Nayz ® gel

General characteristics. Structure:

Active agent: Nimesulide of 10 mg;
excipients: N-methyl-2-пирролидон 250 mg, propylene glycol of 100 mg, a macrogoal of 315,5 mg, isopropanol of 100 mg, the water purified 200 mg, carbomer-940 of 20 mg, butylhydroxyanisole of 0,2 mg tiomersat 0,1 mg, potassium dihydrophosphate of 0,2 mg, fragrance (Narcissus-938) of 4 mg.

Description: transparent gel of light yellow or yellow color, free from foreign particles.

Pharmacological properties:

Найз® gel is non-steroidal anti-inflammatory drug (NPVP) of new generation from a class of sulfonamides. Has local anesthetic and antiinflammatory effect.
Nimesulide - the selection competitive reversible inhibitor of cyclooxygenase II of type (endoperoksid-prostaglandin-H2 sintetaza). Reduces concentration of short-lived H2 prostaglandin, substrate for kinin-stimulated synthesis of E2 prostaglandin, in the center of an inflammation and in the ascending ways of carrying out painful impulses in a spinal cord. Decrease in concentration of E2 prostaglandin (a mediator of an inflammation and pain) reduces activation of prostanoid receptors of ER of type that is shown analgetic and antiinflammatory by effects.
At topical administration causes easing or disappearance of pains in a gel site of application, including joint pains at rest and at the movement, reduces morning constraint and a swelling of joints. Promotes increase in volume of movements.

Pharmacokinetics. When putting gel concentration of active agent in a system blood-groove is extremely low. The maximum concentration after single drawing is noted by the end of the first days, its size more, than 300 times lower that for peroral dosage forms of Nimesulide. Traces of the main metabolite of Nimesulide 4 of hydroxynimesulide in blood are not found.

Indications to use:

Topical symptomatic treatment of inflammatory and degenerative diseases of a musculoskeletal system (a joint syndrome at an exacerbation of gout, a pseudorheumatism, the psoriasis arthritis ankylosing a spondylarthritis, an osteoarthrosis, osteochondrosis with a radicular syndrome, radiculitis, an inflammatory latent injury, sinews, a bursitis, a sciatica, a lumbago).
Muscular pains of a rheumatic and not rheumatic origin. Posttraumatic inflammation of soft tissues and musculoskeletal system (damages and ruptures of sheaves, bruises).

Route of administration and doses:

Outwardly. Before putting gel to wash up and dry up the surface of skin. To apply with a uniform thin layer a column of gel about 3 cm long on area of the maximum morbidity, without rubbing, 3-4 times a day.
The amount of gel and frequency of its use (no more than 4 times a day) can vary depending on the size of the processed site and reaction of the patient. Not to apply gel more than 10 days without consultation of the doctor.

Features of use:

Drug is recommended to be applied only on the unimpaired sites of skin, avoiding hit on open wounds. It is necessary to avoid hit of gel in eyes and other mucous membranes. Not to use gel under air-tight bandages. After putting gel to wash up hands with soap. To densely close a tuba after gel use.

Side effects:

Local reactions: an itch, urticaria, the peeling, tranzitorny discoloration of skin (which is not demanding drug withdrawal).
At emergence of any side reactions it is necessary to stop use of drug and to consult with the doctor.
When putting gel on extensive sites of skin or at long use development of system side reactions is not excluded: heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration mucous digestive tract, increase in activity of "hepatic" transaminases; headache, dizziness; liquid delay, hamaturia; allergic reactions (acute anaphylaxis, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, lengthening of a bleeding time.

Interaction with other medicines:

Pharmacokinetic interaction with the drugs competing for communication with proteins of a blood plasma is not excluded.
It is necessary to be careful at simultaneous use of Nayz® with digoxin, Phenytoinum, lithium drugs, diuretics, cyclosporine, a methotrexate, other NPVP, hypotensive and antidiabetic means.
Before use of gel it is necessary to consult with the doctor if you apply the specified means or you are under observation of the doctor.

Contraindications:

Hypersensitivity to Nimesulide and components of drug; digestive tract erosive cankers in a stage of an aggravation, bleeding from digestive tract, a dermatosis, injuries of epidermis and an infection of integuments to a scope; expressed renal (clearance of creatinine less than 30 ml/min.) or a liver failure, the instruction in the anamnesis on the bronchospasm phenomena connected using acetylsalicylic acid or other NPVP, pregnancy and the period of a lactation, children's age up to 7 years.

With care
Liver failure; renal failure; the expressed heart failure; arterial hypertension; diabetes mellitus 2 types; advanced and children's age.

Overdose:

Cases of overdose of drug are not described. However when drawing the large amounts of gel (exceeding 50 g) on extensive sites of skin overdose development is not excluded. The specific antidote does not exist. It is necessary to see a doctor.

Storage conditions:

Period of validity 2 years. Not to use drug after the expiry date specified on packaging. List B. In the dry, protected from light place at a temperature not above 25 °C. Not to freeze. To store in the place, unavailable to children!

Issue conditions:

Without recipe

Packaging:

Gel for external use of 1%. On 20 g or 50 g in the tuba from the laminated aluminum supplied with a membrane for control of the first opening. The tuba is packed into a cardboard pack with the application instruction.