Xefocam, pills 8mg 10pcs

Composition

Active ingredient:

lornoxicam 8 mg;

Auxiliary substances:

magnesium stearate, povidone (K 25),

sodium croscarmellose,

cellulose,

lactose monohydrate;

Shell:

macrogol (6000),

titanium dioxide, E-171,

talc,

hypromellose.

Pharmacological action

Xefocam is an oxycam-class NSAID.

It has a pronounced analgesic and anti-inflammatory effect.

Lornoxicam has a complex mechanism of action, which is based on the suppression of prostaglandin synthesis, due to the inhibition of the activity of cyclooxygenase isoenzymes. In addition, lornoxicam inhibits the release of oxygen free radicals from activated white blood cells.

The analgesic effect of lornoxicam is not associated with narcotic effects.

The drug XEFOCAM does not have an opiate-like effect on the central nervous system (CNS) and, unlike narcotic analgesics, does not depress breathing, does not cause drug dependence.

Pharmacokinetics

Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract (GIT) after oral use. In this case, the maximum plasma concentrations are reached in about 1-2 hours.

Food intake reduces the maximum concentration (C max) by 30% and increases the time to reach the maximum concentration (Ttah) to 2.3 hours. The absolute bioavailability of lornoxicam is 90-100%. Lornoxicam is present in plasma, mainly in unchanged form and, to a lesser extent, in the form of a hydroxylated metabolite, which does not have pharmacological activity. The binding of lornoxicam to plasma proteins, mainly the albumin fraction, is 99% and does not depend on its concentration.

The average half-life is 4 hours and does not depend on the concentration of the drug. Lornoxicam is completely metabolized in the liver. The isoenzyme CYP2C9 is involved in metabolism. Approximately 1/3 of the metabolites are eliminated from the body by the kidneys and 2/3 – with bile. In the elderly, as well as in patients with renal or hepatic insufficiency, no significant changes in the pharmacokinetics of lornoxicam were found.

Indications

Short-term treatment of pain syndrome of various origins.

Symptomatic therapy of rheumatic diseases (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, joint syndrome with exacerbation of gout, rheumatic soft tissue damage).

Contraindications

Hypersensitivity (including to ASA and NSAIDs etc. ), erosive and ulcerative lesions of the gastrointestinal tract (peptic ulcer of the stomach and 12 duodenal ulcer, ulcerative colitis) in the acute stage, bronchial asthma, severe CHF, hypovolemia, hypocoagulation (including hemophilia, hemorrhagic diathesis, thrombocytopenia), severe liver and/or renal failure, deficiency of glucose-6-phosphate dehydrogenase;

bleeding in the brain (including the suspect), pregnancy, lactation, age under 18 years (no clinical experience).

With caution.

Erosive and ulcerative lesions and bleeding from the gastrointestinal tract (in the anamnesis), moderate renal failure, conditions after surgery, age over 65 years, body weight less than 50 kg.

Side effects

From the gastrointestinal tract and liver: dyspepsia, abdominal pain, dry mouth, stomatitis, nausea, vomiting, heartburn, diarrhea; esophagitis, gastritis, erosive and ulcerative lesions of the gastric and intestinal mucosa, including with perforation and bleeding, constipation, flatulence, melena, impaired liver function, increased liver transaminases;

Nervous system disorders: headache, dizziness, drowsiness, sleep disorders, depression, agitation, tremor, aseptic meningitis, paresthesia;

From the side of the skin and subcutaneous fat: edematous syndrome, ecchymosis, skin rash, pruritus, urticaria, alopecia, Stevens-Johnson syndrome, Lyell’s syndrome, angioedema;

From the urinary system: dysuria, decreased glomerular filtration rate, interstitial nephritis, glomerulonephritis, papillary necrosis, nephrotic syndrome, peripheral edema, acute renal failure;

From the sensory organs: tinnitus, visual impairment;

From the cardiovascular system: development or aggravation of heart failure, tachycardia, increased blood pressure (BP);

From the hematopoietic and hemostatic system: agranulocytosis, leukopenia, anemia, thrombocytopenia, increased bleeding time;

From the respiratory system: pharyngitis, rhinitis, dyspnoea, cough, bronchospasm;

Others: anorexia, increased sweating, weight loss, arthralgia, myalgia.

Interaction

Reduces the effectiveness of uricosuric drugs, increases the effect of anticoagulants, antiplatelet agents, fibrinolytics, side effects of MCS and corticosteroids, estrogens;

reduces the effect of antihypertensive drugs and diuretics; increases the hypoglycemic effect of sulfonylurea derivatives.

Increases the concentration of Li+ and methotrexate in the blood.

Reduces the renal clearance of digoxin.

Cimetidine increases the concentration of lornoxicam in plasma.

Antacids and colestyramine reduce absorption.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

How to take, course of use and dosage

Inside, before meals, with 200 ml of water;

with moderate and severe pain syndrome-8-16 mg,

if necessary-in the first 24 hours an additional 16 mg, in the future-8 mg 2 times a day.

For adults with inflammatory diseases, the initial dose is 12 mg, then 8-16 mg / day in 2-3 divided doses.

The maximum daily dose is 16 mg.

Overdose

Symptoms: increased side effects from the central nervous system and digestive system, acute renal failure.

Treatment: gastric lavage, activated charcoal, symptomatic therapy. Dialysis is ineffective.

Special instructions

During treatment, it is necessary to monitor the state of the gastrointestinal tract in order to prevent ulcerogenic effects or gastrointestinal bleeding.

Concomitant use of omeprazole or H2-histamine receptor blockers, synthetic Pg analogues (misoprostol) can reduce the risk of ulcerogenic effects.

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

In patients with renal insufficiency (plasma creatinine concentration 150-300 mmol/L), dosage adjustment and regular monitoring of renal function are required.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

It retains Na+, K+, Li+ and water in the body, which can worsen the course of arterial hypertension and HF, and in people taking Li+ preparations, increase the severity of side effects of Li+salts.

Elderly patients, as well as those with arterial hypertension, need regular blood pressure monitoring.

During the treatment period, care should be taken when driving vehicles and doing other activities. potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Tablets

Storage conditions

At a temperature of 15-25 °C

Shelf life

5 years

Active ingredient

Lornoxicam

Conditions of release from pharmacies

By prescription

Dosage form

Tablets