Movalis tab 15mg 20 pc

Description

Composition
Active substance:
1 tablet contains: meloxicam – 7.5 mg or 15.0 mg.
Excipients:
Sodium citrate dihydrate – 15 mg (30 mg), lactose monohydrate – 23.5 mg (20 mg), microcrystalline cellulose – 102 mg (87.3 mg), povidone K25 – 10.5 mg (9 mg), colloidal silicon dioxide – 3.5 mg (3 mg), crospovidone – 16.3 mg (14 mg), magnesium stearate – 1.7 mg.
Description:
7.5 mg Tablets
Round, from pale yellow to yellow pills. One side is convex with a beveled edge. On the convex side – company logo; on the other side – the code and the concave risk. Allowed roughness tablets.
15 mg Tablets
Round, from pale yellow to yellow pills. One side is convex with a beveled edge. On the convex side – company logo; on the other side – the code and the concave risk. Allowed roughness tablets.
Product form:
Tablets of 7.5 mg or 15.0 mg. 10 tablets in a blister made of PVC / Al-foil, or PVC / PVDC / Al-foil. 1 or 2 blisters together with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to the active ingredient or auxiliary components of the drug;
Full or partial combination of asthma, recurrent nasal polyposis, and paranasal sinuses, urticaria or angioedema caused by intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs due to cross-sensitivity of the existing probability (including history);
Erosive and ulcerative lesions of the stomach and duodenum in the acute stage or recently transferred;
Inflammatory bowel disease – Crohn’s disease or ulcerative colitis in the acute stage;
Severe hepatic insufficiency;
Severe renal failure (if left hemodialysis, less than 30 ml / min creatinine clearance, as well as the confirmed hyperkalemia), progressive kidney disease;
Active gastrointestinal bleeding, cerebrovascular bleeding recently transferred or established diagnosis of blood coagulation disorders
Expressed uncontrolled heart failure;
Pregnancy;
Breast-feeding;
Therapy perioperative pain during coronary artery bypass surgery;
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).
Precautions: diseases of the gastrointestinal tract in history (gastric ulcer and duodenal ulcer 12-, liver disease); congestive heart failure; renal failure (creatinine clearance 30 – 60 ml / min); coronary artery disease; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; concomitant therapy following preparations: oral steroids, anticoagulants (including warfarin), antiplatelet agents, selective serotonin reuptake inhibitor (including citalopram, fluoxetine, paroxetine, sertraline); peripheral artery disease; elderly age; long-term use of NSAIDs; smoking; Frequent use of alcohol. Pregnancy and lactation.
Dosage
15 mg
Indications
Symptomatic treatment of osteoarthritis (arthrosis, degenerative joint disease), including those with painful component; rheumatoid arthritis; ankylosing spondylitis; other inflammatory and degenerative diseases of the musculoskeletal system such as arthropathies, dorsopathies (e.g., sciatica, low back pain, shoulder periarthritis, etc.), accompanied by pain.
Interaction with other drugs
Other inhibitors of prostaglandin synthesis, including glucocorticoids and salicylates – simultaneous with meloxicam increases the risk of formation of ulcers in the gastrointestinal tract and gastrointestinal bleeding (due to synergistic actions). 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 drugs, selective serotonin reuptake inhibitors – simultaneous 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.
Formulations lithium – lithium NSAIDs increase the level 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
MTX – 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 – the use of 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, as well as inhibitors of angiotensin converting enzyme or combined with NSAIDs decreased glomerular filtration increase, thereby, may lead to the development of acute renal failure, especially in patients with impaired renal function.
Cholestyramine, linking meloxicam in the gastrointestinal tract, leading to its more rapid removal.
NSAIDs, exerting effects on renal prostaglandins may enhance the nephrotoxicity of cyclosporin.
Pemetrexed – while the use of meloxicam and pemetrexed in patients with a creatinine clearance of 45 to 79 ml / min should stop reception of meloxicam five days before the beginning of the reception and pemetrexed may resume after 2 days after dosing. If there is a need for joint use of meloxicam and pemetrexed, the patients should be carefully monitored, especially in respect of myelosuppression and the occurrence of side effects from the gastrointestinal tract. In patients with a creatinine clearance less than 45 mL / min reception meloxicam together with pemetrexed is not recommended.
When used in conjunction with meloxicam drugs which have a certain ability to inhibit CYP 2C9 and / or CYP 3A4 (or metabolized by the participation of these enzymes), such as derivatives of sulphonylurea or probenecid, should take into account the possibility of a pharmacokinetic interaction.
When combined with anti-diabetic agents for oral administration (e.g., sulfonylureas, nateglinide) possible interactions mediated CYP 2C9, which may lead to increased concentrations of both of these drugs, and meloxicam in blood. Patients taking concomitant meloxicam with sulfonylurea or nateglinide should carefully monitor blood sugar levels due to the possibility of hypoglycemia.
With simultaneous use of antacids, cimetidine, furosemide and digoxin, significant pharmacokinetic interactions have been identified.
Overdose
Data on cases of drug overdose has accumulated enough. Likely to present symptoms characteristic of an overdose of NSAIDs, in severe cases, drowsiness, impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, changes in blood pressure, respiratory arrest, asystole.
Treatment: an antidote is not known, in the case of overdose should be carried out: the evacuation of the stomach contents and general supportive therapy. Cholestyramine accelerates the elimination of meloxicam.
pharmachologic effect
Pharmacological group:
Nonsteroidal antiinflammatory drugs – NSAIDs.
Pharmacodynamics:
Movalis is a nonsteroidal antiinflammatory 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 iso-enzyme COX-1 may be responsible for side effects in the stomach and kidney. Meloxicam selectivity against COX-2 is confirmed in various test systems as in vitro, and in vivo. Selective meloxicam ability to inhibit COX-2 is shown when used as a test system in vitro human 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 when other NSAID, with which it was 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 con centration of the drug in the plasma is attained 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 of 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: very good meloxicam binds to plasma proteins, mainly albumin (99%). Penetrates into the synovial fluid, synovial fluid concentration is about 50% of plasma concentrations. 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 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.
Excretion: output 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 is an average of 7 – 12 ml / min after a single dose of meloxicam.
Lack of liver and / or kidney: liver function failure, and is also weakly expressed renal insufficiency 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
It is known that NSAIDs penetrate into breast milk, therefore the use of movalis drug during lactation is contraindicated. As a drug that inhibits the synthesis of cyclooxygenase / prostaglandin movalis can affect fertility, and is therefore not recommended for women planning pregnancy. Meloxicam may lead to delay ovulation. Therefore, in women who have difficulty conceiving and passing examination about such problems, we recommend canceling the reception movalis drug.
Conditions of supply of pharmacies
By prescription.
side effects
The following describes the side effects, whose connection with the drug movalis, regarded as possible.
Side effects registered in post-marketing use, whose connection with the drug intake was regarded as possible are marked with *.
Inside the system-organ classes uses the following categories in the incidence of side effects: very common (> 1/10); common (> 1/100, 1 / 1,000, 1 / 10,000,
From the blood and lymphatic system
It is not often – anemia;
Rarely – change in the number of blood cells, including changes in leukocyte counts, leucopenia, thrombocytopenia.
By the immune system
Infrequently – other reactions of immediate type hypersensitivity *;
Not found – anaphylactic shock * * anaphylactoid reactions.
From the nervous system
Often – headache;
It is not often – dizziness, drowsiness.
mental disorders
Often – mood changes *;
Not set – confusion *, disorientation *.
From the senses
Infrequently – vertigo;
Rarely – * conjunctivitis, visual disturbances, including blurred vision *, tinnitus.
On the part of the gastrointestinal tract
Often – abdominal pain, dyspepsia, diarrhea, nausea, vomiting;
Infrequently – implicit or explicit gastrointestinal bleeding, gastritis *, stomatitis, constipation, bloating, belching;
Rarely – gastroduodenal ulcers, colitis, esophagitis;
Very rarely – perforation of the gastrointestinal tract.
Liver
Infrequently – transient changes in liver function (e.g., increasing fktivnosti transaminases or bilirubin);
Very rarely – hepatitis. *
Skin and subcutaneous tissue disorders
Infrequently – angioedema *, pruritus, skin rash;
Rarely – toxic epidermal necrolysis *, Stevens-Johnson Syndrome, urticaria;
Very rare – bullous dermatitis *, erythema multiforme *;
Not found – photosensitivity.
The respiratory system
Rarely – asthma in patients allergic to acetylsalicylic acid or other NSAIDs.
Cardio – vascular system
Infrequent – increased blood pressure, a sense of “tide” of blood to the face;
Rarely – palpitations.
With the genitourinary system
Infrequently – change indicators of renal function (increased creatinine and / or urea in blood serum), urination disorders, including acute urinary retention *;
Very rarely – acute renal failure *.
On the part of genitals and mammary gland
Infrequently – late ovulation *;
Not found – infertility in women. *
The combined use of drugs, depressing the bone marrow (e.g., methotrexate) may provoke cytopenia.
Gastrointestinal hemorrhage, ulcer or perforation can be fatal.
As with other NSAIDs do not exclude the possibility of interstitial nephritis, glomerulonephritis, renal medullary necrosis, nephrotic syndrome.
special instructions
Пациенты, страдающие заболеваниями желудочно-кишечного тракта, должны регулярно наблюдаться. При возникновении язвенного поражения желудочно- кишечного тракта или желудочно-кишечного кровотечения МОВАЛИС необходимо отменить. Язвы желудочно-кишечного тракта, перфорация или кровотечения могут возникнуть в ходе применения НПВП в любое время, как при наличии настораживающих симптомов или сведений о серьезных желудочно-кишечных осложнениях в анамнезе, так и при отсутствии этих признаков. Последствия данных осложнений в целом более серьезны у лиц пожилого возраста. При применении препарата МОВАЛИС могут развиваться такие серьезные реакции со стороны кожи, как эксфолиативный дерматит, синдром Стивенса-Джонсона, токсический эпидермальный некролиз. Поэтому следует уделять особое внимание пациентам, сообщающим о развитии нежелательных явлений со стороны кожи и слизистых оболочек, а также реакций повышенной чувствительности к препарату, особенно, если подобные реакции наблюдались в течение предыдущих курсов лечения. Развитие подобных реакций наблюдается, как правило, в течение первого месяца лечения. В случае появления первых признаков кожной сыпи, изменений слизистых оболочек или других признаков гиперчувствительности должен рассматриваться вопрос о прекращении применения препарата МОВАЛИС. Описаны случаи при приеме НПВП повышения риска развития серьезных сердечно- сосудистых тромбозов, инфаркта миокарда, приступа стенокардии, возможно со смертельным исходом. Такой риск повышается при длительном применении препарата, а также у пациентов с выше указанными 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, застойная сердечная недостаточность, цирроз печени, нефротический синдром или острые нарушения функции почек, пациенты, одновременно принимающие диуретические средства, ингибиторы АПФ, 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 гипертензии. Поэтому 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 использовании препарата МОВАЛИС (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, МОВАЛИС 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, МОВАЛИС может маскировать симптомы основного инфекционного заболевания. Как препарат, ингибирующий синтез циклооксигеназы/простагландина, МОВАЛИС 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 приема препарата МОВАЛИС. У пациентов со слабой или умеренной почечной недостаточностью (клиренс креатинина более 25 мл/мин) коррекции дозы не требуется. У пациентов с циррозом печени (компенсированным) коррекции дозы не требуется. Влияние на способность управлять автомобилем и другими механизмами Специальных клинических исследований влияния препарата на способность управлять автомобилем и механизмами не проводилось. Однако при управлении автомобилем и работе с механизмами следует принимать во внимание возможность развития головокружения, сонливости, нарушения зрения или других нарушений со стороны центральной нервной системы. Пациентам следует соблюдать осторожность при вождении автомобиля и управлении механизмами.
Storage conditions
Таблетки при температуре не выше 25 °С. Keep out of the reach of children.
Dosing and Administration
Остеоартрит с болевым синдромом: 7,5 мг в сутки. При необходимости эта доза может быть увеличена до 15 мг в день.
Ревматоидный артрит: 15 мг в сутки. В зависимости от лечебного эффекта эта доза может быть снижена до 7,5 мг в день.
Анкилозирующий спондилит: 15 мг в сутки. В зависимости от лечебного эффекта эта доза может быть снижена до 7,5 мг в день.
У пациентов с повышенным риском побочных реакций (заболевания желудочно- кишечного тракта в анамнезе, наличие факторов риска сердечно-сосудистых заболеваний) рекомендуется начинать лечение с дозы 7,5 мг в день (см. Особые указания).
У пациентов с выраженной почечной недостаточностью, находящихся на гемодиализе доза не должна превышать 7,5 мг в день.
Общие рекомендации
Так как потенциальный риск побочных реакций зависит от дозы и продолжительности лечения следует использовать максимально возможные низкие дозы и длительность применения. Максимальная рекомендуемая суточная доза – 15 мг.
Комбинированное применение
You should not use the drug in conjunction with other NSAIDs. Суммарная суточная доза препарата МОВАЛИС, применяемого в виде разных лекарственных форм не должна превышать 15 мг.
Подростки
Максимальная доза у подростков (12 – 18 лет) составляет 0,25 мг/кг и не должна превышать 15 мг
Применение таблеток
Препарат противопоказан детям до 12 лет вследствие невозможности подбора соответствующей дозировки для этой возрастной группы. Общую суточную дозу следует принимать в один прием, во время еды, запивая водой или другой жидкостью.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist