Movalis, 15 mg/1.5 ml 1.5 ml 3 pcs.

Name: Movalis, 15 mg/1.5 ml 1.5 ml 3 pcs.
SKU: 206575
Availability: InStock

€17.42

EAN: 9006968002293 SKU: 206575 Categories: Medicine, Pain and inflammation

Description

Pharmgroup:

Non-steroidal anti-inflammatory drug – NSAID.

Pharmic action:

Movalis is a non-steroidal anti-inflammatory drug, refers to enolic acid derivatives and has anti-inflammatory, analgesic and antipyretic effects. The pronounced anti-inflammatory effect of meloxicam was established in all standard models of inflammation. The mechanism of action of meloxicam is its ability to inhibit the synthesis of prostaglandins – known mediators of inflammation.

In vivo meloxicam inhibits prostaglandin synthesis at the site of inflammation to a greater extent than in the gastric mucosa or kidney.
These differences are due to more selective inhibition of cyclooxygenase-2 (COX-2) compared to cyclooxygenase-1 (COX-1). Inhibition of COX-2 is thought to provide the therapeutic effect of NSAIDs, whereas inhibition of the ever-present COX-1 isoenzyme may cause gastric and renal side effects.

The selectivity of meloxicam against COX-2 has been confirmed in various test systems, both in vitro and ex vivo. The selective ability of meloxicam to inhibit COX-2 was shown when using human whole blood as a test system in vitro. Ex vivo, meloxicam (at doses of 7.5 and 15 mg) was found to be more active in inhibiting COX-2, having a greater inhibitory effect on lipopolysaccharide-stimulated prostaglandin E2 production (COX-2-controlled response) than on thromboxane production involved in blood clotting (COX-1-controlled response). These effects were dose-dependent. Ex vivo, meloxicam at the recommended doses was shown to have no effect on platelet aggregation and bleeding time, in contrast to indomethacin, diclofenac, ibuprofen and naproxen, which significantly inhibited platelet aggregation and increased bleeding time.

In clinical trials, gastrointestinal (GI) side effects were generally less frequent with meloxicam 7.5 and 15 mg than with the other NSAIDs compared. This difference in the frequency of gastrointestinal side effects is mainly due to the fact that such phenomena as dyspepsia, vomiting, nausea, and abdominal pain were observed less frequently while taking meloxicam. The frequency of upper gastrointestinal perforations, ulcers and bleeding associated with the use of meloxicam was low and depended on the size of the dose of the drug.

Pharmacokinetics:

Meloxicam is completely absorbed after intramuscular administration. The relative bioavailability compared to the bioavailability with oral administration is almost 100%. Therefore, no dosage adjustment is required when switching from injectable to oral forms. After administration of 15 mg of the drug intramuscularly, the peak plasma concentration of about 1.62 mcg/ml is reached within about 60 minutes.

Distribution
Meloxicam binds very well to plasma proteins, especially to albumin (99%). It penetrates the synovial fluid, the concentration in synovial fluid is approximately 50% of the plasma concentration. The volume of distribution is low, averaging 11 L. Interindividual variation is 30-40%.

Metabolism
Meloxicam is almost completely metabolized in the liver to form 4 pharmacologically inactive derivatives. The main metabolite, 5′-carboxymeloxicam (60% of the dose value), is formed by oxidation of the intermediate metabolite, 5′-hydroxymethylmeloxicam, which is also excreted, but to a lesser extent (9% of the dose value). In vitro studies have shown that CYP 2C9 plays an important role in this metabolic transformation, CYP 3A4 isoenzyme has additional importance. Peroxidase, the activity of which probably varies individually, is involved in the formation of the other two metabolites (which are, respectively, 16% and 4% of the drug dose).

Elimation
It is excreted equally in the feces and urine, mainly as metabolites. Less than 5% of daily dose is excreted unchanged in feces, the drug is excreted unchanged in urine only in trace amounts. The average half-life of meloxicam is 20 hours. Plasma clearance averages 8 ml/min. Meloxicam exhibits linear pharmacokinetics at doses of 7.5 to 15 mg when administered orally or intramuscularly.

Hepatic and/or renal function deficiencies
Liver function deficiencies and mild to moderate renal failure have no significant effect on the pharmacokinetics of meloxicam.

In terminal renal failure, increased volume of distribution may lead to higher concentrations of free meloxicam, so in these patients the daily dose should not exceed 7.5 mg.

Elderly patients
Elderly patients have slightly lower mean plasma clearance during steady state pharmacokinetics than younger patients.

Indications
Indications

Active ingredient
Active ingredient

Composition
Composition
Active substance:
meloxicam15 mg;
Supplements:
Meglumine;
Glycopurole;
Poloxamer 188 (Pluronic F68);

How to take, the dosage
How to take, the dosage
Intravenous administration of the drug is indicated only during the first 2-3 days of therapy. Subsequently the treatment is continued with enteral forms. The recommended dose is 7.5 mg or 15 mg once daily, depending on the intensity of pain and severity of the inflammatory process.
The maximum recommended daily dose is 15 mg.
The drug is administered by deep intravenous injection.
In view of possible incompatibilities, the contents of MovalisÂ® ampoules should not be mixed with other medicinal products in the same syringe.
Kidney function disorders. In patients with severe renal impairment who are on hemodialysis, the dose should not exceed 7.5 mg/day.
The drug should not be administered intravenously.

Interaction
Interaction
Other GH synthesis inhibitors, including GK and salicylates, when concomitantly administered with meloxicam increase the risk of gastrointestinal ulcers and bleeding (due to synergistic action) and therefore their combination is not recommended. Simultaneous use with other NSAIDs is not recommended.
SIOZS – increased risk of gastrointestinal bleeding.
Lithium drugs – NSAIDs increase plasma lithium concentrations by reducing renal excretion. It is recommended that lithium concentrations be monitored during the administration of MovalisÂ®, when the dose of lithium drugs is changed and when they are withdrawn.
Methotrexate – NSAIDs decrease tubular secretion of methotrexate, thereby increasing its plasma concentrations and hematological toxicity, the pharmacokinetics of methotrexate is not altered. In this regard, concomitant administration of MovalisÂ® and methotrexate in dose more than 15 mg/day is recommended. The risk of interaction between NSAIDs and methotrexate may also occur in patients using methotrexate in low doses, especially in patients with impaired renal function. Therefore, continuous monitoring of blood cell count and renal function is necessary.
The concomitant use of meloxicam had no effect on the pharmacokinetics of methotrexate at a dose of 15 mg per week, but it should be taken into account that hematological toxicity of methotrexate is increased by concomitant use of NSAIDs.
The co-administration of meloxicam and methotrexate for 3 days increases the risk of increased toxicity of the latter.
Contraception – NSAIDs reduce the effectiveness of intrauterine contraceptive devices.
Diuretics – the use of NSAIDs in patients who are dehydrated is accompanied by a risk of acute renal failure.
In patients receiving MovalisÂ® and diuretics, adequate hydration must be maintained. Renal function should be investigated prior to initiation of treatment.
Antihypertensive agents (beta-adrenoblockers, ACE inhibitors, vasodilators, diuretics) – NSAIDs decrease the effect of antihypertensive agents, due to inhibition of PGs, which have vasodilatory properties.
Angiotensin II receptor antagonists when combined with NSAIDs increase decrease of glomerular filtration, which may lead to acute renal failure, especially in patients with impaired renal function. In case of combined therapy, renal function should be monitored.
The NSAIDs may increase the nephrotoxicity of cyclosporine by acting on renal GHGs.
When using with meloxicam medicinal products that have a known ability to inhibit CYP2C9 and/or CYP3A4 (or are metabolized with the participation of these enzymes), the possibility of pharmacokinetic interaction should be taken into account.
The possibility of interaction with hypoglycemic drugs for oral administration cannot be excluded.
When concomitant use of antacids, cimetidine, digoxin and furosemide, no significant pharmacokinetic interactions have been found.

Special Instructions
Special Instructions
Movalis in ampoules is not intended for intravenous administration.
Movalis should be used with caution in coexisting diseases of the upper gastrointestinal tract, as well as in patients receiving anticoagulant therapy. If peptic ulcer or gastrointestinal bleeding occurs, the drug should be discontinued.
When prescribing Movalis, gastrointestinal bleeding, ulceration or perforation may or may not occur if there is a history of prior symptoms and episodes of similar gastrointestinal complications. The course of these complications is more severe in the elderly.
Particular attention must be paid to patients who have had adverse effects on the skin and mucous membranes, in these cases discontinuation of Movalis should be considered.
The NSAIDs inhibit the synthesis of renal prostaglandins, which are involved in maintaining adequate renal blood flow. Administration of NSAIDs to patients with decreased renal blood flow and CBC may precipitate renal decompensation, but renal function generally returns to previous levels after NSAID therapy is discontinued.
The risk of adverse reactions is particularly high in patients with dehydration, congestive heart failure, cirrhosis, nephrotic syndrome, and severe renal disease, in patients treated with diuretics, and in patients who have undergone significant surgery resulting in hypovolemia. Such patients require careful monitoring of diuresis and renal function from the beginning of treatment.
In rare cases, elevated serum transaminases or changes in other parameters characterizing liver function have been reported. In most cases, deviations from the norm were minor and transient. If liver function abnormalities are more pronounced or persistent, discontinue Movalis and perform control laboratory tests.
In patients with clinically non-progressive cirrhosis, there is no need to decrease the dose of the drug.
Weakened and debilitated patients may have more severe side effects; these patients need close monitoring.
Movalis should be used with caution in elderly patients who are more likely to have impaired renal, hepatic or cardiac function. NSAIDs may contribute to sodium, potassium, and water retention and weaken the natriuretic effect of diuretics. As a result, in the presence of predisposing factors, prescribing NSAIDs may lead to progression of heart failure and hypertension.
Impact on driving and operating machinery
During treatment, if visual acuity, dizziness or somnolence are observed, one should refrain from driving and engaging in potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications
Contraindications

Side effects
Side effects
Hematopoietic organs: changes in the number of blood cells, including changes in the leukocytic formula, leukopenia, thrombocytopenia, anemia. A predisposing factor for the occurrence of cytopenias seems to be the simultaneous use of potentially myelotoxic drugs, in particular methotrexate.
Immune system disorders: anaphylactic shock, anaphylactoid/anaphylactic reactions, other immediate-type hypersensitivity reactions.
CNS disorders: headache, dizziness, tinnitus, drowsiness, confusion, disorientation, mood changes.
Gastrointestinal disorders: Gastrointestinal perforation, hidden or overt gastrointestinal bleeding, possibly fatal, gastroduodenal ulcers, colitis, gastritis, esophagitis, stomatitis, abdominal pain, dyspepsia, diarrhea, nausea, vomiting, constipation, bloating, belching, transient changes in liver function parameters (such as increased transaminase or bilirubin activity), hepatitis.
Skin and skin appendages: toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, bullous dermatitis, erythema multiforme, pruritus, skin rash, urticaria, photosensitization.
Respiratory system disorders: bronchial asthma in patients with allergy to acetylsalicylic acid or other NSAIDs.
Systemic diseases: increase in blood pressure, palpitations, blood rush to the face, edema.
Urogenital system disorders: acute renal failure, changes in renal function (increased serum creatinine and/or serum urea levels), urinary disorders, including acute urinary retention.
Visual organs: conjunctivitis, visual disturbances, including blurred vision.

Overdose
Overdose
The antidote is not known, in case of overdose of the drug should be carried out: gastric lavage and general supportive therapy.
In clinical studies it has been shown that cholestyramine accelerates excretion of meloxicam.

Pregnancy use
Pregnancy use

Similarities
Similarities

Additional information
Weight 0.020 kg
Shelf life
5 years
Conditions of storage
In a light-protected place, at a temperature not exceeding 30 °C
Manufacturer
Boehringer Ingelheim Espana S.A., Spain
Medication form
solution
Brand
Boehringer Ingelheim Espana S.A.