Melbek

Melbek – the non-steroidal anti-inflammatory drug used for symptomatic therapy of degenerative and inflammatory diseases of joints which are followed by a pain syndrome.

Form of release and structure

Melbek is issued in two dosage forms:

• Solution for intramuscular introduction: chartreuse color, transparent (on 1,5 ml in ampoules, on 3 ampoules in pallets, on 1 pallet in a cardboard pack);
• Tablets: light yellow color, round, with risky on one of the parties (on 5, 10, 30 pieces in blister strip packagings, on 1-3 packagings in a cardboard pack).

Is a part of 1 ampoule (1,5 ml) of injection solution:

• Active ingredient: to meloksika – 15 mg;
• Auxiliary components: 1 M solution of sodium hydroxide or 1 M Acidum hydrochloricum solution, glycine, меглумин, half-oxameasures 188, гликофурол, sodium chloride, water for injections.

Is a part of 1 tablet:

• Active ingredient: to meloksika – 7,5 mg;
• Auxiliary components: microcrystallic cellulose, sodium citrate, colloid silicon dioxide, кросповидон, lactose, magnesium stearate, povidon-KZO.

Indications to use

Melbek is appointed for symptomatic therapy of an osteoarthrosis, a pseudorheumatism, Bekhterev's disease (an ankylosing spondylarthritis), and also other inflammatory and degenerative diseases of joints with a pain syndrome.

Contraindications

Absolute:

• Dekompensirovanny heart failure;
• Diseases of intestines of inflammatory character (disease Krone, nonspecific ulcer colitis);
• Bleedings (including cerebrovascular);
• The expressed liver failure or active diseases of a liver;
• The expressed renal failure at the patients who are not exposed to dialysis (the clearance of creatinine is less than 30 ml in a minute), the progressing diseases of kidneys, including the confirmed hyperpotassemia;
• The period after performing aortocoronary shunting;
• Combination (partial or full) bronchial asthma, the nose recuring a polypose and okolonosovy bosoms with intolerance of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including instructions in the anamnesis);
• Erosive and ulcer changes of a mucous membrane of a stomach or duodenum, active gastrointestinal bleedings;
• Rare hereditary diseases: a lactose intolerance, deficit of lactase or glyukozo-galaktozny malabsorption (for tablets);
• Intolerance of acetylsalicylic acid and medicines of a pyrazolon row (for tablets);
• Pregnancy;
• Breastfeeding (lactation period);
• Age up to 18 years (for injection solution); up to 15 years (for tablets);
• Hypersensitivity to drug components.

Relative (Melbek it is necessary to apply with care at the following diseases / states):

• The brain diseases caused by pathological changes of cerebral vessels, which are followed by disturbance of cerebral circulation (cerebrovascular diseases);
• Diabetes mellitus;
• Coronary heart disease;
• Lipidemia and/or dislipidemiya;
• Diseases of peripheral arteries;
• Chronic heart failure;
• Somatopathies (at a heavy current);
• Clearance of creatinine of 30-60 ml a minute;
• Digestive tract cankers in the anamnesis;
• Helicobacter pylori infection (Helikobakter of a pilora);
• Frequent use of alcoholic beverages, smoking;
• Long therapy by non-steroidal anti-inflammatory drugs;
• Simultaneous use with selective serotonin reuptake inhibitors, antiagregant, peroral glucocorticosteroids, anticoagulants;
• Advanced age.

From digestive tract it is necessary to apply the smallest effective doses to decrease in risk of emergence of disturbances by minimum possible courses.

Route of administration and dosage

Solution for intramuscular introduction:
The drug should be administered by means of a deep intramuscular injection (intravenous administration of solution is contraindicated).

Melbek in the form of injection solution it is necessary to apply only for the first 2-3 days of therapy then to pass to administration of drug inside. The daily dose is defined by weight of inflammatory process and intensity of pains and can make 7,5 or 15 mg, frequency rate of use – once a day.

It is impossible to mix in one syringe solution with other medicines.

Tablets:
Melbek in tablets accept inside, it is more preferable – during food.

Drug is usually appointed in the following daily doses (in 1 reception):

• Ankylosing spondylarthritis – 15 mg;
• Pseudorheumatism – 15 mg (at improvement the dose can be reduced twice);
• Osteoarthrosis – 7,5 mg (in case of insufficiency of effect it is possible to increase a dose to 15 mg).

The maximum daily dose of Melbek (tablets or injection solution) makes 15 mg. With the increased risk of development of side effects, and also at the patients who are on a hemodialysis with the expressed renal failure it is not necessary to use drug in a daily dose more than 7,5 mg.

Totally the dose of Melbek applied in the form of tablets and injection solution should not exceed 15 mg a day.

Side effects

• Nervous system: often – a headache, dizziness; infrequently – drowsiness, a sonitus, вертиго; seldom – nightmares, a disorientation, emotional lability, confusion of consciousness;
• Cardiovascular system: often – peripheral hypostases; infrequently – heartbeat, increase in arterial pressure, "inflows" of blood to face skin;
• Alimentary system: often – dyspepsia (including nausea, vomiting, diarrhea, abdominal pains, a lock, a meteorism); infrequently – a gastroduodenal ulcer, an eructation, a hyperbilirubinemia, passing increase in activity of hepatic transaminases, an esophagitis, stomatitis, bleeding from digestive tract (including hidden); seldom – hepatitis, perforation of digestive tract, colitis, gastritis;
• Urinary system: infrequently – a hyperpotassemia, a giperkreatininemiya and/or increase in urea in blood serum; very seldom – an acute renal failure; connection with performing therapy is not established – intersticial nephrite, an albuminuria, a hamaturia;
• Respiratory system: seldom – acute development of bronchial asthma, a bronchospasm;
• Bodies of a hemopoiesis: infrequently – anemia; seldom – change of a blood count (including thrombocytopenia, a leukopenia);
• Sense bodys: infrequently – вертиго; seldom – vision disorders (including a sight illegibility, conjunctivitis), a sonitus;
• Integuments: infrequently – an itch, a Quincke's disease, skin rash; seldom – a small tortoiseshell, a toxic epidermal necrolysis, Stephens-Johnson's syndrome; very seldom – violent rashes, a multiformny erythema;
• Allergic reactions: infrequently – anaphylactic/anaphylactoid reactions;
• Local reactions (at use of injection solution): burning and pain in an injection site.

Special instructions

It is necessary to be careful when performing therapy at patients with existence in the anamnesis of instructions on a peptic ulcer of a stomach and duodenum, and also at the patients applying anticoagulants (because of the increased risk of emergence of erosive peptic ulcers of digestive tract).

Correction of the mode of dosing at a renal failure with clearance of creatinine more than 30 ml a minute is not required.

At combined use of Melbek with diuretic drugs it is necessary to accept enough liquid.

In case of the allergic reactions which are shown in the form of skin rash, an itch, a photosensitization or a small tortoiseshell, treatment needs to be stopped.

It is necessary to consider that Melbek can mask symptoms of infectious diseases. Also drug influences fertility in this connection it is not recommended to be applied to women who plan pregnancy.

During therapy such undesirable effects as dizziness, a headache and drowsiness therefore during this period it is recommended to refuse control of motor transport and performance of work which demand from patients of the increased concentration of attention can develop.

Medicinal interaction

At combined use of Melbek with some drugs the following effects can develop:

• Other non-steroidal anti-inflammatory drugs (including acetylsalicylic acid): increase in risk of developing of bleedings of digestive tract and erosive cankers;
• Hypotensive medicines: decrease in their efficiency;
• Thrombolytic drugs, anticoagulants: increase in risk of developing of bleedings (it is required to control periodically indicators of coagulability of blood);
• Methotrexate: increase in risk of development of anemia and a leukopenia because of strengthening of its side effects on system of a hemopoiesis (it is required to control periodically the general blood test);
• Selective serotonin reuptake inhibitors: increase in risk of developing of gastrointestinal bleedings;
• Intrauterine contraceptive means: decrease in their efficiency;
• Lithium drugs: cumulation of lithium and increase in its toxic influence (at joint appointment it is recommended to control concentration of lithium in blood);
• Cyclosporine and diuretics: increase in risk of developing of a renal failure;
• Colestyraminum: strengthening of its removal from digestive tract.

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature up to 25 °C.

Period of validity – 4 years.