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Instruction for use: Nimesulide (Nimesulidum)

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Pharmacological group

Other non-narcotic analgesics, including non-steroidal and other anti-inflammatory drugs

Nosological classification (ICD-10)

K08.8.0 * Painful toothache

Dentinal pain, Dentinal pains, Pain pulpitis, Anesthesia in dentistry, Pain syndromes in dental practice, Pain after removal of tartar, Pain when extracting a tooth, Toothache, Pain after dental interventions

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M07.3 Other psoriatic arthropathies (L40.5 +)

Arthritis psoriatic, The generalized form of psoriatic arthritis, Psoriatic arthritis

M10.9 Gout, unspecified

Arthritis Gouty, Acute gouty arthritis, Acute attack of gout, Gouty Arthritis, Articular syndrome with exacerbation of gout, Articular syndrome with gout, Urarturia, Chronic arthritic arthritis, Acute gout, Salt diathesis

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M35.3 Rheumatic polymyalgia

Pseudoarthritis rhizomelic, Rheumatic polymyalgia, Pain syndrome in rheumatic diseases, Muscle pain with rheumatism, Extra-articular rheumatism, Extra-articular rheumatic syndrome, Extra-articular rheumatic diseases, Extra-articular rheumatic soft tissue injury, Extra-articular forms of rheumatism, Rheumatic soft tissue damage, Rheumatism of soft tissues, Rheumatic diseases of soft tissues, Rheumatic diseases of the periarticular soft tissues, Rheumatic affections of soft tissues, Rheumatic collagen diseases

M42 Osteochondrosis

Pain in spinal osteochondrosis, Cervical osteochondrosis, Radicular syndrome in osteochondrosis, intervertebral osteochondrosis, osteochondrosis, Osteochondrosis with radicular syndrome, Osteocondritis of the spine

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

M54 Dorsalgia

Pain in the back area, Pain in the spine, Back pain, Pain in different parts of the spine, Backache, Painful pain syndrome in the spine, Pain in the musculoskeletal system

M54.1 Radiculopathy

Acute sciatica, Radiculopathy, Radiculitis, Radiculitis with radicular syndrome, Acute radiculopathy, Pain syndrome with radiculitis, Subacute radiculitis, Radiculitis, Chronic radiculitis, Diseases of the spinal column

M54.3 Sciatica

Ishialgia, Neuralgia of the sciatic nerve, Sciatic neuritis

M54.4 Lumbago with sciatica

Pain in the lumbosacral spine, Lumbago, Sciatica, Lumbar syndrome

M54.5 Pain below the back

Pain in the lower back, Lumbar pain, Lumbalia, Painful conditions of the spinal column, Back pain, Lower Back Pain Syndrome

M67.9 Lesion of synovium and tendon, unspecified

Inflammation of the tendons, Inflammation of ligaments, Inflammation of tendons with injuries, Inflammation of tendons

M71 Other bursopathies

Bursitis, Bursopathy, Diseases of soft tissues, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Subacute bursitis

M77.9 Other unspecified

Capsule, Periarthritis, Tendonitis, Tendopathy, Periarthropathy

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

R51 Headache

Pain in the head, Cephalgia, Pain with sinusitis, Pain in the back of the head, Painful headache, Headache of vasomotor genesis, Headache of vasomotor origin, Headache with vasomotor disorders, Headache, Neurological headache, Serial headache

R52.0 Acute pain

Acute pain syndrome, Acute pain syndrome with osteoarthritis, Acute pain syndrome of traumatic origin, Severe pain of a neurogenic nature, Severe pain, Pain syndrome at delivery

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of the joint of the unspecified area of the body

Painful stretching of muscles, Pain and inflammation in tension, Dislocation of dislocation, Degenerative changes in the ligamentous apparatus, Edema due to sprains and bruises, Edema after interventions for sprains, Damage and rupture of ligaments, The musculoskeletal system is damaged, Damage to ligaments, Damage to the joints, Ligament ruptures, Tendon tendons,Ruptures of the tendons of muscles,Stretching, Crick, Stretching of the muscle, Sprain, Tension of the tendons, Extensions,Stretch muscles, Sprains, Tension of the tendons, Injury of the musculoskeletal system, Injuries to the joints, Injuries of capsule-articular tissues, Injuries of the osteoarticular system, Injuries to ligamentsInjuries to the joints, Joint wounds, Stretching of the ligamentous apparatus, Habitual stretching and tearing

T14.6 Injury of muscles and tendons of unspecified body region

Pain syndrome in the pathology of tendons, Pain in tendons, Pre-inflammatory soft tissue inflammation, Muscle rupture, Rupture of muscles without compromising the integrity of the skin, Muscle ruptures, Soft tissue injuries, Injuries of muscle-tendon tissues, Muscle injuries, Soft tissue injuries, Injuries to tendons

T14.9 Injury unspecified

Pain syndrome after trauma, Pain syndrome with injuries, Pain syndrome with trauma and after surgery, Pain in case of injury, Pain of a traumatic nature, Joint pain with injuries, Postoperative and post-traumatic pain, Pain in case of injury, Pain of a traumatic origin, Severe pain syndrome of traumatic origin, Deep tissue damage, Deep scratches on the trunk, Closed injury, Minor Household Injuries, Minor skin damage, Violations of the integrity of soft tissues, Uncomplicated trauma, Extensive traumatic injury, Acute pain syndrome of traumatic origin, Edema with trauma, Postponed sports injuries, Post-traumatic pain, Soft tissue injuries, Joint wounds, Sports injuries, Injury, Traumatic pain, Traumatic pains, Traumatic infiltrate,Injuries to sports

T88.9 Complication of surgical and medical care, unspecified

Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after the removal of hemorrhoids, Pain in the application of excimer laser, Pain with injuries and after surgical interventions, Pain syndromes in the dental practice, Painful diagnostic intervention, Painful diagnostic manipulations, Painful instrumental diagnostic procedures, Painful instrumental manipulation, Painful treatments, Painful manipulations, Painful dressings, Painful therapeutic interventions, Pain in the area of the surgical wound, Pain in the postoperative period, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain during diagnostic procedures, Pain during therapeutic procedures, Pain in orthopedics, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, The pain after dental surgery, postoperative Pain, Pain postoperative and posttraumatic, The pain of tooth extraction, Inflammation after surgery or injury, Inflammation after orthopedic surgery, Inflammation after surgery, The inflammatory syndrome after surgery, Festering postoperative fistula, Operating wound, Complications after tooth extraction

Code CAS51803-78-2

Characteristics of Nimesulide

NSAIDs from the class of sulfonamides.

Pharmacology

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Pharmacodynamics

Granules for oral suspension, tablets

Inhibits the enzyme COX, responsible for the synthesis of PG, mainly COX-2 - an enzyme involved in the synthesis of PG mediators of edema, inflammation and pain in the focus of inflammation.

Reversibly inhibits the formation of PGE2, both in the focus of inflammation, and in the ascending pathways of the nociceptive system, including ways of carrying painful spinal cord impulses. Reduces the concentration of short-lived PGH2, from which, under the action of progaglandine isomerase, PGE2 is formed. Reduction of the concentration of PGE2 leads to a decrease in the activation of prostanoid EP receptors, which is expressed in analgesic and anti-inflammatory effects. Inhibits the release of TNF-α, which causes the formation of cytokinins.

Suppresses the release of histamine, inhibits the synthesis of IL-6 and urokinase, thereby inhibiting the destruction of cartilaginous tissue. Inhibits the synthesis of metalloproteases (elastase, collagenase), preventing the destruction of proteoglycans and cartilaginous collagen. Interacts with glucocorticoid receptors, activating them by phosphorylation, which also enhances its anti-inflammatory effect. Suppresses the aggregation of platelets.

Gel for external use

With topical application it causes a weakening or disappearance of pain in the place of application of the gel, incl. pain in the joints at rest and during movement, reduces the morning stiffness and swelling of the joints. Promotes an increase in the volume of movements.

Pharmacokinetics

Granules for suspension for oral administration

Suction. After ingestion, nimesulide is well absorbed from the gastrointestinal tract, reaching Cmax in the blood plasma after 2-3 hours.

Distribution. Communication with plasma proteins - 95%, red blood cells - 2%, lipoproteins - 1%, acid alpha 1-glycoproteids - 1%. 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 the BBB.

Metabolism. Metabolised in the liver with the cytochrome P450 isoenzyme CYP2C9. The main metabolite is the pharmacologically active parahydroxy derivative of nimesulide - hydroxynimidesulide.

Excretion. T1 / 2 nimesulide is 1.56-4.95 h, hydroxynimidesulide - 2.89-4.78 h. Nimesulide is excreted mainly by the kidneys (about 50% of the dose taken). Hydroxynimidesulide is excreted by the kidneys (65%) and bile (35%), is subjected to enterohepatic recirculation.

The pharmacokinetic profile of nimesulide in elderly patients does not change with the administration of single and multiple / repeated doses.

According to an experimental study conducted with the participation of patients with mild and moderate severity of renal insufficiency (Cl creatinine 30-80 ml / min) and healthy volunteers, Cmax nimesulide and its metabolite in the plasma of patients did not exceed the concentration of nimesulide in healthy volunteers. AUC and T1 / 2 in patients with renal insufficiency were 50% higher, but within pharmacokinetic values. When re-admission nimesulid cumulation is not observed.

Pills

Suction. After ingestion, nimesulide is well absorbed from the digestive tract. Eating lowers the absorption rate without affecting its degree. Tmax - 1,5-2,5 h. Cmax of nimesulide in blood plasma reaches 3.5-6.5 mg / l.

Distribution. The connection with plasma proteins is 95%, erythrocytes - 2%, lipoproteins - 1%, acid alpha 1-glycoproteids - 1%. The dose does not affect the degree of binding to blood proteins. Vd - 0,19-0,35 l / kg. Penetrates into the tissue of the female genital organs, where after a single intake the 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 the BBB.

Metabolism. Metabolized in the liver by tissue monooxygenases. The main metabolite (25%) - 4-hydroxynimidesulide - has a similar pharmacological activity.

Excretion. T1 / 2 nimesulide is 1.56-4.95 h, 4-hydroxynimidesulide - 2.89-4.78 h. 4-Hydroxynymesulide is excreted by the kidneys (65%) and with bile (35%), is subjected to enterohepatic recirculation.

Pharmacokinetics in special clinical cases. In patients with mild or moderate impairment of renal function (Cl creatinine 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.

Gel for external use

When applying the gel, the concentration of the active substance in the systemic blood flow is extremely low. Cmax nimesulide in blood plasma after a single application is noted towards the end of the first day, its value is more than 300 times lower than that for oral dosage forms of nimesulide. Traces of the main metabolite of nimesulide (4-hydroxynimidesulide) in the blood are not detected.

Application of Nimesulide

Granules for suspension for oral administration

Acute pain (pain in the back, lower back, pain syndrome in the pathology of the musculoskeletal system, including trauma, sprains and joints, tendenitis, bursitis, toothache), symptomatic treatment of osteoarthritis with pain syndrome, algodismenorea.

Pills

Rheumatoid arthritis, articular syndrome with exacerbation of gout, psoriatic arthritis, ankylosing spondylitis, osteochondrosis with radicular syndrome, osteoarthritis, myalgia of rheumatic and non-rheumatic genesis, inflammation of ligaments, tendons, bursitis, incl. posttraumatic inflammation of soft tissues, pain syndrome of various genesis (including in the postoperative period, with trauma, algodismenorea, toothache, headache, arthralgia, lumboeishalgia).

Gel for external use

Acute and chronic inflammatory diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammatory defeat of ligaments and tendons, bursitis, sciatica, lumbago), muscular pain of rheumatic and non-rheumatic origin, post-traumatic inflammation of soft tissues and the musculoskeletal system (injuries and ligament ruptures, bruises).

In all dosage forms, nimesulide is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Contraindications

Granules for oral suspension, tablets

Hypersensitivity, a complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in the anamnesis), erosive and ulcerative changes in the mucous membrane of the stomach and duodenum, active gastrointestinal bleeding, cerebrovascular or other bleeding, inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the phase of exacerbation, hemophilia and other disorders of blood coagulability, decompensated heart liver failure, or any active liver disease, anamnestic data on the development of hepatotoxic reactions with nimesulide, alcoholism, drug addiction, severe renal failure (Cl creatinine <30 ml / min), progressive kidney disease, confirmed hyperkalemia, post-coronary artery bypass grafting , simultaneous reception of other hepatotoxic drugs, pregnancy and the period of breastfeeding, children under 12 years.

Gel for external use

Hypersensitivity, incl. to other NSAIDs, a complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (in the anamnesis), erosive and ulcerative lesions of the gastrointestinal tract in the acute stage, dermatosis, epidermal damage and skin infection in the area of application, renal failure of severe degree (Cl creatinine <30 ml / min), severe hepatic insufficiency, pregnancy and breast-feeding period, children under 12 years.

Restrictions for use

Granules for oral suspension, tablets

Arterial hypertension; diabetes; compensated heart failure; IHD; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diseases of peripheral arteries; smoking; renal failure (Cl creatinine 30-60 ml / min); anamnestic data on the presence of ulcerative lesions of the gastrointestinal tract, infection caused by Helicobacter pylori; elderly age; prolonged previous use of NSAIDs; severe physical illness; concomitant therapy with anticoagulants (eg warfarin), antiplatelet agents (eg acetylsalicylic acid, clopidogrel), oral GCS (eg prednisolone), SSRIs (eg citalopram, fluoxetine, paroxetine, sertraline).

The decision to prescribe nimesulide in oral form should be based on an individual risk-benefit assessment.

Gel for external use

Erosive-ulcerative lesions of the gastrointestinal tract in the anamnesis (including peptic ulcer of the stomach and duodenum); hepatic and renal failure of mild to moderate severity; severe heart failure; arterial hypertension; elderly age; children age over 12; diabetes; violation of blood clotting (including hemophilia, lengthening of bleeding time, tendency to bleeding).

pregnancy and lactation

The use of nimesulide is contraindicated in pregnancy and during breastfeeding. If breastfeeding is necessary, breastfeeding should be discontinued.

The use of nimesulide may adversely affect fertility in women and is not recommended for women planning a pregnancy.

Side effects

The incidence of adverse reactions is classified as follows: very often (> 1/10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000); the frequency is unknown (the frequency can not be calculated from the available data).

Granules for oral suspension, tablets

From the blood and lymphatic system: rarely - anemia, eosinophilia; very rarely - thrombocytopenia, agranulocytosis, pancytopenia, purpura thrombocytopenic.

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

From the skin and subcutaneous tissues: infrequently - itching, rash, increased sweating; rarely - erythema, dermatitis; very rarely - urticaria, angioedema, swelling of the face, multiforme exudative erythema, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

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

From the senses: rarely - blurred vision.

From the CCC: infrequent - increased blood pressure; rarely - tachycardia, lability of blood pressure, hot flashes, sensation of palpitations.

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

From the digestive tract: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, dyspepsia, stomatitis, tarry stool, gastrointestinal bleeding, ulceration of the mucosa and / or perforation of the stomach or duodenum.

From the side of the liver and biliary tract: often - an increase in the level of hepatic transaminases; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis.

From the side of the kidneys and urinary tract: rarely - dysuria, hematuria, urinary retention, hyperkalemia; very rarely - renal failure, oliguria, interstitial nephritis.

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

Gel for external use

From the skin and subcutaneous tissues: infrequently - itching, burning, swelling; very rarely - moderate or severe skin irritation, hyperemia, rash, desquamation, peeling, erythema.

With external use of nimesulide, the occurrence of systemic side effects is lower than with oral administration. However, one should keep in mind the possibility of systemic side effects if nimesulide is used in large areas for a long time and at high doses.

Interaction

Granules for oral suspension, tablets

GCS. Increase the risk of gastrointestinal ulcers or bleeding.

Antiplatelet agents and SSRIs. Increase the risk of gastrointestinal bleeding.

Anticoagulants. NSAIDs can enhance the action of anticoagulants, such as warfarin. Because of the increased risk of bleeding, this combination is not recommended and is contraindicated in patients with severe coagulation disorders. If combined therapy can still be avoided, careful monitoring of blood coagulation should be carried out.

Diuretics. NSAIDs may reduce the effect of diuretics. In healthy volunteers, nimesulide temporarily reduces the excretion of sodium by furosemide, to a lesser extent - potassium, and reduces the actual diuretic effect. The simultaneous administration of nimesulide and furosemide results in a decrease (approximately 20%) in AUC and a decrease in cumulative furosemide excretion without altering the renal clearance of furosemide. Co-administration of furosemide and nimesulide requires caution in patients with impaired renal or cardiac function.

ACE inhibitors and angiotensin II receptor antagonists. NSAIDs can reduce the effect of antihypertensive drugs. In patients with mild to moderate renal failure (Cl creatinine 30-80 ml / min), concomitant administration of ACE inhibitors, angiotensin II receptor antagonists, or COX-suppressing agents (NSAIDs, antiaggregants) may further impair kidney function and the onset of acute renal failure, which, as a rule, happens to be reversible. These interactions should be considered in patients taking nimesulide in combination with ACE inhibitors or angiotensin II receptor antagonists. Therefore, joint use of these drugs should be administered with caution, especially elderly patients. Patients should receive a sufficient amount of fluid, the renal function should be carefully monitored after the initiation of co-therapy.

Lithium preparations. There is evidence that NSAIDs decrease lithium clearance, which leads to an increase in the concentration of lithium in the blood plasma and its toxicity. When nimesulide is prescribed, patients receiving lithium therapy should be monitored regularly for plasma lithium concentrations.

Clinically significant interactions with glibenclamide, theophylline, digoxin, cimetidine and antacid drugs (for example, a combination of aluminum and magnesium hydroxide) were not observed.

Nimesulide inhibits the activity of the isoenzyme CYP2C9. At simultaneous reception with nimesulid LS, metabolized with participation of this isoenzyme, their concentration in plasma can increase.

With simultaneous use with antiepileptic (valproic acid), antifungal (ketoconazole), anti-tuberculosis (isoniazid) drugs, amiodarone, methotrexate, methyldopa, amoxicillin in combination with clavulanic acid, additive hepatotoxic effect is possible.

Because of the high degree of binding of nimesulide to plasma proteins, patients taking sulfonilamides at the same time should be under the supervision of a doctor, undergoing a survey at short intervals. Caution is required when administering nimesulide less than 24 hours before or after taking methotrexate. in such cases, the concentration of methotrexate in the plasma and, accordingly, its toxic effects may increase. In connection with the effect on renal PG, the inhibitors of PG synthetases, to which nimesulide belongs, may increase the nephrotoxicity of cyclosporins.

In vitro studies have shown that nimesulide is displaced from the binding sites by tolbutamide, salicylic acid. Despite the fact that these interactions were determined in blood plasma, these effects were not observed in the clinical use of nimesulide.

Gel for external use

With external use, nimesulide does not cause a clinically significant effect on the metabolism of other drugs.

In the case of prolonged use of nimesulide in the form of a gel at maximum doses, interactions with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, hypotensive and antidiabetic drugs can not be ruled out. Before using the gel, you should consult your doctor if you are using these drugs or are under medical supervision.

Overdose

Granules for oral suspension, tablets

Symptoms: apathy, drowsiness, nausea, vomiting, pain in the epigastric region. There may be a gastrointestinal bleeding. In rare cases, it is possible to raise blood pressure, acute renal failure, respiratory depression and coma, anaphylactoid reactions.

Treatment: symptomatic. There is no specific antidote. In case an overdose has occurred within the last 4 hours, it is necessary to induce vomiting and / or to receive activated charcoal (from 60 to 100 g per adult) and / or osmotic laxative. Forced diuresis, hemodialysis are ineffective due to the high binding of nimesulide to plasma proteins.

Gel for external use

Cases of overdose of nimesulide in external application have not been described.

When large amounts of gel (exceeding 50 g) are applied to large areas of the skin or if it is accidentally ingested, systemic adverse reactions (nausea, vomiting) may develop.

Treatment: gastric lavage, induction of vomiting, activated charcoal, forced diuresis, symptomatic therapy. There is no specific antidote. It is necessary to consult a doctor.

Routes of administration

Inside, externally.

Precautions for the substance Nimesulide

Granules for oral suspension, tablets

Nimesulide should be used with caution in patients with gastrointestinal ailments in history (ulcerative colitis, Crohn's disease), as possible exacerbation of these diseases.

The risk of gastrointestinal bleeding, ulcers / perforations of the stomach or duodenum increases with an increase in the dose of NSAIDs in patients with a history of stomach ulcer or duodenal ulcer, especially complicated by bleeding or perforation, and in elderly patients, so treatment should be started with the least possible dose. In patients receiving drugs, reducing blood clotting or suppressing platelet aggregation, the risk of gastrointestinal bleeding also increases. In the event of gastrointestinal bleeding or gastric or duodenal ulcers in patients taking nimesulide, treatment should be discontinued.

When nimesulide is used for more than 2 weeks, it is necessary to monitor the liver function (activity of hepatic transaminases).

If signs of liver damage (itchy skin, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of the urine, increased activity of liver transaminases), stop taking nimesulide and consult your doctor.

Patients with hypertension, cardiac disorders, cerebrovascular diseases nimesulide should be administered with caution. If the condition worsens, treatment with nimesulide should be discontinued.

Since nimesulide is partially excreted by the kidneys, its dose for patients with impaired renal function should be reduced depending on the creatinine clearance values. In case of impaired renal function, nimesulide should be discontinued.

Nimesulide can alter the properties of platelets, so care must be taken when using it in people with hemorrhagic diathesis, but nimesulide does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

During treatment with nimesulide, it is recommended to avoid 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.

Elderly patients are particularly prone to adverse reactions to NSAIDs, incl. risk of gastrointestinal bleeding and perforations of the gastrointestinal tract, threatening the patient's life, as well as worsening of kidney, liver and heart function. When taking nimesulide in this category of patients requires regular clinical monitoring of their condition.

The risk of gastrointestinal bleeding, ulceration or perforation upgraded to high doses of nimesulide in patients with gastric ulcer or duodenal ulcer history, in the elderly. These patients should begin treatment with the lowest dose. In these patients, as well as individuals who take nimesulide in conjunction with cardiac doses of acetylsalicylic acid, combined therapy with gastroprotectors (proton pump inhibitors or misoprostol) should be used.

To reduce the risk of adverse events, a minimally effective dose of nimesulide should be used with the minimum possible short course.

Impact on the ability to manage vehicles and mechanisms. The influence of nimesulide on the ability to drive vehicles and control mechanisms has not been studied, therefore, during the treatment period, care should be taken when driving vehicles and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Gel for external use

Do not apply gel on mucous membranes, eyes, damaged and infected skin areas affected by skin diseases of the area and open wounds. After applying the gel, wash your hands with soap and water. Do not apply an occlusive dressing after applying the gel.

When nimesulide is applied in the form of a gel, an intense burning sensation may occur, which disappears for several days. During the application of the gel and before cleaning hands should not touch sensitive areas of the skin. If you accidentally get the gel on the mucous membranes or sensitive areas of the skin, you should rinse them with plenty of water.

Influence on the ability to drive vehicles, mechanisms. The use of nimesulide in the form of a gel does not affect the ability to drive vehicles and mechanisms.

special instructions

Granules for suspension for oral administration

Since nimesulide in the form of granules containing sucrose (0.15-0.18 XE 100 mg), it should be considered for patients suffering from diabetes and those that comply with low-calorie diet.

Nimesulide in granular form is not recommended for patients with the rare genetic diseases fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

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