Focgo treatment for pain caused by osteoarthritis, rheumatoid arthritis (3 blisters x 10 tablets)

Lornoxicam's action mechanism is partly based on the inhibition of prostaglandin synthesis (Cycloxygenase inhibitor).

pharmacokinetics

Lornoxicam is absorbed quickly and almost completely through the digestive tract. The maximum concentration achieved after about 1 to 2 hours. Absolute bioavailability (calculated by AUC) of Lornoxicam is 90 - 100%.

The average selling time is 3-4 hours. Lornoxicam is found in plasma in the form of unchanged and in its hydroxy metabolic form. Hydroxy metabolites have no pharmacological effects. Lornoxicam is linked to plasma proteins about 99% and does not depend on concentration.

Lornoxicam is completely metabolized, about 2/3 is eliminated through the liver and 1/3 through the kidney in the form of inactive substances.

Lornoxicam is metabolized by cytochrom P450 2C9.

Be cautious when using

Lornoxicam should be used cautiously in the following patients:

Lornoxicam should be used carefully in patients with mild renal impairment (serum creatinine from 150 - 300 micromol/l) and average (serum creatinine from 300 - 700 micromol/l). Lornoxicam treatment should be discontinued if the kidney function is impaired during treatment.

Kidney function should be monitored in patients undergoing severe surgery, heart failure, patients received by diuretics or combined with drugs that can cause kidney damage.

Patients with coagulation disorders

Need to closely monitor clinical and subclinical status (such as TCA).

Hepatic failure (for example: cirrhosis)

Clinical and subclinical monitoring should be performed regularly in patients with liver failure and accumulating Lotnoxicam doses (increase AUC) may occur in the dose range from 12 to 16 mg/day. In addition to this risk, liver failure does not affect the pharmacokinetics of Lornoxicam compared to healthy people.

Long -term treatment (over 3 months)

Need to monitor hemoglobin, creatinine and liver enzyme.

Patients over 65 years old

Monitor kidney and liver function. Be careful in older patients who have undergone surgery.

Avoid simultaneous use of Lornoxicam with other NSAIDs, including Cycloxide-2 inhibitors.

Gastrointestinal bleeding

Gastrointestinal bleeding, ulcers or perforation, sometimes death, has been reported to all NSAIDs at any time of treatment without necessarily there are signs, warnings or a history of serious digestion.

The risk of bleeding, ulcers or gastrointestinal perforation increases according to the dose in the elderly and patients with a history of ulcer, especially in the case of bleeding or perforation.

In these patients, Lornoxicam should be started at the lowest dose possible. Using mucosal protection drugs (e.g. Misoprostol or proton pump inhibitors) should be considered for these patients. Patients with a history of gastrointestinal disease, especially for older patients, should report any abnormal symptoms on the digestive (especially gastrointestinal bleeding), especially at the beginning of treatment.

Be cautious when taking Lornoxicam for patients who are taking drugs that may increase the risk of ulcers or hemorrhage such as oral corticosteroids, anticoagulants (for example: Warfarin), Serotonin reconfusion inhibitors (SSRI) and anti -platelets such as acetylsalicylic acidal acid.

In the case of bleeding or stomach ulcers in patients using Lornoxicam, the treatment must be stopped.

NSAID should be used carefully and under strict supervision in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) due to the risk of getting worse.

Closely monitor patients with a history of mild to moderate hypertension and/or mild to medium heart failure because of the cases of fluid and edema that have been reported related to NSAID treatment.

Clinical research and epidemiological data show that the use of NSAIDs (especially when used in high doses and for a long time) may be related to the risk of arterial thrombosis (for example, myocardial infarction or stroke). Not enough data to eliminate this risk for Lornoxicam.

Unsatreable hypertension patients, congestive heart failure, ischemic heart disease, peripheral artery disease and/or a history of stroke (including small stroke) should be carefully assessed by the percentage of benefits/risks before starting treatment with Locnoxicam. Similarly considered should be done before starting long -term treatment of patients with risk factors for cardiovascular disease (such as hypertension, increased blood fat, diabetes or smoking).

Use in combination with NSAID and heparin in case of spinal or epidural anesthesia increases the risk of spinal or hemorrhoids.

Severe skin reactions, some may cause death, including flaky dermatitis, Stevens Johnson syndrome, Lyell syndrome is rare in reports related to NSAIDs. Lornoxicam should be stopped immediately if there is a skin rash, mucosal damage or other signs of hypersensitivity.

Particularly cautious when used for patients who are or have a history of bronchial asthma, as NSAID can cause bronchospasm in these patients.

Increased risk of sterile meningitis can occur in systemic lupus erythematosus (SLE) and mixed connective tissue disorders.

Lornoxicam reduces platelet aggregation and increases bleeding time. Therefore, it is necessary to be particularly cautious when used for patients tending to increase bleeding.

Combining the treatment of NSAID and Tacrolimus may increase the risk of kidney toxicity due to reduced renal prostacyclin. Therefore, kidney function should be monitored in these patients.

As with most NSAID drugs, increasing the concentration of transaminase, bilirubin, increasing serum and uric acid, abnormal liver function parameters and other biological disorders have been observed. If these abnormalities become serious or persistent, it is advisable to stop using Lornoxicam and investigate the cause clearly.

Lornoxicam, like any drug inhibitors inhibiting prostaglandin cyclooxygenase, can reduce fertility. The use of it is not recommended for women who want to conceive. In women who have difficulty conceiving or are checking for reproductive function, it is advisable to consider stopping the treatment of Lornoxicam.

In addition, chicken pox can be the source of serious skin and soft tissue complications. So far, NSAID's role in the deterioration of infections cannot be excluded. Therefore, avoid using Locnoxicam in case of chickenpox.

This drug contains lactose. Patients with rare genetic problems are galactose tolerance, Lapp lactase minimal or malposive glucose-galactose should not use this drug.

Heart thrombosis

Non -steroid anti -inflammatory drugs (NSAIDs), non -aspirin, use systemic sugar, may increase the risk of the occurrence of heart thrombosis, including myocardial infarction and stroke, which can lead to death. This risk can appear early in the first few weeks of taking the drug and can increase over time. The risk of cardiovascular thrombosis is recorded mainly at high doses.

Doctors need to periodically evaluate the appearance of cardiovascular events, even if the patient has no previous cardiovascular symptoms. Patients should be warned of symptoms of serious cardiovascular events and need to visit the doctor as soon as they appear.

To minimize the risk of adverse events, Focgo is needed at the lowest daily doses in the shortest possible time as possible.

The ability to drive and operate machinery

Patients feel dizzy, sleepy while using the drug should not drive or operate machinery.

Pregnancy

There is no adequate data on the use of lonoxicam in pregnant women, animal studies show toxicity to reproductive function. Therefore, Lornoxicam should not be used for the first and second three months of pregnancy, as well as during childbirth.

Prostaglandin synthesis inhibitors may have harmful effects on the mother and/or coordinate or the development of the fetus.

Data from epidemiological studies shows that after the use of prostaglandin synthetic inhibitors in the early stages of pregnancy, increases the risk of miscarriage and heart defects. This risk is thought to increase according to the dose and treatment time.

In animals, the use of Prostaglandin synthesis inhibitors increases damage before and after fertilization and increases the mortality rate of the embryo. Unless necessary, the use of prostaglandin synthetic inhibitors should be avoided in the first three months and the harm of pregnancy.

Prostaglandin synthetic inhibitors used in the last three months of pregnancy can cause fetal to poison heart - lungs (early acting of arteriosclerotic and pulmonary hypertension), impaired renal function can progress to kidney failure and thus reduce the amount of amniotic fluid.

At the end of the pregnancy, prostaglandin synthetic inhibitors can cause mothers and fetuses to increase bleeding time and inhibit uterine contractions, leading to delay or prolonged labor time.

Therefore, the use of Loccoxicam is contraindicated in the last three months of pregnancy.

Breastfeeding period

There is no data on the excretion of Lornoxicam in breast milk, Lornoxicam is excreted in milk mice of nursing mice with relatively high concentrations. Therefore, avoid using Lornoxicam in breastfeeding women.

Drug interaction

Food can reduce the absorption capacity of Lornoxicam by about 20% and increase TMAX. Therefore, Focgo film tablets should not be taken at meals if needed quickly (analgesic).

cimetidine: Increases the plasma concentration of lornoxicam.

Simultaneous use of Lornoxicam and anticoagulant drugs (for example: Warfarin): can prolong bleeding time. Need to monitor the INR index during use.

phenprocoumon: Lornoxicam reduces the effectiveness of phenprocoumon treatment if shared.

Heparin: Increasing the risk of spinal or external hematoma when used in combination with NSAID with heparin in case of spinal anesthesia or external epidural anesthesia.

sulphonylure: increases the risk of hypoglycemia.

Diuretics: Reduce diuretics and hypotension of diuretics, thiazid diuretics and potassium -saving diuretic.

Memorial inhibitors: reduce the effectiveness of enzyme inhibitors and are at risk of acute renal failure.

Beta channel blockers, Angiotensin II receptor antagonists: reduce the effect of lowering blood pressure of these drugs.

corticosteroids: Increased risk of ulcerative or gastrointestinal bleeding.

Anti -platelet aggregation, serotonin selective inhibitors (SSRI), other NSAIDs: Increased risk of gastrointestinal bleeding.

liti: can lead to an increase in liti levels in the blood, thus being able to increase side effects. Avoid using simultaneously.

methotrexate: Increases the concentration of methotrexate in the blood, avoiding simultaneous use,

Digoxin: Reducing the kidney clearance of Digoxin.

Quinolon: Increased risk of seizures.

cyclosporin: increased blood cyclosporin levels and increased kidney toxicity.

tacrolimus: Increases the toxicity on the kidneys, need to closely monitor the kidney function if shared.

penetrexed: NSAIDs can reduce the kidney clearance of penetrexed, leading to increased toxicity on the kidneys, gastrointestinal tract and marrow.

Lornoxicam interacts with induction drugs and enzyme inhibitors CYP2C9 such as phenytoin, amiodaron, miconazole, tranylcypromin and rifampicin.