Movalis is a drug with analgesic, antipyretic and anti-inflammatory effects, used for the symptomatic treatment of osteoarthritis and rheumatoid arthritis.
Release form and composition
Movalis is available in the following dosage forms:
- Tablets: from pale yellow to yellow color, convex on one side with the company logo and beveled edge, on the other - with code and risk; surface roughness of tablets is allowed (in blisters of 10 pieces; 1 or 2 blisters in a carton box);
- Rectal suppositories: smooth, yellowish-green, with a hollow in the base (in blister packs of 6 pcs .; 1 or 2 packs per box);
- Suspension for oral administration: yellow with a green tint, viscous (in dark glass bottles of 100 ml, 1 bottle in a cardboard box);
- Solution for intramuscular injection: transparent, yellow with a green tint (in ampoules of 1.5 ml, 3 or 5 ampoules in blister packs or pallets; 1 pack or per tray in a carton box).
The composition of 1 tablet includes:
- Active ingredient: meloxicam - 7.5 or 15 mg;
- Auxiliary components: Povidone K25 - 9 mg, magnesium stearate - 1.7 mg, lactose monohydrate - 20 mg, crospovidone - 14 mg, microcrystalline cellulose - 87.3 mg, sodium citrate dihydrate - 30 mg, colloidal silicon dioxide - 3 mg.
The structure of 1 suppository rectal includes:
- Active ingredient: meloxicam - 7.5 or 15 mg;
- Auxiliary components: suppository mass (suppocyrr BP), glycerylhydroxystearate polyethylene glycol (glycerylhydroxystearate macrogol).
The composition of 5 ml suspension for oral administration includes:
- Active ingredient: meloxicam - 7.5 mg;
- Auxiliary components: sodium benzoate - 7.5 mg, purified water - 2463.5 mg, sorbitol 70% - 1750 mg, raspberry flavoring - 10 mg, citric acid monohydrate - 6 mg, sodium saccharinate - 0.5 mg, sodium dihydrogen phosphate dihydrate - 100 mg, xylitol - 750 mg, glycerol 85% - 750 mg, gietelloza - 5 mg, colloidal silicon dioxide - 50 mg.
The composition of 1 ml solution for intramuscular injections includes:
- Active ingredient: meloxicam - 10 mg;
- Auxiliary components: sodium hydroxide - 0.228 mg, poloxamer 188 - 75 mg, water for injection - 1279.482 mg, sodium chloride - 4.5 mg, glycine - 7.5 mg, glycofurfurol - 150 mg, meglumin - 9.375 mg.
Indications for use
Movalis is prescribed for the symptomatic treatment of the following diseases:
- Osteoarthritis, including degenerative diseases of the joints, arthrosis;
- Rheumatoid arthritis;
- Ankylosing spondylitis.
- Symptoms of asthma, nasal polyps, urticaria or angioedema after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs in history;
- Perforation / peptic ulcer and duodenal ulcer (recently transferred or during exacerbation);
- Ulcerative colitis or Crohn's disease (with exacerbation);
- Severe liver failure;
- Severe renal failure (in cases of confirmed hyperkalemia, with creatinine clearance less than 30 ml per minute, if hemodialysis is not performed), progressive kidney disease;
- Gastrointestinal bleeding during the acute period, recently transferred cerebrovascular bleeding or confirmed diseases of the blood coagulation system;
- Severe uncontrolled heart failure;
- Therapy of postoperative pain during coronary artery bypass surgery;
- Rare hereditary intolerance to galactose (for tablets, the maximum daily dose of Movalis with a dose of meloxicam 7.5 / 15 mg, respectively, contains 47/20 mg of lactose);
- Rare hereditary fructose intolerance (for oral suspension, the maximum daily dose of the drug contains 2.45 g of sorbitol);
- Age up to 18 years (for solution for intramuscular administration); up to 12 years (for tablets, oral suspensions, suppositories; except for the treatment of juvenile rheumatoid arthritis);
- Pregnancy and lactation;
- Hypersensitivity to the components of the drug (there is a possibility of cross-hypersensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs).
Movalis is prescribed with caution in the presence of the following diseases / conditions:
- Diseases of the gastrointestinal tract in history (with Helicobacter pylori infection);
- Cerebrovascular diseases;
- Coronary heart disease;
- Congestive heart failure;
- Peripheral artery diseases;
- Renal failure (with creatinine clearance 30-60 ml per minute);
- Hyperlipidemia / dyslipidemia;
- Frequent drinking and smoking;
- Prolonged use of nonsteroidal anti-inflammatory drugs;
- Simultaneous use with methotrexate in a dose of more than 15 mg per week;
- Concomitant use of anticoagulants, oral glucocorticosteroids, antiplatelet agents, selective serotonin reuptake inhibitors;
- Elderly age.
Dosing and Administration
Movalis should be used as soon as possible at the minimum effective dose, since this reduces the likelihood of side effects.
Intramuscular Movalis is indicated only during the first 2-3 days of treatment. In the future, therapy should be continued with the use of enteral forms of the drug.
Depending on the severity of the inflammatory process and the intensity of pain, the recommended dose is 7.5 mg or 15 mg (maximum) 1 time per day.
The solution for injection is administered deep intramuscularly (intravenous administration is contraindicated). Movalis should not be mixed in the same syringe with other drugs.
Movalis in the form of a suspension and tablets are taken orally, before meals. The frequency of admission - 1 time per day.
Depending on the indications, the following daily doses are recommended:
- Osteoarthrosis - 7.5 mg (an increase of 2 times is possible);
- Ankylosing spondylitis, rheumatoid arthritis - 15 mg (a decrease of 2 times is possible).
If there is an increased risk of side effects, it is recommended that therapy be started with a daily dose of 7.5 mg.
For children up to 12 years old, when treating juvenile rheumatoid arthritis, Movalis is prescribed in the form of a suspension for oral administration at the rate of 0.125 mg / kg (maximum 0.25 mg / kg). Depending on body weight, the following dosing regimen is recommended (amount of active substance / volume of suspension):
- 12 kg: 1.5 mg / 1 ml;
- 24 kg: 3 mg / 2 ml;
- 36 kg: 4.5 mg / 3 ml;
- 48 kg: 6 mg / 4 ml;
- From 60kg: 7.5 mg / 5 ml.
The maximum daily dose is 7.5 mg.
The recommended daily dose of rectal suppositories is 7.5 mg. If necessary, it can be increased by 2 times.
In case of end-stage renal failure on patients with hemodialysis, the drug in any dosage form is prescribed at a dose of 7.5 mg per day. In patients with moderate or small functional disorders of the kidneys (with creatinine clearance more than 30 ml per minute), dose adjustment is not required.
With the combined use of various dosage forms of Movalis, the total daily dose of the drug should not exceed 15 mg per day.
The following side effects may develop during the use of Movalis (≥1 / 10 - very often; ≥1 / 100, <1/10 - often; ≥1 / 1000, <1/100 - infrequently; ≥1 / 10 000, <1 / 1000 - rarely; <1/10 000 - very rarely, with an unspecified frequency):
- Gastrointestinal tract: often - dyspepsia, pain in the abdomen, diarrhea, vomiting, nausea; infrequently - gastrointestinal bleeding (hidden or obvious), gastritis, constipation, stomatitis, belching, bloating; rarely - esophagitis, colitis, gastroduodenal ulcers; very rarely - perforation of the gastrointestinal tract;
- Respiratory system: rarely - bronchial asthma (in the presence of allergy to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs);
- Cardiovascular system: infrequently - an increase in blood pressure, a feeling of "flushes" of blood to the face; rarely - heartbeat;
- Nervous system: often - headache; infrequently - drowsiness, dizziness;
- Immune system: infrequently - other immediate type hypersensitivity reactions; with unknown frequency - anaphylactic / anaphylactoid reactions, anaphylactic shock;
- Blood system: infrequently - anemia; rarely - thrombocytopenia, leukopenia, changes in the number of blood cells, including changes in the formula of leukocytes;
- Urinary system: infrequently - changes in the functional parameters of the kidneys (an increase in the level of urea and / or creatinine in the blood serum), urinary disorders, including acute urinary retention; very rarely, acute renal failure;
- Liver and biliary tract: infrequently - transient changes in indicators of liver function (for example, increased bilirubin or transaminase activity); very rarely - hepatitis;
- Skin and subcutaneous tissue: infrequently - itching, angioedema, skin rash; rarely - urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis; very rarely - erythema multiforme, bullous dermatitis; with an unknown frequency - photosensitivity;
- Sense organs: infrequently - vertigo; rarely - tinnitus, visual impairment, including blurred vision, conjunctivitis;
- Mind: seldom - changeable mood; with an unknown frequency - disorientation, confusion;
- General disorders and disorders at the injection site: often - swelling and pain at the injection site; Infrequently - swelling.
At simultaneous use with the drugs oppressing marrow (for example, methotrexate), development of cytopenia is possible.
Gastrointestinal bleeding, perforation, or an ulcer can be fatal.
As with the treatment of other nonsteroidal anti-inflammatory drugs, during the use of Movalis there is a likelihood of developing glomerulonephritis, interstitial nephritis, nephrotic syndrome and renal medullary necrosis.
Patients with diseases of the gastrointestinal tract need to undergo regular monitoring. In cases of gastrointestinal bleeding or ulceration of the gastrointestinal tract Movalis should be canceled.
During therapy, bleeding, perforation, ulcers of the gastrointestinal tract can develop at any time with or without warning signs or information about a serious gastrointestinal complication in history. The consequences of these complications are more serious for elderly patients.
With the use of Movalis, serious reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis can develop on the skin. Particular attention should be paid to patients with adverse events from the mucous membranes and skin, as well as hypersensitivity reactions to the drug, especially if such reactions have been observed during previous courses of therapy. Most often, skin disorders develop during the first 30 days of use of the drug. In some cases, such violations may cause the cancellation of Movalis.
During therapy, cases of increasing the risk of myocardial infarction, serious cardiovascular thrombosis, angina attacks, possibly fatal, are described. The risk of their occurrence increases with prolonged use of Movalis, as well as in the presence of the above diseases in history and in case of a predisposition to their development.
Movalis inhibits kidney synthesis of prostaglandins involved in maintaining renal perfusion. Therapy in patients with a reduced volume of circulating blood or with reduced renal blood flow can lead to decompensation of latent renal failure. As a rule, after the cancellation of Movalis, the kidney function is restored to its original level. Elderly patients are most at risk of developing this reaction; patients with dehydration, congestive heart failure, liver cirrhosis, nephrotic syndrome or acute renal impairment; patients who have undergone serious surgery, which can lead to the development of hypovolemia. In such patients, diuresis and renal function should be carefully monitored at the beginning of treatment. Also, the risk of developing latent renal failure increases with simultaneous use with diuretic agents, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists.
The simultaneous use of Movalis with diuretics can cause water retention, sodium and potassium, and also lead to a decrease in the natriuretic effect of diuretics. Because of this, symptoms of hypertension or heart failure may increase in predisposed patients (adequate hydration and careful monitoring of the condition of these patients are necessary).
Before using Movalis, a study of kidney function is needed. When conducting a combined treatment it is also necessary to monitor the functional state of the kidneys.
During therapy, there may be an intermittent increase in transaminase activity in the serum or other liver function indicators. In most cases, this increase was transient and small. If these changes are significant or do not diminish with time, it is necessary to interrupt therapy and conduct further laboratory monitoring of the changes identified.
Exhausted or weakened patients may suffer worse side effects, and therefore requires careful monitoring of their condition.
Movalis may mask signs of a major infectious disease.
The drug can affect fertility, so its use is not recommended for women who have difficulty conceiving.
When driving vehicles, working with mechanisms and other potentially dangerous types of work that require high concentration of attention and quick psychomotor reactions, it is necessary to take into account the possibility of developing drowsiness, dizziness, visual impairment or other disorders of the central nervous system.
With simultaneous use of Movalis with some drugs, the following effects may occur:
- Other inhibitors of prostaglandin synthesis, including salicylates and glucocorticoids: an increased risk of ulceration in the gastrointestinal tract and gastrointestinal bleeding (due to synergistic action; the combination of drugs is not recommended);
- Selective serotonin reuptake inhibitors: an increased risk of gastrointestinal bleeding;
- Lithium drugs: an increase in plasma lithium concentration (its concentration should be monitored during the appointment of Movalis, as well as when the dose of lithium drugs is changed or canceled);
- Methotrexate: a decrease in tubular secretion and an increase in its concentration in plasma without changing hematologic toxicity and pharmacokinetics (simultaneous use with doses of more than 15 mg per week is not recommended; it is necessary to constantly monitor the number of blood cells and kidney function);
- Intrauterine contraceptive drugs: reducing their effectiveness;
- Diuretics: an increased risk of acute renal failure with dehydration;
- Antihypertensive drugs (beta-blockers, vasodilators, angiotensin-converting enzyme inhibitors, diuretics): reducing their effectiveness;
- Angiotensin II receptor antagonists: increased reduction of glomerular filtration, which can lead to acute renal failure, especially in the presence of functional disorders of the kidneys (with simultaneous use, it is necessary to monitor renal function);
- Cholestyramine: an increase in the rate of elimination of meloxicam;
- Cyclosporine: enhancing its nephrotoxicity;
Also, when used in conjunction with Movalis, the following cautions should be considered:
- Drugs with a known ability to inhibit CYP2C9 and / or CYP3A4: the possibility of pharmacokinetic interaction should be taken into account;
- Diuretics: it is necessary to maintain adequate hydration, a study of renal function should be carried out before the start of therapy;
- Other nonsteroidal anti-inflammatory drugs: the combination is not recommended;
- Oral hypoglycemic drugs: you need to take into account the possibility of interaction.
Terms and conditions of storage
Keep out of the reach of children.
- Solution for intramuscular administration: 5 years at temperatures up to 30 ° C (in the dark place);
- Rectal suppositories: 3 years at temperatures up to 30 ° C;
- Tablets and suspension for oral administration: 3 years at temperatures up to 25 ° C.
After opening the vial with suspension, the drug can be taken within 30 days.