Nimesulide - instructions for use, dose, side effects, contraindications

Excipients: methylpyrrolidone 25.00 g, isopropanol 10.00 g, propylene glycol 10.00 g, carbomer 1.20 g, macrogol 400 31.55 g, lavender oil 0.25 g, trometamol 0.09 g, water - up to 100.00 g.

* Note. If necessary, in order to achieve an optimal gel pH, a change in the content of trometamol in the range of 0.02 g to 0.15 g per 100 g is allowed.

Description:FROMa yellow-yellow or yellow transparent gel with a specific odor.

Pharmacotherapeutic group:NSAIDs

ATX: & nbsp

M.01.A.X Other non-steroidal anti-inflammatory drugs

M.01.A.X.17 Nimesulide

Pharmacodynamics:

Nimesulide Gel is a non-steroidal anti-inflammatory drug (NSAID). It has a local anesthetic and anti-inflammatory effect.

Nimesulide is a selective competitive reversible inhibitor of cyclooxygenase type II (endoperoxide-prostaglandin-H₂ synthetase). Reduces the concentration of short-lived prostaglandin H₂, a substrate for kinin-stimulated prostaglandin E synthesis₂ in the hearth of inflammation. Decrease in the concentration of prostaglandin E₂ (a mediator of inflammation and pain) reduces the activation of prostanoid EP receptors, which is manifested by analgesic and anti-inflammatory effects.

When topical application causes the weakening or disappearance of pain in the place of application of the gel, including joint pain at rest and during movement, reduces morning stiffness and swelling of the joints. Promotes an increase in the volume of movements.

Pharmacokinetics:

When applying the gel, the concentration of the active substance in the systemic blood flow is extremely low. The maximum concentration after a single application is noted towards the end of the first day, its value is more than 300 times lower than that for oral dosage forms of nimesulide. Traces of the main metabolite of nimesulide - 4-hydroxynimidesulide in the blood are not detected.

Indications:

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, inflammatory lesions of ligaments, tendons, bursitis, sciatica, lumbago).

Muscular pain of rheumatic and non-rheumatic origin.

Post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and ruptures of ligaments, bruises).

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

Hypersensitivity to nimesulide and drug components.

Complete or incomplete combination of bronchial asthma, angioedema or urticaria, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including in the anamnesis).

Erosive-ulcerative lesions of the gastrointestinal tract in the stage of exacerbation, bleeding from the gastrointestinal tract.

Dermatoses, epidermal damage and skin infections in the field of application.

Pronounced renal (creatinine clearance less than 30 mL / min) or liver failure.

Pregnancy and the period of breastfeeding, children under 12 years.

Carefully:

Liver failure; renal failure (creatinine clearance 30-60 ml / min); erosive and ulcerative lesions of the gastrointestinal tract in the anamnesis (including peptic ulcer and duodenal ulcer); disorders of blood clotting (including hemophilia, prolonged bleeding time, a tendency to bleed), bleeding from the gastrointestinal tract in an anamnesis; severe heart failure, arterial hypertension; type 2 diabetes mellitus; elderly and children's age.

Pregnancy and lactation:

The drug is contraindicated in pregnancy and during breastfeeding.

Dosing and Administration:

Outwardly. Before applying the gel, wash and dry the surface of the skin.

Adults and children over 12 years of age Apply a uniform gel layer approximately 3 cm to the area of maximum pain, without rubbing, 3-4 times a day.

Do not intensively rub the gel or use under the occlusive dressing.

Do not apply gel for more than 10 days without consulting a doctor.

Side effects:

With external application, the drug is usually well tolerated.

The adverse events presented below are listed according to anatomophysiological classification and frequency of occurrence. The incidence of side effects is determined by WHO and has the following gradation: very often (> 1/10) (> 1/100, <1/10) (> 1/1000, <1/100) (> 1/10000, <1 / 1000) (<1/10000); not installed.

Disturbance of the skin and subcutaneous tissues: infrequently - itching; rarely - urticaria, peeling, transient skin discoloration (not requiring withdrawal of the drug).

If any adverse reactions occur, discontinue use and consult a physician.

When applying the gel to large areas of the skin or with prolonged use, development of systemic adverse reactions is possible: heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal mucosa, increased activity of "liver" transaminases; headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolongation of bleeding time.

Overdose:

Cases of drug overdose are not described.However, when large amounts of gel (exceeding 50 g) are applied to large areas of the skin, an overdose can not be ruled out. There is no specific antidote. It is necessary to consult a doctor.

Interaction:

Pharmacokinetic interaction with drugs competing for binding to blood plasma proteins is not ruled out.

Caution should be exercised when using nimesulide with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, hypotensive and anti-diabetic agents.

Before using the gel, you should consult your doctor if you are using these drugs or are under medical supervision.

Special instructions:

Do not apply gel on the mucous membranes of the eye, damaged and infected skin areas affected by skin diseases of the area and open wounds.

When applying the product, an intense burning sensation can occur, which disappears for several days. During the application of the drug and before cleaning hands should not touch sensitive areas of the skin.If you accidentally hit the gel on mucous membranes or sensitive areas of the skin, you should rinse these areas with plenty of water.

The gel should be used with caution in patients with an increased risk of developing adverse reactions caused by salicylates.

Do not use the drug for an occlusive dressing.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive and other mechanical means.

Form release / dosage:

Gel for external use, 1%.

Packaging:

10 grams, 20 grams, 30 grams of aluminum tubes.

Each tube, 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:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003840

Date of registration:14.09.2016

Expiration Date:14.09.2021

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

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp21.06.2018

Illustrated instructions

Instructions

Nimesulide (Nimesulide)