The tablets covered with a film cover of yellow color, round, biconcave.
1 tab.
lornoxicam 4 mg
Excipients: lactose monohydrate - 47.05 mg, croscarmellose sodium - 3.5 mg, povidone K30 - 1.1 mg, cellulose microcrystalline - 12 mg, magnesium stearate - 0.35 mg.
The composition of the shell: hypromellose - 0.75 mg, titanium dioxide (E171) - 0.6 mg, talc - 0.4 mg, dye quinoline yellow (E104) - 0.1 mg, macrogol 6000 - 0.15 mg.
10 pieces. - blisters (3) - packs of cardboard.
The tablets covered with a film cover of yellow color, round, biconcave.
1 tab.
lornoxicam 8 mg
Excipients: lactose monohydrate - 94.1 mg, croscarmellose sodium - 7 mg, povidone K30 - 2.2 mg, microcrystalline cellulose - 24 mg, magnesium stearate - 0.7 mg.
The composition of the coating: hypromellose - 1.5 mg, titanium dioxide (E171) 1.2 mg, talc 0.8 mg, dye quinoline yellow (E104) 0.2 mg, macrogol 6000 0.3 mg.
10 pieces. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Lornoxicam belongs to the class of oxicams, it has a pronounced analgesic and anti-inflammatory effect. Lornoxicam has a complex mechanism of action, which is based on suppression of the synthesis of prostaglandins, due to inhibition of the activity of COX isoenzymes. In addition, lornoxicam is inhibited by the release of free oxygen radicals from activated leukocytes.
The analgesic effect of lornoxicam is not associated with narcotic effects. The drug has no opiate-like effect on the central nervous system and, unlike narcotic analgesics, does not depress respiration and does not cause drug dependence.
PHARMACOKINETICS
Suction
Lornoxicam quickly and almost completely absorbed from the digestive tract after ingestion. At the same time, Cmax in the blood plasma is reached after about 1-2 hours. Eating reduces the C max of the drug in the blood plasma by 30% and increases the T max to 2.3 h. When re-admission the drug does not accumulate in the body.The absolute bioavailability of lornoxicam is 90-100%.
Metabolism
Lornoxicam is present in the blood plasma mainly unchanged and to a lesser extent in the form of hydroxylated metabolite (5'-hydroxylornoxicam), which does not possess pharmacological activity. Lornoxicam rapidly penetrates into the synovial fluid. AUC of lornoxicam in synovial fluid is 0.5 after taking a dose of 4 mg 2 times / day.
Lornoxicam is completely metabolized in the liver. The isozyme CYP2C9 is involved in the metabolism. The binding of lornoxicam to blood plasma proteins, mainly albumin fraction, is 99% and does not depend on its concentration.
Excretion
T 1/2 on the average is 4 hours and does not depend on the concentration of the drug. Approximately 1/3 of the metabolites are excreted from the body by the kidneys and 2/3 - with the gall. T 1/2 glucuronated metabolites of lornoxicam - about 11 hours.
In elderly patients, as well as in patients with renal or hepatic insufficiency, no significant changes in the pharmacokinetics of lornoxicam were detected.
INDICATIONS
- short-term treatment of pain syndrome of different origin;
- symptomatic therapy of rheumatic diseases (rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, articular syndrome with exacerbation of gout, rheumatic soft tissue damage).
DOSING MODE
Inside. The drug should be taken before meals, washed down with a glass of water.
At the expressed painful syndrome the recommended dose of 8-16 mg / sut, divided into 2-3 admission. The maximum daily dose is 16 mg.
In inflammatory and degenerative rheumatic diseases, the recommended initial 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.
With gastrointestinal diseases. patients with impaired renal or hepatic function, elderly people (over 65 years), after extensive operations, the maximum daily dose is 12 mg, for 3 doses.
To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.
SIDE EFFECT
Depending on the frequency of occurrence, the following groups of side effects are distinguished: very often (> 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100), rarely from? 1/10000 to <1/1000), very rarely (<1/10000), including individual messages.
From the nervous system: often - headache, dizziness; infrequently - sleep disorders, depression; rarely - drowsiness, agitation, tremor, paresthesia; very rarely - aseptic meningitis.
From the digestive system: often - dyspepsia, abdominal pain, nausea, vomiting, diarrhea, heartburn; infrequently gastritis, erosive and ulcerative lesions of the mucous membrane of the stomach and intestines (including perforation and bleeding), constipation, flatulence, increased levels of "liver" transaminases; rarely - dry mouth, esophagitis, melena, dysfunction of the liver, stomatitis.
C side of the skin: infrequent - skin rash, itching, hives, alopecia; rarely - edematous syndrome, Stevens-Johnson syndrome, Lyell's syndrome, angioedema; very rarely - ecchymosis.
From the urinary system: rarely - dysuria, decreased glomerular filtration, interstitial nephritis, glomerulonephritis, papillary necrosis, nephrotic syndrome, peripheral edema, acute renal failure.
From the senses: infrequent - noise in the ears; rarely - visual impairment.
From the cardiovascular system: infrequently - development or exacerbation of heart failure, tachycardia; rarely - increased blood pressure.
From the hemopoiesis: rarely - agranulocytosis, leukopenia, anemia, thrombocytopenia, increased bleeding time.
On the part of the respiratory system: infrequently - rhinitis; rarely - pharyngitis, dyspnoea, cough, bronchospasm.
Other: infrequently - anorexia, increased sweating, weight change, arthralgia; rarely - myalgia.
If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.
CONTRAINDICATIONS
- hypersensitivity to lornoxicam or to one of the components of the drug;
- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in the anamnesis);
- hemorrhagic diathesis or blood clotting disorders, as well as patients who underwent surgery with a risk of bleeding or incomplete hemostasis;
- period after aortocoronary shunting;
- cerebrovascular or other bleeding;
- erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal hemorrhage;
- recurrent gastric ulcer or repeated gastrointestinal bleeding;
- gastrointestinal hemorrhage associated with taking an NSAID in an anamnesis;
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the phase of exacerbation;
Decompensated heart failure;
severe hepatic insufficiency or active liver disease;
- severe renal failure (QC less than 30 ml / min), progressive kidney disease;
- confirmed hyperkalemia;
- hypovolemia or dehydration;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- pregnancy, the period of breastfeeding;
- Children under 18 years of age (due to the lack of clinical data on the use of lornoxicam in this age group).
Carefully
Erosion-ulcerative lesions and bleeding from the gastrointestinal tract (in the anamnesis), moderately expressed renal failure, post-surgical conditions, age over 65 years, ischemic heart disease, in patients with hemostasis defects, risk of developing cardiovascular thrombosis (myocardial infarction, acute disorders of the brain blood circulation (ischemic, hemorrhagic stroke)), chronic heart failure (II-1V functional class according to NYHA classification), cerebrovascular diseases, dyslipidemia / hyperlipidemia, sah molecular mellitus, peripheral arterial disease, smoking, systemic lupus erythematosus, CC less than 60 ml / min, the presence of Helicobacter pylori infection, prolonged use of NSAIDs, alcoholism, severe somatic disorders. simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
PREGNANCY AND LACTATION
The drug is contraindicated during pregnancy. During lactation, breastfeeding should be stopped for the duration of treatment with the drug.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution apply the drug to patients with moderate renal failure.
The use of the drug in patients with severe renal failure (QC less than 30 ml / min) and progressive kidney disease is contraindicated.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The use of the drug for patients with severe hepatic insufficiency or active liver disease is contraindicated.
APPLICATION FOR CHILDREN
The use of the drug for children and adolescents under the age of 18 is contraindicated (due to the lack of clinical data on the use of lornoxicam in this age group).
APPLICATION IN ELDERLY PATIENTS
With caution apply the drug to patients over 65 years of age.
SPECIAL INSTRUCTIONS
The risk of ulcerogenic action of the drug reduces the simultaneous administration of inhibitors of the proton pump and synthetic analogues of prostaglandins. In case of bleeding in the gastrointestinal tract, the drug should be stopped immediately and appropriate emergency measures taken. Especially it is necessary to monitor the condition of those patients with gastrointestinal pathology who are first treated with lornoxicam.
Like other oxicams, lornoxicam inhibits platelet aggregation and therefore may increase bleeding time. When using this drug, it is necessary to carefully monitor the condition of patients who need the absolutely normal functioning of the blood clotting system (for example, patients who are undergoing surgery) who have disorders of the blood coagulation system or who receive medications that suppress blood clotting (including heparin at low doses ), in order to timely detect signs of bleeding.
If there are signs of liver damage (skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of urine, increased level of "liver" transaminases), stop taking the drug and consult a doctor.
Do not use the drug simultaneously with other NSAIDs.
The drug can alter the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.
Patients with impaired renal function caused by large blood loss or severe dehydration, lornoxicam, as an inhibitor of the synthesis of prostaglandins, can be prescribed only after the elimination of hypovolemia and the associated danger of reducing renal perfusion. Like other NSAIDs, lornoxicam can cause an increase in the plasma urea and creatinine plasma levels, as well as water and sodium retention, peripheral edema, arterial hypertension, and other early signs of nephropathy.Long-term treatment of such patients with lornoxicam can lead to the following consequences: glomerulonephritis, papillary necrosis and nephrotic syndrome with transition to acute renal failure. Patients with a marked decrease in renal function drug can not be prescribed. In elderly patients, as well as in patients suffering from hypertension and / or obesity, it is necessary to monitor blood pressure.
It is especially important to monitor kidney function in elderly patients, as well as in patients:
- concomitantly receiving diuretics;
- concurrently receiving medicines that can cause kidney damage.
With prolonged use of the drug, it is necessary to periodically monitor hematological parameters, as well as kidney and liver function. The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy.
Influence on ability to drive vehicles, mechanisms
Care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions. the drug may cause dizziness and other side effects that may affect these abilities.
OVERDOSE
Symptoms: There may be an increase in the described side effects.
Treatment: symptomatic. The intake of activated carbon immediately after taking the drug may help reduce the absorption of lornoxicam. To prevent damage to the mucous membrane of the gastrointestinal tract, you can use anti-ulcer drugs (analogues of prostaglandins or ranitidine). Hemodialysis is ineffective.
DRUG INTERACTION
Simultaneous application of lornoxicam and:
- Cimetidine increases the concentration of lornoxicam in the blood plasma;
- anticoagulants or platelet aggregation inhibitors - bleeding time may be longer (increased risk of bleeding, monitoring of INR is necessary);
- beta-blockers and ACE inhibitors can reduce their hypotensive effect;
- Diuretics - reduces the diuretic effect and hypotensive effect;
- digoxin - reduces renal clearance of digoxin;
- Quinoline antibiotics - increases the risk of convulsive syndrome;
- other NSAIDs or glucocorticosteroids - increases the risk of gastrointestinal bleeding;
- mifepristone - lornoxicam may decrease the effectiveness of mifepristone. The drug should be taken no earlier than 8-12 days after taking mifepristone;
- methotrexate - increases the concentration of methotrexate in the blood plasma;
- selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxegin, sertraline) - increases the risk of gastrointestinal bleeding;
- lithium salts - can cause an increase in the maximum concentration of lithium in the blood plasma and thereby enhance the known side effects of lithium;
- cyclosporine - increases the nephrotoxicity of cyclosporine;
- hypoglycemic agents for oral administration - may enhance the hypoglycemic effect of the latter;
- alcohol, corticotropin, potassium preparations - increases the risk of GIT side effects;
- cefamandole, cefoperazone, cefotetan, valproic acid - increases the risk of bleeding;
- Colestyramine - accelerates the excretion of lornoxicam from the LCG;
- rifampicin - reduces the concentration of lornoxicam in the blood plasma.
Interaction with ranitidine and antacids was not revealed.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light and inaccessible to children at a temperature of no higher than 30 В° C. Shelf life - 2 years.
Do not use after the expiration date.
