Pain may accompany inflammatory process, bring significant discomfort and cause complications. An experienced specialist will help to determine the treatment; Nimesil powder is often prescribed among the prescribed drugs. We will tell you in detail how to drink Nimesil in powder, but we note that it is not recommended to take medications without a doctor's prescription.
About the drug
Nimesil is a non-steroidal sulfonamide that has anti-inflammatory, analgesic, antipyretic effects. The main active substance- nimesulide. It slows down chemical reaction prostaglandin E2 in the focus of inflammation and in the ascending pathways of the nociceptive system. A decrease in the concentration of prostaglandins in the body creates an analgesic and anti-inflammatory effect.
The drug is produced by the leader of the pharmacological market, the Berlin-Chemie company. Thanks to modern technologies, German manufacturers base their products on new generation components. The nimesulide group belongs to those, it has maximum effect with minimal side effects. Wide range indications allows the use of Nimesil in various branches of medicine.
The drug contains Excipients: Ketomacrogol 1000, sucrose, maltodextrin, citric acid and orange flavor for flavoring.
Indications for use
The drug is prescribed for children over 12 years old, available in several forms:
- Powder.
- Suspension.
- Lozenges.
- Soluble tablets.
The liver is mainly responsible for the absorption of the drug, the rest of the drug is excreted by the kidneys by 50%. In blood maximum concentration marked 2-3 hours after ingestion. The spectrum of action of the drug is extensive, the indications for its use include:
- Pain in muscles and joints.
- Pain in lumbar and back.
- Inflammation of the tendons (tendonitis), periarticular tissues (bursitis).
- Sports injuries, sprains, bruises.
- Toothache.
- Pain syndrome in osteochondrosis and osteoarthritis.
- Pain during the menstrual cycle.
- Recovery after surgical intervention(relieving inflammation and pain).
- Colds, fevers.
The drug is taken orally, the powder is previously dissolved in warm water to a suspension. Before use, it is important to familiarize yourself with the contraindications.
Contraindications
Each organism is unique, therefore, before using the medicine, you should consult a doctor, he will help to identify possible complications taking into account individual characteristics and compatibility with other drugs. It is not recommended to drink Nimesil in cases of:
- Pregnancy and breastfeeding period.
- Diseases of the gastrointestinal tract in the acute stage.
- Hepatic and renal failure.
- Bronchial asthma in acute course.
- Hemophilia and other causes of poor blood clotting.
- Thrombophilia.
- Children under 12 years of age.
- Alcohol abuse tendencies.
- Individual intolerance to the components of the drug.
It is worth using the drug with caution in case of cardiovascular disorders - vascular system, visual impairment, high blood pressure. In old age, the use of the medicine is possible only under the supervision of a doctor. Babies under 12 years old can be given forms intended for children, when prescribing Nimesil to a child under 6 years old, strict supervision of a pediatrician is required.
If the use of Nimesil is shown to you, then it is important to take into account the dosage correctly.
Application and dosage
A common option for selling the drug is a powder packaged in a 2-gram sachet. This amount of the drug - single dose, it should be diluted with 100 ml warm water... Typical use is 2 sachets per day for adults. For children, the dosage is calculated on the basis of weight, 1.5 mg per 1 kg up to 3 times a day.
In cases where the patient takes others medications has liver problems or kidney failure, the doctor may reduce the dosage. In acute pain, the dose may be increased. For kids maximum dose is 5 mg per 1 kg 3 times a day.
According to the doctor's prescription, the drug can be used course treatment, the daily dosage is minimal, the duration of the course is 15 days.
The tool can cause dizziness and drowsiness, so you should carefully monitor your condition, if it becomes necessary to get behind the wheel, it is better to abandon the idea. It is better to avoid driving a car until the drug is excreted from the body.
The correct dosage is essential for effective application and avoiding side effects.
Side Symptoms
Unpleasant symptoms appear only in case of violation permissible norm, it includes:
- Nausea, heartburn, and vomiting.
- Drowsiness, feeling tired and apathetic.
- Enhancement blood pressure, dizziness.
- Allergic reaction: dermatitis, urticaria.
- In rare cases, exacerbation chronic diseases: ulcerative bleeding, attacks of suffocation, exacerbation of renal failure.
- In case of severe overdose, it is possible anaphylactic shock and coma.
Nimesil for toothache
The tool belongs to drugs broad action and can be prescribed for toothache. To relieve pain symptoms, dilute the powder according to the instructions. It is better to drink the suspension after meals. The effect can be felt 20 minutes after ingestion, the duration of the drug is 12 hours.
Due to its anti-inflammatory action, Nimesil can be used for gum diseases, enter into therapy for fluxes or other inflammation of soft tissues. Remember that the drug only relieves symptoms, but cannot cure diseases of the oral cavity, therefore, it is imperative to visit a dentist.
This medicine - efficient way get rid of pain and inflammation. Thanks to broad list indications and the minimum number of contraindications, Nimesil is often used in medical practice... The cost of the drug is also its advantage. One sachet - sachet costs from 25 rubles, 30 pcs per pack. will have to pay about 730 rubles.
In pharmacology, other drugs have been created on the basis of the main active ingredient of nimesulide. Analogs include:
- Nimesulide tablets, their advantage is the price, average cost packaging of 20 tablets - 40 rubles.
- Nise tablets, price 170 rubles for 20 tab.
- Gel Nise for topical application, cost from 150 rubles for 20 mg.
- Nimika tablets, price from 120 rubles for 20 pcs.
The advantage of Nimesil powder is its form, the suspension is absorbed faster into the intestinal walls, giving a quick effect. By following all the recommendations of experts, you can safely get rid of pain for little money.
Nimesil instruction - video
Nimesil is an anti-inflammatory drug belonging to the sulfonamide class.
Pharmacological action of Nimesil
According to the instructions, Nimesil has a pronounced antipyretic, anti-inflammatory, analgesic effect. The drug is well tolerated during a long course of administration. The active ingredient of the drug is nimesulide. Nimesil has a rapidly developing therapeutic effect during use. The action of Nimesil continues for six hours after administration.
Forms of issue
Nimesil powder is produced (it can be in the form of granules), from which a suspension is prepared for oral administration. At the pharmacy, you can buy the drug in sachets containing 100 mg of nimesulide.
Indications for the use of Nimesil
According to the instructions, Nimesil is used primarily to remove infectious inflammation... The use of Nimesil is effective for the treatment of degenerative inflammatory pathologies musculoskeletal system. According to reviews, Nimesil is often used for diseases of arthritis, bursitis, osteochondrosis, sciatica, rheumatism. The use of Nimesil is also used to eliminate fever of various origins... Sometimes the drug is also used to eliminate toothache.
Method of administration and dosage
Nimesil powder is taken orally in a dissolved form. Use 1 sachet twice a day. The drug Nimesil is recommended to be taken after meals. The contents of the sachet must be poured into a glass and dissolved in about 100 ml of water. The prepared solution is not stored. Nimesil for children over 12 years old is given twice a day, one packet at a time.
Contraindications
Nimesil is not used for treatment in children under 12 years of age. According to the instructions, Nimesil is contraindicated in patients with ulcers and heavy bleeding in the gastrointestinal tract. Nimesil powder is not used for type 2 diabetes, severe renal pathology, diarrhea, hypersensitivity, heartburn and vomiting. Cardiac congestive failure, high blood pressure and complaints of abdominal pain are also a contraindication for the use of Nimesil.
Application during pregnancy
This drug is contraindicated in women during pregnancy and lactation.
Overdose
In case of an overdose, Nimesil can cause apathy, drowsiness, nausea, vomiting, and abdominal pain. According to reviews, Nimesil can cause gastrointestinal bleeding in case of an overdose. An overdose of a drug can provoke an increase in blood pressure. Phenomena such as acute renal failure, respiratory depression and coma, anaphylactoid reactions are also possible.
In case of overdose, carry out next treatment: it is necessary to induce vomiting and take activated charcoal. Adults need 60 to 100 grams activated carbon... You can take an osmotic laxative.
Side effects of Nimesil
Nimesil can sometimes cause side effects. At the beginning of therapy and with individual sensitivity, dizziness, nervousness, encephalopathy, anxiety occur, headache, tachycardia. Hot flashes, increased pressure, hemorrhage are also possible.
In case of severe side effects, you should immediately stop taking the drug Nimesil. It is imperative to consult a doctor in such a situation.
Storage conditions and periods
Nimesil must be stored in a dry place, protected from sunlight. The drug must be out of reach of children. The storage temperature is recommended not higher than 25 degrees.
Nimesil can be stored for two years. You can not use the drug after the expiration date, which is indicated on the packaging of the drug.
Pharmacodynamics. Nimesulide (4-nitro-2-phenoxymethanosulfonanilide) - NSAIDs of the methanesulfonanilide group, has anti-inflammatory, analgesic and antipyretic effects. Therapeutic effect Nimesulide is due to the fact that it affects the metabolism of arachidonic acid and reduces the biosynthesis of prostaglandins by inhibiting COX. At the expense of selective action on COX-2, the synthesis of prostaglandins with a cytoprotective effect in the gastric mucosa is not disturbed, the risk of side effects is reduced. In addition, nimesulide reduces the formation of superoxide anions by neutrophilic granulocytes and inhibits the formation of free radicals formed during inflammation.
Pharmacokinetics. Well absorbed when oral administration reaching Cmax in blood plasma after 2-3 hours. Up to 97.5% of nimesulide binds to plasma proteins.
Nimesulide is actively metabolized in the liver with the participation of CYP 2C9, an isoenzyme of cytochrome P450. The main metabolite is the parahydroxy derivative, which also has pharmacological activity. T1 / 2 - 3.2-6 hours. Nimesulide is excreted in the urine - about 50% of the dose taken. About 29% of the dose taken is excreted in the feces in a metabolized form, and only 1-3% is excreted from the body unchanged. The pharmacokinetic profile in the elderly does not change. With prolonged use, it does not accumulate in the body.
Indications for the use of the drug Nimesil
Spicy pain syndrome. Symptomatic treatment osteoarthritis with pain syndrome. Primary dysmenorrhea.
Application of the drug Nimesil
Nimesil is prescribed after a careful assessment of the benefit / risk ratio. Apply a minimum effective dose for the shortest possible time to reduce side effects. The maximum duration of the course of treatment with Nimesil is 15 days.
Adults and the elderly: 1 sachet of 100 mg 2 times a day ( daily dose- 200 mg). Children over the age of 12: No dose adjustment required.
Patients with impaired renal function: for patients with mild or moderate degree renal failure (creatinine clearance - 30-80 ml / min) dose adjustment is not required.
The contents of portioned sachets are poured into a glass, dissolved in water and taken orally after meals.
Contraindications to the use of the drug Nimesil
Increased sensitivity to nimesulide or to any component of the drug. History of hyperergic reactions (bronchospasm, rhinitis, urticaria) in connection with the use of acetylsalicylic acid or other NSAIDs. History of hepatotoxic reaction to nimesulide. Peptic stomach ulcer or duodenum in the acute phase, recurrent peptic ulcers or gastrointestinal bleeding, cerebrovascular bleeding or other bleeding conditions. Significant bleeding disorder. Severe heart failure. Severe renal failure. Liver failure... Children under the age of 12. In the III trimester of pregnancy and lactation. Elevated temperature body and flu-like symptoms, suspected acute surgical pathology. Do not use simultaneously with other drugs that may cause hepatotoxic reactions. Alcoholism and drug addiction.
Side effects of the drug Nimesil
The frequency of side effects is classified as follows: very common (≤1 / 10); often (1/100 and ≤1 / 10); sometimes (1/1000 and ≤1 / 100); rarely (1/10 000 and ≤1 / 1000); very rare (≤1 / 10,000), including special cases.
- Rarely Anemia, eosinophilia.
- Very rare Thrombocytopenia, pancytopenia, purpura.
From the immune system:
- Rarely Hypersensitivity
- Very rare Anaphylaxis
Metabolic and metabolic disorders:
- Rarely Hyperkalemia
Mental disorders:
- Rare Feeling of fear, nervousness, nightmares
From the nervous system:
- Sometimes Dizziness
- Very rare Headache, drowsiness, encephalopathy (Reye's syndrome)
- Rarely Blurred vision
- Very rare Visual impairment
On the part of the organ of hearing and balance:
- Very rare Dizziness
On the part of the cardiovascular system:
- Sometimes Hypertension
- Rarely Tachycardia, hemorrhages, blood pressure lability, hot flashes
From the respiratory system:
- Sometimes shortness of breath
- Very rare BA, bronchospasm
From the gastrointestinal tract:
- Often Diarrhea, nausea, vomiting
- Sometimes constipation, flatulence, gastritis
- Very rare Abdominal pain, dyspepsia, stomatitis, black stool (melena), gastrointestinal bleeding, ulcer, perforating stomach and duodenal ulcer
From the liver and biliary system:
- Very rare Hepatitis, fulminant hepatitis (including fatal cases), jaundice, cholestasis
On the part of the skin and appendages:
- Sometimes itching skin rash, excessive sweating
- Rarely Erythema, dermatitis
- Very rare Urticaria, angioedema, facial edema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
- Rarely Dysuria, hematuria, urinary retention.
- Very rare Renal failure, oliguria, interstitial nephritis
General violations:
- Sometimes swelling
- Rarely Weakness, asthenia
- Very rare Hypothermia
Laboratory research data:
- Often Increased levels of hepatic transaminases.
Special instructions for the use of the drug Nimesil
Risk of occurrence side effects can be reduced if nimesulide, if possible, is used for a minimum period of time. Treatment should be discontinued in the absence of a positive clinical effect for several days. With an increase in body temperature and the appearance of flu-like symptoms in patients using nimesulide, the drug should be discontinued. With the use of nimesulide, there have been reports of serious adverse reactions from the liver (very rarely with a fatal outcome), therefore, with prolonged use of nimesulide, it is necessary to monitor liver function indicators with a frequency of 1 every 2 weeks. If patients taking nimesulide experience changes in liver function indicators (increased ALT, ASAT, ALP), symptoms of liver damage appear (anorexia, nausea, vomiting, abdominal pain, dark urine), the drug is canceled and is not prescribed in the future. There have been reports of liver damage (most of which were reversible) after short-term use of the drug. During treatment with nimesulide, its combined use with drugs with a hepatotoxic effect, as well as alcohol abuse, should be avoided, since these substances can increase the risk of adverse reactions from the liver. When treating with nimesulide, you should refrain from using other analgesics.
Nimesulide should be used with caution in patients with gastrointestinal disorders (peptic ulcer, history of gastrointestinal bleeding, ulcerative colitis or Crohn's disease). At any stage of treatment, nimesulide can provoke gastrointestinal bleeding, the appearance of a peptic ulcer or perforation of a hollow organ, regardless of whether there was a history of the disease digestive tract... In the event of such complications, treatment with nimesulide should be discontinued.
Patients with impaired renal or cardiac function should use Nimesil with caution, as it can cause or exacerbate these impairments. In this case, therapy with Nimesil should be discontinued. The drug can cause fluid retention in the body, therefore, in patients with hypertension ( arterial hypertension) and heart failure, it should be used with extreme caution.
The drug may cause drowsiness or dizziness. Older persons are more prone to developing side effects when using NSAIDs, such as gastrointestinal bleeding or perforation, dysfunction of the heart, liver or kidneys, therefore, these patients need constant medical monitoring. Nimesulide can disrupt platelet function, so it should be prescribed with caution in hemorrhagic diathesis.
Nimesil should not be used as a substitute for acetylsalicylic acid for cardiovascular prophylaxis. Nimesulide can mask an increase in body temperature associated with a bacterial infection.
During pregnancy and breastfeeding. It is not recommended to prescribe nimesulide to women planning pregnancy. Patients who have complications of pregnancy or women who are being screened for infertility should not take nimesulide. It is not recommended to use nimesulide during breastfeeding.
Influence on the ability to drive vehicles and work with precision mechanisms. Studies of the effect of nimesulide on the ability to drive vehicles and work with mechanisms have not been conducted. If dizziness or drowsiness occurs when using nimesulide, you should stop similar species activities.
Nimesil drug interactions
Patients using warfarin or other indirect anticoagulants or acetylsalicylic acid have increased risk the occurrence of bleeding with the simultaneous use of Nimesil, therefore this combination is not recommended, and with severe forms blood clotting disorders, it is contraindicated. If such a combination cannot be avoided, regular monitoring of the state of the blood coagulation system is necessary. In healthy individuals, nimesulide temporarily reduces diuretic action furosemide and excretion of sodium and, to a lesser extent, potassium, therefore, with the simultaneous use of nimesulide and furosemide in case of impaired renal or cardiac function, special care should be taken. There is evidence that NSAIDs reduce the clearance of lithium, which leads to an increase in the level of lithium in the blood plasma and an increase in its toxicity. If Nimesil is prescribed to a patient receiving lithium preparations, frequent monitoring of the lithium level in the blood plasma is required.
With simultaneous use with glibenclamide, theophylline, warfarin, digoxin, cimetidine and antacids no clinically significant interactions were noted. Care should be taken if nimesulide is prescribed less than 24 hours before or after taking methotrexate, since the latter may increase in plasma levels and increase its toxicity. With simultaneous use with cyclosporine, an increase in the nephrotoxicity of the latter is possible.
Overdose of the drug Nimesil, symptoms and treatment
Symptoms: apathy, drowsiness, nausea, vomiting, epigastric pain. These symptoms are usually reversible. Possible gastrointestinal bleeding, hypertension (arterial hypertension), acute renal failure, respiratory depression, coma. However, such phenomena are rarely noted.
Treatment: symptomatic; there is no specific antidote. There are no data on the elimination of nimesulide by hemodialysis, but taking into account high degree binding of nimesulide to blood plasma proteins (up to 97.5%), it is unlikely that dialysis will be effective. Shows gastric lavage, the use of activated carbon.
Storage conditions of the drug Nimesil
In a dry, dark place at room temperature.
List of pharmacies where you can buy Nimesil:
- St. Petersburg
As a pregnant woman, every woman is interested in which medications should be taken and which should be discarded. As an example, consider such a popular medicine today as Nimesil.
What does Nimesil help from?
Nimesil belongs to non-steroidal anti-inflammatory drugs (NSAIDs), which have a pronounced analgesic, antipyretic and anti-inflammatory effect. The main indications for its use are:- pain syndrome, which includes toothache and headache, postoperative pain, etc.;
- diseases of the musculoskeletal system of an inflammatory nature (arthritis, arthrosis, radiculitis, etc.);
- diseases accompanied by an increase in body temperature;
- traumatic diseases that are of an infectious and inflammatory nature;
- problems in the gynecological and urological part.
Composition
The main active ingredient of the drug is nimesulide, which, unlike most NSAIDs, does not suppress the action of enzymes necessary for protection gastrointestinal tract from all kinds of mechanical and chemical damage.TO additional components included are maltodextrin, citric acid, sucrose, artificial orange flavor and ketomacrogol 1000.
Nimesil instructions for use powder how to dilute?
As follows from the instructions for use of the drug, the sachet must be dissolved in 100 ml of warm boiled water. After pouring the powder into water, the mixture should be thoroughly stirred until a homogeneous consistency. Since the medicine is not subject long-term storage, then you need to drink it immediately after stirring.
Cold medicine for fever
Because colds usually accompanied not only by a significant increase in temperature, but also by a severe headache, as well as the appearance pain in the muscles and joints, then Nimesil may be just the remedy that will help you recover as quickly as possible from the disease.The obvious advantages of Nimesil include its good absorption, duration of action (6 - 8 hours), as well as minimal harm health with its long-term use.
With menstruation
Nimesil can be used with strong menstrual pain, which quite often pursue women in the first days of menstruation. Moreover, the drug can be taken both in powder form and in tablets.Method of administration for breastfeeding
Like most medicines of the NSAID class, it is undesirable to take Nimesil not only during pregnancy, but also with breastfeeding... Only possible variant- a decrease in the dose taken, although this method is rejected by most specialists.How many times can you drink a day?
The maximum duration of treatment is 15 days. The recommended daily dose of Nimesil is 1 sachet twice a day after meals.
Can I give it to children: from how old?
According to the instructions, the minimum age for a child at which he is allowed to take Nimesil is 12 years. However, some doctors recommend refraining from taking the drug until you reach adulthood.
Proportions for children
Children over the age of 12 can take the powder in the same way as adults, namely 1 sachet twice a day after meals.Nimesil during pregnancy
As already mentioned, Nimesil is contraindicated at any stage of pregnancy. This is due to the fact that the medicine can negatively affect both the pregnancy itself and the development of the fetus.
Indications for use
In some cases, doctors still prescribe Nimesil during pregnancy. To reduce the risks of occurrence various diseases and pathologies, the drug is prescribed in smaller doses and only for a few days.How long does it take to act: reviews
As most reviews testify, the effect of the drug begins to be felt within 40-50 minutes after taking it. The action of Nimesil is usually about 8 hours, so that the analgesic and antipyretic effect of it is quite high.Nimesil analogues are cheaper
In certain cases, Nimesil can be quite expensive, and this can negatively affect the family budget. To cheaper ones, but not less effective analogues include Nimulid, Nise, Aponil. But in any case, before choosing a drug in mandatory consultation with a specialist is necessary, who will give the go-ahead for the use of a particular medicine.Trade name of the drug: Nimesil ®
International non-proprietary name(MIN): nimesulide
Dosage form: granules for preparation of oral suspension.
Composition:
1 package contains:
Active substance: nimesulide 100 mg;
Excipients: ketomacrogol 1000, sucrose, maltodextrin, anhydrous citric acid, orange flavor.
Description: light yellow granular powder with an orange scent.
Pharmacotherapeutic group:
non-steroidal anti-inflammatory drugs (NSAIDs).ATX code: M01AX17
Pharmacological properties
Pharmacodynamics Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) from the sulfonamide class. It has anti-inflammatory, analgesic and antipyretic effects. Nimesulide acts as an inhibitor of the enzyme cyclooxygenase, which is responsible for the synthesis of prostaglandins and inhibits mainly cyclooxygenase 2.
Pharmacokinetics After oral administration, the drug is well absorbed from the gastrointestinal tract, reaching a maximum concentration in blood plasma after 2-3 hours; connection with plasma proteins - 97.5%; the half-life is 3.2-6 hours. Easily penetrates histohematogenous barriers.
It is metabolized in the liver by the cytochrome P450 isoenzyme (CYP) 2C9. The main metabolite is the pharmacologically active parahydroxy derivative of nimesulide - hydroxynimesulide. Hydroxynimesulide is excreted in the bile in a metabolized form (found exclusively in the form of glucuronate - about 29%). Nimesulide is excreted from the body, mainly by the kidneys (about 50% of the dose taken). The pharmacokinetic profile of nimesulide in the elderly does not change with the appointment of single and multiple / repeated doses.
According to experimental research conducted with the participation of patients with mild to moderate renal failure (creatinine clearance 30-80 ml / min) and healthy volunteers, the maximum concentration of nimesulide and its metabolite in the plasma of patients did not exceed the concentration of nimesulide in healthy volunteers. The area under the concentration-time curve (AUC) and half-life in patients with renal insufficiency were 50% higher, but within the pharmacokinetic values. With repeated administration of the drug, cumulation is not observed.
Indications for use
- Treatment acute pain(back pain, lower back; pain syndrome in musculoskeletal system including injuries, sprains and dislocations of the joints; tendenitis, bursitis; toothache);
- Symptomatic treatment of osteoarthritis with pain syndrome;
- Algodismenorrhea.
Contraindications
- Hypersensitivity to nimesulide or to one of the components of the drug.
- Hyperergic reactions (in history) for example, bronchospasm, rhinitis, urticaria, associated with taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, including nimesulide. Hepatotoxic reactions to nimesulide (in history).
- Concomitant (simultaneous) reception medicines with potential hepatotoxicity, for example, paracetamol or other analgesic or non-steroidal anti-inflammatory drugs.
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase. The period after coronary artery bypass grafting.
- Feverish syndrome with colds and acute respiratory viral infections.
- Complete or incomplete combination bronchial asthma, recurrent polyposis of the nose or paranasal sinuses with intolerance to acetylsalicylic acid and other NSAIDs (including a history);
- Peptic ulcer of the stomach or duodenum in the acute phase, a history of ulcers, perforation or bleeding in the gastrointestinal tract.
- A history of cerebrovascular bleeding or other bleeding, as well as diseases accompanied by bleeding.
- Severe bleeding disorders.
- Severe heart failure.
- Severe renal failure (creatinine clearance<30 мл/мин), подтвержденная гиперкалиемия.
- Liver failure or any active liver disease.
- Children under the age of 12.
- Pregnancy and lactation.
- Alcoholism, drug addiction.
Carefully: severe forms of arterial hypertension, type 2 diabetes mellitus, heart failure, ischemic heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min.
Anamnestic data on the presence of ulcerative lesions of the gastrointestinal tract, infection caused by Helicobacter pylori; elderly age; long-term previous use of NSAIDs; severe somatic diseases.
Concomitant therapy with the following drugs: anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, sertrain, paroxetine). The decision to prescribe the drug Nimesil ® should be based on an individual assessment of the "risk-benefit" when taking the drug.
Method of administration and dosage
Nimesil is taken orally, 1 sachet (100 mg of nimesulide) twice a day. The drug is recommended to be taken after meals. The contents of the sachet are poured into a glass and dissolved in about 100 ml of water. The prepared solution cannot be stored.
Nimesil ® is used only for the treatment of patients over 12 years old.
Adolescents (12 to 18 years old): on the basis of the pharmacokinetic profile and 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 renal failure (creatinine clearance 30-80 ml / min).
Elderly patients: when treating elderly patients, the need to adjust the daily dose is determined by the doctor based on the possibility of interaction with other drugs.
The maximum duration of treatment with nimesulide is 15 days.
To reduce the risk of unwanted side effects, the minimum effective dose should be used in a minimally short course.
Side effects
The frequency is classified by headings, depending on the occurrence of the case: very often (> 10), often (<10-<100), нечасто (<100-<1000), редко (<1000-<10000), очень редко (<10000).
Disturbances from the circulatory and lymphatic systems: rarely - anemia, eosinophilia, hemorrhages; very rarely - thrombocytopenia, pancytopenia, thrombocytopenic purpura.
Allergic reactions: infrequently - itching, rash, excessive sweating; rarely - hypersensitivity reactions, erythema, dermatitis; very rarely - anaphylactoid reactions, urticaria, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
Central nervous system disorders: infrequently - dizziness; rarely - a feeling of fear, nervousness, nightmares; very rarely - headache, drowsiness, encephalopathy (Reye's syndrome).
Sensory disorders: rarely - blurry vision.
Cardiovascular disorders: infrequently - arterial hypertension, tachycardia, blood pressure lability, "hot flashes".
Respiratory system disorders: infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm.
Gastrointestinal disorders: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, dyspepsia, stomatitis, tarry stools, gastrointestinal bleeding, ulcer and / or perforation of the stomach or duodenum.
Liver and biliary system disorders: very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis, increased activity of liver enzymes.
Kidney and urinary tract disorders: rarely - dysuria, hematuria, urinary retention; very rarely - renal failure, oliguria, interstitial nephritis.
General violations: rarely - malaise, asthenia; very rarely - hypothermia.
Others: rarely, hyperkalemia.
Overdose
Symptoms: apathy, drowsiness, nausea, vomiting, epigastric pain. These symptoms are usually reversible with maintenance therapy for gastropathy. Gastrointestinal bleeding is possible. In rare cases, an increase in blood pressure, acute renal failure, respiratory depression and coma, anaphylactoid reactions are possible.
Treatment: Symptomatic. There is no specific antidote. In case an overdose has occurred within the last 4 hours, it is necessary to induce vomiting and / or provide the intake of activated charcoal (from 60 to 100 g per adult) and / or an osmotic laxative. Forced diuresis, hemodialysis are ineffective due to the high connection of the drug with proteins (up to 97.5%). Control of kidney and liver function is shown.
Interaction with other medicinal products
Pharmacodynamic interactions:
Glucocorticosteroids: Increases the risk of gastrointestinal ulcers or bleeding.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine: increase the risk of gastrointestinal bleeding.
Anticoagulants: NSAIDs can enhance the effect of anticoagulants such as warfarin. Due to the increased risk of bleeding, this combination is not recommended and is contraindicated in patients with severe coagulation disorders. If the combination therapy still cannot be avoided, it is necessary to carefully monitor the blood clotting parameters.
Diuretics
NSAIDs can reduce the effect of diuretics.
In healthy volunteers, nimesulide temporarily reduces the excretion of sodium by furosemide, to a lesser extent - excretion of potassium, and reduces the actual diuretic effect.
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 nimesulide requires caution in patients with impaired renal or cardiac functions.
ACE inhibitors and angiotensin II receptor antagonists
NSAIDs can reduce the effects of antihypertensive drugs. In patients with mild to moderate renal failure (creatinine clearance 30-80 ml / min), with the co-administration of ACE inhibitors, angiotensin II receptor antagonists or substances that suppress the cyclooxygenase system (NSAIDs, antiplatelet agents), further deterioration of renal function and the occurrence of acute renal failure, which is usually reversible. These interactions should be considered in patients taking Nimesil in combination with ACE inhibitors or angiotensin I receptor antagonists. Therefore, coadministration of these drugs should be prescribed with caution, especially for elderly patients. Patients should receive adequate fluid intake, and renal function should be closely monitored after starting concomitant therapy.
Pharmacokinetic interactions with other drugs:
There is evidence that NSAIDs reduce the clearance of lithium, which leads to an increase in the concentration of lithium in the blood plasma and its toxicity. When nimesulide is prescribed to patients receiving therapy with lithium preparations, regular monitoring of the concentration of lithium in plasma should be carried out.
Clinically significant interactions with glibenclamide, theophylline, digoxin, cimetidine and antacids (for example, a combination of aluminum and magnesium hydroxides) were not observed.
Nimesulide inhibits the activity of the isoenzyme CYP2C9. With the simultaneous administration of drugs that are substrates of this enzyme with nimesulide, the concentration of these drugs in plasma may increase.
When prescribing nimesulide less than 24 hours before or 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 synthetases, which include nimesulide, can increase the nephrotoxicity of cyclosporins.
Interaction of other drugs with nimesulide:
In vitro studies have shown that nimesulide is displaced from the binding sites by 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.
special instructions
Undesirable side effects can be minimized by using the minimum effective dose of the drug in the smallest possible short course. Nimesil® should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since these diseases may exacerbate.
The risk of gastrointestinal bleeding, ulcers or perforation of the ulcer increases with an increase in the dose of NSAIDs in patients with a history of ulcers, especially complicated by bleeding or perforation, as well as in elderly patients, so treatment should be started with the lowest possible dose. Patients receiving drugs that reduce blood clotting or inhibit platelet aggregation also have an increased risk of gastrointestinal bleeding. In the event of gastrointestinal bleeding or ulcers in patients taking Nimesil ®, drug treatment should be canceled.
Since Nimesil ® is partially excreted by the kidneys, its dosage for patients with impaired renal function should be reduced, depending on the level of urination. There is evidence of rare cases of liver reactions. If signs of liver damage appear (skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of "liver" transaminases), stop taking the drug and consult your doctor. Despite the rarity of visual impairment in patients taking nimesulide concurrently with other NSAIDs, treatment should be discontinued immediately. If any visual impairment occurs, the patient should be examined by an ophthalmologist. The drug can cause fluid retention in the tissues, therefore, patients with high blood pressure and cardiac disorders should use Nimesil ® with extreme caution.
In patients with renal or heart failure, Nimesil® should be used with caution, since renal function may deteriorate. If the condition worsens, treatment with Nimesil should be discontinued. Clinical studies and epidemiological data suggest that NSAIDs, especially in high doses and with prolonged use, can lead to a small risk of myocardial infarction or stroke. There is insufficient data to exclude the risk of such events when using nimesulide. The composition of the drug includes sucrose, this should be taken into account in patients with diabetes mellitus (0.15-0.18 XE per 100 mg of the drug) and people who follow a low-calorie diet. Nimesil® is not recommended for patients with rare hereditary diseases of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose deficiency.
If signs of a "cold" or acute respiratory viral infection occur during treatment with Nimesil ®, the drug should be discontinued. Do not use Nimesil ® concurrently with other NSAIDs.
Nimesulide can change the properties of platelets, therefore, care must be taken when using the drug in persons with hemorrhagic diathesis, however, the drug does not replace the prophylactic action of acetylsalicylic acid in cardiovascular diseases.
Elderly patients are particularly susceptible to adverse reactions to NSAIDs, including the risk of gastrointestinal bleeding and perforation, life-threatening the patient, and deterioration of kidney, liver and heart function. When taking the drug Nimesil ® for this category of patients, proper clinical control is required.
Like other drugs of the NSAID class that inhibit the synthesis of prostaglandins, nimesulide can adversely affect the course of pregnancy and / or the development of the embryo and can lead to premature closure of the ductus arteriosus, hypertension in the pulmonary artery system, impaired renal function, which can turn into renal failure with oligohydramnia, to an increased risk of bleeding, a decrease in uterine contractility, the occurrence of peripheral edema. In this regard, nimesulide is contraindicated during pregnancy and lactation. The use of Nimesil ® can adversely affect female fertility and is not recommended for women planning pregnancy. When planning a pregnancy, it is necessary to consult with your doctor.
There is evidence of the occurrence in rare cases of skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) to nimesulide as well as to other NSAIDs. At the first signs of a skin rash, mucosal lesions or other signs of an allergic reaction, the drug Nimesil should be discontinued.
The effect of the drug on the ability to drive vehicles and control mechanisms
The effect of Nimesil® on the ability to drive vehicles and control mechanisms has not been studied, therefore, during the period of treatment with Nimesil®, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
Release form
Granules for preparation of oral suspension, 100 mg.
2 g of granulate in three-layer bags (paper / aluminum / polyethylene).
9,15 or 30 bags with instructions for use in a cardboard box.
Storage conditions
List B.
Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children!
Shelf life
Do not use after the expiration date printed on the package.
Dispensing from pharmacies
Prescribed by a doctor.
Applicant / manufacturer:
"Laboratory Guidotti S.P.A.", Italy, produced by "Laboratory Menarini S.A.", Spain
Distributor: Berlin - Chemi / Menarini Pharma GmbH Gliniker Veg 125, 12489, Berlin, Germany
Address for filing claims: 115162, Moscow, st. Shabolovka, building 31, building B
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