Nimulide, pills 100mg 20pcs

Composition

Active ingredient:

nimesulide 100 mg;

Auxiliary substances:

lactose,

croscarmellose sodium,

colloidal silicon dioxide,

corn starch,

povidone,

sodium docusate,

polysorbate,

hydrochloric acid*,

purified water*,

magnesium stearate (*- removed during production).

Pharmacological action

Nimulide – analgesic, anti-inflammatory.

Pharmacodynamics

Nimulide is an NSAID in the class of sulfonanilides. It has anti-inflammatory, analgesic and antipyretic effects.

Nimesulide belongs to NSAIDs, the mechanism of action of which is associated with selective inhibition of COX-2 and the effect on a number of other factors — suppression of platelet activation factor, tumor necrosis factor alpha, suppression of proteinases and histamine. Selectively suppressing COX-2 reduces biosynthesis PG in the focus of inflammation, has a less pronounced depressing effect on COX-1 (less often causes side effects associated with inhibition of PG synthesis in healthy tissues).

Pharmacokinetics

Oral absorption is high (food intake reduces the rate of absorption without affecting its degree). The relationship with plasma proteins is 95%, with red blood cells-2%, with lipoproteins-1%, with acidic alpha-1-glycoproteins-1%. Changing the dose does not affect the degree of binding. Cmax — 3.5–6.5 mg/l. Vd — 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 inflammatory focus (40%), synovial fluid (43%). Easily penetrates through histohematic barriers.

It is metabolized in the liver by tissue monooxygenases. The main metabolite,4-hydroxynimesulide (25%), has similar pharmacological activity, but due to a decrease in the size of molecules, it can quickly diffuse along the hydrophobic COX — 2 channel to the active site of the methyl group binding. 4-Hydroxynimesulide is a water-soluble compound that does not require glutathione and phase II conjugation reactions (including sulfation, glucuronidation).

T1 / 2 of nimesulide is about 1.56-4.95 hours,4-hydroxynimesulide-2.89–4.78 hours. 4-Hydroxynimesulide is excreted by the kidneys (65%) and with bile (35%), undergoes enterohepatic recirculation.

In patients with renal insufficiency (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

• articular syndrome with exacerbation of gout;
• ankylosing spondylitis, low back pain with radicular syndrome;
• rheumatoid arthritis;
• psoriatic arthritis;
• osteoarthritis;
• myalgia, rheumatic and non-rheumatic origin;
• inflammation of the ligaments, tendons, bursitis, including post-traumatic inflammation of soft tissue;
• pain syndrome of different Genesis (including in the postoperative period for injuries, algomenorrhea, toothache, headache, arthralgia, lumboischialgia);
• symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications

• hypersensitivity to nimesulide and components of the drug;
• erosive and ulcerative changes in the mucous membrane of the stomach and duodenum;
• inflammatory bowel disease in the acute phase;
• active gastrointestinal bleeding;
• severe disturbances of liver function and/or kidney disease, severe renal insufficiency (Cl creatinine <30 ml/min);
• progressive kidney disease;
• severe hepatic impairment or active liver disease;
• severe heart failure;
• severe blood coagulation disorders;
• confirmed hyperkalemia;
• the period following the coronary artery bypass surgery;
• anamnestic information about the attack of bronchial mast, rhinitis, urticaria after ingestion of acetylsalicylic acid or other NSAIDs (full or partial syndrome of intolerance to acetylsalicylic acid, rhinosinusitis, urticaria, mucosal polyps of the nose, asthma);
• pregnancy and lactation;
• children’s age up to 12 years.

Side effects

From the digestive system: often – diarrhea, nausea, vomiting; infrequently-constipation, flatulence, gastritis; very rarely-abdominal pain, stomatitis, tarry stools, gastrointestinal bleeding, ulceration and / or perforation of the stomach or duodenum.

From the central nervous system: infrequently-dizziness; rarely-a feeling of fear, nervousness, nightmares; very rarely-headache, drowsiness, encephalopathy (Reye’s syndrome).

From the respiratory system: infrequently-shortness of breath; very rarely-bronchospasm; possible exacerbation of bronchial asthma.

From the cardiovascular system: infrequently-arterial hypertension; rarely-tachycardia, hemorrhages, hot flashes. Sensory organs: rarely-blurred vision.

From the skin and mucous membranes: infrequently-itching, rash, increased sweating; rarely-erythema, dermatitis.

From the liver and biliary system: often-increased activity of hepatic transaminases; very rarely-hepatitis, lightning hepatitis, jaundice, cholestasis.

From the urinary system: infrequently-edema; rarely-dysuria, hematuria, urinary retention, hyperkalemia; very rarely-renal failure, oliguria, interstitial nephritis.

From the hematopoietic system: rarely-anemia, eosinophilia; very rarely-thrombocytopenia, pancytopenia, purpura, prolongation of bleeding time.

Allergic reactions: rarely-hypersensitivity reactions; very rarely-anaphylachtoid reactions, urticaria, angioedema, facial edema, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).

General reactions: rarely-general weakness; very rarely – hypothermia.

If you experience any other side effects that are not mentioned above, or if you feel unwell, please contact your doctor immediately.

Interaction

The effect of medications that reduce blood clotting is enhanced when they are used simultaneously with nimesulide. Nimesulide may reduce the effect of furosemide. Reduces the therapeutic effect of antihypertensive drugs. Nimesulide increases the occurrence of side effects when taking methotrexate at the same time.

The level of lithium in plasma increases with simultaneous use of lithium and nimesulide preparations.

Nimesulide may increase the nephrotoxic effect of cyclosporine on the kidneys. Use with glucocorticosteroids, serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

How to take, course of use and dosage

Adults and children over 12 years of age (body weight more than 40 kg) inside Nimulid prescribed 1 tablet 2 times a day.

Tablets are taken after a meal with a sufficient amount of water. The maximum daily dose is 5 mg / kg.

Patients with chronic renal failure should reduce the daily dose of Nimulide to 100 mg.

Course of treatment: as prescribed by your doctor.

Overdose

Symptoms: apathy, drowsiness, nausea, vomiting. Gastrointestinal bleeding, hypertension, acute renal failure, and respiratory depression may occur.

Treatment: symptomatic treatment of the patient is required, there is no specific antidote. If an overdose has occurred within the last 4 hours, it is necessary to induce vomiting, provide activated charcoal (60-100 g per adult), osmotic laxatives. Forced diuresis and hemodialysis are ineffective due to the high binding of the drug to proteins.

Special instructions

Nimulide should be used with caution in patients who have experienced a tendency to bleed, in patients with diseases of the upper gastrointestinal tract, or in patients receiving anticoagulants.

Since Nimulide is partially excreted by the kidneys, its dosage for patients with impaired renal function should be reduced, depending on the indicators of creatinine clearance.

Given reports of visual impairment in patients taking other NSAIDs, treatment should be stopped immediately if any visual impairment occurs and the patient should be examined by an optometrist.

The drug can cause fluid retention in the tissues, so patients with high blood pressure and cardiac disorders Nimulid should be used with extreme caution.

To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course.

Influence on the ability to drive motor vehicles and manage mechanisms

Patients who have severe side effects: dizziness, drowsiness, blurred vision, should be careful when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C.

Shelf

life is 3 years.

Active ingredient

Nimesulide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets