Finalgel (piroxicam) gel 50 g.

Description

Finalgel Composition
active substance: piroxicam;

1 g of gel contains 5 mg of piroxicam;

excipients: propylene glycol, isopropyl alcohol, polyethylene glycol glyceryl cocoates, hypromellose, sodium hydroxide, sodium metabisulfite (E 223), potassium dihydrogen phosphate, purified water.

Finalgel Dosage form
Gel.

Basic physical and chemical properties: transparent gel of light yellow color with a slight smell of isopropyl alcohol.

Finalgel Pharmacotherapeutic group
Drugs used topically for joint and muscle pain. Topical non-steroidal anti-inflammatory drugs. ATX code М02А А07.

Pharmacodynamics
Piroxicam is a non-steroidal anti-inflammatory drug that is effective against an inflammatory mediator and has the ability to inhibit the synthesis of prostaglandins. In humans, piroxicam reduces pain and swelling caused by inflammation. Piroxicam also inhibits ADP-induced platelet aggregation.

Pharmacokinetics
The balance of the active substance between the skin, muscles and synovial fluid is established within a few hours after application.

The bioavailability of piroxicam after topical application is approximately 5-10% compared to bioavailability after oral or rectal administration.

A high concentration is achieved at the site of application.

The study of piroxicam gel with other dosage forms shows that the half-life after external use is about 79 hours. The half-life after oral administration of piroxicam is approximately 50 hours (period 30-60 hours).

Indications
For local supportive treatment of pain and inflammatory syndrome in diseases of the musculoskeletal system: tendinitis and tendovaginitis; humeroscapular periarthritis; bruises, sprains, dislocations of the joints.

Contraindications
Hypersensitivity to piroxicam or to an excipient;
previous hypersensitivity reactions (eg, asthma attacks, skin reactions, or coryza) to acetylsalicylic acid or other NSAIDs;
III trimester of pregnancy and lactation (see section “Use during pregnancy or lactation”);
renal failure
age up to 14 years.
Interaction with other medicinal products and other types of interactions
No interactions with other drugs were reported when Finalgel was used according to indications.

Application features
Patients with asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease or chronic lung infections are more sensitive to NSAIDs and respond more often with asthma attacks, local mucocutaneous edema and urticaria.

Serious skin adverse reactions have been reported with systemic use of piroxicam. These reactions occurred during the first month of piroxicam treatment. The development of such reactions is not associated with topical application of piroxicam, but their occurrence cannot be ruled out. Patients should be advised that in the event of any symptoms of severe adverse skin reactions (for example, a progressive skin rash, often with blisters, or mucosal damage) after topical application of piroxicam, they should stop treatment and seek immediate medical attention. The risk of severe skin adverse reactions is greatest during the first weeks of treatment. It is important to diagnose such reactions as soon as possible and to stop using any drugs that can cause severe skin damage. If a patient develops severe skin side reactions while taking piroxicam, in no case should piroxicam be restarted.

In case of development of local irritation, the use of Finalgel should be discontinued and, if necessary, appropriate therapy should be prescribed.