Flamadeks tab n / 25mg film about 10 pc

$4.27

Flamadeks tab n / 25mg film about 10 pc

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Description

Composition
Active substance:
dexketoprofen trometamol – 36.9 mg, in terms of dexketoprofen – 25 mg;
Excipients:
microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch (sodium starch glycolate), magnesium stearate;
shell composition: titanium dioxide, hypromellose (hypromellose 2910), polydextrose, macrogol.
Description:
Round biconvex tablets, film-coated white color, with the notch on both sides. The cross-sectional core of a white or nearly white.
Product form:
Tablets, film-coated, 25 mg.
10 tablets in blisters of PVC film and aluminum foil.
1 contour cellular packaging together with instructions for use in a stack of cardboard.
Contraindications
– hypersensitivity to deksketoprofenu, other ingredients, 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 gastrointestinal tract in the acute stage;
– gastrointestinal bleeding or perforation history, including those related to the previous use of NSAIDs;
– gastrointestinal bleeding or other active bleeding (including suspected intracranial hemorrhage);
– inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute stage;
– severe hepatic impairment severity (10-15 points on a scale Child-Pugh);
– progressive kidney disease, confirmed hyperkalemia;
– chronic kidney disease: For step (glomerular filtration rate (GFR) was 45-59 ml / min / 1.73 m2), 36 (GFR 30-44 ml / min / 1.73 m2) and 4 (GFR
– the period after coronary artery bypass surgery;
– severe heart failure (III-IV class NYHA classification);
– hemorrhagic diathesis and other coagulation disorders;
– the age of 18 years (due to lack of efficacy and safety data);
– Pregnancy and lactation.
Carefully
Peptic ulcer and duodenal ulcer, ulcerative colitis, Crohn’s disease, a history of liver disease, hepatic porphyria, chronic kidney disease, stage 2 (GFR 60-89 ml / min / 1.73 m2), chronic heart failure, arterial hypertension, significant decrease in circulating blood volume (including after surgery), elderly patients older than 65 years (including receiving diuretics, debilitated patients with low body weight), bronchial asthma, concomitant use of corticosteroids (including prednisolone), en ikoagulyantov (including warfarin) angiagregantov (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral vascular disease, smoking, presence of infection Helicobacter pylori, systemic lupus erythematosus (SLE) and other systemic connective tissue diseases, long-term use of nonsteroidal anti-pre Paraty tuberculosis expressed osteoporosis, alcoholism, severe somatic diseases.
Dosage
25 mg
Indications
Musculo-skeletal pain (mild to moderate), tuberculosis, toothache.
The drug is intended for the symptomatic therapy reduce pain and inflammation at the time of application.
Interaction with other drugs
The following interactions are common to all NSAIDs.
unwanted kombinaiii
With other NSAIDs, salicylates including high doses (greater than 3 g / d): the simultaneous use of several NSAIDs due to the synergistic effect increases the risk of gastrointestinal bleeding and ulceration.
Since anticoagulants: dexketoprofen, like other NSAIDs, may enhance the effect of anticoagulants, such as warfarin due to the high degree of binding to plasma proteins, platelet aggregation inhibition and mucosal lesions of the gastrointestinal tract. If necessary, the simultaneous use requires careful monitoring of the patient and regular monitoring of laboratory parameters.
Since heparin: the simultaneous use of an increased risk of bleeding (due to the inhibition of platelet aggregation and damage to the mucous membrane of the gastrointestinal tract). If necessary, the simultaneous use requires careful monitoring of the patient and regular monitoring of laboratory parameters.
Since glucocorticosteroids: while the application increases the risk of ulcerative lesions of the gastrointestinal tract and bleeding.
With lithium preparations: NSAIDs increase the concentration of lithium in the blood plasma of up to toxic in this connection, the active component is necessary to control, while the use deksketoprofenom, changing the dosage, and after withdrawal of NSAIDs.
With high-dose methotrexate (15 mg / week or more) ‘, may increase the hematologic toxicity of methotrexate in connection with a reduction in its renal clearance while the use of NSAIDs.
With gidayatoinami and sulfonamidami: may enhance their toxic effect. Combinations requiring caution
With diuretics, angiotensin converting enzyme (ACE) inhibitors, antibiotics of the aminoglycoside, angiotensin 11 receptor antagonists: the simultaneous use of NSAIDs is associated with the risk of acute renal failure in dehydrated patients (decreased glomerular filtration rate due to reduced synthesis of prostaglandins). With simultaneous use of NSAIDs may reduce the antihypertensive effect of certain drugs. With simultaneous use of dexketoprofen and diuretics must ensure that the patient has no signs of dehydration, as well as at the beginning of the simultaneous application of monitor renal function.
With methotrexate at low doses (less than 15 mg / week) may increase the hematologic toxicity of methotrexate in connection with a reduction in its renal clearance amid simultaneous application NPVG1. Requires blood cell count at the start of simultaneous application. In the presence of impaired renal function, even a mild degree, as well as in the elderly, the need for careful medical supervision.
Pentoxifylline: Possible increased risk of bleeding. Careful clinical monitoring and regular check bleeding time (time clotting).
With Zidovudine: there is a risk of increased toxic effects on red blood cells caused by exposure to reticulocytes, with severe anemia in a week after the start of NSAIDs. It is necessary to conduct blood count with the counting of reticulocytes after 1-2 weeks after initiation of NSAID therapy.
With perorachnymi hypoglycemic agents: NSAIDs may enhance the hypoglycemic effect of sulfonylurea displacement due sulfonylurea binding sites of plasma proteins.
Combinations to be taken into account
C / 1-blockers: while the use of NSAIDs may decrease the antihypertensive effect of P-blockers due to the inhibition of prostaglandin synthesis.
Since cyclosporin and tacrolimus: NSAIDs may increase nephrotoxicity that is mediated by the action of renal prostaglandins. With simultaneous application must monitor renal function.
With thrombolytics: increased risk of bleeding.
Increases the risk of bleeding from the gastrointestinal tract while the use of inhibitors of serotonin reuptake (citalopram, fluoxetine, sertraline) and anti-coagulants.
With probenecid: NSAIDs may increase the plasma concentration that may be due to the inhibitory effect of probenecid on renal tubular secretion and / or conjugation with glucuronic acid; may require dose adjustment of NSAIDs.
With cardiac glycosides: simultaneous application of NSAIDs may lead to increased concentrations of cardiac glycosides in blood plasma.
Since mifepristone: in relation to a theoretical risk mnfepristona efficiency changes under the influence of prostaglandin synthesis inhibitors, NSAIDs should not be used earlier than 8-12 days after withdrawal mnfepristona.
With hiiolonami: data from experimental animal studies indicate a high risk of seizures, while the use of NSAIDs with high doses of quinolones.
If necessary, the simultaneous use Flamadeks preparation with the above drugs should consult a physician.
Overdose
Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia.
Treatment: symptomatic therapy, if necessary – gastric lavage, administration of activated charcoal, hemodialysis ineffective.
pharmachologic effect
Pharmacological group:
nonsteroidal anti-inflammatory drug
ATX code: M01AE17
Pharmacodynamics:
Dexketoprofen trometamol, Flamadeks active agent formulation “refers to a nonsteroidal anti-inflammatory drugs (NSAIDs) have analgesic, antiinflammatory and antipyretic action. Dexketoprofen mechanism of action is based on the inhibition of prostaglandin synthesis at the level of cyclooxygenase (COX-1 and COX-2).
Analgesic effect occurs within 30 minutes after taking the drug inside, the duration of therapeutic action is 4-6 hours.
Pharmacokinetics:
Suction
The time to reach maximum concentration (TStah) dexketoprofen in blood plasma after a single oral administration of a single dose of an average 30 minutes (15-60 min). Simultaneous reception write slows absorption of dexketoprofen. Area under the curve “concentration-time» (AUC), after single and repeated receptions are similar, indicating a lack of accumulation of the drug.
Distribution
For dexketoprofen a high degree of binding to plasma proteins (99%). The mean value of the distribution volume (Vd) is less than 0.25 L / kg, poluraspredeleniya period of about 0.35 hours.
Metabolism and excretion
The main route of metabolism dexketoprofen is its conjugation with glucuronic acid with subsequent renal excretion. The half-life (T1 / 2) is 1.65 dexketoprofen hours. In the elderly elongation observed T1 / 2 to 48% and reduced total clearance of the drug.
Pregnancy and breast-feeding
Use of the drug Flamadeks during pregnancy and lactation is contraindicated.
Conditions of supply of pharmacies
Without a prescription.
side effects
Possible side effects are given in accordance with the classification the World Health organnizatsii descending frequency of occurrence: very often (> 1/10), often (> 1/100, 1/1000, 1/10000,
Blood disorders and lymphatic system:
very rarely – neutropenia, thrombocytopenia.
Violations by the immune system:
rare – swelling of the larynx;
very rarely – anaphylactic reactions, including anaphylactic shock.
Disorders of the nervous system:
rarely – headache, dizziness, drowsiness;
rarely – paresthesia, syncope (fainting transient short).
Violations by the psyche:
rarely – insomnia, feeling of anxiety.
Violations by the organ of hearing and labyrinth disorders:
rare – vertigo;
very rarely – ringing in the ears.
Violations by the organ of vision:
very rarely – blurred vision.
Violations of the cardiovascular system:
rarely – palpitations, hot flashes, flushing of the skin;
rarely – increased blood pressure;
very rarely – tachycardia, decreased blood pressure.
Violations of the respiratory system:
rarely – bradypnea;
very rarely – bronchospasm, dyspnea.
Disorders of the gastrointestinal tract:
often – nausea, vomiting, abdominal pain, dyspepsia, diarrhea;
rarely – gastritis, constipation, dry mouth, flatulence;
rarely – erosive and ulcerative lesions of the gastrointestinal tract (GIT), bleeding ulcers, or perforation;
very rare – the defeat of the pancreas.
Disorders of the liver and eyuelchevyvodyaschih ways:
rarely – hepatitis, increased activity “liver” enzymes, and t h alaninamino- aspartate transferase (ACT and ALT);..
very rarely – liver damage.
Violations of the kidneys and urinary tract:
rarely – polyuria, acute renal failure;
very rarely – nephritis or nephrotic syndrome.
Violations of the reproductive system:
rarely – in women – menstrual disorders, men – transient dysfunction of the prostate long-term use.
Violations by the musculoskeletal system:
rarely – back pain.
Violations of the skin and subcutaneous tissue disorders:
seldom – a skin rash;
rarely – urticaria, acne, increased sweating;
very rarely – severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome)), angioneurotic edema of the face, allergic dermatitis, photosensitivity, pruritus.
Violation of metabolism: rarely – anorexia.
General disorders:
rarely – fatigue, asthenia, chills, malaise;
very rarely – peripheral edema.
As with other NSAIDs, may develop following side effects: aseptic meningitis, developing mainly in patients with systemic lupus erythematosus or other connective tissue diseases, hematologic disorders (thrombocytopenic purpura, aplastic and hemolytic anemias, in rare cases – agranulocytosis and hypoplasia of the bone brain).
special instructions
The undesirable side effects can be carried to a minimum when using the drug in the lowest effective dose with a minimum duration of application required for the relief of pain.
The risk of complications from the gastrointestinal tract is increased in patients with ulcerative lesions of the gastrointestinal tract in history, in elderly patients, with increasing doses of NSAIDs; therefore, use of the drug Flamadeks in these patients should be started with the lowest recommended dose.
Patients above categories as well as patients who required the simultaneous use of low-dose acetylsalicylic acid or other agents which increase the risk of complications from the gastrointestinal tract, it is recommended further simultaneous application gastroprotectives (misoprostol or proton pump blockers).
Patients taking concomitant antiplatelet agents or anticoagulants, steroids, also increases the risk of gastrointestinal bleeding.
Patients with disorders of the gastrointestinal tract or gastro-intestinal diseases in history should be under close medical supervision. In case of gastrointestinal bleeding or ulceration, Flamadeks® use of the drug should be discontinued.
Flamadeks® The drug should be used with caution in patients with gastrointestinal diseases in history (ulcerative colitis, Crohn’s disease), since it is possible aggravation of these diseases.
All NSAIDs may inhibit platelet aggregation and increase of bleeding time by inhibiting the synthesis of prostaglandins. In connection with this application Flamadeks® drug in patients receiving both drugs affecting the hemostatic system such as warfarin, coumarin derivatives and heparin, it is not recommended.
Like other NSAIDs, Flamadeks® preparation may lead to increased concentrations of nitrogen and creatinine in blood plasma. As with other inhibitors of prostaglandin synthesis, Flamadeks® drug can have side effects on the urinary system, which can lead to the development of glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. Caution should be exercised when using the drug in patients simultaneously applying diuretics, and patients who may develop hypovolemia, due to the increased risk of nephrotoxicity.
As with other NSAIDs, on the background of therapy with Flamadeks® may be a slight transient increase in activity of “liver” enzymes. Elderly patients should be monitored liver and kidney function. In case of a significant increase in the use of indicators Flamadeksk preparation should be discontinued.
Like other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases. In the event of evidence of infection or degradation being Flamadeks® against application of the drug, the patient should immediately contact a physician.
The drug can cause fluid retention in the body, so in hypertensive patients with renal and / or heart failure drug Flamadeks * should be used with extreme caution. In case of deterioration application Flamadeks® preparation should be discontinued.
Patients with uncontrolled hypertension, ischemic heart disease, congestive heart failure, peripheral arterial disease and / or cerebrovascular disease, the drug should be used with caution. A similar approach is applicable to patients with risk factors for cardiovascular diseases (hypertension, hyperlipidemia, diabetes, smoking).
Care should be taken when administering the drug Flamadeks® patients with a history of cardiovascular disease, especially patients with heart failure due to the possible risk of progression.
Клинические исследования и эпидемиологические данные позволяют сделать вывод о том, что НПВП, особенно в высоких дозах и при длительном применении, могут приводить к незначительному риску развития острого инфаркта миокарда или инсульта. Для исключения риска данных событий при применении декскетопрофена данных недостаточно.
Пожилые пациенты особенно подвержены неблагоприятным реакциям при применении НПВП, в том числе, риску возникновения желудочно-кишечных кровотечений и перфораций, угрожающим жизни пациента, снижению функций почек, печени и сердца. При применении препарата Фламадекс® у данной категории пациентов необходим надлежащий клинический контроль.
Имеются данные о возникновении редких случаев кожных реакций (таких как эксфолиативный дерматит, синдром Стивенса-Джонсона, токсический эпидермальный некролиз) при применении НПВП. При первых проявлениях кожной сыпи, поражении слизистых оболочек или других признаках аллергической реакции прием препарата Фламадекс® следует немедленно прекратить и обратиться к врачу.
The effect on the ability to operate vehicles, machinery
В связи с возможным возникновением головокружения и сонливости в период применения декскетопрофена, способность к концентрации внимания и быстрота психомоторных реакций у пациентов могут снижаться, особенно в первый час после приема. Поэтому во время применения препарата Фламадекс® следует соблюдать осторожность при управлении транспортными средствами и занятиях потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
In dry protected from light at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Препарат Фламадекс® принимают внутрь во время еды. Одновременный прием пищи замедляет всасывание декскетопрофена, поэтому в случае острой боли рекомендуется применение препарата не менее чем за 30 минут до приема пищи.
В зависимости от интенсивности болевого синдрома, рекомендуемая доза для взрослых составляет 12,5 мг (‘/г таблетки препарата Фламадекс®) каждые 4-6 ч или 25 мг (1 таблетка препарата Фламадекс®) каждые 8 ч.
Максимальная суточная доза составляет 75 мг.
Препарат Фламадекс® не предназначен для длительной терапии, курс лечения препаратом не должен превышать 3-5 дней.
Пациенты 65 лет и старше
Пациентам пожилого возраста следует принимать препарат Фламадекс®, начиная с минимальной рекомендованной дозы. Максимальная суточная доза составляет 50 мг.
В случае хорошей переносимости могут применяться дозы, рекомендованные для общей популяции.
Patients with hepatic insufficiency
Пациентам с печеночной недостаточностью легкой и средней степени тяжести следует принимать препарат Фламадекс®, начиная с минимальной рекомендованной дозы.
Максимальная суточная доза составляет 50 мг. Применение препарата Фламадекс® у пациентов с печеночной недостаточностью тяжелой степени тяжести противопоказано.
Patients with renal insufficiency
Пациентам с почечной недостаточностью легкой степени тяжести — хроническая болезнь почек, стадия 2 (СКФ 60-89 мл/мин/1,73 м2) следует принимать препарат Фламадекс®, начиная с минимальной рекомендованной дозы. Максимальная суточная доза составляет 50 мг.
Применение препарата Фламадекс® у пациентов с хронической болезнью почек стадий За (СКФ 45-59 мл/мин/1,73 м2), 36 (СКФ 30-44 мл/мин/1,73 м2) и 4 (СКФ
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

SOTEX

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