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

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, inflammatory damage to ligaments, tendons, bursitis, sciatica, lumbago).

Muscle pain of rheumatic and non-rheumatic origin.

Post-traumatic inflammation of soft tissues and the musculoskeletal system (damage and rupture of ligaments, bruises).

Pharmacological effect

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug (NSAID)

ATX code: M01AX17

Pharmacological action

Nise® gel is a new generation non-steroidal anti-inflammatory drug (NSAID) from the sulfonamide class. It has a local analgesic 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 synthesis of prostaglandin E2, at the site of inflammation and in the ascending pathways of pain impulses in the spinal cord. A decrease in the concentration of prostaglandin E2 (a mediator of inflammation and pain) reduces the activation of EP type prostanoid receptors, which is manifested by analgesic and anti-inflammatory effects.

When applied topically, it causes a weakening or disappearance of pain at the site of application of the gel, including pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints. Helps increase range of motion.

Pharmacokinetics

When applying the gel, the concentration of the active substance in the systemic circulation is extremely low. The maximum concentration after a single application is observed at the end of the first day; its value is more than 300 times lower than that for oral dosage forms of nimesulide. No traces of the main metabolite of nimesulide, 4-hydroxynimesulide, are found in the blood.

Special instructions

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

Active ingredient

Nimesulide

Composition

1 g of gel contains:

active substance:

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,

butylated hydroxyanisole 0.2 mg,

thiomersal 0.1 mg,

potassium dihydrogen phosphate 0.2 mg,

flavor (Narcissus-938) 4 mg.

Pregnancy

Contraindicated during pregnancy and lactation.

Contraindications

Hypersensitivity to nimesulide and the components of the drug;
erosive and ulcerative lesions of the gastrointestinal tract in the acute stage, bleeding from the gastrointestinal tract, dermatoses, damage to the epidermis and skin infections in the area of ​​application;
severe renal (creatinine clearance less than 30 ml/min.) or liver failure, a history of bronchospasm associated with the use of acetylsalicylic acid or other NSAIDs, pregnancy and lactation, children under 7 years of age.

With caution

Liver failure; renal failure; severe heart failure; arterial hypertension; diabetes mellitus type 2; elderly and children’s age.

Side Effects

Local reactions: itching, urticaria, peeling, transient change in skin color (not requiring discontinuation of the drug).

If any adverse reactions occur, you should stop using the drug and consult your doctor.

When applying the gel to large areas of the skin or with prolonged use, the 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.

Interaction

A pharmacokinetic interaction with drugs that compete for binding to plasma proteins is possible.

Caution should be exercised when using Nise® simultaneously with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and antidiabetic agents.

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

Overdose

Cases of drug overdose have not been described. However, when large quantities of gel (exceeding 50 g) are applied to large areas of the skin, the development of an overdose cannot be ruled out. There is no specific antidote. You need to see a doctor.

Storage conditions

At a temperature not higher than 25 ºС.

Shelf life

2 years.

Manufacturer

Dr. Reddy’s Laboratories Ltd, India