MOBIC Tablet

គុណភាពព្យាបាល៖

ឱសថនេះស្ថិតក្នុងក្រុម NSAIDs មានមុខងារប្រឆាំងនឹងការរលាក បំបាត់ការឈឺចាប់ និងបញ្ចុះកំដៅប្រើក្នុងការព្យាបាលឈឺសរសៃសន្លាក់ ឈឺដោយការគាំងស្អិតសន្លាក់ឆ្អឹងខ្នង និងឈឺសន្លាក់ឆ្អឹង។

កម្រិត និងរបៀបប្រើ៖

ចំពោះមនុស្សពេញវ័យ៖

- ឈឺសន្លាក់ឆ្អឹង លេបម្តង1គ្រាប់ (7,5 ម.ក្រ) 1ថ្ងៃ 1ដងនៅពេលបាយ។ ក្នុងករណីចាំបាច់អាចលេប 1ថ្ងៃ 2គ្រាប់។

- ឈឺសរសៃសន្លាក់ លេប 1ថ្ងៃ 2គ្រាប់ បើធូរស្រាលហើយអាចបន្ថយលេប 1ថ្ងៃ 1គ្រាប់។

- ឈឺដោយការគាំងស្អិតសន្លាក់ឆ្អឹងខ្នង លេប 1ថ្ងៃ 2គ្រាប់ បើធូរស្រាលហើយអាចបន្ថយលេប 1ថ្ងៃ 1គ្រាប់។

*កំណត់សម្គាល់៖

- ជៀសវាងផលរំខានកើនឡើងត្រូវចាប់ផ្តើមប្រើ 1ថ្ងៃ 1គ្រាប់បានហើយជៀសវាងប្រើរយៈពេលយូរ

- ចំពោះអ្នកជំងឺលាងឈាមដោយខ្សោយតម្រងនោម ហាមប្រើលើសពី 1គ្រាប់ (7,5 ម.ក្រ) ក្នុង 1ថ្ងៃ

- ឱសថនេះត្រូវប្រើចំពោះតែយុវវ័យ និងមនុស្សពេញវ័យ កម្រិតប្រើគឺ 0,25ម.ក្រ/គ.ក្រ/ថ្ងៃ (កម្រិតអតិបរមាគឺ 2គ្រាប់ក្នុង1ថ្ងៃ)

- ឱសថនេះត្រូវលេបនៅពេលបាយ ឬក្រោយបាយភ្លាមជាមួយទឹកគ្រប់គ្រាន់ (1កែវ)

- រយៈពេលប្រើត្រូវកំណត់ដោយគ្រូពេទ្យព្យាបាល។

INDICATION

MOBIC is a non-steroidal anti-inflammatory drug indicated for symptomatic treatment of:

-painful osteoarthritis (arthrosis, degenerative joint disease)

-rheumatoid arthritis -ankylosing spondylitis

DOSAGE AND ADMINISTRATION

Osteoarthritis: 7.5 mg/day. If necessary,the dose may be increased to 15 mg/day.

Rheumatoid arthritis: 15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day.

Ankylosing spondylitis: 15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day.

In patients with increased risks of adverse reactions: start treatment at the dose of 7.5mg/day.

In dialysis patients with severe renal failure: the dose should not exceed 7.5mg/day.

- អ្នកធ្លាប់មានប្រតិកម្មជាមួយឱសថនេះ ឱសថក្រុម NSAIDs និង Aspirin

- អ្នកមានជំងឺហឺត អ្នកមានជំងឺដុះសាច់ក្នុងច្រមុះ អ្នកមានជំងឺហើមសរសៃ អ្នកមានជំងឺដំបៅក្រពះ ពោះវៀន កំពុងវិវឌ្ឍន៍ ឬធ្លាយក្រពះ អ្នកមានជំងឺថ្លើមខ្សោយធ្ងន់ធ្ងរ អ្នកមានជំងឺខ្សោយតម្រងនោមធ្ងន់ធ្ងរ អ្នកមានជំងឺក្រពះ ពោះវៀនហូរឈាម អ្នកមានជំងឺហូរឈាមក្នុងខួរក្បាល អ្នកមានជំងឺហូរឈាមទូទៅ អ្នកមានជំងឺខ្សោយបេះដូងធ្ងន់ធ្ងរ ក្មេងអាយុក្រោម 12ឆ្នាំ ស្រ្តីមានផ្ទៃពោះ ស្ត្រីបំបៅកូន និងអ្នកវះកាត់សរសៃឈាមបេះដូង។

- Known hypersensitivity to meloxicam or any excipient of the product.

- There is a potential for cross sensitivity to acetylsalicylic acid and other non-steroidal antiinflammatory drugs (NSAIDs).

- MOBIC should not be given to patients who have developed signs of asthma, nasal polyps, angio-L2

ឱសថនេះមានភាពអនុគ្រោះល្អ ចំពោះមនុស្សភាគច្រើន លើកលែងមនុស្សមួយចំនួនតូចអាចមានអាការៈ វិបត្តិក្រពះពោះវៀន ពិបាករំលាយអាហារ ចង្អោរ រាក ឈឺពោះ ហើមពោះ រលាកក្រពះ រលាកបំពង់ក ជួនកាលអាចធ្វើឱ្យធ្លាយពោះវៀន (លាមកខ្មៅ ក្អួតឈាមតាមមាត់) ដែលត្រូវរាយការណ៍ជូនគ្រូពេទ្យ។

ក្នុងករណីកម្រ អាចធីងធោង ងងុយដេក ស្រវាំងភ្នែក វិលមុខ ហ៊ឺងត្រចៀក ឈឺក្បាល ប្រតិកម្មពន្លឺ ប្រតិកម្មអាល្លែកហ្ស៊ី ឡើងកន្ទួលរមាស់ កន្ទួលក្រហម សម្ពាធឈាមឡើង មុខក្រហម ហើមដៃជើង អត្រាអង់ហ្ស៊ីមថ្លើមឡើង ខ្សោយថ្លើម ខ្សោយតម្រងនោម។

ត្រូវមានការប្រុងប្រយ័ត្នប្រើចំពោះអ្នកធ្លាប់មានដំបៅក្រពះ ពោះវៀន ឬធ្លាប់ហូរឈាមក្រពះ ពោះវៀន អ្នកខ្សោយថ្លើមធ្ងន់ធ្ងរ ឬខ្សោយតម្រងនោមធ្ងន់ធ្ងរ អ្នកកំពុងព្យាបាលដោយឱសថប្រឆាំងនឹងឈាមកក អ្នកមានជំងឺបេះដូងធ្ងន់ធ្ងរ អ្នកសម្ពាធឈាមឡើង ពិសេសមនុស្សចាស់។

Cardiac disorders:

Palpitations

Vascular disorders:

Blood pressure increased, flushing

Respiratory, thoracic and mediastinal disorders:

Asthma, in individuals allergic to aspirin or other NSAIDs

Gastrointestinal disorders:

Gastrointestinal perforation, occult or macroscopic gastrointestinal haemorrhage, gastroduodenal ulcer, colitis, gastritis, oesophagitis, stomatitis, abdominal pain, dyspepsia, diarrhoea, nausea, vomiting, constipation, flatulence, eructation.

Gastrointestinal haemorrhage, ulceration or perforation may potentially be fatal.

Hepatobiliary disorders:

Hepatitis, liver function test abnormal (e.g. raised transaminases or bilirubin)

Skin and subcutaneous tissue disorders:

Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, dermatitis bullous, erythema multiforme, rash, urticaria, photosensitivity reaction, pruritus

Renal and urinary disorders:

Renal failure acute, renal function test abnormal (increased serum creatinine and/or serum urea)

The use of NSAIDs may be related to micturition disorders, including acute urinary retention.

General disorders and administration site conditions:

Oedema

ឱសថនេះអាចមានអន្តរកម្មជាមួយឱសថក្រុម Glucocorticoid, Oral anticoagulant, Lithium, NSAIDs ផ្សេងទៀត Salicylate, Methotrexate, Contraceptive drug, Diuretic, Antihypertensive drug, Cholestyramine, Cyclosporine...។

- Other Prostaglandin Synthetase Inhibitors (PSI) including glucocorticoids and salicylates (acetyl- salicylic acid): Co-administration of PSIs may increase the risk of gastro-intestinal ulcers and bleeding, via a synergistic effect, and is not recommended.The concomitant use of meloxicam with other NSAIDs is not recommended.

- Oral anticoagulants, systemically administered heparin, thrombolytics: increased risk of bleeding.

If such co-prescribing cannot be avoided, close monitoring of their effects on coagulation is required, (for solution for injection: see section Contraindications)

- Antiplatelet drugs, and Selective Serotonin Re uptake Inhibitors (SSRIs): increased risk of bleeding, via inhibition of platelet function.

- Lithium: NSAIDs have been reported to increase lithium plasma levels (via decreased renal excretion of lithium), which may reach toxic values.The concomitant use of lithium and NSAIDs is not recommended. If this combination appears necessary, lithium plasma concentrations should be monitored carefully during the initiation, adjustment and withdrawal of meloxicam treatment.

- Methotrexate: NSAIDs can reduce the tubular secretion of methotrexate thereby increasing the plasma concentrations of methotrexate. For this reason, for patients on high dosages of methotrexate (more than 15 mg/week) the concomitant use of NSAIDs is not recommended. The risk of an interaction between NSAID preparations and methotrexate, should be considered also in patients on low dosage of methotrexate, especially in patients with impaired renal function. In case combination treatment is necessary blood cell count and the renal function should be monitored.

- ហាមប្រើចំពោះស្ត្រីមានផ្ទៃពោះ ព្រោះអាចគ្រោះថ្នាក់ដល់បេះដូង សួត និងតម្រងនោមនៃទារក។

- ហាមប្រើចំពោះ ស្រ្តីបំបៅកូនព្រោះឱសថនេះអាចជ្រាបចូលក្នុងទឹកដោះម្តាយ។

- MOBIC is contraindicated during pregnancy.

- NSAIDs are known to pass into mother’s milk. Administration therefore is contraindicated in women who are breastfeeding.

- The use of meloxicam, may impair fertility and is not recommended in women attempting to conceive.

- ហាមប្រើចំពោះស្ត្រីមានផ្ទៃពោះ ព្រោះអាចគ្រោះថ្នាក់ដល់បេះដូង សួត និងតម្រងនោមនៃទារក។

- ហាមប្រើចំពោះ ស្រ្តីបំបៅកូនព្រោះឱសថនេះអាចជ្រាបចូលក្នុងទឹកដោះម្តាយ។

- ត្រូវមានការប្រុងប្រយ័ត្នប្រើចំពោះអ្នកបើកបរ និងអ្នកបញ្ជាម៉ាស៊ីន ពិសេសពេលពិសាស្រា ព្រោះឱសថនេះអាចធ្វើឱ្យធីងធោង ងងុយដេក ស្រវាំងភ្នែក វិលមុខ។

Precautions

caution should be exercised when treating patients with a history or gastro-intestinal disease and in patients receiving treatment with anticoagulants. Patients with gastro-intestinal symptoms should be monitored. MOBIC should be with-drawn if peptic ulceration or gastro-intestinal bleeding occurs.

gastro-intestinal bleeding, ulceration or perforation, potentially fatal, can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastro-intestinal events. The consequences of such events are generally more serious in the elderly.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. MOBIC should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

NSAIDs inhibit the synthesis of renal prostaglandins, which play a supportive role in the maintenance of renal perfusion. In patients whose renal blood flow and blood precipitate overt renal decompensation which is typically followed by recovery to pre-treatment state upon discontinuation of non-steroidal anti-inflammatory therapy.

Patients at greatest risk of such a reaction are elderly individuals, dehydrated patients, those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease, those receiving a concomitant treatment with a diuretic, ACE inhibitor or angiotensinⅡreceptor antagonists or those having undergone major surgical procedures, which led to hypovolaemia. In such patients the volume of diuresis and the renal function should be carefully monitored at the beginning of therapy.

In rare instances NSAIDs may be the cause of interstitial nephritis, glomerulonephritis, renal medullary necrosis or nephrotic syndrome.

The dose of MOBIC in patients with end-stage renal failure on haemodialysis should not be higher than 7.5mg. No dose reduction is required in patients with mild or moderate renal impairment (i.e. in patients with a creatinine clearance of greater than 25mL/min).

As with other NSAIDs, occasional elevations of serum transaminases or other parameters of liver function have been reported. In most cases these have been small and transient increases above the normal range. If the abnormality is significant or persistent, MOBIC should be stopped and follow up tests carried out. No dose reduction is required in patients with clinically stable liver cirrhosis.

Frail or debilitated patients may tolerate side effects less well and such patients should be carefully supervised. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function.

Induction of sodium, potassium and water retention and interference with the natriuretic effects of diuretics may occur with NSAIDs. Cardiac failure or hypertension may be precipitated or exacerbated in susceptible patients as a result. For patients at risk, clinical monitoring is recommended.

Meloxicam, as any other NSAID may mask symptoms of underlying infectious disease.

The use of meloxicam, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive.

Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of meloxicam should be considered.

For relevant drug interactions that require particular attention, see section “interactions”.

There are no specific studies about effects on the ability to drive vehicles and to use machinery. Patients who experience visual disturbances, drowsiness or other central nervous system disturbances should refrain from these activities.

MOBIC tablets 7.5mg contains 47mg lactose per maximum recommended daily dose. Patients with rare hereditary conditions of galactose intolerance, e.g. galactosaemia, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine.

inhibit the biosynthesis of prostaglandins