Meloflam 15mg Egis treat osteoarthritis (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Meloxicam

Ingredient

Composition information	Content
Meloxicam	15mg

Uses

Indications

Meloflam 15 mg is indicated in the following cases:

Treatment of exacerbated symptoms of osteoarthritis (short -term use). anti -inflammatory, analgesic and antipyretic properties. Meloxicam's anti -inflammatory activity has been shown in common testing models. The mechanism of exact effects is not known.

However, nonsteroidal anti -inflammatory drugs (including meloxicam) are thought to have the same mechanism of inhibiting biosynthesis of prostaglandin, which are intermediate substances of inflammation.

pharmacokinetic

absorption

Meloxicam is well absorbed from the digestive system, the bioavailability of the drug is 89% after taking capsules. The forms of preparation of tablets, oral fluids and capsules are similar. After taking the single dose of Meloxicam, the average peak concentration is achieved after 2 hours for the chemical form and 5–6 hours for solid drugs (capsules and tablets).

When the dose is repeated, the peak status is reached within 3–5 days. When taken once daily, the plasma concentration has a relatively small vibrant peak in the range of 0.4–1.0 µg/ml for a dose of 7.5 mg and 0.8–2,0 µg/ml for 15 mg dose (corresponding to the lowest cmin concentration and the highest cmax concentration in the constant state).

Meloxicam's serum peak concentration is in the state of accomplishment within 5–6 hours for tablets, capsules and oral fluids. The absorption of meloxicam after drinking is not changed by the accompanying food.

Distribution

Meloxicam is heavily connected to serum protein, mainly albumin (99%). Meloxicam penetrates well into the epidemic, the concentration in the epidemic increases about half of the plasma concentration. The low and average distribution volume is 11 L. The variation between individuals is about 30–40%.

Metabolism

Meloxicam is metabolized in the liver. The four different metabolic products of Meloxicam are found in urine, all of which are not physically active. Main metabolites, 5’-carboxy Meloxicam (accounting for 60% of the dose), created from oxidation of intermediate metabolism 5’-hydroxymethyl meloxicam, this substance is also eliminated at less than 49% of the dose.

In vitro studies show that CYP 2C9 plays an important role in this transformation, with the small contribution of ISOENZEMME CYP 3A4. There are two other metabolic products that account for 16% and 4% respectively of the dose into the body, probably created by Peroxidase enzymes.

Elimination

Meloxicam is excreted mainly in the form of metabolic products with equal levels in urine and feces. Less than 5% of the daily dose is eliminated in feces in the form of non -change Meloxicam, while only the trace of the original drug is seen in the urine. The average disposal time is about 20 hours. The average plasma in the average plasma clearance is 8 ml/min.

Before taking Meloflam 15mg Egis treat osteoarthritis (2 blisters x 10 tablets)

How to use

Oral drugs.

Take medicine once a day. Take tablets with water or another liquid, during meals.

Dosage

The necessary dose of the patient to reduce symptoms and respond to scene treatments periodically, especially in patients with chronic osteoarthritis.

Exacection of osteoarthritis: 7.5 mg/day. If necessary, when symptoms do not improve, the dose may be increased to 15 mg/day.

rheumatoid arthritis: 15 mg/day. Depending on the response, the dose may be reduced to 7.5 mg/day.

Age -adhesive spondylitis: 15 mg/day. Depending on the response, the dose may be reduced to 7.5 mg/day.

Do not overdose 15 mg per day.

Elderly and patients have an increase in the risk of side effects: The recommended dose for long -term treatment of rheumatoid arthritis and stiff spine arthritis in the elderly is 7.5 mg daily. Patients with increased risk of side effects must be started at a dose of 7.5 mg daily.

Renal failure: In patients with severe dialysis, dose does not exceed 7.5 mg daily. There is no need to reduce the dose for patients with mild to medium mild renal impairment (for example, patients have creatinine clearance more than 25 ml/minute).

Hepatic failure: There is no need to reduce the dose for patients with mild or medium liver failure.

Children and teenagers: Contraindicated to use Meloflam for children and teenagers under 16 years old. The maximum dosage recommended when treating teenagers is 0.25 mg/kg of weight.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Increasing Meloxicam excretion with orally 4 g cholestyramine 3 times a day has been proven in a clinical trial.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Meloflam 15 mg , you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: headache.

digestive: indigestion, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea.

Uncommon, 1/1000

Blood: Anemia.

immune: allergic reactions except sensitive reaction and anaphylactic reaction.

nerve: dizziness, drowsiness.

Hypertension, flushing. digestive: gastrointestinal bleeding can be seen with the eyes, stomatitis, gastritis, belching. liver: liver dysfunction (such as increased concentration of transaminase or bilirubin).

Skin and subcutaneous tissue: edema, itching, rash.

kidney and urinary: Keep sodium and water, hyperkalemia, kidney function test (increase creatinine and/or urea).

Systemic: edema includes lower chi.

Rare, 1/10000

Blood: abnormal blood formula (such as abnormal leukocytes), leukopenia, thrombocytopenia.

Mental: Change mood, nightmares. Eye: vision disorders include blurred vision, conjunctivitis.

ears and mesmerizing: tinnitus.

Heart: Brushing chest drum, heart failure.

Respiratory: Asthma attacks in patients allergies to aspirin or other nonsteroidal anti -inflammatory drugs.

digestive: colitis, peptic ulcer, esophagitis

Skin and subcutile skin: Meed and skin reaction: Steven - Johnson syndrome and poisonous epidermal necrosis.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Meloflam 15 mg contraindicated in the following cases:

Hypersensitivity to Meloxicam or any other ingredient of the drug.

Cross allergy with acetylsalicylic acid or other nonsteroidal anti -inflammatory drugs.

Severe heart failure.

Digestive ulcer is progressing or having a history of stomach/hemorrhage recurrence (two or more obvious waves due to ulcers or hemorrhage).

History of bleeding instead of digestive perforation, related to previous non -steroid anti -inflammatory treatments.

Severe liver failure.

Severe kidney failure and no hemolysis.

Children and teenagers under 16 years old.

The last three months of pregnancy.

There is a history of cerebral vascular hemorrhage or other bleeding disorders.

Patients who have just undergone coronary artery surgery.

Precautions when using

can reduce the minimum of unwanted effects by the lowest dosage effectively and in the shortest time enough to control symptoms.

Do not use the doses in excess of the maximum recommended dose in case the treatment has not been achieved, nor the additional anti -inflammatory analgesic analgesic drugs may increase the toxicity of the drug while the treatment effect has not been proven.

Avoid using Meloflam simultaneously with nonsteroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors). Meloxicam is not suitable for treating patients who need acute analgesic.

In case the symptoms have not improved after a few days of drug use, the review of the clinical benefits of therapy.

Patients with a history of esophagitis, gastritis and/or peptic ulcer must certainly treat these diseases before starting to use Meloxicam. Always be cautious with the ability to relapse in patients treated with Meloxicam with a history of these diseases.

affect digestion:

Hemorrhage, ulcers or gastrointestinal perforation can be fatal, which has been reported to all non -steroid anti -inflammatory drugs at any time during treatment with Meloxicam, whether or not there is notice symptoms or a history of digestive complications.

The risk of bleeding, ulcers or gastrointestinal perforation increases when increased the dose of nonsteroidal anti -inflammatory drugs, in patients with a history of ulcer, especially when accompanied by hemorrhage or perforation and in the elderly. These patients must start treating at the lowest dose possible.

Consider coordination with protective drugs (such as Misoprostol of proton pump inhibitors) for these patients, as well as for patients who need to be used with low -dose aspirin, or drugs that can increase digestion.

Patients with digestive history, especially the elderly, must immediately report any abdominal abdominal symptoms, especially the gastrointestinal bleeding, especially in the early stages of the treatment process.

Be cautious for patients used with drugs that may increase the risk of ulcer or hemorrhage, such as oral corticosteroids, heparin, or medications for the elderly, anticoagulants such as warfarin, or other nonsteroidal anti -inflammatory drugs, including acetylsalicylic acid used with anti -inflammatory doses (1 g 1 g, total daily dosage ≥ 3 g).

When hemorrhage or gastrointestinal ulcer occurs, Meloxicam is needed. Be cautious when using non -steroid anti -inflammatory drugs for patients with a history of gastrointestinal gastrointestinal ulcers, Crohn's disease because their condition may get worse.

Effects on the heart and cerebral vessels:

Must monitor and advise appropriate for patients with a history of hypertension and/or mild congestive heart failure to medium, because it has noticed water retention and edema when taking nonsteroidal anti -inflammatory drugs.

Clinical monitoring of blood pressure is required in patients at risk, especially during the first time of Meloxicam treatment.

Risk of cardiovascular thrombosis:

Non -steroid anti -inflammatory drugs (NSAIDs), non -aspirin, use systemic sugar, may increase the risk of cardiovascular thrombosis, including myocardial and stroke, which can lead to death.

This risk may 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 see a doctor as soon as they appear.

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

Hypertension:

Only use Meloxicam after careful consideration if the patient has uncontrolled hypertension, congestion heart failure, even peripheral artery, and/or brain vascular disease.

It is necessary to consider the same before conducting long -term treatment for patients with risk factors for cardiovascular disease such as hypertension, hyperlipidemia, diabetes, smoking.

Skin reaction

The skin reaction on the skin of Stevens - Johnson syndrome and poisoned epidermal necrosis has the ability to be life -threatening that has been reported when using Meloxicam. Patients should be instructed on signs and symptoms and tightly control the skin reactions. The highest risk of Stevens - Johnson syndrome and poisoning epidermal necrosis is in the first weeks of treatment.

If the signs and symptoms of Steven - Johnson syndrome occur or poisoned epidermal necrosis (such as progressive skin rash often accompanied by blisters or mucosal damage), it is necessary to stop treatment with meloxicam. Stop the medicine early for better prognosis. If the patient has had Stevens - Johnson syndrome or poisoned epidermal necrosis when using Meloxicam, it is never used to use Meloxicam for this patient.

Liver and kidney function indicators:

Like the majority of nonsteroidal anti -inflammatory drugs, sometimes there is an increase in serum transaminase levels, increased serum bilirubin or changes in other parameters of liver function, as well as increased serum creatinine and nitrogen bleeding or disorders of other test parameters.

Most of these cases are unusual and lightweight abnormalities. If this change is significant or prolonged, Meloxicam must be stopped and carefully checked.

Renal function decline:

Non -steroid anti -inflammatory drugs for prostaglandin synthesis in the kidneys, which may cause impaired renal function due to reduced glomerular filtration. This side effect depends on the dose. Need to closely monitor the amount of urine and kidney function at the beginning of treatment or after increasing the dose for patients with the following risk factors:

Elderly.

Concomitant use of angiotensin (ACE) transferred inhibitors, Angiotensin II antagonists, sartan, diuretics.

Reduce blood volume due to any cause.

Server congestive heart failure.

Renal failure, kidney syndrome.

Lupus kidney disease.

Severe liver dysfunction (serum albumin

In some rare cases, nonsteroidal anti -inflammatory drugs of the body cause interstitial nephritis, glomerular inflammation, nephropathy or nephrotic syndrome.

In patients with end -stage renal impairment, the dosage of blood decomposition should not exceed 7.5 mg. There is no need to reduce the dose for patients with mild or medium renal failure (clearing creatinine> 25 ml/min).

Keeping sodium, potassium and water and affects the effect of increasing the sodium diuretics of diuretics that may occur when using nonsteroidal anti -inflammatory drugs. Moreover, there may be reduced effects of anti -hypertension drugs.

The consequence is that it can cause edema, heart failure or severe hypertension in these sensitive patients. Clinical monitoring for patients at risk.

Hyperbysical hyperka will be promoted when patients have diabetes or when used on time with drugs known to increase potassium. In these cases, you need to monitor the concentration of potassium.

Elderly, sick people often suffer more side effects, so they need to be carefully monitored. Meloxicam, like other nonsteroidal anti -inflammatory drugs, can cover the symptoms of an infection.

Meloxicam, just like any other drug inhibits the synthesis of cyclooxygenase/prostaglandin, can reduce fertility and should not be used for women who want to get pregnant. Must stop Meloxicam in women who are difficult to conceive, or are being examined infertility.

The drug contains 30 mg of lactose monohydrate. Do not use this medication if the patient has rare genetic conditions that do not tolerate galactose, deficiency of lactase or malventine -galactose malabsorption.

The ability to drive and operate machinery

There are no studies to determine the effects of Meloxicam on driving and operating machinery. However, from the pharmacological data and unwanted effects to be reported, Meloxicam does not seem to affect or do not significantly affect the ability to drive or operate machinery.

However, when there are side effects such as vision disorders or drowsiness, dizziness or other disorders in the central nervous system, should stop driving and operating machinery,

Pregnancy

Prostaglandin synthesis inhibitors may be harmful to pregnancy and/or fetus/fetal development. Data from epidemiological research shows that there is an increase in miscarriage and heart defects and abdominal cracks after taking the prostaglandin synthesis inhibitors in the early stages of pregnancy.

In addition, the increase in the rate of different malformations, including cardiovascular defects, in animals that are suppressed inhibitors in the synthesis of prostaglandin in the formation phase.

Do not use Meloxicam in the first three months and three months of pregnancy, unless really necessary. If used, it must be low and the treatment time is as shorter as possible.

During the last three months of pregnancy, all prostaglandin synthesis inhibitors can cause fetal:

Heart - pulp (early closed arteriosclerotic and pulmonary hypertension).

Renal dysfunction, which can progress to renal failure and reduce amniotic fluid for mothers and babies, at the end of pregnancy will be encountered.

The bleeding time can be prolonged, which can cause anti -platelet aggregation effect, even very low doses.

Inhibition of uterine spasms working delayed or prolonged.

Therefore contraindicated use of meloxicam in the last three months of pregnancy.

Breastfeeding period

While there is no specific experience for Meloxicam, nonsteroidal anti -inflammatory drugs are known to have secretion into breast milk. Therefore, avoid taking medicine for breastfeeding women.

Drug interaction

Medication interactions have only been conducted in adults.

Pharmacological interactions:

Not used simultaneously with other nonsteroidal anti -inflammatory drugs including acetylsalicylic acid with doses with anti -inflammatory effects (≥ 1 g at each time or ≥ 3 g per day).

Be careful when used simultaneously with corticosteroids due to increased risk of bleeding and digestive ulcers.

Anticoagulant or heparin used in the aging at the dose of treatment: Use simultaneously with these drugs significantly increases the risk of bleeding and harms the gastric mucosa.

Non -steroid anti -inflammatory drugs can increase the effects of anticoagulants like warfarin. Do not use nonsteroidal anti -inflammatory drugs simultaneously with anticoagulants or heparin used in aging or at the dose of treatment.

In cases of using the remaining heparin, caution is needed due to increased risk of bleeding. When it is impossible to avoid the combination of the above drugs, Inr value should be monitored.

Medications that soluble thrombosis and anti -platelets: Increases the risk of bleeding due to inhibition of platelet function and harms the stomach lining.

Selective Serotonin reabsorption inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.

Diuretics, Angiotensin (ACE) and Angiotensin II: Non -steroid anti -inflammatory drugs can reduce the effects of diuretics and other hypertension drugs.

In some patients with impaired renal function (for example, dehydrated patients or elderly people with impaired renal function), simultaneously used with an angiotensin transferring enzyme inhibitors or Angiotensin II receptor antagonists and cycloxygenase inhibitors that can cause additional impaired renal function, including can cause acute renal insufficiency, often recovered.

Therefore should be cautious when using these drugs especially in the elderly. Patients need to be adequate water supplements and monitor kidney function after starting to use these drugs and periodically later.

Other anti -hypertension drugs (beta blockers): may cause a decrease in anti -hypertension effect (due to prostaglandin inhibitors as vasodilators).

Calcineurin inhibitors (such as cyclosporine, tacrolimus): nonsteroidal anti -inflammatory drugs may increase the toxicity of calcineurin inhibitors in the kidneys by indirect effect on prostaglandin in the kidneys. While treating drug combination, kidney function is needed. Need to closely monitor kidney function, especially in the elderly.

The contraceptive tool in the uterus: nonsteroidal anti -inflammatory drugs reduce the effectiveness of the contraceptive tools placed in the uterus. The reduction of the effectiveness of the contraceptives placed in the uterus of nonsteroidal anti -inflammatory drugs has been previously reported but should be further confirmed.

Dynamic interactions:

Meloxicam's effect on the dynamics of other drugs:

Lithi: Non -steroid anti -inflammatory drugs increase lithium concentration in the blood due to reducing lithium elimination through the kidneys, which can increase to toxicity. Lithium should not be used simultaneously and nonsteroidal anti -inflammatory drugs. If it is necessary to use simultaneously, careful monitoring of lithium concentration in plasma when starting treatment, adjusting the dose and stopping meloxicam.

methotrexate: Non -steroid anti -inflammatory drugs can reduce methotrexate excretion through the renal tubules thus increasing the concentration of methotrexate in plasma.

Therefore, for patients with high doses of methotrexate (greater than 15 mg/week), should not be used simultaneously with nonsteroidal anti -inflammatory drugs. The risk of interaction between nonsteroidal anti -inflammatory drugs and methotrexate is also considered in patients using low doses of methotrexate, especially in patients with impaired renal function.

In case of need for combination treatment, blood formula and kidney function need to be monitored. Be cautious when using nonsteroidal anti -inflammatory drugs and methotrexate within 3 days, then the concentration of methotrexate in plasma may increase and cause toxicity.

Effect of other drugs that get Meloxicam's dynamics:

Cholestyramine: Cholestyramine increases the excretion of meloxicam due to interrupting the intestinal circulation, thus clearing Meloxicam increases by 50% and the selling time is reduced to 13 ± 3 hours. This interaction has clinical significance. There is no clinical pharmacokinetic interaction when used on time with antacids, cimetidine and digoxin.

Storage

Store drugs at temperatures below 30 ° C, avoid moisture. To be out of reach of children.

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