, starch, oksipropiltsellyuloza.

Structure of 1 capsule:

• Active ingredient: piroxicam – 0,01 or 0,02 g;
• Auxiliary components: wheat starch, microcrystallic cellulose, glycine, talc, silicon dioxide colloid, magnesium stearate;
• Capsule cover: titanium dioxide, gelatin, indigo carmine of Fd&C Blue 2 (dosage of 0,01 g), iron oxide yellow and Sunset yellow (dosage of 0,02 g).

Composition of 1 suppository:

• Active ingredient: piroxicam – 0,02 g;
• Auxiliary components: poly(ethylene oxide) 400, poly(ethylene oxide) 1500.

Structure of 1 g of gel:

• Active ingredient: piroxicam – 0,005 or 0,01 g;
• Auxiliary components: propylene glycol, trietanolamine (троламин), alcohol of 95% (ethanol of 95%), carbomer, methylparahydroxybenzoate (нипагин, methylparaben), the water purified – to 1 g.

Indications to use

Tablets, capsules, suppositories Piroxicam are intended for symptomatic therapy of diseases of a musculoskeletal system: an osteoarthrosis, a pseudorheumatism, spondylites, gout, a sciatica, a tendovaginitis, a bursitis, neuralgia, a mialgiya, a spondylarthritis ankylosing (Bekhterev's disease), backbone pains, an inflammation of soft tissues, posttraumatic pains and for reduction of a pain syndrome at primary dysmenorrhea. Drug reduces an inflammation and pain, but does not exert impact on the course of a disease.

Gel is applied to removal of a pain syndrome at sports injuries (bruises, stretchings, dislocations, injuries of muscles and sheaves), an ankylosing spondylarthritis, an osteoarthrosis, a pseudorheumatism, chronic juvenile arthritis, a tendinitis, a tendovaginitis, a humeroscapular syndrome.

Contraindications

Absolute (general):

• Full or partial combination of the nose recuring a polypose and okolonosovy bosoms, bronchial asthma and anaphylactoid sensitivity to acetylsalicylic acid or other NPVS (including data in the anamnesis);
• Heavy disturbances of renal functions (CC (clearance of creatinine) ≤ 30 ml/min.);
• III trimester of pregnancy;
• Period of a lactation (breastfeeding);
• Children's and teenage age (for tablets, capsules, suppositories – up to 18 years, for gel – up to 14 years);
• Hypersensitivity to piroxicam and auxiliary components of drug, and also to acetylsalicylic acid and other NPVS.

Absolute (in addition for tablets, capsules, suppositories):

• Noncompensated heart failure;
• The post-operational period after aortocoronary shunting;
• Erosive and ulcer pathologies mucous a stomach or a 12-perstny gut, gastrointestinal bleeding in an active phase;
• Intestines inflammations (ulcer colitis, disease Krone);
• Bleedings, including cerebrovascular;
• Dekompensirovanny stage of a liver failure or disease of a liver in an active phase;
• The expressed and chronic renal failure (KK ≤ 30 ml/min.).

It is also contraindicated to use gel at disturbances of integrity of integuments in places of alleged drawing.

With care, in view of the increased risk of negative side effects, Piroxicam is applied at: coronary heart disease, cerebrovascular diseases, congestive heart failure, дислипидемии / lipidemia, diabetes mellitus, diseases of peripheral arteries, smoking, frequent alcohol intake, long use NPVS, heavy somatopathies, KK ≤ 60 ml/min., existence of data in the anamnesis on ulcer pathologies of a GIT (digestive tract), infection of Helicobacter pylori and in advanced age. Also it is necessary to be careful in case of the accompanying therapy by anticoagulants (warfarin), antiagregant (klopidogret, acetylsalicylic acid), peroral glucocorticosteroids (Prednisolonum), selective serotonin reuptake inhibitors (fluoxetine, пароксетин, to tsitalopra, sertraline).

It is necessary to be careful when using gel along with other NPVS, and also at a hepatic porphyria (especially in an aggravation stage), a heavy liver failure or diseases of a liver in an active stage, erosive cankers of bodies of a GIT in an aggravation stage (including a peptic ulcer of a stomach and a 12-perstny gut, a disease Krone, ulcer colitis), the progressing diseases of kidneys, the confirmed hyperpotassemia, bronchial asthma, CHF (chronic heart failure), blood coagulation disturbances (including hemophilia, lengthening of a bleeding time, hemorrhagic diathesis, tendency to bleedings), after performing aortocoronary shunting, at advanced age, during pregnancy (the I-II trimester).

Route of administration and dosage

Piroxicam is not drug of the first choice because of a safety profile therefore primary prescription of medicine the doctor with experience diagnostic has to carry out estimates and therapies of inflammatory or degenerative rheumatic diseases.

At simultaneous use of various forms of drug (a tablet, capsules, gel, suppositories), or other medicines on the basis of piroxicam, its general dose should not exceed 0,04 g a day.

Tablets and capsules
Tablets and the Piroxicam capsules are intended for oral administration, they should be accepted during food.

Duration of a course of therapy and dosage of drug are determined by the attending physician.

If there are no other appointments, the recommended dosing mode, depending on a state/disease, following:

• Diseases of a musculoskeletal system and/or joints (osteoarthrosis, pseudorheumatism, spondylites): 0,01-0,02 in days once or for 2 receptions; in case of need it is temporarily possible to increase a daily dose to 0,03 g (once or for several receptions) or to lower to 0,01 g;
• Acute diseases of a musculoskeletal system: the first 2 days – 0,04 g a day (once or for several receptions), further for 1-2 weeks – 0,02 g a day;
• Bad attack of gout: 0,04 g a day for 3-5 days;
• Dysmenorrhea (with the advent of the first symptoms): the first 2 days – 0,04 g a day (once or for several receptions), in the next 1-3 days – 0,02 g a day for 1 reception;
• Posttraumatic pains: an initial dose – 0,02 g of 1 times a day; increase in a dose in the first 2 days to 0,04 g is allowed if necessary (once or for several receptions).

In case of exceeding of the recommended daily doses the probability of emergence of side effects increases.

For adults the maximum daily dose makes 0,04 g.

Suppositories rectal
Suppositories apply Piroxicam rektalno after a cleansing enema; before introduction it is recommended to moisten suppository with water.

The recommended dosing mode – on 1 piece of 1 times a day. Duration of a course is determined by the attending physician taking into account the current and disease severity reached therapeutic effect and the general tactics of treatment.

Most recommended daily dose – 0,02 g (1 suppository).

It is necessary to estimate effect of use and portability of drug each 2 weeks. When long therapy is necessary, such assessment should be carried out more often. It is proved that use of piroxicam increases risk of gastrointestinal complications therefore it is required to weigh carefully need of a combination therapy with gastroprotektorny drugs (мизопростол or inhibitors of the proton pump), especially at elderly patients.

Before use of suppository it is required to tear off from the blister packaging 1 pieces in primary packaging through perforation, then to pull for edges of a film in different directions and, having broken off it, to exempt suppository from primary packaging.

Gel for external use
Piroxicam gel is intended for external use.

The column of gel 5-10 mm long is applied on an integument over painful area by 3-4 times a day and carefully rub.

Therapy duration, depending on expressiveness of symptoms, averages:

• Tendinitis, tendovaginitis and humeroscapular syndrome – 2 weeks;
• Sports injuries – 1-2 weeks.

The maximum duration of therapy – 2 weeks.

Side effects

Tablets, capsules, suppositories

• Digestive organs: nausea, vomiting, an eructation, dryness in a mouth, stomatitis, pains in epigastric area, a loss of appetite, diarrhea or locks, a meteorism, erosive cankers (before perforation) and/or bleedings (in exceptional cases to anemia) bodies of a GIT, increase in activity of liver enzymes, a liver failure, increase in concentration in nitrogen plasma;
• Urinary system: a renal failure, intersticial nephrite, a nephrotic syndrome, a nephrosis, a proteinuria, an erythrocyturia, a hyperpotassemia, a papillary necrosis, a glomerulonephritis, increase in plasma of concentration of creatinine and urea;
• Central nervous system: drowsiness, headache, dizziness, sonitus; more rare – sleeplessness, a depression, irritability, paresthesias, block, hallucinations, emotional lability;
• System of a hemopoiesis and system of a hemostasis: a leukopenia, an eosinophilia, anemia (including aplastic and hemolitic), decrease in level of a hematocrit; seldom – hemorrhages, thrombocytopenia, Shenleyn-Genokh's disease (Werlhof's disease);
• Cardiovascular system: hypertensia or hypotension, symptoms of heart failure; seldom – an asthma, heartbeat;
• Allergic reactions: an enanthesis, dermatitis with exfoliating of a corneous layer, the itch, a mnogoformny exudative erythema, a malignant exudative erythema (Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease), an acute anaphylaxis, a bronchospasm, a vasculitis, a photosensitization, a serum disease, is probable a Quincke's disease;
• Other reactions: hyper - and a hypoglycemia, a vision disorder, hypostases of feet and shins, a hyperhidrosis, increase or a degrowth of a body.

Side effects from digestive organs are most often shown; at increase in a daily dose of piroxicam the probability of the listed reactions increases.

Overdose symptoms peroral forms of drug are: nausea, vomiting, abdominal pain, vision disorder, drowsiness; in case of reception of very high doses – a syncope, a coma. Therapy of a state – symptomatic, is required to wash out a stomach with reception of absorbent carbon, antacids are used for absorption delay. At heavy degree of poisoning of the patient hospitalize. There is no specific antidote.

Gel for external use

• Local reactions (in the field of putting gel): reddening, inflammation, itch, peeling, contact dermatitis, photosensitization, eczema;
• System reactions (in connection with small concentration in a system blood-groove of piroxicam): extremely seldom – an abdominal pain, nausea, dyspepsia, gastritis; sometimes – an asthma; single messages – a malignant exudative erythema (Stephens-Johnson's syndrome) and a toxic epidermal necrolysis (Lyell's disease);
• Hypersensitivity reactions: rhinitis, bronchospasm, small tortoiseshell, Quincke's disease.

At development of any (including local) side effects use of drug needs to be stopped.

The overdose at external use of gel is almost impossible because of low system absorption of piroxicam.

As a result of an accidental proglatyvaniye of gel can be observed: nausea, vomiting, burning in oral cavities, salivation, system side reactions (short wind, pain in epigastriums, a headache), intersticial nephrite with a renal failure and a nephrotic syndrome. It is required to make a gastric lavage and oral cavities, if necessary to carry out symptomatic therapy. The hemodialysis in this case is inefficient.

Special instructions

Drug is used only on doctor's orders by minimum possible short course in the smallest effective dose for the purpose of the prevention of undesirable side effects. Long use of piroxicam in a daily dose more than 0,03 g increases risk of side reactions, first of all from a GIT.

Use of several NPVS at the same time increases risk of emergence of side effects, but does not improve therapeutic action.

Function of a liver and kidneys, and also cellular composition of blood is required to be controlled to patients: with dysfunctions of a GIT, after extensive operative measures, with bronchial asthma, and also chronic bronkhoobstruktivny diseases in the anamnesis, at advanced age.

The round ulcer or bleeding from a GIT demand the treatment termination; when use of piroxicam is absolutely necessary, therapy is continued under observation of the doctor.

In case of a vision disorder it is necessary to consult at the specialist.

As piroxicam influences a myometrium tone at women perhaps decrease in contraceptive effect of an intrauterine spiral.

Recommendations about use of drug at children's and teenage age are not developed now.

Patients at bronchial asthma, allergic rhinitises are more sensitive, as a rule, to NPVS, recuring a polypose of a nose and okolonosovy bosoms, chronic obstructive diseases slight or persistent pulmonary infections. At them attacks of bronchial asthma can become frequent, be observed a small tortoiseshell, a Quincke's edema.

It is required to exclude alcohol intake during therapy by piroxicam.

It is necessary to abstain from the types of activity demanding speed of psychomotor reactions and the increased concentration of attention.

Gel is applied only on the unimpaired skin, avoiding its hit on open wound surfaces, mucous membranes and in eyes. It is impossible to apply an occlusive bandage the site processed by gel.

Medicinal interaction

Tablets, capsules, suppositories

• Glucocorticosteroids and/or NPVS – the risk of emergence of side effects from a GIT increases (including bleedings);
• Phenobarbital – reduces the level of concentration of piroxicam in blood serum;
• Cimetidinum, пробенецид and Sulfinpyrazonum – can increase the level of concentration of piroxicam in blood serum owing to what strengthening of its side effects is possible;
• Phenytoinum and/or lithium, and also kaliysberegayushchy diuretics and donators ^{of K+} – increase in plasma of level of concentration of lithium, Phenytoinum and potassium is possible;
• Diuretics and hypotensive substances / drugs – piroxicam weakens their action;
• Anticoagulants – control of coagulability of blood is required;
• Acetylsalicylic acid – decreases in blood serum the level of concentration of piroxicam, the probability of formation of erosive cankers of a GIT increases;
• Selective serotonin reuptake inhibitors (fluoxetine, to tsitalopra, sertraline, пароксетин) – increase probability of formation of erosive cankers of a GIT;
• Methotrexate – increase in its concentration and strengthening of toxic effect is possible.

Gel for external use
Clinically significant interaction of piroxicam in the form of gel with other medicinal substances / drugs was not noted, but the possibility of strengthening of influence of the means causing a photosensitization is not excluded.

Terms and storage conditions

To store in the dark, dry place unavailable to children, at a temperature up to 25 °C.

Period of validity:

• Tablets, capsules – 3 years;
• Gel, suppositories – 2 years.