Universal reference book for medicines
Name of the drug: NICE® (NISE)

Active substance: nimesulide

Type: NSAID for external use

Manufacturer: DR.
REDDY`S LABORATORIES (India)
Composition, form of production and packaging
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Gel for external use 1% light yellow or yellow, transparent, free from foreign particles.
1 g

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, butyl hydroxy anisole 0.2 mg, thiomersal 0.1 mg , potassium dihydrogen phosphate 0.2 mg, flavor (Narciss 938) 4 mg.

20 g - tubes from laminated aluminum (1) - packs cardboard.

50 g - tubes of laminated aluminum (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

A new generation of NSAIDs from the sulfonanilide class.
Has a local anesthetic and anti-inflammatory effect.
Nimesulide is a selective competitive reversible inhibitor of COX-2 (endoperoxide-prostaglandin-H 2 synthetase).
Reduces the concentration of short-lived prostaglandin H 2 , a substrate for kinin-stimulated prostaglandin E 2 synthesis, in the inflammatory focus and in the ascending ways of pain impulses in the spinal cord. The decrease in the concentration of prostaglandin E 2 (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 weakening or disappearance of pain in the place of application of the gel, incl.
pain in the joints 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.
C max after 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:

- articular syndrome with exacerbation of gout;

- rheumatoid arthritis;

- psoriatic arthritis;

ankylosing spondylitis;

- osteoarthrosis;

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).

DOSING MODE

Outwardly.
Before applying the gel, you should wash and dry the surface of the skin. Apply a uniform layer of gel with a length of about 3 cm to the area of ​​maximum soreness, not rubbing, 3-4 times / day.
The amount of gel and frequency of its use (no more than 4 times / day) can vary depending on the size of the treated area and the patient's reaction.

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

SIDE EFFECT

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

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 hepatic transaminases;
headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolongation of bleeding time.
If any side effects occur, the patient should stop using the drug and consult a doctor.

CONTRAINDICATIONS

- hypersensitivity to nimesulide and the components of the drug;

- erosive and ulcerative lesions of the gastrointestinal tract in the phase of exacerbation;

bleeding from the gastrointestinal tract;

- dermatoses, damage to the epidermis and skin infections in the area of ​​application;

- renal failure of severe degree (CK <30 ml / min);

- severe hepatic impairment;

- an indication in an anamnesis of bronchospasm due to the use of acetylsalicylic acid or other NSAIDs;

- Pregnancy;

- the period of lactation (breastfeeding);

- Children under 7 years.

With caution: liver failure;
kidney failure; severe heart failure; arterial hypertension; type 2 diabetes mellitus; old age, children's age.
PREGNANCY AND LACTATION

Contraindicated in pregnancy, during lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in renal failure of severe degree (CK <30 ml / min).

With caution: kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe hepatic insufficiency.

With caution: liver failure.

APPLICATION FOR CHILDREN

Contraindicated in children under 7 years.

With caution should prescribe the drug in childhood older than 7 years.

APPLICATION IN ELDERLY PATIENTS

Caution should be given to elderly patients.

SPECIAL INSTRUCTIONS

It is recommended to apply the drug only to undamaged skin areas, avoiding getting on open wounds.

Avoid contact with eyes and other mucous membranes.

Do not use gel under airtight bandages.

After applying the gel, wash your hands with soap and water.

After using the gel, it is necessary to close the tube tightly.

OVERDOSE

Cases of drug overdose are not described.
However, when applying a large amount of gel (more than 50 grams) to large areas of the skin, it is possible to develop an overdose. There is no specific antidote. It is necessary to consult a doctor.
DRUG INTERACTION

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

It should be used with caution Nize® concomitantly with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, hypotensive and hypoglycemic agents.

If the patient uses these drugs or is under the supervision of a doctor, then before using the gel, consult a doctor.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Do not freeze. Shelf life - 2 years.
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