Ksefokam tablets p / o 8mg, No. 30

• short-term treatment of pain syndrome of various origins;

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

The drug is taken orally before meals with a glass of water.

With severe pain syndrome, the recommended dose is 8-16 mg / day, divided into 2-3 doses. The maximum daily dose is 16 mg.

For inflammatory and degenerative rheumatic diseases, the recommended starting dose is 12 mg. The standard dose is 8-16 mg / day, depending on the patient's condition.

The duration of therapy depends on the nature and course of the disease.

For diseases of the gastrointestinal tract, patients with impaired renal or liver function, elderly patients (over 65 years old), after extensive operations - the maximum daily dose is 12 mg in 3 doses.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used in the smallest possible short course.

Film-coated tablets

1 tab.

lornoxicam

Excipients: magnesium stearate, povidone K25, croscarmellose sodium, cellulose, lactose monohydrate.

• 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);

• hemorrhagic diathesis or bleeding disorders;

• recent surgeries associated with the risk of bleeding or incomplete hemostasis;

• period after coronary artery bypass grafting;

• erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;

• cerebrovascular or other bleeding;

• recurrent stomach ulcer or repeated gastrointestinal bleeding;

• Gastrointestinal bleeding associated with a history of NSAIDs;

• inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase;

• decompensated heart failure;

• severe liver failure or active liver disease;

• severe renal failure (serum creatinine level more than 300 ?mol / l), progressive kidney disease;

• confirmed hyperkalemia;

• hypovolemia or dehydration;

• pregnancy;

• lactation period (breastfeeding);

• children and adolescents up to 18 years of age (due to the lack of clinical data on its use in this age group);

• hypersensitivity / allergy to lornoxicam or to one of the components of the drug.

With care: erosive and ulcerative lesions and bleeding from the gastrointestinal tract (in history); moderately severe renal failure, CC less than 60 ml / min; conditions after surgery; Ischemic heart disease, chronic heart failure; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; peripheral arterial disease; presence of Helicobacter pylori infection; long-term use of NSAIDs; severe somatic diseases; simultaneous use of oral corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); smoking, alcoholism; age over 65.

pharmachologic effect

NSAIDs. 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 COX isoenzymes. In addition, lornoxicam inhibits the release of free oxygen radicals from activated leukocytes.

The analgesic effect of lornoxicam is not drug-related.

The drug Ksefokam does not have an opiate-like effect on the central nervous system and, unlike narcotic analgesics, does not depress respiration, does not cause drug dependence.

Pharmacokinetics

Absorption and distribution

After oral administration, lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract. In this case, Cmax in plasma is reached after about 1-2 hours. Food intake reduces Cmax by 30% and increases Tmax to 2.3 hours. The absolute bioavailability of lornoxicam is 90-100%. The binding of lornoxicam to plasma proteins, mainly to the albumin fraction, is 99% and does not depend on its concentration.

Metabolism and excretion

Lornoxicam is completely metabolized in the liver. The isoenzyme CYP2C9 is involved in metabolism. Lornoxicam is present in plasma mainly unchanged and, to a lesser extent, in the form of a hydroxylated metabolite, which has no pharmacological activity.

T1 / 2 averages 4 hours and does not depend on the concentration of the drug. Approximately 1/3 of metabolites are excreted from the body by the kidneys and 2/3 - with bile.

Pharmacokinetics in special patient groups

In the elderly, as well as in patients with renal or hepatic insufficiency, no significant changes in the pharmacokinetics of lornoxicam were found.

Side effect

From the digestive system: dyspepsia, abdominal pain, dry mouth, stomatitis, nausea, vomiting, heartburn, diarrhea; esophagitis, gastritis, erosive and ulcerative lesions of the mucous membrane of the stomach and intestines, incl. with perforation and bleeding, constipation, flatulence, melena, abnormal liver function, increased levels of hepatic transaminases.

From the nervous system: headache, dizziness, drowsiness, sleep disturbances, depression, agitation, tremor, aseptic meningitis, paresthesia.

From the senses: tinnitus, visual impairment.

From the side of the cardiovascular system: development or worsening of heart failure, tachycardia, increased blood pressure.

Respiratory system: pharyngitis, rhinitis, dyspnea, cough, bronchospasm.

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

On the part of the skin and subcutaneous fat: edematous syndrome, ecchymosis, skin rash, itching, urticaria, alopecia, Stevens-Johnson syndrome, Lyell's syndrome, angioedema.

On the part of the hematopoietic system and the hemostatic system: agranulocytosis, leukopenia, anemia, thrombocytopenia, increased bleeding time.

Others: anorexia, increased sweating, changes in body weight, arthralgia, myalgia.

Application during pregnancy and lactation

The use of the drug is contraindicated during pregnancy and lactation.

Application for violations of liver function

Patients with impaired liver function - the maximum daily dose is 12 mg in 3 doses.

Application for impaired renal function

Patients with impaired renal function - the maximum daily dose is 12 mg, given in 3 doses.

Application in children

Contraindication: age up to 18 years (due to the lack of clinical data on its use in this age group).

Use in elderly patients

Elderly patients (over 65 years old) - the maximum daily dose is 12 mg, in 3 doses.

special instructions

The risk of ulcerogenic action of the drug can reduce the simultaneous administration of proton pump inhibitors and synthetic analogs of prostaglandins. If bleeding occurs in the gastrointestinal tract, the drug should be stopped immediately and appropriate urgent measures should be taken. Especially carefully it is necessary to monitor the condition of those patients with gastrointestinal pathology who are receiving treatment with Ksefokam for the first time.

Like other oxicams, the drug Xefocam inhibits platelet aggregation and therefore may increase the bleeding time. When using this drug, it is necessary to carefully monitor the condition of patients who need absolutely normal functioning of the blood coagulation system (for example, patients who are to undergo surgery), who have disorders of the blood coagulation system or who are receiving drugs that inhibit coagulation (including heparin in low doses) , in order to timely detect signs of bleeding.

If signs of liver damage appear (skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased hepatic transaminases), the patient should stop taking the drug and consult a doctor.

The drug should not be used concomitantly with other NSAIDs.

The drug can change the properties of platelets, but does not replace the prophylactic effect of acetylsalicylic acid in cardiovascular diseases.

For patients with impaired renal function caused by large blood loss or severe dehydration, Ksefokam, as an inhibitor of prostaglandin synthesis, can be prescribed only after elimination of hypovolemia and the associated risk of decreased renal perfusion. Like other NSAIDs, Xefocam can cause an increase in the concentration of urea and creatinine in the blood, as well as water and sodium retention, peripheral edema, arterial hypertension and other early signs of nephropathy. Long-term treatment of such patients with Ksefokam can lead to the following consequences: glomerulonephritis, papillary necrosis and nephrotic syndrome with the transition to acute renal failure. Patients with a pronounced decrease in renal function should not be prescribed Ksefokam. In elderly patients, as well as in patientssuffering from arterial hypertension and / or obesity, it is necessary to control the level of blood pressure.

It is especially important to monitor renal function in elderly patients, as well as in patients:

• simultaneously receiving diuretics;

• concurrently receiving drugs that can cause kidney damage.

With prolonged use of the drug Ksefokam, it is necessary to periodically monitor hematological parameters, as well as the function of the kidneys and liver.

The use of the drug may adversely affect female fertility and is not recommended for women planning a pregnancy.

Patients using the drug should refrain from drinking alcohol.

Influence on the ability to drive vehicles and use mechanisms

Patients using the drug should refrain from work requiring increased attention and speed of psychomotor reactions.

Overdose

Symptoms: It is possible that the side effects of the drug described above may increase.

Treatment: carrying out symptomatic therapy. Taking activated charcoal immediately after taking Xefocam can help reduce the absorption of the drug. Antiulcer drugs can be used to prevent damage to the mucous membrane. Dialysis is ineffective.

Drug interactions

Drug interaction is observed with the simultaneous use of the drug Ksefokam and the following drugs.

Cimetidine - an increase in the plasma concentration of lornoxicam. Interactions with ranitidine and antacids have not been identified.

Anticoagulants or platelet aggregation inhibitors - bleeding time may increase (increased risk of bleeding), MHO monitoring is necessary.

Beta-blockers and ACE inhibitors - it is possible to reduce their hypotensive effect.

Diuretics - a decrease in the diuretic effect and the hypotensive effect of loop and thiazide diuretics.

Digoxin - decreased renal clearance of digoxin.

Quinolone antibiotics - increase the risk of developing convulsive syndrome.

Other NSAIDs or GCS - an increased risk of bleeding from the gastrointestinal tract.

Methotrexate - an increase in serum methotrexate concentration.

Selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline) - an increased risk of bleeding from the gastrointestinal tract.

Lithium salts - Potential increases in peak plasma lithium concentrations increase the known side effects of lithium.

Cyclosporine - an increase in the nephrotoxicity of cyclosporine.

Sulfonylurea derivatives - the hypoglycemic effect of the latter may be enhanced.

Tacrolimus - increased risk of nephrotoxic effect due to inhibition of prostacyclin synthesis in the kidneys.

Ethanol, corticotropin, potassium preparations - an increase in the risk of side effects from the gastrointestinal tract.

Cefamandol, cefoperazone, cefotetan, valproic acid - increased risk of bleeding.