Nimesulide

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Clinical Pharmacology

Nimesulide is a nonsteroidal anti-inflammatory agent from the sulfonamide class. It has anti-inflammatory, analgesic and antipyretic effects. In contrast to non-selective NSAIDs, nimesulide mainly inhibits cyclooxygenase-2 (COX-2), inhibits the synthesis of prostaglandins in the focus of inflammation; has a less pronounced inhibitory effect on cyclooxygenase-1 (COX-1).

Suggested use

Orally, the contents of the bag are dissolved in approximately 100 ml of water at room temperature (a suspension of white or light yellow color is formed).

The prepared solution is not subject to storage.

The drug Naisulid is used only for the treatment of patients older than 12 years.

Adults and children over 12 years old: 1 sachet twice a day, after meals.

Elderly patients: in the treatment of elderly patients, the need to adjust the daily dose is determined by the doctor based on the possibility of interaction with other drugs.

Patients with renal insufficiency: patients with mild or moderate severity of renal insufficiency (creatinine clearance 30-60 ml / min) do not require dose adjustment, while patients with severe renal insufficiency (creatinine clearance <30 ml="" min="" nauslide="" contraindicated="" p="">

Patients with liver failure:

Use of the drug Naisulid * in patients with hepatic insufficiency is contraindicated

To reduce the likelihood of side effects, it is recommended to take the minimum effective dose for the shortest possible time.

The maximum daily dose for adults and children over 12 years old is 200 mg.

The maximum duration of the course of treatment is 15 days.

Indications

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use; Nimesulide is recommended for therapy as a second-line drug.

Composition

1 sachet contains:

active ingredient: nimesulide 100 mg;

excipients: sugar (sucrose), maltodextrin, cetomacrogol 1000 (macrogol cetostearyl ether), anhydrous citric acid, orange flavoring.

Nimesulide is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
			granules
Nise	Canonpharma	Russia	granules
Nise	Dr. Reddy`s	India	pills
Nimesulide	Izvarino Pharma	Russia	pills
Nimesan	Shreya	India	pills
Nimulid	Panacea Biotek	India	pills
Nemulex	Sotex	Russia	granules
Nimesulide-Teva	Teva	Israel	pills
Nimulid	Panacea Biotek	India	suspension
Nise	Dr. Reddy`s	India	gel
Nimika	Ipka	India	pills
			pills
Nimesil	Laboratorios Menarini S.A	Italy	granules
Nimulid	Panacea Biotek	India	gel

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Adverse reactions

The frequency is classified according to the recommendations of the World Health Organization, depending on the occurrence of the case: very often ≥), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥ 1/10000, <1/1000), very rarely, including individual messages

Violations of the blood and lymphatic system

Rarely: anemia, eosinophilia, hemorrhage;

Very rarely: thrombocytopenia, pancytopenia, thrombocytopenic purpura.

Immune system disorders

Seldom: hypersensitivity reactions;

Very rare: anaphylactoid reactions.

Violations of the skin and subcutaneous tissue

Infrequently: itching, skin rash, excessive sweating;

Rarely: erythema, dermatitis;

Very rarely: urticaria, angioedema, facial swelling, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

Nervous system disorders

Infrequently: dizziness;

Very rarely: headache, drowsiness, encephalopathy (Reye's syndrome).

Mental disorder

Seldom: feeling of fear, nervousness, nightly "dreadful" dreams.

Violations by the organ of vision

Rarely: blurred vision;

Very reoko: blurred vision.

Disturbances from an organ of hearing and labyrinth disturbances

Very rare: vertigo.

Violations of the cardiovascular system

Infrequently: increase in arterial pressure;

Rarely: tachycardia, blood pressure lability, "flush" of blood to the skin of the face, a sensation of heartbeat.

Respiratory disorders

Infrequently: shortness of breath;

Very rare: exacerbation of asthma, bronchospasm.

Disorders of the gastrointestinal tract

Often: diarrhea, nausea, vomiting;

Infrequently: constipation, flatulence, gastritis, gastrointestinal bleeding, ulcers and / or perforation of the stomach or duodenum;

Very rare: abdominal pain, dyspepsia, stomatitis, tarry stools

Disorders of the liver and biliary tract

Often: increased activity of "liver" enzymes;

Very rarely: hepatitis, fulminant (fulminant) hepatitis (including deaths), jaundice, cholestasis.

Kidney and urinary tract disorders

Rarely: dysuria, hematuria, urinary retention;

Very rare: renal failure, oliguria, interstitial nephritis.

Violations by water and electrolyte metabolism

Rarely: hyperkalemia.

Other

Infrequently: peripheral edema;

Rarely: malaise, asthenia;

Very rare: hypothermia.

Contraindications

Carefully

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

Ulcer lesion of the gastrointestinal tract in history; history of Helicobacter pylori infection; elderly age; prolonged prior use of NSAIDs; severe somatic diseases.

Concurrent 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, paroxetin.

Drug interactions

Glucocorticosteroids increase the risk of gastrointestinal ulcers or bleeding.

Anti-thromboabial agents and selective serotonix reuptake inhibitors

(SSRls) * for example, fluoxetine, increase the risk of gastrointestinal bleeding.

NSAIDs can 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, it is necessary to carefully monitor blood clotting rates.

Diuretics

NSAIDs can reduce the effect of diuretics. In healthy volunteers, nimesulide temporarily reduces the excretion of sodium under the action of furosemide, to a lesser extent - the excretion of potassium and reduces the actual diuretic effect.

The simultaneous use of nimesulide and furosemide leads to a decrease (approximately 20%) in the area of the concentration-time curve (AUC) and a reduction in the cumulative excretion of furosemide without altering the renal clearance of furosemide.

Simultaneous use of furosemide and nimesulide requires caution in patients with renal or heart failure.

ACE inhibitors and angiotezin-II reieperator antagonists

NSAIDs can reduce the effect of antihypertensive drugs. In patients with mild to moderate renal insufficiency (creatine clearance and 30–80 ml / min) with simultaneous use of ACE inhibitors, angiotensin II receptor antagonists and agents that suppress the cyclooxygenase system (NSAIDs, antiplatelet agents), there may be a further deterioration in kidney function and the occurrence of acute renal failure, which, as a rule, is 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 carried out with caution, especially in elderly patients. Patients should receive a sufficient amount of fluid, and renal function should be carefully monitored after the start of simultaneous use.

Mifepristone

Theoretically, it is possible to reduce the effectiveness of mifepristone and prostaglandin analogues in one application or another with NSAIDs (including acetylsalicylic acid) due to the antiprostaglandi of the new action of the latter. Limited data show that the use of NSAIDs on the day the prostaglandin analog is used does not adversely affect the effect of mifepristone or the prostaglandin analog on cervical dilatation, uterine contractility and does not reduce the clinical efficacy of a drug-induced abortion.

There is evidence that NSAIDs reduce lithium clearance, which leads to an increase in plasma concentration of lithium and its toxicity. In the application of nimesulide in patients undergoing therapy with lithium preparations, it is necessary to regularly monitor the plasma concentration of lithium.

There were no clinically significant interactions with glibenclaide, theophylline, α-digostin, cimetidine, and anti-acid drugs (for example, a combination of aluminum and magnesium hydroxides).

Nimesulide inhibits the activity of CYP2C9 isoenzyme. With simultaneous use with nimesulide drugs that are the substrates of this enzyme, the concentration of the latter in the plasma may increase.

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

Due to the effect on renal prostaglandins. inhibitors of prostaglandin synthetases, such as nimesulide, can increase the nephrotoxicity of cyclosporins.

Special instructions

Undesirable side effects can be minimized with the use of the drug in the minimum effective dose with the minimum duration of use needed 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 no drugs or other medications. If symptoms similar to signs of liver damage appear (anorexia, pruritus, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of the urine, increased activity of "liver" trance and naz), you should immediately discontinue the use of Naisulid and consult a doctor. Repeated use of the drug Naisulid in these patients is contraindicated.

Reported reactions from the liver, which in most cases is reversible, with short-term use of the drug.

During the use of the drug Naisulid, the patient should refrain from taking other analgesics, including NSAIDs (including selective COX-2 inhibitors).

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

The risk of gastrointestinal bleeding, peptic ulcers / perforation of the stomach or duodenum increases in patients with ulcerative lesions of the gastrointestinal tract (ulcerative colitis, Crohn's disease) in history, as well as in elderly patients, with an increase in the dose of NSAIDs, so treatment should be started with the lowest possible dose. Such patients, as well as patients requiring simultaneous use of low doses of acetylsalicylic acid or other agents that increase the risk of complications of the gastrointestinal tract, are advised to additionally take gastroprotective medications (misoprostol or proton pump blockers).

Patients with gastrointestinal diseases in history, especially elderly patients, should inform the doctor about the newly emerged symptoms of the gastrointestinal tract (especially the symptoms that may indicate a possible gastrointestinal bleeding).

Nasulid® should be prescribed 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 anti-platelet agents, such as acetylsalicylic acid).

In the case of gastrointestinal bleeding or ulcerative lesions of the gastrointestinal tract in patients who are taking the drug Naisulid, treatment with the drug should be stopped.

Considering the reports of visual impairment in patients taking other NSAIDs, if any visual impairment occurs, the use of the drug Naisulid should be immediately stopped and an ophthalmologic examination should be carried out.

The drug can cause fluid retention, so in patients with arterial hypertension, with renal and / or heart failure, the drug Naisulid should be used with extreme caution. In case of deterioration of the condition, treatment with Knight should be discontinued.

Clinical studies and epidemiological data suggest that NSAIDs, especially in high doses and with prolonged use, can lead to a slight risk of myocardial infarction or stroke. To eliminate the risk of such events when using nimesulide data is not enough. The preparation contains sucrose, this should be taken into account for patients with diabetes mellitus (0.15-0.18 XE per 100 mg of the drug) and persons who are on a low-calorie diet. The drug Naisulid is not recommended to be prescribed to patients with fructose intolerance, sucrose-isomaltose deficiency or glucose-galactose malabsorption syndrome. If any signs of "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 care must be taken when using the drug in people with hemorrhagic diathesis, but the drug does not replace the prophylactic effect of acetylsalicylic acid in cardiovascular diseases. Elderly patients are particularly susceptible to adverse reactions to NSAIDs, including the risk of gastrointestinal bleeding and perforations that threaten the patient’s life, reduced kidney, liver and heart function. At reception of a prepagat Najsulid for this category of patients appropriate clinical control is necessary.

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

The effect of the drug on the ability to drive vehicles and other mechanisms

The effect of Naisulid on the ability to drive vehicles and machinery has not been studied, therefore, during the period of use of Naisulid, care should be taken when driving vehicles and practicing potentially hazardous activities that require increased concentration and psychomotor reactions.

Overdosage

Symptoms: apathy, drowsiness, nausea, vomiting, pain in the epigastric region. These symptoms are usually reversible with symptomatic and maintenance therapy.

Possible increase in blood pressure, the occurrence of gastrointestinal bleeding, acute renal failure, respiratory depression, coma, anaphylactoid reactions.

Treatment: symptomatic and supportive therapy. There is no specific antidote. In case overdose occurred within the last 4 hours, it is necessary to induce vomiting and. or provide reception of activated carbon (from 60 to 100 g per adult) and / or osmotic laxative. Forced diuresis, hemodialysis, hemoperfusion, alkalization of urine are ineffective due to the high degree of nimesulide binding to plasma proteins (up to 97.5%). Necessary to monitor the state of the function of the kidneys and liver.

Brand name: Naisulid
Active ingredient: Nimesulide
Dosage form: A mixture of powder and granules from white with a yellowish tinge to a light yellow color with an orange smell. When mixing the contents of one sachet in 100 ml of water, a suspension from white to light yellow with an orange smell is formed.
Manufacturer: Dr. Reddy`s