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  • Movalis solution for injection 15 mg/1.5 ml, 1.5ml x 5 ampoules — Made in Spain — Free Delivery

Movalis solution for injection 15 mg/1.5 ml, 1.5ml x 5 ampoules — Made in Spain — Free Delivery

(Movalis solution )
Movalis solution for injection 15 mg/1.5 ml, 1.5ml x 5 ampoules — Made in Spain — Free Delivery
Movalis solution for injection 15 mg/1.5 ml, 1.5ml x 5 ampoules — Made in Spain — Free Delivery
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Boehringer Ingelheim Brand: Boehringer Ingelheim
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Description Movalis solution for injection 15 mg/1.5 ml, 1.5ml x 5 ampoules — Made in Spain — Free Delivery

Pharmacological properties

Pharmacodynamics. Movalis is an NSAID of the enolic acid class, it has anti-inflammatory, analgesic and antipyretic effects. meloxicam exhibits high anti-inflammatory activity in all standard models of inflammation. As with other NSAIDs, its exact mechanism of action remains unknown. however, there is a common mechanism of development for all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins, which are inflammatory mediators.
Pharmacokinetics
Absorption. Meloxicam is well absorbed in the gastrointestinal tract after oral administration, the absolute bioavailability is 90% (capsules). Tablets, oral suspension and capsules are bioequivalent. After a single use of meloxicam, Cmax in blood plasma is achieved within 5-6 hours for solid oral forms (capsules and tablets). With repeated administration, stable concentrations are reached on the 3rd-5th day. The dosing regimen once a day leads to an average concentration in blood plasma with relatively small fluctuations in peaks in the range of 0.4-1.0 μg / ml for 7.5 mg and 0.8-2.0 μg / ml for 15 mg, respectively (Cmin and Cmax in a stable state, respectively). The average concentration of meloxicam in blood plasma in a stable state is reached within 5-6 hours for tablets, capsules and suspension for oral administration, respectively.
The simultaneous intake of food or the use of inorganic antacids does not affect the absorption of the preparation.
Meloxicam is completely absorbed after i / m injection. Relative bioavailability compared to oral administration is 100%. Therefore, there is no need to adjust the dose when switching from intramuscular to oral administration. After i / m injection of 15 mg Cmax in blood plasma is in the range of 1.6-1.8 μg / ml and is achieved within 1-6 hours.
Distribution. Meloxicam binds very well to blood plasma proteins, mainly albumin (99%). Meloxicam penetrates into the synovial fluid, the concentration of which is 2 times less than in the blood plasma. The volume of distribution is low, on average 11 liters after i / m or i / v use, individual deviations within 7–20% are noted. The volume of distribution after repeated administration of oral doses of meloxicam (7.5–15 mg) is 16 liters with a deviation rate of 11–32%.
Biotransformation. Meloxicam undergoes extensive biotransformation in the liver. Four different metabolites of meloxicam have been identified in urine, which are pharmacodynamically inactive. The main metabolite of 5'-carboxymeloxicam (60% of the dose) is formed by oxidation of the intermediate metabolite 5'-hydroxymethylmeloxicam, which is also released to a lesser extent (9% of the dose). In vitro studies suggest that CYP 2C9 plays an important role in the metabolic process, while CYP 3A4 isoenzymes contribute to a lesser extent. The peroxidase activity in patients is possibly responsible for two other metabolites, which account for 16 and 4% of the dose taken, respectively.
Elimination. Excretion of meloxicam occurs mainly in the form of metabolites in equal parts with urine and feces. Less than 5% of the daily dose is excreted unchanged in the feces, a small amount is excreted in the urine. T1 / 2 changes from 13 to 25 hours after oral administration, in / m and / in use. Plasma clearance is about 7-12 ml / min after a single oral dose of IV or rectal administration.
Dose linearity. Meloxicam exhibits linear pharmacokinetics within a therapeutic dose of 7.5 to 15 mg after oral and intramuscular administration.
Special groups of patients
Patients with hepatic / renal impairment. Mild to moderate hepatic and renal failure do not significantly affect the pharmacokinetics of meloxicam. Patients with moderate renal failure showed a higher total clearance. Decreased binding to blood plasma proteins was detected in patients with end-stage renal failure. In end-stage renal failure, an increase in the volume of distribution may lead to an increase in the concentration of free meloxicam. Do not exceed a dose of 7.5 mg (see APPLICATION).
Elderly patients. In elderly male patients, the mean pharmacokinetic parameters are similar in young male volunteers. In elderly female patients, the AUC value is higher and T½ is longer than in young volunteers of both sexes. The mean clearance from blood plasma in the equilibrium state in elderly patients is somewhat lower than in young volunteers.

Indications

Tablets: short-term symptomatic treatment of exacerbation of osteoarthritis. long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis.
Solution for injection: short-term symptomatic treatment of an acute attack of rheumatoid arthritis and ankylosing spondylitis, when the oral and rectal routes of administration cannot be used.

Application

The tablets are taken orally.
The total daily amount of the preparation should be used once with water or other liquid during meals.
Adverse reactions can be minimized by using the lowest effective dose for the minimum period of treatment necessary to control symptoms (see SPECIAL INSTRUCTIONS). The patient's need for symptomatic improvement and the response to treatment should be periodically assessed.
Exacerbation of osteoarthritis: 7.5 mg / day (1 tablet 7.5 mg or half a tablet 15 mg). If necessary, the dose can be increased to 15 mg / day (1 tablet 15 mg or 2 tablets 7.5 mg).
Rheumatoid arthritis, ankylosing spondylitis: 15 mg / day (1 tablet 15 mg or 2 tablets 7.5 mg).
See Special Patient Categories below.
According to the therapeutic effect, the dose can be reduced to 7.5 mg / day (1 tablet 7.5 mg or half a tablet 15 mg).
Do not exceed 15 mg / day
Special categories of patients
Elderly patients and patients with an increased risk of adverse reactions. The recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg / day. Patients with an increased risk of developing adverse reactions should start with 7.5 mg (see SPECIAL INSTRUCTIONS).
Renal failure In patients with severe renal failure on dialysis, the dose should not exceed 7.5 mg. Patients with mild to moderate renal impairment (namely, patients with creatinine clearance above 25 ml / min) do not require dose reduction (for patients with severe renal impairment without dialysis, see CONTRAINDICATIONS).
Liver failure. No dose reduction is required in patients with mild to moderate hepatic impairment (for patients with severe hepatic impairment, see CONTRAINDICATIONS).
Solution for injection:
V / m application.
One injection of 15 mg once a day.
Do not exceed 15 mg / day.
Treatment should be limited to one injection at the beginning of therapy with a maximum duration of up to 2-3 days in justified exceptional cases (for example, when oral and rectal routes of administration are not possible). Adverse reactions can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms (see SPECIAL INSTRUCTIONS).
The patient's need for symptomatic relief and his response to treatment should be periodically assessed.
Special categories of patients.
Elderly patients and patients with an increased risk of adverse reactions. The recommended dose for elderly patients is 7.5 mg per day. Patients with an increased risk of adverse reactions should start with 7.5 mg (half an ampoule of 1.5 ml) (see SPECIAL INSTRUCTIONS).
Renal failure For patients with severe renal failure on dialysis, the dose should not exceed 7.5 mg per day (half an ampoule of 1.5 ml).
Patients with moderate to moderate renal impairment (namely, patients with creatinine clearance of 25 ml / min) do not require dose reduction. For patients with severe renal impairment without dialysis, see CONTRAINDICATIONS.
Liver failure. No dose reduction is required in patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, see CONTRAINDICATIONS.
Mode of application. The preparation should be injected slowly, by deep intramuscular injection into the upper outer quadrant of the buttock, adhering to a strict aseptic technique. In case of repeated injection, it is recommended to alternate the left and right buttocks. It is important to check before injection that the needle point is not in the vessel.
The injection should be stopped immediately in case of severe pain during the injection.
In the case of a hip prosthesis, the injection should be given in the other buttock.

Contraindications

  • Hypersensitivity to meloxicam or other components of the preparation or active substances with a similar effect, such as NSAIDs, acetylsalicylic acid. meloxicam should not be prescribed to patients who have experienced symptoms of asthma, nasal polyps, angioedema or urticaria after taking acetylsalicylic acid or other NSAIDs;
  • III trimester of pregnancy (see Use during pregnancy and lactation);
  • children and adolescents under the age of 16;
  • gastrointestinal bleeding or perforation associated with previous NSAID therapy in history;
  • a history of active or recurrent ulcer / bleeding (2 or more separate confirmed cases of ulcer or bleeding);
  • severe liver failure;
  • severe renal failure without dialysis;
  • gastrointestinal bleeding, history of cerebrovascular bleeding, or other bleeding disorders;
  • severe heart failure;
  • not used to treat perioperative pain in coronary artery bypass grafting;
  • for injection solution also - children under the age of 18; impaired hemostasis or the simultaneous use of anticoagulants (contraindications are associated with the route of use).

Side effects

Research data and epidemiological data suggest that the use of some NSAIDs (especially at high doses and with long-term treatment) may be associated with a slight increased risk of vascular thrombotic events (for example, myocardial infarction or stroke) (see special instructions).
Edema, hypertension and heart failure were detected in the treatment of NSAIDs.
Most of the reported side effects are of gastrointestinal origin. Possible ulcer, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients (see SPECIAL INSTRUCTIONS). After application, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, vomiting of blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease were noted (see SPECIAL INSTRUCTIONS). Gastritis was detected with a lesser frequency.
Criteria for assessing the incidence of adverse preparation reactions: very often (≥1 / 10), often (≥1 / 100, 1/10); infrequently (≥1 / 1000, 1/100), rarely (≥1 / 10,000, 1/1000), very rarely (1/10 000), unknown (cannot be determined from the available data).
On the part of the blood and lymphatic system: infrequently - anemia; rarely - deviations of blood test parameters from the norm (including changes in the number of leukocytes), leukopenia, thrombocytopenia.
Very rare cases of agranulocytosis have been reported (see Selected Serious and / or Frequent Adverse Reactions).
From the immune system: infrequently - allergic reactions, except for anaphylactic or anaphylactoid; unknown - anaphylactic reactions, anaphylactoid reactions, including shock.
Mental disorders: rarely - mood changes, nightmares; unknown - confusion, disorientation, insomnia.
From the nervous system: often - headache; rarely - dizziness, drowsiness.
From the side of the organ of vision: rarely - visual impairment, including blurred vision; conjunctivitis.
On the part of the organ of hearing and vestibular apparatus: infrequently - dizziness; rarely - ringing in the ears.
Cardiac disorders: rarely - palpitations.
Heart failure associated with NSAID treatment has been reported.
Vascular disorders: infrequently - increased blood pressure (see SPECIAL INSTRUCTIONS), hot flashes.
From the respiratory system, chest and mediastinal organs: rarely - asthma in patients with allergies to acetylsalicylic acid and other NSAIDs; unknown - upper respiratory tract infections, cough.
From the digestive tract: very often - dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; infrequently - latent or macroscopic gastrointestinal bleeding, stomatitis, gastritis, belching; rarely - colitis, gastroduodenal ulcer, esophagitis; very rarely - gastrointestinal perforation.
Gastrointestinal bleeding, ulceration, or perforation can be severe and potentially fatal, especially in elderly patients (see SPECIAL INSTRUCTIONS).
On the part of the digestive system: infrequently - a violation of liver function indicators (for example, an increase in transaminases or bilirubin); very rarely - hepatitis; unknown - jaundice, liver failure.
On the part of the skin and subcutaneous tissue: infrequently - angioedema, itching, rash; rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria; very rarely - bullous dermatitis, erythema multiforme; unknown - photosensitivity, exfoliative dermatitis.
From the urinary system: infrequently - sodium and water retention, hyperkalemia (see SPECIAL INSTRUCTIONS, INTERACTIONS), changes in renal function indicators (increased creatinine and / or urea in the blood plasma); very rarely - acute renal failure, in particular in patients with risk factors (see SPECIAL INSTRUCTIONS); unknown - urinary tract infections, urinary frequency disorder.
General disorders and disorders at the injection site: often - hardening at the injection site, pain at the injection site; infrequently - edema, including edema of the lower extremities; unknown - flu-like symptoms.
From the musculoskeletal system: unknown - arthralgia, back pain, signs and symptoms associated with joints.
Isolated serious and / or frequent adverse reactions. Very rare cases of agranulocytosis have been reported in patients taking meloxicam and other potentially myelotoxic preparations (see INTERACTIONS).
Adverse reactions that were not noted when using the preparation, but which are generally accepted for other compounds of the class. Organic kidney disease likely to lead to acute renal failure: Very rare cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, and papillary necrosis have been reported (see SPECIAL INSTRUCTIONS).

Special instructions

Adverse reactions can be minimized by applying the lowest effective dose for the short duration of treatment necessary to control symptoms (see Application and Information on Gastrointestinal and Cardiovascular Risks below).
The recommended maximum daily dose should not be exceeded in case of insufficient therapeutic effect, and additional NSAIDs should not be used, as this may increase toxicity, while therapeutic benefits have not been proven. The simultaneous use of meloxicam with NSAIDs, including selective COX-2 inhibitors, should be avoided. Meloxicam is not suitable for the treatment of patients who require a reduction in the severity of acute pain.
If there is no improvement after several days, the clinical benefits of treatment should be re-evaluated.
It is necessary to pay attention to the history of esophagitis, gastritis and / or peptic ulcer in order to ensure their complete cure before starting therapy with meloxicam. It should be regularly monitored for the possible manifestation of relapse in patients taking meloxicam and in patients with a history of such cases.
Gastrointestinal disorders. As with other NSAIDs, potentially fatal gastrointestinal bleeding, ulceration, or perforation may occur at any time during treatment with or without prior symptoms or a history of serious gastrointestinal disease.
The risk of gastrointestinal bleeding, ulceration or perforation is increased with increasing NSAID doses in patients with a history of ulcers, especially those complicated by bleeding or perforation (see CONTRAINDICATIONS), and in elderly patients. In such patients, treatment should be started with the lowest effective dose. For these patients, combination therapy with protective preparations (such as misoprostol or proton pump inhibitors) should be considered, as well as for patients requiring a low dose of acetylsalicylic acid or other preparations that increase gastrointestinal risks (see information below, and the INTERACTIONS section).
Patients with a history of gastrointestinal toxicity, especially elderly patients, should be reported about all unusual abdominal symptoms (especially gastrointestinal bleeding), mainly during the initial stages of treatment.
Caution should be exercised in patients concurrently taking preparations that may increase the risk of ulcers or bleeding, in particular heparin, as radical therapy or in geriatric practice, anticoagulants such as warfarin or other NSAIDs, including acetylsalicylic acid at anti-inflammatory doses (≥1 g single dose or ≥3 g total daily dose) (see INTERACTIONS).
If gastrointestinal bleeding or ulceration occurs in patients using meloxicam, treatment should be discontinued.
NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since these conditions may worsen (see SIDE EFFECTS).
Liver disorders. ≤15% of patients taking NSAIDs (including Movalis) may have an increase in one or more liver function tests. Such laboratory abnormalities may progress, remain unchanged, or be temporary with continued treatment. A significant increase in ALT or AST (approximately ≥3 times higher than normal) was noted in 1% of patients during clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions have been reported, including jaundice and fulminant lethal hepatitis, liver necrosis and liver failure, some of them fatal.
Patients with symptoms or suspected hepatic dysfunction, or who have had abnormal liver function tests, should be assessed for the development of symptoms of more severe hepatic impairment during Movalis therapy. If clinical signs and symptoms are compared with the development of liver disease or if systemic manifestations of the disease are noted (for example, eosinophilia, rash, etc.), then the use of Movalis should be discontinued.
Cardiovascular disorders. The condition of patients with hypertension and / or mild to moderate congestive heart failure in history is recommended to be closely monitored, since fluid retention and edema were detected during NSAID therapy.
In patients with risk factors, clinical monitoring of blood pressure is recommended at the beginning of therapy, especially at the beginning of the course of treatment with meloxicam. Research data and epidemiological data suggest that the use of some NSAIDs (especially in high doses and with long-term treatment) may be associated with a slight increase in the risk of vascular thrombotic events (for example, myocardial infarction or stroke). Insufficient data are available to rule out this risk for meloxicam.
Patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral arterial disease and / or cerebrovascular disease should be treated with meloxicam only after careful analysis. Such an analysis is necessary at the beginning of long-term treatment of patients with risk factors for cardiovascular diseases (such as hypertension, hyperlipidemia, diabetes mellitus, smoking). NSAIDs can increase the risk of serious cardiovascular thrombotic complications, myocardial infarction and stroke, sometimes fatal. The increased risk is associated with the duration of use. Patients with cardiovascular disease or risk factors for developing such a pathology may be at increased risk.
Skin disorders. Life-threatening severe skin lesions have been reported: Stevens-Johnson syndrome and toxic epidermal necrolysis with meloxicam. Patients should be informed of the signs and symptoms of severe lesions and should be closely monitored for skin reactions. The risk of developing Stevens-Johnson syndrome or toxic epidermal necrolysis is greatest during the first weeks of treatment. If the patient has symptoms or signs of Stevens-Johnson syndrome or toxic epidermal necrolysis (for example, a progressive skin rash, often with vesicles or mucosal lesions), meloxicam treatment should be discontinued. It is important to diagnose and stop using any preparations that can cause severe skin lesions as soon as possible, such as Stevens-Johnson syndrome or toxic epidermal necrolysis. This is associated with a better prognosis for severe skin lesions. If a patient has Stevens-Johnson syndrome or toxic epidermal necrolysis when using meloxicam, the preparation should not be used at any time in the future.
Anaphylactic reactions. As with the use of other NSAIDs, anaphylactic reactions may occur in patients without a known reaction to Movalis. Movalis should not be used in patients with the aspirin triad. This symptomatic complex is detected in patients with asthma who have reported rhinitis with or without nasal polyps or with severe, potentially fatal bronchospasm after the use of acetylsalicylic acid or other NSAIDs. Emergency measures should be taken when an anaphylactoid reaction is detected.
Liver parameters and kidney function. As in the treatment of most NSAIDs, isolated cases of an increase in the level of transaminases, serum bilirubin or other indicators of liver function have been described, as well as an increase in serum creatinine and urea nitrogen in the blood, and other laboratory abnormalities. In most cases, these deviations were minor and temporary. If there is a significant or persistent confirmation of such deviations, the use of meloxicam should be discontinued and control tests should be carried out.
Functional renal failure. NSAIDs, by inhibiting the vasodilating effect of renal prostaglandins, can induce functional renal failure due to a decrease in glomerular filtration. This side effect is dose dependent. At the beginning of treatment or after increasing the dose, careful monitoring of urine output and renal function is recommended in patients with the following risk factors:
  • elderly age;
  • simultaneous use with ACE inhibitors, angiotensin II antagonists, sartans, diuretics (see INTERACTIONS);
  • hypovolemia (of any genesis);
  • congestive heart failure;
  • renal failure;
  • nephrotic syndrome;
  • lupus nephropathy;
  • severe hepatic dysfunction (plasma albumin 25 g / L or ≥10 Child-Pugh classification).
In rare cases, NSAIDs can lead to interstitial nephritis, glomerulonephritis, renal medullary necrosis, or nephrotic syndrome. The dose of meloxicam for patients with end-stage renal failure on dialysis should not exceed 7.5 mg. Patients with mild to moderate renal insufficiency do not need to reduce the dose (creatinine clearance 25 ml / min).
Retention of sodium, potassium and water. NSAIDs can increase sodium, potassium and water retention and interfere with the natriuretic effect of diuretics. In addition, it is possible to reduce the antihypertensive effect of antihypertensive preparations (see INTERACTIONS). Therefore, as a result, in sensitive patients, an increase in the severity or exacerbation of edema, heart failure, or hypertension may be noted. Therefore, patients with such risks are advised to conduct clinical monitoring (see APPLICATION and CONTRAINDICATIONS).
Hyperkalemia. Hyperkalemia may be promoted by diabetes mellitus or the concomitant use of preparations that increase potassium (see INTERACTIONS). In such cases, you should regularly monitor the level of potassium.
Combination with pemetrexed. In patients with mild to moderate renal impairment taking pemetrexed, meloxicam treatment should be suspended for at least 5 days prior to pemetrexed administration, on the day of administration, and for at least 2 days after administration (see INTERACTIONS).
Other warnings and security measures. Adverse reactions are often worse tolerated by elderly patients, weak or debilitated patients who require careful monitoring. As with other NSAIDs, caution should be exercised in the elderly, who are more likely to have decreased kidney, liver and heart function. In elderly patients, there is a higher incidence of adverse reactions with the use of NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see APPLICATION).
Meloxicam, like any other NSAID, can mask the symptoms of infectious diseases.
The use of meloxicam can negatively affect reproductive function and is not recommended for women who wish to become pregnant. Therefore, for women planning pregnancy or undergoing examination for infertility, the possibility of discontinuing meloxicam should be considered (see Use during pregnancy and lactation).
Movalis 7.5 mg and 15 mg tablets contain lactose, therefore, the preparation is not recommended for patients with rare congenital galactose intolerance, lactase deficiency or malabsorption of glucose or galactose.
Masking inflammation and fever. The pharmacological action of Movalis to reduce the severity of fever and inflammation can complicate the diagnosis of suspected non-infectious pain syndrome.
Treatment with corticosteroids. Movalis may not be a likely corticosteroid substitute in the treatment of corticosteroid deficiency.
Hematological effects. Anemia can occur in patients receiving NSAIDs, including Movalis. This may be due to fluid retention, gastrointestinal bleeding of unknown origin, or gross or fully described effects on erythropoiesis. Patients on long-term treatment with NSAIDs, including Movalis, should monitor hemoglobin or hemocritis if symptoms and signs of anemia are detected.
NSAIDs inhibit platelet aggregation and may increase bleeding time in some patients. Unlike acetylsalicylic acid, their effect on platelet function is quantitatively less, short-term and reversible. The condition of patients taking Movalis should be carefully monitored, in whom side effects are possible regarding changes in platelet function, in particular, blood clotting disorders, or patients receiving anticoagulants.
Use in patients with asthma. Patients with asthma may have aspirin-sensitive asthma. The use of acetylsalicylic acid in patients with aspirin-sensitive asthma is associated with severe bronchospasm, which can be fatal. Given the cross-reaction, including bronchospasm, between acetylsalicylic acid and other NSAIDs, Movalis should not be used in patients sensitive to acetylsalicylic acid, and should be used with caution in patients with asthma.
During pregnancy and breastfeeding.
Fertility Meloxicam, like other preparations that inhibit the synthesis of COX / prostaglandin, may adversely affect reproductive function and is not recommended for women planning a pregnancy. Therefore, for women who are planning a pregnancy or undergoing examination for infertility, the possibility of discontinuing meloxicam should be considered.
Pregnancy. Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or the development of the embryo and fetus. Data from epidemiological studies suggest an increased risk of miscarriage and the development of heart defects and gastroschisis after the use of inhibitors of prostaglandin synthesis in the early period of pregnancy. The absolute risk of developing heart defects increased from ≤1% to about 1.5%. It is assumed that this risk increases with dose and duration of treatment.
In the first and second trimester of pregnancy, meloxicam should not be used unless absolutely necessary. If a woman is planning a pregnancy or is using meloxicam in the first and second trimester of pregnancy, the dose and duration of treatment should be minimal.
In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can cause risks to the fetus:
cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
impaired renal function, may develop into renal failure with oligohydramnios.
Possible risks in the last stages of pregnancy for the mother and the newborn:
the likelihood of prolongation of bleeding time, antiaggregatory effect even when very low doses are taken;
inhibition of uterine contractions, which leads to a delay or delay in labor.
Therefore, meloxicam is contraindicated in the third trimester of pregnancy.
Lactation. Although there is no specific data on the preparation Movalis, it is known with respect to NSAIDs that they can pass into breast milk. Therefore, the use is not recommended for women who are breastfeeding.
Children. Movalis, tablets 7.5 mg and 15 mg, is contraindicated in children under the age of 16 (see CONTRAINDICATIONS).
Solution for injection - contraindicated in children under the age of 18.
The ability to influence the reaction rate when driving or working with other mechanisms. There are no special studies of the effect of the preparation on the ability to drive a car or work with mechanisms. However, on the basis of the pharmacodynamic profile and the identified adverse reactions, it can be assumed that meloxicam does not affect or has a slight effect on these activities. However, patients who have experienced visual impairment, including blurred vision, dizziness, drowsiness, vertigo or other disorders of the central nervous system, are advised to refrain from driving or operating machinery.

Interactions

Interaction studies were conducted only with adults.
Risks associated with hyperkalemia. Certain preparations or therapeutic groups can contribute to hyperkalemia: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, low molecular weight or unfractionated heparins, cyclosporin, tacrolimus, and trimethoprim.
The onset of hyperkalemia may depend on whether there are associated factors. The risk of developing hyperkalemia increases if the above drugs are used simultaneously with meloxicam.
Pharmacodynamic interactions
Other NSAIDs and acetylsalicylic acid. The combination with other NSAIDs is not recommended (see PRECAUTIONS), including acetylsalicylic acid in anti-inflammatory doses (≥500 mg single dose or ≥3 g total daily dose).
Corticosteroids (eg glucocorticoids). Concomitant use with corticosteroids requires caution due to the risk of bleeding or ulcers in the gastrointestinal tract.
Anticoagulants or heparin used in geriatric practice or at therapeutic doses. The risk of bleeding is significantly increased due to inhibition of platelet function and damage to the gastroduodenal mucosa. NSAIDs can enhance the effects of anticoagulants such as warfarin (see SPECIAL INSTRUCTIONS). The simultaneous use of NSAIDs and anticoagulants or heparin in geriatric practice or in therapeutic doses is not recommended (see SPECIAL INSTRUCTIONS).
In other cases of heparin use, caution is required because of the increased risk of bleeding. Careful monitoring of the INR (International Normalized Ratio) is required if it is proven impossible to avoid this combination.
Thrombolytic and antiplatelet preparations: increased risk of bleeding due to suppression of platelet function and damage to the gastroduodenal mucosa.
Selective serotonin reuptake inhibitors. Increased risk of gastrointestinal bleeding.
Diuretics, ACE inhibitors and angiotensin II antagonists. NSAIDs can reduce the effect of diuretics and other antihypertensive preparations. In some patients with impaired renal function (patients with dehydration or elderly patients with impaired renal function), the simultaneous use of ACE inhibitors or angiotensin II antagonists and preparations that depress COX may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be used with caution, especially in elderly patients. Patients need to receive an adequate amount of fluid, and kidney function should be monitored after the start of combination therapy and periodically thereafter (see SPECIAL INSTRUCTIONS).
Other antihypertensive preparations (eg β-adrenergic receptor blockers). As for the following preparations, it is possible to reduce the antihypertensive effect of β-adrenergic receptor blockers (due to inhibition of prostaglandins with a vasodilating effect).
Calcineurin inhibitors (eg cyclosporin, tacrolimus). The nephrotoxicity of calcineurin inhibitors may be enhanced by NSAIDs due to mediation of the effects of renal prostaglandins. During treatment, kidney function should be monitored. Careful monitoring of renal function is recommended, especially in elderly patients.
Deferasirox. The simultaneous use of meloxicam and deferasirox may increase the risk of gastrointestinal adverse reactions. Care should be taken when combining these medicines.
Pharmacokinetic interactions: the effect of meloxicam on the pharmacokinetics of other preparations
Lithium. There is evidence of NSAIDs that increase the concentration of lithium in the blood plasma (due to a decrease in renal excretion of lithium), which can reach toxic levels. Concomitant use of lithium and NSAIDs is not recommended (see SPECIAL INSTRUCTIONS). If combination therapy is necessary, the level of lithium in the blood plasma should be carefully monitored at the beginning of treatment, when choosing a dose and when stopping treatment with meloxicam.
Methotrexate. NSAIDs can reduce tubular secretion of methotrexate, thereby increasing its concentration in blood plasma. For this reason, the concomitant use of NSAIDs in patients taking a high dose of methotrexate (15 mg / week) is not recommended (see SPECIAL INSTRUCTIONS). The risk of interaction between NSAIDs and methotrexate should also be considered in patients taking a low dose of methotrexate, in particular with impaired renal function. If combined treatment is required, it is necessary to monitor the parameters of the blood test and kidney function. Caution should be exercised if NSAIDs and methotrexate are taken for 3 consecutive days, as the plasma levels of methotrexate may rise and increase toxicity. Although the pharmacokinetics of methotrexate (15 mg / week) does not change with concomitant treatment with meloxicam, it should be borne in mind that the hematological toxicity of methotrexate may increase with the treatment of NSAIDs (see information above; SIDE EFFECTS).
Pemetrexed. With the simultaneous use of meloxicam with pemetrexed in patients with mild to moderate renal insufficiency (creatinine clearance 45–79 ml / min), meloxicam should be suspended for 5 days before the administration of pemetrexed, on the day of administration and for 2 days after administration. If the combination of meloxicam with pemetrexed is necessary, patients should be carefully monitored, especially with regard to the occurrence of myelosuppression and gastrointestinal adverse reactions. For patients with severe renal impairment (creatinine clearance 45 ml / min), the simultaneous use of meloxicam with pemetrexed is not recommended.
For patients with normal renal function (creatinine clearance ≥80 ml / min), doses of 15 mg of meloxicam can reduce the elimination of pemetrexed, therefore, increase the incidence of adverse reactions associated with pemetrexed. Thus, caution should be exercised when prescribing meloxicam 15 mg concurrently with pemetrexed for patients with normal renal function (creatinine clearance ≥80 ml / min).
Pharmacokinetic interactions: the effect of other drugs on the pharmacokinetics of meloxicam
Kolestyramine. Cholestyramine accelerates the elimination of meloxicam due to impaired intrahepatic circulation, therefore, the clearance of meloxicam increases by 50% and T½ is reduced to 13 ± 3 hours. This interaction is clinically significant. There was no clinically significant pharmacokinetic interaction when taken simultaneously with antacids, cimetidine and digoxin.

Overdose

Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive therapy. gastrointestinal bleeding may occur. severe poisoning can lead to ag, opn, liver dysfunction, respiratory depression, coma, seizures, cardiovascular failure, and cardiac arrest. anaphylactoid reactions have been reported with the therapeutic use of NSAIDs, which can also occur with overdose.
In case of an overdose of NSAIDs, patients are recommended symptomatic and supportive measures. Studies have shown an acceleration of the elimination of meloxicam by taking 4 oral doses of cholestyramine 3 times a day.

Storage conditions

In a dark place at a temperature not exceeding 25 ° C.

Tags: Movalis

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Weleda Baby Face cream,Calendula 50 ml — Made in Germany — Free Delivery

Weleda Baby Face cream,Calendula 50 ml — Made in Germany — Free Delivery

Product descriptionBaby face cream WELEDA Calendula - delicate moisturizing and protection of delicate baby skin.With this delicate cream, baby's skin remains soft and healthy.It is very important to understand that from the moment a baby is born, his skin is constantly developing. Initially, it is ..

$24.19

Coldysept Nano Silver,ear drops 15 ml — Made in Poland — Free Delivery

Coldysept Nano Silver,ear drops 15 ml — Made in Poland — Free Delivery

Product descriptionEar drops Coldisept Nanosilver are prescribed for inflammation of the external auditory canal of various etiologies and limit the growth of bacteria and fungi.Indications for useColdisept Nanosilver ear drops soften the surface of the external ear canal and remove impurities, as w..

$26.28

Dermedic Hydrain 3 Hialuro, Moisturizing physiotonic 200 ml — Made in Poland — Free Delivery

Dermedic Hydrain 3 Hialuro, Moisturizing physiotonic 200 ml — Made in Poland — Free Delivery

Indications:DERMEDIC HYDRAIN 3 HYALURO A moisturizing physiotonic recommended for the care of sensitive, dry, very dry and dehydrated skin. Recommended for use immediately after face cleansing products.Properties:Moisturizing physiotonic DERMEDIC HYDRAIN 3 HIALURO tones and helps to maintain the phy..

$26.50

3 x RUSCOVEN BIO GEL 100ML — MADE IN POLAND — FREE SHIPPING

3 x RUSCOVEN BIO GEL 100ML — MADE IN POLAND — FREE SHIPPING

RUSCOVEN BIO GEL The effectiveness of RuscoVen biożel is based on the functional synergy of freeze-dried extracts of pine and chestnut with water-alcohol extracts of vines and vacrots, which, when dissolved in an aqueous solution of marshmallow mucus, provide a high concentration of active subs..

$55.37

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