Meloxicam 7.5mg Table 20 pcs kanonfarma

Description

Composition
Active substance:
1 tablet contains: meloxicam 7.5 mg and 15 mg ;.
Excipients:
Potato starch 16.7 mg; 33.4 mg colloidal silicon dioxide (Aerosil) 2.2 mg; 4.4 mg lactose monohydrate (milk sugar) 82.5 mg; 165 mg Magnesium stearate 1.1 mg; 2.2 mg.
Description:
Tablets of light yellow color with a greenish tinge, ploskotsilindri-shape-bevelled.
Product form:
7.5 mg tablets and 15 mg.
At 10 or 30 tablets in blisters of PVC film and aluminum foil printed patent.
1, 2, 3, 5 contour cell packs of 10 pills, or 1, 2 contour cell packs of 30 tablets together with instructions for use placed in a pile of cardboard.
Contraindications
– hypersensitivity to meloxicam or auxiliary components of the drug; the structure includes lactose, so patients with rare hereditary diseases such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take the drug; – condition after coronary artery bypass surgery; – decompensated heart failure; – anamnestic data fit bronchial, rhinitis, – urticaria after ingestion of aspirin or other NSAIDs (full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including history) – erosive and ulcerative changes in gastric mucosa and 12 duodenal ulcer, active gastrointestinal bleeding, – inflammatory bowel disease (ulcerative colitis, a disease Cr it) – cerebrovascular bleeding or other bleeding; – severe hepatic failure or active liver disease; – Chronic renal failure (CRF) in patients not undergoing dialysis (creatinine clearance less than 30 mL / min), progressive renal disease including confirmed hyperkalemia, – pregnancy, breast-feeding; – children up to age 12 years.
Carefully
Ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, medical history of the development of ulcerative lesions gastrointestinal tract, the presence of infection Helicobacter pylori, chronic renal failure with creatinine clearance 30-60 ml / min, older age , long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs: – anticoagulants (eg, warfarin); – antiplatelet agents (e.g., aspirin, clopidogrel); – oral corticosteroids (e.g., prednisone); – selective serotonin reuptake inhibitor (such as citalopram, fluok-Cetin, paroxetine, sertraline).
To reduce the risk of adverse effects on the gastrointestinal tract should use the lowest effective dose for the shortest possible course.
Dosage
7.5 mg
Indications
Symptomatic treatment of osteoarthritis;
Symptomatic treatment of rheumatoid arthritis;
Symptomatic treatment of ankylosing spondylitis (Bechterew’s disease) and other degenerative diseases of the joints, accompanied by pain.
Interaction with other drugs
While the use of other nonsteroidal anti-inflammatory drugs (and also with acetylsalicylic acid) increases the risk of erosive ulcers and gastrointestinal bleeding.
While the use of antihypertensive drugs may decrease the effectiveness of the latter.
While the use of drugs lithium may develop lithium accumulation and increase its toxic effect (recommended control the concentration of lithium in the blood).
While the use of methotrexate amplified side effects of the latter on the hematopoietic system (risk of anemia and leukopenia shown periodic blood count).
While the use of diuretics and cyclosporine increases the risk of renal failure.
While the use of intrauterine contraceptive devices may reduce the effectiveness of the latter.
While the use of anticoagulants (heparin, ticlopidine, warfarin), as well as with thrombolytic drugs (streptokinase, fibrinolizin) increases the risk of bleeding (requires periodic monitoring of indicators of blood clotting).
While the use of colestyramine is accelerated excretion of the drug.
While the use of selective serotonin reuptake inhibitor increases the risk of gastrointestinal bleeding.
Overdose
Symptoms: violation of consciousness, nausea, vomiting, epigastric pain, gastrointestinal-bleeding, acute renal failure, liver failure, respiratory arrest, asystole.
Treatment: No specific antidote; with an overdose of the drug should be to gastric lavage, administration of activated charcoal (during the next hour, symptomatic therapy Forced diuresis, urinary alkalization, hemodialysis -. ineffective due to high drug connection with blood proteins.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
Meloxicam – a non-steroidal anti-inflammatory drug having analgesic, antiinflammatory and antipyretic action. The mechanism of action is related to the inhibition of prostaglandin synthesis as a result of selective suppression of the enzymatic activity of cyclooxygenase-2 (COX-2) involved in the biosynthesis of prostaglandins in inflammation. When used in high doses and long-term use of individual peculiarities of body COX-2 selectivity decreases. Inhibits the synthesis of prostaglandins in inflammation to a greater extent than in the gastric mucosa and kidney, which is associated with relatively selective inhibition of COX-2. Less common causes of erosive and ulcerative changes in the gastrointestinal tract (GIT). To a lesser extent meloxicam acts on cyclooxygenase-1 (COX-1) participating in the synthesis of prostaglandins that protect mucous membrane of the gastrointestinal tract and involved in the regulation of renal blood flow.
Pharmacokinetics:
Well absorbed from the gastrointestinal tract, the absolute bioavailability of meloxicam – 89%. Simultaneous food intake does not modify absorption. When using the drug orally at doses of 7.5 and 15 mg doses are proportional to its concentration. The equilibrium concentration is reached within 3-5 days. With prolonged use of drugs (for more than 1 year), a concentration similar to those that have been observed after first reaching the steady state pharmacokinetics.
Plasma protein binding is more than 99%. 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 pg / mL (shown, respectively, the values ​​Cmin and Cmax). Meloxicam penetrates the blood-tissue barriers, concentrations in synovial fluid reaches 50% of the maximum drug concentration in plasma. Almost completely metabolized in the liver to form four pharmacologically inactive derivatives. The main metabolite, 5`-carboxy-meloxicam (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 conversion of the important role played by CYP2C9, additional important isoenzyme CYPZA4. The formation of two other metabolites (components, respectively, 16% and 4% of the dose) participates peroxidase activity which probably varies individually.
Displayed equally through the intestine and the kidney, mainly in the form of metabolites.
Through the intestine unchanged output of less than 5% of the daily dose in the urine as unchanged drug is detected only in trace amounts. The half-life (T1 / 2) of meloxicam is 15-20 hours. Plasma clearance is an average of 8 ml / min. In the elderly the clearance of the drug is reduced. The volume of distribution is low, and amounts to an average of 11 liters.
Hepatic or renal failure moderate no significant effect on the pharmacokinetics of meloxicam.
Pregnancy and breast-feeding
The drug is not recommended for use during pregnancy and lactation.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of adverse reactions listed below, was determined according to the following: – Very often (> 1/10); – common (> 1/100,
special instructions
Caution should be exercised when using the drug in patients with a history in which the gastric ulcer and duodenal ulcers, as well as in patients on anticoagulant therapy. In these patients, increased risk of erosive and ulcerative lesions of the gastrointestinal tract. Care should be taken to monitor renal function when using the drug in elderly patients, patients with chronic heart failure with symptoms of circulatory insufficiency in patients with cirrhosis, and in patients with hypovolemia resulting from surgical procedures.
Patients with low or moderate decrease in renal function (creatinine clearance of 30 ml / min) is required dosing regime correction. Patients taking both diuretics and meloxicam, should take plenty of fluids.
Meloxicam, like other NSAIDs, may mask the symptoms of infectious diseases.
Use of meloxicam, as well as other drugs that block prostaglandin synthesis can affect fertility, is not recommended for women planning pregnancy.
If during treatment with any allergic reactions (itching, skin rash, urticaria, fotosesibilizatsiya), as well as patients, observed on the background of the drug impairment, seek medical advice with a view to resolving the issue of termination of dosing.
During the period of treatment must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In dry protected from light at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
The drug is taken orally during meal time in a daily dose of 7.5-15 mg.
The recommended dosing regimen:
Rheumatoid Arthritis: 15 mg per day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg per day.
Osteoarthritis: 7.5 mg. When inefficiency dose may be increased to 15 mg per day.
Ankylosing spondylitis 15 mg per day. The maximum daily dose should not exceed 15 mg.
In patients with an increased risk of side effects, as well as in patients with severe renal impairment on hemodialysis, the dose should not exceed 7.5 mg per day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist