Naisylate, 600 mg 20 pcs.

Pharmacodynamics

Amtolmethine guacil is a non-steroidal anti-inflammatory drug (NSAID), a non-selective cyclooxygenase inhibitor (COX). Amtolmethine guacil is a precursor of tolmethine. It has anti-inflammatory, analgesic, antipyretic, desensitizing effect, has gastroprotective effect. It suppresses pro-inflammatory factors, decreases platelet aggregation, inhibits COX-1 and COX-2, disrupts arachidonic acid metabolism, decreases prostaglandin formation (including in inflammation focus), suppresses exudative and proliferative phases of inflammation. It decreases capillary permeability, stabilizes lysosomal membranes, inhibits synthesis or inactivates inflammatory mediators (prostaglandins, histamine, bradykinins, cytokines, complement factors).

Indications

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular syndrome with exacerbation of gout, bursitis, tenosynovitis.

Pain syndrome (weak and moderate intensity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algomenorrhea; pain from injuries, burns.

Intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Pharmacological effect

Pharmacodynamics

Amtolmetin guacil is a non-steroidal anti-inflammatory drug (NSAID), a non-selective cyclooxygenase (COX) inhibitor. Amtolmetin guacil is a precursor to tolmetin. It has anti-inflammatory, analgesic, antipyretic, desensitizing effects, and has a gastroprotective effect. Suppresses pro-inflammatory factors, reduces platelet aggregation; inhibits COX-1 and COX-2, disrupts the metabolism of arachidonic acid, reduces the formation of prostaglandins (including at the site of inflammation), suppresses the exudative and proliferative phases of inflammation. Reduces capillary permeability; stabilizes lysosomal membranes; inhibits the synthesis or inactivates inflammatory mediators (prostaglandins, histamine, bradykinins, cytokines, complement factors).

Special instructions

During treatment with Nizilat, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

Treatment should be stopped 48 hours before determining 17-ketosteroids.

During treatment, you should refrain from engaging in potentially hazardous activities that require increased attention and speed of mental and motor reactions.

Active ingredient

Amtolmetin guacil

Composition

Each film-coated tablet contains:

Pregnancy

The safety of the drug during pregnancy or breastfeeding has not been established.

Contraindications

Hypersensitivity to amtolmetin, tolmetin; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history); erosive and ulcerative changes in the mucous membrane of the stomach and duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding; inflammatory bowel diseases (Crohn’s disease, ulcerative colitis) in the acute phase; hemophilia and other bleeding disorders; decompensated heart failure; liver failure or active liver disease; severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease, confirmed hyperkalemia; period after coronary artery bypass surgery; arterial hypertension; congenital lactase deficiency, lactose intolerance, glucose-galactose malabsorption; deficiency of glucose-6-phosphate dehydrogenase; pregnancy, lactation period, children under 18 years of age.

With caution:

Hyperbilirubinemia, chronic heart failure, coronary heart disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (creatinine clearance 30-60 ml/min), history of ulcerative lesions of the gastrointestinal tract, presence of H. pulori infection, long-term use of NSAIDs, alcoholism, severe somatic diseases, old age, simultaneous use of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Side Effects

The frequency of side effects is classified depending on the frequency of occurrence of the case: often (1-10%); infrequently (0.1-1%); rarely (0.01-0.1%); very rare (less than 0.01%), including isolated reports and frequency unknown.

Gastrointestinal disorders: often – nausea; uncommon – dyspepsia, discomfort in the stomach and intestines, bloating; rarely – abdominal pain, diarrhea, vomiting, constipation, gastritis; very rarely – peptic ulcer, liver dysfunction.

Interaction

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Reduces the effectiveness of uricosuric, antihypertensive drugs and diuretics.

Enhances the hypoglycemic effect of sulfonylurea derivatives, the effect of anticoagulants, antiplatelet agents, fibrinolytics, side effects of estrogens, corticosteroids and mineralocorticoids.

Antacids and cholestyramine reduce absorption.

Increases the concentration of lithium and methotrexate in the blood.

In some patients with impaired renal function, co-administration of NSAIDs and ACE inhibitors may lead to further deterioration of renal function.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Overdose

Symptoms:

abdominal pain, nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract, impaired renal function, metabolic acidosis.

Treatment:

gastric lavage, administration of adsorbents (activated carbon) and symptomatic therapy (maintaining vital functions of the body). There is no specific antidote.

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children!

Shelf life

2 years

Manufacturer

Dr. Reddy’s Laboratories Ltd, India