Nimulid pills 100mg №20

Composition

1 pill contains:

Active ingredient: Nimesulide 100 mg;

Excipients: lactose, croscarmellose sodium, colloidal silicon dioxide, corn starch, povidone, sodium dusate, polysorbate, hydrochloric acid *, purified water *, Magnesium stearate (* - are removed during production).

pharmachologic effect

Nimulid is a NSAID of the sulfonalide class. It has anti-inflammatory, analgesic and antipyretic effects.
Nimesulide refers to NSAIDs, the mechanism of action of which is associated with the selective inhibition of cyclooxygenase-2 (COX-2) and the impact on a number of other factors: inhibition of platelet activating factor, tumor necrosis factor alpha, inhibition of proteinases and histamine. Selectively suppressing COX-2, reduces the biosynthesis of prostaglandins in the inflammation, has a less pronounced inhibitory effect on COX-1 (rarely causes side effects associated with inhibition of the synthesis of prostaglandins in healthy tissues).

Pharmacokinetics

Oral absorption is high (food intake decreases the rate of absorption without affecting its degree). Plasma protein binding - 95%, with erythrocytes - 2%, with lipoproteins - 1%, with acid alpha1-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.It penetrates the tissue of the female genital organs, where, after a single dose, its concentration is about 40% of the concentration in plasma. It penetrates well into the acidic environment of the focus of inflammation (40%), synovial fluid (43%). Easily penetrates histohematogenous barriers.
Metabolized in the liver by tissue mono-oxygenases. The main metabolite, 4-hydroxynimesulide (25%), has similar pharmacological activity, but due to a decrease in the size of molecules, it is able to quickly diffuse through the hydrophobic channel of COX-2 to the active binding site of the methyl group. 4-hydroxynimesulide is a water-soluble compound, for the elimination of which glutathione and conjugation reactions of the second phase of metabolism (sulfation, glucuronide and others) are not required.
T1 / 2 nimesulide - about 1.56-4.95 h, 4-hydroxynimesulide - 2.89-4.78 h. 4-hydroxynimesulide is excreted by the kidneys (65%) and, with bile (35%), undergoes enterohepatic recycling.
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

• 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 the ligaments, tendons, bursitis, including post-traumatic inflammation of the soft tissues;
• pain syndrome of various genesis (including in the postoperative period, with injuries, algomenorrhea, toothache, headache, arthralgia, lumbar ischalgia);
• symptomatic therapy to reduce pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications

- erosive and ulcerative changes of the mucous membrane of the stomach and duodenum, including inflammatory bowel disease in the acute phase;
- active Gastrointestinal bleeding;
- severe impaired function of the liver and / or kidneys, severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease;
- severe heart failure;
- pronounced coagulation disorders;
- confirmed hyperkalemia;
- the period after the aortocranial bypass;
- Anamnestic data on the attack of bronchial obstruction, rhinitis, urticaria after taking Acetylsalicylic acid or other NSAIDs (complete or incomplete intolerance syndrome of acetylsalicylic acid - rhinosinusitis, urticaria, nasal polyps, asthma);
- severe liver failure or active liver disease;
- pregnancy;
- lactation period;
- children's age up to 12 years;
- Hypersensitivity to nimesulide and components of the drug Nimulid.
With care: coronary heart disease, cerebrovascular diseases, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus,peripheral artery diseases, smoking, creatinine clearance less than 60 ml / min, history of gastrointestinal ulcers, Helicobacter pylori infection, old age, prolonged use of NSAIDs, frequent alcohol use, severe somatic diseases, concomitant therapy with the following drugs:
- anticoagulants (for example, warfarin);
- antiplatelet agents (for example, acetylsalicylic acid, clopidogrel);
- oral GCS (for example, prednisone);
- selective serotonin reuptake inhibitors (for example, citalopram, Fluoxetine, paroxetine, sertraline).

Use during pregnancy and lactation

The drug is contraindicated in pregnancy and lactation.

special instructions

Nimulid should be used with caution in patients who have a tendency to bleed, in patients with diseases of the upper GI tract, or in patients receiving anticoagulants.
Since Nimulid is partially excreted by the kidneys, its dosage for patients with impaired renal function should be reduced, depending on the creatinine clearance parameters.
Considering reports of visual impairment in patients taking other NSAIDs, treatment should be immediately discontinued if any visual impairment occurs and the patient should be examined by an oculist.
The drug can cause fluid retention in the tissues, so patients with high blood pressure and with impaired cardiac activity Nimulid should be used with extreme caution.
To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose of the shortest possible course.
Influence on ability to drive motor transport and control mechanisms
Patients who have side effects: dizziness, drowsiness, blurred vision, must be careful when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and psychomotor reactions.

Dosage and administration

Adults and children over 12 years old (body weight more than 40 kg) with Nimulid, take 1 pill 2 times / day.
Take the pills after meals with enough water. The maximum daily dose is 5 mg / kg.
Patients with chronic renal failure require a reduction in the daily dose of Nimulid to 100 mg.
The course of treatment: prescribed by a doctor.

Side effects

On the part of the digestive system: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, stomatitis, tarry stools, gastrointestinal bleeding, ulcers and / or perforation of the stomach or duodenum.
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).
On the part of the respiratory system: infrequently - shortness of breath; very rarely - bronchospasm; possible exacerbation of asthma.
Since the cardiovascular system: infrequently - arterial hypertension; rarely - tachycardia, hemorrhage, hot flashes.
Sense organs: rarely - blurred vision.
From the skin and mucous membranes: infrequently - itching, rash, increased sweating; rarely - erythema, dermatitis.
On the part of the liver and biliary system: often - increased activity of hepatic transaminases; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis .
From the urinary system: infrequently - swelling; rarely - dysuria, hematuria, urinary retention, hyperkalemia; very rarely - renal failure, oliguria, interstitial nephritis.
From the hemopoietic system: rarely - anemia, eosinophilia; very rarely, thrombocytopenia, pancytopenia, purpura, lengthening of the bleeding time.
Allergic reactions: rarely - hypersensitivity reactions; very rarely - anaphylachidic reactions, urticaria, angioedema, swelling of the face, erythema multiforme, including exudative erythema. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
General reactions: rarely - general weakness; very rarely - hypothermia.
In the event of the appearance of other side effects not mentioned above or deterioration of your health, please contact your doctor immediately.

Drug interaction

The effect of drugs that reduce blood clotting, increases with their simultaneous use with nimesulide.
Nimesulide may reduce the effects of Furosemide . Reduces the therapeutic effect of antihypertensive drugs. Nimesulide increases the onset of side effects while taking Methotrexate .
The level of lithium in plasma increases while taking drugs of lithium and nimesulide.
Nimesulide may enhance the nephrotoxic effect of cyclosporine on the kidneys. Use with glucocorticosteroids, serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

Overdose

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

Treatment: symptomatic treatment of the patient is required, there is no specific antidote. If an overdose occurred during the last 4 hours, it is necessary to induce vomiting, to receive Activated carbon (60-100 g per adult), osmotic laxatives. Forced diuresis, hemodialysis are ineffective due to the high association of the drug with proteins.

Storage conditions

In a dry, dark place at a temperature of no higher than 25 ° C.

Pharmacy sales terms

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