Atimecox 15mg medicine reduces signs and symptoms of osteoarthritis (3 blisters x 10 tablets)

ATC code: M1AC06

Meloxicam is an nonsteroidal anti -inflammatory drug (NSAID) of the Oxicam family, with anti -inflammatory, analgesic and antipyretic properties.

Meloxicam shows anti -inflammatory activity in all standard inflammatory models. Like other NSAIDs, its exact operation mechanism has not been well known.

However, there is a common mechanism of effects of all NSAIDs (including Meloxicam) that have known: Prostaglandin biosynthesis, inflammatory intermediate.

Dynamic pharmacokinetics

absorption

Meloxicam is well absorbed through the gastrointestinal tract, absolutely highly used 89% after drinking. Tablets, oral fluids and capsules have been shown to be biological equivalent.

After using Meloxicam a single dose, the maximum concentration in plasma is within 5-6 hours. When using many doses, stable state is achieved within 3 to 5 days. With a one -time dose per day, the concentration of plasma drugs with the peak - the bottom is relatively small in the range of 0.4 - 1.0 µg/ml for the dose of 7.5 mg and 0.8 - 2.0 µg/ml for the dose of 15 mg, respectively (cmin and cmax in a stable state).

Meloxicam's absorption is not affected by food.

distribution

Meloxicam is very strong with plasma proteins, mainly albumin (99%). Meloxicam diffuses well into joint fluid, concentration in joint fluid is approximately 50% of plasma concentrations.

Low distribution volume, average 11 liters and ranges from 30-40% between individuals.

transformation

Meloxicam metabolizes almost entirely through the liver. The four different metabolites of Meloxicam are found in the urine, and all have no pharmacological effects. Main metabolites, 5'-carboxymeloxicam (accounting for 60% of the dose), formed by the oxidation of intermediate metabolism 5'-hydroxymethylmeloxicam, this substance is excreted at a lower level (9% dose). In vitro studies show that CYP 2C9 plays an important role in this metabolic path and a small part of isenzyme CYP 3A4.

The activity of Peroxidase enzyme plays a role in the remaining two metabolites accounting for 16% and 4% of the dose.

Elimination

Meloxicam is excreted mainly in the form of metabolites in the equal level of urine and feces. Under 5% of the daily dose is excreted in the form of unchanged in the feces, which only finds the original drug in the form of traces in the urine.

The average selling time is about 20 hours. The average total plasma clearance is 8 ml/min.

Special subjects

Liver failure, kidney failure: both liver failure, mild and medium renal failure without significant effects on Meloxicam's pharmacokinetics. In end -stage renal failure, increased distribution volume can lead to higher free meloxicam concentration and not to exceed the daily dose of 7.5 mg.

Elderly: Average plasma clearance in stable state in the elderly is a little lower than younger people.

Liver disorders - bile:

Instructions on how to handle ADR:

To minimize the undesirable effect on the gastrointestinal tract, take the medicine immediately after eating or use in combination with antacids and protect the stomach lining.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

To minimize unwanted effects, use the lowest doses to effectively treat in the shortest possible time.

Do not overdose daily recommendations daily in case of unexpected treatment effect, nor do not treat other NSAID drugs to therapy because this can increase toxicity while the benefits of treatment have not been proven. Avoid using Meloxicam in general with NSAID drugs including Cycloxide-2 inhibitors (COX-2).

Meloxicam is not suitable for treating patients with acute analgesic.

In case the patient does not improve after a few days of treatment, it is necessary to re -evaluate the treatment effect of the drug.

Patients need to definitely treat esophagitis, gastritis and/or peptic ulcer before starting treatment with Meloxicam. Pay attention to the possibility of causing recurrence for patients with a history of these diseases.

Heart thrombosis

Non -steroid anti -inflammatory drugs (NSAID), non -aspirin, use systemic sugar, may increase the risk of cardiovascular thrombosis, including myocardial 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 assess the appearance of cardiovascular events, even if the patient has no previous cardiovascular symptoms. Patients need to be warned of symptoms of serious cardiovascular events and need to see a doctor as soon as they appear. To minimize the risk of adverse incidents, the use of scattered tablets of Atimecox 15 mg should be used at the lowest daily dose effective in the shortest possible time.

Effects on the gastrointestinal tract

Bleeding, ulcers or gastrointestinal perforation, likely to be reported to all NSAIDs at any time during treatment, with or without warning signs or a history of serious diseases on the gastrointestinal tract.

In patients with a history of gastrointestinal ulcer, especially those who have complications of hemorrhage or perforation, the elderly will increase the risk of hemorrhage, ulcers or puncture gastrointestinal tract when increased by NSAID dose. These patients, should be treated at the lowest dose, should be considered in combination with gastric mucosal protection drugs such as Misoprostol or proton pump inhibitors, and patients who need simultaneous treatment with low -dose aspirin or other drugs that can increase the risk of adverse adverse reactions on the digestive tract.

Patients with a history of gastrointestinal poisoning, especially the elderly, should be notified to the doctor when there are signs of abdominal abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment.

Be cautious in patients being treated simultaneously with drugs that may increase the risk of ulcer or gastrointestinal bleeding such as heparin, anticoagulic drugs, other NSAIDs including aspirin used in doses with anti -inflammatory effects (≥ 1 g of doses or ≥ 3 g daily daily dose).

When hemorrhage or gastrointestinal ulcer occurs, it is necessary to stop the drug.

affects the heart and blood vessels

Monitoring and advising patients with a history of hypertension, congestion from mild to medium because there is a report on water retention and edema related to NSAID.

recommendation of blood pressure monitoring in patients at risk and especially during the first treatment with Meloxicam.

Patients with uncontrolled hypertension, congestive heart failure, myocardial ischemia, peripheral artery disease, cerebrovascular disease should only be treated with oral meloxicam after careful review. Similarly, it is necessary to consider before starting long -term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, smoking, diabetes).

Skin reaction

Rarely reports on serious skin reactions such as flaking dermatitis, Stevens-Johnson syndrome, poisoned epidermal necrosis related to the use of NSAID drugs, and there are cases of death. The highest risk of these reactions early is in the first month of treatment. Meloxicam must be stopped as soon as the skin rash appears, mucosal damage or any signs of sensitivity.

Indicators of liver and kidney function

Like most other NSAIDs, sometimes increased transaminase concentration in serum or other parameters of liver function, as well as increased serum creatinine, blood urea nitrogen (bun), has been reported. In most cases, only slightly increased and transient above normal. If this abnormal is significant or prolonged, it is necessary to stop using Meloxicam and conduct appropriate tests.

Renal function impairment

NSAID drugs, by inhibiting the vasodilation effect of the kidney prostaglandin, can cause impaired renal function due to reducing glomerular filtration. This effect depends on the dose. Careful monitoring of kidney and kidney function in patients with the following risk factors at the beginning of treatment or after increasing the dose:

In some rare cases, NSAID may be the cause of interstitial nephritis, glomerulonephritis, kidney necrosis and nephrotic syndrome.

Keeping sodium, potassium and water

Keeping sodium, potassium and water can occur when using NSAIDs with diuretics, hypotension drugs. The result is to cause edema, heart failure or hypertension, making it worse in high -risk patients. So clinical monitoring is necessary in these patients.

Hemorrhage

Hyassassassassical hyperka can be common in patients with diabetes, or in patients who use drugs that have increased blood potassium. Need to monitor the concentration of blood potassium regularly in these patients.

Unwanted effects often become more serious in the elderly, weak or depressed physical condition, so careful monitoring in these patients. Like other NSAIDs, it is necessary to be particularly cautious when using Meloxicam in the elderly, people with impaired liver, kidney and heart function. Elderly people have a higher incidence of unwanted effects than other patients, especially the risk of death from gastrointestinal bleeding and gastric perforation.

Meloxicam as well as any other NSAIDs can obscure the symptoms of hidden infections.

The use of Meloxicam or any drug has been known to inhibit the synthesis of COX and Prostaglandin, which can impair fertility.

The drug is not recommended for use in women who want to get pregnant. Therefore, in women who are difficult to conceive or are treating infertility, it is advisable to consider stopping meloxicam.

Autodity warning

The drug contains lactose, patients with rare genetic disorders such as galactose intolerance, completely lactase deficiency or poor absorption of glucose-galactose should not use this drug.

The ingredient contains aspartam, aspartam is a rich source of nutritious phenylalanin. This substance can be harmful if the patient has phenylceton, a rare genetic disorder causing phenylalanin accumulation because the body cannot eliminate it as usual.

The effect of drugs on driving and operating machinery

There is no specialized research on effects on driving and operating machinery. However, based on the brief description of the pharmaceutical force and unwanted effects of the drug, Meloxicam does not seem to have or have negligible effects on these possibilities.

If the patient has visual disorders, falling asleep or other central nervous system disorders, do not drive or operate machinery.

Use drugs for women during pregnancy and lactation

Pregnant women

Prostaglandin synthesis inhibitors may have a disadvantage of pregnant women and/or the development of pregnancy.

Epidemiological research data shows the risk of miscarriage, heart defects and gastritis when using prostaglandin synthetic inhibitors at the beginning of pregnancy. The risk of heart defects increases from Do not use Meloxicam for the first three months and three months between pregnancy unless really necessary. If using drugs for women who are trying to conceive, first three months of pregnancy or three months in the middle of pregnancy, the lowest dose should be effective in short time as shorter as possible.

During the last three months of pregnancy, all Prostaglandin synthetic inhibitors may cause:

fetus:

For mothers and babies or at the end of pregnancy:

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

breastfeeding women

Although there is no clear experience for Meloxicam, NSAIDs are known to go into breast milk. Therefore, do not use meloxicam for breastfeeding women.

Drug interaction

Drug studies are only done in adults.

Meloxicam is metabolized in the liver, mainly through CYP 2C9 and CYP 3A4, it is necessary to consider the possibility of pharmacokinetic interaction between Meloxicam and inhibitors or drugs metabolized by CYP 2C9 and CYP 3A4.

Pharmacological interaction

NSAID and Aspirin drugs ≥ 3 g/day: It is not recommended to use Meloxicam in combination with other NSAID drugs, including aspirin with doses with anti -inflammatory effects (≥ 1 g of doses or ≥ 3 g of total daily amount).

corticosteroid (such as glucocorticoid): Be cautious when used simultaneously with corticosteroids because of the increased risk of bleeding or gastrointestinal ulcer.

Oral anticoagulant, systemic heparin, hemolytic drugs, platelet aggregation and Serotonin (SSRI): Increasing the risk of bleeding due to inhibition of platelet function and damage to the gastric mucosa. If it is impossible to avoid combining with the above drugs, it is necessary to monitor the patient closely.

Diuretics, enzyme inhibitors and Angiotensin-II antagonistic drugs: NSAID can reduce the effects of diuretics and other antihypertensive drugs. In some patients with kidney function (such as dehydration patients or elderly patients with impaired renal function), simultaneous use of NSAID with these drugs may seriously seriously add kidney failure, including acute renal failure, but this often recovers after stopping the drug. Therefore, it is necessary to be careful when combined treatment, especially in elderly patients. A sufficient rehydration for patients, monitoring kidney function after starting treatment simultaneously and periodically later.

Other antihypertensive drugs (such as B blockers): reduce the effects of antihypertensive drugs (due to prostaglandin inhibitors that have vasodilation effects) when treated with NSAIDs.

Calcineurin inhibitors (such as cyclosporin, tacrolimus): NSAIDs can increase the kidney toxicity of calcineurin inhibitors through the intermediate effect of prostaglandin in the kidneys. Need to evaluate kidney function when used in combination, especially in elderly patients.

The uterus equipment: NSAID drugs have been reported to reduce the effectiveness of the contraceptive tools placed in the uterus. This effect has been reported earlier when treated with NSAIDs, but it also needs to be verified.

pharmacokinetic interaction

Meloxicam affects the pharmacokinetics of other lithium drugs: NSAID has been recognized as increasing lithium concentration in the blood (due to reducing renal excretion), which can reach toxicity. Unable to simultaneously use Lithi and NSAID.

If it is necessary to combine these two drugs, careful monitoring of lithium concentration in plasma at the beginning of treatment, adjusting the dose and when stopping using Meloxicam.

methotrexate: NSAID can reduce methotrexate excretion through the kidneys, thus increasing the concentration of the drug in plasma. For this reason, for patients with high doses of methotrexate (> 15 mg/week), it is not recommended to simultaneously use with NSAID.

The risk of interaction between NSAID and Methotrexate products should also be considered in patients with low doses of methotrexate, especially patients with impaired renal function. In case of need for combination treatment, blood formula and kidney function need to be monitored. Be careful in case of simultaneous use of NSAID and methotrexate within 3 days, when plasma methotrexate levels may increase and increase toxicity.

Although the pharmacokinetics of methotrexate (15 mg/week) are not affected when used simultaneously with Meloxicam, it is necessary to consider toxicity on the hematopathy of methotrexate that can be enhanced due to simultaneous use with NSAID.

Other drugs that affect Meloxicam's pharmacokinetics

Cholestyramin: Cholestyramin increases the excretion of meloxicam by interrupting the intestinal circulation, leading to 50% of Meloxicam clearance and the sale time decreases to 13 ± 3 hours. This interaction has clinical significance.

Do not detect pharmacokinetic pharmacokinetic interactions - clinically related drugs when used simultaneously with stomach, cimetidine, digoxin antacids.