Nise tab 100mg 30 pieces

Description

Composition
Active substance:
1 tablet contains: nimesulide 100 mg.
Excipients:
75 mg Calcium hydrogenphosphate, microcrystalline cellulose (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:
White with yellowish tinge round biconvex tablets with a smooth surface.
Product form:
Tablets of 100 mg.
3 PVC / aluminum blisters with 10 tablets together with instructions for use packed in a cardboard box.
Contraindications
Hypersensitivity to the active substance or auxiliary components; complete or partial combination of asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including history); erosive and ulcerative changes of the gastric mucosa and duodenal ulcer (DU), active gastrointestinal bleeding, cerebrovascular bleeding or otherwise; inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in acute phase; hemophilia and other bleeding disorders; decompensated heart failure; hepatic failure or any active liver disease; anamnestic data about the development of hepatotoxic reactions using formulations of nimesulide; concomitant use of potentially hepatotoxic substances; alcoholism, drug addiction; severe renal failure (less than 30 ml / min creatinine clearance), progressive renal disease, confirmed hyperkalemia; since the aortocoronary bypass surgery; pregnancy, lactation; Children up to age 12 years (for a given dosage form, see. “Special Instructions” section).
Carefully
Ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidaemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 mL / min. A history of the development of ulcerative lesions gastrointestinal tract, the presence of infection Helicobacter pylori, old age, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases associated with anticoagulation therapy (eg, warfarin), antiplatelet agents (eg, aspirin, clopidogrel), oral corticosteroids ( e.g., prednisone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).
Dosage
100 mg
Indications
Rheumatoid arthritis; Articular Syndrome in exacerbation of gout; psoriatic arthritis; ankylosing spondylitis; osteochondrosis with radicular syndrome; osteoarthritis; rheumatic myalgia and nonrheumatic; inflammation of ligaments, tendons, bursitis, including post-traumatic inflammation of soft tissues; pain of various genesis (including postoperative trauma, tuberculosis, toothache, headache, arthralgia, lumbar ischialgia).
The drug is intended for the symptomatic therapy reduce pain and inflammation at the time of use, does not affect the progression of the disease.
Interaction with other drugs
Action medicines that reduce blood clotting, increases with their simultaneous use with nimesulide. Nimesulide may reduce the effect of furosemide. Nimesulide may increase the possibility of occurrence of side effects while taking methotrexate. Lithium plasma levels are increased while taking drugs lithium and nimesulide. Nimesulide may exacerbate the effects of cyclosporine on the kidney.
Use with corticosteroids, serotonin reuptake inhibitors increase the risk of gastrointestinal bleeding.
Overdose
Symptoms: lethargy, drowsiness, nausea, vomiting. It may be gastrointestinal bleeding, high blood pressure, acute renal failure, respiratory depression.
Treatment: symptomatic treatment is required of the patient and supportive care of him. No specific antidote. If overdose has occurred during the last 4 hours necessary to induce vomiting, to ensure the reception of activated carbon (60-100 g per human adult), osmotic laxatives. Forced diuresis, ineffective dialysis because of high communications protein preparation.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
Nonsteroidal anti-inflammatory drug (NSAID) class of sulfonanilides. Is a selective competitive inhibitor of cyclooxygenase-2 (COX-2) inhibits the synthesis of prostaglandins in inflammation. The inhibitory effect on COX-1 is less pronounced (sometimes causes side effects associated with inhibition of prostaglandin synthesis in healthy tissues). Has anti-inflammatory, analgesic and antipyretic effect pronounced.
Pharmacokinetics:
Absorption ingestion – high (meal lowers the absorption rate without affecting its degree). The time to reach maximum concentration (TCmax) – 1,5-2,5 hours Connection to plasma proteins -. 95%, from red blood cells – 2%, with lipoproteins – 1%, with alpha 1-acid glycoproteins – 1%. Changing the dose has no effect on the binding. The magnitude of the maximum concentration (Cmax) – 3,5-6,5 mg / l. The volume of distribution – 0,19-0,35 l / kg. It penetrates the tissues of female reproductive organs, where after a single dose, its concentration is about 40% of the concentration in plasma. It penetrates the acidic environment of the inflammatory focus (40%), synovial fluid (43%). Easily penetrates the blood-tissue barriers.
It is metabolized in the liver tissue monooxygenase. The major metabolite – 4-hydroxynimesulide (25%), has a similar pharmacological activity, but due to the reduction in size of molecules capable of rapidly diffusing hydrophobic channel COX-2 binding to the active site of a methyl group. 4-hydroxynimesulide is a water soluble compound, for which removal is not required and glutathione conjugation reaction phase II metabolism (sulfation, glucuronidation, and others).
The half-life (T1 / 2) Nimesulide – 1,56-4,95 h, 4 h 2,89-4,78 gidroksinimesulida–4-hydroxynimesulide excreted by the kidneys (65%) and in bile (35%) undergoes enterohepatic. recycling. In patients with renal failure (creatinine clearance 1,8-4,8 l / hr or 30-80 ml / min) as well as in children and elderly pharmacokinetic profile of Nimesulide is not significantly changed.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of side effects is classified depending on the frequency of occurrence of cases: frequent (1-10%), and sometimes (0.1-1%), rare (0.01-0.1%), very rarely (less than 0.01%) , including isolated reports.
Allergic reactions: seldom – hypersensitivity reaction; very rare – anaphylactoid reactions.
On the part of the central nervous system: rare – dizziness; seldom – a sense of fear, nervousness, nightmares; very rarely – headache, somnolence, encephalopathy (Reye’s syndrome).
For the skin: rarely – itching, rash, increased sweating; rare: erythema, dermatitis; very rare: urticaria, angioneurotic edema, swelling of the face, exudative erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).
From the urinary system: rarely – swelling; rarely – dysuria, hematuria, urinary retention, hyperkalemia; very rarely – renal failure, oliguria, interstitial nephritis.
Gastro-intestinal tract: often – diarrhea, nausea, vomiting; rarely – constipation, flatulence, gastritis; very rare – abdominal pain, stomatitis, tarry stools, gastrointestinal bleeding, ulcers and / or perforation of the stomach or duodenum.
Liver and biliary system: often – increase in “liver” transaminase; very rarely – hepatitis, fulminant hepatitis, jaundice, cholestasis.
From the side of hematopoiesis: rarely – anemia, eosinophilia; very rarely – thrombocytopenia, pancytopenia, purpura, prolongation of bleeding time.
The respiratory system: rarely – shortness of breath; very rarely – worsening of asthma, bronchospasm.
From the sensory organs: rarely – blurred vision.
Cardio-vascular system: seldom – hypertension; rarely – tachycardia, hemorrhage, “hot flashes.”
Other: rarely – weakness; very rarely – hypothermia.
special instructions
Since Nayz® partly excreted by the kidneys, the dose for patients with impaired renal function should be reduced, depending on the performance of creatinine clearance. Taking into account the reports of visual disturbances in patients treated with other NSAIDs, treatment should be stopped immediately if there is any disturbance of vision, and the patient should inspect the eye doctor. The drug can cause fluid retention in the tissues, so patients with high blood pressure and cardiac function Nayz® should be used with extreme caution. Patients should undergo regular medical supervision if they take along with nimesulide medicines, which are characterized by the effect on the gastrointestinal tract.
When the liver disease symptoms (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, raising the level of “liver” transaminases) should stop taking the drug and consult a doctor. You should not use the drug in conjunction with other NSAIDs.
The preparation may modify the properties of platelets, but does not replace the prophylactic effect of aspirin in cardiovascular diseases. Use of the drug can impair female fertility and is not recommended for women planning pregnancy.
After 2 weeks of drug application necessary to monitor biochemical indicators of liver function.
This dosage form is contraindicated for children up to 12 years, but if necessary, formulations of nimesulide for children older than 7 years of age can be used dispersible tablets 50 mg and suspension in strict accordance with the instructions attached thereto for medical use. Since the drug can cause drowsiness, dizziness and blurred vision, use caution when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In the dark place at a temperature not higher than 25 ° C.
Keep out of the reach of children!.
Dosing and Administration
It should use the minimum effective dose short course minimum possible. Tablets are taken with a sufficient amount of water, preferably after the meal.
Adults and children over 12 years – into 1 pill 2 times per day. In the presence of diseases of the gastrointestinal tract is desirable to take the drug at the end of a meal or after a meal. The maximum daily dose for adults – 200 mg. Patients with chronic renal failure requires lowering the daily dose to about 100 mg.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist