Naize - instructions for use, doses, side effects, contraindications

microcrystalline cellulose 38 mg, calcium dihydrogen phosphate 35 mg, starch corn 25.5 mg, carboxymethyl starch sodium 28.5 mg, magnesium stearate 1.5 mg, talc 0.5 mg, silicon dioxide colloid 3.5 mg, aspartame 7.5 mg, pineapple flavor 5 mg.

Description:

Light yellow with bevelled edges of a tablet in the shape of a letter "D", on one side - embossing "NK", the other side is smooth.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug

ATX: & nbsp

M.01.A.X Other non-steroidal anti-inflammatory drugs

M.01.A.X.17 Nimesulide

Pharmacodynamics:

Non-steroidal anti-inflammatory drug (NSAID) from the class of sulfonanilides. It is a selective competitive inhibitor of cyclooxygenase-2 (COX-2), inhibits the synthesis of prostaglandins in the inflammatory focus. The inhibitory effect on COX-1 is less pronounced (it rarely causes side effects associated with the inhibition of prostaglandin synthesis in healthy tissues). Has anti-inflammatory, analgesic and pronounced antipyretic effect.

Nimesulide is able to inhibit the synthesis of interleukin-6 and urokinase, preventing the destruction of cartilaginous tissue. Inhibits the synthesis of metalloproteases (elastase, collagenase), preventing the destruction of proteoglycans and cartilaginous collagen.

It has antioxidant properties, inhibits the formation of toxic products of oxygen decay due to a decrease in the activity of myeloperoxidase. Interacts with glucocorticoid receptors, activating them by phosphorylation, which also enhances the anti-inflammatory effect of the drug.

Pharmacokinetics:

Absorption when ingested - high (eating intake reduces the rate of absorption, without affecting its degree). T_Cmah 1.5-2.5 hours.Communication with plasma proteins 95%, with erythrocytes - 2%, with lipoproteins - 1%, with acid alpha 1-glycoproteids - 1%. The dose change does not affect the degree of binding. FROM_max - 3,5-6,5 mg / l. The volume of distribution is 0.19-0.35 l / kg. Penetrates into the tissue of the female genital organs, where after a single intake its concentration is about 40% of the concentration in the plasma. It penetrates into the acidic environment of the inflammatory focus (40%), synovial fluid (43%). Easily penetrates through the histohematological barriers.

Metabolized in the liver by tissue monooxygenases. The main metabolite is 4-hydroxynimidesulide (25%), has a similar pharmacological activity, but due to the decrease in the size of the molecules it is able to diffuse quickly through the hydrophobic channel of COX-2 to the active binding site of the methyl group. 4-hydroxynimidesulide is a water-soluble compound, for the elimination of which is not required glutathione and the conjugation reaction of the second phase of metabolism (sulfation, glucuronidation and others).

T_1/2 nimesulide - 1.56-4.95 h, 4-hydroxynimidesulide - 2.89-4.78 h. 4-hydroxynimidesulide is excreted by the kidneys (65%) and bile (35%), subjected to enterohepatic recirculation.

In patients with renal insufficiency (creatinine clearance 1.8-4.8 l / h or 30-80 ml / min), as well as in children and the elderly, the pharmacokinetic profile of nimesulide does not change significantly.

Indications:

- Rheumatoid arthritis;

- articular syndrome with exacerbation of gout;

- psoriatic arthritis;

- ankylosing spondylitis;

- osteochondrosis with radicular syndrome;

- osteoarthritis;

- myalgia of rheumatic and non-rheumatic origin;

- inflammation of ligaments, tendons, bursitis, including post-muscle inflammation of soft tissues;

- pain syndrome of various genesis (including in the postoperative period, with trauma, algodismenorea, toothache, headache, arthralgia, lumboeishalgia);

- febrile syndrome in infectious and inflammatory diseases.

Contraindications:

Hypersensitivity to the drug components, erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation), bleeding from the gastrointestinal tract; a history of bronchospasm, urticaria, or acute rhinitis associated with the use of acetylsalicylic acid, NSAIDs; liver failure; renal failure (creatinine clearance less than 30 ml / min),severe heart failure, severe blood clotting disorders, post-coronary artery bypass grafting, pregnancy, lactation, children under 7 years.

Carefully:Arterial hypertension, heart failure, ischemic heart disease, type 2 diabetes.

Dosing and Administration:

Children over 7 years of age and a body weight of more than 30 kg are prescribed tablets dispersible 50 mg, based on a single dose of 1.5 mg / kg body weight of the child 2-3 times a day, the maximum daily dose of the drug is 5 mg / kg (not more than 200 mg ). Before use, the tablet should be dissolved in 5 ml (1 teaspoon) of water.

Adults - inside 1-2 tablets 2 times a day. Tablets are taken with a sufficient amount of water preferably before meals. In the presence of diseases of the gastrointestinal tract, the drug should be taken at the end of the meal or after eating. The maximum daily dose is 200 mg.

Side effects:

The frequency is classified according to the headings, depending on the occurrence of the event: very often (> 10), often (<10- <100), infrequently (<100- <1000), rarely (<1000- <10000), very rarely (<10000 ).

Gastrointestinal tract: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, stomatitis, tarry stools,gastrointestinal bleeding, ulcer and / or perforation of the stomach or duodenum.

central nervous system: infrequently - dizziness; rarely - a sense of fear, nervousness, nightmarish dreams; very rarely - headache, drowsiness, encephalopathy (Reye syndrome).

Respiratory system: infrequently - shortness of breath; very rarely - bronchial asthma, bronchospasm. The cardiovascular system: infrequently - arterial hypertension; rarely - tachycardia, hemorrhages, "hot flashes".

Sense organs: rarely - blurred vision, very rarely - dizziness.

Skin and mucous membranes: infrequently - itching, rash, increased sweating; rarely: erythema, dermatitis; very rarely: urticaria, angioedema, facial swelling, multiform exudative erythema, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

Liver and biliary system: often - increased "liver" transaminases; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis.

Kidney and urinary system: infrequently - swelling; rarely - dysuria, hematuria, urinary retention, hyperkalemia; very rarely - renal failure, oliguria, interstitial nephritis.

Organs of hematopoiesis: rarely - anemia, eosinophilia; very rarely - thrombocytopenia, pancytopenia, purpura, prolonged bleeding time.

Allergic reactions: rarely - hypersensitivity reactions; very rarely anaphylactoid reactions.

General Reagents: rarely - general weakness; very rarely - hypothermia.

In case of occurrence of other, not mentioned above, side effects or worsening of your state of health, please contact your doctor immediately.

Overdose:

Symptoms: apathy, drowsiness, nausea, vomiting. They are usually reversible in providing supportive care for patients. There may be gastrointestinal bleeding, arterial hypertension, acute renal failure, respiratory depression.

Treatment: requires symptomatic treatment of the patient and maintenance of care for him. There is no specific antidote. In case an overdose has occurred within the last 4 hours, it is necessary to induce vomiting, to receive activated charcoal (60-100 g per adult), osmotic laxatives. Forced diuresis, hemodialysis are ineffective because of the high connection of the drug with proteins.

Interaction:

The effect of medications that reduce blood coagulability, increases with their simultaneous use with nimesulide.

Nimesulide may reduce the action of furosemide. Nimesulide can increase the possibility of side effects with the simultaneous administration of methotrexate. The level of lithium in the plasma increases with simultaneous reception of lithium and nimesulide preparations. Because of the high degree of binding of nimesulide to plasma proteins, patients who are treated with hydantoin and sulfonamides at the same time should be under the supervision of a physician, passing the examination at short intervals.

Nimesulide can enhance the action of cyclosporin on the kidneys.

Special instructions:

Nyzes should be used with caution in patients who have a tendency to bleeding, patients with upper gastrointestinal tract diseases or patients receiving medications that reduce blood clotting, or drugs that inhibit platelet aggregation. Since Nyz® is partially is excreted by the kidneys, dosage for patients with impaired renal function should be reduced, depending on the level of urination.

Given reports of visual impairment in patients taking other NSAIDs, treatment should be stopped immediately if any visual impairment occurs and the oculist should examine the patient.

The drug can cause fluid retention in tissues, so patients with high blood pressure and with cardiac abnormalities Nyz® should be used with extreme caution. Patients should undergo regular medical supervision if they take medications along with nimesulide, which are characterized by an effect on the gastrointestinal tract.

Effect on the ability to drive transp. cf. and fur:Patients whose work requires concentration (constant attention) should be aware that the drug may cause drowsiness or dizziness.

Form release / dosage:

Tablets are dispersible 50 mg.

Packaging:For 1, 2 or 10 PVC / Al blisters of 10 tablets together with instructions for use are packed in a cardboard box.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012824 / 01

Date of registration:14.03.2008

Expiration Date:Unlimited

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

Dr. Reddy`c Laboratoris Ltd. India

Information update date: & nbsp28.05.2018

Illustrated instructions

Instructions

Naise® (Nise®)