Natondix 750mg anti -inflammatory, reducing pain, stiffness due to osteoarthritis (4 blisters x 15 tablets)

Dosage form Box of 4 blisters x 15 tablets
Specifications Nabumeton

Ingredient

Composition information	Content
Nabumeton	750mg

Uses

Indication

Anti -inflammatory, anti -inflammatory in case of osteoarthritis and rheumatoid arthritis.

Pharmacokology

Pharmacological group: nonsteroidal anti -inflammatory drugs.

Code ATC: M01AX01

Mechanism of action:

Nabumeton is a drug belonging to the non-steroid anti-inflammatory group (Non-Stoidal Anti-Inflammatory Drug) that inhibits prostaglandin synthesis. After being absorbed in the gastrointestinal tract, Nabumeton was quickly metabolized in the liver to create a product that inhibits the synthesis of Prostaglandin: 6-methoxy-2-naphthylacetic (6-mNA).

Nabumeton does not affect the stomach lining. In addition, Nabumeton also has a weak effect against platelets due to collagen but does not affect bleeding time.

Compared to other NSAIDs, Nabumeton has less ulcer, hemorrhage or gastrointestinal perforation.

Pharmacokinetics

absorption

Nabumeton is absorbed almost completely through the digestive tract (> 80%). Absorption increases when used with food or milk, but the total amount of 6-mna metabolites in plasma does not change. Invitro research for

Seeing 6-mna has no gut cycle. The bioavailability of 6-mna in the form of a 500 mg film tablet is about 35% (23-52%). The peak concentration of 6-NMA plasma is reached for about 3 hours (1-12 hours) after taking the drug.

Distribution

No nibumeton is not found in the form of non -metabolic in plasma. 6-mNA is strongly linked to plasma proteins (> 99%). The free amount of 6-mna depends on its total concentration in plasma and dose. This form of free accounts for 0.2-0.3% when taking a daily dose of 1 g and about 0.6-0.8% when using 2 g daily. Due to links with strong protein, 6-mna cannot be separated.

Type using intravenous line, the measured distribution volume is 7.51 (6.8-8.41), the clearance is 4.4 ml/min (1.0-6.9 ml/min).

Researching the type of venous line on the mouse shows that Nabumeton quickly distributed throughout the body, stored in lipid organizations. 6-mna metabolites, distributed into inflammatory tissue, passing through the placenta and excreting into breast milk.

Metabolism

Nabumeton is strongly metabolized in the liver to form 6-mna-champions with Prostaglandin synthesis inhibitors and other non-active metabolites.

Elimination

6-mNA is excreted mainly by participating in the metabolic process, mainly in conjunction with glucuronic acid and participating in the o-demethyl reaction.

Their main excretion path is to be exported through urine. Selling duration of plasma of 6-NMA about 1 day.

Special patient groups

Elderly

A plasma concentration in the elderly is higher, and longer the sale time (29.8 ± 8.1 hours) compared to healthy young people.

kidney failure

In patients with severe renal impairment (Cla

Before taking Natondix 750mg anti -inflammatory, reducing pain, stiffness due to osteoarthritis (4 blisters x 15 tablets)

How to use

Drink whole tablets with a large cup of water. Should drink in or after eating.

Dosage

Caution should be careful to evaluate the effectiveness and risk of nababeton treatment compared to other measures before starting treatment.

Lowest dose and the shortest treatment period is effective depending on the treatment goals of each patient.

Adults:

Recommended the starting dose of 1000 mg (*) 1 time/day. Some patients may need higher doses from 1500 mg/day to 2000 mg/day. Can be used for 1 time/day or divided into 2 times/day. The dose of over 2000 mg/day has not been studied. Using the lowest dose effectively to treat chronic diseases. Patients less than 50 kg rarely need to take a dose of over 1000 mg, so it is necessary to observe the patient's response to the initial treatment dose to adjust the dose to suit each individual.

Elderly:

Do not take the dose more than 1g daily. Elderly people are at high risk of unwanted effects. Need to monitor gastrointestinal bleeding on this patient when using NSAID.

Children:

Do not recommend using Nabumeton for children.

Patients with renal failure:

mild renal failure (Clc 250 ml/minute): No dose adjustment. After closely monitoring the kidney function, if necessary, the dose can be increased to a maximum of 1500 mg daily. After monitoring the function carefully, if necessary, the dose can be increased to up to 1000 mg daily.

Patients with liver failure:

The formation of metabolites depends on the biochemical processes in the liver, so these forms of chemicals may be reduced when it is severe hepatitis.

Be careful when using the drug for this patient.

(*): Natondix tablets are not appropriate when taking the dose of 500 mg, 1000 mg. Need to use other preparations suitable for patients.

What to do when overdose?

Symptoms

Headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea (rare), disorientation, stimulation, coma, dizziness, tinnitus, fainting and occasional convulsions. In case of acute poisoning can cause kidney failure and liver damage.

Management:

There is no specific antidote and 6-mna metabolic products are not separated. Patients should be treated symptoms. Within 1 hour of toxicity, activated carbon can be used.

In addition, in adults, if an overdose causes life -threatening, it is necessary to wash the intestines for 1 hour after taking Nabumeton. Need to ensure adequate urine for patients. Closely monitor liver function and kidney function. It is necessary to monitor patients at least 4 hours after taking Nabumeton. Use intravenous diazepam to treat seizures.

Other factors also need to be evaluated depending on the patient condition.

What to do when forgetting a dose?

Side Effects

Common ADR (1/100

ears: hearing disorders. 1/100)

Mental: Confusion, restlessness, insomnia Duodenal ulcer, gastrointestinal bleeding, stomach ulcer, gastrointestinal syndrome, black stools, vomiting, gastritis, dry mouth. Liver function test increased.

reproductive system: menstruality.

ADR is very rare (ADR

Blood and lymphatic system: platelet reduction. Hair.

Blood and lymphatic system: neutropenia, granulocytosis, leukopenia, property anemia, hemolytic anemia. Blood.

Kidney: interstitial nephritis Clinical and epidemiological testing shows that the use of NSAID (high doses, for a long time) may increase the risk of arterial thrombosis (such as myocardial infarction or stroke). About the risk of cardiovascular thrombosis, see more warning and caution when used.

Warnings

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

contraindicated

sensitive to nababeton or any ingredients of the drug. There is a history of asthma by NSAID.

Caution when using

Unwanted effects can be limited by using the lowest dose and the shortest treatment time effectively.

Do not combine Nabumeton with other NSAIDs, including the selective inhibitors of COX-2 (COX: Cycloxygenase).

Elderly: Increasing the unwanted effect rate on the digestive tract causing gastrointestinal bleeding, can lead to death.

Respiratory: Be cautious when using nababeton for patients with a history or being bronchial asthma.

Hepatic failure, kidney failure and cardiovascular disease: Numeton use may reduce the dependence on the dosage of prostaglandin synthesis and cause kidney failure. Patients with impaired renal function, heart failure, liver failure, users of diuretics and the elderly are the highest -risk people who have this unwanted effect.

Patients with severe renal impairment (CLC

Patients with average renal failure (Clc = 30-49 ml/minute) with 50% of 6-mna freedom in plasma, therefore, Nabumeton dose is needed.

Need to monitor liver function when using Nabumeton.

Effects on the heart and blood vessels:

Risk of cardiovascular thrombosis: nonsteroidal anti -inflammatory drugs (NSAID), non -aspirin, using systemic sugar, can increase the risk of cardiovascular 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, Natondix is needed in the lowest daily daily doses in the shortest possible time.

Patients with a history of hypertension and/or congestive to moderate congestion need to be closely monitored, edema when using Nabumeton.

Patients with hypertension, congestive heart failure, myocardial infarction, peripheral artery disease, untreated cerebrovascular disease, only treated with nababeton when considered carefully. For patients with high risk of cardiovascular diseases, before long -term treatment with Nabumeton, should also be carefully considered.

Gastrointestinal bleeding, ulcers or puncture: may cause death when using NSAID. Patients with a history of digestive ulcers, especially the elderly need to report to the doctor when abnormal abdominal pain.

Can use gastrointestinal protection agents such as Misoprostol, Proton pump inhibitors (PPI: Proton Pump Inhitor), especially when coordinating NSAID with drugs at risk of gastrointestinal ulcers.

Be cautious with patients with combination of drugs that increase the risk of digestive ulcers such as corticosteroids, anticoagulants (Warfarin), other NSAIDs, Serotonin recovery inhibitors (SSRI: SEROTONIN SELECTIVE REATEKE Igibitor)

When bleeding or gastrointestinal ulcers due to the use of nabumeton, this medication should be stopped.

Use NSAIDs carefully with patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) because the drug can make these diseases worse.

Patients with gastrointestinal ulcers, need to be assessed effectively and risk when using nababeton, ensuring suitable for the treatment of gastrointestinal ulcer and closely monitoring the patient's progress.

Nabumeton is more tolerant than other NSAIDs due to less effect on the digestive system. Overview data from clinical trials with Nabumeton shows that the average frequency of ulcer, hemorrhage, and gastrointestinal perforation in patients treated with Nabumeton 3-6 months, 1 year and 2 years is 0.3%, 0.5%and 0.8%respectively. Although these indicators are lower than other NSAIDs, the doctor still needs to note that these ADRs may still occur even if the patient previously had no gastrointestinal ulcer.

Although Nabumeton is safe with kidneys and gastrointestinal tract, still need to be cautious when using nabumeton for patients:

Having the above gastrointestinal ulcer: It is necessary to ensure that Nabumeton treatment is appropriate before starting treatment. Lupus erythematosus and connective tissue disease: Increased risk of sterile meningitis. Patients with the highest risk of these reactions at the early stages of the treatment. These reactions mainly onset in the first month of treatment. Need to stop treatment if using Nabumeton causes these reactions

nabumeton can hide infection.

There have been reports on blurred vision cases, reduced vision when using NSAID. If using Nabumeton and this situation, eye examination.

The effect of the drug on the ability to drive and operate machinery

Natondix can cause drowsiness, dizziness, fatigue, vision disorders. If you have these unwanted effects, do not drive or operate machinery.

Using drugs for women during pregnancy and lactation

Case of pregnancy

NSAID usage may impair fertility of women. It is not recommended to use NSAID for women who are trying to get pregnant. Women are hard to get pregnant or suspected of being infertile should consider stopping Nabumeton.

Nabumeton is contraindicated for pregnant women in the last 3 months of pregnancy.

Do not use drugs for pregnant women in the first 6 months, only used when really necessary.

Breastfeeding case

There is no data on whether Nabumeton can go to breast milk or not. However, its metabolic product 6-mna is excreted in milk in mice.

Do not use nababeton for breastfeeding women to avoid the risk of unwanted effects on children.

Drug interaction

When used in combination with Nabumeton, there may be interactions.

Other NSAIDs including COX-2 inhibitors: may increase the risk of unwanted effects.

Diuretics and other hypertension medications (such as transferred enzyme inhibitors, angiotensin receptor inhibitors): may be reduced treatment effect when combined with NSAID. For a few people (for example, an elderly or dehydrated person) can lead to reduced kidney function and even acute renal failure, so it is necessary to rehydrate and regularly monitor these patients.

Potassium diuretics: can increase potassium.

cardiac glycosides: NSAIDs can worsen heart failure, reduce clearance and increase heart glycosides in plasma.

Methotrexate: Nabumeton reduces methotrexate excretion.

Lithi: Nabumeton reduces lithium elimination.

ciclosporin: Increased risk of kidney toxicity.

Mifepriston: NSAIDs should not be used within 8-12 days after using Mifepriston as NSAID can reduce the effect of Mifepriston.

corticosteroid: The drug increases the risk of gastrointestinal ulcer.

Anticoagulant: NSAID can increase the effects of anticoagulants. Need to be cautious and monitor signs of overdose when used in combination with nabumeton.

Antibiotics Quinolon: Animal research shows that NSAID may increase the risk of convulsions.

Anti -platelet aggregation and Serotonin selective re -inhibitors: Increasing the risk of gastrointestinal bleeding.

tacrolimus: may increase the risk of kidney toxicity.

Zidovudin: Increased risk of toxicity on blood cells.

Linking drugs with protein (such as sulphonamid, sulphonylure, hydrogen): may show signs of overdose when used with nabumeton.

There is no specific study of the interactions between Nabumeton and the stated drugs. However, need to be careful when using coordination.

Storage

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

To be out of reach of children, read the instructions carefully before use.

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