Oxyliten (tenoxicam) coated tablets 20 mg. №10

Description

Oxyliten composition
active substance: tenoxicam;
1 tablet contains tenoxicam 20 mg;
excipients: lactose monohydrate; corn starch; talc; magnesium stearate; shell: hypromellose, talc, titanium dioxide (E 171), iron oxide yellow (E 172).

Dosage form
Film-coated tablets.

Pharmacological properties
Oxyliten is a nonsteroidal anti-inflammatory drug of the oxycam class. It has analgesic and anti-inflammatory effects, antipyretic effect is less pronounced. The mechanism of action is based on non-selective blocking of the activity of isoenzymes COX-1 and COX-2, impaired metabolism of arachidonic acid, resulting in reduced synthesis of prostaglandins at the site of inflammation, as well as other body tissues. In addition, tenoxicam reduces the accumulation of white blood cells at the site of inflammation. Tenoxicam reduces capillary permeability, stabilizes lysosomal membranes; inhibits the release of macroergic compounds (primarily ATP) in the processes of oxidative phosphorylation; inhibits the synthesis or inactivates inflammatory mediators (prostaglandins, histamine, bradykinins, lymphokines, complement factors, etc.). Blocks the interaction of bradykinin with tissue receptors, restores impaired microcirculation and reduces pain sensitivity at the site of inflammation. Affects the thalamic centers of pain sensitivity (local blockade of the synthesis of PgEl, PgE2 and PgF2 alpha).
The analgesic effect is due to a decrease in the concentration of biogenic amines, which have allogeneic properties, and an increase in the threshold of pain sensitivity of the receptor apparatus. Relieves or reduces the intensity of pain of any etiology, reduces morning stiffness, increases the mobility of the affected joints. With prolonged use has a desensitizing effect. A feature of tenoxicam is its long action.

Indication
Treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis.
Short-term treatment of inflammatory-degenerative diseases of the musculoskeletal system, including dislocations and other soft tissue injuries.

Contraindication
Hypersensitivity to tenoxicam, to other components of the drug, to ibuprofen, acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs) (symptoms of bronchial asthma, rhinitis, angioneurotic edema or urticaria); severe heart, liver and kidney failure; active peptic ulcer, bleeding from the digestive tract in the acute stage, ulcers or bleeding in the anamnesis (two or more pronounced established episodes of ulceration or bleeding); gastrointestinal bleeding or perforation (history) associated with previous NSAID use.

Children
There are no data on the safety of tenoxicam in children, so it should not be prescribed to this category of patients.

Use during pregnancy or breastfeeding
Do not use the drug Oxyliten. During treatment with the drug should stop breastfeeding, as the effect on infants during breastfeeding is unknown.

Method of application and dosage
Oxyliten tablets should be taken orally with liquid, preferably with or after food.
Adults: the recommended dose is 1 tablet (20 mg) once a day at the same time daily.
Do not exceed the recommended doses, as this does not give a significant therapeutic effect, but at the same time increases the risk of side effects.
In acute diseases of the musculoskeletal system, the duration of treatment usually exceeds 7 days, but in severe cases, the reception can be extended up to 14 days.

Overdose
No severe cases of tenoxicam overdose have been reported.
Symptoms: headache, dizziness, nausea, vomiting, diarrhea, pain or discomfort in the epigastrium, diarrhea, gastrointestinal bleeding, loss of orientation, agitation, coma, drowsiness, dizziness, tinnitus, weakness, fainting, and sometimes convulsions. Possible active renal or hepatic failure in severe poisoning.
Treatment. If necessary, carry out symptomatic therapy. In the first hour of poisoning should be gastric lavage and take activated charcoal. Good urine output should be ensured. Kidney and liver function should be monitored. Patients should be monitored by a physician for 4 hours after an overdose. At frequent and long spasms enter intravenously diazepam. There is no specific antidote.

Side effects:

• From the digestive tract: nausea, vomiting, diarrhea, constipation, heartburn, dyspepsia, abdominal pain, melena, epigastric distress, hematemesis, flatulence, ulcerative stomatitis, gastrointestinal hemorrhage, gastritis, peptic ulcers or gastrointestinal ulcers.
• From the hepatobiliary system: liver dysfunction, hepatitis, jaundice, possible increase in blood levels of transaminases.
• From the blood and lymphatic system: thrombocytopenia; thrombocytopenic purpura; neutropenia; agranulocytosis; aplastic anemia and hemolytic anemia; decrease in hemoglobin level not associated with bleeding; leukopenia; eosinophilia.
• From the metabolic side: hyperglycemia, weight gain or loss.
• From the nervous system: agitation, optic neuritis, paresthesia, depression, nervousness, hallucinations (confusion), drowsiness or insomnia, sleep disturbances, tinnitus, malaise, weakness, fatigue, headache, dizziness, tremor.
• From the eyes: irritation and swelling of the eyes, blurred vision.
• There were no cases of visual disturbances detected by examination with a slit lamp or ophthalmoscope.
• From the cardiovascular system: edema, dyspnea, tachycardia, palpitations. Possible development of heart failure, hypertension associated with NSAID treatment. Elderly people with cardiac dysfunction should be used with caution, as increased edema may lead to congestive heart failure.
• NSAIDs (at high doses and long-term use) may increase the risk of arterial thrombosis (myocardial infarction, stroke).
• From the urinary system: nephrotoxicity, including interstitial nephritis, nephrotic syndrome and renal failure.
• Hypersensitivity reactions: nonspecific allergic reactions, anaphylactic reactions, airway reactivity, including bronchial asthma, bronchospasm or dyspnea; skin disorders – rash, pruritus, urticaria, angioneurotic edema, bullous dermatitis (including toxic epidermal necrolysis, erythema multiforme and exfoliative dermatitis), possible alopecia, photosensitization, Lyell’s syndrome, John’s syndrome – Stevens.
• Laboratory parameters: increase in blood levels of transaminases, hyperglycemia, reversible increase in urea nitrogen and creatinine in blood plasma.

If any of the side effects occur, treatment should be stopped. Adverse reactions can be minimized by using low effective doses in a shorter time.

Expiration date
3 years.

Storage conditions
Store Oxyliten in the original package at a temperature not exceeding 25 ° C.
Keep out of reach of children.