Meloksikam
Producer: JSC Borisovsky Plant of Medical Supplies Republic of Belarus
Code of automatic telephone exchange: M01AC06
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 7,5 mg or 15 mg of a meloksikam in 1 tablet.
Excipients: cellulose microcrystallic, lactoses monohydrate, sodium citrate, silicon dioxide colloid anhydrous, povidone, кросповидон, magnesium stearate.
Indications to use:
Symptomatic short-term treatment of the activated arthroses.
Symptomatic long-term treatment of a pseudorheumatism (chronic polyarthritis) or ankylosing spondylarthritis (Bekhterev's Disease).
Route of administration and doses:
Inside, once a day, during food, washing down with a glass of water or other liquid.
As the probability of emergence of side reactions increases with increase in a dosage and duration of reception of a meloksikam, it is recommended to appoint the lowest effective daily dose throughout the smallest period.
The maximum daily dose should not exceed 15 mg.
The activated arthroses: 7,5 mg a day (1 tablet 7,5 mg or ½ tablets of 15 mg). In the absence of therapeutic effect the dose can be increased to 15 mg a day (2 tablets 7,5 mg or 1 tablet of 15 mg).
The pseudorheumatism ankylosing a spondylarthritis: 15 mg a day (2 tablets 7,5 mg or 1 tablet of 15 mg). Depending on therapeutic effect the dose can be lowered to 7,5 mg a day.
Features of use:
At patients with a peptic ulcer of a stomach and duodenum in the anamnesis, and also the patients who are on anti-coagulative therapy the risk of developing of ulcer and erosive diseases of digestive tract is increased. At emergence of cankers reception of medicine should be stopped.
It is necessary to be careful and control indicators of function of kidneys, and also to provide receipt of enough liquid at use of drug for patients of advanced age, patients with chronic heart failure with the circulatory unefficiency phenomena, at the patients receiving diuretic means, inhibitors of the angiotensin-converting enzyme (ACE) and blockers of receptors of angiotensin at patients with cirrhosis, and also at patients with a hypovolemia as a result of surgical interventions.
At patients with a renal failure if the clearance of creatinine more than 25 ml/min. is not required to correction of the mode of dosing. At the patients finding on dialysis, the dosage of drug should not exceed 7,5 mg/days.
If in the course of treatment there were allergic reactions (an itch, skin rash, a small tortoiseshell, a photosensitization), it is necessary to see a doctor for the purpose of the solution of a question of the termination of administration of drug.
Medicine contains lactose therefore patients with rare hereditary intolerance of a galactose, deficit of Lapp-lactase or disturbance of absorption of a glucose/galactose, should not accept this medicine.
The corresponding control and consultation of patients with a hypertension and/or with easy to dekompensirovanny moderately severe heart failure and the anamnesis as use of a meloksikam together with diuretics can lead to a delay of sodium, potassium and water, and also to decrease in a natriuretic effect of diuretics are required. As a result of it at predisposed patients strengthening of symptoms of heart failure or hypertensia is possible. Therefore monitoring of the arterial pressure (AP) before and at the beginning of reception of a meloksikam is necessary.
As well as other NPVP, to meloksika the risk of development of serious cardiovascular thromboses, a myocardial infarction, a stenocardia attack can raise, it is possible from the death. Such risk increases at use of high doses and at long-term treatment, and also at the patients with the above-stated diseases in the anamnesis predisposed to such diseases (a lipidemia, a diabetes mellitus, smoking).
At patients with the unchecked raised ABP, heart failure, the existing ischemic heart disease, a peripheral arterial disease and/or a cerebrovascular disease the decision on purpose of a meloksikam has to be made only after careful weighing of a ratio advantage/risk.
Use of a meloksikam is not recommended to the women wishing to become pregnant as influence on fertility is possible. At disturbance of ability to conceive at women or carrying out inspection concerning infertility it is necessary to consider a question of cancellation of a meloksikam.
Use during pregnancy and the feeding period a breast. Meloksikam is contraindicated to use at pregnancy and in the period of a lactation (breastfeeding).
Side effects:
From cardiovascular system: tachycardia, increase in arterial pressure, feeling of "inflows".
From the central and peripheral nervous system: headache, dizziness, sonitus, disorientation, confusion of consciousness, sleep disorder, drowsiness, emotional lability.
From the alimentary system: nausea, vomiting, eructation, abdominal pain, diarrhea, lock, meteorism, erosive cankers of the digestive tract (DT), perforation of a stomach or intestines, gastrointestinal bleeding (hidden or explicit), increase in activity of "hepatic" enzymes, hyperbilirubinemia, hepatitis, colitis, stomatitis, dryness of a mouth, esophagitis.
From respiratory system: aggravation of a course of asthma, cough.
From urinogenital system: hypostases, intersticial nephrite, a renal medullary necrosis, a proteinuria, a hamaturia, a renal failure, a hypercreatinemia and/or increase in urea in blood serum.
Organs of sight: conjunctivitis, sight illegibility.
Allergic reactions: anaphylactoid reactions (including acute anaphylaxis), hypostasis of lips and language, allergic vasculitis.
From system of a hemopoiesis: anemia, leukopenia, thrombocytopenia.
Dermatological reactions: an itch, skin rash, a small tortoiseshell, a mnogoformny exudative erythema (including Stephens-Jones's syndrome), a toxic epidermal necrolysis (Lyell's disease), the increased photosensitivity.
Others: fever.
Interaction with other medicines:
At simultaneous use with other non-steroidal anti-inflammatory drugs (including salicylates) and corticosteroids the risk of emergence of erosive cankers and bleedings of a GIT increases.
At simultaneous use with hypotensive drugs (beta-blockers, diuretics, APF inhibitors), decrease in efficiency of action of the last is possible.
At simultaneous use with drugs of lithium increase in level of lithium in plasma is possible (control of concentration of lithium in blood is recommended).
At simultaneous use with a methotrexate (in a dose more than 15 mg/week) gematotoksichesky action of the last amplifies (periodic control of the general blood test is shown).
At simultaneous use with diuretics and with cyclosporine there is potentiality of development of an acute renal failure in patients with dehydration.
At simultaneous use with intrauterine contraceptive means decrease in efficiency of action of the last is possible.
At simultaneous use with anticoagulants (heparin, тиклопидин, warfarin), and also with thrombolytic drugs (Streptokinasa, fibrinolysin) the risk of development of bleedings increases (periodic control of indicators of coagulability of blood is necessary).
Contraindications:
• hypersensitivity to any component of drug;
• hypersensitivity to acetylsalicylic acid and other NPVP;
• "aspirinovy" bronchial asthma;
• an ulcer illness / perforation of a stomach and duodenum in a stage of an aggravation or recently postponed, including in connection with the previous therapy by non-steroidal anti-inflammatory drugs;
• gastrointestinal (acute and in the anamnesis), cerebrovascular or other bleeding;
• a heavy renal failure (if the hemodialysis is not carried out);
• heavy liver failure;
• heavy heart failure;
• children and teenagers aged up to 16 years;
• pregnancy and period of a lactation.
With care appoint at digestive tract diseases in the anamnesis, chronic heart failure, a renal failure, the coronary heart disease (CHD), cerebrovascular diseases, дислипидемии / a lipidemia, a diabetes mellitus, diseases of peripheral arteries, at advanced age, long use of NPVP, smoking, frequent alcohol intake.
Overdose:
Symptoms: a vozmozhnousileniye of the described side effects.
Treatment: there is no specific antidote. It is necessary to carry out a gastric lavage, reception of absorbent carbon (within the next hour), symptomatic therapy. Holestiramin accelerates removal of drug from an organism.
Storage conditions:
In the place protected from light and moisture, at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to apply after the termination of a period of validity.
Issue conditions:
According to the recipe
Packaging:
On 10 tablets in a blister strip packaging, in packaging No. 10×2, No. 10×3.