Loxidol 15 mg rectal suppositories 6's

The instruction for medical use of LOKSIDOL medicine the Trade name Loksidol Mezhdunarodnoye the unlicensed name Meloksikam Lekarstvennaya a form Suppositories rectal 15 mg Structure 1 suppository contains active agent - a meloksikam of 15 mg, excipients: makrogolglitserilgidroksistearat (Cremophor RH 40), fat firm (suppotsir AM) the Description Suppositories of pale yellow color, a torpedo-shaped form with a smooth fat surface Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs. Oksikama. ATX M01AC06 code Pharmacological Pharmacokinetics Absorption properties: parameters of absorption are similar to oral forms of drug. The maximum plasma concentration are observed in 5-6 hours after use of suppositories Loksidol. Distribution: to meloksika very well contacts proteins of plasma, especially albumine (99%). Gets into synovial fluid, concentration in synovial fluid makes about 50% of concentration in plasma. Distribution volume low, on average 11 liters. Metabolism: Meloksikam is almost completely metabolized in a liver with formation of the 4th pharmacological inactive derivatives. The main metabolite, 5 '-karboksimeloksikam (60% of dose size), is formed by oxidation of an intermediate metabolite, 5 '-hydroksimetilmeloksikama which is also excreted, but to a lesser extent (9% of dose size). Removal: Meloksikam is brought equally with a stake and urine, mainly in the form of metabolites. In not changed view with a stake less than 5% of the size of a daily dose are removed, in urine in not changed look drug is found only in trace quantities. Average elimination half-life of a meloksikam makes 20 hours. The plasma clearance averages 8 ml/min. At elderly patients the plasma clearance is a little lower. Pharmacokinetic parameters practically do not change in a renal/liver failure. The pharmacodynamics Loksidol is derivative enoliyevy acid and belongs to group of non-steroidal anti-inflammatory drugs, has anti-inflammatory, analgetic and febrifugal effect. The mechanism of action is caused by ability to inhibit biosynthesis of prostaglandins — inflammation mediators at the expense of selection inhibition of TsOG-2. Indications Symptomatic treatment of a pain syndrome - in an osteoarthritis (arthrosis, degenerative diseases of joints) - the pseudorheumatism ankylosing a spondylitis. A route of administration and doses For rectal use. Loksidol is applied on 1 suppository a day (15 mg of a meloksikam a day) as the risk of emergence of side reactions depends on the size of a dose and duration of use the drug it is necessary to take during shorter term. The maximum recommended dose makes 15 mg/day. Side effects - a digestive disturbance, nausea, vomiting, an abdominal pain, a konstipation, a meteorism, diarrhea Seldom: - gastrointestinal bleeding, an ulceration or perforation of heavy degree, especially at patients of advanced age is anemia, a leukopenia, thrombocytopenia, an agranulocytosis, especially in case of simultaneous treatment by a methotrexate - an itching, rash Infrequently - reaction of photosensitivity, a small tortoiseshell, Stephens's syndrome - Johnson and a toxic epidermal necrolysis, a Quincke's disease, vesical dermatitis as a mnogoformny erythema - anaphylactic/anaphylactoid reactions - to meloksika can cause asthma attack, in particular in persons with an allergy to aspirin or other non-steroidal anti-inflammatory drugs (NPVP) - feeling of intoxication, a headache, dizziness, a ring in ears, drowsiness, confusion of consciousness, orientation disturbance - hypostases, increase in the ABP, heartbeat, inflows - change of indicators of function of kidneys (the increased content of creatinine and/or urea in serum) and seldom acute renal failure - temporary increase in transaminase or bilirubin) Is rare - hepatitis - illegibility of sight of the Contraindication - the known hypersensitivity to a meloksikam or any component of drug. There is a probability of cross sensitivity to acetylsalicylic acid and other NPVP. Patients at whom earlier after intake of acetylsalicylic acid or other NPVP symptoms of bronchial asthma, nose polyposes, a Quincke's disease or a small tortoiseshell - existence in the anamnesis of gastrointestinal bleeding or perforation of NPVP connected with reception - a peptic ulcer of a stomach and duodenum in an aggravation phase - a heavy liver failure - a heavy renal failure (if the hemodialysis is not carried out) - gastrointestinal bleeding, recent cerebrovascular bleeding or other bleeding - heavy heart failure - existence in the history of a disease of a proctitis or rectal bleeding - children's age to 15 years - pregnancy and the period of a lactation Medicinal interactions Other NPVP, including salicylates (acetylsalicylic acid) were noted cannot appoint drug: simultaneous use more than one NPVP increases risk of formation of ulcers in zheludochno – an intestinal path and gastrointestinal bleedings owing to synergism of action. Combined use of a meloksikam and other NPVP is not recommended. Anticoagulants, antiagregant, heparin for system use, thrombolytic means: increase risk of bleeding. In case of impossibility to avoid simultaneous use of these drugs, careful observation of effect of anticoagulants is necessary. Lithium: NPVP increase concentration of lithium in plasma due to decrease in renal excretion of lithium. Combined use of lithium and NPVP is not recommended. In case of need such combination therapy should control concentration of lithium in plasma in an initiation of treatment, at selection of a dose and cancellation of a meloksikam. Methotrexate: NPVP can reduce canalicular secretion of a methotrexate and thus increase concentration of a methotrexate in plasma. In need of combination therapy it is necessary to control a blood count and function of kidneys. It is necessary to be careful if NPVP and a methotrexate are applied at the same time within 3 days since concentration of a methotrexate in plasma can increase and, as a result, there can be toxic effects. Cyclosporine: NPVP, having effect on renal prostaglandins, can increase nephrotoxicity of cyclosporine. In case of performing combination therapy it is necessary to control function of kidneys. Intrauterine contraceptives: NPVP reduce efficiency of intrauterine contraceptives. Diuretics: use of NPVP increases risk of developing an acute renal failure at patients with dehydration. The patients accepting at the same time to meloksika and diuretics have to receive enough liquid. Prior to treatment the research of function of kidneys is necessary. Antihypertensive drugs (for example, beta blockers, inhibitors of angiotensin-converting enzyme (APF), vazodilatator, diuretics) NPVP reduce effect of antihypertensive drugs owing to inhibition of prostaglandins having vazodilatiruyushchy properties. Holestiramin: increases removal of a meloksikam owing to binding it in zheludochno – an intestinal path. The special instructions Loksidol's Use, as well as other NPVP, demands strict observation of patients with gastrointestinal diseases in the anamnesis and also for the patients accepting anticoagulants. NPVP inhibit synthesis of the renal prostaglandins necessary for maintenance of a renal blood-groove. With a reduced renal blood-groove the use of NPVP can cause the renal failure disappearing after drug withdrawal in patients. At patients with slightly or moderate renal failures the dose of drug can be not reduced, however careful control of function of kidneys is necessary. In separately exceptional cases of NPVP can lead ment of interstitial nephrite, glomerulonephritis, renal medullary necrosis or development of a nephrotic syndrome. Patients with chronic kidney disease, after extensive surgeries (which caused a hypovolemia) and also patients with cirrhosis are inclined to such complications. Control of a diuresis and function of kidneys from the very beginning of therapy is in that case necessary. NPVP at joint reception with diuretics can strengthen a delay of sodium, potassium and water in an organism and to affect natriuretic effect of diuretic drugs owing to what at predisposed patients the heart failure or arterial hypertension can arise or amplify. With care appoint drug to the weakened patients, elderly people, patients with heart failure. Loksidol, as well as any other NPVP, can mask symptoms of the basic infectious disease. As well as other medicines inhibiting synthesis of COG/prostaglandins, to meloksika can damage to fertilization process therefore it is not recommended to women who are going to become pregnant. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Should abstain from driving or mechanisms to the patients noting any side effects from the central nervous system. Overdose Symptoms: strengthening of side effects. Treatment: symptomatic the Form of release and packing On 3 suppositories in blister strip packaging from PVC with polyethylene of low density. 2 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not higher than 25 0 C. To store out of children's reach. 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription K.O Producer. "MASTER К&К S.R. L. ", Boulevard Aurel Влайку № 82А, Constanta, Romania (S.C. 'MAGISTRA С&С S.R.L.', 82A of Aurel Vlaicu Blvd., Constanta, Romania). The owner of the registration certificate of UORLD MEDITSIN LIMITED, Great Britain Vladelets of a trademark and the certificate of registration is the UORLD MEDITSIN LIMITED company, GREAT BRITAIN ('WORLD MEDICINE LIMITED', GREAT BRITAIN).
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