Амелотекс

Амелотекс – non-steroidal anti-inflammatory drug (NPVS).

Form of release and structure

• Solution for intramuscular introduction: transparent or slightly opalescent liquid of color, yellow with a greenish shade (on 1,5 ml in colourless glass ampoules, on 3 or 5 ampoules in blister strip packagings, in a pack cardboard 1 or 2 packagings on 3 ampoules, 1, 2 or 4 packagings on 5 ampoules);
• Tablets: round, convex from two parties, pale yellow color (the weak greenish shade is possible), existence of a mramornost of a color and easy roughness is allowed, on tablets of 15 mg on the one hand is risk (on 10 pieces in blister strip packagings, in a pack cardboard 1 or 2 packagings);
• Gel for external use: yellow color (the greenish shade), almost transparent or transparent, with a specific smell (on 30 and 50 g in aluminum tubas, in a pack a cardboard 1 tuba is possible).

Active agent – to meloksika:

• 1 ampoule of solution – 15 mg;
• 1 tablet – 7,5 or 15 mg;
• 1 g of gel – 10 mg.

Solution excipients: glycofurfural, half-oxameasures 188, Megluminum, глицерол, hydroxide sodium solution 1M, sodium chloride, water for injections.

Additional components of tablets: кросповидон, cellulose microcrystallic, lactoses monohydrate, povidone, silicon dioxide colloid, sodium citrate, magnesium stearate.

Gel excipients: carbomer, ethanol of 95%, метилпирролидон, трометамол, the water purified oil of flowers of orange and oil of a lavender.

Indications to use

For solution and tablets:

• Ankylosing spondylarthritis (Bekhterev's disease);
• Osteoarthrosis;
• Pseudorheumatism.

In the form of solution of Ameloteks, besides, appoint at degenerative and inflammatory diseases of the joints which are followed by a pain syndrome.

In the form of gel drug is used for treatment of the osteoarthrosis which is followed by a pain syndrome.

Амелотекс it is intended for symptomatic therapy, decrease in an inflammation and reduction of a pain syndrome, it does not influence progressing of a disease.

Contraindications

Absolute for solution and tablets:

• The period after performing aortocoronary shunting;
• Inflammatory diseases of intestines, such as nonspecific ulcer colitis and disease Krone;
• The progressing diseases of kidneys, including the confirmed hyperpotassemia;
• Cerebrovascular or other bleedings;
• Active gastrointestinal bleeding;
• Erosive cankers of a mucous membrane of a stomach or 12-perstny gut;
• The expressed liver failure;
• Active disease of a liver;
• Dekompensirovanny heart failure;
• The expressed renal failure at the patients who are not exposed to dialysis (clearance of creatinine <30 ml/minute);
• Full or incomplete combination of bronchial asthma, the nose recuring a polypose and okolonosovy bosoms, and also intolerance of other NPVS, including acetylsalicylic acid (in the anamnesis including);
• Age up to 15 years;
• Period of pregnancy and lactation;
• Rare hereditary diseases, such as glyukozo-galaktozny malabsorption, lactose intolerance and deficit of lactase (only for tablets);
• Hypersensitivity to any component of Ameloteks.

Relative for solution and tablets:

• Coronary heart disease;
• Congestive heart failure;
• Cerebrovascular diseases;
• Diabetes mellitus;
• Дислипидемия / lipidemia;
• Existence of an infection of Helicobacter pylori;
• Instructions in the anamnesis on development of a canker of the digestive tract (DT);
• Diseases of peripheral arteries;
• Clearance of creatinine less than 60 ml/minute;
• Heavy somatopathies;
• Frequent alcohol intake;
• Smoking;
• Advanced age;
• Prolonged use of NPVS;
• The accompanying therapy by peroral glucocorticosteroids (for example, Prednisolonum), antiagregant (including klopidogrely or acetylsalicylic acid), anticoagulants (for example, warfarin), selective serotonin reuptake inhibitors (for example, paroksetiny, tsitalopramy, sertraline, fluoxetine).

Absolute for gel:

• Disturbance of integrity of integuments in places of intended application of drug;
• Full or incomplete combination of bronchial asthma, the nose recuring a polypose and okolonosovy bosoms, and also intolerance of other NPVS, including acetylsalicylic acid (in the anamnesis including);
• Age up to 18 years;
• Pregnancy and lactation;
• Hypersensitivity to any component of Ameloteks.

Relative for gel:

• Peptic ulcer of a stomach and 12-perstny gut in an aggravation phase;
• Active gastrointestinal bleeding;
• The confirmed hyperpotassemia;
• Chronic heart failure;
• The progressing diseases of kidneys;
• Active disease of a liver or heavy liver failure;
• Coagulation disturbances;
• Inflammatory diseases of intestines;
• Advanced age.

Route of administration and dosage

Solution for intramuscular introduction
In the form of solution of Ameloteks enter intramusculary 7,5-15 mg of 1 times a day.

The highest admissible daily dose – 15 mg.

The patients with a heavy renal failure who are on a hemodialysis should not exceed a daily dose of 7,5 mg.

Tablets
In the form of tablets drug should be accepted in 1 times a day.

The recommended daily doses:

• Pseudorheumatism – 15 mg, if necessary reduce a dose to 7,5 mg;
• Osteoarthrosis – 7,5 mg, if necessary raise a dose to 15 mg;
• Ankylosing spondylarthritis – 15 mg.

The highest admissible daily dose – 15 mg.

The patients with a heavy renal failure who are on a hemodialysis should not exceed a daily dose of 7,5 mg.

Gel for external use
In this dosage form of Ameloteks it is necessary to apply on clean dry skin over the center of defeat and to rub slightly within 2-3 minutes.

The single dose makes – 2 g of gel (a strip about 4 cm long). Frequency rate of use – 2 times a day.

Duration of treatment is defined individually depending on indications, weight of a course of a disease, the place of defeat and medical effect of drug, but should not exceed 4 weeks.

Side effects

Possible side effects at Ameloteks's use in the form of solution and tablets:

• Allergic reactions: anaphylactoid and anaphylactic reactions, Quincke's disease;
• From a nervous system: sonitus, headache, dizziness, drowsiness, emotional lability, confusion of consciousness, вертиго, disorientation;
• From the alimentary system: locks or diarrhea, stomatitis, an abdominal pain, nausea, vomiting, a meteorism, hepatitis, colitis, an esophagitis, erosive cankers and perforation of bodies of a GIT, an eructation, gastrointestinal bleeding (including hidden), gastritis, a hyperbilirubinemia, increase in activity of hepatic transaminases;
• From respiratory system: bronchospasm;
• From an urinary system: increase in concentration of urea in blood serum, a giperkreatininemiya, hypostases; in rare instances – an albuminuria, intersticial nephrite, a hamaturia, an acute renal failure;
• From sense bodys: vision disorder (including illegibility of visual perception), conjunctivitis;
• From cardiovascular system: rushes of blood to face skin and an upper part of a thorax, increase in arterial pressure, peripheral hypostases, a heart consciousness;
• From bodies of a hemopoiesis: leukopenia, anemia, thrombocytopenia;
• From integuments: photosensitization, urticaria, violent rashes, skin rash, mnogoformny erythema, itch, toxic epidermal necrolysis;
• Local reactions at intramuscular introduction: burning and pain in the place of an injection.

Possible side effects at Ameloteks's use in the form of gel:

• Allergic reactions: peeling, papular and vesicular rashes, photosensitization, hyperemia;
• Allergic reactions: system anaphylactic reactions, mnogoformny erythema, itch and burning of skin, small tortoiseshell.

Special instructions

Under constant observation and control of indicators of function of kidneys during treatment there have to be elderly people, patients with chronic heart failure and the phenomena of a circulatory unefficiency, sick with cirrhosis, patients with a hypovolemia as a result of surgical intervention.

At simultaneous use of different dosage forms of Ameloteks (for example, tablets and gel for external use) it is necessary to consider that the total daily dose of a meloksikam should not exceed 15 mg.

Solution for intramuscular introduction and a tablet
At patients with a peptic ulcer of a stomach and a 12-perstny gut in the anamnesis and at the patients receiving anticoagulating therapy the risk of development of erosive and ulcer gastrointestinal diseases is high.

To patients with a renal failure (provided that the clearance of creatinine more than 30 ml/minute) Ameloteks's dose should be adjusted.

At permanent and essential change of indicators of function of a liver, including increase in transaminases, it is necessary to cancel drug and to carry out control tests.

Patients who during treatment by Ameloteks accept diuretics have to use a large amount of liquid.

In case of development of allergic reactions drug is cancelled.

As well as other NPVS, to meloksika can mask symptoms of an infectious disease.

Амелотекс can cause drowsiness, dizziness and a headache. In case of their development it is necessary to refrain from driving and performance of potentially dangerous types of works.

Gel for external use
Drug should be applied only on the unimpaired sites of skin, to avoid hit on open wounds, in eyes and on mucous membranes.

It is necessary to apply to decrease in risk of development of side effects of Ameloteks in a minimal effective dose minimum short course. If the state does not improve, it is necessary to consult with the doctor.

In order to avoid risk of development of reactions of photosensitivity during treatment it is necessary to avoid ultra-violet radiation and visit of a sunbed.

In the form of gel of Ameloteks does not exert a negative impact on the speed of reactions and ability to concentration of attention.

Medicinal interaction

Solution for intramuscular introduction and a tablet:

• Other NPVS: the risk of cankers of a GIT and gastrointestinal bleeding increases;
• Selective serotonin reuptake inhibitors: the probability of development of gastrointestinal bleedings increases;
• Lithium drugs: concentration of lithium in a blood plasma increases;
• Intrauterine contraceptives, anti-hypertensive drugs: their efficiency decreases;
• Myelotoxic means: manifestations of a gematotoksichnost of Ameloteks amplify;
• Indirect anticoagulants, trombolitik (Streptokinasa, fibrinolysin), heparin, тиклопидин: the risk of bleedings increases (it is necessary to control periodically indicators of coagulability of blood);
• Methotrexate: miyelodepressivny effect of drug amplifies;
• Colestyraminum: removal of a meloksikam accelerates;
• Diuretics: the risk of development of renal failures increases;
• Cyclosporine: nephrotoxic action of a meloksikam amplifies.

In the form of gel of Ameloteks it is not necessary to apply along with other NPVS and means intended for external use.

Terms and storage conditions

To store in dry (tablets), the unavailable to children, protected from light place at a temperature up to 25 ºС.

Solution cannot be stored in the refrigerator.

Period of validity of solution and gel – 2 years, tablets – 3 years.