Nimulide, gel 1% 30 g

Nimulide is a non-narcotic anti-inflammatory drug (NSAID) of sulfonanilide class, a selective COX-2 inhibitor. It has anti-inflammatory, analgesic, antipyretic effects.

Nimesulide belongs to NSAIDs, the mechanism of action of which is connected with selective inhibition of COX-2 and influence on several other factors – inhibition of platelet-activating factor, tumor necrosis factor-alpha, inhibition of proteinases and histamine.

With selective inhibition of COX-2 it decreases biosynthesis of PG in inflammation focus, has less pronounced inhibitory effect on COX-1 (causes side effects connected with inhibition of PG synthesis in healthy tissues less frequently).

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Indications

Local symptomatic treatment of diseases of the musculoskeletal system (articular syndrome, including exacerbation:
– gout,
– rheumatic diseases,
– psoriasis,
– 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.
ATX code: [M01AX17]

Pharmacological action
The active component of the drug Nimulid is nimesulide, a non-steroidal anti-inflammatory drug (NSAID), which has the properties of a selective inhibitor of cyclooxygenase type II. Nimesulide reduces the concentration of short-lived prostaglandin H2, which is a substrate for kinin-stimulated synthesis of prostaglandin E2 at the site of inflammation. 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 joint pain at rest and during movement, and 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

Nimulid should not be applied to mucous membranes, including the conjunctiva, as well as to areas of the skin affected by dermatoses or infections. Not recommended for use on open wounds or damaged skin. Nimulid should not be rubbed vigorously into the skin. The areas of skin treated with it should not be covered with occlusive dressings. Close the tube tightly after use.

Impact on the ability to drive vehicles and machinery
The drug does not affect the ability to drive vehicles and mechanisms that require increased concentration and speed of psychomotor reactions.

Active ingredient

Nimesulide

Composition

Each gram of gel contains:

Active ingredient:
Nimesulide 10.00 mg

Excipients:
Hyprolose 16.67 mg, carbomer-940 5.00 mg, ethanol* (95%) 667.00 mg, purified water 75.35 mg, triacetin 70.00 mg, dimethylacetamide 150.00 mg, phosphoric acid 4.37 mg, flavor MSC-03 0.805 mg, flavor – 0106-G 0.805 mg.

*- Equivalent to absolute alcohol 634.00 mg

Pregnancy

The safety and effectiveness of nimesulide in gel form have not been studied during pregnancy and breastfeeding. There is no data on the effect on fetal development. The use of nimesulide during pregnancy and breastfeeding is contraindicated.

Contraindications

Hypersensitivity to nimesulide and other components of the drug; erosive and ulcerative lesions of the gastrointestinal tract in the acute stage, bleeding from the gastrointestinal tract, dermatosis, 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 breastfeeding, children under 12 years of age.

With caution
Liver failure; renal failure; severe heart failure; arterial hypertension; diabetes mellitus type 2; coagulation disorders, elderly and children.

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 Nimulid gel simultaneously with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and hypoglycemic 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 amounts of gel (exceeding 50 g) are applied to large areas of skin, an overdose cannot be ruled out.
There is no specific antidote. You need to see a doctor.

Storage conditions

At a temperature not exceeding 25 ° C, away from open fire and protected from direct sunlight, with the lid tightly screwed on. Do not store in the refrigerator.
Keep out of the reach of children.

Shelf life

3 years.
Do not use the drug after the expiration date indicated on the package.

Manufacturer

Panacea Biotech, India