Compatibility of nise gel and polydex. Instructions for use and composition of Nise Nise tablets for adults
Instructions
general characteristics
The tablets are almost white to yellow in color, round, with an even convex surface on both sides.
Compound for 1 tablet:
active substance: nimesulide - 100 mg;
Excipients: anhydrous calcium hydrogen phosphate,
microcrystalline cellulose, corn starch, sodium starch glycolate (type A), magnesium stearate, colloidal anhydrous silicon dioxide, purified talc.
Pharmacotherapeutic group
Non-steroidal anti-inflammatory and antirheumatic drugs.
ATX code. M01AX17.
Pharmacological properties
Pharmacodynamics. Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties that acts as an inhibitor of the enzyme cyclooxygenase, which is responsible for the synthesis of prostaglandins.
Pharmacokinetics. Nimesulide is well absorbed when taken orally. After taking a single dose of 100 mg of nimesulide, in adults, the maximum plasma concentration is reached after 2 to 3 hours and is 3 to 4 mg / l. The area under the curve (AUC) is 20 - 35 mg h / l. When taking nimesulide at a dose of 100 mg once or twice a day for 7 days, there were no differences in pharmacokinetic properties.
Up to 97.5% of nimesulide binds to plasma proteins.
Nimesulide is actively metabolized in the liver by various pathways with the participation of the cytochrome P450 isoenzyme (CYP) 2C9. Therefore, in cases of joint use of nimesulide with medications that are metabolized with the participation of this isoenzyme, the possible occurrence of drug interactions should be taken into account. The main metabolite is the pharmacologically active parahydroxy derivative of nimesulide. The time until the detection of this metabolite in the circulating blood is short (0.8 h), but the amount of its formation is small and much less than the amount of absorption of nimesulide. Hydroxynimesulide is the only metabolite found in plasma. This metabolite is almost entirely present in bound form. The half-life is from 3.2 to 6 hours.
Nimesulide is excreted from the body mainly in the urine (about 50% of the dose taken). Only 1 - 3% is displayed unchanged. Hydroxynimesulide is the main metabolite, found exclusively in the form of glucuronate. Approximately 29% of the dose taken is excreted in the metabolized form in the feces.
The pharmacokinetic profile of nimesulide in the elderly does not change with the appointment of single and multiple / repeated doses.
In a short-term experimental study conducted with the participation of patients with mild to moderate forms of renal failure (creatinine clearance 30 - 80 ml / min) and healthy volunteers, the maximum concentration of nimesulide and its main metabolite in the plasma of patients was no more than the concentration in healthy volunteers. The area under the concentration-time curve (AUC) and elimination half-life (t1 / 2 beta) in patients with renal insufficiency were 50% higher, but were always in the range of pharmacokinetic values observed in healthy volunteers taking nimesulide. Repeated administration of the drug did not lead to accumulation. Nimesulide is contraindicated in patients with hepatic impairment.
Indications for use
- Treatment of acute pain
- Primary dysmenorrhea
- Nimesulide can only be prescribed as a second-line therapy. The decision to prescribe nimesulide should be based on an overall risk assessment for each patient.
Method of administration and dosage
In order to minimize unwanted side effects, the lowest effective dose should be taken with the shortest duration of treatment.
The maximum duration of treatment with nimesulide is 15 days.
Adult patients:
100 mg of nimesulide twice a day after meals.
Elderly patients:
When treating elderly patients, there is no need to reduce the daily dose.
Children and adolescents:
Children (under 12 years old): for this category of patients, the appointment of nimesulide-containing drugs is contraindicated.
Adolescents (12 to 18 years old): Based on the pharmacokinetic profile in adults and the pharmacodynamic characteristics of nimesulide, there is no need to adjust the dose in adolescents.
Patients with impaired renal function:
Based on pharmacokinetic data, there is no need to adjust the dose in patients with mild to moderate forms of renal failure (creatinine clearance 30 - 80 ml / min), while in patients with severe renal failure (creatinine clearance
Patients with hepatic impairment:
Nise is contraindicated in patients with hepatic impairment.
The undesirable effects of therapy can be reduced by administering the lowest effective dose of the drug for as short a time as possible to treat the underlying disease.
Side effect
general description
According to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially in high doses for a long time, may be accompanied by a slight increase in the risk of developing pathology caused by arterial thrombosis (for example, myocardial infarction or stroke).
Against the background of treatment with NSAIDs, edema, increased blood pressure and heart failure were also reported.
With the use of NSAIDs, there is evidence of very rare cases of bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
In the treatment of NSAIDs, the most common adverse events were the phenomena from the gastrointestinal tract. Possible development of peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients. There is information about the appearance of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, vomiting of blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease after taking the drug. Less commonly, gastritis is observed.
Side effects listed below are based on data from controlled clinical trials *.
The incidence is classified as follows: very common (≥ 1/10), often (≥ 1/100,
* - the frequency is based on the results of clinical trials
Contraindications
- Known hypersensitivity to nimesulide or one of the excipients of the drug.
- Hyperergic reactions that have taken place in the past (for example, bronchospasm, rhinitis, urticaria) in connection with the intake of acetylsalicylic acid or other NSAIDs.
- Past hepatotoxic reactions to nimesulide.
- Concomitant intake of other substances with potential hepatotoxicity.
- Alcoholism, drug addiction.
- Preexisting gastrointestinal bleeding or perforation associated with previous NSAID therapy.
- Stomach or duodenal ulcer in the acute phase, a history of ulcers, perforation or bleeding in the gastrointestinal tract.
- A history of cerebrovascular bleeding or other hemorrhages, as well as diseases accompanied by bleeding.
- Severe bleeding disorders.
- Severe heart failure.
- Severe renal failure.
- Liver failure.
- Patients with cold or flu symptoms.
- Age up to 12 years.
- Prescription of the drug is contraindicated in the third trimester of pregnancy and during lactation.
Overdose
Symptoms of an acute overdose of H11BC are usually limited to the following: apathy, drowsiness, nausea, vomiting, and epigastric pain. With maintenance therapy, these symptoms are usually reversible. Gastrointestinal bleeding is possible. In rare cases, an increase in blood pressure, acute renal failure, respiratory depression and coma are possible. It has been reported about the occurrence of anaphylactoid reactions when taking therapeutic doses of NSAIDs and in case of an overdose of such drugs.
In case of an overdose of NSAIDs, treatment is symptomatic and supportive. There is no specific antidote. There is no data on the elimination of nimesulide by hemodialysis, however, based on the high level of binding to plasma proteins (up to 97.5%), it can be concluded that dialysis is ineffective in case of drug overdose. In the presence of symptoms of an overdose or after taking a large dose of the drug within 4 hours after administration, patients may be prescribed: induction of vomiting and / or taking activated charcoal (60-100 grams for adults) and / or taking an osmotic laxative. Forced diuresis, urinary alkalinization, hemodialysis, or hemoperfusion may be ineffective due to the high level of binding of the drug to blood proteins. Kidney and liver function should be monitored.
Precautionary measures
Undesirable side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control the symptoms of the disease.
If symptoms do not improve, drug therapy should be discontinued.
Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially the incidence of gastrointestinal bleeding and perforation (in some cases even fatal), as well as impaired renal, liver and heart function. Therefore, appropriate clinical observation is recommended.
Liver disorders
Reported rare cases of serious liver reactions, including very rare cases of death associated with the use of nimesulide-containing drugs. Patients who experience symptoms similar to those of liver damage during Nise treatment (eg, anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine) or patients whose liver function laboratory test deviates from normal values, should cancel drug treatment. Re-appointment of nimesulide is contraindicated in such patients. Reported liver damage, in most cases reversible, after short-term drug exposure.
During treatment with Nise, the patient should refrain from taking other analgesics. The concomitant use of Nise and other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Patients treated with nimesulide and who develop symptoms similar to the flu or colds should stop the drug treatment.
Gastrointestinal disorders
Gastrointestinal bleeding, ulcers and ulcers perforation can be life-threatening if there is a history of similar problems with any NSAID taken during treatment (regardless of the elapsed time), with or without dangerous symptoms, or a history serious disorders of the gastrointestinal tract.
The risk of gastrointestinal bleeding, ulcers or perforation of the ulcer increases with increasing doses of NSAIDs in patients with a history of ulcers, especially those complicated by hemorrhage or perforation, as well as in elderly patients. For these patients, treatment should be started at the lowest dose possible. For these patients, as well as for patients taking concomitant low doses of aspirin or other drugs that increase the risk of gastrointestinal disease, combination therapy with protective agents (for example, misoprostol or proton pump inhibitors) should be considered.
Patients with gastrointestinal toxicity, especially the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding). This is especially important in the early stages of treatment.
Gastrointestinal bleeding, as well as the formation of ulcers or perforations are noted for all NSAIDs at different stages of treatment, regardless of the presence of precursor symptoms or a history of gastrointestinal pathology. With the development of gastrointestinal bleeding or manifestations of nimesulide should be canceled. Nimesulide should be used with caution in patients with diseases of the gastrointestinal tract, including peptic ulcer, history of gastrointestinal bleeding, ulcerative colitis and Crohn's disease. Patients taking concomitant medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin, should be advised to be careful when taking the medication facilities.
If patients receiving Nise develop gastrointestinal bleeding or ulcers, drug treatment should be discontinued.
NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since an exacerbation of these diseases is possible.
In patients with renal or heart failure, Nise should be used with caution, since the drug may impair renal function. If the condition worsens, treatment should be canceled.
Skin reactions
There is evidence of very rare cases of severe skin reactions to NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, some of which can be fatal. Apparently, patients are at the greatest risk of developing skin reactions during the initial period of therapy. Nise should be canceled at the first sign of skin rash, mucosal lesions and other signs of hypersensitivity.
Kidney disorders
It is necessary to prescribe the drug with caution to patients with impaired renal or cardiac function, since the use of nimesulide can lead to a deterioration in renal function. If it worsens, treatment should be interrupted.
Impact on fertility
The use of nimesulide can reduce female fertility, therefore it is not recommended to prescribe it to women planning pregnancy. In women who have problems with conception or undergoing examination for infertility, the possibility of canceling nimesulide should be considered.
Disorders from the cardiovascular and cerebrovascular systems
Patients with arterial hypertension and / or mild / moderate acute heart failure in history, as well as patients with fluid retention and edema, as a reaction to the use of NSAID therapy, require appropriate monitoring of the condition and consultation with a doctor.
Clinical studies and epidemiological data suggest that some NSAIDs, especially in high doses and with prolonged use, may lead to a small risk of arterial thrombotic events (for example, myocardial infarction or stroke). There is insufficient data to eliminate the risk of such events when using nimesulide.
In patients with uncontrolled arterial hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease, nimesulide should be prescribed after a thorough assessment of the condition. An equally careful assessment of the condition should be performed before starting long-term treatment of patients with risk factors for cardiovascular disease (for example, with arterial hypertension, hyperlipidemia, diabetes mellitus, smoking).
Since nimesulide can affect platelet function, it should be used with caution in patients with hemorrhagic diathesis. However, Nise does not replace acetylsalicylic acid in the prevention of cardiovascular disease.
Application during pregnancyand breastfeeding
In the third trimester of pregnancy, the use of Nise is contraindicated.
Pregnancy
Suppression of prostaglandin synthesis can adversely affect pregnancy and / or fetal development. The data obtained in epidemiological studies suggest that in the early stages of pregnancy, the use of drugs that suppress prostaglandin synthesis may increase the risk of spontaneous abortion, fetal heart disease and gastroschisis. The absolute risk of cardiovascular abnormalities increased from less than 1% to about 1.5%. The risk is believed to increase with dose and duration of use.
In animals, administration of an inhibitor of prostaglandin synthesis led to an increase in pre- and post-implantation loss and an increase in embryonic mortality. In addition, data were obtained that in animals that received an inhibitor of prostaglandin synthesis during the period of organogenesis, the incidence of various fetal malformations, including the cardiovascular system, increased.
You should not take nimesulide during the first and second trimester of pregnancy unless absolutely necessary. In the case of using the drug by women trying to become pregnant, or in the first and second trimester of pregnancy, the lowest possible dose and the shortest possible duration of treatment should be chosen.
In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis:
1) can lead to the development in the fetus:
- pneumocardial toxic damage (with premature closure of the arterial ducts and hypertension in the pulmonary artery system);
- renal dysfunction, which can progress to renal failure with the development of oligohydramnios;
2) in the mother and fetus at the end of pregnancy, it is possible:
- an increase in bleeding time, antiaggregatory effect, which can occur even with the use of very low doses of the drug;
- suppression of the contractile activity of the uterus, which can lead to a delay or lengthening of the period of labor.
Therefore, nimesulide is contraindicated in the third trimester of pregnancy.
Lactation. It is currently unknown whether nimesulide is excreted in breast milk. Nise is contraindicated for use in nursing mothers.
Fertility Like other NSAIDs, drugs containing nimesulide are not recommended for women planning a pregnancy.
Impact on the ability to drive a car or other mechanisms
Studies on the effect of nimesulide-containing medicinal product on the ability to drive vehicles and control machines and mechanisms have not been conducted. Despite this, patients experiencing headache, dizziness or drowsiness after taking Nise should not operate a vehicle, machinery or mechanisms.
Interaction with drwith drugs
Pharmacodynamic interactions
Other non-steroidal anti-inflammatory drugs (NSAIDs)
The combined use of drugs containing nimesulide and other NSAIDs, including acetylsalicylic acid in anti-inflammatory doses (≥ 1 g once or ≥ 3 g as the total daily dose) is not recommended.
Corticosteroids: Increases the risk of gastrointestinal ulcers or bleeding.
Anticoagulants: NSAIDs can enhance the effect of anticoagulants such as warfarin or acetylsalicylic acid. Due to the increased risk of bleeding, this combination is not recommended and is contraindicated in patients with severe coagulation disorders. If the combination therapy still cannot be avoided, it is necessary to carefully monitor the blood clotting parameters.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increase the risk of gastrointestinal bleeding.
Diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), type 2 angiotensin receptor antagonists (A II A):
NSAIDs can reduce the effectiveness of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients), co-administration of ACE inhibitors or angiotensin II antagonists, as well as substances that suppress the cyclooxygenase system, can cause a further decrease in renal function up to acute renal failure, which is usually reversible.
This interaction should be taken into account in patients taking Nise in conjunction with ACE inhibitors or AIIA. Therefore, when prescribing this combination of drugs, caution should be exercised, especially in elderly patients. Patients should receive adequate fluid intake and the need to monitor renal function after initiation of combination therapy and periodically thereafter should be considered.
Farm acokinetic interactions: the effect of nimesulide on pharmacokinetics of other drugs:
Furosemide: in healthy volunteers, nimesulide temporarily reduced the effect of furosemide on sodium excretion, to a lesser extent on potassium excretion, and reduced the diuretic response. Co-administration of nimesulide and furosemide leads to a decrease (by approximately 20%) in the area under the concentration-time curve (AUC) and a decrease in the cumulative excretion of furosemide without changing the renal clearance of furosemide.
The joint appointment of furosemide and drugs containing nimesulide requires caution in patients with impaired renal or cardiac function.
Lithium: There is evidence that NSAIDs reduce the clearance of lithium, resulting in increased plasma lithium levels and lithium toxicity. When Nise is prescribed to patients receiving lithium drug therapy, frequent monitoring of plasma lithium levels should be carried out.
Research has been done in vivo in order to identify possible pharmacokinetic interactions with glibenclamide, theophylline, warfarin, digoxin, cimetidine and antacid drugs (for example, a combination of aluminum and magnesium hydroxide). No clinically significant interactions were observed.
Nimesulide inhibits the activity of the CYP2C9 enzyme. With the simultaneous administration of drugs, which are substrates of this enzyme, with Nise, the concentration of these drugs in plasma may increase.
When prescribing nimesulide less than 24 hours before or less than 24 hours after taking methotrexate, caution is required, since in such cases, the plasma level of methotrexate and, accordingly, the toxic effects of this drug may increase.
Due to the effect on renal prostaglandins, inhibitors of prostaglandin synthesis, such as nimesulide, can increase the nephrotoxicity of cyclosporins.
Pharmacokinetic interactions: effects of other drugs on the pharmacokinetics of nimesulide:
Research in vitro showed that nimesulide is displaced from the binding sites with tolbutamide, salicylic acid and valproic acid. Despite the fact that these interactions were determined in blood plasma, these effects were not observed during the clinical use of the drug.
Storage conditions and shelf life
Store at a temperature not exceeding 25 ° C in a place protected from light and moisture. Keep out of the reach of children.
Shelf life is 3 years. Do not use after the expiration date printed on the package.
Vacation conditions
Dispensed by prescription.
Package
10 tablets in a blister strip packaging. 2 blisters, together with instructions for medical use, are placed in a cardboard box.
Produced. Dr. Reddy's Laboratories Ltd, 8-2-337, No. 3 Road, Banyara Hills, Hyderabad 500034, Telangana, India.
Packed. JSC "Nesvizh plant of medical preparations", Republic of Belarus, 222603, Minsk region, Nesvizh district, pos. Alba, st. Factory, 1.
Nise is a highly effective drug for any type of pain. It is convenient to take, and the action develops quickly enough.
Nise - description and action
Nise refers to non-steroidal anti-inflammatory drugs (NSAIDs), produced in the form of tablets. The drug is manufactured by Dr. Reddys Laboratories (India). The cost of 20 tablets is 240 rubles. Other forms of release - gel for external use, powder granules for making a suspension.
The active substance of Nise tablets is nimesulide 100 mg.
In appearance, the tablets are white, slightly yellowish, smooth, biconvex. The medicine also includes a number of additional substances - calcium hydrogen phosphate, cellulose, starch, magnesium stearate, talc. How does Nise work? These are pain-relieving pills, the active substance of which belongs to the class of sulfonanilides. inhibits the release of cyclooxygenase, which is a precursor of inflammatory mediators (prostaglandins).
The drug also has an antipyretic effect. It eliminates the manifestations of pain and inflammation of various etiologies. The drug is rapidly absorbed by mouth, while food intake reduces absorption. Nimesulide perfectly penetrates into the synovial fluid, therefore it is widely used in the treatment of rheumatological diseases.
Indications for use
The most common indication for pills is articular syndrome. The drug can be taken for arthralgia of various origins - it includes pain in the following diseases:
Also among the indications for the use of Nise tablets is rheumatoid arthritis, which, when exacerbated, causes severe pain. The medicine can be taken for headaches. Tablets help if unpleasant symptoms are caused by vascular spasm, migraine. In dentistry, Nise is often prescribed for toothache - the effect will be pronounced when removing a tooth, performing dental operations. As a temporary measure, the tablets will serve for carious dental pain.
Drinking Nise is recommended as an emergency remedy against post-traumatic conditions - rupture of ligaments, fracture.
For adults, the remedy will help against osteochondrosis and the associated inflammation, from radicular syndrome, sciatica, lumbodynia. Muscle pain is also an indication for taking Nise tablets.
Contraindications for pills
The medicine is allowed for children from 12 years old. Until this age, taking the drug is a contraindication. Also, the annotation indicates the following strict prohibitions on treatment with these NSAIDs:
Drug addiction and alcoholism are also contraindications to therapy. Nise has poor compatibility with alcohol; joint intake can provoke bleeding from the digestive system. During pregnancy, lactation Nise is not accepted, an approved substitute should be found. With caution, take a short course of pills for ischemia of the heart, diabetes, high cholesterol, smoking. Caution must also be observed when carrying out therapy with antiplatelet agents that thin the blood in old age.
Side effects
Side effects for this remedy are less common than for other drugs of the NSAID group. Nevertheless, the list of them is about the same as during treatment with other means. Allergy can manifest itself as cutaneous forms and asthma, breathing disorders, Quincke's edema, anaphylaxis.
The development of dermatitis, itching of the skin and erythema, toxic epidermal necrolysis is possible.
The nervous system is able to respond to Nise's reception with dizziness and nervousness, fear, but such phenomena are rare. In isolated cases, encephalopathy - Reye's syndrome - was noted. The excretory system occasionally reacts with the following signs:
Often there are reactions from the gastrointestinal tract - nausea, heartburn, abdominal pain, epigastric pain. Bloating, diarrhea may occur, and constipation is less common. In severe cases, the intestines, the oral cavity become inflamed, there are intestinal bleeding and even stomach perforation. Among the side effects, changes in liver parameters, jaundice, and hepatitis are also observed. There is a risk of developing visual impairments, increased blood pressure, weakness, hot flashes.
Instructions for use
How much and how to take Nise tablets? The dosage should be selected by the doctor, especially if a course appointment is planned. The dose should be minimal (if possible), the course should be the shortest, but effective. The order of therapy will be as follows:
It is dangerous to overdose with NSAIDs. It can cause severe cases of poisoning with vomiting, nausea, apathy, or drowsiness. The risk of bleeding from the gastrointestinal tract, gastric perforation is high. Pressure may rise sharply. In the most serious cases, renal failure develops and breathing is impaired. Therapy is symptomatic; if detected early (4 hours), vomiting should be induced and sorbents and laxatives should be taken.
Analogs of Nise tablets
Among the analogues, there are cheaper drugs from the NSAID group, although Nise is not an expensive drug, but rather high quality.
You can not simultaneously take drugs that reduce blood clotting, and Nise. This seriously increases the risk of bleeding. With the development of any visual impairment, therapy should be stopped urgently, there may be consequences for the retina, optic nerve head.
The medicine is capable of retaining fluid in the tissues, therefore, in case of problems with the kidneys and heart, it must be taken with caution. It makes sense for patients with chronic gastrointestinal pathologies to drink in parallel or other drugs of the same group, this will reduce the risk of exacerbation of the inflammatory process.
Nise is a non-steroidal anti-inflammatory drug with analgesic and antipyretic action.
Release form and composition
Nise is available in the following forms:
- Dispersible tablets: in the shape of the letter "D", the edges are beveled, on one side there is an embossing "NK", the other side is smooth, the color is light yellow (10 pieces in blisters, in a cardboard box 1, 2 or 10 blisters);
- Suspension for oral administration: yellow, with a characteristic taste and pleasant odor, redispersible when shaken (60 ml in dark glass vials, in a cardboard box 1 vial complete with a dosage cap);
- Gel for external use 1%: transparent, yellow or light yellow, without foreign particles (20 g and 50 g in tubes of laminated aluminum, in a cardboard box 1 tube).
Active ingredient: nimesulide - 50 mg in 1 tablet; 50 mg in 5 ml of suspension; 10 mg in 1 g of gel.
Auxiliary components:
- Dispersible tablets: calcium phosphate, sodium carboxymethyl starch, talc, aspartame, microcrystalline cellulose, corn starch, magnesium stearate, colloidal silicon dioxide, pineapple flavor;
- Oral suspension: propylparaben, methylparaben, citric acid, sorbitol, polysorbate 80, xanthan gum, glycerol, pineapple flavor, quinoline yellow WS dye, purified water;
- Gel for external use: propylene glycol, isopropanol, carbomer 940, thiomersal, N-methyl-2-pyrrolidone, macrogol, butylhydroxyanisole, potassium dihydrogen phosphate, purified water, flavor (Narciss-938).
Indications for use
- Psoriatic arthritis;
- Osteochondrosis with radicular syndrome;
- Sciatica;
- Radiculitis;
- Rheumatoid arthritis;
- Ankylosing spondylitis;
- Articular syndrome with exacerbation of gout and rheumatism;
- Arthralgia;
- Lumbago;
- Myalgia of rheumatic and non-rheumatic origin;
- Osteoarthritis;
- Bursitis, inflammation of tendons, ligaments;
- Arthritis of various origins;
- Pain syndrome of various etiologies (including trauma, in the postoperative period, headache, toothache, algomenorrhea);
- Post-traumatic inflammation of the musculoskeletal system and soft tissues (bruises, ruptures and damage to the ligaments);
- Fever of various origins (including infectious and inflammatory diseases).
Contraindications
Absolute:
- Bleeding from the gastrointestinal tract;
- Exacerbation of erosive and ulcerative lesions of the gastrointestinal tract;
- Severe renal failure;
- Liver dysfunction;
- "Aspirin triad";
- Skin infections, dermatoses and damage to the epidermis in the area of application (for gel);
- The period of pregnancy and breastfeeding;
- Children under 2 years of age (for suspension), up to 3 years (for tablets), up to 7 years (for gel);
- Hypersensitivity to the main or auxiliary components of Nise and other non-steroidal anti-inflammatory drugs.
Relative:
- Arterial hypertension;
- Heart failure;
- Renal and / or hepatic impairment;
- Type 2 diabetes mellitus;
- Elderly and children's age.
Method of administration and dosage
Nise in the form of tablets and suspensions is administered orally. The recommended dose for adult patients is 100 mg 2 times a day. The maximum dose per day is 400 mg.
The suspension is preferable to take before meals, however, in case of discomfort in the stomach, it is possible to take the drug at the end of a meal or after a meal.
Dispersible tablets are taken at the end of a meal or after a meal, after dissolving one tablet in a teaspoon (5 ml) of water.
For children, the drug is prescribed at the rate of 3-5 mg per kg of body weight 2-3 times a day. The maximum daily dose is 5 mg / kg in 2-3 doses. For adolescents weighing more than 40 kg, Nise is prescribed 2 times a day, 100 mg each.
The duration of treatment is 10 days.
Elderly patients do not need to adjust the dosage regimen.
The drug in the form of a gel is used externally. Before applying the product, the surface to be treated should be washed and dried. Then it is necessary to squeeze out a column of gel about 3 cm long and apply it with an even thin layer on the area of maximum pain, do not rub. Frequency rate of application - 3-4 times a day.
The frequency of application (no more than 4 times a day) and the amount of gel may vary and depend on the patient's response and the size of the treated area. Without consulting a doctor, Nise gel is used for no more than 10 days.
Side effects
Systemic adverse reactions:
- Digestive system: nausea, vomiting, diarrhea, heartburn, erosive and ulcerative lesions of the gastrointestinal tract, pain in the stomach, toxic hepatitis, increased activity of hepatic transaminases;
- Hematopoietic system: leukopenia, agranulocytosis, anemia, thrombocytopenia;
- Central nervous system: dizziness, headache;
- Allergic reactions: bronchospasm, anaphylactic shock, skin rash;
- Others: hematuria, prolonged bleeding time, fluid retention.
Local reactions that can occur when Nise gel is applied:
- Hives;
- Transient discoloration of the skin (drug withdrawal is not required);
- Peeling.
With prolonged use of the gel on large areas of the skin, systemic side reactions are possible, typical for the drug in the form of tablets and suspensions.
special instructions
Nise is prescribed with caution to patients with visual impairment.
With prolonged use, kidney and liver function should be monitored.
Patients who are engaged in potentially dangerous activities requiring the speed of psychomotor reactions and increased concentration of attention, due to the possible development of such adverse reactions as drowsiness and dizziness, the drug is prescribed with caution.
Nise in the form of a gel is not recommended for use on open wounds and damaged skin areas. It should also avoid contact with mucous membranes and eyes. Do not use under airtight dressings. After the application procedure, you must tightly close the tube and wash your hands with soap and water.
Drug interactions
Nise is prescribed with caution together with phenytoin, digoxin, methotrexate, cyclosporine, diuretics, lithium preparations, hypoglycemic and antihypertensive drugs and other non-steroidal anti-inflammatory drugs.
Terms and conditions of storage
Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children. Do not freeze (for gel).
The shelf life of dispersible tablets and suspensions is 3 years, of a gel - 2 years.
Nise is a drug from the group of non-steroidal anti-inflammatory drugs, inhibitors of COX-2.
Release form
Pharmacological effects
Indications and contraindications
Adverse Reactions
Interaction with other medications
Price and reviews
Release form, composition
The active ingredient 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) 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 prostaglanid, 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 cartilage tissue, 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 joint swelling.
The drug is excreted through the kidneys and bile.
Indications for use
Before starting to use Nise in any dosage form, the patient should be informed that this drug is used only for symptomatic treatment.
This medication has no effect on the systemic course of the disease.
Indications for the use of Nise in the form of a gel are:
- carrying out local symptomatic therapy of the inflammatory process and pain in the joint area;
- complex therapy of arthritis: rheumatoid, psoriatic;
- osteoarthritis and osteochondrosis;
- radiculitis;
- sprains;
- bursitis;
- muscle pains of a rheumatic and non-rheumatic nature;
- damage to soft tissues - tears, 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 spondyloarthritis;
- with inflammation of 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 when:
- 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 the presence 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 in case of ischemic heart disease, angina pectoris, diabetes mellitus, peptic ulcer disease, 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.
Application 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 medication is required during lactation, it is necessary to consider 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;
- the 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 interact with drugs that include digoxin, lithium, 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 for use before the main meal. However, in the event that the patient develops discomfort or pain in the abdomen, the drug can be taken after eating.
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 a dry, clean skin surface. The drug is applied in a thin layer to the area with the maximum manifestation of pain syndrome. You do not need to rub in the drug. Frequency rate 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, there has been no information on cases of overdose with Nise. In the event of an accidental overdose, such reactions of the body may develop as an increase in blood pressure, disruption of the normal functioning of the gastrointestinal tract and kidneys, the development of seizures and respiratory depression. In this case, it is recommended to immediately flush 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 medication, 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 there is no need 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 Nise for the period of 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.
Analogs of the drug Nise are the following drugs: Nimica, Nimulid, Nimesil, Aponil.
If replacement is necessary, a preliminary consultation with the attending physician is required.
Reviews
The use of Nise for relieving 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 component of 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. The result is high analgesic and anti-inflammatory activity. All this makes it possible to use Nise 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 topical use of the drug to relieve back pain. I am very pleased 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 within 10 minutes after applying the drug. If you take another pill, the pain does not make itself felt throughout the day. I use it together with muscle relaxants and nootropic drugs.
Victoria
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Artrosan injections and tablets - complete instructions for use
Artrosan is an anti-inflammatory, non-steroidal drug. 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 effect on COX-1, which is involved in the synthesis of prostaglandins (PG).
Pharmacokinetics of the drug
The bioavailability of the active ingredient Artrosan 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% of meloxicam binds to blood plasma proteins.
The difference between the maximum and basal concentration in the body is small and amounts to a ratio (2.5: 1).
Nominal distribution space is 11 liters. The desired plasma concentration at steady state is reached after 3-5 days.
It is excreted equally in urine and feces.
Indications for use
As follows from the instructions, the drug is prescribed for degenerative diseases of the joints, in particular, for the relief of acute and chronic pain.
Suitable for arthritis, ankylosing spondyloarthritis, osteoarthritis.
Contraindications
There is also a fairly large number of contraindications:
- individual hypersensitivity to the components of the drug;
- children under 15;
- renal or hepatic impairment;
- peptic ulcer of the duodenum or stomach, postponed erosive and ulcerative lesions of the gastrointestinal tract;
- aspirin asthma;
- pregnancy, lactation;
- heart failure.
Medication dosage
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 intramuscular injections 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 per pack;
- 15 tablets in a blister, 1/2/3 blisters in a package.
Injections: 2.5 ml ampoules 3/5/10 pieces per package.
Suppositories: 7.5-15 mg of active substance in a 25/50/100 mg suppository.
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 alkalization of urine are ineffective in case of an overdose of Artrosan, since it has a high binding capacity with blood proteins.
Side effects
Often (1 in 100) the following side effects occur:
- indigestion, nausea, vomiting;
- skin rash, itching;
- dizziness, drowsiness;
- belching;
- anemia.
Sometimes (1 in 500):
- ulcers of the stomach and duodenum;
- gastrointestinal bleeding;
- noise in ears;
- the formation of an abscess with intramuscular injection;
- palpitations, increased blood pressure;
- exacerbation of bronchial asthma, cough.
Rarely (1 in 5000):
- photosensitivity;
- erythema multiforme;
- toxic epidermal necrolysis;
- renal medullary necrosis;
- bullous reactions;
- disorientation.
Very rare (1 in 10,000):
- hyperbilrubinemia;
- hyperemia of the face;
- leukopenia;
- esophagitis;
- conjunctivitis.
special instructions
It is undesirable to take Artrosan for smokers, patients with alcohol dependence and drug addiction.
The drug is prescribed with caution in patients with diabetes mellitus, with peripheral arterial pathology.
The medicine reduces blood clotting.
Interaction with alcohol
Serious, unforeseen conditions are possible after taking, in particular, large doses of alcohol, which can be fatal.
Reception for dysfunction of the kidneys and liver
The exacerbation of any kidney or liver disease should be considered when planning the use of the drug. And it is possible only with hemodialysis.
Interaction with other drugs
Drugs of the SSRI group, fibrinolytics, vitamin K antagonists, Heparin increase the risk of bleeding.
It is necessary to take intrauterine contraceptives with caution, as Artrosan can reduce the contraceptive effect.
Artrosan reduces the effectiveness of antihypertensive drugs.
When taken simultaneously with diuretics and cyclosporine, acute renal failure may develop.
Taking Kolestyramine accelerates the elimination of meloxicam from the body.
NSAID drugs increase the risk of gastrointestinal ulceration.
Reception during pregnancy and lactation
TO 
It is strictly forbidden to take pregnant and lactating women, meloxicam negatively affects the fetus, provokes internal bleeding in the digestive tract, and disrupts the normal functioning of the kidneys.
It is not advisable to take the drug for women planning pregnancy, as they reduce female fertility.
How doctors and patients respond about the drug
We suggest studying the reviews of doctors and patients who have used injections or Artrozan tablets.
What patients say
Opinion of doctors
In general, Artrozan is popular among the prescribed anti-inflammatory nonsteroidal drugs, for the treatment of arthritis and similar diseases, with doctors.
Neurologists highly appreciate the drug in its ability to localize and suppress acute pain.
The dosage should be adjusted or the medication should be canceled only upon prior consultation with a doctor.
It is undesirable to drive a car, or work on site with the necessary increased care.
Pros and cons of the medication
The downside is the shortage in pharmacies of such a form of Artrosan as gel and suppositories, even with their effectiveness, they occupy a very small niche among anti-inflammatory drugs.
Registration number:
P No. 12824/03 - 040411
Trade name of the drug: Nise ®
International non-proprietary name of the drug: nimesulide.
Dosage form:
tabletsCompound
Each tablet contains:
Active substance: nimesulide 100 mg.
Excipients: calcium hydrogen phosphate 75 mg, cellulose
microcrystalline (type 114) 40 mg, corn starch 54 mg, sodium carboxymethyl starch 35 mg, magnesium stearate 3 mg, colloidal silicon dioxide 2 mg, talc 1 mg.
Description
Round biconvex tablets with a smooth surface, white with a yellowish sheen.
Pharmacotherapeutic group:
non-steroidal anti-inflammatory drug (NSAID).ATC code: M01AX17.
Pharmacological properties
Pharmacodynamics
Non-steroidal anti-inflammatory drug (NSAID) from the sulfonanilide class. It is a selective competitive inhibitor of cyclooxygenase-2 (COX-2), inhibits the synthesis of prostaglandins in the focus of inflammation. The inhibitory effect on COX-1 is less pronounced (less often it causes side effects associated with inhibition of prostaglandin synthesis in healthy tissues). It has anti-inflammatory, analgesic and pronounced antipyretic effects.
Pharmacokinetics
Oral absorption is high (food intake reduces the rate of absorption without affecting its degree). Time to reach maximum concentration (T max) - 1.5-2.5 hours. Communication with plasma proteins - 95%, with erythrocytes - 2%, with lipoproteins - 1%, with acid alpha-glycoproteins - 1%. Dose variation does not affect the degree of binding. The maximum concentration (C max) is 3.5-6.5 mg / l. The volume of distribution is 0.19-0.35 l / kg. Penetrates into the tissues of the female genital organs, where after a single dose, its concentration 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 histohematogenous barriers.
It is metabolized in the liver by tissue monooxygenases. The main metabolite, 4-hydroxynimesulide (25%), has a similar pharmacological activity, but due to a decrease in the size of the molecules, it is able to quickly diffuse into the hydrophobic channel of COX-2 to the active binding site of the methyl group. 4-hydroxynimesulide is a water-soluble compound that does not require glutathione and phase II metabolism conjugation reactions (sulfation, glucuronidation, etc.) to be eliminated.
The half-life (T1 / 2) of nimesulide is 1.56-4.95 hours, 4-hydroxynimesulide is 2.89- 4.78 hours. 4-hydroxynimesulide is excreted by the kidneys (65%) and with bile (35%), undergoes enterohepatic recycling.
In patients with renal failure (creatinine clearance 1.8-4.8 l / h or 30-80 ml / min), as well as in children and the elderly, the pharmacokinetic profile of nimesulide does not change significantly.
Indications for use
Rheumatoid arthritis;
- articular syndrome with exacerbation of gout;
- psoriatic arthritis;
- ankylosing spondylitis;
- osteochondrosis with radicular syndrome;
- osteoarthritis;
- myalgia of rheumatic and non-rheumatic genesis;
- inflammation of ligaments, tendons, bursitis, including post-traumatic inflammation
soft tissues;
- pain syndrome of various origins (including in the postoperative period, with
trauma, algodismenorrhea, toothache, headache, arthralgia, lumboishalgia).
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.
Contraindications
Hypersensitivity to the active substance or auxiliary components; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history); erosive and ulcerative changes in the mucous membrane of the stomach and duodenum (duodenum), active gastrointestinal bleeding, cerebrovascular or other bleeding; inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase; hemophilia and other blood clotting disorders; decompensated heart failure; liver failure or any active liver disease; anamnestic data on the development of hepatotoxic reactions when using nimesulide preparations; concomitant use of potentially hepatotoxic substances; alcoholism, drug addiction; severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia; the period after coronary artery bypass grafting; pregnancy, lactation period; children under 12 years of age (for this dosage form, see the section "Special instructions").
Carefully
Ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min. Anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of infection Helicobacter pylori, old age, long-term use of NSAIDs, frequent alcohol consumption, severe medical illness, concomitant therapy with anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (eg, prednisolone), selective serotonin inhibitors (eg, seizure inhibitors) citalopram, fluoxetine, paroxetine, sertraline).
Method of administration and dosage
The minimum effective dose should be used in the shortest possible short course. The tablets are taken with sufficient water, preferably after meals. Adults and children over 12 years of age inside 1 tablet 2 times a day. 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. The maximum daily dose for adults is 200 mg. Patients with chronic renal failure require a daily dose reduction of up to 100 mg.
Side effect
The frequency of side effects is classified depending on the frequency of occurrence of the case: often - (1-10%), sometimes (0.1-1%), rarely (0.01-0.1%), very rarely (less than 0.01% ), including individual messages.
Allergic reactions: rarely - hypersensitivity reactions; very rarely - anaphylactoid reactions.
From the side of the central nervous system: infrequently - dizziness; rarely - a feeling of fear, nervousness, nightmares; very rarely - headache, drowsiness, encephalopathy (Reis syndrome).
From the side of the skin: infrequently - itching, rash, increased sweating; rarely: erythema, dermatitis; very rare: urticaria, angioedema, facial edema, exudative erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
From the urinary system: infrequently - edema; rarely - dysuria, hematuria, urinary retention, hyperkalemia; very rarely - renal failure, oliguria, interstitial nephritis.
From the gastrointestinal tract: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, stomatitis, tarry stools, gastrointestinal bleeding, ulcer and / or perforation of the stomach or duodenum. From the liver and biliary system: often - an increase in "hepatic" transaminases; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis. From the side of the hematopoietic organs: rarely - anemia, eosinophilia; very rarely - thrombocytopenia, pancytopenia, purpura, prolonged bleeding time From the respiratory system: infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm. From the senses: rarely - blurred vision.
On the part of the cardiovascular system: infrequently - arterial hypertension; rarely, tachycardia, hemorrhages, "hot flashes". Others: rarely - general weakness; very rarely - hypothermia.
Overdose
Symptoms: apathy, drowsiness, nausea, vomiting. Gastrointestinal bleeding, increased blood pressure, acute renal failure, respiratory depression may occur.
Treatment: requires symptomatic treatment and supportive care for the patient. There is no specific antidote. If an overdose has occurred within the last 4 hours, it is necessary to induce vomiting, ensure the intake of activated carbon (60-100 g per adult), osmotic laxatives. Forced diuresis, hemodialysis are ineffective due to the high connection of the drug with proteins.
Interaction with other medicinal products
The effect of drugs that reduce blood clotting is enhanced by their simultaneous use with nimesulide.
Nimesulide can reduce the effect of furosemide. Nimesulide may increase the possibility of side effects while taking methotrexate.
The level of lithium in plasma increases with the simultaneous administration of lithium and nimesulide preparations.
Nimesulide may increase the effect of cyclosporine on the kidneys.
Use with glucocorticosteroids, serotonin reuptake inhibitors, increases the risk of gastrointestinal bleeding.
special instructions
Since Nise is partially excreted by the kidneys, its dose for patients with impaired renal function should be reduced, depending on the creatinine clearance parameters. Given the reports of visual impairment in patients taking other NSAIDs, treatment should be discontinued immediately if any visual impairment occurs and the patient should be examined by an ophthalmologist.
The drug can cause fluid retention in tissues, therefore, patients with high blood pressure and cardiac dysfunctions should use Nise® with extreme caution.
Patients should undergo regular medical supervision if they take medications along with nimesulide, which are characterized by an effect on the gastrointestinal tract.
If signs of liver damage appear (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased levels of "liver" transaminases), stop taking the drug and consult your doctor. The drug should not be used concomitantly with other NSAIDs.
The drug can change the properties of platelets, but does not replace the prophylactic effect of acetylsalicylic acid in cardiovascular diseases. The use of the drug may adversely affect female fertility and is not recommended for women planning a pregnancy.
After 2 weeks of using the drug, it is necessary to monitor the biochemical parameters of liver function.
This dosage form is contraindicated for children under 12 years old, but if it is necessary to use nimesulide in children over 7 years old, dispersible tablets 50 mg and suspension can be used, in strict accordance with the instructions for medical use attached to them.
Since the drug can cause drowsiness, dizziness and blurred vision, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
Release form
Tablets 100 mg. 1, 2 or 10 PVC / aluminum blisters of 10 tablets together with instructions for use are packed in a cardboard box.
Storage conditions
List B.
In a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children!
Best before date
3 years.
Do not use after the expiration date printed on the package.
Conditions of dispensing from pharmacies
On prescription.
Manufacturer
Dr. Reddy's Laboratories Ltd., 7-1-27, Amirpet, Hyderabad - 500016, Andhra Pradesh, India
Production site address
Dr. Reddy of Laboratories Ltd.
1. Sites 42, 45 and 46, Bachupalli Village, Qutbullapur Mandal, Ranga Reddy District, Andhra Pradesh, India
2. Khol village, Nalagarh Road, Buddy Consumer claims should be addressed to the following address: Representative office of Dr. Reddy with Laboratories Ltd: 115035, Moscow, Ovchinnikovskaya nab., 20, building 1 Solan district, Himachal Pradesh , India
