Nise: instructions, indications and contraindications

Pharmacological properties of the drug Nise

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.

conclusions

Briefly about the main thing:

1. Nise and Nimulid are drugs from the group of non-steroidal anti-inflammatory drugs. They are prescribed as symptomatic therapy where it is necessary to relieve pain and reduce the inflammatory process.
2. Nise and Nimulid are generics of the original drug Aulin. They contain the same active ingredient, have similar release forms, general indications and contraindications.
3. The effectiveness of nimesulide in Nise has been confirmed by clinical trials.

There is no need to talk about the difference in the effects of the drugs Nise and Nimulid - no studies have been conducted on this issue.

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.

Assessing the effectiveness of drugs

There are more than 100 articles in the PubMed medical database for nimesulide. Several randomized, double-blind, placebo-controlled studies were presented, during which it was proven:

1. Nimesulide can be considered for short-term treatment of pain due to damage to the musculoskeletal system. The drug reliably relieves pain and improves the patient's condition. But for long-term therapy, nimesulide is recommended due to the high risk of side effects.
2. Nimesulide suppresses pain and the development of the inflammatory process in the postoperative period - in particular, in.
3. Nimesulide with pain syndrome in osteoarthritis and other chronic joint diseases - but is used only during exacerbation of the disease.
4. At the beginning of the century, many scientists doubted whether nimesulide in the form of a gel would have an effect. The drug is applied to the skin and, according to pharmacokinetics, practically does not penetrate into the systemic bloodstream. It causes fewer side effects, but does it work at all? A study conducted in 2006: nimesulide applied to the joint area penetrates the synovial fluid and is effective. Of course, the concentration of the drug in the joint cavity will be lower than when taking tablets and suspension, but this is enough to achieve results.
5. In Russian-language literature, nimesulide is used as a strong remedy in the fight against pain and inflammation in diseases of the musculoskeletal system. It has been proven that the drug does its job better than many other NSAIDs.

A comparative analysis of drugs based on nimesulide (Nise and Nimulid) is not presented in the medical literature. There is no data on which agent works better in vitro and in clinical practice.

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: on 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: 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.

Adverse reactions and overdose

Clinical studies have shown that use of the drug in high dosages may increase the risk of developing diseases caused by arterial thrombosis. During therapeutic manipulations, patients experienced swelling, increased blood pressure, and heart failure.

Common adverse reactions to Nise include:

• bleeding from the gastrointestinal tract;
• peptic ulcers, gastric perforation;
• attacks of vomiting with nausea;
• active gas formation, diarrhea;
• dyspeptic disorders;
• pain in the abdominal area;
• tarry stools, ulcerative stomatitis.

The development of gastritis was observed less frequently in patients.

Accidentally exceeding the prescribed amount of Nise can cause drowsiness, apathy, discomfort in the epigastric region, vomiting with nausea. These phenomena are reversible and can be treated with symptomatic treatment.

Sometimes there is an increase in blood pressure, respiratory depression, bleeding from the gastrointestinal tract, and coma. An overdose of NSAIDs threatens the development of allergic reactions, including angioedema and anaphylaxis.

The pathological condition is treated with maintenance therapy using activated carbon (1 tablet per 10 kg of body weight) or an osmotic laxative. At the same time, renal and hepatic functionality is monitored.

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 the speed of reaction when driving a vehicle or working with other mechanisms. Throughout treatment, care must be taken when driving a vehicle and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

What's inside: composition and form of release of drugs

Nise and Nimulid have a lot in common:

1. They belong to one pharmaceutical group - non-steroidal anti-inflammatory drugs (NSAIDs).
2. They contain one active ingredient – ​​nimesulide.
3. Dispensed at the pharmacy with a prescription. Such restrictions are associated with a large number of side effects due to uncontrolled use of drugs.

Medicines differ in the form of release. Nimulid is presented in film-coated tablets and lozenges. This is convenient - not all people can swallow the drug without chewing. There is also a suspension - it is usually prescribed to children. For external use, a gel is used.

Nise is also available in tablets, including dispersible ones - that is, capable of dissolving in the mouth and not requiring swallowing. There is no ready-made suspension - it is obtained from granules. A gel is used externally to treat muscles and joints.

Nise is produced by Dr. Reddy's Laboratories Ltd, Nimulid - Panacea Biotec. Both companies are based in India. The cost of the drugs is almost the same and amounts to 150-450 rubles, depending on the form of release.

Nise and Nimulid are generics of the original drug Aulin (Ireland). In comparison with the original, the following important points need to be taken into account:

1. A generic medicine, by definition, contains the same active ingredient as the original medicine.
2. The generic differs in its production technology and content of excipients.
3. The original drug undergoes a full cycle of clinical trials confirming its effectiveness and safety. This is not necessary for a generic. On the territory of Russia, it is enough that the reproduced drug has the same composition and does not differ in the rate of absorption and excretion. These parameters are assessed in laboratory conditions - in vitro and on experimental animals. Clinical trials on human volunteers are not usually conducted for generic drugs. As a result, the production costs of generics are lower, which means the price of the drug will be lower.

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, epigastric pain, 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.

Application diagram

Nimesulide and Nise are prescribed according to the same regimen and have common indications:

1. systemic connective tissue diseases - exacerbation of rheumatoid arthritis, gout, ankylosing spondylitis, psoriatic arthritis, etc.;
2. diseases of the spine with pain syndrome – osteochondrosis with damage to the nerve roots;
3. joint diseases - arthritis, osteoarthritis of various origins;
4. inflammatory processes in muscles, ligaments, periarticular tissues;
5. pain syndrome in gynecology – in complex therapy of diseases of the uterus and appendages, algodismenorrhea;
6. pain syndrome in the postoperative period;
7. toothache.

Nimesulide is prescribed where pain and inflammation need to be relieved. The drug also reduces body temperature, but this effect is considered auxiliary. Nimesulide is not prescribed as an antipyretic for respiratory infections and other similar conditions.

It is important to remember: the drug only relieves symptoms, but does not cure the disease. It alleviates the patient's condition, but does not eliminate the cause and does not affect the mechanisms of disease development.

The dosage and duration of treatment is determined by the doctor. Usually the drug is prescribed 2 times a day. The dose and frequency of administration of the drug cannot be exceeded - the risk of adverse reactions increases. The course of therapy lasts 5-7 days.

Long-term treatment with nimesulide is dangerous and can lead to disruption of the functioning of internal organs and the hematopoietic system. If you need to take the drug for more than 7-14 days, monitor the parameters of a general blood test, liver and kidney function.