Teva-Meloxicam 15mg tab 20 pc

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Teva-Meloxicam 15mg tab 20 pc

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Description

Composition
Active substance:
15 mg meloxicam
Excipients:
lactose monohydrate 69.7 mg microcrystalline cellulose 56.0 mg Sodium Citrate dihydrate 18.0 mg, Povidone K30 6.0 mg Crospovidone 12.0 mg silica colloidal 1.5 mg magnesium stearate 1.8 mg .
Description:
Tablets oval of yellow color, with a light “marble”. On one side of the separation of risk, on the other – engraving «MLX 15″.
Product form:
Tablets of 15 mg.
10 tablets in a blister made of PVC / PE / PVDC / Al foil. 2 in the blister pack carton along with instructions for use.
Contraindications
– Hypersensitivity to the active ingredient or auxiliary ingredients. There is a possibility of cross-sensitivity to acetylsalicylic acid and other NSAIDs.
– full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history).
– Erosive and ulcerative lesions of the stomach and duodenum in the acute stage or recently transferred.
– inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute stage.
– Severe hepatic insufficiency.
– Severe renal insufficiency (unless hemodialysis, less than 30 ml / min creatinine clearance, as well as confirmed hyperkalemia), progressive renal disease.
– active gastrointestinal bleeding, cerebrovascular bleeding recently transferred or established diagnosis of diseases of the blood coagulation system.
– Severe uncontrolled heart failure.
– Pregnancy.
– The period of breastfeeding.
– Treatment of perioperative pain during coronary artery bypass.
– Children up to age 12 years.
– Rare hereditary galactose intolerance (maximum daily dose of drug at a dosage of 7.5 mg meloxicam and 15 mg contains 47 mg lactose and 20 mg, respectively).
Be wary – Coronary heart disease.
– Cerebrovascular disease.
– Chronic heart failure.
– Renal failure (creatinine clearance of 30-60 ml / min).
– Dyslipidemia / Hyperlipidemia.
– Diabetes.
– Peripheral Arterial Disease.
– Smoking.
– Diseases of the gastrointestinal tract in history (peptic ulcer and 12 duodenal ulcer, liver disease).
– Elderly age.
– Long-term use of NSAIDs.
– Frequent use of alcohol.
– Concomitant therapy following medications: anticoagulants (including warfarin), antiplatelet agents, oral corticosteroids (e.g., prednisone), selective serotonin reuptake inhibitor (including citalopram, fluoxetine, paroxetine, sertraline).
Dosage
15 mg
Indications
Cimptomaticheskoe treatment:
– osteoarthritis (arthrosis, degenerative joint disease), including those with painful component;
– rheumatoid arthritis;
– ankylosing spondylitis
Interaction with other drugs
– other inhibitors of prostaglandin synthesis, including glucocorticoids and salicylates:
concomitant use of meloxicam with an increased risk of ulcers in the gastrointestinal tract and gastrointestinal bleeding (due to synergy of action). Simultaneous treatment with other NSAIDs is not recommended.
– Anticoagulants for oral administration for systemic use heparin, thrombolytic agents: simultaneous with meloxicam increases the risk of bleeding. In the case of simultaneous application of careful monitoring of the blood coagulation system.
– Antiplatelet agents, serotonin reuptake inhibitors: Simultaneous reception with meloxicam increases the risk of bleeding due to inhibition of platelet function. In the case of simultaneous application of careful monitoring of the blood coagulation system.
– lithium Formulations: NSAIDs increase the level of lithium in the plasma by reducing its excretion by the kidneys. The simultaneous use of meloxicam with lithium therapy is not recommended. If necessary, the simultaneous use recommended careful control of the concentration of lithium in the plasma during the course of application of drugs lithium.
– Methotrexate: Methotrexate NSAIDs reduce the secretion by the kidneys, thereby increasing its concentration in plasma. The simultaneous use of meloxicam and methotrexate (in a dose of 15 mg per week) did not recommended. In the case of simultaneous use of careful monitoring of renal function and blood formula. Meloxicam may enhance methotrexate hematologic toxicity, particularly in patients with impaired renal function. When the joint application of meloxicam and methotrexate within 3 days increases the risk of increasing the toxicity of the latter.
– Contraception: there is evidence that NSAIDs may reduce the effectiveness of intrauterine contraceptive devices, but this is not proven.
– Diuretics: NSAIDs in the case of dehydration of patients with a risk of developing acute renal failure.
– Antihypertensive agents (beta-blockers, ACE inhibitors, vasodilators, diuretics): NSAIDs reduce the effect of antihypertensive agents by inhibiting prostaglandins having vasodilating properties.
– Antagonists of angiotensin-II receptors: when combined with NSAIDs enhance reduction of glomerular filtration, which can lead to acute renal failure, especially in patients with impaired renal function.
– Cholestyramine: linking meloxicam in the gastrointestinal tract, cholestyramine leads to its more rapid removal.
– Ciclosporin: NSAIDs, exerting effects on renal prostaglandins may enhance the nephrotoxicity of cyclosporin.
– In the application of meloxicam in conjunction with drugs which have a certain ability to inhibit CYP2C9, and / or CYP3A4 (or metabolized by the participation of these enzymes) should take into account the possibility of a pharmacokinetic interaction.
– We can not exclude the possibility of interaction with antidiabetic drugs for oral administration.
– With the simultaneous use of antacids, cimetidine, digoxin and furosemide significant pharmacokinetic interactions have been identified.
Overdose
Data on cases of drug overdose is not enough. Likely to present symptoms characteristic of an overdose of NSAIDs, in severe cases, drowsiness, impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, changes in blood pressure, acute renal failure,
respiratory arrest, asystole.
Treatment: an antidote is not known; in the case of an overdose of the drug should carry out the evacuation of the stomach contents and general supportive therapy. Cholestyramine accelerates the elimination of meloxicam.
pharmachologic effect
Pharmacological group:
nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
Meloxicam – a non-steroidal anti-inflammatory drug, refers to derivatives enolovoy acid and has anti-inflammatory, analgesic and antipyretic action. Pronounced antiinflammatory action of meloxicam is set on all standard models of inflammation. The mechanism of action of meloxicam is its ability to inhibit prostaglandin synthesis – known inflammatory mediators.
Meloxicam in vivo inhibits prostaglandin synthesis at the site of inflammation to a greater extent than in the gastric mucosa and kidney. These differences are associated with a selective inhibition of cyclooxygenase-2 (COX-2) over cyclooxygenase-1 (COX-1). It is believed that inhibition of COX-2 provides therapeutic effects of NSAIDs, while the inhibition constant present isoenzyme COX-1 may be responsible for side effects in the stomach and kidney. Meloxicam selectivity for COX-2 was confirmed in various testsistemah as in vitro, so in vivo. Selective meloxicam ability to inhibit COX-2 is shown when used as a test system in vitro whole blood.
It has been established that meloxicam (at doses of 7.5 and 15 mg) actively inhibited COX-2 by providing a greater inhibitory effect on prostaglandin E2 production stimulated by lipopolysaccharide (reaction controlled by COX-2) than for the products of a thromboxane involved in blood clotting (reaction controlled by COX-1). These effects depend on the dose. In ex vivo studies have demonstrated that meloxicam (in doses of 7.5 mg and 15 mg) has no effect on platelet aggregation, and bleeding time.
In clinical studies, side effects from the gastrointestinal tract (GIT) is generally less likely to arise when receiving meloxicam 7.5 mg and 15 than the reception of other NSAIDs, which were compared. This difference in the incidence of side effects from the gastrointestinal tract is mainly due to the fact that when taking meloxicam rarely observed phenomena such as dyspepsia, vomiting, nausea, abdominal pain. The frequency of the perforations in the upper gastrointestinal tract ulceration and bleeding, are contacted with meloxicam, it was low and was dependent on the dose of the drug.
Pharmacokinetics:
Absorption.
Meloxicam is well absorbed from the gastrointestinal tract, as evidenced by a high absolute bioavailability (90%) after oral administration of the drug.
After a single application of meloxicam maximum plasma concentrations achieved within 5-6 hours. Simultaneous food intake and inorganic antacids does not alter absorption. When using the drug administration (at doses of 7.5 and 15 mg) doses are proportional to its concentration. Steady state pharmacokinetics is achieved within 3-5 days. The range differences between the maximum and basal concentrations of the drug after administration once a day is relatively small and is at a dose of 7.5 mg 0.4-1.0 g / ml, and at a dose of 15 mg – 0.8-2, 0 g / ml (shown, respectively, Cmin and Cmax values ​​during steady-state pharmacokinetics) although observed and values ​​outside the specified range.
The maximum concentration of meloxicam in plasma during the steady-state pharmacokinetics is achieved 5-6 hours after ingestion.
Distribution.
Meloxicam very well bound to plasma proteins, mainly albumin (99%). Penetrates into the synovial fluid; concentration in the synovial fluid of approximately 50% concentration in plasma. The volume of distribution after repeated oral administration of meloxicam (at doses ranging from 7.5 mg to 15 mg) is about 16 liters, with a coefficient of variation from 11 to 32%.
Metabolism.
Meloxicam is almost completely metabolized in the liver to form 4 pharmacologically inactive derivatives. The main metabolite, 5′-karboksimeloksikam (60% of the dose), formed by oxidation of an intermediate metabolite 5’gidroksimetilmeloksikama which is also excreted, but to a lesser extent (9% of the dose). In vitro studies have shown that this metabolic transformation plays an important role of CYP2C9, the added value is the CYP3A4 isoenzyme. The formation of two other metabolites (components, respectively, 16% and 4% of the dose) participates peroxidase activity which probably varies individually.
Withdrawal.
Displayed equally through the intestine and the kidney, mainly in the form of metabolites. In an unmodified form with the faeces derived at least 5% of the daily dose in the urine as unchanged drug is detected only in trace amounts.
The average half-life of meloxicam ranging from 13 to 25 hours.
Plasma clearance averages 12.7 ml / min after a single dose of meloxicam.
Impaired function of the liver and / or kidney. Liver failure, and kidney failure weakly expressed significant effect on the pharmacokinetics of meloxicam has not. The rate of excretion from the body of meloxicam significantly higher in patients with moderate renal insufficiency. Meloxicam is less bound to plasma proteins in patients with end-stage renal failure. When ESRD increase in the volume of distribution can result in higher concentrations of free meloxicam, so these patients the daily dose should not exceed 7.5 mg.
Elderly patients.
Elderly patients compared to younger patients have similar pharmacokinetic parameters. In elderly patients, the mean plasma clearance between the equilibrium state pharmacokinetics is slightly lower than in younger patients. In women older higher values ​​of AUC (area under the concentration-time curve) and a long half-life compared to young patients of both sexes.
Pregnancy and breast-feeding
Pregnancy
Use of the drug meloxicam-Teva is contraindicated during pregnancy.
Breast-feeding
It is known that NSAIDs penetrate into breast milk, therefore the use of the drug meloxicam-Teva during breast-feeding is contraindicated.
fertility
As a drug that inhibits the synthesis of cyclooxygenase / prostaglandin-meloxicam Teva may have an effect on fertility, and is therefore not recommended for women planning pregnancy. Meloxicam can cause delay ovulation. Therefore, in women who have difficulty conceiving and passing examination about such problems, we recommend removal of the drug meloxicam-Teva.
Conditions of supply of pharmacies
Prescription.
side effects
The following describes adverse reactions, whose connection with the use of meloxicam
It regarded as possible.
The incidence of adverse reactions within the system-organ classes determined in accordance with the recommendations of the World Health Organization: very common (>
1/10); often (> 1/100 1/1000 1/10000
From the blood and lymphatic system: rarely – anemia; rarely – change in the number of blood cells, including changes in leukocyte counts, leukopenia, thrombocytopenia; very rare: agranulocytosis *.
Immune system: Infrequent – other reactions of immediate type hypersensitivity; frequency is unknown – anaphylactic shock (for intramuscular injection), anaphylactoid reactions.
From the nervous system: often – headache; rarely – dizziness, drowsiness.
Mental disorders: often – mood changes, nightmares; frequency is unknown –
confusion, disorientation.
From a sight organ: seldom – conjunctivitis, visual disturbances, including blurred vision.
On the part of the organ of hearing: rare – vertigo; rarely – ringing in the ears.
Gastro-intestinal tract: often – abdominal pain, dyspepsia, diarrhea, nausea, vomiting; rarely – constipation, abdominal distention, stomatitis, gastritis, belching, implicit or explicit gastrointestinal bleeding **; rarely – gastroduodenal ulcers, colitis,
esophagitis; very rarely – perforation of the gastrointestinal tract; frequency is unknown –
pancreatitis.
Liver: infrequently – transient changes in liver function indicators (e.g., elevated transaminases or bilirubin); very rarely – hepatitis.
Skin and subcutaneous tissue disorders: rarely – angioneurotic edema, itching, skin rash; rarely – toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria; very rare – bullous dermatitis, erythema multiforme; frequency is unknown – photosensitivity reactions.
The respiratory system: rarely – asthma in patients allergic to acetylsalicylic acid or other NSAIDs.
Of the heart: rarely – palpitations, the frequency is unknown – heart failure (associated with NSAID).
On the part of the vessels: Infrequent – increased blood pressure, a sense of “tide” of blood to the face.
The kidneys and the urinary tract: infrequently – hyperkalemia, change indicators of renal function (increased creatinine and / or urea in blood serum), urination disorders, including acute urinary retention; very rarely – acute renal failure in patients with risk factors (see “Special Instructions” section.).
General disorders: Infrequent – edema, including swelling of the lower extremities.
Description of the individual undesirable reactions * predisposing factor for agranulocytosis is potentially myelotoxic simultaneous use of drugs, particularly methotrexate.
** Gastrointestinal bleeding ulcer or perforation can be fatal.
As with other NSAIDs there is a possibility of occurrence of interstitial nephritis,
glomerulonephritis, renal medullary necrosis, nephrotic syndrome.
special instructions
Patients suffering from diseases of the gastrointestinal tract should be monitored regularly. In the event of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding drug meloxicam-Teva should be abolished.
Ulcers of the gastrointestinal tract, perforation or bleeding may occur during the use of NSAIDs at any time, as in the presence of warning signs or information about serious gastrointestinal complications in history, and in the absence of these signs. The consequences of these complications are generally more serious in the elderly.
In applying the drug-Teva Meloxicam can develop such serious skin reactions, as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. In this regard, special attention should be given to patients reporting of adverse events by the skin and mucous membranes, as well as hypersensitivity reactions to the drug, especially if such reactions were observed during the previous courses of treatment. The development of such reactions occur usually within the first month of treatment. In the case of the first signs of skin rash, mucosal changes or other signs of hypersensitivity should be considered the question of terminating the application of the drug meloxicam-Teva.
Описаны случаи при приеме НПВП повышения риска развития серьезных сердечнососудистых тромбозов, инфаркта миокарда, приступа стенокардии, возможно со смертельным исходом. Такой риск повышается при длительном применении препарата, а также у пациентов с вышеуказанными заболеваниями в анамнезе и предрасположенных к таким заболеваниям.
НПВП ингибируют в почках синтез простагландинов, которые участвуют в поддержании почечной перфузии. Применение НПВП у пациентов со сниженным почечным кровотоком или уменьшенным объемом циркулирующей крови может привести к декомпенсации скрыто протекающей почечной недостаточности. После отмены НПВП функция почек обычно восстанавливается до исходного уровня. В наибольшей степени риску развития этой реакции подвержены пожилые пациенты; пациенты, у которых отмечается дегидратация, хроническая сердечная недостаточность, цирроз печени, нефротический синдром или острые нарушения функции почек; пациенты, одновременно принимающие диуретические средства, ингибиторы ангиотензинпревращающего фермента, антагонисты ангиотензин II рецепторов; а также пациенты, перенесшие серьезные хирургические вмешательства, которые ведут к гиповолемии. У таких пациентов в начале терапии следует тщательно контролировать диурез и функцию почек.
Применение НПВП совместно с диуретиками может приводить к задержке натрия, калия и воды, а также к снижению натрийуретического действия мочегонных средств. В результате этого у предрасположенных пациентов возможно усиление признаков сердечной недостаточности или артериальной гипертензии. В связи с этим необходим тщательный контроль состояния таких пациентов, а также у них должна поддерживаться адекватная гидратация. До начала лечения необходимо исследование функции почек.
В случае проведения комбинированной терапии следует также контролировать функцию почек.
При применении препарата Мелоксикам-Тева (так же как и большинства других НПВП) возможно эпизодическое повышение активности трансаминаз в сыворотке крови или других показателей функции печени. В большинстве случаев это повышение было небольшим и преходящим. Если выявленные изменения существенны или не уменьшаются со временем, препарат Мелоксикам-Тева следует отменить и проводить наблюдение за выявленными лабораторными изменениями.
Ослабленные или истощенные пациенты могут хуже переносить нежелательные явления, в связи с чем такие пациенты должны тщательно наблюдаться.
Подобно другим НПВП препарат Мелоксикам-Тева может маскировать симптомы основного инфекционного заболевания.
Как препарат, ингибирующий синтез циклооксигеназы/простагландина, препарат Мелоксикам-Тева может оказывать влияние на фертильность и поэтому не рекомендуется женщинам, имеющим трудности с зачатием. В связи с этим у женщин, проходящих обследование по этому поводу, рекомендуется отмена препарата Мелоксикам-Тева.
У пациентов с легкой или умеренной почечной недостаточностью (клиренс креатинина более 25 мл/мин) коррекции дозы не требуется.
У пациентов с циррозом печени (компенсированным) коррекции дозы не требуется.
The effect on the ability to operate vehicles, machinery
Специальных исследований в отношении влияния препарата на способность управлять транспортными средствами и механизмами не проводилось. Однако при управлении транспортными средствами и механизмами следует принимать во внимание возможность развития головокружения, сонливости, нарушения зрения или других нарушений со стороны нервной системы. Пациентам следует соблюдать осторожность при управлении транспортными средствами и механизмами.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children!
Dosing and Administration
Inside.
Общую суточную дозу следует принимать в один прием, во время еды, запивая водой или другой жидкостью.
Osteoarthritis: 7.5 mg. При необходимости эта доза может быть увеличена до 15 мг в сутки.
Rheumatoid Arthritis: 15 mg per day. В зависимости от лечебного эффекта эта доза может быть снижена до 7,5 мг в сутки.
Ankylosing spondylitis 15 mg per day. В зависимости от лечебного эффекта эта доза может быть снижена до 7,5 мг в сутки.
У пациентов с повышенным риском нежелательных реакций рекомендуется начинать лечение с дозы 7,5 мг в день.
У пациентов с тяжелой почечной недостаточностью, находящихся на гемодиализе, доза не должна превышать 7,5 мг в день.
Общие рекомендации
Так как потенциальный риск нежелательных реакций зависит от дозы и продолжительности лечения, следует использовать максимально возможные низкие дозы и короткую продолжительность применения.
The maximum recommended daily dose – 15 mg.
Комбинированное применение
You should not use the drug in conjunction with other NSAIDs.
Суммарная суточная доза препарата Мелоксикам-Тева, применяемого в виде разных лекарственных форм, не должна превышать 15 мг.
Children and adolescents
Максимальная доза у подростков составляет 0,25 мг/кг.
Препарат противопоказан детям до 12 лет.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TEVA

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