Ksefokam Rapid Tab n / 8mg film about 12 pc

Description

Composition
Active substance:
1 tablet contains: mg lornoxicam 8.
Excipients:
Calcium stearate 1.6 mg giproloza 16.0 mg, 40.0 mg sodium bicarbonate, monobasic giproloza 48.0 mg, 96.0 mg microcrystalline cellulose, calcium hydrogen phosphate, anhydrous 110.4 mg.
Sheath: Propylene glycol was about 1.1 mg, about 3.6 mg of talc, titanium dioxide, about 3.6 mg, 5.7 mg of hypromellose.
Description:
Round, biconvex tablets covered with a foil wrapper, from white to pale yellow color.
Product form:
6 or 10 tablets per blister. 1.2 to 6 tablets blister or blisters 1,2,3,5,10 or 25 to 10 tablets with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to lornoxicam or any of the excipients; complete or partial combination of asthma, recurrent nasal polyposis or paranasal sinuses, rhinitis, angioedema, urticaria, and intolerance to acetylsalicylic acid and other NSAIDs (including history); hemorrhagic diathesis or bleeding disorders, as well as those who underwent surgery, coupled with the risk of bleeding or incomplete hemostasis; decompensated heart failure; erosive and ulcerative changes in gastric mucosa and 12 duodenal ulcer, active gastrointestinal bleeding; cerebrovascular bleeding or otherwise; gastrointestinal bleeding or perforation ulcer history associated with taking NSAIDs; active peptic ulcer or recurrent peptic ulcer history; inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in acute phase; severe hepatic failure; 3 severe renal impairment (serum creatinine 300 umol / L), progressive renal disease, confirmed hyperkalemia; since the aortocoronary bypass surgery; pregnancy during breastfeeding; Patients under the age of 18 years (due to insufficient clinical experience).
Caution: the following violations of the drug Ksefokam Rapid should be administered only after a careful assessment of the expected benefits of therapy and the possible risks. Renal dysfunction: mild (serum creatinine 150300 mol / l) and moderate (serum creatinine 300 700 .mu.mol / l), since the maintenance of renal blood flow depends on the level of renal prostaglandins. Receiving lornoxicam should stop in case of deterioration of renal function during treatment; Monitoring of renal function should be performed in patients who underwent major surgery, heart failure patients receiving diuretics, as well in the case of drugs with proven or predrolagaemoy nephrotoxicity. Violation of the blood coagulation system: recommended careful clinical monitoring and assessment of laboratory parameters such as: activated partial thrombin time (APTT). Abnormal liver function (hepatic cirrhosis) should be regular clinical observation and evaluation of laboratory parameters, as in the treatment of lornoxicam at a daily dose of 1216 mg of drug accumulation is possible. Long-term treatment (more than 3 months): Recommended Regular assessment laboratory blood parameters (hemoglobin), renal function (creatinine) and liver enzymes. Patients older than 65 years: the recommended monitoring of liver and kidney function. Use with caution in the elderly in the postoperative period. It is necessary to avoid simultaneous reception with other NSAIDs, including selective inhibitors tsiklooksigenazy2. Gastrointestinal bleeding, ulcers, perforation, noted earlier in the application of NSAIDs at any stage of treatment and may lead to death. The presence of Helicobacter pylori. Gastrointestinal toxicity phenomenon in history, particularly in the elderly. When simultaneous administration of such drugs as oral corticosteroids (e.g., prednisone), anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline), and antiplatelet drugs (e.g., aspirin, clopidogrel). With simultaneous use of NSAIDs and heparin during spinal or epidural anesthesia increases the risk of hematoma. The pathology of the digestive tract in history (ulcerative colitis, Crohn’s disease), as their condition may deteriorate. Hypertension and / or heart failure history, as observed in the application of NSAIDs fluid retention and development of edema. In the presence of peripheral arterial disease or cerebrovascular disease, the presence of risk factors for cardiovascular diseases such as hypertension, hyperlipidemia, diabetes, smoking, Lornoxicam should be administered only after careful assessment of the expected benefit of therapy and the possible risk. Severe skin reactions leading to death, including exfoliative dermatitis, StivensaDzhonsona syndrome and toxic epidermal necrolysis. The simultaneous use of NSAIDs and tacrolimus may increase the risk nephrotoxic action due to inhibition of synthesis of prostacyclin in the kidney. The use of lornoxicam as any drug that suppresses prostaglandin synthesis, may interfere with the ability to fertilize therefore not recommended for women wishing to become pregnant.
Dosage
8 mg
Indications
Short-term treatment of pain of mild to moderate intensity.
Interaction with other drugs
Simultaneous use of the drug and Ksefokam: cimetidine – increases the concentration in plasma of lornoxicam. Interactions with ranitidine and antacids have been identified; anticoagulants or platelet aggregation inhibitors – may increase bleeding time (increased risk of bleeding, requires control of international normalized ratio (INR); fenprokoumona: reduction in efficacy fenprokoumonom; Heparin: NSAIDs increase the risk of spinal / epidural hematoma while the use of heparin during spinal or epidural, beta-blockers and ACE inhibitors may reduce their hypotensive effec t; diuretics – reduces diuretic effect and hypotensive effect of loop and thiazide diuretics, digoxin – reduces renal clearance of digoxin quinolone antibiotics – increased risk of seizures;. Other NSAIDs or glucocorticoids – increases the risk of peptic ulcer or digestive tract bleeding; methotrexate – increases the concentration of methotrexate serum; selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline) increases the risk of gastrointestinal bleeding. lithium salts – can cause an increase in peak plasma concentrations of lithium and thereby amplify the known side effects of lithium; cyclosporine – increase cyclosporine nephrotoxicity. sulfonylurea derivatives – can enhance the hypoglycemic effect of the latter; Tacrolimus – increased risk of nephrotoxic effects due to inhibition of the synthesis of prostacyclin in the kidney;
Meal may reduce the absorption by 20% and increase the time to reach maximum blood concentration.
Overdose
In the event of an overdose of the drug Ksefokam Rapid, the following symptoms may occur: nausea and vomiting, cerebral symptoms (dizziness, visual disturbances, ataxia, turning into a coma and convulsions). Possible changes in the liver and kidneys and blood clotting disorders. When real or perceived overdose should stop taking the medication. Due to the short half-life, lornoxicam is rapidly excreted from the body. Dialysis is ineffective. Hitherto specific antidote is not known. It is necessary to provide for the immediate holding of ordinary activities, including gastric lavage. Based on common principles, the use of activated carbon only if its reception immediately after the reception Ksefokam Rapid drug may reduce the absorbability of the drug. For the treatment of gastrointestinal disorders, prostaglandin analogues or ranitidine may apply.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
Lornoxicam is a nonsteroidal anti-inflammatory agent, has a pronounced analgesic and anti-inflammatory action, refers to a class of oxicams. The basis of the mechanism of action is inhibition of prostaglandin synthesis (inhibition of the cyclooxygenase enzyme), resulting in suppression of inflammation. Lornoxicam has no effect on vital signs: body temperature, heart rate (HR), blood pressure (BP), the data of an electrocardiogram (ECG), spirometry). The analgesic effect of lornoxicam not associated with narcotic action. The drug has no Ksefokam Rapid opiate action on the central nervous system (CNS) and, in contrast to narcotic analgesics without respiratory depression does not cause drug dependence. Due to the locally irritating action on the gastrointestinal tract (GIT) and systemic ulcerogenic effect associated with inhibition of prostaglandin synthesis, complications from the gastrointestinal tract are frequent undesirable effects in the treatment of non-steroidal anti-inflammatory drugs.
Pharmacokinetics:
Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentrations are achieved 30 minutes after ingestion. Rapid drug Cmax Ksefokam higher than the Cmax of the drug tablets and Ksefokam equivalent Cmax for lornoxicam dosage forms intended for parenteral administration. Absolute bioavailability Ksefokam Rapid tablets, film-coated, is 90-100% and equivalent bioavailability of the drug Ksefokam tablets. First pass effect of the drug through the liver is observed. The half-life is 3-4 hours. The plasma Lornoxicam is found in an unmodified form or in the form of its hydroxylated metabolite. Hydroxylated metabolite of pharmacological activity does not show. Communication lornoxicam plasma protein is 99% and is independent of its concentration. Lornoxicam completely metabolized to form pharmacologically inactive metabolite; 2/3 excreted in the bile and 1/3 via the kidneys. Lornoxicam completely metabolized in the liver to form initially inactive 5-gidroksilornoksikama. The metabolism is involved isoenzyme CYP2C9. As a result of genetic polymorphism exist person sustained and intensive metabolism, which may be expressed in a marked increase in plasma levels of lornoxicam in patients with a slow metabolism. Lornoxicam causes no induction of liver enzymes not koumouliruet after repeated reception of recommended doses. At simultaneous reception with food lornoxicam can be expected to decrease in Cmax and an increase in Tmax, and also reduce the intake of lornoxicam in the elderly the clearance is reduced by 30-40%. Patients with impaired renal or liver function has also been observed significant changes lornoxicam kinetics, except for accumulation in patients with chronic liver disease after 7 days of treatment at a daily dose of 12 mg or 16 mg.
Pregnancy and breast-feeding
Due to lack of data on the drug Ksefokam Rapid during pregnancy and lactation Lornoxicam should not be used. Suppression of prostaglandin synthesis can have side effects on pregnancy and / or fetal development. The use of inhibitors of prostaglandin synthesis in early pregnancy increases the risk of miscarriage or development of heart disease. It is believed that the risk is proportional to the dose and duration of treatment. Purpose of inhibitors of prostaglandin synthesis in the third trimester of pregnancy can lead to toxic effects on the heart and lungs of the fetus (premature closure of the ductus arteriosus and pulmonary hypertension), as well as renal dysfunction and, consequently, reduce the amniotic fluid. The use of the later stages can cause prolonged bleeding in the mother and the fetus, as well as the suppression of uterine activity, which could delay or extend the delivery period.
Conditions of supply of pharmacies
On prescription.
side effects
The most common adverse reactions to NSAIDs are marked from the gastrointestinal tract: may develop peptic ulcers, perforation or gastrointestinal bleeding. After application of NSAIDs noted nausea, vomiting, diarrhea, bloating, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation colitis or Crohn’s disease. In more rare cases gastritis. Approximately 20% of patients treated with lornoxicam can develop adverse reactions. The most common are – nausea, vomiting, diarrhea, dyspepsia, indigestion, abdominal pain. In each particular category of side effects grouped by system-organ class and presented in decreasing order of frequency:
Very often – 1/10 assignments (> 10%)
Often – 1/100 assignments (> 1% and 0.1% and 0.01%, and
Infections and infestations
Rare: Pharyngitis.
hematopoietic system and the lymphatic system
Rare: anemia, thrombocytopenia, leukopenia, increased bleeding time.
Very rare: ecchymosis.
Immune system disorders
Rare: hypersensitivity.
Metabolic and nutritional disorders
Uncommon: Anorexia, weight changes.
psychiatric disorders
Uncommon: sleep disorders, depression.
Rare: confusion, nervousness, agitation.
neurological disorders
Common: transient headaches weak intensity, dizziness.
Rare: somnolence, parestazii, taste disturbance, tremor, migraine.
visual disturbances
Uncommon: conjunctivitis.
Rare: visual disturbances.
Disorders of vestibular apparatus
Uncommon: vertigo, tinnitus.
cardiac disorders
Uncommon: palpitations, tachycardia, edema, heart failure.
vascular disorders
Uncommon: a rush of blood to the face.
Rare: hypertension, flushing, bleeding, hematoma.
Disorders in the respiratory system, thoracic and mediastinal disorders
Uncommon: Rhinitis.
Rare: dyspnoea, cough, bronchospasm.
Gastrointestinal Disorders
Common: nausea, abdominal pain, dyspepsia, diarrhea, vomiting.
Uncommon: constipation, flatulence, belching, dry mouth, gastritis, gastric ulcer, epigastric pain, duodenal ulcer, ulcerations in the mouth.
Rare: melena, bloody vomiting, stomatitis, esophagitis, gastroesophageal reflux, dysphagia, aphthous stomatitis, glossitis, perforated peptic ulcer.
Hepatobiliary disorders
Infrequently: improving performance tests of liver function, glutamate-pyruvate transaminase (ALT) or glutamate-oxaloacetate transaminase (AST).
Rare: abnormal liver function.
Very rare: damage to hepatocytes.
Cutaneous manifestations and disorders in the subcutaneous tissues
Uncommon: rash, itching, sweating, erythematous rash, urticaria, alopecia.
Rare: dermatitis, purpura.
Very rarely, edema, bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Disorders of the musculoskeletal system and connective tissue
Uncommon: arthralgia.
Rare: bone pain, muscle cramps, myalgia.
Kidney disorders and urinary disorders
Rare: Nocturia, micturition disorders, increase in urea and creatinine in the blood.
General appearance and condition of the injection site
Uncommon: malaise, swelling of the face.
Rare: asthenia.
special instructions
Patients who marked dizziness and / or drowsiness during treatment with lornoxicam should refrain from driving and machine control. You should not use the drug in conjunction with other NSAIDs. When the liver disease symptoms (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased levels of “hepatic transaminases”) should stop taking the drug and consult a doctor. 7 The preparation may modify the properties of platelets, but does not replace the prophylactic effect of aspirin in cardiovascular diseases.
Storage conditions
At a temperature of not higher than 30 C
Keep out of the reach of children.
Dosing and Administration
Ksefokam Rapid film-coated tablet intended for oral use and should be washed down with sufficient amount of liquid. Special dose adjustment for elderly patients is not required when there is no failure, renal or hepatic function, in which case the daily dose should be reduced. For all patients the appropriate dosing regimen should be based upon individual response to treatment. On the first day of treatment may be administered 16 mg initial dose of 8 mg and 12 hours after its administration. In the following days, the maximum daily dose should not exceed 16 mg. The usual method of the preparation of 8-16 mg per day (1-2 tablets). To reduce the adverse effects of risk on the part of the digestive tract, you should use the lowest effective dose of the lowest possible short course.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist