Nice instructions for use. Nise instructions for use in ampoules

Do you know what Nise (tablets) helps with? If you do not have such information, we will present it in the materials of this article.

Packaging of the drug and its composition

We will talk about what Nise (tablets) can help with below. The active ingredient of this medicine is nimesulide. It also includes components such as microcrystalline cellulose, aspartame, calcium phosphate, colloidal silicon dioxide, corn starch, magnesium stearate, sodium carboxymethyl starch, pineapple flavor and talc.

The medication in question goes on sale in blisters of 10 tablets, packed in cardboard packs.

The principle of action of the drug

Before answering the question of what Nise (tablets) helps with, you should tell us how this drug works.

According to the instructions, this is an NSAID that selectively inhibits COX-2, that is, an enzyme involved in the synthesis of prostaglandins - mediators of pain, inflammation and swelling. In addition to anti-inflammatory properties, the drug in question exhibits antipyretic and analgesic effects.

It should also be said that this medication inhibits (reversibly) the formation of prostaglandin E2 in the ascending pathways of the nociceptive system and the source of inflammation, as well as in the pathways of impulses (pain) in the spinal cord.

The drug "Nise", analogs of which are listed below, reduces the concentration of prostaglandin H2 (short-lived), from which, under the influence of prostaglandin isomerase, prostaglandin E2 arises. A decrease in the concentration of the latter leads to a decrease in the degree of activation of EP-type receptors (prostanoid), which is expressed in anti-inflammatory and analgesic effects.

It should also be noted that the drug in question affects COX-1 to a small extent. Under physiological conditions, it almost does not prevent the formation of prostaglandin E2 from arachidonic acid. Due to this, the number of side effects of the drug is reduced.

Basic properties of the drug (NSAIDs)

The drug "Nise" is capable of suppressing this by inhibiting the synthesis of thromboxane A2 and endoperoxides. In addition, it suppresses the release of histamine and also reduces the degree of bronchospasm that was caused by exposure to acetaldehyde and histamine.

Experts have proven that nimesulide effectively suppresses the synthesis of urokinase and interleukin-6, preventing the destruction of cartilage tissue. In addition, it inhibits the synthesis of metalloproteases, preventing the destruction of collagen and proteoglycans.

According to the instructions, by reducing the activity of myeloperoxidase, the drug in question exhibits antioxidant properties and slows down the formation of (toxic) O2 breakdown products. It interacts with glucocorticoid receptors and activates them, which enhances the anti-inflammatory effect.

Drug kinetics

After oral administration, the painkiller "Nise" is absorbed from the intestines. Eating reduces the rate of absorption of the drug, but does not affect its extent.

The peak concentration of nimesulide in the blood is reached after 2.6 hours. Its binding to proteins reaches 95%.

This drug penetrates into all tissues of the woman’s genital organs. In addition, it is found in the acidic environment of the inflammation site and synovial fluid.

Metabolism of nimesulide occurs in the liver. Its half-life is 5 hours. It is excreted mainly by the kidneys, as well as with bile.

Indications for taking tablets

What does Nise (tablets) help with? The drug in question is prescribed for:

radiculitis, rheumatoid arthritis, sciatica;
lumbago, osteoarthritis, articular syndrome in rheumatic disease and exacerbation of gout;
arthralgia, ankylosing spondylitis;
arthritis of various origins, osteochondrosis with radicular syndrome;
inflammation of the ligaments, myalgia of non-rheumatic and rheumatic origin, bursitis, inflammation of the tendons;
pain syndrome of various origins (including injuries, in the postoperative period, toothache, algodismenorrhea, headache);
inflammation of the musculoskeletal system, as well as soft tissues.

It should also be noted that “Nise” helps well with temperature. This drug is used for fever of various origins, including inflammatory and infectious diseases.

Contraindications for NSAIDs

The drug "Nise" should not be prescribed during pregnancy. It should also not be used for:

“aspirin triad”;
erosive and ulcerative lesions of the gastrointestinal tract (with exacerbation);
breastfeeding;
bleeding from the gastrointestinal tract;
impaired liver function;
in children under two years of age;
severe renal failure;
hypersensitivity.

This drug is prescribed with extreme caution for type 2 diabetes mellitus, arterial hypertension and heart failure.

How to take Nise?

The medication in question in tablet form is prescribed only orally. Adult patients are recommended to take 100 mg twice a day. The maximum dosage of the drug per day is 400 mg.

As for dispersible tablets, before taking such a medicine, it should first be dissolved in 5 ml of plain water (in 1 dessert spoon). This remedy should be taken at the end of a meal or after a meal.

The drug in tablet form is not prescribed to children. For them, there is another form of medication - a suspension. It is recommended to take it from the age of two years.

Side effects

The drug "Nise", the dosage of which was presented above, can cause such undesirable reactions as:

Cases of overdose

What symptoms occur when taking a large number of Nise tablets? The dosage of this medication must be determined by your doctor. If the drug is accidentally ingested (in large quantities), the patient may develop the following symptoms: convulsions, increased blood pressure, irritation of the gastrointestinal mucosa, impaired renal function, liver failure and respiratory depression.

To eliminate such conditions, the patient's stomach is washed, activated charcoal is prescribed and symptomatic therapy is carried out.

Drug interactions

With simultaneous oral administration of the drug "Nise" with diuretics, "Digoxin", "Phenytoin", antihypertensive drugs and lithium drugs, as well as with other NSAIDs, cyclosporine, anticoagulants, methotrexate, hypoglycemic medications (orally), the patient may experience drug interactions (from - due to competition of these agents for binding to proteins).

The drug "Nise": analogues and reviews

You can replace the drug in question with such medications as “Nimulid”, “Aponil”, “Arcoxia”, “Mesulide”, “Meloxicam”, “Nimesil”, “Movalis”, “Nimesulide”, “Denebol”, “Nimica”.

Most consumer reviews about the drug in question are positive. According to them, Nise quickly relieves pain, and the drug is also used as highly effective. Although some patients claim that this medication has one significant drawback. It very often causes side effects such as dizziness, weakness and problems with the digestive system. In this case, doctors recommend replacing the drug with a similar remedy.

Registration number:

P No. 12824/03 - 040411

Trade name of the drug: Nise ®

International nonproprietary name of the drug: nimesulide.

Dosage form:

pills

Compound

Each tablet contains:
Active substance: nimesulide 100 mg.
Excipients: calcium hydrogen phosphate 75 mg, cellulose
microcrystalline (type 114) 40 mg, corn starch 54 mg, sodium carboxymethyl starch 35 mg, magnesium stearate 3 mg, colloidal silicon dioxide 2 mg, talc 1 mg.

Description

White with a yellowish tint, round biconvex tablets with a smooth surface.

Pharmacotherapeutic group:

non-steroidal anti-inflammatory drug (NSAID).

CodeATX:M01AX17.

Pharmacological properties

Pharmacodynamics

Non-steroidal anti-inflammatory drug (NSAID) from the sulfonanilide class. It is a selective competitive inhibitor of cyclooxygenase-2 (COX-2), inhibits the synthesis of prostaglandins at the site of inflammation. The inhibitory effect on COX-1 is less pronounced (less likely to cause side effects associated with inhibition of prostaglandin synthesis in healthy tissues). It has anti-inflammatory, analgesic and pronounced antipyretic effects.

Pharmacokinetics

Absorption when taken orally is high (food intake reduces the rate of absorption without affecting its degree). Time to reach maximum concentration (T max) - 1.5-2.5 hours. Communication with plasma proteins - 95%, with erythrocytes - 2%, with lipoproteins - 1%, with acidic alpha glycoproteins - 1%. Changing the dose does not affect the degree of binding. The maximum concentration value (Cmax) is 3.5-6.5 mg/l. Volume of distribution - 0.19-0.35 l/kg. Penetrates into the tissues of the female genital organs, where after a single dose its concentration is about 40% of the concentration in plasma. Penetrates well into the acidic environment of the inflammation site (40%) and synovial fluid (43%). Easily penetrates histohematic barriers.

Metabolized in the liver by tissue monooxygenases. The main metabolite, 4-hydroxynimesulide (25%), has similar pharmacological activity, but due to a decrease in molecular size, it is able to quickly diffuse through the hydrophobic COX-2 channel to the active binding site of the methyl group. 4-hydroxynimesulide is a water-soluble compound, the elimination of which does not require glutathione and phase II metabolic conjugation reactions (sulfation, glucuronidation, etc.).

The half-life (T1/2) of nimesulide is 1.56-4.95 hours, 4-hydroxynimesulide is 2.89-4.78 hours. 4-hydroxynimesulide is excreted by the kidneys (65%) and bile (35%), is subject to enterohepatic recycling.

In patients with renal failure (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 for use

Rheumatoid arthritis;
- articular syndrome during 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-traumatic inflammation
soft tissues;
- pain syndrome of various origins (including in the postoperative period, with
injuries, algodismenorrhea, toothache, headache, arthralgia, lumbar ischalgia).

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Contraindications

Hypersensitivity to the active substance or auxiliary components; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history); erosive and ulcerative changes in the mucous membrane of the stomach and duodenum (duodenum), active gastrointestinal bleeding, cerebrovascular or other bleeding; inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase; hemophilia and other bleeding disorders; decompensated heart failure; liver failure or any active liver disease; anamnestic data on the development of hepatotoxic reactions when using nimesulide preparations; concomitant use of potentially hepatotoxic substances; alcoholism, drug addiction; severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease, confirmed hyperkalemia; period after coronary artery bypass surgery; pregnancy, lactation period; children under 12 years of age (for this dosage form, see section “Special instructions”).

Carefully

Coronary heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml/min. Anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of infection Helicobacter pylori, old age, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).

Directions for use and doses

The minimum effective dose should be used for the shortest possible short course. The tablets are taken with enough water, preferably after meals. Adults and children over 12 years of age, take 1 tablet orally 2 times a day. If you have diseases of the gastrointestinal tract, it is advisable to take the drug at the end of a meal or after a meal. The maximum daily dose for adults is 200 mg. Patients with chronic renal failure require a reduction in the daily dose to 100 mg.

Side effect

The frequency of side effects is classified depending on the frequency of occurrence of the case: often - (1-10%), sometimes (0.1-1%), rarely (0.01-0.1%), very rarely (less than 0.01% ), including individual messages.

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

From the central nervous system: infrequently - dizziness; rarely - a feeling of fear, nervousness, nightmares; very rarely - headache, drowsiness, encephalopathy (Reis syndrome).

From the skin: uncommon - itching, rash, increased sweating; rarely: erythema, dermatitis; very rare: urticaria, angioedema, facial swelling, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

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

From the 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. From the liver and biliary system: often - increased “liver” transaminases; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis. From the hematopoietic organs: rarely - anemia, eosinophilia; very rarely - thrombocytopenia, pancytopenia, purpura, prolonged bleeding time From the respiratory system: infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm. From the senses: rarely - blurred vision.

From the cardiovascular system: infrequently - arterial hypertension; rarely - tachycardia, hemorrhages, hot flashes. Others: rarely - general weakness; very rarely - hypothermia.

Overdose

Symptoms: apathy, drowsiness, nausea, vomiting. Gastrointestinal bleeding, increased blood pressure, acute renal failure, and respiratory depression may occur.

Treatment: Symptomatic treatment of the patient and supportive care are required. There is no specific antidote. If an overdose occurs within the last 4 hours, it is necessary to induce vomiting, take activated carbon (60-100 g per adult), and osmotic laxatives. Forced diuresis and hemodialysis are ineffective due to the high binding of the drug to proteins.

Interaction with other drugs

The effect of medications that reduce blood clotting is enhanced when used simultaneously with nimesulide.

Nimesulide may reduce the effect of furosemide. Nimesulide may increase the possibility of side effects while taking methotrexate.

Plasma lithium levels increase when lithium and nimesulide are taken simultaneously.

Nimesulide may enhance the effect of cyclosporine on the kidneys.

Use with glucocorticosteroids and serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

special instructions

Since Nise ® is partially excreted by the kidneys, its dose for patients with impaired renal function should be reduced, depending on creatinine clearance. Given reports of visual disturbances in patients taking other NSAIDs, treatment should be stopped immediately if any visual disturbance occurs and the patient should be examined by an ophthalmologist.

The drug can cause fluid retention in tissues, so patients with high blood pressure and cardiac problems should use Nise ® with extreme caution.

Patients should undergo regular medical monitoring if they, along with nimesulide, take medications that are characterized by an effect on the gastrointestinal tract.

If signs of liver damage appear (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased levels of liver transaminases), you should stop taking the drug and consult your doctor. The drug should not be used simultaneously with other NSAIDs.

The drug can change the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases. The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy.

After 2 weeks of using the drug, monitoring of biochemical indicators of liver function is necessary.

This dosage form is contraindicated for children under 12 years of age, but if it is necessary to use nimesulide in children over 7 years of age, 50 mg dispersible tablets and suspension can be used in strict accordance with the instructions for medical use attached to them.

Since the drug can cause drowsiness, dizziness and blurred vision, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form

Tablets 100 mg. 1, 2 or 10 PVC/aluminum blisters of 10 tablets, along with instructions for use, are packed in a cardboard box.

Storage conditions

List B.
In a dry place, protected from light, at a temperature not exceeding 25°C.
Keep out of the reach of children!

Best before date

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

Conditions for dispensing from pharmacies

On prescription.

Manufacturer

Dr. Reddy's Laboratories Ltd., 7-1-27, Ameerpet, Hyderabad - 500016, Andhra Pradesh, India

Address of production place

Dr. Reddy's Laboratories Ltd.

1. Plot No. 42, 45 and 46, Bachupally Village, Qutbullapur Mandal, Ranga Reddy District, Andhra Pradesh, India

2. Village Khol, Nalagarh Road, Baddi Consumer claims should be sent to the following address: Representative office of the company "Dr. Reddy" with Laboratories Ltd.: 115035, Moscow, Ovchinnikovskaya embankment, 20, building 1, Solan district, Himachal Pradesh , India

Nimesulide is an active substance that has anti-inflammatory, analgesic and antipyretic properties. Nimesulide selectively inhibits COX-2 and inhibits the synthesis of prostaglandins at the site of inflammation. Nimesulide inhibits the release of the enzyme myeloperoxidase, and also inhibits the formation of free oxygen radicals, without affecting the processes of phagocytosis and chemotaxis, and inhibits the formation of tumor necrosis factor and other inflammatory mediators.
After oral administration, nimesulide is quickly absorbed into the gastrointestinal tract. The maximum concentration in the blood plasma is determined after 2-3 hours. The binding of nimesulide to plasma proteins reaches 97.5%.
The drug is metabolized in the liver, the main product of metabolism is hydroxynimesulide, a pharmacologically active substance. About 65% of the administered dose of nimesulide is excreted in the urine, the remaining 35% in feces.

Indications for use of the drug Nise

Acute pain; symptomatic treatment of osteoarthritis with pain syndrome; primary dysmenorrhea.

Use of the drug Nise

In order to prevent the occurrence and to reduce the severity of adverse reactions, the drug should be taken for the shortest possible time and in the minimum effective dose. The drug should be prescribed only after a careful assessment of the risk/benefit ratio.
The drug is taken orally after meals and washed down with a sufficient amount of liquid.
For adults and children over 12 years old - 1 tablet (100 mg) 2 times a day - morning and evening.
The suspension is prescribed to adults and children over 12 years of age at a dose of 100 mg (10 ml) 2 times a day after meals. The maximum daily dose is 200 mg.
The maximum duration of treatment is 15 days.
For elderly patients, this dosage regimen does not require correction.

Contraindications to the use of the drug Nise

peptic ulcer of the stomach and duodenum in the acute stage; severe liver dysfunction (liver failure) and a history of hepatotoxic reactions to taking the drug, simultaneous use with potentially hepatotoxic drugs; severe renal dysfunction (creatinine clearance less than 30 ml/min), severe blood clotting disorders; severe heart failure; hypersensitivity to nimesulide or any other component of the drug, as well as a history of hypersensitivity reactions to other NSAIDs; period of pregnancy (III trimester) and breastfeeding; children under 12 years of age; alcoholism, drug addiction; elevated body temperature, flu-like condition, suspicion of acute surgical pathology.

Side effects of the drug Nise

When using the drug, the following side effects may occur, mainly during the 1st week from the start of treatment:
from the skin: most often - rash, itching, increased sweating, erythema, dermatitis; in some cases - angioedema, facial edema, erythema multiforme, urticaria, Stevens-Johnson syndrome and toxic epidermal necrolysis;
from the gastrointestinal tract: nausea, gastritis, abdominal pain, diarrhea, constipation, flatulence; in some cases - stomatitis, melena, peptic ulcer of the stomach or duodenum, perforation of the ulcer or gastrointestinal bleeding;
from the liver: jaundice, cholestasis, increased levels of liver transaminases, sometimes cases of acute hepatitis are possible, even with a fatal outcome;
from the central nervous system: drowsiness, headache, dizziness, encephalopathy (Reye's syndrome);
mental disorders: feeling of anxiety, nervousness, nightmares;
from the kidneys: edema, dysuria, hematuria, urinary retention, isolated cases of oliguria, interstitial nephritis and renal failure;
from the blood system: anemia, eosinophilia, isolated cases of pancytopenia, purpura and thrombocytopenia;
from the immune system: hypersensitivity reactions, anaphylaxis;
from the respiratory system: dyspnea, in some cases - asthma, bronchospasm, especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs;
from the cardiovascular system: tachycardia, hypertension (arterial hypertension), rarely - bleeding, hot flashes, blood pressure fluctuations. Also, while taking the drug, blurred vision, asthenia, hypothermia, and hyperkalemia are possible.

Special instructions for the use of the drug Nise

To reduce the risk of side effects, it is necessary to use the minimum effective dose with the shortest duration of treatment. If the patient's condition does not improve, treatment should be stopped.
If liver enzyme levels increase or signs of liver damage are detected (for example, anorexia, nausea, vomiting, abdominal pain, feeling tired, dark urine), the drug should be discontinued. Such patients are prohibited from further prescribing nimesulide.
During treatment with nimesulide, it is recommended to avoid the simultaneous use of hepatotoxic drugs, analgesics, other NSAIDs, and also to refrain from drinking alcohol.
Gastrointestinal bleeding or ulcer/perforation may develop at any time while using the drug, with or without warning symptoms, with or without a history of gastrointestinal complications. If gastrointestinal bleeding or ulcers occur, the drug should be discontinued.
Nimesulide should be prescribed with caution to patients with a history of gastrointestinal disorders, ulcerative colitis or Crohn's disease.
The drug should be prescribed with caution to patients with renal or heart failure, as its use may lead to deterioration of renal function. If renal function decreases, the drug must be discontinued.
Elderly patients most often develop side effects due to taking the drug, including gastrointestinal bleeding, perforation, dysfunction of the heart, kidneys and liver. Therefore, regular clinical monitoring of the patient's condition is recommended.
Since nimesulide can increase platelet function in patients with hemorrhagic diathesis, it should be used with caution and under constant monitoring.
The use of NSAIDs may mask the increase in body temperature associated with an underlying bacterial infection. If your body temperature rises or flu-like symptoms appear, you should stop taking the drug.
Children
The drug is contraindicated in children under 12 years of age. Dosing for children over 12 years of age is the same as for adults.
Use during pregnancy or breastfeeding
The use of nimesulide is contraindicated in the last trimester of pregnancy.
The use of nimesulide may interfere with female fertility and is therefore not recommended for women who are planning to become pregnant. Like other NSAIDs that inhibit prostaglandin synthesis, nimesulide can cause premature closure of the ductus botalus, pulmonary hypertension, oliguria, and oligohydramnios. The risk of bleeding, uterine atony and peripheral edema increases. Considering also the lack of data regarding the use of the drug during pregnancy, it is not recommended to prescribe nimesulide in the 1st and 2nd trimester of pregnancy.
Since it is unknown whether nimesulide passes into breast milk, its use is contraindicated during breastfeeding.
The ability to influence reaction speed when driving a vehicle or working with other mechanisms
During treatment, it is necessary to exercise caution when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Nise drug interactions

When used simultaneously with warfarin and similar anticoagulants, acetylsalicylic acid, there is an increased risk of bleeding.
The simultaneous use of nimesulide and furosemide requires caution when treating patients with impaired renal and cardiac function.
NSAIDs reduce the clearance of lithium, which leads to increased plasma lithium concentrations and increased toxicity. Therefore, when using nimesulide and lithium simultaneously, it is necessary to carefully monitor the concentration of lithium in the blood plasma.
When nimesulide was used simultaneously with digoxin, theophylline, glibenclamide, ranitidine, and antacids, no clinically significant interaction was observed.
Nimesulide inhibits the action of the CYP2C9 enzyme. Therefore, the plasma concentration of drugs that are affected by this enzyme can be increased when used simultaneously with nimesulide.
Caution should be exercised if the drug is taken less than 24 hours after or 24 hours before the use of methotrexate, since the concentration of methotrexate in the blood serum and its toxicity increases.
Increased nephrotoxicity of cyclosporines is possible when used simultaneously with nimesulide.

Nise drug overdose, symptoms and treatment

symptoms: lethargy, drowsiness, nausea, vomiting, pain in the epigastric region, gastrointestinal bleeding, hypertension (arterial hypertension), acute renal failure, respiratory depression, anaphylactoid reactions and coma may also occur.
Treatment. There is no specific antidote. In case of overdose, symptomatic therapy should be carried out. During the first 4 hours, patients need to rinse their stomach and take activated charcoal. Hemodialysis is not effective. Careful monitoring of liver and kidney function is necessary.

Storage conditions for the drug Nise

In a dry place, protected from light, at a temperature of 15-25 ° C.

List of pharmacies where you can buy Nise:

Saint Petersburg

The active substance is nimesulide.

Manufacturers

Dr. Reddis Laboratories Ltd (India)

pharmachologic effect

The drug is a new generation nonsteroidal anti-inflammatory drug (NSAID) from the sulfonamide class.

Has a local 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.

Side effects of Nise

Local reactions:

hives,
peelings,
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.

Indications for use

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).

Contraindications Nise

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.

Directions for use and dosage

Before applying the gel, wash and dry the skin surface.

Apply a uniform thin layer of gel approximately 3 cm long to the area of maximum pain, without rubbing, 3-4 times a day.

The amount of gel and the frequency of its use (no more than 4 times a day) may vary depending on the size of the treated area and the patient’s response.

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

Overdose

Cases of drug overdose have not been described.

However, when large quantities of gel (exceeding 50 g) are applied to large areas of skin, the development of an overdose cannot be ruled out.

There is no specific antidote.

You need to see a doctor.

Interaction

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

Caution should be exercised when using the drug 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.

special instructions

Carefully.

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

Avoid getting the gel into 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.

Storage conditions

Do not freeze.

Store in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25 C.

There are contraindications. Before starting use, consult your doctor.

Commercial names abroad (abroad) - Actasulid, Ainex, Aldoron, Antipen, Aulin, Defam, Donulide, Eskaflam, Inim, Lupisulide, Mesid, Mesulid, Migraless, Nicip, Nidol, Nilide, Nilup, Nimalgex, Nimbid, Nimdus, Nimed , Nimfast, Nimi Rapi, Nimupain, Nimuwin, Nodard, Novolid, Orthobid, Prolid, Pronim, Remulide, Scaflam, Scaflan, Zega.

Other Non-steroidal PVA and non-narcotic analgesics.

You can ask a question or leave a review about the medicine (please, do not forget to indicate the name of the drug in the text of the message).

Preparations containing Nimesulide (Nimesulide, ATC code M01AX17):

Frequent release factors (more than 100 offers in Moscow pharmacies)
Name	Release form	Packaging, pcs.	Country, manufacturer	Price in Moscow, r	Offers in Moscow
Nise	gel 1% 20g	1	India, Dr. Reddis	173- (average 198) -310	832↗
Nise	gel 1% 50g	1	India, Dr. Reddis	220- (average 292) -437	444↗
Nise	tablets 100mg	20	India, Dr. Reddis	127- (average 206↗) -347	892↗
Nemulex	granules 100mg	10 and 30	Russia, Sotex	for 10 pieces: 130- (average 215) -380; for 30pcs: 366- (average 366) -779	376↗
Nimesil		9 and 30	Italy, Guidotti and Menarini	for 9 pieces: 675- (average 771) -900; for 30pcs: 550- (average 795↗) -1324	857↗
Nimesulide	tablets 100mg	20	Macedonia, Replekfarm	48- (average 71) -158	281↗
Nimesulide	granules for suspension preparation - 100 mg of nimesulide per 2 g granules	30	Macedonia, Replekfarm	550- (average 795↗) -1324	857↗
Nimica	tablets 50mg	20	India, Ipka	56- (average 140) -198	814↘
Nimica	tablets 100mg	20	India, Ipka	92- (average 242↗) -398	223↘
Nimulid	gel 1% 30g	1	India, Panacea	135- (average 236↗) -332	244↗
Nimulid	tablets 100mg	30	India, Panacea	204- (average 400↗) -567	740↘
Nimulid	lozenge tablets 100mg	10 and 20	India, Panacea	for 10 pieces: 69- (average 133↗) -206; for 20pcs: 127- (average 257↗) -419	758↗
Nimulid	suspension for oral administration 50 mg in 5 ml	1	India, Panacea	82- (average 197) -390	459↗
Rarely encountered and discontinued release forms (less than 100 offerings in Moscow pharmacies)
Name	Release form	Packaging, pcs.	Country, manufacturer	Price in Moscow, r	Offers in Moscow
Aponil	tablets 100mg	20	Cyprus, Medokemi	92- (average 170↗) -184	82↗
Nise	tablets 50mg	10	India, Dr. Reddis	175-269	3↗
Nimulid	gel 1% 20g	1	India, Panacea	No	No
Prolid	tablets 100	10	India, Protech	35- (average 112↗) -151	65↗
Coxtral	tablets 100mg	10 and 30	Czech Republic, Zentiva	No	No

Answers from the site author to typical requests from page visitors:

Does blood pressure increase when taking Nise tablets?

Yes, increased blood pressure and increased heart rate are common side effects of Nimesulide medications.

Nimesil (Nimesulide) - instructions for use. The drug is a prescription, the information is intended only for healthcare professionals!

Clinical and pharmacological group:

NSAIDs. Selective COX-2 inhibitor

Indications for use of the drug NIMESIL®

treatment of acute pain (back pain, lower back pain; pain syndrome in the musculoskeletal system, including injuries, sprains and dislocations of joints, tendonitis, bursitis; toothache);
symptomatic treatment of osteoarthritis with pain syndrome;
algodismenorrhea.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use.

Dosage regimen

Nimesil is taken orally, 1 sachet (100 mg of nimesulide) 2 times a day. It is recommended to take the drug after meals. The contents of the sachet are poured into a glass and dissolved in approximately 100 ml of water. The prepared solution cannot be stored.

Nimesil is used only to treat patients over 12 years of age.

Adolescents (ages 12 to 18 years): Based on the pharmacokinetic profile and pharmacodynamic characteristics of nimesulide, no dose adjustment is necessary in adolescents.

Patients with impaired renal function: based on pharmacokinetic data, there is no need for dose adjustment in patients with mild to moderate forms of renal failure (creatinine clearance 30-80 ml/min).

Elderly patients: when treating elderly patients, the need to adjust the daily dose is determined by the physician based on the possibility of interaction with other drugs.

The maximum duration of treatment with nimesulide is 15 days.

To reduce the risk of unwanted side effects, the minimum effective dose should be used for the shortest possible course.

Side effect

From the hematopoietic system: rarely - anemia, eosinophilia, hemorrhagic syndrome; very rarely - thrombocytopenia, pacytopenia, thrombocytopenic purpura.

Allergic reactions: uncommon - itching, rash, increased sweating; rarely - hypersensitivity reactions, erythema, dermatitis; very rarely - anaphylactoid reactions, urticaria, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

From the side of the central nervous system: infrequently - dizziness; rarely - a feeling of fear, nervousness, nightmares; very rarely - headache, drowsiness, encephalopathy (Reye's syndrome).

From the organ of vision: rarely - blurred vision.

From the cardiovascular system: infrequently - arterial hypertension, tachycardia, lability of blood pressure, hot flashes.

From the respiratory system: infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm.

From the digestive system: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, dyspepsia, stomatitis, tarry stools, gastrointestinal bleeding, ulcer and/or perforation of the stomach or duodenum; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis, increased activity of liver enzymes.

From the urinary system: rarely - dysuria, hematuria, urinary retention; very rarely - renal failure, oliguria, interstitial nephritis.

General disorders: rarely - malaise, asthenia; very rarely - hypothermia.

Other: rarely - hyperkalemia.

Contraindications to the use of NIMESIL®

history of hyperergic reactions, for example, bronchospasm, rhinitis, urticaria, associated with taking acetylsalicylic acid or other NSAIDs, incl. nimesulide;
history of hepatotoxic reactions to nimesulide;
concomitant (simultaneous) use of drugs with potential hepatotoxicity, for example, paracetamol or other analgesic or non-steroidal anti-inflammatory drugs;
inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase;
period after coronary artery bypass surgery;
fever in infectious and inflammatory diseases;
complete or partial combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses with intolerance to acetylsalicylic acid and other NSAIDs (including a history);
peptic ulcer of the stomach and duodenum in the acute phase, a history of ulcers, perforation or bleeding in the gastrointestinal tract;
a history of cerebrovascular hemorrhage or other bleeding, as well as diseases accompanied by bleeding;
severe blood clotting disorders;
severe heart failure;
severe renal failure (CK< 30 мл/мин), подтвержденная гиперкалиемия;
liver failure or any active liver disease;
children under 12 years of age;
pregnancy and breastfeeding;
alcoholism, drug addiction;
hypersensitivity to the components of the drug.

With caution: severe forms of arterial hypertension, type 2 diabetes mellitus, heart failure, coronary heart disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, peripheral arterial disease, smoking, CC< 60 мл/мин, анамнестические данные о наличии язвенного поражения ЖКТ, инфекции, вызванной Helicobacter pylori; пожилой возраст; длительное предшествующее использование НПВП; тяжелые соматические заболевания; сопустствующая терапия следующими препаратами: антикоагулянты (например, варфарин), антиагреганты (например, ацетилсалициловая кислота, клопидогрел), пероральные глюкокортикостероиды (например, преднизолон), селективные ингибиторы обратного захвата серотонина (например, циталопрам, флуоксетин, сертралин).

The decision to prescribe Nimesil should be based on an individual risk-benefit assessment when taking the drug.

Use of the drug NIMESIL® during pregnancy and breastfeeding

Like other drugs of the NSAID class that inhibit prostaglandin synthesis, nimesulide can adversely affect pregnancy and/or embryo development and can lead to premature closure of the ductus arteriosus, hypertension in the pulmonary artery system, impaired renal function, which can lead to renal failure with oligodyramnia, to an increased risk of bleeding, decreased uterine contractility, and the occurrence of peripheral edema. In this regard, the drug is contraindicated during pregnancy and breastfeeding.

Use for liver dysfunction

The drug is contraindicated in liver failure or any active liver disease.

Use for renal impairment

In patients with renal failure, Nimesil should be used with caution, as renal function may deteriorate. If the condition worsens, treatment with Nimesil should be stopped. The drug is contraindicated in severe renal failure (CR< 30 мл/мин).

In patients with mild to moderate forms of renal failure (creatinine clearance 30-80 ml/min), there is no need for dose adjustment.