Nimesil: instructions for use, how to dilute the powder?

Release form, composition

The drug Nimesil is available in a dosage form, a powder for the preparation of a suspension, which is intended for oral administration. It has a light green color, coarse grain, and an orange scent. The main active component of the drug is nimesulide, its content in 1 sachet of powder is 100 mg. The drug also contains additional compounds, which include:

Sucrose.
Orange flavor.
Ketomacrogol.
Anhydrous citric acid.
Maltodextrin.

Nimesil powder is packaged in aluminum foil bags of 2 g each. A cardboard pack contains 9, 15 or 30 bags.

pharmachologic effect

The main active ingredient of Nimesil is nimesulide, which is a sulfonamide. This substance suppresses the activity of cyclooxygenase-2 in the body, the enzyme responsible for the production of prostaglandins, which are synthesized during the development of pathological processes. A decrease in the amount of synthesized prostaglandins, as a result of exposure to nimeslin, helps to reduce irritation of nerve endings in the area of inflammation, which, in turn, leads to the disappearance of pain.

After entering the body, the drug begins to act actively. It is easily absorbed from the stomach and intestines, penetrates the blood, binding to plasma proteins. The largest amount of active substance in the blood is observed approximately 2-3 hours after taking the medicine. The main metabolic processes take place in the liver, and the resulting inactive products are eliminated within 6 hours (half-life).

According to research results, repeated use of the drug does not cause accumulation.

Time of receipt

The instructions for the drug must indicate the time of its administration in relation to food intake:

“on an empty stomach” - no less than 60 minutes. before the start of a meal and no earlier than 120 minutes. after its completion);
“before meals” - 30 - 60 minutes. before starting a meal;
“during a meal” - within 30 minutes before the start or after the end, or immediately before a meal;
“after meals” - for 30 - 120 minutes. after eating;

In the absence of any instructions in the package insert, the medicine should be taken 30 minutes before meals. This applies to the bulk of drugs.

Indications for use of Nimesil

Nimesil is prescribed for:

pain syndromes of various origins (headache, dental pain, menstrual pain, consequences of injuries, postoperative pain, pain from rheumatism, etc.);
infectious and inflammatory diseases (traumatic and postoperative inflammation)
degerative and inflammatory diseases of the musculoskeletal system (arthritis, osteoarthrosis, osteochondrosis, bursitis, radiculitis, rheumatism, etc.);
urological, gynecological and vascular diseases;
diseases accompanied by increased body temperature.

This remedy is appropriate both for long-term treatment therapy and for dulling severe pain syndromes.

Contraindications

Before taking the medication, you must eat the contraindications indicated by the manufacturer. In particular, it is prohibited to take it in the following situations:

Hypersensitivity to the active base (nimesulide) or an auxiliary component of the drug.
History of hyperergic reactions of the body: rhinitis, urticaria, bronchospasm, laryngospasm associated with taking any drug from the NSAID group, including nimesulide.
History of hepatotoxic reactions of the body to nimesulide.
Simultaneous treatment with other drugs that have hepatotoxic effects (especially from the NSAID group).
Inflammatory processes in the intestines in the acute phase (Crohn's syndrome, nonspecific ulcerative colitis).
Recovery period after coronary artery bypass surgery.
Fever that accompanies colds and acute respiratory viral infections.
A combination of bronchial asthma, polyposis of the paranasal sinuses or nose with a recurrent course and a history of intolerance to NSAIDs;
Exacerbation of a stomach or duodenal ulcer;
History of ulcer with bleeding or perforation;
History of cerebrovascular and other bleeding;
Diseases accompanied by bleeding;
Severe bleeding disorder;
Severe heart failure;
Severe renal failure;
Confirmed hyperkalemia;
Liver disease in the acute phase;
Liver failure;
Children under 12 years old;
Pregnancy, lactation;
Drug addiction, alcoholism.

Prescribed with caution for the following pathologies and factors:

heart failure of any degree;
severe arterial hypertension;
diabetes mellitus type 2;
IHD;
hereditary fructose intolerance;
malabsorption of glucose-galactose;
sucrose-isomaltose deficiency;
dys- or hyperlipidemia;
cerebrovascular pathologies;
severe somatic illnesses;
arterial diseases (peripheral);
infection caused by Helicobacter pylori;
creatinine clearance less than 60 ml/min;
long-term treatment with NSAIDs;
elderly age;
smoking.

Nimesil, gran d/susp pack 100mg/2g No. 9

Type of drug drug

Granule release form

Minimum age of use : 12 years

Purpose for bone restoration

Indications for use : treatment of acute pain (back pain, lower back pain; pain syndrome in the musculoskeletal system, including injuries, sprains and dislocations of joints, tendonitis, bursitis; toothache); — symptomatic treatment of osteoarthritis with pain syndrome; - algodismenorrhea. The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use.

Contraindications - history of hyperergic reactions, for example, bronchospasm, rhinitis, urticaria, associated with taking acetylsalicylic acid or other NSAIDs, incl. nimesulide; - history of hepatotoxic reactions to nimesulide; - concomitant (simultaneous) use of drugs with potential hepatotoxicity, for example, paracetamol or other analgesic or non-steroidal anti-inflammatory drugs; - inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase; — the period after coronary artery bypass grafting; — fever in infectious and inflammatory diseases; - complete or partial combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses with intolerance to acetylsalicylic acid and other NSAIDs (including a history); - peptic ulcer of the stomach and 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 blood clotting disorders; - severe heart failure; - severe renal failure (CR

Effect on the ability to drive vehicles and operate machinery The effect of Nimesil on the ability to drive vehicles and operate machinery has not been studied, therefore, during treatment with Nimesil, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient Nimesulide

Method of administration and dosage Nimesil is taken orally, 1 sachet (100 mg of nimesulide) 2 times a day. It is recommended to take the drug after meals. The contents of the sachet are poured into a glass and dissolved in approximately 100 ml of water. The prepared solution cannot be stored. Nimesil is used only to treat patients over 12 years of age. Adolescents (ages 12 to 18 years): Based on the pharmacokinetic profile and pharmacodynamic characteristics of nimesulide, no dose adjustment is necessary in adolescents. Patients with impaired renal function: based on pharmacokinetic data, there is no need for dose adjustment in patients with mild to moderate forms of 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 physician 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 for the shortest possible course.

Side effects From the hematopoietic system: rarely - anemia, eosinophilia, hemorrhagic syndrome; very rarely - thrombocytopenia, pacytopenia, thrombocytopenic purpura. Allergic reactions: uncommon - itching, rash, increased sweating; rarely - hypersensitivity reactions, erythema, dermatitis; very rarely - anaphylactoid reactions, urticaria, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome). From the side of the central nervous system: infrequently - dizziness; rarely - a feeling of fear, nervousness, nightmares; very rarely - headache, drowsiness, encephalopathy (Reye's syndrome). From the side of the organ of vision: rarely - blurred vision. From the cardiovascular system: infrequently - arterial hypertension, tachycardia, lability of blood pressure, hot flashes. From the respiratory system: infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm. From the digestive system: 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; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis, increased activity of liver enzymes. From the urinary system: rarely - dysuria, hematuria, urinary retention; very rarely - renal failure, oliguria, interstitial nephritis. General disorders: rarely - malaise, asthenia; very rarely - hypothermia. Other: rarely - hyperkalemia.

Storage conditions List B. Store in a dry place, protected from light and out of reach of children, at a temperature not exceeding 25 °C. Shelf life: 2 years. Do not use after the expiration date stated on the package.

Overdose Symptoms: apathy, drowsiness, nausea, vomiting, pain in the epigastric region. With maintenance therapy for gastropathy, these symptoms are usually reversible. Gastrointestinal bleeding may occur. In rare cases, increased blood pressure, acute renal failure, respiratory depression and coma, and anaphylactoid reactions are possible. Treatment: carry out symptomatic therapy. There is no specific antidote. If an overdose has occurred within the last 4 hours, it is necessary to induce vomiting and/or provide activated carbon (adults from 60 to 100 g) and/or an osmotic laxative. Forced diuresis and hemodialysis are ineffective due to the high binding of the drug to proteins (up to 97.5%). Monitoring of kidney and liver function is indicated.

Special instructions Undesirable side effects can be minimized by using the minimum effective dose of the drug in the shortest possible short course. Nimesil should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since exacerbation of these diseases is possible. The risk of gastrointestinal bleeding, ulceration or perforation of an ulcer increases with increasing dose of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, and 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. If gastrointestinal bleeding or ulcers occur in patients taking Nimesil, treatment with the drug should be discontinued. 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 (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of liver transaminases), you should stop taking the drug and consult your doctor. Despite the rarity of visual impairment in patients taking nimesulide concomitantly with other NSAIDs, treatment should be stopped immediately. If any visual disturbance occurs, the patient should be examined by an ophthalmologist. The drug can cause fluid retention in tissues, so patients with high blood pressure and cardiac problems should use Nimesil with extreme caution. In patients with renal or heart failure, Nimesil should be used with caution, as renal function may deteriorate. If the condition worsens, treatment with Nimesil should be stopped. Clinical studies and epidemiological data suggest that NSAIDs, especially at high doses and with long-term use, may lead to a small risk of myocardial infarction or stroke. There is insufficient data to exclude the risk of such events when using nimesulide. The drug contains sucrose, this should be taken into account by patients suffering from diabetes mellitus (0.15-0.18 XE per 100 mg of the drug) and those on a low-calorie diet. Nimesil is not recommended for use in 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. Nimesil should not be used simultaneously with other NSAIDs. Nimesulide can change the properties of platelets, so caution must be exercised when using the drug in people with hemorrhagic diathesis, however, the drug does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases. Elderly patients are especially susceptible to adverse reactions to NSAIDs, including life-threatening gastrointestinal bleeding and perforation, deterioration of renal, liver and cardiac function. When taking the drug Nimesil for this category of patients, proper clinical monitoring is necessary. Like other drugs of the NSAID class that inhibit prostaglandin synthesis, nimesulide can adversely affect pregnancy and/or embryo development and can lead to premature closure of the ductus arteriosus, hypertension in the pulmonary artery system, impaired renal function, which can lead to renal failure with oligodyramnia, to an increased risk of bleeding, decreased uterine contractility, and the occurrence of peripheral edema. In this regard, nimesulide is contraindicated during pregnancy and lactation. The use of the drug Nimesil can negatively affect female fertility and is not recommended for women planning pregnancy. When planning a pregnancy, consultation with your doctor is necessary. 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, damage to the mucous membranes or other signs of an allergic reaction, Nimesil should be discontinued.

Interaction Pharmacodynamic interactions: When used together with glucocorticosteroids, the risk of gastrointestinal ulcers or bleeding increases. When used together with antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, the risk of gastrointestinal bleeding increases. NSAIDs may 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 combination therapy cannot be avoided, careful monitoring of blood clotting parameters is necessary. Diuretics: NSAIDs may reduce the effect of diuretics. In healthy volunteers, nimesulide temporarily reduces the excretion of sodium under the influence of furosemide, to a lesser extent the excretion of potassium, and reduces the diuretic effect itself. 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. Co-administration of furosemide and nimesulide requires caution in patients with impaired renal and cardiac function. ACE inhibitors and angiotensin II receptor antagonists: NSAIDs may reduce the effect of antihypertensive drugs. In patients with mild to moderate renal failure (creatinine clearance 30-80 ml/min), co-administration of ACE inhibitors, angiotensin II receptor antagonists or substances that suppress the cycloxygenase system (NSAIDs, antiplatelet agents) may further deteriorate renal function and cause acute renal failure. , which, as a rule, is reversible. These interactions should be taken into account in patients taking Nimesil in combination with ACE inhibitors or angiotensin II receptor antagonists. Therefore, coadministration of these drugs should be used with caution, especially in elderly patients. Patients should be kept adequately hydrated and renal function should be closely monitored after initiating concomitant therapy. Pharmacokinetic interactions with other drugs: There is evidence that NSAIDs reduce the clearance of lithium, which leads to increased plasma lithium concentrations and its toxicity. When prescribing nimesulide to patients receiving lithium therapy, plasma lithium concentrations should be regularly monitored. No clinically significant interactions were observed with glibenclamide, theophylline, digoxin, cimetidine and antacid drugs (for example, a combination of aluminum and magnesium hydroxides). Nimesulide inhibits the activity of the CYP2C9 isoenzyme. When taking 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 their effect on renal prostaglandins, inhibitors of prostaglandin synthetase, such as nimesulide, may increase the nephrotoxicity of cyclosporines. Interaction of other drugs with nimesulide: In vitro studies have shown that nimesulide is displaced from binding sites by tolbutamide, salicylic acid and valproic acid. Although these interactions were determined in blood plasma, these effects were not observed during clinical use of the drug.

Pharmacological action Non-steroidal anti-inflammatory drug from the sulfonamide class. Has anti-inflammatory, analgesic and antipyretic effects. Nimesulide acts as an inhibitor of the cyclooxygenase enzyme responsible for the synthesis of prostaglandins and inhibits mainly cyclooxygenase-2.

Composition Active ingredient: nimesulide 100 mg Excipients: ketomacrogol 1000, sucrose, maltodextrin, anhydrous citric acid, orange flavor.

Source : Vidal Medicinal Directory

Registration number P N011439/01

State registration date 2010/08/18 00:00:00

Side effects

Before using the medication, it is extremely important to familiarize yourself with the list of possible side effects provided by the manufacturer:

increased potassium levels in the blood;
mild general weakness, decreased body temperature;
anemia, thrombocytopenia;
problems with urination, development of kidney failure;
sweating, skin rashes of various types, dermatitis, erythema, nephrotic edema;
disturbances in the normal functioning of the liver (in particular, the synthesis of certain enzymes);
headache and dizziness, causeless anxiety, apathy, drowsiness;
visual impairment;
shortness of breath, coughing attacks;
disruption of the gastrointestinal tract, bleeding, ulcers;
increase in pressure.

In order to reduce the likelihood of side effects, it would be best to minimize the dose of medication taken and shorten the duration of treatment with it as much as possible.

Side effects of the drug Nimesil

The frequency of side effects is classified as follows: very often (≤1/10); often (1/100 and ≤1/10); sometimes (1/1000 and ≤1/100); rare (1/10,000 and ≤1/1000); very rare (≤1/10,000), including special cases.

Rarely Anemia, eosinophilia.
Very rarely Thrombocytopenia, pancytopenia, purpura.

From the immune system:

Rarely Hypersensitivity
Very rare Anaphylaxis

Metabolic and metabolic disorders:

Rarely Hyperkalemia

Mental disorders:

Rarely Feeling of fear, nervousness, nightmares

From the nervous system:

Sometimes Dizziness
Very rare: Headache, drowsiness, encephalopathy (Reye's syndrome)

From the side of the organ of vision:

Rarely Blurred vision
Very rare Visual impairment

From the organ of hearing and balance:

Very rareDizziness

From the cardiovascular system:

Sometimes hypertension
Rarely Tachycardia, hemorrhages, blood pressure lability, hot flashes

From the respiratory system:

Sometimes Shortness of breath
Very rare asthma, bronchospasm

From the gastrointestinal tract:

Common Diarrhea, nausea, vomiting
Sometimes Constipation, flatulence, gastritis
Very rare Abdominal pain, dyspepsia, stomatitis, black stool (melena), gastrointestinal bleeding, ulcer, perforating gastric and duodenal ulcer

From the liver and biliary system:

Very rare Hepatitis, fulminant hepatitis (including fatal cases), jaundice, cholestasis

From 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

From the kidneys and urinary tract:

Rarely: Dysuria, hematuria, urinary retention.
Very rare Renal failure, oliguria, interstitial nephritis

General violations:

Sometimes swelling
Rarely Weakness, asthenia
Very rare Hypothermia

Laboratory data:

Often Increased levels of liver transaminases.

How to dilute Nimesil powder - instructions for use

According to the instructions, Nimesil powder is intended for preparing a suspension that is taken orally.

One sachet is dissolved in 1 glass of water with a volume of 100 ml. The prepared suspension should be used immediately; it cannot be stored. The average therapeutic dosage is 100 mg of nimesulide (1 sachet) 2 times a day.

The maximum duration of treatment with Nimesil powder should not exceed 15 days. Dosage adjustment is usually not required for adolescents over 12 years of age, the elderly, and patients with concomitant mild renal impairment.

Drug interactions

The drug enhances the effect of medications that are used to reduce blood clotting. Nimesil can also increase the effect of furosemide. When taking Nimesil and methotrexate simultaneously, side effects may worsen. Nimesulide quickly binds to plasma proteins, so persons treated with sulfonamides and hydantoin should be under close medical supervision. The drug enhances the effect of cyclosporine on the kidneys. If Nimesil is used simultaneously with lithium preparations, the concentration of lithium in the plasma will increase.

Treatment with Nimesil requires caution if blood pressure medications, diuretics, or other anti-inflammatory and painkillers are used in combination with it.

Combination of several drugs

If the doctor prescribes several medications, they are taken separately. Because the:

their combined use puts a greater burden on the liver and gastrointestinal tract;
under the influence of the individual environment of the stomach, several medications taken simultaneously can cause the formation of toxic agents in the stomach;
Several medications taken at the same time can affect each other, resulting in changes in their effect on the body.

Taking medications should be spaced out so that the interval between doses is at least 15-30 minutes.

special instructions

According to Nimesil's instructions, if the patient has a risk of ulcers, gastrointestinal bleeding, as well as with simultaneous treatment with drugs from the above, Nimesil therapy is started with the lowest dose, monitoring the patient's condition. At the slightest side or undesirable reactions, treatment is stopped.

Nimesil contains sucrose, which should be taken into account by patients with diabetes: 1 sachet contains 0.15-0.18 XE.
If ARVI and colds occur during Nimesil therapy, treatment is stopped.
During treatment with Nimesil, caution should be exercised when driving a car and performing precise, dangerous work.

Medicines and alcohol

Their combined use is strictly prohibited. This combination can cause the most severe complications. Here are just a few examples:

simultaneous use of aspirin and alcohol can cause not only ulceration, but also intestinal perforation;
paracetamol and drugs containing it with alcohol cause toxic liver poisoning and depression of the nervous system;
hypoglycemic agents used to treat type 1 and type 2 diabetes mellitus, and even small amounts of alcohol lead to a sharp decrease in glucose levels and even coma;
sleeping pills and alcohol reinforce each other, which leads to deep sleep, direct blockade of the respiratory center and death.

Analogs

The following drugs are similar in composition to the active substance nimesulide: Nemulex, Actasulide, Aponil, Ameolin, Aulin, Nimesulide, Nimulid, Sulaydin, etc. Some of them have a much lower cost with the same effectiveness as Nimesil.

The difference between granules for preparing a suspension and tablets (cheaper) is only that the effect occurs a little faster, due to faster absorption of the suspension, but the effectiveness remains the same.

What to drink with it?

If there are no special instructions, then the medications are washed down with plain boiled water. Water is a good solvent and does not affect the active substance.

You should not take medications with:

Do not drink with milk: cardiac glycosides, caffeine, antiulcer drugs, enzymes, antibiotics, iron and calcium supplements;
It is also not recommended to take medications with tea: it contains tannin, which forms insoluble compounds with nitrogen-containing drugs;
Calcium supplements should not be taken with carbonated water.

Reviews from doctors and people

Svetlana Kharkovaya, dentist. Toothache can be quite severe and should not be tolerated. Taking Nimesil can help the patient. Of course, it is very important to pay attention to possible side effects and contraindications - not everyone can take the medicine. In some cases, I recommend Nimesil to relieve pain after treatment or tooth extraction. And I can say with confidence that during my long practice, no one complained that Nimesil did not help or that it made me feel ill.
Ekaterina Menshikova. Nimesil became a real salvation for me at the time when I was treating my teeth. The pain was unbearable, both before visiting the doctor and in the first days after treatment (two teeth had to be removed due to inflammation). The advantage of this medicine is that it is easily diluted and begins to act very quickly. Of course, there are cheaper analogues - but I don’t want to experiment, since Nimesil has already been tested by time.