Meloxicam | Movalis ampoules 1.5 ml / 15 mg, 3 pcs.

Release form

Solution for intramuscular administration.

Packing

3 ampoules.

Pharmacological action

Movalis - NSAIDs. Belongs to the class of oxycams, is a derivative of enolic acid. It has anti-inflammatory, analgesic and antipyretic effects. The mechanism of action is associated with a decrease in prostaglandin biosynthesis as a result of inhibition of the enzymatic activity of COX. In this case, Movalis more actively affects COX-2, which is involved in the synthesis of prostaglandins in the focus of inflammation, which reduces the risk of side effects on the upper gastrointestinal tract and slightly affects COX-1.

At the same time, meloxicam does not affect the synthesis of proteoglycan by chondrocytes of the articular cartilage, does not affect the development of spontaneous arthrosis in rats and mice, which indicates its chondroneutrality.

Indications

Symptomatic treatment: - rheumatoid arthritis

- osteoarthritis

- ankylosing spondylitis.

Contraindications

- Hypersensitivity to meloxicam and other NSAIDs (including salicylates)

- peptic ulcer of the stomach and duodenum in the exacerbation phase

- severe hepatic dysfunction

- renal failure (without hemodialysis)

- pregnancy

- lactation (breast-feeding)

up to 15 years of age - children and children for intramuscular injection should not be prescribed to patients receiving anticoagulants, given the possible risk of developing intramuscular hematoma

- Movalis is not prescribed for patients who, in connection with the appointment of acetylsalicylic acid or other NSAIDs, asthma attacks, nasal mucosa polyps, angioedema, urticaria were observed.

Use during pregnancy and lactation

Contraindicated.

Special instructions

Movalis in ampoules is not intended for iv administration.

Movalis should be used with caution in concomitant diseases of the upper gastrointestinal tract, as well as in patients receiving anticoagulant therapy. In case of peptic ulcer or gastrointestinal bleeding, the drug should be discontinued.

With the appointment of Movalis, the development of gastrointestinal bleeding, ulcerative lesion or perforation is possible, if the patient has a history of previous symptoms and episodes of similar complications from the gastrointestinal tract, and without them. In old age, a more severe course of these complications is noted.

Particular attention should be paid to patients who have undesirable effects on the part of the skin and mucous membranes, in such cases, you should consider stopping the use of Movalis.

NSAIDs inhibits the synthesis of renal prostaglandins, which are involved in maintaining an adequate level of renal blood flow. The administration of NSAIDs to patients with reduced renal blood flow and BCC can accelerate the decompensation of the kidneys, however, after discontinuation of NSAID therapy, renal function usually returns to its previous level.

The risk of adverse reactions is especially high in patients with dehydration phenomena, congestive heart failure, liver cirrhosis, nephrotic syndrome and severe kidney diseases, in patients receiving diuretics, as well as in those who underwent significant surgery that led to hypovolemia. Such patients from the very beginning of treatment require careful monitoring of diuresis and renal function.

In rare cases, an increase in serum transaminase levels or a change in other indicators characterizing liver function has been reported. In most cases, deviations from the norm were minor and transient. With a more pronounced or permanent nature of violations of the liver function indicators, you should stop taking Movalis and conduct control laboratory studies.

In patients with clinically non-progressive cirrhosis, a dose reduction is not required.

Weakened and emaciated patients can tolerate more severe side effects, such patients need careful monitoring.

Movalis should be used with caution in elderly patients who are more likely to have impaired renal, hepatic, or cardiac function. NSAIDs can help delay sodium, potassium and water and weaken the natriuretic effect of diuretics. As a result, in the presence of predisposing factors, the appointment of NSAIDs can lead to the progression of heart failure and hypertension.

Effect on the ability to drive vehicles and control mechanisms

During the treatment period, when visual impairment, dizziness or drowsiness occurs, you must refrain from driving vehicles and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Composition

1 ml of the solution contains meloxicam 10 mg (1 ampoule - 15 mg)

excipients: N-methyl-D-glucamine, glucofurol, pluronic F68, sodium chloride, glycine, sodium hydroxide.

Dosage and administration of

The drug is prescribed for adults.

Movalis can be used IM only in the first few days of treatment. For subsequent therapy, dosage forms of the drug for oral administration (tablets) should be prescribed.

With rheumatoid arthritis and ankylosing spondylitis, the drug is prescribed at 15 mg / day, if a positive therapeutic effect is achieved, the dose can be reduced to 7.5 mg / day.

In osteoarthritis, the daily dose is 7. 5-15 mg / day.

The maximum daily dose is 15 mg.

Inside In individuals with an increased risk of side effects, treatment should be started with a dose of 7.5 mg / day.

In patients with severe renal failure who are on hemodialysis, the drug is prescribed in a daily dose of 7.5 mg.

In patients with moderate renal failure (CC greater than 25 ml / min), a dose reduction is not required.

Movalis solution should be administered deeply in oil.

Side effects of

From the digestive system:> 1% - dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea 0.1-1% - transient changes in liver function indices (t. including an increase in the level of transaminases or bilirubin), belching, esophagitis, ulcerative lesions of the gastrointestinal tract, latent or macroscopically visible gastrointestinal bleeding

From the hematopoietic system:> 1% - anemia 0.1-1% - change in the hemogram, including a change in the number of individual types of white blood cells, leukopenia, thrombocytopenia.

Dermatological reactions:> 1% - itching, rash 0. 1-1% - stomatitis, urticaria <0.1% - photosensitivity.

Allergic reactions: in some cases - bullous reactions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the respiratory system:

From the nervous system:> 1% - headache 0.1-1% - dizziness, tinnitus, drowsiness

From the cardiovascular system:> 1% - edema 0.1-1% - increased blood pressure palpitations, hot flashes.

From the urinary system: 0.1-1% - change in kidney function (increased creatinine and / or urea in the blood) less than 0.1% - acute renal failure in some cases - interstitial nephritis, glomerulonephritis, renal medullary necrosis, nephrotic syndrome.

On the part of the organ of vision:

Allergic reactions:

Drug Interactions

With the simultaneous administration of more than one drug from the NSAID group due to synergism, there may be an increased risk of ulcerative lesions or bleeding from the gastrointestinal tract.

NSAIDs have been reported to increase plasma lithium levels. Repeated determination of the concentration of lithium in plasma at the beginning and end of treatment, as well as after changing the dose of Movalis, is recommended.

With simultaneous administration with potentially myelotoxic drugs, cytopenia may develop. Movalis may enhance hematologic toxicity of methotrexate. In such cases, monitoring of the number of blood cells is necessary.

There are reports that NSAIDs reduce the effectiveness of intrauterine contraceptives.

In the treatment of NSAIDs, there is the potential for the development of acute renal failure in patients with dehydration. Patients using Movalis concurrently with diuretics should receive a sufficient amount of fluid, before starting Movalis therapy, they need to determine the functional state of the kidneys.

During therapy with NSAIDs, a decrease in the effectiveness of antihypertensive agents (e.g. beta-blockers, acetylcholinesterase inhibitors, vasodilators, diuretics) due to inhibition of the synthesis of prostaglandins-vasodilators.

Colestyramine binds to meloxicam in the gastrointestinal tract, which leads to accelerated elimination of meloxicam from the body.

NSAIDs can indirectly enhance the nephrotoxicity of cyclosporin via renal prostaglandins. With the simultaneous appointment of Movalis and cyclosporine, renal function should be monitored.

The possibility of drug interaction of meloxicam with hypoglycemic agents cannot be ruled out.

NSAIDs can cause sodium, potassium, fluid retention and weaken the action of saluretics. As a result, in predisposed patients, the administration of NSAIDs can lead to progression of heart failure and hypertension.

The possibility of pharmacokinetic interaction with the simultaneous administration of meloxicam and drugs that reduce activity or are metabolized with the participation of CYP2C9 or CYP3A4 isoenzymes should be considered.

No pharmacokinetic drug interaction was detected with the simultaneous administration of meloxicam and antacids, cimetidine, digoxin, furosemide.

There are no data on possible incompatibilities, therefore, meloxicam injection should not be mixed with other drugs in the same syringe.

Overdose

There are insufficient data on cases of drug overdose. Symptoms of overdose of NSAIDs in severe cases are likely to be present: drowsiness, impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, changes in blood pressure, respiratory arrest, asystole.

Treatment: Antidote is unknown. In case of overdose of the drug, symptomatic therapy should be used. Colestyramine is known to accelerate the elimination of meloxicam.

Storage Conditions

The product should be stored in a dark place at a temperature not exceeding 25 РC.

Shelf life

5 years.

Active ingredient

Meloxicam

Terms of dispatch from

pharmacies Prescription

dosage form

injection

Possible product names

MOVALIS 0.015 / 1.5ML N3 AMP

MOVALIS 0.015 / 1.5ML N3 AMP R-V / M

Movalis 15mg / 1.5ml No. 3

MOVALIS 15MG / 1.5ML. No. 3 RR D / IN. V / M AMP.

Movalis 15mg / 1.5ml solution for v / m administration. 1.5ml Amp. X3

Beringer Ingelyhaym, Austria