Mobic 15mg Boehringer treatment for osteoarthritis treatment (10 blisters x 2 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Meloxicam

Ingredient

Composition information	Content
Meloxicam	15mg

Uses

Indication

mobic 15mg is a nonsteroidal anti -inflammatory drug that is indicated for symptomatic treatment in:

osteoarthritis (arthritis, disease osteoarthritis ).

rheumatoid arthritis . Animals. Meloxicam has anti -inflammatory activity on all standard inflammatory models. The common mechanism for the above effects may be due to Meloxicam inhibits biosynthesis of prostaglandin known as inflammatory intermediaries.

Comparison of ulcers and anti -inflammatory doses on the arthritis model in the rats has confirmed the benefit of the treatment of non -steroid anti -inflammatory drugs on animals. In Vivo, Meloxicam has inhibited prostaglandin biosynthesis in a stronger inflammatory position in the gastric or kidney mucosa.

It is thought that the above differences are related to the selective inhibition on COX -2 compared to COX - 1 and it is believed that the Cox - 2 inhibitors bring the therapeutic effects of NSAIDs while the main inhibition of COX - 1 can be responsible for side effects on the stomach or kidney mucosa.

Selective inhibition on COX - 2 of Meloxicam has been confirmed in a number of in vitro and EX Vivo testing systems. In a human blood test, Meloxicam shows the selective inhibitors of COX - 2 on in vitro. In Ex Vivo test, Meloxicam (7.5 & 15mg) shows more inhibition on COX - 2, as it has been proved by more inhibiting PGE2 production stimulated by Lipopolysaccaride (COX - 2) compared to the production of thromboxan in blood clots (COX - 1). These effects depend on the dose. Meloxicam does not have an impact on platelet aggregation or bleeding time at recommended doses in Ex Vivo test, while indomethacine, diclofenac, ibuprofen and naproxen significantly inhibit platelet aggregation and prolong bleeding.

In clinical trials, generally Meloxicam 7.5 and 15mg causes less side effects on the gastrointestinal tract than NSAIDs compare due to significantly lower frequency of side effects such as indigestion, vomiting and abdominal pain. The frequency of perforation, ulcers, gastrointestinal bleeding is reported related to Meloxicam, which is low and the dose depends on the dose.

There is no individual research large enough to detect differences in terms of frequency of perforation, obstruction, gastrointestinal bleeding significantly clinically between Meloxicam and other NSAIDs. A blistering analysis was conducted in patients with osteoarthritis, rheumatoid arthritis and joint spondylitis treated with Meloxicam in 35 clinical trials. The time for using Meloxicam in this trial varies from 3 weeks to 1 year (most patients are accepted to participate in 1 -month studies). Most patients who are allowed to participate in the above tests have a history of perforation, ulcer or gastrointestinal bleeding.

frequency of perforation, blockage or hemorrhage (POB) is regression assessed after the 'blind' evaluation and independent cases.

pharmacokinetic

absorption

Used by oral:

Meloxicam is well absorbed through the digestive tract, expressed through absolute bioavailability by oral about 90%.

Tablets, oral fluids and capsules have biological equivalent.

After taking the single dose of Meloxicam, the median of the peak concentration in plasma is achieved after 2 hours for the epidemic and 5-6 hours for solid preparation (capsules and tablets).

Meloxicam absorption level after oral use is not affected by the use of food or use of inorganic anti -acid. Linear dosage is shown after oral use within the treatment dose range from 7.5mg to 15mg.

With multiple doses, stable state achieved after 3-5 days.

Dosage once a day leads to medium concentration in plasma with a relatively small base/vertex in the corresponding range of 0.4 - 1.0pg/ml at a dose of 7.5 mg and 0.8 - 2.0pg/ml at a dose of 15mg (minimum concentration and maximum concentration in stable, corresponding state).

Maximum maximum concentration of Meloxicam in plasma in a stable state is achieved within 5-6 hours corresponding to tablets, capsules and oral fluid.

Distribution

Meloxicam is strongly linked to plasma proteins, mainly albumin (99%).

Meloxicam penetrates well into joint fluid and reaches the concentration of approximately half of plasma concentrations.

Low distribution volume, approximately 11l after intramuscular or veins, and shows vary depending on individuals from 7 - 20%.

The volume of distribution after use of Meloxicam oral doses (7.5mg to 15mg) is about 16L with a variable coefficient within the limit from 11 to 32%.

Biological shift

Meloxicam metabolizes strongly through the liver.

Four metabolic forms of Meloxicam through urine have been determined without biological activity.

Main metabolic form, 5'-carboxymeloxicam (60% dose) is made up of oxidation of intermediate metabolic oxidation 5'-hydroxymethylmeloxicam, also eliminated less (9% dose). In vitro research shows that CYP2C9 plays an important role in this metabolic line with a small contribution from Isenzyme CYP 3A4. Antioxidant activity in patients is probably responsible for two other metabolites, with the number of 16% and 4% corresponding to the dose.

Elimination

Meloxicam is excreted mainly through urine and stools at the same level as a metabolic. Under 5% of the dose is discharged in the stool in the form, while only a very small amount is excreted in the urine in the form of integer.

The average selling time ranges from 13 and 25 hours after drinking, intramuscularly and intravenously. Plasma clearance is about 7 - 12ml/min after taking single dose, using intravenous or rectal.

linear/non -linear

Meloxicam indicates linear pharmacokinetic pharmacokinetic in the treatment range of 7.5mg to 15mg oral as well as intramuscularly.

Special patient group

Patients with liver/kidney failure:

Both the case of liver and kidney failure from mild to medium does not affect Meloxicam pharmacokinetics. Patients with renal impairment The average level has significantly higher drug clearance. Observed significantly reduced protein bonds in end -stage renal failure patients. In case of end -stage renal failure, increased distribution integral can lead to increased freedom concentration of Meloxicam and should not be used more than 7.5mg/day.

Elderly:

Men's elderly patients have average pharmacokinetic parameters equivalent to young men. Elderly female patients show higher AUC values and longer -selling time than young men and women. The average plasma clearance in a stable state in the elderly is inferior to young people.

Children:

In a study on 36 children, pharmacokinetic measurements were conducted on 18 children with a dose of 0.25mg/kg weight used in the form of oral fluid. The maximum concentration in CMAX plasma (-34%) as well as the area under the AUC0 curve. (-28%) tends to be lower in groups of younger children (from 2-6 years old, 7 children) compared to older age groups (7 to 14 years old, 11 children) while the average clearance of young children is higher. The trend is shorter than adults (15 - 20 hours).

Before taking Mobic 15mg Boehringer treatment for osteoarthritis treatment (10 blisters x 2 tablets)

How to use

oral medication. Should drink intact tablets with water or other liquid drinks at the same meal.

Dosage

osteoarthritis: 7.5mg/day. If necessary, the dose may increase to 15mg/day.

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

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

In patients with high risk of adverse reactions: the initial treatment at a dose of 7.5mg/day.

In patients with severe dialysis: Dosage must not exceed 7.5mg/day.

General recommendation:

Because it is likely to react adverse doses and duration of use, so the drug should be used in the shortest possible time and with the lowest doses that are effective.

Meloxicam's daily daily dose is provided in the form of tablets and injection solutions not exceeding 15mg.

For teenagers:

The maximum dose is recommended for 0.25mg/kg. Total daily dose should be used as single dose (disposable).

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 using overdose? A clinical trial shows that Cholestyramine increases the speed of Meloxicam elimination.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using the drug, you may experience unwanted effects (ADR).

The following side effects may be related to the use of mobic through the reports received when the drug is circulating.

Unwanted effects can be related to the use of mobic, which has been known through the results of the reports related to the use of oral form after being marketed by some reference.

Blood and lymphatic disorders: Abnormal blood formula (including counting leukocytes), leukopenia, thrombocytopenia, anemia used simultaneously with toxic drugs for the marrow especially methotrexate, becoming a factor promoting cell reduction.

Immune disorders: Anaphylaxis reactions, anaphylactic reactions and other instant hypercertia reactions.

Mental disorders: confusion, loss of orientation, mood change.

neurological disorders: dizziness, drowsiness, headache.

Eye disorders: visual disorders include blurred vision, conjunctivitis.

Disorders and vestibular disorders: dizziness, tinnitus.

Heart disorders: Heart beat fast.

Vascular disorders: Hypertension, hot face.

Chest, mediastinum and respiratory disorders: asthma , depending on the individual due to allergies to aspirin or other NSAIDs.

Gastrointestinal disorders:

Perforated gastrointestinal tract, microcontroller or gastrointestinal bleeding, peptic ulcer, colitis, gastritis, esophagitis, stomatitis, abdominal pain, digestive disorders, diarrhea, nausea, vomiting, constipation, flatulence, belching. Example: increase transaminase or bilirubin).

Skin and subcutaneous disorders: epidermal poisoning, Stevens - Johnson syndrome, angioedema, water glossy dermatitis, diverse rash, rash, urticaria, sensitive light reaction, itching.

Kidney and urinary disorders: acute renal failure , abnormal kidney function test (increased serum creatinine and/or serum urea). Using NSAIDs may be related to urination disorders, including urinary retention.

General disorders and expression at the place where the injection place: edema.

Notify the doctor the 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

Contraindications in the following cases:

Parentive history of Meloxicam or any excipients of the product. Other non -steroid inflammation.

clear gastrointestinal hemorrhage, recent brain hemorrhage or systemic bleeding disorders have been established.

Children under 12 years old.

Precautions when used

like other nonsteroidal anti -inflammatory drugs, need to be cautious when taking this medication in patients with a history of gastrointestinal diseases and patients who are being treated with anticoagulants. Careful monitoring patients with symptoms of the gastrointestinal tract. Mobic must be discontinued if there is a peptic ulcer or gastrointestinal bleeding.

Like other NSAIDs gastrointestinal bleeding, ulcers or perforation, likely to be fatal, may occur at any time during treatment that whether or not there are warning signs or a history of severe complications on the gastrointestinal tract. The consequences of these complications are often worse in the elderly patients.

Serious skin reactions, some may cause death, including skin peeling, Stevens - Johnson syndrome, epidermal poisoning, very rare reports related to the use of nonsteroidal anti -inflammatory drugs. Patients who have the highest risk of these adverse adverse reactions are usually in the early stages when they start treatment, in most cases, the reaction onset in the first month of treatment. MoBic should be stopped as soon as the skin appears on the skin, lesions in the mucosa or any signs of sensitivity.

Steroid anti -inflammatory drugs may increase severe cardiovascular thrombosis, myocardial infarction, stroke, which can lead to death. This risk may increase during use. Patients with cardiovascular disease or high risk factors for cardiovascular disease may have higher risk.

Non -steroid anti -inflammatory drugs (NSAIDs) inhibit the synthesis of kidney prostaglandin plays a supportive role in maintaining kidney perfusion. Patients with the volume and blood flow through the kidneys decrease, the use of NSAIDs can quickly reveal the loss of the kidney, but this condition is often restored to the old state as before treatment if stopped using nonsteroidal anti -inflammatory drugs.

Patients with the highest risk of the above reaction are elderly patients, patients with dehydration, congestive heart failure, cirrhosis, nephrotic syndrome and significant kidney disease, patients are being treated simultaneously with diuretics, enzyme inhibitors or angiotensin II receptors or patients who are undergoing surgery that can lead to reduced blood volume. In the aforementioned patients, it is necessary to closely check the volume of urine and kidney function at the beginning of treatment.

More rare, nonsteroidal anti -inflammatory drugs can cause nephritis, glomerulonephritis, kidney necrosis or nephrotic syndrome.

Mobic's dose in patients with end -stage renal impairment is dialysis must not exceed 7.5mg. There is no need to reduce the dose in patients with mild or medium renal failure (as in patients with creatinine clearance above 25ml/minute).

As most of other nonsteroidal anti -inflammatory drugs, the transient increase in serum transaminase or other parameters of the liver function have been recorded. In most cases, a slight increase is on normal and transient limits. If the abnormalities are significant or prolonged, it is necessary to stop using mobic and conduct monitoring tests.

No dose reduction in clinical stable cirrhosis patients.

Need to monitor carefully in weak or weak physical condition patients with inferiority of the side effects of the drug. As with other nonsteroidal anti -inflammatory drugs, it is necessary to be cautious when taking the drug in the elderly patients because they are more likely to have impaired kidney, liver or heart function.

NSAIDs can cause sodium, potassium and water salts as well as prevent the effect of stimulating sodium secretion in urine of diuretics. Heart failure or hypertension may appear or worsen in sensitive patients. Patients at risk should be closely monitored.

Meloxicam, as well as other NSAIDs can cover the symptoms of the main infection.

Use meloxicam as well as cyclooxygenase inhibitors/other prostaglandin synthesis may cause harmful effects on reproduction and are recommended not to be used for women who want to get pregnant.

Therefore, women are difficult to get pregnant or women who are conducting a poor reproductive function to consider stopping treatment with Meloxicam.

With related drug interactions need special care, see the "interaction with other drugs".

There is no specific research on the effect of the drug on the ability to drive and operate machinery. Patients with visual disorders, chicken sleep, or other central neurological disorders should avoid those activities.

7.5mg mobic tablets contain 47mg of lactose at the maximum recommended dosage per day. In patients with intolerance with galactose, for example, galactoza blood, lapp - lactase deficiency or poor absorption of glucose - galactose due to genetic factors, though rarely occur, should not use this product.

15mg mobic tablets contain 20mg lactose at the maximum recommended doses every day. On patients with galactose intolerance, for example, blood galactose, lapp - lactase deficiency or poor absorption of glucose - galactose due to genetic factors, though rarely occur, should not use this drug.

The ability to drive and operate machinery

Not used for drivers operating machinery.

Pregnancy and lactation

Not for pregnant and lactating women.

Medicinal interaction

Prostaglandin synthetic inhibitors (PSI) including glucocorticoids and salicylates (acetylsalicylic acid): It is not recommended to use simultaneously with Prostaglandin synthetic inhibitors that can increase the risk of ulcer and gastrointestinal bleeding through copper effect. Do not recommend simultaneously Meloxicam with other NSAIDs.

Simultaneously used with aspirin (1000mg 3 times/day) healthy volunteers tend to increase AUC (10%) and CMAX (24%) of Meloxicam. Unknown clinical significance of this interaction.

Anticoagulant oral medication, heparin using systemic sugar, thrombolytic drugs: increasing the risk of bleeding. It is necessary to closely monitor the anticoagulant effect if you have to combine the drug (for injection solution: see the control item).

Anti -platelet aggregation drugs and selective Serotonin recovery (SSRIs): Increasing the risk of bleeding, through inhibition of platelet function.

Lithium: Non -steroid anti -inflammatory drugs have been recorded in an increase in plasma lithium (due to reducing lithium secretion through the kidney), which can lead to toxicity. It is not recommended to simultaneously use Lithium and NSAIDs. If it is necessary to combine these 2 drugs, plasma lithium concentration should be monitored while starting treatment, adjustment and when stopping meloxicam.

methotrexate: NSAIDs can reduce the secretion of methotrexate through the kidney thus increases the concentration of methotrexate in plasma. For this reason, for patients with high doses of methotrexate (over 15mg/week), it is not recommended to simultaneously use with NSAIDs. 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 necessity to combine treatment, blood formula and kidney function should be monitored. Be careful in case of simultaneous use of NSAIDs and methotrexate within 3 days, when plasma methotrexate concentrations may increase and increase toxicity. Although the pharmacokinetics of methotrexate (15mg/week) are not affected when used simultaneously with Meloxicam, it is necessary to consider the toxicity of the hematopathy of methotrexate may be amplified due to the treatment with NSAIDs.

contraception: The effectiveness of the contraceptive tools placed in the uterus due to NSAIDs has been recorded but should be further confirmed.

Diuretics: Used with nonsteroidal anti -inflammatory drugs that are more likely to lead to acute renal failure in patients with dehydration. Patients who are using mobic with diuretics should be fully added with water and monitor kidney function before starting treatment.

Antid for hypertension (β blocker, enzyme inhibition, vasodilators, diuretic): Reducing the effects of antihypertensive drugs by the inhibition of prostaglandin causing vasodilation has been recorded during treatment with NSAIDs.

NSAID, Angiotensin II receptor inhibitors as well as enzyme inhibitors have a synergistic effect that reduces glomerular filtration level. In patients with impaired renal function, can lead to acute renal failure.

cholestyramine attached to meloxicam in the gastrointestinal tract leads to faster meloxicam elimination.

Steroid anti -inflammatory drugs can increase the toxicity of the kidneys of cyclosporin through the intermediate effect of prostaglandin, need to check the kidney function assessment in combined treatment.

Meloxicam is excluded almost entirely by liver change, of which about 2/3 through the intermediaries of cytochrome enzymes (CYP) P450 (through the main metabolic path CYP 2C9 and CYP 3A4 auxiliary transmission line) and 1/3 through other transformation lines, for example, peroxidase oxidation, attention should be paid to the possibility of pharmacokinetic interaction when using Meloxicam Preparation, or being changed by CYP 2C9 and/or CYP3A4.

There are no clear pharmacokinetic interactions - clear drugs detected with simultaneous use of antacids, cimetidine, digoxin and furosemide.

Not excluded the possibility of interaction with oral medications for oral diabetes.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.