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

Excipients: ethanol 95% (ethyl alcohol 95%) - 200.0 mg; propylei glycol 150.0 mg; trolamine (triethanolamine) - 13.0 mg; carbomer - 7.0 mg; megylparahydroxybenzoate (methylparaben, nipagin) - 1.5 mg; purified water - up to 1.0 g.

D1%

active substance: piroxicam - 10.0 mg;

Excipients: ethanol 95% (ethyl alcohol 95%) - 200.0 mg; propylei glycol 150.0 mg; trolamine (triethanolamine) - 18.0 mg; carbomer - 7.0 mg; methylparahydroxybenzoate (methylparaben, nipagin) - 1.5 mg; purified water - up to 1.0 g.

Description:

Transparent gel from light yellow to greenish-yellow color, with the smell of ethanol. Opalescence and air bubbles are allowed.

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

ATX: & nbsp

M.02.A.A.07 Piroxicam

Pharmacodynamics:

Piroxicam is a non-steroidal anti-inflammatory drug with analgesic and anti-inflammatory effects. Suppresses the production of inflammatory mediators by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). Piroxicam reduces the pain syndrome, including: pain in the joints, muscles in mowing and while moving, reduces the swelling associated with inflammation, helps increase the volume of movements.

Pharmacokinetics:

Suction

With external application piroxicam penetrates the surface of the skin in the underlying muscles and tissues of the joints.

Rasdistribution

The equilibrium between the concentrations of piroxicam in the skin and muscles (or synovial fluid) is achieved within a few hours after application. When applying the gel in a daily dose equivalent to 20 mg of piroxicam for ingestion for 14 days, the concentration of active substance in the blood plasma slowly increases and reaches 200 ng / mg on day 4. The equilibrium concentration of piroxicam in blood plasma is 300-400 ng / ml, which is about 5% of the concentration achieved with the use of piroxicam preparations in the appropriate oral dosage forms.

Excretion

The half-life of plasma is 79 hours.

Indications:

Pain syndrome:

- sports injuries (bruises, dislocations, sprains, damage to ligaments and muscles);

- ankylosing spondylitis;

- osteoarthritis;

- rheumatoid arthritis;

- chronic juvenile arthritis;

- tendonitis;

- tenosynovitis;

- humerus syndrome.

Contraindications:

- hypersensitivity to piroxicam, acetylsalicylic acid, other NSAIDs or other components of the drug;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in history);

- severe renal failure (creatinine clearance less than 30 ml / min);

- violation of the integrity of the skin at the site of the intended application;

- III trimester of pregnancy;

- the period of breastfeeding;

- age to 14 years.

Carefully:

- simultaneous application with other PPTA;

- hepatic porphyria (exacerbation);

- severe hepatic insufficiency or liver disease in the active stage;

- erosive and ulcerative diseases of the gastrointestinal tract in the phase of exacerbation (including peptic ulcer and duodenal ulcer, ulcerative colitis, Crohn's disease);

- progressive kidney disease;

- confirmed hyperkalemia;

- bronchial asthma;

- chronic heart failure;

- a disorder of blood clotting (including hemophilia, lengthening bleeding time, a tendency to bleeding, hemorrhagic diathesis);

- condition after aorto-coronary bypass surgery;

- I-II trimesters of pregnancy;

- elderly age.

Pregnancy and lactation:

Pregnancy

The drug is contraindicated for use in the III trimester of pregnancy. The drug should be used with caution in the first and second trimesters of pregnancy.

Breastfeeding period

Piroxicam in small amounts can penetrate into breast milk, so the use of the drug is contraindicated in the period of breastfeeding.

Dosing and Administration:

Outwardly.

The gel is applied to the skin over the affected area (5-10 mm) and gently rubbed 3-4 times a day.

The duration of treatment depends on the severity of the symptoms and on average is 2 weeks with tendinitis, tendovaginitis and humerus syndrome; 1-2 weeks - with sports injuries.

Duration of treatment should not exceed 2 weeks.

Side effects:

Local Reactions

Skin irritation at the site of application (inflammation, redness, peeling, itching, contact dermatitis, eczema), photosensitization.

Allergic reactions (in patients with hypersensitivity)

Hives, angioedema, bronchospasm, rhinitis.

Systemic adverse reactions, due to the low concentration of piroxicam in the systemic circulation, are extremely rare and limited to abdominal pain, nausea, dyspepsia, gastritis. Sometimes there may be shortness of breath. However, there are isolated reports of the development of Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) with the use of external forms of piroxicam.

If any (including local) adverse reactions develop, the drug should be discontinued.

Overdose:

Low systemic absorption of piroxicam for external application makes an overdose almost impossible.

Symptoms

Symptoms of overdose are possible only if the gel is accidentally swallowed, with burning in the mouth, salivation, nausea, vomiting, systemic side effects (headache, nausea, epigastric pain, dyspnea), interstitial nephritis with functional kidney failure and nephrotic syndrome .

Treatment

It is necessary to rinse the mouth and stomach; if necessary, prescribe symptomatic treatment. Hemodialysis is ineffective.

Interaction:

Clinically significant interaction of piroxicam in forms for external use with other drugs has not been described. However, the possibility of enhancing the effect of drugs that cause photosensitivity is not ruled out.

Special instructions:

Patients with bronchial asthma, allergic rhinitis, recurrent polyposis of the nose and paranasal sinuses, chronic obstructive pulmonary disease or chronic pulmonary infections are usually more sensitive to the use of NSAIDs. In these patients, asthma attacks, Quincke's edema and urticaria may become more frequent.

The gel should only be applied to intact skin, avoiding contact with open wounds. After applying, do not apply an occlusive dressing. Do not allow the product to come into contact with the eyes.

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

With external application, the effect of the drug on the ability to perform potentially hazardous activities was not revealed,requiring increased concentration of attention and speed of psychomotor reactions (vehicle management, work with moving mechanisms).

Form release / dosage:

Gel for external use 0,5% and 1%.

Packaging:

For 30 g, 50 g or 100 g in tubes of aluminum.

Each tube together with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-002482

Date of registration:29.12.2011

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp16.10.2015

Illustrated instructions

Instructions

Piroxicam (Piroxicam)