The drug "Nise" (tablets): composition, properties and indications for use. Nise tablets for which Nise for injection is used instructions for use
Nise is an analgesic and antipyretic drug from the group of non-steroidal anti-inflammatory drugs.
It is mainly prescribed as a symptomatic drug as part of complex therapy for various conditions and diseases accompanied by fever, pain and inflammation.
The main areas of application of Nise are the treatment of osteoarthritis and osteoarthritis, as well as the relief of pain syndrome of various etiology and localization (for example, trauma, toothache, menstrual pain, diseases of the ear, throat, nose, etc.) and lowering body temperature during infections.
Clinical and pharmacological group
NSAIDs. Selective COX-2 inhibitor.
Terms of dispensing from pharmacies
Released without a doctor's prescription.
Prices
How much does Nise cost in pharmacies? The average price in 2018 is at the level of 210 rubles.
Release form and composition
The main component of the drug is nimesulide. It has good absorption, its maximum amount appears in the blood after 1-2 hours. It is excreted from the body almost completely through the bile and kidneys.
Also, the drug includes additional elements:
- calcium phosphate;
- cellulose;
- starch (usually corn);
- talc;
- magnesium stearate;
- flavoring additives;
- aspartame;
- sodium glycolate;
- silicon dioxide (colloidal).
Nise is a convex tablet, round on both sides, containing 100 mg of the main element. One blister contains 10 pieces. It can also be produced in the form of granules for suspension, ointment or gel. All types of medicines are placed in a cardboard box.
Pharmacological effect
Nimesulide (active ingredient) has an anti-inflammatory, antipyretic and analgesic effect on the human body.
Nise is effective in diseases associated with inflammation, pain and swelling. It inhibits platelet aggregation, and also significantly reduces bronchospasm, which is provoked by the action of acetaldehyde and histamine. In addition, Nise slows down the formation of toxins and has an antioxidant effect.
The gel, when applied topically, reduces morning stiffness, relieves swelling and relieves pain in the joints.
Indications for use
What helps Nise? There are many reasons for prescribing a drug. The most common:
- radiculitis;
- acute back pain;
- ankylosing spondylitis;
- elevated temperature;
- joint damage from;
- (as well as psoriatic and other types);
- exacerbation of gout;
- muscle and joint pain;
- bursitis (inflammation of mucous bags, often in the joints);
- inflammatory processes of various origins;
- pains: headache, toothache, menstrual.
Contraindications
Before starting therapy with the drug, you should carefully read the attached instructions. Nise tablets are contraindicated in patients with the following conditions:
- Aspirin triad;
- Individual intolerance to the medicinal composition;
- Pregnancy and the period of breastfeeding;
- Chronic erosive processes in the organs of the digestive tract during the period of exacerbation;
- Gastrointestinal bleeding or suspicion of it;
- Severe violations of the liver and kidneys;
- Acute liver or kidney failure;
- The age of children under 12 years of age for this dosage form;
- Atopic dermatitis or bronchial asthma.
With caution, Nise is prescribed to patients with arterial hypertension and type 2 diabetes mellitus.
Use during pregnancy and lactation
Nise can have a negative impact on fertility, pregnancy and fetal development, so the drug is not recommended for use during the entire period of childbearing, as well as at the stage of pregnancy planning.
It is also contraindicated to use Nise when breastfeeding, since it is not known whether the drug is excreted in milk.
Dosage and method of application
The instructions for use indicate that Nise tablets should be used in the minimum effective dose for the shortest possible short course. Tablets are taken with sufficient water, preferably after meals. In the presence of diseases of the gastrointestinal tract, it is advisable to take the drug at the end of a meal or after a meal.
- Adults and children over 12 years old - inside 1 tab. 2 times/day The maximum daily dose for adults is 200 mg.
Patients with chronic renal failure require a reduction in the daily dose to 100 mg.
Side effects
According to reviews, Nise, when taken orally, can cause the following side effects:
- Headache and dizziness;
- Anaphylactic shock, skin rash or bronchospasm;
- Fluid retention, hematuria, prolongation of bleeding time;
- Heartburn, nausea and vomiting, stomach pain, erosive and ulcerative lesions of the gastrointestinal tract, diarrhea, increased activity of hepatic transaminases and toxic hepatitis;
- Leukopenia, thrombocytopenia, anemia or agranulocytosis.
Overdose
An overdose of Nise can lead to serious consequences and be accompanied by impaired renal function, liver failure, convulsions, increased blood pressure, respiratory depression, drowsiness and lethargy. Sometimes the situation of the patient is aggravated by the development of gastrointestinal bleeding. In case of an overdose, the patient is sent to the hospital, where they do a gastric lavage, prescribe sorbents (Enterosgel, Polysorb, Polypefan) and osmotic laxatives.
To prevent overdose, you should strictly follow the instructions for the drug and do not exceed the maximum allowable daily doses. The dose of medicine for a child should be calculated by the attending physician, taking into account body weight, age, severity of symptoms and other individual characteristics.
special instructions
Before you start using the drug, read the special instructions:
- The drug is contraindicated in children under the age of 12 years.
- After 2 weeks of using the drug, it is necessary to control the biochemical parameters of liver function.
- Given reports of visual impairment in patients taking other NSAIDs, treatment should be stopped immediately if any visual impairment occurs and the patient should be examined by an ophthalmologist.
- Since nimesulide is partially excreted by the kidneys, its dose for patients with impaired renal function should be reduced, depending on the CC value.
- Regular medical supervision is required if the patient, along with nimesulide, is taking medications that are characterized by an effect on the gastrointestinal tract.
- The drug can cause fluid retention in the tissues, so patients with high blood pressure and with cardiac disorders Nise should be used with extreme caution.
- Do not use the drug simultaneously with other NSAIDs.
- If there are signs of liver damage (skin itching, yellowness of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of liver transaminases), you should stop taking the drug and consult your doctor.
- The drug can change the properties of platelets, but does not replace the preventive action of acetylsalicylic acid in cardiovascular diseases.
The drug can cause drowsiness, dizziness and blurred vision, so you need to be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
drug interaction
When using the drug, it is necessary to take into account the interaction with other drugs:
- Nimesulide is able to reduce the effect of furosemide.
- Nimesulide may enhance the effect of cyclosporine on the kidneys.
- The concentration of lithium in plasma increases with the simultaneous administration of lithium preparations and nimesulide.
- Nimesulide may increase the possibility of adverse reactions while taking methotrexate.
- Due to the high degree of binding of nimesulide to plasma proteins, patients who are simultaneously treated with hydantoin and sulfonamides should be under the supervision of a physician, undergoing examination at short intervals.
- The effect of drugs that reduce blood clotting is enhanced by their simultaneous use with nimesulide.
- When used simultaneously with GCS, serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.
> Nise for children
Description of the medicine (not an instruction for use!):
Before using the medicine "Nise baby" Be sure to consult your doctor!
Age restrictions : the manufacturer strongly recommends that Nise be prescribed to older children - starting from the age of twelve.
Composition and type of dispensing in pharmacies
: The active substance of Nise is Nimesulide. Excipients depend on the form of release (tablets, suspension, gel).
Oral tablets containing 0.1 g of Nimesulide and soluble tablets containing 0.05 g of Nimesulide are packed in blister packs of 10 pieces and placed in cardboard boxes. 1 box can contain 1, 2 or 10 blister packs.
Suspension containing 0.01 g of Nimesulide per 1 ml is poured into dark glass bottles with a capacity of 60 ml, equipped with a dosing cap, and packed in cardboard boxes.
Indications for use :
- Pain syndrome: toothache, postoperative and post-traumatic, neurogenic pain (sciatica, sciatica, neuropathy, migraine);
- Fever, fever against the background of infectious and inflammatory diseases of any tissues and organs (at a temperature above 38.50C);
- Non-rheumatic, rheumatic and rheumatoid diseases of the joints and ligaments (arthritis, arthrosis, spondylosis, myalgia, arthralgia).
Inhibition of COX-2 leads to the cessation of the synthesis of prostaglandin E2, which is responsible for several mechanisms of inflammation. Thus, Nimesulide provides anti-edematous, anti-inflammatory, antipyretic and analgesic effects.
Pharmacokinetics and pharmacodynamics: Nimesulide is almost completely absorbed from the intestine, simultaneous food intake reduces the rate of absorption, but does not affect the maximum concentration of the drug in blood plasma, which is achieved on average one and a half to two and a half hours after ingestion.
During the first passage of Nimesulide through the liver, its metabolites are formed, which have activity similar to Nimesulide. Subsequently, these metabolites are processed by the liver to inactive substances, one third of which is excreted in the bile and excreted in the feces, and two thirds are removed from the body in the urine. In children, in the elderly and in patients with moderately severe renal insufficiency, the excretion of Nimesulide remains practically unchanged. Nimesulide and its active metabolites penetrate well into all organs and tissues, including the focus of inflammation.
Instructions for use : For adults, the average therapeutic dose is 200 mg per day, the maximum therapeutic dose is 400 mg per day. These doses should be divided into two (for the maximum dose - four) doses.
For children weighing more than 40 kg, Nise is prescribed 100 mg twice a day (maximum daily dose).
For children weighing less than 40 kg, Nise is prescribed in a daily dose at the rate of 3 to 5 mg per 1 kg of body weight of the child. The dose calculated in this way should be divided into 2-3 doses. The maximum daily dose for children is 5 mg per 1 kg of body weight.
Children aged two to twelve are given either a suspension or soluble tablets. Children over 12 years old can be prescribed regular tablets.
special instructions : It is not recommended to take the drug regularly for more than ten days. With prolonged use, it is necessary to control the functional state of the liver and kidneys. Nise should be used with caution by people employed in hazardous industries, as well as drivers of vehicles, since it can provoke dizziness and drowsiness.
Nise is able to enhance the effect of drugs from the group of cardiac glycosides (digoxin and its analogues), diuretics, lithium preparations, drugs to reduce blood clotting, phenytoin, antitumor agents, drugs for the treatment of non-insulin-dependent diabetes mellitus, NSAIDs.
Contraindications and side effects :
- Children under two years of age.
- Liver dysfunction, severe renal and heart failure.
- Hypersensitivity to Nimesulide or other components of the drug.
- During pregnancy and breastfeeding.
- Inflammatory and ulcerative diseases of the stomach and intestines.
- Blood clotting disorders, bleeding.
- Non-insulin dependent diabetes mellitus (type II).
- Gastrointestinal tract: irritation (nausea, heartburn, vomiting, pain), ulceration, bleeding, drug-induced hepatitis, diarrhea;
- Nervous system: depression, drowsiness, dizziness;
- The system of hematopoiesis and hemostasis: inhibition of the red bone marrow and a decrease in the formation of all types of blood cells, a decrease in blood clotting.
- Hypersensitivity reactions (allergy): rash, angioedema, bronchospasm, anaphylaxis.
Reviews about "Nise for children":
Tanya they showed on TV how a child got into a coma through this medicine
Olga The child has a hygroma of the right knee. Nise was prescribed by a rheumatologist. Without a special case, I don’t give the child serious medicines. Therefore, with the mother’s statement: let’s not be afraid, I don’t agree. In our time, even vitamins are dangerous. But there are times when taking such drugs is necessary. Including many children from high fever, convulsions begin. And in the case of cerebral palsy, children with high fever should not be allowed at all.
Catherine Daughter 8 months old, tonsillitis, t39. She roared over her for 3 days, the temperature with Nurofen stopped decreasing on the second day, the child really suffered. Nise was advised by a neighbor, they gave the baby with teeth, for a long time they did not dare to give (restriction up to 2 years after all). I read the reviews here and decided. After 1.5 hours the child slept with a normal temperature. The main thing is not to abuse it, the age limit was not groundlessly made up, and no one canceled the allergy to drugs. And so, in emergency cases, it is quite possible to apply, the drug was satisfied, the baby at least rested from the temperature.
Mariyka I gave my daughter with lacunar angina for the night half a tablet, the temperature was 39, it lasted for 23 hours, but then in the evening it rose again to 37.8, gave another half, probably it was not necessary to use it anymore at such a temperature ...
Oksana It is me again. I beg your pardon, the drug for children is called nimulide
Oksana Great product.....for adults. But I would not give a child in pills. There is a good alternative for children, the same nise, but in syrup, it's called nisemulide, sort of.
Alyona I have two children, 7 and 4 years old, we use nise, nothing else helps.
Natalia It helps me and the children just FOR
Allochka I was also prescribed by a dentist when my wisdom tooth erupted, there were such pains, I began to drink, the pain goes away literally after 10 minutes, but do not abuse them, I drank only when I was not at all able to. Any pills treat one thing and cripple another.
Evgenia can nise be taken as an anti-inflammatory agent if the child does not have a temperature, and the inflammatory process does not go away?
Ramzizya It helps us a lot too.
Alexey They say Nise affects male patentity, is that true?
Olya we, too, are always saved only by nize. with the whole family.
ghoul from the age of 2 we drink nise nothing else helps 1/4 now 1/2 once for an illness when it’s really tight. there were no side effects
Natalia The child was eight months old, bronchitis, temperature was under forty, Efferalgan did not reduce, the doctor advised Nise, in tablets, 1/4 each. Helped a lot. It does not reduce the temperature quickly, 1.5-2 hours, but the effect lasts a very long time. Of course, we try to get by with drugs that are more adapted for childhood, but there are cases when it is worth giving nise, in the end, you must agree that a fever for a long time in a child can be much more dangerous than the side effects of nise, which are present in everyone without exception medicines.
Julia I am breastfeeding a child. a tooth was pulled out, a gum was sewn up, the anesthesia went away, the pain was hellish. drank nise everything went away now I think how it will affect the child when feeding. Help.
Elvira great help for the whole family
Olga My knee hurt a lot. It was impossible to get up without help and support. I drank one pill and after three hours there was no pain. :
Alexei My head hurts very rarely, but quite strongly. My brother has increased weather sensitivity. I am 15 years old. excellent drug and brother always helps
Alexander Otitis with wild pain, prescribed drops do not help, one tablet of nise and suddenly a magician flew in ... a night of deep sleep, even sciatica does not bother.
Elena Nise is a common drug, you just need to use it wisely.
igor does it really help?
Love Nise are monster pills. I drank them for 7 days and twisted them so that it could not do without an ambulance. The doctor said: "And we have idiots in medicine ......" I will not write further. But I realized that not everything is good, what the doctor ordered. Nise in my first aid kit is a complete ban.
Inna Ibuklin is released. The pharmacy said that he was on re-registration, now he is everywhere.
Said do they release ibuklin who knows
tatya I don’t understand why this group of drugs is considered in the antiviral group ??? NSAIDs do not belong to the above group of drugs. Nice drug is good, especially if alternatives like paracetamol and ibuprofen don't help...
Julia Although they say it’s harmful, but I give Nise to a child. We are already 5 years old. The first time the doctor prescribed it at three years old for a cold. I like the result, the child does not suffer.
Natalia Daughter 13 years old, appointed NIZ due to arthritis. When taken, there is increased fatigue, depression and irritability. The doctor wanted to release from school at the time of the appointment, we refused, apparently, we will have to use the exemption. Affects when doing lessons. Intelligence slows down.
Irina A very effective drug, the main thing is not to abuse it. We use it from the age of 2, already for 7 years, but only at a temperature of 38.5 and above.
galina daughter is 2 years old. sick often. temperature up to 40. Nise helps very well. but they say very harmful. poet try to do without it.
Ksenia Excellent pills. The child is 1 year and 8 months old. I give from 9 months. always immediately knocks down. A neighbor is afraid to let her children lie constantly in the hospital, they are given injections. What can you say about her as soon as you sympathize with her mindset.
Natalia My son is 1.3 years old. When teeth are cut in a child T40! And not a single drug based on paracetamol or nurofen reduces it! You can pour even a bucket into a child - zero sense. Nise in suspension at the recommended dose of 2 ml reduces the temperature immediately and permanently. With a cold, it knocks down for a day or even a day. So what is there to talk about the dangers of this drug in the minimum dosage compared to the huge and useless number of ml. other "recommended" children's preparations?!
Sergey Son is 11 years old. For 4 years already, as with an increase in temperature above 38, we use nize. Positive action, indeed, does not give soon, but for a long time.
Evgeniya My daughter is 4 years old. From the age of 2, we bring down the temperature only with a nize. It helps quickly and for a long time.
Svetlana Very effective pills! But I heard somewhere that frequent use is harmful ...
Olga Daughter is 9 years old. When the temperature rises, neither paracetamol, nor ibuprofen, nor even an injection of a "lytic mixture" helps. Nise always helps to lower the temperature. The only drawback is that it works after 1.5 - 2 hours.
Irina They brought down the daughter's temperature with Nimulid (the same Nise only in the form of a suspension). It starts to act after 2 hours, but it also brings down the temperature for a long time - 12-24 hours, depending on the cause of the temperature increase. My daughter is 2 years old, so we try not to abuse this drug, we give it only when the temperature is above 39 degrees and paracetamol and ibuprofen do not reduce it.
© 2020 , . The use of materials is allowed with a link to the site. All trademarks belong to their rightful owners.
The information posted on the site is for informational purposes only. Be sure to consult with a specialist.
If you find an error in the text, an incorrect review or incorrect information in the description, please report this to the site administrator.
Most people know that Nise's medicine helps with pain. But few people think about what kind of pain this drug will save. But it is very important, before taking any pill, to find out if it will help and whether it is right for you to drink it.
Description of the drug
Nise - drug, which helps in the treatment of diseases of the joints and relieves pain of various origins.
The drug is of synthetic origin. The active substance is nimesulide, which has anti-inflammatory, analgesic and antipyretic effects.
There are excipients in the composition: corn starch, talc, calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch and colloidal silicon dioxide.
Used for pain, swelling, inflammation in the joints. The medicine prevents the formation of toxins.
In pharmacies, you can find Nise in different forms of release..
- In tablets.
- In the form of a gel for topical use.
- In dispersible tablets.
- In the form of a suspension for oral administration.
Indications for taking the drug
For the treatment and prevention of various diseases Nise is used in any form of release.
Instructions for use of the drug
Before you start taking the medicine, consult with a specialist so that he prescribes an adequate treatment regimen and explains how to properly use the drug.
Tablets and suspension are taken twice a day for 100 mg. The total amount of the drug per day should not exceed 400 mg. The course of treatment lasts 10 days. Ordinary tablets, like suspension, are drunk before meals, and dispersible tablets are taken after meals.
In special cases, it is allowed to take the drug in the form of dispersible tablets or suspensions for children from 3 to 12 years old. The dose is calculated based on body weight. Take the drug 2-3 times a day, 3-5 mg per kg of body weight.
Gel Nise is applied to the desired area of the body in a small layer, it is not necessary to rub the drug.
The action of the tablet Nise begins half an hour after ingestion. Gradually, the anti-inflammatory and analgesic effect begins to decrease, since the active ingredient nimesulide begins to be excreted from the body as early as 3 hours after taking the pill.
Interaction with other drugs
With extreme caution, Nise should be used in conjunction with drugs containing lithium, cyclosporine, diuretics, phenytoin, digoxin and oral hypoglycemic agents.
When Nise is taken with Aspirin, bleeding may occur. Reduces the effect of Furosemide and significantly increases the toxicity and concentration in the body of Methotrexate.
It is necessary to observe the exact dosage of the medication. You can not use a tablet more often than once in 6 hours and no more than 4 pieces per day.
There are no prohibitions on taking the drug. The drug is used even when removing a hangover syndrome: headache and fever. But still, experts suggest not to take risks and not take medicine before and during the feast. Alcohol, like the active ingredient Nise nimesulide, can retain fluid in the body, and this can lead to toxic poisoning.
Contraindications for use
Before you start using Nise, read the instructions and make sure you have there are no contraindications to its use.
With great care, you can take the drug for arterial hypertension, heart failure and insulin dependence.
Side effects
As with any drug, Nise has side effects.
- Heartburn.
- Nervousness.
- Insomnia and nightmares.
- Lyell's syndrome.
- Nausea, up to vomiting.
- Diarrhea.
- Stomach pains.
- Decrease in the amount of hemoglobin in the blood.
- Migraine.
- A sharp decrease in body temperature.
- Stomatitis.
- The occurrence of ulcers and erosions of the gastrointestinal tract.
- Vertigo.
- Medical jaundice.
- Increased sweating.
- Rash and irritation on the skin.
- Anaphylactic shock.
- Edema.
- Poor blood clotting.
- General weakness.
When taking a large amount of Nise, an overdose may occur. Therefore, how many pills to take, the doctor should prescribe. If you have drunk a large amount of the medicine, then convulsions, loss of consciousness, hypertension, impaired liver and kidney function may occur. In any case, as soon as there are suspicions of an overdose or the manifestation of side effects, it is necessary to call specialists.
Nise storage conditions
The drug must be stored out of the reach of children. Shelf life of tablets - 3 years, gel - 2 years. The temperature should not exceed 25 ⁰ C. In a pharmacy, Nise tablets can only be purchased with a doctor's prescription, and the gel is sold without a specialist prescription.
There are many analogues this medicinal product. Basically, these are painkillers.
In principle, any analogue of the drug performs the same action as Nise. But do not chase for cheaper medicines. Before changing the drug, ask the opinion of your doctor.
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 mucosa of the gastrointestinal tract, 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, darkening of 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.
Found a mistake in the text? Select it and press Ctrl + Enter.
Pills almost white with a yellowish tint, round, biconvex, with a smooth surface.
Excipients: microcrystalline cellulose, corn starch, calcium hydrogen phosphate, sodium starch glycolate, purified talc, magnesium stearate, anhydrous colloidal silicon.
10 pieces. - blisters (1) - cardboard boxes.
10 pieces. - blisters (2) - cardboard boxes.
10 pieces. - blisters (10) - cardboard boxes.
Clinical and pharmacological group
NSAIDs. Selective COX-2 inhibitorpharmachologic effect
NSAIDs from the sulfonanilide class. Selective inhibitor of COX-2 - an enzyme involved in the synthesis of prostaglandins - mediators of edema, inflammation and pain. The drug has anti-inflammatory, analgesic and antipyretic effects.
It reversibly inhibits the formation of prostaglandin E 2 both in the focus of inflammation and in the ascending pathways of the nociceptive system, including the pathways for pain impulses in the spinal cord.
Reduces the concentration of short-lived prostaglandin H 2 , from which prostaglandin E 2 is formed under the action of prostaglandin isomerase. A decrease in the concentration of prostaglandin E 2 leads to a decrease in the degree of activation of prostanoid EP-type receptors, which is expressed in analgesic and anti-inflammatory effects.
To a small extent, it acts on COX-1, practically does not prevent the formation of prostaglandin E 2 from arachidonic acid under physiological conditions, thereby reducing the number of side effects of the drug.
The drug inhibits platelet aggregation by inhibiting the synthesis of endoperoxides and thromboxane A 2, inhibits the synthesis of platelet aggregation factor, inhibits plasminogen activation by increasing the concentration of inhibitor-1. Suppresses the release of histamine, and also reduces the degree of bronchospasm caused by the effects of histamine and acetaldehyde.
The drug also inhibits the release of tumor necrosis factor alpha, which causes the formation of cytokines.
It has been shown that nimesulide is able to suppress the synthesis of interleukin-6 and urokinase, thereby preventing the destruction of cartilage tissue. Inhibits the synthesis of metalloproteases (elastase, collagenase), preventing the destruction of proteoglycans and collagen in cartilage tissue.
It has antioxidant properties, inhibits the formation of toxic oxygen decay products by reducing the activity of myeloperoxidase. Interacts with glucocorticoid receptors, activating them by phosphorylation, which also enhances the anti-inflammatory effect of the drug.
Pharmacokinetics
Suction
After oral administration, nimesulide is well absorbed from the gastrointestinal tract. Eating reduces the rate of absorption without affecting its degree. C max nimesulide in plasma is achieved 1.5-2.5 hours after administration and is 3.5-6.5 mg / l. It undergoes a "first pass" effect through the liver.
Distribution
Plasma protein binding is 95%, with erythrocytes - 2%, with lipoproteins - 1%, with acidic α 1 -glycoproteins - 1%. The dose of the drug does not affect the degree of binding to blood proteins.
V d is 0.19-0.35 l / kg. It penetrates into the tissues of the female genital organs, where, after a single dose, the concentration of nimesulide is about 40% of the plasma concentration. It penetrates well into the acidic environment of the focus of inflammation (40%), synovial fluid (43%). Easily penetrates through histo-hematic barriers.
Metabolism
Nimesulide is actively metabolized in the liver by tissue monooxygenases. The main metabolite - 4-hydroxynimesulide (25%) has a similar pharmacological activity.
breeding
T 1/2 - 1.56-4.95 h, T 1/2 4-hydroxynimesulide - 2.89-4.78 h. The metabolite is excreted by the kidneys (65%) and bile (35%).
Pharmacokinetics in special clinical situations
In patients with renal insufficiency (CC from 80 to 30 ml / min), as well as in children and the elderly, the pharmacokinetic profile of nimesulide does not change significantly.
Indications for the use of the drug
- rheumatoid arthritis;
- osteoarthritis;
- arthritis of various etiologies;
- arthralgia;
- myalgia;
- postoperative and post-traumatic pain;
- bursitis;
- tendinitis;
- algomenorrhea,
- toothache,
- headache.
Dosing regimen
inside adults appoint 100 mg 2 times / day. The maximum daily dose is 400 mg.
The tablets should be taken with sufficient water, preferably before meals. In the presence of diseases of the gastrointestinal tract, it is advisable to take the drug at the end of a meal or after a meal.
Children over 12 years old the drug is prescribed in a single dose of 1.5 mg / kg of body weight of the child 2-3 times / day. The maximum dose is 5 mg / kg / day. Adolescents weighing over 40 kg the drug is prescribed 100 mg no more than 2 times / day.
Side effect
From the digestive system: heartburn, nausea, vomiting, diarrhea, gastralgia, erosive and ulcerative lesions of the gastrointestinal tract, increased activity of hepatic transaminases.
From the side of the central nervous system: headache, dizziness.
From the hematopoietic system: thrombocytopenia, leukopenia, anemia, agranulocytosis.
Allergic reactions: skin rash, anaphylactic shock, bronchospasm.
Others: fluid retention, prolongation of bleeding time, hematuria.
Contraindications to the use of the drug
- erosive and ulcerative lesions of the gastrointestinal tract in the acute phase;
- bleeding from the gastrointestinal tract;
- ""aspirin"" asthma;
- liver failure;
- severe renal insufficiency<30 мл/мин);
- pregnancy;
- lactation period (breastfeeding);
- children's age up to 12 years;
- Hypersensitivity to the drug.
WITH caution the drug should be prescribed for arterial hypertension, heart failure, type 2 diabetes mellitus (non-insulin dependent).
The use of the drug during pregnancy and lactation
Nise is contraindicated for use during pregnancy.
If necessary, the use of the drug during lactation, breastfeeding should be discontinued.
Application for violations of liver function
Contraindicated in violations of liver function.
Application for violations of kidney function
The drug is contraindicated in severe renal failure (CC<30 мл/мин).
special instructions
With prolonged use, systematic monitoring of liver and kidney function is necessary.
When using the drug in elderly patients, correction of the dosing regimen is not required.
Overdose
Currently, cases of overdose of the drug Nise are not described. There is no specific antidote.
drug interaction
There may be manifestations of drug interactions (due to drug competition for protein binding) while ingestion of Nise with digoxin, phenytoin, lithium preparations, diuretics, antihypertensive drugs, other NSAIDs, cyclosporine, methotrexate, oral hypoglycemic agents.
Terms of dispensing from pharmacies
The drug is dispensed by prescription.
Terms and conditions of storage
List B. The drug should be stored in a dry, dark place, out of the reach of children, at a temperature not exceeding 25°C. Shelf life - 3 years.
"