Pyroxicam-Vertex, gel 1% 50 g

Indications

– sports injuries (bruises, sprains, sprains, ligament and muscle injuries);

– osteoarthritis;

– tendinitis;

– tendovaginitis;

– shoulder and scapular syndrome.

The drug is intended for symptomatic therapy, to reduce pain and inflammation at the time of use, has no effect on the progression of the disease.

Active ingredient

Composition

1 g of the gel contains:

Dosage 0.5%

the active ingredient: pyroxicam – 5.0 mg;

components: Ethyl alcohol 95% (ethanol 95%), 200.0 mg; propylene glycol, 150.0 mg; trolamine (triethanolamine), 16.0 mg; carbomer, 8.4 mg; purified water, up to 1.0 g.

Dosage 1%

the active ingredient: pyroxicam – 10.0 mg;

excipients: Ethyl alcohol 95% (ethanol 95%) – 200.0 mg; propylene glycol – 150.0 mg; trolamine (triethanolamine) – 22.0 mg; carbomer – 8.4 mg; purified water – up to 1.0 g.

How to take, the dosage

Externally. Depending on the affected area, if not prescribed otherwise: not more than 5 mg of pyroxicam (1.5-2 cm columns of 1% gel, 3-4 cm columns of 0.5% gel) should be applied to the skin and rubbed in gently 3-4 times a day.

The duration of treatment depends on the severity of symptoms and is about 2-3 weeks for tendinitis, tendovaginitis and brachial scapular syndrome; 1-2 weeks for sports injuries.

Interaction

No clinically significant interaction of pyroxicam in forms for external use with other drugs has been described. However, the possibility of enhancing the effect of drugs that cause photosensitization is not excluded.

Special Instructions

Hypersensitivity

Patients with bronchial asthma, allergic rhinitis, chronic obstructive pulmonary disease or chronic lung infections are more sensitive to NSAID use. These patients may have more frequent attacks of bronchial asthma, Quincke’s edema, or urticaria.

Serious cutaneous adverse reactions (TKRA)

TKRA have been reported with systemic administration of piroxicam. These reactions have not been associated with topical administration of piroxicam, but the possibility of TKPR with topical administration of piroxicam cannot be excluded.

Patients should note that if they experience TKPR after topical use of piroxicam (such as a progressive skin rash, often accompanied by vesicles or mucosal lesions) they should stop treatment and seek immediate medical attention. If a patient develops TKPR after using piroxicam, treatment of that patient with piroxicam should not be resumed.

Kidney disease

NSAIDs, including piroxicam, may lead to the development of interstitial nephritis, nephrotic syndrome and renal failure. The development of interstitial nephritis, nephrotic syndrome, and renal failure after topical application of piroxicam has also been reported. A causal relationship with topical application of piroxicam has not been established, but the possibility of an adverse effect with topical application of piroxicam has not been excluded.

Intravenous irritation

If local irritation has developed during use, the drug should be stopped, and appropriate therapy should be administered as necessary.

Should not get in the eyes or on mucous surfaces. The gel should not be applied to damaged skin, including open wounds. No occlusive dressing should be applied after application.

Influence on driving and operating machinery When used topically there is no effect of pyroxicam on the ability to perform potentially dangerous activities requiring increased concentration and speed of psychomotor reactions (driving vehicles, operating moving machinery).

Synopsis

Transparent gel of light yellow to greenish-yellow color with a characteristic odor. Opalescence and air bubbles are allowed.

Contraindications

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

– The complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (including a history);

– Severe renal insufficiency (creatinine clearance less than 30 ml/min);

– Skin integrity disorders at the site of intended application;

– Pregnancy;

– Breast-feeding period;

– Age less than 18 years (due to insufficient data on efficacy and safety for this group of patients).

– hepatic porphyria (exacerbation);

– severe liver and kidney function disorders;

– Ulcerative diseases of the gastrointestinal tract in the acute phase (including gastric and duodenal ulcer, ulcerative colitis, Crohn’s disease);

– bronchial asthma;

– allergic rhinitis;

– chronic obstructive pulmonary disease or chronic lung infections;

– chronic heart failure;

– blood clotting disorders (including hemophilia, prolonged bleeding time, susceptibility to bleeding, hemorrhagic diathesis);

– older age.

Side effects

Immune system disorders:

Hypersensitivity reactions and angioedema may occur in predisposed patients. If hypersensitivity reactions occur (may take the form of skin reactions), the use of the drug should be discontinued and appropriate treatment should be prescribed (see section “Special Precautions”).

Skin and subcutaneous tissue disorders:

Skin reactions with symptoms such as skin irritation, erythema, rash, vesicles, peeling and itching at the site of application may occur. Severe skin adverse reactions (SARA) such as, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Contact dermatitis, eczema, and skin photosensitization have been identified in long-term experience with piroxicam.

Renal and urinary tract disorders:

In isolated cases of tubulointerstitial nephritis, renal failure and nephrotic syndrome have been observed (see section “Special Indications”).

When applying piroxicam to large areas of the skin, systemic effects are possible. The following side effects have been reported:

Disorders of the respiratory system, thorax and mediastinum:

Bronchospasm and dyspnea.

Gastrointestinal disorders:

Nausea, dyspepsia, abdominal pain and gastritis.

Overdose

The low systemic absorption of pyroxicam when used topically makes overdose unlikely.

Symptoms

Only when the gel is accidentally swallowed or when using the drug in doses higher than recommended may symptoms of overdose develop: Burning in the mouth, salivation, nausea, vomiting and the appearance of systemic side effects (headache, nausea, epigastric pain, shortness of breath), interstitial nephritis, renal failure and nephrotic syndrome.

Treatment

Mouth and gastric lavage are necessary; symptomatic treatment is indicated if necessary. Hemodialysis is ineffective.

Pregnancy use

Pregnancy

The drug is contraindicated for use in pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy. Epidemiologic studies indicate an increased risk of spontaneous miscarriage after the use of prostaglandin synthesis inhibitors in early pregnancy.

In animals, administration of prostaglandin synthesis inhibitors resulted in increased pre- and postimplantation fetal loss.

Breastfeeding period

The drug is contraindicated for use during breastfeeding because clinical safety has not been established.

Fertility

Based on the mechanism of action, use of NSAIDs, including piroxicam, may delay or prevent ovarian ovulation, which may lead to decreased fertility. Women who are planning a pregnancy or undergoing treatment for infertility are not recommended to use the drug.

Similarities