Nayzilat tab n / 600mg film about 20 pc

Description

Composition
Active substance:
1 tablet coated with a film coating comprising: amtolmetin guatsil 600 mg.
Excipients:
Lactose monohydrate 40.1 mg Hypromellose (15 cps) 6,0 mg Lactose monohydrate (Flowlac 100) 120.3 mg Colloidal silicon dioxide 1.6 mg Sodium carboxymethylstarch (type A) 24.0 mg Magnesium stearate 8.0 mg;
Film coating: Hypromellose (5 cps) 12.5 mg, 6.25 mg of titanium dioxide, Macrogol 400 1.25 mg.
Description:
Kapsulovidnye tablets, film-coated, white to almost white color with a characteristic smell.
Product form:
Tablets, film-coated, 600 mg.
10 tablets in the blister of opaque PVC / PVDC film / aluminum foil.
2 blisters together with instructions for use in a cardboard pack.
Contraindications
Hypersensitivity to amtolmetinu, tolmetin; 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 duodenum 12, 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 active liver disease; severe renal failure (less than 30 ml / min creatinine clearance), progressive renal disease, confirmed hyperkalemia; since the aorto-coronary bypass; arterial hypertension; congenital lactase deficiency, lactose intolerance, glucose-galactose malabsorption; deficiency of glucose-6-phosphate dehydrogenase; pregnancy, lactation, children under 18 years.
Precautions for use:
Hyperbilirubinemia, chronic heart failure, coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (creatinine clearance of 30-60 ml / min), ulcerative lesions of the gastrointestinal tract in the history, the presence of N. pulori infection, long-term use of NSAIDs, alcoholism, severe physical illness, advanced age, concomitant use of oral corticosteroids (including prednizolo a), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
Indications
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, joint syndrome in exacerbation of gout, bursitis, tenosynovitis. Pain (mild to moderate intensity): arthralgia, myalgia, neuralgia, migraine, toothache, and headaches, tuberculosis; pain with injuries, burns. It is intended for symptomatic therapy, reduce pain and inflammation at the time of use, does not affect the progression of the disease.
Interaction with other drugs
Inductors microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of active hydroxylated metabolites. Reduces the efficiency of uricosuric, antihypertensive drugs and diuretics. Enhances hypoglycemic effect of sulfonylurea derivatives, anticoagulants, antiplatelet agents, fibrinolytic agents, the side effects of estrogen, glucocorticoid and mineralocorticoid. Antacids colestyramine and reduce absorption.
Increases concentration of lithium in blood preparations, methotrexate. In some patients with impaired renal function, co-administration of NSAIDs and angiotensin converting enzyme (ACE) inhibitors may lead to further deterioration of kidney function. Myelotoxicity drugs increase the expression gematotoksichnosti drug.
Overdose
Symptoms: abdominal pain, nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract, renal dysfunction, metabolic acidosis.
Treatment: gastric lavage, administration of adsorbents (activated charcoal) and symptomatic therapy (maintenance of the vital functions of the body). There is no specific antidote.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug.
Pharmacodynamics:
Amtolmetin guatsil is a nonsteroidal anti-inflammatory drug (NSAID), non-selective cyclooxygenase (COX). Amtolmetin guatsil is a precursor tolmetin. Anti-inflammatory, analgesic, antipyretic, antiinflammatory effect, has gastroprotective effect. Inhibits proinflammatory factors reduces platelet aggregation; inhibits COX-1 and COX-2, gives the metabolism of arachidonic acid, reduces the formation of prostaglandins (including in inflammation), suppresses the exudative and the proliferative phases of inflammation. Reduces capillary permeability; stabilizes lysosomal membranes; inactivates or inhibits the synthesis of inflammatory mediators (prostaglandins, histamine, bradykinin, cytokines, complement factors). Blocks the interaction with tissue bradykinin receptors, restores the microcirculation and reduce pain sensitivity in the inflammation. It affects the thalamic centers of pain sensitivity; reduces the concentration of biogenic amines having algogenov properties; It increases the threshold of pain sensitivity of the receptor apparatus. Eliminates or reduces the intensity of pain, morning stiffness and reduces swelling, increases range of motion in the affected joints after 4 days of treatment. The protective effect amtolmetin guatsila the mucosa of the stomach is realized by stimulation of capsaicin receptor (also called vanilloid receptor) present in the walls of the gastrointestinal tract. Due to the fact that in the present amtolmetin guatsila vanillic group, it can stimulate kapsaitinovye receptors, which in turn causes the release of the peptide, calcitonin gene-encoded (PKGK) and the subsequent increase in the production of nitric oxide (NO). Both of these actions to counterbalance the negative effects caused by reducing the amount of prostaglandins due to inhibition of COX. Amtolmetin guatsil well tolerated for prolonged use (within 6 months).
Pharmacokinetics:
Amtolmetin guatsil Absorption after oral administration is rapid and complete. In general the drug is concentrated in the walls of the stomach and intestines, where during the 2 hours after taking it maintained a very high concentration. After absorption amtolmetin guatsil immediately hydrolyzed by esterases to form the plasma of three metabolites: MED-5, tolmetin and gviakol which are transformed to the active metabolite tolmetin, which penetrates into the tissue, exerting a pharmacological action. The main route of metabolism of tolmetin – oxidation of the methyl group on the benzene ring to a carboxy.
The time to reach maximum concentration (TCmax) after ingestion – 20-60 minutes.
Relationship to plasma proteins – 99%. The half-life (T1 / 2) in adults -. About 5 hours, within 24 hours the drug is almost completely excreted from the body in the form of glucuronides (urine – 80%, with bile – 20%).
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%), rare (0.1-1%), rare (0.01-0.1%), very rarely (less than 0.01%) , including isolated reports.
From the digestive system: often – nausea; infrequently – dyspepsia, discomfort in the stomach and intestines, bloating; rare – abdominal pain, diarrhea, vomiting, constipation, gastritis; very rarely – peptic ulcer, liver function abnormalities.
From the urinary system: elevated levels of blood urea nitrogen, urinary tract infections
From the sensory organs: rarely – ringing in the ears, blurred vision.
The respiratory system: rarely – bronchospasm, dyspnea, rhinitis, swelling of the larynx.
Central nervous system: often – dizziness, headache, drowsiness; rarely – depression.
Cardio-vascular system: often – a rise in blood pressure.
From the side of hematopoiesis: rarely – anemia, thrombocytopenia, agranulocytosis, leukopenia.
For the skin: rare – skin rash (including maculopapular rash), purpura, rarely – exfoliative dermatitis (fever with chills or without redness, induration or peeling of the skin, swelling and / or tenderness of the tonsils), urticaria, Stevens-Johnson syndrome , Lyell’s syndrome.
Allergic reactions: rare – anaphylaxis or anaphylactoid reaction (change in skin color, skin rash, hives, itchy skin, tachypnea and dyspnea, edema of the eyelids, periorbital edema, dyspnea, wheezing, heaviness in the chest, wheezing).
Other: often – weakness; Infrequent – edema (face, legs, ankles, fingers, feet, weight gain); rarely – increased sweating, fever, lymphadenopathy; very rare – swelling of the tongue.
special instructions
During treatment requires monitoring picture peripheral blood and functional state of the liver and kidneys. The treatment should be discontinued 48 hours prior to determination of 17-ketosteroids. During the treatment should refrain from activities potentially hazardous activities that require attention and speed of mental and motor responses.
Storage conditions
In a dry, dark place at a temperature not higher than 25 ° C.
Keep out of the reach of children!.
Dosing and Administration
Amtolmetin guatsila recommended dose is 600 mg twice a day. Depending on the degree of control of symptoms maintenance dose may be reduced to 600 mg once a day. The maximum daily dose – 1800 mg. To save the gastroprotective effect of the drug, Nayzilat should be taken on an empty stomach.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist