Nise tablets: instructions for use. What Nise tablets help from: instructions for use Nise tablets method of application

Nise is a drug with antipyretic, analgesic and anti-inflammatory effects.

Release form and composition

Nise is produced in the following dosage forms:

  • Tablets: white with a yellowish tinge, biconvex, round, with a smooth surface (10 pieces in blisters, 1-2, 10 blisters in a carton box);
  • Dispersible tablets: light yellow, in the shape of the letter "D", with beveled edges, one side is smooth, on the other - embossed "NK" (10 pieces in blisters, 1-2, 10 blisters in a carton box);
  • Suspension: yellow with a characteristic taste and pleasant smell, redispersible when shaken (60 ml in vials);
  • Gel for external use 1%: transparent, light yellow or yellow, free from admixture of foreign particles (20 or 50 g in laminated aluminum tubes, 1 tube in a carton box).

The composition of 1 tablet includes:

  • Active ingredient: nimesulide - 100 mg;
  • Auxiliary components: talc - 1 mg; calcium hydrophosphate - 75 mg; microcrystalline cellulose (type 114) - 40 mg; magnesium stearate - 3 mg; corn starch - 54 mg; sodium carboxymethyl starch - 35 mg; colloidal silicon dioxide - 2 mg.

The composition of 1 dispersible tablet includes:

  • Active ingredient: nimesulide - 50 mg;
  • Auxiliary components: talc - 0.5 mg; microcrystalline cellulose - 38 mg; calcium dihydrogen phosphate - 35 mg; sodium carboxymethyl starch - 28.5 mg; corn starch - 25.5 mg; magnesium stearate - 1.5 mg; colloidal silicon dioxide - 3.5 mg; pineapple flavor - 5 mg; aspartame - 7.5 mg;

The composition of 1 ml suspension includes:

  • Other Ingredients: Sorbitol, Sucrose, Propylparaben, Methylparaben, Pineapple Flavor, Xanthan Gum, Citric Acid, Quinoline Yellow WS, Glycerin, Polysorbate 80, Purified Water.

The composition of 1000 mg of gel includes:

  • Active ingredient: nimesulide - 10 mg;
  • Auxiliary components: N-methyl-2-pyrrolidone - 250 mg; propylene glycol - 100 mg; macrogol - 315.5 mg; isopropanol - 100 mg; carbomer 940 - 20 mg; butylhydroxyanisole - 0.2 mg; thiomersal - 0.1 mg; potassium dihydrogen phosphate - 0.2 mg; flavor (Narcissus-938) - 4 mg; purified water - 200 mg.

Indications for use

Nise (orally or externally) is prescribed for symptomatic treatment, reducing pain and inflammation in the following diseases:

  • Rheumatoid and psoriatic arthritis;
  • Arthralgia;
  • Articular syndrome with exacerbation of gout and rheumatism;
  • Ankylosing spondylitis;
  • Osteochondrosis with radicular syndrome;
  • Osteoarthritis;
  • Radiculitis;
  • Lumbago;
  • Sciatica;
  • Arthritis of various etiologies;
  • Bursitis, inflammation of the tendons and ligaments;
  • Myalgia of non-rheumatic and rheumatic origin;
  • Post-traumatic inflammation of soft tissues and the musculoskeletal system (ruptures and injuries of ligaments, bruises);
  • Pain syndrome of various origins (including algomenorrhea, toothache and headache, pain during injuries, in the postoperative period);
  • Fever of various origins (including those arising from infectious and inflammatory diseases).

Nise has no effect on the progression of the disease.

Contraindications

  • The combination of intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs with bronchial asthma (complete or incomplete) and recurrent polyposis of the nose or paranasal sinuses (including history);
  • Erosive and ulcerative changes in the mucous membrane of the stomach and duodenum;
  • Active gastrointestinal bleeding;
  • Severe renal failure (with creatinine clearance less than 30 ml per minute);
  • liver failure or any active liver disease;
  • Damage to the epidermis, dermatosis and infections of the skin in the area of ​​application (gel for external use);
  • Pregnancy and lactation;
  • Age up to 2 years for suspension, 3 years for dispersible tablets, 7 years for topical gel and 12 years for tablets;
  • Hypersensitivity to the components of the drug.

Additional contraindications to the use of Nise in the form of tablets are:

  • Inflammatory bowel disease (including nonspecific ulcerative colitis, Crohn's disease) in the acute phase;
  • Cerebrovascular or other bleeding;
  • Hemophilia and other bleeding disorders;
  • Hepatotoxic reactions when using nimesulide preparations (if there are indications in the anamnesis);
  • Decompensated heart failure;
  • Confirmed hyperkalemia;
  • progressive kidney disease;
  • Simultaneous use with potentially hepatotoxic substances;
  • Drug addiction, alcoholism;
  • The period after coronary artery bypass grafting.

Nise tablets should be taken with caution in the presence of the following diseases/conditions:

  • Cardiac ischemia;
  • Diseases of the brain caused by pathological changes in cerebral vessels with impaired cerebral circulation (cerebrovascular diseases);
  • congestive heart failure;
  • Arterial hypertension;
  • Hyperlipidemia/dyslipidemia;
  • Diabetes;
  • Diseases of peripheral arteries;
  • Renal failure with creatinine clearance less than 60 ml per minute;
  • Ulcerative lesions of the gastrointestinal tract (indications in history);
  • Presence of Helicobacter pylori infection;
  • Somatic diseases with a severe course;
  • Simultaneous use with anticoagulants (for example, warfarin), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone);
  • Prolonged use of non-steroidal anti-inflammatory drugs;
  • Elderly age;
  • Frequent drinking, smoking.
  • Arterial hypertension;
  • Heart failure;
  • Diabetes mellitus type 2 (non-insulin dependent).

Externally, Nise should be used with caution in the presence of diseases / conditions such as:

  • Hepatic, renal and severe heart failure;
  • Type 2 diabetes;
  • Arterial hypertension;
  • Elderly and children's age.

Method of application and dosage

Nise should be used at the lowest effective dose for the shortest possible time.

The tablets should be taken with a sufficient amount of water.

Nise in the form of tablets and suspensions is preferably taken before meals, but if you feel discomfort in the stomach or the presence of diseases of the gastrointestinal tract, you can take it at the end of the meal or after it. Dispersible tablets should be taken at the end or after a meal, after dissolving a single dose in 1 teaspoon (5 ml) of water.

Adults and children from 12 years of age are prescribed Nise 2 times a day for 100 mg (1 tablet). The maximum dose is 2 tablets per day. In chronic renal failure, the daily dose should be reduced by 2 times.

Nise children are prescribed 2-3 times a day, 3-5 mg / kg of body weight (maximum - 5 mg / kg). With a body weight of more than 40 kg, the drug is prescribed in an adult dose. When using the drug in children, you need to choose the dosage form according to age: suspension - from 2 years; dispersible tablets - from 3 years; tablets - from 12 years.

Nise in the form of a gel is applied externally, applying (without rubbing) a thin, even layer to the area of ​​\u200b\u200bmaximum soreness. The surface of the skin should be washed and dried beforehand. A single dose is about 3 cm of gel, the frequency of use is 3-4 times a day. The dosage regimen may vary depending on the area of ​​the treated surface and the response to therapy (but not more than 4 times a day).

Nise should not be used for longer than 10 days without medical advice.

Side effects

When using Nise in the form of tablets, the following side effects may develop:

  • Cardiovascular system: infrequently - arterial hypertension; rarely - hemorrhages, tachycardia, hot flashes;
  • Digestive system: often - nausea, diarrhea, vomiting; infrequently - flatulence, constipation, gastritis; very rarely - stomatitis, abdominal pain, gastrointestinal bleeding, tarry stools, ulcers and / or perforation of the stomach or duodenum;
  • Respiratory system: infrequently - shortness of breath; very rarely - bronchospasm, exacerbation of bronchial asthma;
  • Urinary system: infrequently - edema; rarely - dysuria, urinary retention, hematuria, hyperkalemia; very rarely - oliguria, renal failure, interstitial nephritis;
  • Central nervous system: infrequently - dizziness; rarely - a feeling of fear, nightmares, nervousness; very rarely - drowsiness, headache, encephalopathy (Reye's syndrome);
  • Skin: infrequently - itching, increased sweating, rash; rarely - dermatitis, erythema; very rarely - puffiness of the face, erythema multiforme exudative, including Stevens-Johnson and Lyell syndrome;
  • Liver and biliary system: often - increased hepatic transaminases; very rarely - fulminant hepatitis, hepatitis, jaundice, cholestasis;
  • Sense organs: rarely - blurred vision;
  • Organs of hematopoiesis: rarely - eosinophilia, anemia; very rarely - pancytopenia, thrombocytopenia, prolongation of bleeding time, purpura;
  • Allergic reactions: rarely - hypersensitivity reactions; very rarely - angioedema, urticaria, anaphylactoid reactions;
  • Others: rarely - general weakness; very rarely - hypothermia.

When using Nise in the form of dispersible tablets, the following disorders may develop:

  • Central nervous system: dizziness, headache;
  • Digestive system: diarrhea, heartburn, vomiting, nausea, pain in the stomach, toxic hepatitis, erosive and ulcerative lesions of the gastrointestinal tract, increased activity of hepatic transaminases;
  • Hematopoietic system: thrombocytopenia, anemia, leukopenia, agranulocytosis;
  • Allergic reactions: skin rash, anaphylactic shock, bronchospasm;
  • Others: fluid retention, prolongation of bleeding time, hematuria.

Nise in the form of a suspension is usually well tolerated by patients. In some cases, there may be: nausea, stomach pain, vomiting, diarrhea, urticaria, itching, bronchospasm.

When using an external gel, local reactions may develop in the form of itching, peeling, urticaria, transient changes in skin color (does not require drug withdrawal). With prolonged therapy or when applied to large areas of the skin, systemic adverse reactions may occur, manifested as heartburn, nausea, diarrhea, vomiting, ulceration of the gastrointestinal mucosa, gastralgia, increased activity of hepatic transaminases, dizziness, headache, fluid retention, hematuria, allergic reactions, leukopenia, thrombocytopenia, agranulocytosis, anemia, prolongation of bleeding time.

In cases of development of any side effects, treatment should be interrupted and a doctor should be consulted.

special instructions

With functional impairment of the kidneys, the dose of Nise should be reduced depending on the value of creatinine clearance.

In cases of any visual impairment, it is necessary to interrupt therapy and consult an ophthalmologist.

With simultaneous use with drugs that affect the gastrointestinal tract, regular medical supervision is required.

Patients with high blood pressure and cardiac disorders should use the drug with extreme caution.

With the development of signs of liver damage (in the form of itching, yellowness of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of hepatic transaminases), it is necessary to stop taking Nise and consult your doctor.

Do not use the drug simultaneously with other non-steroidal anti-inflammatory drugs.

Nise can change the properties of platelets, however, in cardiovascular diseases, it does not replace the preventive effect of acetylsalicylic acid.

After 14 days of using Nise, you need to check the biochemical parameters of liver function.

The gel should not be used under airtight dressings. After applying it, wash your hands with soap and water.

Since, when taken orally, Nise can cause dizziness, drowsiness and blurred vision, during therapy it is recommended to be careful when driving vehicles and performing other types of work that require increased concentration and quick psychomotor reactions.

drug interaction

With the simultaneous use of Nise orally with certain drugs, the following effects may occur:

  • Furosemide: reduction of its action;
  • Methotrexate: increased risk of adverse reactions;
  • Lithium preparations: an increase in the concentration of lithium in plasma;
  • Cyclosporine: increased action on the kidneys;
  • Medicines that reduce blood clotting: strengthening their action;
  • Glucocorticosteroids, serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

When used simultaneously with sulfonamides and hydantoin, patients should be under the supervision of a doctor and undergo examination at short intervals.

When used with drugs that compete for binding to plasma proteins, pharmacokinetic interaction is not excluded.

Nise should be used with caution concomitantly with other non-steroidal anti-inflammatory drugs, cyclosporine, phenytoin, digoxin, lithium preparations, diuretics, methotrexate, hypoglycemic and antihypertensive drugs.

Terms and conditions of storage

Store in a dark, dry place out of the reach of children at temperatures up to 25 °C.

Best before date:

  • Tablets, dispersible tablets, suspension - 3 years;
  • Gel for external use - 2 years.

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Instructions for use:

Nise is a synthetic drug used in the treatment of joint diseases and the reduction of pain of various etiologies.

pharmachologic effect

The active substance of the drug Nise has an analgesic, anti-inflammatory and antipyretic effect.

The drug is effective in processes associated with pain, inflammation and swelling. Nise inhibits platelet aggregation and reduces bronchospasm, which is caused by the action of histamine and acetaldehyde. Also, the drug has an antioxidant effect and slows down the formation of toxins.

When applied topically, Nise is said to relieve pain and swelling in the joints and reduce morning stiffness.

Release form

The drug is produced in several dosage forms:

  • Nise tablets containing 100 mg of the active substance nimesulide, 10 pieces in a blister;
  • Nise dispersible tablets containing 50 mg of the active substance nimesulide, 10 pieces in a blister;
  • Suspensions for oral administration, in 5 ml - 50 mg of nimesulide, in 60 ml vials with a dosing cap;
  • Gel Nise 1% for external use, in 1 g - 10 mg of nimesulide, in aluminum tubes of 20 g.

Indications for use Nise

In any dosage forms, Nise is used for:

  • Rheumatoid and psoriatic arthritis;
  • Radiculitis;
  • Articular syndrome with exacerbation of gout and rheumatism;
  • Ankylosing spondylitis;
  • Osteochondrosis with radicular syndrome;
  • sciatica;
  • Arthritis of various etiologies;
  • Lumbago;
  • Fever of various origins, including infectious and inflammatory diseases;
  • Myalgia of rheumatic and non-rheumatic origin;
  • Post-traumatic inflammation of soft tissues, bruises and injuries and torn ligaments;
  • arthralgia;
  • Osteoarthritis;
  • Inflammation of tendons, ligaments, bursitis;
  • Pain caused by trauma or in the postoperative period, with menstrual, toothache or headache.

Contraindications

According to Nise's instructions, it is contraindicated to take orally with:

  • Erosive and ulcerative lesions and bleeding of the gastrointestinal tract;
  • Impaired liver function;
  • "Aspirin triad";
  • Children's age up to 2 years;
  • Severe renal failure.

Gel Nise is contraindicated in case of damage to the epidermis, dermatoses and skin infections in the area of ​​application.

Nise in any dosage forms is contraindicated for use during pregnancy, lactation, as well as in case of hypersensitivity to nimesulide, acetylsalicylic acid or other components of the drug.

Nise is used with caution in heart failure, arterial hypertension, type 2 diabetes mellitus, visual impairment and kidney function.

Instructions for use Nise

In the form of tablets or suspension, the drug is usually prescribed to adults twice a day, 100 mg, maximum - up to 400 mg. The course of treatment is 10 days.

Children 2-3 years old are allowed to take Nise according to the instructions only in the form of a suspension, 3-12 years old - in the form of a suspension and dispersible tablets, over 12 years old - in the form of tablets.

A single dose for children up to 40 kg is calculated depending on body weight - 3-5 mg per 1 kg of body weight. Take the drug 2-3 times a day. If you weigh more than 40 kg, you can take the adult dose - 100 mg twice a day.

Caution should be exercised when Nise is taken orally with lithium, digoxin, diuretics, antihypertensive drugs, phenytoin, methotrexate, anticoagulants, cyclosporine and oral hypoglycemic agents.

Gel Nise, without rubbing, is applied in a thin layer up to 4 times a day on painful areas.

The maximum daily dose of the drug is 30 g. The course of treatment with Nise gel is 10 days.

Side effects

According to reviews, Nise, when taken orally, can cause the following side effects:

  • Heartburn, nausea and vomiting, stomach pain, erosive and ulcerative lesions of the gastrointestinal tract, diarrhea, increased activity of hepatic transaminases and toxic hepatitis;
  • Fluid retention, hematuria, prolongation of bleeding time;
  • Headache and dizziness;
  • Anaphylactic shock, skin rash or bronchospasm;
  • Leukopenia, thrombocytopenia, anemia or agranulocytosis.

When using Nise in the form of a gel, urticaria, itching, peeling, and a temporary change in skin color are possible.

According to reviews, Nise, when applied to large areas of the skin, can cause the development of systemic adverse reactions.

In case of an overdose of Nise, according to the instructions, convulsions, impaired renal function, respiratory depression, liver failure and increased blood pressure are possible.

Storage conditions

Suspension and tablets Nise belong to the drugs of list B and are dispensed by prescription, the shelf life is up to 3 years. Gel Nise is an over-the-counter drug with a shelf life of 2 years.

Nise is a drug from the group of non-steroidal anti-inflammatory drugs, COX-2 inhibitors.

Release form
Pharmacological effects
Indications and contraindications
Adverse reactions
Interaction with other drugs
Price and reviews

Release form, composition

The active substance of the drug is nimesulide. Microcrystalline cellulose, starch, magnesium stearate, silicon dioxide are used as auxiliary components.

Nise is available in the form of tablets (including soluble ones) for oral administration, suspension, and gel for external application.

Pharmacological effects

Nise is a selective inhibitor of an enzyme that is involved in the formation of prostaglandin, a mediator of inflammation, pain and edema. This drug has a pronounced anti-inflammatory, analgesic, antipyretic effect. The use of nimesulide also contributes to the suppression of platelet aggregation, the release of histamine, and a decrease in the degree of bronchospasm.

Nimesulide also prevents the development of the process of destruction of cartilaginous tissues, has an antioxidant effect and is involved in the production of elastase and collagenase.

When applied topically, Nise eliminates pain in the area of ​​application of the gel, including joint pain that occurs at rest or when moving, helps to eliminate morning stiffness and eliminates swelling of the joint.

Excretion of the drug is carried out through the kidneys and bile.

Indications for use

Before using Nise in any dosage form, the patient should be informed that this drug is used only for symptomatic treatment.

This medicine does not affect the systemic course of the disease.

Indications for the use of the drug Nise in the form of a gel are:

  • carrying out local symptomatic therapy of the inflammatory process and pain syndrome in the joints;
  • complex therapy of arthritis: rheumatoid, psoriatic;
  • osteoarthritis and osteochondrosis;
  • radiculitis;
  • sprains;
  • bursitis;
  • muscle pain of a rheumatic and non-rheumatic nature;
  • soft tissue injuries - ruptures, bruises.

Nise in the form of tablets for oral administration is indicated for use in the following conditions:

  • with rheumatoid arthritis;
  • articular syndrome;
  • with exacerbation of gout;
  • with osteochondrosis and osteoarthritis;
  • myalgia and spondylitis;
  • with inflammation of the ligaments and tendons;
  • to eliminate pain of various origins (including dental, headache).

In the treatment of diseases of the spine, you can combine the use of drugs in the form of tablets for oral administration and in the form of a gel.

Contraindications

Nise in the form of tablets is contraindicated for use in:

  • incomplete combination of polyposis of the nasal sinuses and nose, bronchial asthma and individual intolerance to aspirin (as well as other drugs from the group of non-steroidal anti-inflammatory drugs);
  • in case of ulcerative lesions of the stomach and duodenum;
  • with the development of gastric bleeding;
  • with inflammatory diseases of the gastrointestinal tract;
  • with diseases of the hematopoietic system;
  • in case of development of heart failure;
  • with serious violations of the normal functioning of the kidneys and liver;
  • under the age of 12.

The drug in the form of tablets is prescribed with extreme caution for ischemic heart disease, angina pectoris, diabetes mellitus, peptic ulcer, in old age, and also if the patient is a smoker.

Caution is also required in cases where the patient additionally takes drugs from the group of anticoagulants, corticosteroids, antiplatelet agents.

Use during pregnancy

The use of the drug Nise is contraindicated during the period of bearing a child. In the event that the use of this drug during lactation is required, consideration should be given to stopping breastfeeding.

Adverse reactions

The drug Nise, intended for oral administration, can provoke the development of undesirable side reactions:

  • heartburn, nausea, vomiting, pain in the intestines, the development of ulcerative lesions and other side effects from the gastrointestinal tract;
  • headache and dizziness;
  • development of thrombocytopenia, anemia, leukopenia;
  • allergic manifestations: itching, urticaria, redness of the skin;
  • fluid retention;
  • the drug may increase the duration of bleeding.

Nise gel can cause the development of allergic manifestations at the site of application of the drug: itching, urticaria, peeling, discoloration of the skin.

In the event that the patient applies the gel to large areas of the skin, the risk of developing systemic side effects increases.

Interaction with other groups of drugs

The drug Nise can enter into drug interactions with drugs that include digoxin, lithium, with drugs from the group of hypoglycemic agents, diuretics and non-steroidal anti-inflammatory drugs, anticoagulants, antibacterial drugs (cyclosporins), as well as methotrexate.

Mode of application

Nise in the form of a suspension is recommended to be used before the main meal. However, in the event that the patient develops discomfort or pain in the abdomen, the drug can be taken after meals.

The drug in the form of tablets for oral administration is recommended to be used after the main meal (including for patients with gastrointestinal diseases), drinking plenty of water. In case of violations of the normal functioning of the kidneys, the maximum daily dosage should not exceed 100 mg. For other categories of patients, the maximum daily dose is 200 mg of the drug.

Nise gel must be applied to dry, clean skin. The drug is applied in a thin layer to the area with the maximum manifestation of pain. It is not necessary to rub the drug. Multiplicity of application - up to 4 times a day.

Nise gel can be used for no more than 10 days.

What to do in case of overdose?

To date, no cases of overdose with Nise have been reported. In case of accidental overdose, body reactions such as increased blood pressure, disruption of the normal functioning of the gastrointestinal tract and kidneys, the development of seizures and respiratory depression may develop. In this case, it is recommended to immediately wash the stomach and carry out symptomatic treatment. There is no specific antidote.

Nise is prescribed with caution to patients with a history of impaired renal function and vision problems.

With prolonged use of this drug, systematic monitoring of the condition of the liver and kidneys is required.

In the event that the use of this medication is required in patients of older age groups, then it is not necessary to adjust the dosage.

Since the use of Nise can contribute to the development of dizziness, patients whose activities require increased concentration of attention and a quick psychomotor reaction should be especially careful.

Cost, analogues

The cost of the drug Nise for the period May 2015 is formed as follows:

  • Gel 1%, 20 grams - 160-180 rubles.
  • Gel 1%, 50 grams - 260-290 rubles.
  • Tablets 10 grams, No. 20 - 200-220 rubles.

Analogues of the drug Nise are the following drugs: Nimika, Nimulid, Nimesil, Aponil.

If replacement is necessary, a preliminary consultation with the attending physician is mandatory.

Reviews

The use of Nise for the relief of pain in the lower back has proven to be effective. A pronounced therapeutic effect is observed by the 10th day of taking the drug. In comparison with other drugs from the group of non-steroidal anti-inflammatory drugs, the active ingredient Nise (nimesulide) completely relieves pain and restores posture with fewer side effects (according to research results - 13 to 21).

Patients with a history of osteoarthritis took this drug and noted a decrease in radicular symptoms and an increase in the volume of active movements. The functional state of the spine also improves, according to the Schober test. As a result, high analgesic and anti-inflammatory activity. All this allows Nise to be used in the complex treatment of diseases of the spine with other groups of drugs to eliminate the main symptoms of the disease.

Vera Nikolaevna, doctor

The doctor prescribed oral administration and local use of the drug to eliminate back pain. Very satisfied with this tool. I noted this feature - the local application of the gel allows you to reduce the dosage of tablets and reduces the risk of side effects. The pain syndrome disappears 10 minutes after the application of the drug. If you take another pill - the pain does not make itself felt throughout the day. I use it in conjunction with muscle relaxants and nootropics.

Victoria

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Artrozan injections and tablets - complete instructions for use

Artrozan is an anti-inflammatory non-steroidal agent. It has a pronounced antipyretic and analgesic effect.

Meloxicam is the active ingredient of the drug.

The effect occurs due to inhibition of the activity of cyclooxygenase-2 (COX-2), less affects COX-1, which is involved in the synthesis of prostaglandins (PG).

Pharmacokinetics of the drug

The bioavailability of the active substance Artrozan is 89%. When taken simultaneously with food, the percentage of absorption does not change. Well absorbed in the gastrointestinal tract.

The maximum concentration is reached in 4-5 hours. The half-life is 12-14 hours.

99% percent of meloxicam binds to plasma proteins.

The difference between the maximum and basal concentration in the body is small and is a ratio (2.5:1).

The conditional distribution space is 11 liters. The desired plasma concentration at steady state is reached after 3-5 days.

Excreted equally with urine and feces.

Indications for use

As follows from the instructions, the drug is prescribed for degenerative diseases of the joints, in particular, to relieve acute and chronic pain.

Suitable for arthritis, ankylosing spondylitis, osteoarthritis.

Contraindications

There is also a fairly large number of contraindications:

  • individual hypersensitivity to the components of the drug;
  • children under 15;
  • kidney or liver failure;
  • peptic ulcer of the duodenum or stomach, erosive and ulcerative lesions of the gastrointestinal tract;
  • aspirin asthma;
  • pregnancy, lactation;
  • heart failure.

Medication dosages

Instructions for use for injections and tablets Artrozan indicates that the drug can be used orally, rectally, intramuscularly, depending on the form of release.

The dosage is selected individually, the minimum effective dose is found:

  • the initial dose is - 7.5;
  • taken once a day (7.5 - 15 mg) with meals, without chewing;
  • rectally - 1 suppository per day;
  • when taking tablets and injections intramuscularly together, the daily dosage should not exceed 15 mg;

Release form

Tablets are available in this form:

  • 10 tablets in a blister, 1/2/3/5 blisters in a pack;
  • 15 tablets in a blister, 1/2/3 blister in a pack.

Injections: 2.5 ml ampoules 3/5/10 pieces per pack.

Candles: 7.5-15 mg of the active substance in a candle weighing 25/50/100 mg.

The package contains 10 suppositories.

Ointment: 5% ointment in tubes of 30/50 g.

Overdose and additional instructions

In case of an overdose, nausea, bleeding in the gastrointestinal tract, vomiting, asystole, renal and hepatic failure, loss of consciousness, epigastric pain are observed.

Hemodialysis, forced diuresis and alkalinization of urine are ineffective in case of an overdose of Artrozan, since it has a high binding capacity to blood proteins.

Side effects

Often (1 case per 100) the following side effects occur:

  • dyspepsia, nausea, vomiting;
  • skin rash, itching;
  • dizziness, drowsiness;
  • belching;
  • anemia.

Sometimes (1 in 500):

  • stomach and duodenal ulcer;
  • gastrointestinal bleeding;
  • noise in ears;
  • abscess formation with intramuscular injection;
  • palpitations, hanging blood pressure;
  • exacerbation of bronchial asthma, cough.

Rare (1 case in 5000):

  • photosensitivity;
  • erythema multiforme;
  • toxic epidermal necrolysis;
  • renal medullary necrosis;
  • bullous reactions;
  • disorientation.

Very rare (1 case in 10,000):

  • hyperbilrubinemia;
  • hyperemia of the face;
  • leukopenia;
  • esophagitis;
  • conjunctivitis.

special instructions

It is undesirable to take Artrozan for smokers, patients with alcohol dependence and drug addiction.

The drug is prescribed with caution to patients with diabetes mellitus, with pathology of peripheral arteries.

The medicine reduces blood clotting.

Interaction with alcohol

Severe, unforeseen conditions are possible after taking, in particular, large doses of alcohol, which can be fatal.

Admission for dysfunction of the kidneys and liver

Exacerbation of any kidney or liver disease should be taken into account when planning the use of the drug. And it is possible only with hemodialysis.

Interaction with other drugs

SSRIs, fibrinolytics, vitamin K antagonists, Heparin increase the risk of bleeding.

It is necessary to take intrauterine contraceptives with caution, since Artrozan may reduce the contraceptive effect.

Artrozan reduces the effectiveness of antihypertensive drugs.

When taken simultaneously with diuretics and Cyclosporine, acute renal failure may develop.

Taking Colestyramine accelerates the excretion of meloxicam from the body.

NSAIDs increase the risk of gastrointestinal ulceration.

Admission during pregnancy and lactation

TO it is strictly forbidden to take it to pregnant and lactating women, meloxicam negatively affects the fetus, provokes internal bleeding in the digestive tract, disrupts the normal functioning of the kidneys.

It is not desirable to take the drug for women planning pregnancy, as they reduce female fertility.

How doctors and patients respond about the drug

We offer to study the feedback of doctors and patients who used Artrozan injections or tablets.

What patients say

Doctors' opinion

In general, Artrozan is popular among prescribed non-steroidal anti-inflammatory drugs for the treatment of arthritis and similar diseases by doctors.

Neurologists highly appreciate the drug in the possibility of localization and suppression of acute pain.

Adjusting the dosage or canceling the medication should only be done after consulting a doctor.

It is undesirable to drive a car or work on site with the necessary increased care.

Pros and cons of medication

The downside is the shortage in pharmacies, such a form of Artrozan as gel and suppositories, even with their effectiveness, they occupy a very small niche among anti-inflammatory drugs.

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

The packaging of the drug and its composition

About what helps "Nise" (tablets), we will describe below. The active ingredient in this medicinal product is nimesulide. It also includes such components as microcrystalline cellulose, aspartame, calcium phosphate, colloidal silicon dioxide, corn starch, magnesium stearate, sodium carboxymethyl starch, pineapple flavor and talc.

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

The principle of action of the drug

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

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

It is impossible not to say that this medication inhibits (reversibly) the formation of prostaglandin E2 in the ascending pathways of the nociceptive system and the focus of inflammation, as well as in the pathways for conducting impulses (pain) in the spinal cord.

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

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

The main properties of the drug (NSAIDs)

The drug "Nise" is able to suppress. This happens through inhibition of the synthesis of thromboxane A2 and endoperoxides. In addition, it inhibits the release of histamine and also reduces the degree of bronchospasm, which was caused by exposure to acetaldehyde and histamine.

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

According to the instructions, by reducing the activity of myeloperoxidase, the drug in question exhibits antioxidant properties and slows down the formation of (toxic) O 2 decay products. It interacts with glucocorticoid receptors and activates them, which enhances the anti-inflammatory effect.

Drug Kinetics

After ingestion, the Nise pain reliever is absorbed from the intestines. Eating reduces the rate of absorption of the drug, but does not affect its degree.

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

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

The metabolism of nimesulide is carried out in the liver. Its half-life is 5 hours. It is excreted mainly by the kidneys, and also along with bile.

Indications for taking tablets

What helps "Nise" (pills)? The agent in question is prescribed for:

  • sciatica, rheumatoid arthritis, sciatica;
  • lumbago, osteoarthritis, articular syndrome in rheumatic disease and exacerbation of gout;
  • arthralgia, ankylosing spondylitis;
  • arthritis of various origins, osteochondrosis with radicular syndrome;
  • inflammation of the ligaments, myalgia of non-rheumatic and rheumatic origin, bursitis, inflammation of the tendons;

  • pain syndrome of various origins (including injuries, in the postoperative period, toothache, algomenorrhea, headache);
  • inflammation of the musculoskeletal system, as well as soft tissues.
  • It should also be noted that "Nise" helps well with temperature. This drug is used for fever of various origins, including inflammatory and infectious diseases.

    Contraindications for NSAIDs

    The drug "Nise" during pregnancy is prohibited. Also, it should not be used when:

    • "aspirin triad";
    • erosive and ulcerative lesions of the gastrointestinal tract (with exacerbation);
    • breastfeeding;
    • bleeding from the gastrointestinal tract;
    • impaired liver function;
    • in childhood up to two years;
    • severe renal failure;
    • hypersensitivity.

    With extreme caution, this remedy is prescribed for type 2 diabetes mellitus, arterial hypertension and heart failure.

    How to take "Nise"?

    The medication in question in the form of tablets is prescribed only inside. For adult patients, it is recommended to take 100 mg twice a day. The maximum dosage of the drug per day is 400 mg.

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

    Children do not prescribe the drug in tablets. For them, there is another form of medication - a suspension. It is recommended to take it from the age of two years.

    side effects

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


    Cases of overdose

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

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

    Drug interaction

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

    The drug "Nise": analogues and reviews

    You can replace the remedy in question with such medicines as Nimulide, Aponil, Arcoxia, Mesulid, Meloxicam, Nimesil, Movalis, Nimesulide, Denebol, Nimika.

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

Granules for oral suspension - 1 sachet:

  • active ingredient: nimesulide - 100 mg;
  • excipients: orange flavor, crospovidone, anhydrous citric acid, maltodextrin, sucrose.

Granules for suspension for oral administration, 100 mg.

2 g in a bag of combined material (paper / foil / polyethylene).

9, 15 or 30 bags, together with instructions for use, are placed in a cardboard box.

Description of the dosage form

A mixture of light yellow granules and powder with an orange scent.

pharmachologic effect

Non-steroidal anti-inflammatory drug (NSAID).

Pharmacokinetics

Nimesulide is well absorbed from the gastrointestinal tract (GIT).

The maximum plasma concentration (Cmax) after oral administration of a single dose of nimesulide, which is 100 mg, is achieved on average after 2-3 hours and is 3-4 mg / l. The area under the concentration-time curve (AUC) is 20-35 mg * h / l. Communication with blood plasma proteins - up to 97.5%.

Metabolized in the liver by cytochrome P450 isoenzyme CYP2C9. The main metabolite is the pharmacologically active parahydroxy derivative of nimesulide, hydroxynimesulide, which is found exclusively as glucuronate.

Nimesulide is excreted from the body mainly by the kidneys (about 50% of the dose taken), in a metabolized form, about 29% is excreted through the intestines. The half-life (T1 / 2) is 3.2-6 hours.

The pharmacokinetic profile of nimesulide in the elderly and in patients with mild to moderate renal insufficiency does not change when using single and multiple / repeated doses.

In a study conducted in patients with mild to moderate renal insufficiency (creatinine clearance 30-80 ml / min), Cmax of nimesulide and its main metabolite were not higher than in healthy volunteers. AUC and T1 / 2 were 50% higher, but were within the AUC and T1 / 2 values ​​observed in healthy volunteers while using nimesulide. Repeated use did not lead to cumulation of nimesulide.

Pharmacodynamics

Nimesulide is a non-steroidal anti-inflammatory drug from the sulfonamide class.

It has anti-inflammatory, analgesic and antipyretic effects. Unlike 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).

Indications for use Nise

Acute pain (pain in the back, lower back; pain in the musculoskeletal system, including bruises, sprains and dislocations of the joints; tendinitis, bursitis: toothache).

Symptomatic treatment of osteoarthritis (osteoarthritis) with pain syndrome.

Primary algomenorrhea.

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.

Contraindications to the use of Nise

Hypersensitivity to nimesulide or other components of the drug.

Hyperergic reactions in history (bronchospasm, rhinitis, urticaria) associated with the use of acetylsalicylic acid or other NSAIDs, including nimesulide.

Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses with intolerance to acetylsalicylic acid and other NSAIDs (including history).

Hepatotoxic reactions to nimesulide in history.

Simultaneous use with other drugs with potential hepatotoxicity (for example, other NSAIDs).

Chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase.

The period after coronary artery bypass grafting.

Feverish syndrome with 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.

History of cerebrovascular bleeding or other diseases accompanied by increased bleeding.

Severe bleeding disorders.

Severe heart failure.

Severe renal failure (creatinine clearance

Liver failure or any active liver disease.

Alcoholism, drug addiction.

Hereditary fructose intolerance, sucrase-isomaltase deficiency and glucose-galactose malabsorption syndrome.

Pregnancy and the period of breastfeeding.

Children's age up to 12 years.

Carefully

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

Ulcerative lesion of the gastrointestinal tract in history; an infection caused by Helicobacter pylori in history; elderly age; long-term previous use of NSAIDs; severe somatic diseases.

Simultaneous use with the following drugs: anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

Nise Use in pregnancy and children

Like other drugs from the NSAID class that inhibit prostaglandin synthesis, nimesulide can adversely affect the course of pregnancy and / or embryo development and can lead to premature closure of the ductus arteriosus, hypertension in the fetal pulmonary artery system, impaired renal function, which can turn into renal failure with oliguria in the fetus, an increased risk of bleeding, a decrease in uterine contractility, the occurrence of peripheral edema in the mother.

Data obtained in the course of epidemiological studies indicate a possible increase in the risk of spontaneous abortion, the risk of heart disease and gastroschisis when using drugs that block the synthesis of prostaglandins in early pregnancy. The absolute risk of developing an abnormality of the cardiovascular system increases from about 1% to 1.5%. It is believed that the risk increases with increasing dose and duration of use.

Data on the penetration of nimesulide into breast milk is not available.

The use of nimesulide during pregnancy and during breastfeeding is contraindicated.

The use of nimesulide can adversely affect female fertility and is not recommended for women planning a pregnancy. When planning pregnancy, consultation with your doctor is necessary.

Nise side effects

The frequency of occurrence of adverse reactions is determined in accordance with the recommendations of the World Health Organization: very often (≥ 1/10), often (≥ 1/100 -

Blood and lymphatic system disorders

Rare: anemia, eosinophilia, hemorrhage. Very rare: thrombocytopenia, pancytopenia, thrombocytopenic purpura.

Immune System Disorders

Rare: hypersensitivity reactions. Very rare: anaphylactoid reactions.

Skin and subcutaneous tissue disorders

Infrequently: itching, skin rash, increased sweating. Rare: erythema, dermatitis. Very rare: urticaria, angioedema, facial edema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

Nervous System Disorders

Uncommon: dizziness. Very rare: headache, drowsiness, encephalopathy (Reye's syndrome).

Mental disorders

Rarely: a feeling of fear, nervousness, nightly "nightmares" dreams.

Violations of the organ of vision

Rare: blurred vision. Very rare: blurred vision.

Hearing and labyrinth disorders

Very rare: vertigo.

Heart disorders

Rare: tachycardia, palpitations.

Vascular disorders

Uncommon: increased blood pressure. Rare: lability of blood pressure, flushing of blood to the skin of the face.

Respiratory, thoracic and mediastinal disorders

Uncommon: shortness of breath. Very rarely: exacerbation of bronchial asthma, bronchospasm.

Gastrointestinal disorders

Often: diarrhea, nausea, vomiting. Infrequently: constipation, flatulence, gastritis, gastrointestinal bleeding, ulcer and / or perforation of the stomach or duodenum. Very rare: abdominal pain, dyspepsia, stomatitis, tarry stools.

Liver and biliary tract disorders

Often: increased activity of "liver" enzymes. Very rarely: hepatitis, fulminant (fulminant) hepatitis (including deaths), jaundice, cholestasis.

Renal and urinary tract disorders

Rarely: dysuria, hematuria, urinary retention. Very rare: renal failure, oliguria, interstitial nephritis.

Laboratory and instrumental data

Rare: hyperkalemia.

Uncommon: peripheral edema. Rarely: malaise, asthenia. Very rare: hypothermia.

drug interaction

Glucocorticosteroids increase the risk of erosive and ulcerative lesions of the gastrointestinal tract or bleeding.

Antiplatelet agents and selective serotonin reuptake inhibitors (SSR/s), such as fluoxetine, increase the risk of gastrointestinal bleeding.

Anticoagulants. NSAIDs may increase 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 still cannot be avoided, careful monitoring of blood coagulation parameters should be carried out.

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

The simultaneous use of nimesulide and furosemide leads to a decrease (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 and / or heart failure.

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin-II receptor antagonists. NSAIDs may reduce the effect of antihypertensive drugs. In patients with mild to moderate renal insufficiency (creatinine clearance 30-60 ml / min), with the simultaneous use of ACE inhibitors, angiotensin II receptor antagonists and agents that suppress the cyclooxygenase system (NSAIDs, antiplatelet agents), further deterioration of renal function and the occurrence of acute renal 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 carried out with caution, especially in elderly patients. Patients should be adequately hydrated and renal function should be closely monitored after initiation of concomitant use.

mifepristone. 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 show that the use of NSAIDs on the day of prostaglandin analogue administration does not adversely affect the effect of mifepristone or prostaglandin analogue on cervical dilatation, uterine contractility, and does not reduce the clinical efficacy of medical abortion.

lithium preparations. There is evidence that NSAIDs reduce the clearance of lithium, which leads to an increase in the concentration of lithium in the blood plasma and its toxicity. When using nimesulide in patients on lithium therapy, regular monitoring of the concentration of lithium in the blood plasma should be carried out.

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

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

Methotrexate. 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.

Cyclosporins. In connection with the action on renal prostaglandins, prostaglandin synthetase inhibitors, which include nimesulide, can increase the nephrotoxicity of cyclosporins.

Dosage Nise

inside. The contents of the sachet are dissolved in approximately 100 ml of water at room temperature (a white or light yellow suspension is formed).

The prepared solution cannot be stored.

Nise® is used only for the treatment of patients over 12 years of age.

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

In patients with mild to moderate renal insufficiency (creatinine clearance 30-60 ml / min), dose adjustment is not required, while patients with severe renal insufficiency (creatinine clearance

Patients with liver failure

The use of nimesulide 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 of age is 200 mg. The maximum duration of the course of treatment is 15 days.

Overdose

Symptoms: apathy, drowsiness, nausea, vomiting, pain in the epigastric region. These symptoms are usually reversible with symptomatic and supportive therapy. It is possible to increase blood pressure, the occurrence of gastrointestinal bleeding, acute renal failure, respiratory depression, the development of coma, anaphylactoid reactions.

Treatment: symptomatic and supportive therapy. There is no specific antidote. If an overdose has occurred within the last 4 hours, it is necessary to induce vomiting and / or provide activated charcoal (60 to 100 g for an adult) and / or an osmotic laxative. Forced diuresis, hemodialysis, hemoperfusion, alkalinization of urine are not effective due to the high degree of binding of nimesulide to plasma proteins (up to 97.5%). It is necessary to monitor the state of kidney and liver function.

Precautionary measures

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

It is reported about reactions from the liver, which in most cases are reversible, with short-term use of the drug.

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

Nimesulide should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as 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 ulcers (ulcerative colitis, Crohn's disease) and in elderly patients, with an increase in the dose of NSAIDs, so treatment should be started with the lowest possible dose. In such patients, as well as 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 elderly patients, should report new gastrointestinal symptoms (especially symptoms that may indicate possible gastrointestinal bleeding) to the doctor.

Nimesulide 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).

In the event of gastrointestinal bleeding or ulcerative lesions of the gastrointestinal tract in patients taking nimesulide, treatment with nimesulide should be stopped immediately.

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

The drug can cause fluid retention, so in patients with arterial hypertension, with renal and / or heart failure, nimesulide should be used with extreme caution. If the condition worsens, treatment with nimesulide 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 are not enough data to exclude the risk of such events when using nimesulide.

In patients with arterial hypertension, with renal and / or heart failure, coronary heart disease, peripheral arterial disease and / or cerebrovascular diseases, with the presence of risk factors for the development of cardiovascular diseases (for example: hyperlipidemia, diabetes mellitus, in smokers), nimesulide should be used with special care. If the condition worsens, treatment with nimesulide should be discontinued.

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

If there are signs of a "cold" or an acute respiratory viral infection when using nimesulide, 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 preventive effect of acetylsalicylic acid in cardiovascular diseases.

Elderly patients are particularly susceptible to adverse reactions to NSAIDs, including the risk of life-threatening gastrointestinal bleeding and perforation, the risk of reduced kidney, liver and heart function. When using nimesulide in this category of patients, proper clinical monitoring is necessary.

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

Influence on the ability to drive vehicles and mechanisms

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

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