Melbec is a non-steroidal anti-inflammatory drug used in the symptomatic treatment of inflammatory and degenerative diseases of the joints, which are accompanied by pain.
Release form and composition
Melbek produced in the following dosage forms:
- Tablets: round, light yellow, with a risk on one of the sides (in blister packs of 5, 10, 30 pcs., 1-3 packs in a carton box);
- Solution for intramuscular injection: greenish-yellow, transparent (in ampoules of 1.5 ml, 3 ampoules in pallets, 1 pallet in a carton box).
The composition of 1 tablet includes:
- Active ingredient: meloxicam - 7.5 mg;
- Auxiliary components: sodium citrate, crospovidone, colloidal silicon dioxide, povidone-QSO, microcrystalline cellulose, lactose, magnesium stearate.
The composition of 1 ampoule (1.5 ml) of a solution for intramuscular administration includes:
- Active ingredient: meloxicam - 15 mg;
- Auxiliary components: meglumine, glycofurol, poloxamer 188, glycine, sodium chloride, 1 M solution of sodium hydroxide or 1 M solution of hydrochloric acid, water for injection.
Indications for use
Melbeck is prescribed for the symptomatic treatment of rheumatoid arthritis, osteoarthrosis, ankylosing spondyloarthritis (ankylosing spondylitis), as well as other degenerative and inflammatory diseases of the joints, accompanied by pain.
- Decompensated heart failure;
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis);
- Cerebrovascular bleeding or other bleeding;
- Active liver disease or severe liver failure;
- Severe renal failure in patients not undergoing dialysis (with creatinine clearance less than 30 ml per minute), progressive kidney disease, including confirmed hyperkalemia;
- The period after coronary artery bypass surgery;
- The combination (full or partial) of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (including in history);
- Active gastrointestinal bleeding, erosive and ulcerative changes in the mucous membrane of the stomach or duodenum;
- Pregnancy and lactation (breastfeeding);
- Age up to 15 (tablets) or 18 years (solution for intramuscular administration);
- Hypersensitivity to the drug.
Additionally, Melbek in the form of tablets is contraindicated in the presence of intolerance to acetylsalicylic acid and pyrazolone preparations, as well as rare hereditary diseases (lactose intolerance, lactase deficiency or glucose-galactose malabsorption).
Melbek should be used with caution in elderly patients, as well as in the following diseases / conditions:
- Cerebrovascular diseases;
- Coronary heart disease;
- Hyperlipidemia / dyslipidemia;
- Chronic heart failure;
- Peripheral artery diseases;
- Severe somatic diseases;
- Creatinine clearance from 30-60 ml per minute;
- Smoking, frequent use of alcoholic beverages;
- Helicobacter pylori infection (Helicobacter pylori);
- A history of the development of ulcerative lesions of the gastrointestinal tract;
- Prolonged use of nonsteroidal anti-inflammatory drugs;
- Concomitant therapy with anticoagulants (warfarin), antiplatelet agents (acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (prednisolone), selective serotonin reuptake inhibitors (citalopram, paroxetine, fluoxetine, sertraline).
To reduce the risk of development of adverse events from the gastrointestinal tract, it is necessary to use the smallest effective dose with the shortest possible course.
Dosing and Administration
Melbek in the form of tablets is taken orally, during meals.
The frequency of admission - 1 time per day. Recommended dosing regimen:
- Rheumatoid arthritis: 15 mg per day. Depending on the effectiveness, a dose reduction of 2 times is possible;
- Ankylosing spondylitis: 15 mg per day;
- Osteoarthritis: 7.5 mg per day. With the ineffectiveness of the drug may increase the dose by 2 times.
Melbek in the form of a solution is administered by deep intramuscular injection (intravenous administration is contraindicated).
Intramuscular administration is indicated only during the first 2-3 days. In the future, therapy should be continued using the oral form of the drug (tablets). Depending on the severity of the inflammatory process and the intensity of the pain, the recommended daily dose is 7.5 mg or 15 mg. The drug is used 1 time per day.
The contents of the ampoules should not be mixed in the same syringe with other drugs.
The maximum dose of Melbek in any dosage form is 15 mg per day. In patients with an increased risk of side effects, as well as those on hemodialysis patients with severe renal insufficiency, the daily dose should not be higher than 7.5 mg.
The total daily dose of Melbek, used in the form of injections and tablets - up to 15 mg.
During therapy may develop disorders of some body systems:
- Cardiovascular system: often - peripheral edema; infrequently - increased blood pressure, palpitations, flushing of the face;
- Nervous system: often - headache, dizziness; infrequently - tinnitus, vertigo, drowsiness; rarely - disorientation, confusion, nightmares, emotional lability;
- Urinary system: infrequently - hypercreatininemia and / or increase in serum urea, hyperkalemia; very rarely, acute renal failure; connection with the drug is not installed - albuminuria, interstitial nephritis, hematuria;
- The digestive system: often - dyspepsia, including nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea; infrequently - transient increase in liver transaminases, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, gastrointestinal bleeding (including latent), stomatitis; rarely - perforation of the gastrointestinal tract, hepatitis, gastritis, colitis;
- Respiratory system: rarely - bronchospasm, acute development of bronchial asthma;
- Skin: rarely - itching, angioedema, skin rash; rarely, toxic epidermal necrolysis, urticaria, Stevens-Johnson syndrome; very rarely - erythema multiforme, bullous eruptions;
- Sense organs: infrequently - vertigo; rarely, visual impairment, including conjunctivitis, blurred vision, tinnitus;
- Blood formation organs: infrequently - anemia; rarely - a change in blood counts, including thrombocytopenia, leukopenia;
- Allergic reactions: infrequently - anaphylactic / anaphylactoid reactions;
- Local reactions (intramuscular): possible pain and burning at the injection site.
When using Melbek in patients with a history of gastric ulcer and duodenal ulcer, as well as in patients undergoing anticoagulant therapy, care must be taken (due to the increased risk of erosive and ulcerative diseases of the gastrointestinal tract).
Also, therapy should be carried out with caution and under the control of indicators of kidney function in elderly patients, patients with chronic heart failure with clinical manifestations, cirrhosis of the liver and hypovolemia associated with surgical interventions.
In patients on dialysis, the Melbek daily dose should not exceed 7.5 mg.
Patients with renal insufficiency with creatinine clearance of more than 30 ml per minute do not require correction of the dosage regimen.
With the simultaneous use of Melbek with diuretics it is necessary to take a sufficient amount of fluid.
If allergic reactions develop during therapy (itching, skin rash, urticaria, photosensitization), the use of the drug should be discontinued. Like other nonsteroidal anti-inflammatory drugs, Melbeck can mask the symptoms of infectious diseases.
The use of the drug may affect fertility, so it is not recommended to appoint women planning pregnancy.
The use of Melbek can lead to undesirable effects in the form of dizziness, headache and drowsiness, therefore during the therapy it is recommended to abandon driving and work requiring concentration.
With the simultaneous use of Melbek with some drugs, undesirable effects may occur:
- Antihypertensive drugs: reducing their effectiveness;
- Other nonsteroidal anti-inflammatory drugs (also acetylsalicylic acid): an increase in the risk of erosive-ulcerative lesions and bleeding in the gastrointestinal tract;
- Methotrexate: enhancing its side effects on the hematopoietic system (risk of leukopenia and anemia, periodic monitoring of the complete blood count is shown);
- Lithium preparations: the development of cumulation of lithium and an increase in its toxic effect (with simultaneous use, it is recommended to control the concentration of lithium in the blood);
- Intrauterine contraceptives: a decrease in their effectiveness;
- Diuretics and cyclosporine: an increased risk of developing renal failure;
- Kolestiramin: enhancing its excretion through the gastrointestinal tract;
- Anticoagulants (ticlopidine, heparin, warfarin), as well as with thrombolytic drugs (fibrinolysin, streptokinase): an increased risk of bleeding (periodic monitoring of blood clotting parameters is necessary);
- Selective serotonin reuptake inhibitors: an increased risk of gastrointestinal bleeding.
Terms and conditions of storage
Store in a dark, dry place inaccessible to children at temperature up to 25 ° C.
Shelf life - 4 years.