Artrozan tab 15mg 20 pc

Description

Composition
Active substance:
1 tablet contains: meloxicam – 7.5 mg or 15 mg ;.
Excipients:
For dosage of 7.5 mg – Potato starch 64.5 mg lactose monohydrate 100 mg, povidone (polyvinylpyrrolidone of middle medical) 3.2 mg Sodium citrate 18.8 mg magnesium stearate 2 mg Colloidal silicon dioxide (Aerosil) 4 mg ;
Dosing 15 mg – Potato starch 94.5 mg lactose monohydrate 150 mg, povidone (polyvinylpyrrolidone of middle medical) 4.5 mg sodium citrate 27 mg magnesium stearate 3 mg Colloidal silicon dioxide (Aerosil) 6 mg.
Description:
Tablets from light yellow to yellow, round, Valium, with a facet and Valium. Slight marbling.
Product form:
7.5 mg Tablets, 15 mg.
10, 15, 20 tablets in blisters. 1, 2, 3 or 5 the contour of cellular packages with instructions for use 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 galactose intolerance, lactase deficiency or glucose-galactose malabsorption, should not take the drug; heart failure decompensation; early postoperative period after coronary artery bypass surgery; complete or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history); aggravation of gastric ulcer and duodenal ulcer; active gastrointestinal bleeding; inflammatory bowel disease (ulcerative colitis, Crohn’s disease in the acute phase); cerebrovascular bleeding or other bleeding; severe hepatic impairment or active liver disease; chronic renal failure (in patients not undergoing hemodialysis (creatinine clearance less than 30 mL / min); progressive renal disease, including hyperkalemia confirmed; children up to 15 years, pregnancy, breast-feeding period.
Carefully
The drug should be used cautiously in elderly patients and in the presence of the following conditions in the anamnesis: coronary artery disease, congestive heart failure, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral vascular disease, chronic renal failure with a creatinine clearance of 30-60 ml / min; ulcerative lesion of the gastrointestinal tract, the presence of infection Helicobacter pylori.
Long term use of NSAIDs, alcohol abuse, concomitant anticoagulation therapy (e.g. warfarin), antiplatelet agents (e.g., aspirin, clopidogrel), oral corticosteroids (e.g., prednisone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, sertraline, paroxetine) must be taken into account in the appointment of meloxicam.
To reduce the risk of adverse effects on the gastrointestinal tract should use the lowest effective dose for the shortest possible course.
Dosage
15 mg
Indications
Symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis (Bechterew’s disease), osteoarthritis, and other inflammatory and degenerative diseases of the musculo-articular system, accompanied by pain.
Interaction with other drugs
While the use of other nonsteroidal anti-inflammatory drugs (including aspirin) increases the risk of erosive and ulcerative lesions and bleeding of the gastrointestinal tract; while the use of antihypertensive drugs may decrease the effectiveness of the latter; while the use of drugs lithium may develop lithium accumulation and increasing 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 control); while the use of diuretics and cyclosporine increases the risk of kidney failure; while the use of intrauterine contraceptive devices may reduce the effectiveness of the latter; while the use of anticoagulants (heparin, warfarin), thrombolytic drugs (streptokinase, fibrinolysin) and antiplatelet (ticlopidine, clopidogrel, acetylsalicylic acid) increases the risk of bleeding (requires periodic monitoring of blood coagulation parameters); while the use of colestyramine meloxicam accelerated excretion through the gastrointestinal tract while the use of selective serotonin reuptake inhibitor increases the risk of gastrointestinal bleeding.
Overdose
Symptoms: violation of consciousness, nausea, vomiting, epigastric pain, bleeding in the gastrointestinal tract, acute renal failure, liver failure, respiratory arrest, asystole.
Treatment: No specific antidotes and antagonists. If overdose – gastric lavage, administration of activated charcoal (during the next hour), symptomatic therapy. Forced diuresis, urinary alkalization, ineffective dialysis because of high communications drug with blood proteins.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug.
Pharmacodynamics:
Artrozan® – a non-steroidal anti-inflammatory drug (NSAID), having anti-inflammatory, antipyretic and analgesic action.
Refers to a class of oxicams is enolievoy acid derivative.
The mechanism of action is related to the inhibition of prostaglandin synthesis as a result of selective inhibition of cyclooxygenase enzyme activity of the second type (COX-2) involved in the biosynthesis of prostaglandins in inflammation. When administered in high doses and long-term use of individual peculiarities of body selectivity for COX-2 is reduced. To a lesser extent cyclooxygenase acts on the first type (COX-1) participating in the synthesis of prostaglandins that protect mucous membrane of the gastrointestinal tract and is involved in the regulation of renal blood flow. Due to the selectivity of said suppression of COX-2 preparation causes less erosive-ulcerous lesions of the gastrointestinal tract.
Pharmacokinetics:
Well absorbed from the gastrointestinal tract, the absolute bioavailability – 89%. Simultaneous ingestion does not alter the absorption of the drug. When using the drug orally at doses of 7.5 and 15 mg doses are proportional to its concentration. The equilibrium concentrations are reached within 3-5 days of treatment. With prolonged use of drugs (for more than 1 year) concentrations similar to those that have been observed after first reaching the steady state pharmacokinetics.
Plasma protein binding is 99%. When applying the dose of 7.5 mg minimum concentration (Cmin) is 0.4 ug / ml, the maximum concentration (Cmax) – 1,0 g / ml; at a dose of 15 mg Cmin – 0.8 g / ml, Cmax – 2,0 mcg / ml. Almost completely metabolized in the liver to form four 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). Studies in vitro have shown that in this metabolic conversion plays an important role CYP isozyme 2C9, additional importance CYP 3A4 isozyme. In the formation of two other metabolites (components, respectively, 16% and 4% of the dose) participates peroxidase, which activity is likely to vary.
The drug penetrates the blood-tissue barriers, concentrations in synovial fluid was 50% of the maximum plasma concentration.
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 significant effect on the pharmacokinetics of meloxicam has not.
Displayed in equal proportions with the feces and urine, mainly as 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.
Conditions of supply of pharmacies
On prescription.
side effects
From the digestive system: more than 1% – indigestion, including nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence; 0.1-1% – transient increase in activity of “liver” transaminases, hyperbilirubinemia, regurgitation, esophagitis, gastric ulcer and 12 duodenal ulcer, gastrointestinal bleeding (implicit or explicit), stomatitis; less than 0.1% – perforation of the intestine, colitis, hepatitis, gastritis.
From the side of hematopoiesis: more than 1% – anemia; 0.1-1% – leukopenia, thrombocytopenia.
For the skin: more than 1% – itching, skin rash; 0.1-1% – urticaria; less than 0.1% – photosensitivity, bullous eruptions, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis.
The respiratory system: less than 0.1% – bronchospasm.
On the part of the central nervous system: more than 1% – dizziness, headache; 0.1-1% – tinnitus, drowsiness; less than 0.1% – emotional lability, confusion, disorientation.
Cardio-vascular system: more than 1% – peripheral edema; 0.1-1% – increase in blood pressure, palpitations, facial flushing.
From the urinary system: 0.1-1% – hypercreatininemia, increased serum concentrations of urea; less than 0.1% – acute renal failure; connection with the intake of meloxicam is not installed – interstitial nephritis, albuminuria, hematuria.
From the senses: less than 0.1% – conjunctivitis, blurred vision.
Allergic reactions: less than 0.1% – angioneurotic edema, anaphylactic, anaphylactoid reactions.
special instructions
Caution should be exercised when using the drug by patients with a history of which there are indications of gastric ulcer and 12 duodenal ulcers, and patients on anticoagulant therapy. In these patients, increased risk of erosive and ulcerative diseases of the gastrointestinal tract.
Care should be taken and monitored daily diuresis and renal function when using the drug in elderly and patients with reduced BCC and reduced glomerular filtration (dehydration, chronic heart failure, liver cirrhosis, nephrotic syndrome, symptomatic kidney disease, diuretics, dehydration after major surgery ).
Patients with low or moderate decrease in renal function (creatinine clearance of 30-60 ml / min) a dose adjustment is required.
Patients taking both diuretics and meloxicam, should take plenty of fluids.
If you experience allergic reactions (itching, skin rash, urticaria, photosensitivity) during the treatment should consult a doctor with a view to resolving the issue of termination of dosing.
Meloxicam, like other NSAIDs, may mask the symptoms of infectious diseases.
Use of meloxicam, as well as other drugs that block the synthesis of prostaglandins, can affect fertility, it is therefore not recommended for receiving women planning pregnancy.
Use of the drug can cause the occurrence of headache, dizziness and drowsiness. If you experience these effects should avoid driving and performing other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
Store 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. As necessary, the dose may be reduced to 7.5 mg per day. – Osteoarthritis, low back pain, and other inflammatory and degenerative diseases of the musculo-articular system, accompanied by pain syndrome: 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 advanced renal failure 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