Naise, gel 1% 50 g

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

ATX code: M01AX17

Pharmacological action

Nais® Gel is a new generation non-steroidal anti-inflammatory drug (NSAID) of sulfonamide class. It has local analgesic and anti-inflammatory effect.

Nimesulide is a selective competitive reversible inhibitor of cyclooxygenase type II (endoperoxide-prostaglandin-H2 synthetase). It reduces the concentration of short-lived prostaglandin H2, a substrate for kinin-stimulated synthesis of prostaglandin E2, in the focus of inflammation and in the ascending pathways of pain impulses in the spinal cord. Reducing the concentration of prostaglandin E2 (mediator of inflammation and pain) reduces the activation of prostanoid receptors EP type, which is manifested by analgesic and anti-inflammatory effects.

When applied topically, it causes alleviation or disappearance of pain at the site of application of the gel, including joint pain at rest and on movement, reduces morning stiffness and joint swelling. Helps increase range of motion.

Pharmacokinetics

On application of the gel, the concentration of the active substance in the systemic bloodstream is extremely low. Maximum concentration after a single application is observed by the end of the first day, its value is more than 300 times lower than that of oral dosage forms of nimesulide. Traces of the main metabolite of nimesulide – 4-hydroxynimesulide are not detected in the blood.

Indications

Arthrosis, Sprains and strains, Myositis, Gout, Neck pain, Tendon inflammation, Osteochondrosis, Radiculitis, Arthritis, Sciatica, Back pain, Pain, Myalgia (muscle pain), Rheumatoid arthritis, Lumbago, Pain after injuries and operations, Bursitis, Bruises, Pain in the joints (arthralgia) Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (joint syndrome in gout exacerbation, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, inflammatory ligament, tendon, bursitis, sciatica, lumbago).

Muscle pain of rheumatic and non-rheumatic origin.

Post-traumatic inflammation of soft tissues and musculoskeletal system (ligament injuries and tears, contusions).

Active ingredient

Nimesulide

Composition

1 g of the gel contains:

the active ingredient:

nimesulide 10 mg;

excipients:

N-methyl-2-pyrrolidone 250 mg,

propylene glycol 100 mg,

macrogol 315.5 mg,

Isopropanol 100 mg,

purified water 200 mg,

carbomer-940 20 mg,

butylhydroxyanisole 0.2 mg,

thiomersal 0.1 mg,

/p>

potassium dihydrophosphate 0.2 mg,

flavoring (Narcissus-938) 4 mg.

How to take, the dosage

Externally. Wash and dry the skin surface before applying the gel. Apply a column of gel about 3 cm long in an even, thin layer on the area of maximum soreness, without rubbing, 3-4 times a day.

The amount of gel and the frequency of application (no more than 4 times a day) can vary depending on the size of the area to be treated and the patient’s reaction.

Do not use the gel for more than 10 days without medical advice.

Interaction

Pharmacokinetic interaction with drugs competing for binding to plasma proteins is not excluded.

Caution should be exercised when using Naiz® concomitantly with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, hypotensive and antidiabetic drugs.

You should consult your physician before using the gel if you are using the above medications or are under a physician’s care.

Special Instructions

It is recommended to apply the drug only to intact skin areas, avoiding contact with open wounds. Avoid getting the gel into the eyes and other mucous membranes. Do not use the gel under airtight bandages. After applying the gel wash your hands with soap and water. Close the tube tightly after using the gel.

Contraindications

• High sensitivity to nimesulide and drug components;
• .gastrointestinal erosive-ulcerative lesions in the acute stage, bleeding from the gastrointestinal tract, dermatoses, epidermal damages and skin infections in the application area;
• expressed renal (creatinine clearance less than 30 ml/min.
• Hepatic impairment, history of bronchospasm associated with use of acetylsalicylic acid or other NSAIDs, pregnancy and lactation, children under 7 years of age.

With caution

Hepatic failure; renal failure; marked heart failure; arterial hypertension; type 2 diabetes mellitus; advanced age and childhood.

Side effects

Local reactions: itching, urticaria, peeling, transient discoloration of the skin (not requiring withdrawal of the drug).

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

If the gel is applied to large areas of skin or if it is used for a long time, systemic adverse reactions may occur: heartburn, nausea, vomiting, diarrhea, gastralgia, gastrointestinal mucosa ulceration, increased activity of “liver” transaminases; headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolonged bleeding time.

Overdose

Cases of overdose of the drug have not been described. However, when applying large amounts of gel (more than 50 g) on large areas of skin, overdose can not be excluded. There is no specific antidote. It is necessary to consult a doctor.

Pregnancy use

It is contraindicated in pregnancy and lactation.

.

Similarities

Naiz, Nimesil, Nimesulide, Nemulex, Nimesulide-TEVA, Nimulide, Nimesan tablets 100 mg 20 pcs, Naisulide, Mialais