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Amtolmetin guacil is a NSAID, non-selective inhibitor of cyclooxygenase (COX). Amtolmetin guacil is a precursor of tolmetin. It has anti-inflammatory, analgesic, antipyretic, desensitizing effect, has a gastroprotective effect. Suppresses pro-inflammatory factors, reduces platelet aggregation; inhibits COX-1 and COX-2, violates the metabolism of arachidonic acid, reduces the formation of prostaglandins (including in the focus 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). It blocks the interaction of bradykinin with tissue receptors, restores impaired microcirculation and reduces pain sensitivity in the inflammatory focus. Affects the thalamic centers of pain sensitivity; reduces the concentration of biogenic amines with algogenic properties; increases the threshold of pain sensitivity of the receptor apparatus. Eliminates or reduces the intensity of pain, reduces morning stiffness and swelling, increases range of motion in the affected joints after 4 days of treatment.
The protective effect of amtolmetin guacil on the gastric mucosa is realized by stimulating the capsaicin receptors (also called vanilloid receptors) present in the walls of the gastrointestinal tract. Due to the fact that amtolmetin guacil contains a vanillin group, it can stimulate capsaicin receptors, which, in turn, causes the release of the peptide encoded by the calcitonin gene (PCHC) and the subsequent increase in nitric oxide production (NO). Both of these actions create a counterbalance to the negative effect caused by a decrease in the number of prostaglandins due to inhibition of COX. Amtolmetin guacil was well tolerated by patients with long-term use (for 6 months).
Pain syndrome (low and medium intensity):
- toothache and headache;
- pain with injuries, burns.
Designed for symptomatic therapy, reducing pain and inflammation at the time of use; the progression of the disease is not affected.
Each film-coated tablet contains:
Active substance: amtolmetin guacil 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 carboxymethyl starch (type A) 24.0 mg, magnesium stearate 8.0 mg;
Film shell: hypromellose (5 cps) 12.5 mg, titanium dioxide 6.25 mg, macrogol-400 1.25 mg.
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Dosage and Administration
The recommended dose of Nyzilat is 600 mg twice a day. Depending on the degree of control of the symptoms of the disease, the maintenance dose may be reduced to 600 mg once a day. The maximum daily dose is 1800 mg. To preserve the gastroprotective action of the drug, Neisylate should be taken on an empty stomach.
From the digestive system: often nausea; infrequently - dyspepsia, discomfort in the stomach and intestines, bloating; rarely - abdominal pain, diarrhea, vomiting, constipation, gastritis, very rarely - peptic ulcer, abnormal liver function.
From the urinary system: increased urea nitrogen in the blood, urinary tract infections.
From the senses:rarely - tinnitus, visual disturbances.
On the part of the respiratory system:rarely - bronchospasm, shortness of breath, rhinitis, laryngeal edema.
From the side of the central nervous system:often - dizziness, drowsiness headache; rarely - depression.
Since the cardiovascular system:often - the rise of blood pressure.
From the side of blood-forming organs: rarely - anemia, thrombocytopenia, agranulocytosis, leukopenia.
On the part of the skin: infrequently - skin rash (including maculo-papular rash), purpura; rarely, exfoliative dermatitis (fever with or without chills, redness, hardening or peeling of the skin, swelling and / or tenderness of the tonsils), urticaria, Stevens-Johnson syndrome, Lyell's syndrome.
Allergic reactions: rarely - anaphylaxis or anaphylactoid reactions (discoloration of the skin, skin rash, urticaria, skin itching, tachypnea or dyspnea, eyelid edema, periorbital edema, shortness of breath, difficulty breathing, chest pain, wheezing).
Other: often - weakness; infrequently - swelling (face, legs, ankles, fingers, feet, weight gain); rarely, excessive sweating, fever, lymphadenopathy; very rarely - swelling of the tongue.
Carefully: hyperbilirubinemia; chronic heart failure; coronary heart disease; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; peripheral arterial disease; smoking; chronic renal failure (Clcreatin 30–60 ml / min); ulcerative lesions of the gastrointestinal tract in history; infectionN. pylori; prolonged use of NSAIDs; alcoholism; severe somatic diseases; elderly age; simultaneous administration of oral GCS (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), SSRIs (including cytalopram, fluoxetine, paroxetine, sertraline ).
Inductors 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 action of anticoagulants, antiplatelet agents, fibrinolytics, side effects of estrogens, glucocorticosteroids and mineralcorticoids.
Antacids and colestyramine reduce absorption.
Increases the blood concentration of drugs lithium, methotrexate.
In some patients with impaired renal function, co-administration of NSAIDs and angiotensin-converting enzyme (ACE) inhibitors can lead to a further deterioration in the functioning of the kidneys.
Myelotoxic drugs increase the hematotoxicity of the drug.
During treatment with Neyzilat, it is necessary to monitor the pattern of peripheral blood and the functional state of the liver and kidneys. Treatment should be discontinued 48 hours before the determination of the 17-ketosteroids. During treatment, you should refrain from engaging in potentially hazardous activities that require increased attention and speed of mental and motor responses.
Symptoms: abdominal pain, nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract, impaired renal function, metabolic acidosis.
Treatment:gastric lavage, the introduction of adsorbents (Activated charcoal) and symptomatic therapy (maintaining the vital functions of the body). There is no specific antidote.
- Brand name: Niselat
- Active ingredient: Amtolmetin guacil
- Dosage form: pills, film coated.
- Manufacturer: Dr. Reddy`s
- Country of Origin: India