Indication
Mobixin® is a non-steroidal anti-inflammatory drug indicated for:
- Short-term symptomatic treatment of exacerbations or osteoarthritis .
- Long term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis
Composition
Each Tablet of Mobixin®15 Contains:
- Meloxicam 15 mg.
Each Tablet of Mobixin®7.5 Contains:
- Meloxicam 7. 5 mg.
Each suppository of Mobixin®15 Contains:
- Meloxicam 15 mg.
Dosage
¤ Oral dosage: The total daily amount should be taken as single dose ,with water or another liquid during meal.
¤ Undesirable effects may be minimized by using the lowest dose for the shortest duration necessary to control symptoms.
¤ The patient’s need for symptomatic relief , any response to therapy should be re-evaluated periodically ,especially in patient with osteoarthritis.
- Osteoarthritis: 7.5 mg/day .If necessary ,the dose may be increase to 15 mg/day.
- Rheumatoid arthritis: 15 mg/day According to the therapeutic response , the dose may decrease to 7.5 mg/day.
- Ankylosing spondylitis: 15 mg/day According to the therapeutic response the dose may decrease to 7.5 mg/day.
- In dialysis patients with severe renal failure: the dose should exceed 7.5 mg/day no dose reduction is required in patients with mild to rnoderate renal impairment (i.e. patients with a creatinine clearance of greater than 25ml/min) .
- Hepatic impairment: no dose reduction is required in patients with mild to rnoderate hepatic impairment.
- Elderly patients and patients with increased risks for adverse reactions:
- the recommended dose for long term treatment of rheumatic arthritis and ankylosing spondylitis in elderly patients is 7.5 mg/day .
- In patients with increased risks for adverse reactions:
- short treatment at dose of 7.5 mg/day.
- Adolescent: the maximum recommended dose 0.25 mg /kg
¤ as dose for use in children has not yet been established ,usage should be restricted to adolescent and adults.
¤ The maximum recommended daily dose of Mobixin® is 15 mg .
- Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) , of the Oxicam family ,with anti-inflammatory, analgesic and antipyretic properties
- Meloxicam As other NSAIDS, its precise mechanism of action remains unknown , however, there isat least one common mode of action shared by all NSAIDS, including Meloxicam, inhibition of biosynthesis of prostaglandin, known inflammation mediators.
- Meloxicam is well absorbed from the gastrointestinal tract ,which is reflected by a high absolute bioaviabiality of 89% following oral administration .
- Following single dose administration of meloxicam, mean maximum plasma concentrations are achieved within 5- 6 hours with solid oral dosage forms .with multiple dosing , steady state conditions were reached within 3 to 5 days .
- Extent of absorbtion for meloxicam following oral administration is not altered by concomitant food intake.
- Meloxicam is 99.4 % bound to human plasma protien ( specialiy albumin ) within the theraputic range, and penetrates into synovial fluid to give concentrations approximately half of those in plasma.
- Meloxicam undergoes extensive hepatic biotranformation .four different metabolites of meloxicam were identified in urine, which are all pharmcodynamically inactive.the major metabolite, 5-carboxymeloxicam (60 %of dose )is formed by oxidation of an intermediate metabolite 5-hydroxymethyl meloxicam , which is also excreted to a lesser extent (9% of dose).
- Meloxicam is excreted predominately in the form of metabolites and occur to equal extent in urine and faces . less than 5% of the daily dose is excreted unchanged in the faces , which only traces of the parent compound are excreted in urine. The mean elimination half –life is about 20 hours,Total plasma clearance amounts on average 8 ml/min.
Each Tablet of Mobixin®15 Contains:
- Meloxicam 15 mg.
Each Tablet of Mobixin®7.5 Contains:
- Meloxicam 7. 5 mg.
Each suppository of Mobixin®15 Contains:
- Meloxicam 15 mg.
Mobixin® is a non-steroidal anti-inflammatory drug indicated for:
- Short-term symptomatic treatment of exacerbations or osteoarthritis .
- Long term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis
- Hypersensitivity to Mobixin®,or hypersensitivity to substances with a similar action e.g. : NSAIDs as Aspirin . Mobixin®, should not be given to patients who have developed signs of asthma , nasal polyps ,angionurtic edema or urticaria following the administration of Aspirinor other NSAIDs.
- History of gastrointestinal bleeding or perforation ,related to previous NSAIDs therapy.
- Active ,or history of recurrent peptic ulcer , hemorrhage (two or more distinct episodes of proven ulceration or bleeding ) .
- Severely impaired liver function and non – dialyzed sever renal failure Gastrointestinal bleeding , cerebrovascular bleeding or other bleeding disorders ,sever heart failure ,Children under 15 years .
- Administration of several NSAIDs together may increase the risk of gastrointestinal ulceration and bleeding via synergistic action.
- Corticosteroids: increase risk of gastrointestinal ulceration or bleeding .
- Anticoagulants ,antiplatlet drugs, systemically administrated heparin ,thrombolytic increased risk of bleeding in the gastrointestinal tract by inhibiting platelet function and damaging the lining of the stomach and duodenum..
- Selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding .
- NSAIDs increase lithium plasma levels, which may reach toxic values.
- NSAIDs can reduce tubular secretion of methotrexate therapy increasing plasma concentrations of methotrexate.
- NSAIDs decrease the efficacy intrauterine devices .
- Diuretics: patient treated with NSAIDs and diuretics should be adequately hydrated and be monitored for renal function prior initiating treatment .
- Antihypertensive effect reduced by NSAID.
- In patients with pre-existing renal impairment this may lead to acute renal failure,when NSAID and angiotensin II are administered.
- Cholystyramine accelerated the elimination of Meloxicam ,so that clearance for Meloxicam increase by 50% and half life of decrease to 13± 3hrs.
- is contraindicated during pregnancy ,especially during the third trimester .
- NSAIDs are known to pass into mother’s milk .administration should therefore be avoided in women who are breast feeding .
- Common : light –headedness , headache ,dyspepsia, nausea ,vomiting, abdominal pain, constipation flatulence, diarrhea , Edema including edema of lower limbs.
- Uncommon : Anemia ,vertigo, tinnitus, drowsiness ,Palpitations (In this case, symptomatic and supportive therapy should be given as appropriate.(ECG and blood ) potassium levels should be monitored, increase in blood pressure , flushes, gastrointestinal bleeding, gastrointestinal ulcers, esophagitis, stomatisis , Angioedema, pruritus , rash ,sodium and water retention, hyperkalaemia .
- Rare : disturbances of blood count :leucocytopenia , thrombocytopenia, agranulocytosis , anaphylactic / anaphylactoid reaction , Mood disorders, insomnia and nightmares,Confusion, Conjunctivitis , Visual disturbances including blurred vision , onset of asthma attacks in certain individuals allergic to aspirin or other NSAIDs, gastrointestinal perforation, gastritis, colitis ,peptic ulcers, perforation or gastrointestinal bleeding that may occur can be sometimes sever , especially in elderly patients , Hepatitis, Urticaria ,Steven –Johnson syndrome and toxic epidermal necrolysis , angioderma, bullous reactions , such as erythema multiform , photosensitivity reactions, Acute functional renal failure in patient with risk factors .
- Others : isolated cases of agranulocytosis have been reported in patients treated with Mobixin® and other potentially myelotoxic drugs.
Over dosage:
- In case of overdose the standard measures of gastric evacuation and general supportive measures should be used as there is no known antidote .It has been shown in a clinical trial that cholystyramin accelerated the elimination of Mobixin®.
¤ Oral dosage: The total daily amount should be taken as single dose ,with water or another liquid during meal.
¤ Undesirable effects may be minimized by using the lowest dose for the shortest duration necessary to control symptoms.
¤ The patient’s need for symptomatic relief , any response to therapy should be re-evaluated periodically ,especially in patient with osteoarthritis.
- Osteoarthritis: 7.5 mg/day .If necessary ,the dose may be increase to 15 mg/day.
- Rheumatoid arthritis: 15 mg/day According to the therapeutic response , the dose may decrease to 7.5 mg/day.
- Ankylosing spondylitis: 15 mg/day According to the therapeutic response the dose may decrease to 7.5 mg/day.
- In dialysis patients with severe renal failure: the dose should exceed 7.5 mg/day no dose reduction is required in patients with mild to rnoderate renal impairment (i.e. patients with a creatinine clearance of greater than 25ml/min) .
- Hepatic impairment: no dose reduction is required in patients with mild to rnoderate hepatic impairment.
- Elderly patients and patients with increased risks for adverse reactions:
- the recommended dose for long term treatment of rheumatic arthritis and ankylosing spondylitis in elderly patients is 7.5 mg/day .
- In patients with increased risks for adverse reactions:
- short treatment at dose of 7.5 mg/day.
- Adolescent: the maximum recommended dose 0.25 mg /kg
¤ as dose for use in children has not yet been established ,usage should be restricted to adolescent and adults.
¤ The maximum recommended daily dose of Mobixin® is 15 mg .
- Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
- The recommended maximum daily dose should not be exceeded in case of insufficient therapeutic effect , nor an additional should be added to the therapy because this may increase the toxicity with therapeutic advantage has been proven before starting treatment with Mobixin®.
- Any history of esophagitis ,gastritis and peptic ulcer must be sought in order to ensure their total cure , Attention should be paid to the possible onset of a recurrence in patient treated with Mobixin® and with a past history of this type.
- The use of Mobixin® with Concomitant NSAIDS inclnding cyclo-oxygenase II selective inhibitor should be avoided.
- Mobixin® 15 tablets (blister of 10 tablets ,pack of one blister).
- Mobixin® 7.5 tablets (blister of 10 tablets ,pack of two blister) .
- Mobixin® 15 suppositories (blister of 6 suppositories , pack of one blister) .
- Tablets: Store at a temperature below 30ºC in a dry place .
- suppositories: Store below 25°C ,and Protect from heat .