Naisulide - instructions for use, doses, side effects, contraindications, price, where to buy

Naisulid® (Neusulid)

Undesirable side effects can be minimized by using the drug in the minimum effective dose with the minimum duration of use necessary to relieve pain.

There is evidence of very rare cases of serious reactions from the liver, including cases of death, associated with the use of nimesulide-containing drugs. If symptoms similar to signs of liver damage appear (anorexia, itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of liver transaminases), you should immediately stop using the drug Naisulide® and consult a doctor. Repeated use of Naisulide® in such patients is contraindicated.

Liver reactions, which are in most cases reversible, have been reported with short-term use of the drug.

While using the drug Naisulide®, the patient should refrain from taking other analgesics, including NSAIDs (including selective COX-2 inhibitors).

The drug Naisulide® should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since exacerbation of these diseases is possible.

The risk of gastrointestinal bleeding, peptic ulcer/perforation of the stomach or duodenum increases in patients with a history of gastrointestinal ulceration (ulcerative colitis, Crohn's disease), as well as in elderly patients, with an increase in the dose of NSAIDs, so treatment should begin with the lowest possible dose. In such patients, as well as in patients who require the simultaneous use of low doses of acetylsalicylic acid or other drugs that increase the risk of complications from the gastrointestinal tract, it is recommended to additionally prescribe gastroprotectors (misoprostol or proton pump blockers). Patients with a history of gastrointestinal disease, especially older patients, should report new gastrointestinal symptoms (especially symptoms that may indicate possible gastrointestinal bleeding) to their physician.

Naisulide should be administered with caution to patients taking drugs that increase the risk of ulceration or bleeding (oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid).

If gastrointestinal bleeding or ulcerative lesions of the gastrointestinal tract occur in patients taking Naisulide®, treatment with the drug must be discontinued.

Given reports of visual impairment in patients taking other NSAIDs, if any visual impairment occurs, use of Naisulide should be immediately discontinued and an ophthalmological examination performed.

The drug may cause fluid retention, therefore, in patients with arterial hypertension, renal and/or heart failure, Naisulide® should be used with extreme caution. If the condition worsens, treatment with Naisulide® should be discontinued.

Clinical studies and epidemiological data suggest that NSAIDs, especially at high doses and with long-term use, may lead to a small risk of myocardial infarction or stroke. There is insufficient data to exclude the risk of such events when using nimesulide.

The drug contains sucrose, this should be taken into account by patients suffering from diabetes mellitus (0.15-0.18 XE per 100 mg of the drug) and those on a low-calorie diet. The drug Naisulide® is not recommended for use in patients with fructose intolerance, sucrose-isomaltose deficiency or glucose-galactose malabsorption syndrome.

If signs of a “cold” or acute respiratory viral infection occur during the use of the drug Naisulid®, the drug should be discontinued.

Nimesulide can change the properties of platelets, so caution must be exercised when using the drug in people with hemorrhagic diathesis, however, the drug does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

Elderly patients are especially susceptible to adverse reactions to NSAIDs, including the risk of life-threatening gastrointestinal bleeding and perforation, and decreased renal, liver, and cardiac function. When taking the drug Naisulide® for this category of patients, proper clinical monitoring is necessary.

There is evidence of rare cases of skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) when taking NSAIDs, including nimesulide. At the first manifestations of a skin rash, damage to the mucous membranes or other signs of an allergic reaction, taking Naisulide® should be stopped immediately.

Naisulide granules for suspension. orally 100 mg 2 g pack. 30 pcs

Undesirable side effects can be minimized by using the drug in the minimum effective dose with the minimum duration of use necessary to relieve pain. There is evidence of very rare cases of serious reactions from the liver, including cases of death, associated with the use of nimesulide-containing drugs. If symptoms similar to signs of liver damage appear (anorexia, itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of liver transaminases), you should immediately stop using the drug Naisulide® and consult a doctor. Repeated use of Naisulide® in such patients is contraindicated.

Liver reactions, which are in most cases reversible, have been reported with short-term use of the drug.

While using the drug Naisulide®, the patient should refrain from taking other analgesics, including NSAIDs (including selective COX-2 inhibitors).

The drug Naisulide® should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since exacerbation of these diseases is possible.

If gastrointestinal bleeding or ulcerative lesions of the gastrointestinal tract occur in patients taking Naisulide®, treatment with the drug must be discontinued.

Given reports of visual impairment in patients taking other NSAIDs, if any visual impairment occurs, use of Naisulide should be immediately discontinued and an ophthalmological examination performed.

If signs of a “cold” or acute respiratory viral infection occur during the use of the drug Naisulid®, the drug should be discontinued.

The effect of the drug on the ability to drive vehicles and other mechanisms. The effect of the drug Naisulid® on the ability to drive vehicles and mechanisms has not been studied, therefore, during the period of use of the drug Naisulid®, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention. and speed of psychomotor reactions.

Naisulide 100 mg, 20 tablets dispersible in the oral cavity

Registration Certificate Holder

FP OBOLENSKOE (Russia)

Dosage form

Medicine - Najsulid® (Najsulid)

Description

Oral dispersible tablets

from light yellow to yellow, round, flat-cylindrical, chamfered, with a characteristic pineapple smell.

1 tab.

nimesulide 100 mg

Excipients

: microcrystalline cellulose, pregelatinized corn starch, colloidal silicon dioxide (Aerosil), citric acid monohydrate, sodium carboxymethyl starch (type A), aspartame, talc, magnesium stearate, pineapple flavor.

10 pieces. — cellular contour packages (1) — cardboard packs. 10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — cellular contour packages (3) — cardboard packs. 10 pieces. — contour cell packaging (4) — cardboard packs. 10 pieces. — contour cell packaging (5) — cardboard packs.

Indications

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

Contraindications for use

Hypersensitivity to nimesulide; history of hyperergic reactions (bronchospasm, rhinitis, urticaria) associated with the use of acetylsalicylic acid or other NSAIDs, incl. nimesulide; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses with intolerance to acetylsalicylic acid and other NSAIDs (including a history); history of hepatotoxic reactions to nimesulide; simultaneous use with other drugs with potential hepatotoxicity (for example, other NSAIDs); chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase; period after coronary artery bypass surgery; febrile syndrome due to colds and acute respiratory viral infections; suspicion of acute surgical pathology; peptic ulcer of the stomach or duodenum in the acute phase; erosive and ulcerative lesions of the gastrointestinal tract; history of perforation or gastrointestinal bleeding; a history of cerebrovascular bleeding or other diseases accompanied by increased bleeding; severe bleeding disorders; severe heart failure; severe renal failure (creatinine clearance <30 ml/min), confirmed hyperkalemia; children under 12 years of age; pregnancy, breastfeeding period; alcoholism, drug addiction; liver failure, active liver disease.

Carefully

Arterial hypertension, diabetes mellitus, compensated heart failure, coronary artery disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, peripheral arterial diseases, hemorrhagic diathesis, smoking, CC 30-60 ml/min.

History of ulcerative lesions of the gastrointestinal tract; history of infection caused by Helicobacter pylori; elderly age; long-term previous use of NSAIDs; severe somatic diseases.

Concomitant use with the following drugs: 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).

pharmachologic effect

NSAIDs from the sulfonanilide class, a selective competitive reversible inhibitor of COX-2. Has anti-inflammatory, analgesic and antipyretic effects. It has a less pronounced inhibitory effect on COX-1.

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.

Drug interactions

GCS increases the risk of gastrointestinal ulcers or bleeding.

Antiplatelet agents and selective serotonin reuptake inhibitors such as fluoxetine increase the risk of gastrointestinal bleeding.

NSAIDs may enhance the effect of anticoagulants such as warfarin. Due to the increased risk of bleeding, this combination is not recommended and is contraindicated in patients with severe coagulation disorders. If combination therapy cannot be avoided, careful monitoring of blood clotting parameters is necessary. NSAIDs can reduce the effect of diuretics. In healthy volunteers, nimesulide temporarily reduces sodium excretion under the influence of furosemide, and to a lesser extent, potassium excretion and reduces the diuretic effect itself. Concomitant use of nimesulide and furosemide leads to a decrease (by approximately 20%) in AUC and a decrease in the cumulative excretion of furosemide without changing the renal clearance of furosemide. The simultaneous use of furosemide and nimesulide requires caution in patients with renal or heart failure.

NSAIDs can reduce the effect of antihypertensive drugs. In patients with mild to moderate renal failure (creatinine clearance 30-80 ml/min), with simultaneous use of ACE inhibitors, angiotensin II receptor antagonists and drugs that suppress the COX system (NSAIDs, antiplatelet agents), further deterioration of renal function and the occurrence of acute renal disease may occur. failure, which is usually reversible. These interactions should be considered in patients taking nimesulide in combination with ACE inhibitors or angiotensin II receptor antagonists. Therefore, the simultaneous use of these drugs should be done with caution, especially in elderly patients. Patients should remain adequately hydrated and renal function should be closely monitored after concomitant use is initiated. Theoretically, it is possible to reduce the effectiveness of mifepristone and prostaglandin analogues when used simultaneously with NSAIDs (including acetylsalicylic acid) due to the antiprostaglandin action of the latter. Limited data indicate that use of an NSAID on the same day as a prostaglandin analogue does not adversely affect the effects of mifepristone or a prostaglandin analogue on cervical dilatation, uterine contractility, or reduce the clinical effectiveness of medical abortion.

There is evidence that NSAIDs reduce the clearance of lithium, which leads to increased plasma lithium concentrations and its toxicity. When using nimesulide in patients undergoing lithium therapy, the concentration of lithium in the blood plasma should be regularly monitored.

Nimesulide inhibits the activity of the CYP2C9 isoenzyme. When drugs that are substrates of this enzyme are used simultaneously with nimesulide, the concentration of the latter in plasma may increase.

When using nimesulide less than 24 hours before or after using methotrexate, caution is required, because in such cases, the concentration of methotrexate in the blood plasma and, accordingly, the toxic effects may increase.

Due to their effect on renal prostaglandins, inhibitors of prostaglandin synthetase, such as nimesulide, may increase the nephrotoxicity of cyclosporines.

Dosage regimen

Orally 100 mg 2 times/day, after meals.

Side effect

From the hematopoietic system:

rarely - anemia, eosinophilia, hemorrhage; very rarely - thrombocytopenia, pancytopenia, thrombocytopenic purpura.

From the immune system:

rarely - hypersensitivity reactions; very rarely - anaphylactoid reactions, very urticaria, angioedema.

For the skin and subcutaneous tissues:

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

From the nervous system:

infrequently - dizziness; very rarely - headache, drowsiness, encephalopathy (Reye's syndrome).

Mental disorder:

rarely - a feeling of fear, nervousness, nightmares.

From the side of the organ of vision:

rarely - blurred vision; very rarely - visual impairment.

Hearing and labyrinth disorders:

very rarely - vertigo.

From the cardiovascular system:

infrequently - increased blood pressure; rarely - tachycardia, blood pressure lability, “flushes” of blood to the skin of the face, palpitations.

From the respiratory system:

infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm.

From the digestive system:

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

From the liver and biliary tract:

often - increased activity of liver enzymes; very rarely - hepatitis, fulminant hepatitis (including deaths), jaundice, cholestasis.

From the urinary system:

rarely - dysuria, hematuria, urinary retention;
very rarely - renal failure, oliguria, interstitial nephritis. Metabolic disorders:
rarely - hyperkalemia; uncommon - peripheral edema; very rarely - hypothermia.

Other:

rarely - malaise, asthenia.

special instructions

If symptoms similar to signs of liver damage appear (anorexia, itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of liver transaminases), you should immediately stop using nimxulide and consult a doctor. Repeated use of nimesulide in such patients is contraindicated.

Liver reactions, which are in most cases reversible, have been reported with short-term use of nimesulide.

While using nimasulide, the patient should refrain from taking other analgesics, including NSAIDs (including selective COX-2 inhibitors).

Use caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since exacerbation of these diseases is possible. The risk of gastrointestinal bleeding, peptic ulcer/perforation of the stomach or duodenum increases in patients with a history of gastrointestinal ulceration (ulcerative colitis, Crohn's disease), as well as in elderly patients, with an increase in the dose of NSAIDs, so treatment should begin with the lowest possible dose. In such patients, as well as in patients who require the simultaneous use of low doses of acetylsalicylic acid or other drugs that increase the risk of complications from the gastrointestinal tract, it is recommended to additionally prescribe gastroprotectors (misoprostol or proton pump blockers). Patients with a history of gastrointestinal disease, especially older patients, should report new gastrointestinal symptoms (especially symptoms that may indicate possible gastrointestinal bleeding) to their physician.

If gastrointestinal bleeding or gastrointestinal ulceration occurs in patients taking nimesulide, it should be discontinued.

Given reports of visual impairment in patients taking other NSAIDs, if any visual impairment occurs, use of nimesulide should be discontinued immediately and an ophthalmological examination should be performed.

Nimesulide can cause fluid retention, so it should be used with extreme caution in patients with arterial hypertension, renal and/or heart failure. If the condition worsens, treatment with nimesulide should be discontinued.

If signs of a cold or acute respiratory viral infection occur while using nimesulide, it should be discontinued immediately.

Nimesulide can change the properties of platelets, so caution must be exercised when using it in people with hemorrhagic diathesis, however, nimesulide does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

Elderly patients are especially susceptible to adverse reactions to NSAIDs, incl. the risk of gastrointestinal bleeding and perforation that threatens the patient’s life, decreased function of the kidneys, liver and heart. When taking nimesulide for this category of patients, proper clinical monitoring is necessary.

At the first manifestations of a skin rash, damage to the mucous membranes or other signs of an allergic reaction, nimesulide should be stopped immediately.
Effect on the ability to drive vehicles and other mechanisms
During the period of use of nimesulide, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions during breastfeeding - Contraindicated. Nimesulide is contraindicated for use during pregnancy and breastfeeding.

Use for renal impairment

Restrictions for impaired renal function - Contraindicated.

Contraindicated in renal failure (creatinine clearance less than 30 ml/min).

Use for liver dysfunction

Restrictions for liver dysfunction - Contraindicated.

Contraindicated in moderate and severe liver failure.

Use in elderly patients

Restrictions for elderly patients - With caution. For external use, a doctor's monitoring of the condition of elderly patients with impaired renal function, liver function, and congestive heart failure is required.

Use in children

Restrictions for children - With caution. When used in pediatrics, dosage forms intended for children should be used.

NIMESULIDE

special instructions

Since iimesulide is partially eliminated by the kidneys, its dose in patients with impaired renal function should be reduced depending on creatinine clearance.
Considering reports of visual impairment 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 disorders should use nimesulide with extreme caution.

Patients should undergo regular medical monitoring if they, along with nimesulide, take medications that are known to affect the gastrointestinal tract. If signs of liver damage appear (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of liver transaminases), you should stop taking the drug and consult your doctor. The drug should not be used simultaneously with other NSAIDs.

During treatment with nimesulide, it is recommended to avoid the simultaneous use of hepatotoxic drugs, analgesics, other NSAIDs (with the exception of low doses of acetylsalicylic acid used in antiplatelet doses) and the use of ethanol does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases and 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.

Gastrointestinal bleeding or ulcer/perforation may develop at any time while using the drug, with or without clinically significant symptoms. both with and without a history of gastrointestinal complications. The risk of their development is higher when high doses of NSAIDs are prescribed, when taken by patients with a history of gastric and duodenal ulcers, as well as by the elderly. If therapy is necessary in these cases, the need for concomitant use of misoprostol or proton pump inhibitors should be considered. If gastrointestinal bleeding or gastrointestinal ulcers occur, the drug should be discontinued.

Elderly patients most often develop side effects when taking the drug, including gastrointestinal bleeding, perforation, dysfunction of the heart, kidneys, and liver, so regular clinical monitoring of the condition of these patients is recommended.

Naisulide Nimesulide tablet 100 mg x20

Clinical and pharmacological group: NSAIDs. Selective inhibitor of COX-2 Pharmacotherapeutic group: NSAIDs Pharmacological action of NSAIDs, the structure of which contains a sulfonylide group. It is believed that nimesulide is a selective COX-2 inhibitor. It has a pronounced anti-inflammatory, as well as analgesic and, to a lesser extent, antipyretic effect. The mechanism of action is associated with inhibition of prostaglandin synthesis. Suppresses the synthesis of prostaglandins in the area of inflammation to a greater extent than in the gastric mucosa or kidneys, which is due to inhibition primarily of COX-2. In addition, in the mechanism of the anti-inflammatory action of nimesulide, its ability to suppress the formation of free oxygen radicals (without affecting hemostasis and phagocytosis) and inhibit the release of the enzyme myeloperoxidase is important.

Pharmacokinetics After oral administration, nimesulide is well absorbed from the gastrointestinal tract, Cmax in blood plasma is reached after 1-2 hours.

Protein binding is 99%. After oral administration of a single dose of 100 mg, nimesulide is present in the tissues of the female genital organs in a concentration of 40% of the concentration in plasma.

Metabolized in the liver, the main metabolite hydroxynimesulide has pharmacological activity.

T1/2 from plasma is 2-3 hours

It is excreted from the body mainly through urine, about 98% of the dose is excreted within 24 hours. With prolonged therapy, accumulation of nimesulide is not observed.

Indications Osteoarthritis, extra-articular rheumatic diseases, pain and inflammatory processes after surgery, pain and fever during acute inflammatory processes in the upper respiratory tract, pain associated with dysmenorrhea. ICD-10 codes ICD-10 code Indication M05 Seropositive rheumatoid arthritis M15 Polyarthrosis M25.5 Joint pain N94.4 Primary dysmenorrhea N94.5 Secondary dysmenorrhea R07 Sore throat and chest R50 Fever of unknown origin R52.0 Acute pain R52.2 Other constant pain (chronic)

Dosage regimen: Orally for adults 100-200 mg 2 times a day, for children - 1.5 mg/kg 2-3 times a day.

The maximum dose for children is 5 mg/kg/day in 2-3 doses.

Side effects From the digestive system: heartburn, nausea, stomach pain, in some cases - tarry stools, melena (associated with bleeding and erosive and ulcerative lesions of the gastrointestinal tract).

From the side of the central nervous system: rarely - headaches, dizziness, drowsiness.

Allergic reactions: skin rash, erythema, urticaria.

Other: rarely - oliguria, fluid retention in the body, local or systemic edema, in some cases - thrombocytopenic purpura.

Contraindications for use Peptic ulcer of the stomach and duodenum in the acute phase, acute bleeding from the gastrointestinal tract, moderate and severe liver failure, renal failure (creatinine clearance less than 30 ml/min), pregnancy, lactation, hypersensitivity to nimesulide and other NSAIDs (including including acetylsalicylic acid). Use during pregnancy and lactation Nimesulide is contraindicated for use during pregnancy and lactation.

There are no direct indications of the embryotoxic and tocolytic effects of nimesulide.

Use for liver dysfunction Contraindicated in moderate and severe liver failure. Use for impaired renal function Contraindicated in renal failure (creatinine clearance less than 30 ml/min). Use in children When used in pediatrics, dosage forms intended for children should be used. In children under 6 years of age, when using nimesulide externally, medical supervision is required.

Use in elderly patients When used externally, physician supervision is required over the condition of elderly patients with impaired renal function, liver function, and congestive heart failure.

Special instructions: Use orally with caution in patients with impaired renal function, arterial hypertension, cardiac dysfunction, and visual impairment.

When used externally, a doctor's monitoring of the condition of elderly patients with impaired renal function, liver function, and congestive heart failure is required.

When used in pediatrics, dosage forms intended for children should be used. In children under 6 years of age, when using nimesulide externally, medical supervision is required.

Impact on the ability to drive vehicles and operate machinery

Due to the fact that nimesulide, when taken orally, can cause dizziness and drowsiness, it should be used with caution in patients engaged in potentially hazardous activities that require increased concentration and rapid psychomotor reactions.

Drug interactions Manifestations of drug interactions are possible when nimesulide is taken orally simultaneously with digoxin, phenytoin, lithium preparations, diuretics, antihypertensive drugs, other NSAIDs, anticoagulants, cyclosporine, methotrexate, and oral hypoglycemic agents.

Naisulide gel for 30g No. 1

Name

Naisulide gel dnar.approx. 10 mg 1 g in tubes 30 g in pack No. 1

Description

Homogeneous transparent or almost transparent yellow gel. Air bubbles are allowed.

Main active ingredient

Nimesulide

Release form

gel

Dosage

30g

special instructions

You should consult your doctor before using the gel. Naisulide® gel should be used with caution when:

peptic ulcer in the acute phase or severe bleeding disorder;
renal dysfunction;
impaired liver function, with moderate and severe liver failure;
bronchial asthma, allergic rhinitis;
prescribed to elderly patients with impaired renal function, liver function, and congestive heart failure.

Naisulide® Gel should not be used concomitantly with other topical medications. Do not apply the drug to skin affected by dermatoses or infectious processes, to damaged areas of the skin, or to open wounds. It is necessary to avoid getting the gel into the eyes and mucous membranes. The gel should not be used under airtight dressings. If local skin reactions occur, the gel must be discontinued. By using a low effective dose for short-term use, side effects can be reduced. In exceptional cases, burning sensations may occur on the skin: photo dermatitis; Caution must be exercised during treatment. Naisulide® gel. To reduce the risk of photosensitivity, patients should avoid exposure to direct sunlight or tanning lamps. If symptoms persist or the condition worsens, you should consult a doctor.

Indications for use

acute painful manifestations that occur with uncomplicated injuries, including sports ones; for sprains or ruptures of ligaments and tendons, tendinitis; bruises of muscles and ligaments.

Directions for use and doses

For external use, wash and dry the skin surface before applying the gel. Approximately 3 cm of gel is applied to the affected area and rubbed in lightly; the procedure is repeated 3? 4 times a day. Do not rub the gel vigorously or use bandages. After applying the gel, you must wash your hands thoroughly, except in cases where the drug must be applied directly to your hands. The duration of treatment is selected individually; is usually 7? 15 days. Long-term use of the drug is carried out under mandatory systematic monitoring of the patient’s kidney and liver function.

Use during pregnancy and lactation

Naisulid® gel is contraindicated for use during pregnancy and lactation. If it is necessary to prescribe the drug during lactation, it is necessary to decide on stopping breastfeeding.

Interaction with other drugs

When using the drug cutaneously, its interaction with other drugs has not been established. By displacing some drugs from the sites where they bind to plasma proteins, nimesulide can significantly increase both their effectiveness and the toxicity of these drugs. The drug should be prescribed with caution simultaneously with anticoagulants, digoxin, phenytoin, lithium drugs, diuretics, antihypertensive drugs, other NSAIDs, cyclosporine, methotrexate, and oral hypoglycemic drugs. With simultaneous local use of several NSAIDs, skin redness, peeling, and urticaria may occur.

Contraindications

hypersensitivity to nimesulide or other components of the drug;
increased sensitivity to non-steroidal anti-inflammatory drugs;
dermatitis and infectious skin diseases;
damage to the epidermis;
renal failure (creatinine clearance less than 30 ml/min);
pregnancy and lactation;
children's age up to 12 years.

Compound

1 g of gel contains 10 mg of nimesulide as an active ingredient. Excipients: ethyl alcohol 96%, carbomer, macrogol 400, propylene glycol, dimethyl sulfoxide.

Overdose

There were no cases of overdose when using the gel. When using the gel on large areas of the skin or if recommended doses are exceeded, systemic side effects characteristic of nimesulide and other NSAIDs are possible: dyspepsia, headache, dizziness, pain in the epigastric region. Treatment: symptomatic. A dose reduction or discontinuation of the drug is required.

Side effect

The incidence of side effects is assessed according to the following scheme: very often (? 1/10); often (? 1/100 to ? 1/10); infrequently (? 1/1000 to ? 1/100); rare (? 1/10000 to ? 1/1000); very rare (? 1/10000). On the part of the skin and subcutaneous tissue: in isolated cases, erythema, local irritation, rash, itching, peeling, change in skin color (especially with prolonged use of the gel) in the form of skin hyperemia and allergic reactions are possible. From the respiratory system, chest and mediastinal organs: rarely? Quincke's edema, vasomotor rhinitis, suffocation, bronchospasm. If the listed adverse reactions occur, as well as a reaction not listed in the package insert, you should stop using the gel and consult a doctor.

Storage conditions

Store in a place protected from light at a temperature not exceeding 25 °C. Keep out of the reach of children.