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

Excipients: Carbomer (ULTREZ 10) 0.70 g, ethanol 95% 20.00 g, propylene glycol 15.00 g, trolamine 1.30 g, methyl parahydroxybenzoate 0.15 g, water up to 100 g.

Description:

Transparent gel from light yellow to greenish-yellow with a characteristic odor. Air bubbles are allowed.

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

ATX: & nbsp

M.02.A.A.07 Piroxicam

Pharmacodynamics:

Has anti-inflammatory, analgesic, local cooling effect. Non-selectively inhibits cyclooxygenase type 1 and 2 (COX-1 and COX-2), thereby reducing the content of prostaglandins in the tissues, which are mediators of inflammation.The drug reduces pain in the joints, muscles, increases range of movements and reduces swelling associated with inflammation.

Pharmacokinetics:

With external application piroxicam penetrates the surface of the skin in the underlying muscles and tissues of the joints. When applying the gel in a daily dose equivalent to 20 mg of piroxicam for ingestion, the concentration of active substance in the blood slowly increases during 14 days and reaches 200 ng / mg on day 4. The equilibrium concentration of piroxicam in the blood (Css) 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. The half-life of plasma is 79 hours.

Indications:

Pain syndrome: ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, juvenile chronic arthritis, tendonitis, tendovaginitis, humerus syndrome; sports injuries (bruises, damage to ligaments and muscles).

Contraindications:

Hypersensitivity to piroxicam, other NSAIDs, or other components of the drug, a complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history),severe renal failure (creatinine clearance less than 30 ml / min), breach of the integrity of the skin at the site of the intended application, pregnancy III trimester, the period of breastfeeding, children's age (under 14 years).

Carefully:

Simultaneous use with other non-steroidal anti-inflammatory drugs, hepatic porphyria (exacerbation), erosive and ulcerative diseases of the gastrointestinal tract in the exacerbation phase (including gastric ulcer and duodenal ulcer, ulcerative colitis, Crohn's disease), chronic heart failure, bronchial asthma, elderly age, blood clotting disorders (including hemophilia, lengthening bleeding time, propensity to bleed, hemorrhagic diathesis); progressive kidney disease, severe hepatic insufficiency or active liver disease, condition after aortocoronary shunting, confirmed hyperkalemia, pregnancy I-II trimester.

Pregnancy and lactation:

The drug is contraindicated for use in the III trimester of pregnancy.

It should be used with caution during the first and second trimester of pregnancy.

Piroxicam in small amounts can penetrate into breast milk, so it is not recommended to use the drug during breastfeeding.

Dosing and Administration:

Outwardly.

The gel is applied to the skin over the affected area (a 1-2 cm column, which is about 1 g) 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: irritation of the skin at the site of application (inflammation, redness, peeling, pruritus, contact dermatitis, eczema), photosensitization.

Allergic reactions in patients with hypersensitivity: urticaria, angioedema, bronchospasm, rhinitis.

Systemic adverse reactions in connection with 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 epidermalnecrolysis (Lyell's syndrome) when using 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 of overdose are possible only with accidental swallowing of the ointment, with burning in the mouth, salivation, nausea, vomiting, systemic side effects (headache, nausea, epigastric pain, dyspnea), interstitial nephritis with functional renal failure and nephrotic syndrome .

Treatment: washing of the mouth and stomach is necessary; 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 the drug to enhance the effect of drugs that cause photosensitivity is not ruled out.

Special instructions:

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

Do not apply gel to damaged skin, including open wounds. After applying, do not apply an occlusive dressing. Avoid contact with eyes.

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

With external use of piroxicam, there is no evidence of an effect on the ability to drive or work with machinery.

Form release / dosage:

Gel for external use 0,5%.

Packaging:

For 30 or 50 grams of aluminum tubes.

By 10, 15, 20, 25, 30 or 50 g in cans of dark glass such as BTS made of glass fiber with pull-on lids. The label is self-adhesive on the can.

Each tube or jar, together with the instruction for use, is placed in a cardboard package (bundle).

Storage conditions:

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

Keep 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:LP-002664

Date of registration:20.10.2014

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp15.10.2015

Illustrated instructions

Instructions

Piroxicam (Piroxicam)