Meloxicam-N

MELOXICAM-N

Solution for injection 10 mg/ml 1.5 ml in ampoules No.5

Meloxicam- N is a non-steroid anti-inflammatory drug (NSAID) of enolic acid class, which has anti-inflammatory, analgesic and anti-pyretic effect.

Marketing Authorization No. UA/12990/01/01

Composition

Active ingredient: meloxiсam;

1 ml of solution contains 10 mg of meloxiсam;

Excipients: meglumine, glycofurol, poloxamer 188, sodium chloride, glycine, sodium hydroxide, water for injections.

Pharmaceutical form

Solution for injection.

Main physical-chemical properties: clear yellow liquid with the green tint.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory drugs.

ATC-code М01А С06.

Pharmacological properties

Pharmacodynamics.

Meloxicam-N is the nonsteroidal anti-inflammatory drug (NSAID) of enolic acid class that possesses anti-inflammatory, analgesic and antipyretic effects.

Meloxicam demonstrates high anti-inflammatory activity on all standard models of inflammation. As for other NSAIDs, its accurate mechanism of action remains unknown. However, there is a common mechanism of activity for all NSAIDs (including meloxicam): oppression of biosynthesis of prostaglandins, which are mediators of inflammation.

Pharmacokinetics.

Absorption. Meloxicam is completely absorbed after the intramuscular injection. Relative bioavailability is almost 100% in comparison with such in case of oral application. Therefore, it is not necessary to adjust the dose when you move from intramuscular to oral application approach. After the intramuscular injection of 15 mg, the concentration in blood plaza gets to its maximum of 1,6-1,8 mcg/ml during 1-6 hours.

Distribution. Meloxicam is well-bound with plasma proteins, mostly with albumin (99 %). Meloxicam penetrates into synovial fluid, where its concentration is twice lower, than in blood plasma. The distribution volume is low, 11 l on average after the intramuscular or intravenous way of application and shows individual deviation within 7-20 %. The distribution volume after the multiple oral doses of meloxicam (from 7,5 to 15 mg) is 16 l with the deviation coefficient within the limits from 11% to 32%.

Biotransformation. Meloxicam is subject to extensive biotransformation in liver.

Four different metabolites of Meloxicam were identified in urine, which are pharmacodynamically inactive. The main metabolite 5’-carboxymeloxicam (60% of dose) is formed by oxidation of intermediate metabolite 5’-hydroxymethylmeloxicam, which is formed in smaller amount (9% od dose). In vitro research assumes that CYP 2C9 plays an important role in metabolism process, while CYP 3A4 isoenzymes play smaller role. The activity of peroxidase among patients may attribute to  for other two metabolites, which are 16% and 4% of the prescribed dose respectively.

Elimination. Excretion of Meloxicam occurs mainly through  metabolites with urine and feces equally. Less than 5% of daily dose is eliminated in the unchanged form with feces, insignificant amount is eliminated with urine. The period of semi-elimination is from 13 to 25 hours depending on the way of administration (oral, intramuscular or intravenous). Plasma clearance is about 7-12 ml/min after single oral dose of intravenous or rectal application.

Linearity of the dose. Meloxicam shows linear pharmacokinetics within the limits of therapeutic dose from 7,5 mg to 15 mg after oral and intramuscular administration.

Special groups of patients.

Patients with hepatic/renal failure. Hepatic and renal failures from mild to middle degrees do not influence significantly pharmacokinetics of meloxicam. Patients with moderate degree of hepatic failure had considerably higher general clearance. Reduced connection with blood plasma proteins was observed among patients with terminal hepatic failure. In case of terminal hepatic failure, an increase in distribution volume can cause an increase in concentration of free meloxicam. You should not exceed the daily dose of 7,5 mg (see section “Posology and method of administration”).

Elderly patients. Average pharmacokinetic parameters among elderly male patients are similar to those of young male volunteers. AUC parameters are higher and the period of semi-elimination is longer among female patients in comparison to the respective parameters among young volunteers of both genders. Average clearance of plasma at steady state was lower among elderly patients, than among young volunteers.

Clinical characteristics

Indications.

Short-term symptomatic treatment of acute attack of rheumatoid arthritis and ankylosing spondylitis, when oral and rectal ways of application cannot be used.

Contraindications

  • Hypersensitivity to meloxicam or to other components of drug, or to active ingredients with the same effect, such as NSAIDs, aspirin. Meloxicam should not be prescribed for the patients, who had symptoms of asthma, nasal polyps, angioedema or urticaria after use of aspirin or other NSAIDs;
  • III trimester of pregnancy (see section “Use during pregnancy or lactation”);
  • age of a patient is below 18 years;
  • gastrointestinal bleeding or perforation, which is connected with the prior NSAID therapy in medical history;
  • active or recurrent peptic ulcer/bleeding in medical history (two or more separate confirmed incidents of ulcer or bleeding);
  • severe hepatic failure;
  • severe renal failure, without application of dialysis;
  • gastrointestinal bleeding, cerebrovascular bleeding in past medical history or other clotting disorders;
  • hemostasis disorders or simulations application of anticoagulants (contraindications are connected with the way of application);
  • severe heart failure;
  • treatment of perioperative pain during coronary artery bypass grafting (CABG).

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Interaction with other drugs and other types of interactions

Only adults took part in research of interaction.

Pharmacodynamical interactions.

Other nonsteroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid ≥ 3 g/day. It is not recommended to combine with other NSAIDs (see section “Precautions for use”), including acetylsalicylic acid in anti-inflammatory doses (≥ 1 g single dose or 3 g total daily dose).

Corticosteroids (for example, glucocorticoids). Simultaneous application with corticosteroids requires caution because of high risk of bleeding or appearance of ulcer in gastrointestinal tract. 

Anticoagulants or heparin applied in geriatric practice or therapeutic doses. The risk of bleeding increases significantly due to inhibition of platelet function and damage of gastroduodenal mucosa. NSAIDs can enhance effects of anticoagulants, such as warfarin (see section “Precautions for use”). It is not recommended to use NSAIDs with anticoagulants or heparin in geriatric practice or in therapeutic doses (see section “Precautions for use”).

In other cases of heparin application, caution is necessary due to increased risk of bleeding. Thorough INR (International Normalized Ratio) control is necessary, if it is not possible to avoid such combination.

Thrombolytic and anti-aggregational drugs. Increased risk of bleeding through inhibition of platelet function and damage of gastroduodenal mucosa.

Selective serotonin re-uptake inhibitors (SSRI). Increased risk of gastrointestinal bleeding.

Diuretics, ACE inhibitors and antagonists of angiotensin II. NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some cases when patients suffer from kidney dysfunction (for example, patients with dehydration or elderly patients with kidney dysfunction), simultaneous usage of ACE inhibitors or antagonists of angiotensin II and drugs, that oppress cyclooxygenase, can lead to further deterioration of kidney function, including possible acute renal failure, which is usually reversible. By this reason, the combination should be applied with caution, especially by the elderly patients. Patients should receive an adequate amount of liquid, and kidney function has also to be under control after the beginning of joint therapy and periodically in the future (see section “Precautions for use”).

Other antihypertensive drugs (for example, beta-blockers). As in case of use of the below-listed drugs, the decrease of antihypertensive effect of beta-blockers can develop (due to the oppression of prostaglandins with vasodilating effect).

Inhibitors of calcineurin (for example, ciclosporin tacrolimus). Nephrotoxicity of inhibitors of calcineurin can enhance NSAID through mediation of effects of renal prostaglandins. Renal function has to be under control during the process of treatment. Thorough control of kidney function is highly recommended to elderly patients.

Intrauterine contraceptives. NSAIDs reduce the efficiency of intrauterine contraceptives. It was reported earlier about the reduction of effectiveness of intrauterine contraceptives in case of application of NSAIDs, but it requires further confirmation.

Pharmacokinetic interaction: influence of meloxicam on pharmacokinetics of other drugs.

Lithium. There is an information about NSAIDs, which increase the level of concentration of lithium in blood plasma (through reduction of lithium excretion) to the toxic amount. Simultaneous application of lithium and NSAID is not recommended (see section “Precautions for use”If combined therapy is necessary, the level of lithium in blood plasma has to be under accurate control in the beginning of treatment, during the dose adjustment and in the end of treatment by meloxicam.

Methotrexate. NSAIDs can reduce tubular secretion of methotrexate and, thereby, increase its concentration in blood plasma. By this reason, it is not recommended to apply NSAIDs simultaneously by the patients, who apply the high dose of methotrexate (more than 15 mg/week) (see section “Precautions for use”). The risk of interaction of NSAID and methotrexate has to be taken into account by the patients, who apply the small dose of methotrexate, including patients with renal dysfunction. In case of necessity of combined treatment, indexes of blood analysis and kidney functions have to be under control. If the application of NSAID and methotrexate lasts for 3 days in sequence, one has to be careful, because plasma level of methotrexate can rise and enhance the toxicity. Although pharmacokinetics of methotrexate (15 mg/week) did not suffer from influence of concomitant treatment by meloxicam, it should be considered that hematological toxicity can rise in case of treatment by NSAID (see above) (see section “Adverse reactions”).

Pharmacokinetic interaction: influence of other drugs on pharmacokinetics of meloxicam.

Cholestyramine accelerates the removal of meloxicam through intrahepatic circulation disorder, that is why the clearance of meloxicam increases by 50 % and the period of semi-elimination decreases to 13 ± 3 hours. This interaction is clinically meaningful.

In case of simultaneous application with antacids, cimetidine and digoxin, clinically meaningful pharmacokinetic interaction was not detected.

Precautions for use

Adverse reactions can be minimized through the application of the smallest effective dose during the shortest period of treatment, required for control of symptoms (see section “Application methods and doses” and information on gastrointestinal and cardiovascular risks below).

Recommended maximal daily dose should not be exceeded in case of insufficient therapeutic effect, also it is not recommended to apply NSAID additionally, because it can increase toxicity, while therapeutic advantages are not proved. You should avoid simultaneous application of meloxicam with NSAID, including selective inhibitors of cyclooxygenase-2.

Meloxicam should not be used for treatment of patients, who need a relief of acute pain.

Clinical advantages of treatment should be reconsidered if there is no improvement after several days.

One should put attention to esophagitis, gastritis and/or peptic ulcer in anamnesis in order to cure them completely before the start of therapy by meloxicam. One should pay attention regularly on possible appearance of recurrence  if the patient was cured by meloxicam and patients with such cases in anamnesis.

Gastrointestinal tract.

As in case of application of other NSAIDs, potentially mortal gastrointestinal bleedings, ulcer or perforation can occur at any time during the process of treatment with or without former symptoms or severe gastrointestinal illnesses in anamnesis.

The risk of gastrointestinal bleeding, ulcer or perforation is higher when the dose of NSAID is increased in case of patients with ulcer in medical history, especially complicated by bleeding or perforation (see section “Contraindications”), and in case of elderly patients. Such patients should start the treatment with the lowest effective dose. For such patients the combined therapy with protective drugs (such as, misoprostol or proton pump inhibitors) should be considered, as well as for patients who require the joint application of small dose of aspirin or other drugs, that increase gastrointestinal risks (see section “Interaction with other drugs and other types of interactions”).

Patients with gastrointestinal toxicity in anamnesis, especially elderly patients, should inform about all unusual abdominal symptoms (especially about gastrointestinal bleedings), mainly at the initial stages of treatment.

Especially careful should be

  • patients, who simultaneously apply drugs, that can increase the risk of ulcer or bleeding, such as heparin, as radical therapy;
  • elderly patients, who simultaneously administer anticoagulants, such as warfarin or other nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid in anti-inflammatory doses (≥ 1 g single dose or ≥ 3 g total daily dose) (see section “Interaction with other drugs and other types of interactions”).

In case the patient is treated with  meloxicam and the gastrointestinal bleeding or ulcer appear, the treatment process should be stopped.

NSAIDs should be applied carefully by the patients with gastrointestinal illnesses in anamnesis (ulcerative colitis, Chron’s disease), since these states may worsen (see section “Adverse reactions”).

Liver disorders.

Up to 15% of patients, who use NSAID (including Meloxicam-N) can have an increase in level of one or more hepatic tests. Such laboratory deviations can progress, stay unchanged or can be temporary during the treatment. During the clinical tests of NSAIDs, 1% of patients had a significant increase of ALT or AAT (approximately three and more times above the norm). Besides, during the clinical tests of NSAIDs there were some rare cases of severe hepatic reaction, including jaundice and fulminant lethal hepatitis, liver necrosis and liver failure, some of them are fatal.

Those patients with symptoms and/or signs of hepatic dysfunction or those who had liver tests deviations should be evaluated by symptoms development of more severe hepatic failure during the therapy by Meloxicam-N. If clinical signs and symptoms match the development of liver illnesses or if there are systemic manifestations of diseases (for example, eosinophilia, rashes), then the application of Meloxicam-N should be stopped.

Cardiac and vascular system.

To those patients, who suffer from arterial hypertension and/or congestive heart failure from light to middle level in anamnesis, thorough supervision is recommended, since during the NSAID therapy fluid retention and edema were observed.

To those patients with risk factors, clinical supervision of arterial pressure is recommended in the beginning of therapy, especially in  the beginning of treatment course by meloxicam.

Research data and epidemiological data allow to assume that application of some NSAIDs (especially in high doses and in case of long treatment) can be connected to insignificant increase of risk of vascular thrombotic events (such as, myocardial infarction or stroke). Due to the lack of epidemiological data, such risk cannot be excluded for meloxicam.

To those patients with uncontrolled arterial hypertension, congestive heart failure, defined ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, therapy by meloxicam should be conducted only after thorough analysis. Such analysis is required before the start of long-term treatment of patients with risk factors of cardio-vascular diseases (for example, with arterial hypertension, hyperlipidemia, diabetes, smokers).

NSAIDs can increase risk of severe cardio-vascular thrombotic complications, myocardial infarction and stroke, which can be lethal. Risk increase in connected to the length of application. Patients with cardio-vascular diseases or risk factors of cardio-vascular diseases can have higher risk of thrombotic complications.

Dermal reactions.

In rare cases of NSAIDs application, there were severe skin reactions, some of them were fatal, including exfoliative dermatitis, Stevens-Johnson’s syndrome and toxic epidermal necrolysis (see section “Adverse reactions”). The highest risk of appearance of such reaction was observed in the beginning of treatment and, herewith, such reactions appeared mainly during the first month of treatment. If rash occurs or there are damages of mucous membrane or other signs of hypersensitivity, discontinue the use of meloxicam.

Anaphylactic reactions.

Patients can have anaphylactic reactions without known reaction on meloxicam, as in case of application of other NSAIDs. Patients with aspirin triad should not use Meloxicam-N. Such sympthomatic complex occurs if patients have asthma, who had rhinitis with or without nasal polyps or who had severe potentially lethal bronchospasm after application of aspirin or other NSAIDs. First Aid Measures should be applied if first signs of anaphylactic reaction occur.

Liver parameters and kidney functions.

As in case of treatment by majority of NSAIDs, single cases of increase of transaminase level in blood serum or other parameters of liver function, increase of creatine in blood serum and blood urea nitrogen, and other deviations of laboratory indexes are described. Mainly, these deviations were insignificant and temporary. In case of significant or sustainable confirmation of such deviations, meloxicam application should be stopped and control tests have to be conducted.

Functional renal failure.

As a result of oppression of vasodilator effect of renal prostaglandins, NSAIDs can induce functional renal failure by decrease of glomerular filtration. This side effect is dose-dependent. In the beginning of treatment or after increase of dose, thorough supervision of diuresis and renal functions of patients with such risk factors is recommended:

  • elderly age;
  • joint application of ACE inhibitors, antagonists of angiotensin II, sartans, diuretics (see section “Interaction with other drugs and other types of interactions”);
  • hypovolemia (of any genesis);
  • congestive heart failure;
  • renal failure;
  • nephrotic syndrome;
  • lupus nephropathy;
  • severe degree of renal dysfunction (serum albumin ˂ 25 g/l or ≥ 10 according to Child-Pugh classification).

In rare cases NSAIDs can lead to interstitial nephritis, glomerulonephritis, renal medullary necrosis or nephrotic syndromes.

If the patient has terminal renal failure, that is in dialysis, dose of meloxicam should not exceed 7,5 mg. The patients with kidney failure from light to middle degree can leave the dose unchanged (level of creatinine clearance – more than 25 ml/min).

Sodium, potassium and water retention.

NSAIDs can increase sodium, potassium and water retention and influence on natriuretic effects of diuretics. Besides, reduction of antihypertensive effect of hypotensive drugs can also be observed (see section “Interaction with other drugs and other types of interactions”). As a result, sensitive patients can have an acceleration and exacerbation of edema, heart failure and arterial hypertension. That is why, to those patients, who has a risk of sodium, potassium and water retention, the performance of clinical monitoring is recommended (see sections “Posology and method of administration” and “Contraindications”).

Hyperkalemia.

Diabetes or simultaneous application of drugs, that increase kalemia, can contribute to hyperkalemia (see section “Interaction with other drugs and other types of interactions”). In such cases, the potassium level control has to be conducted on regular basis.

Other warnings and security measures.

Elderly patients, weak or weakened patients, who are under thorough supervision, often have worse tolerance to adverse reactions. As in case of treatment by other NSAIDs, one should be careful with regard to elderly patients, who most probably have problems with kidneys, liver and heart. Elderly patients are more often prone to adverse reactions from NSAIDs, especially gastrointestinal bleedings and perforation that can be fatal (see section “Application methods and doses”).

As in case of intramuscular application of NSAIDs, abscess or necrosis can appear at the site of injection.

The application of meloxicam can negatively influence on reproductive function and is not recommended to women who want to become pregnant. That why women who want to become pregnant or undergo an analysis concerning the infertility, should consider an opportunity to discontinue the use of meloxicam (see section “Use during pregnancy or lactation”).

Drug contains less than 1 mmol of sodium (23 mg) in 1,5 ml ampoule, or, in other words, is free from sodium.

Disguise of inflammation and fewer.

Pharmacological activity of Meloxicam-N, that is aimed to reduce  fewer and inflammation can reduce the benefit from diagnostics data in case of determination of complications on suspicion of non-infectious painful state.

Treatment by corticosteroids.

Meloxicam-N cannot be a possible substitute of corticosteroids during the treatment of corticosteroidal insufficiency.

Hematological effects. 

      

Patients, who receive NSAIDs, including Meloxicam-N, can suffer from anemia. This can be caused by liquid retention, gastrointestinal bleeding of unknown origin or macroscopic bleeding, or incompletely described effect on erythropoiesis. In case of long-term treatment by NSAIDs, including Meloxicam-N, patients should control hemoglobin or hematocrit, if there are symptoms and signs of anemia.

NSAIDs inhibits the platelet aggregation and can depict the prolongation of bleeding time in some patients. In contrast to aspirin, their influence on platelets’ function is quantitatively lower, temporary and reversible.  Patients should be under thorough control, if Meloxicam-N is prescribed and if there can be adverse reactions on platelets’ functions, such as clotting disorder, or if patients use anticoagulants.

Application by patients with asthma.

Patients with asthma can have aspirin-sensitive asthma. Application of aspirin by patients with aspirin-sensitive asthma can lead to severe bronchospasm that can be lethal. Due to cross-reaction, including bronchospasm, between aspirin and other NSAIDs, Meloxicam-N should not be used by patients who are sensitive to aspirin and should be used carefully by patients with asthma.

Use during pregnancy or lactation

Fertility. Meloxicam, like other drugs, inhibits the synthesis of cyclooxygenase / prostaglandin, can negatively affect reproductive function and is not recommended for women who want to become pregnant. Therefore, for women who are planning a pregnancy or undergoing infertility examination, the possibility of using meloxicam should be considered.

Pregnancy. The inhibition of prostaglandin synthesis may adversely affect pregnancy and /or embryo/fetal development. Data from epidemiological studies suggest an increase in the 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 heart disease increased from less than 1% to about 1.5%. It is believed that this risk increases with the dose increase and duration of treatment.

During the I and II trimester of pregnancy, meloxicam should not be used, except for the urgent need. If a woman who is trying to become pregnant or during the first and second trimester of pregnancy uses meloxicam, the dosing and duration of treatment should be the smallest.

During the III trimester of pregnancy, all inhibitors of prostaglandin synthesis can create a risk for the fetus:

  • cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
  • disruption of kidney function, which can develop into renal failure with oligohydroamnion;

possible risks during the last periods of pregnancy for the mother and newborn:

  • possibility of prolongation of bleeding time, anti-aggregation effect even at very low doses;
  • oppression of uterine contractions, which leads to delay or prolongation of labor.

Therefore, meloxicam is contraindicated during the third trimester of pregnancy.

Lactation. Although there is no specific data on Meloxicam-H, it is known that NSAIDs can penetrate into breast milk. Therefore, its use is not recommended for women during breastfeeding.

The ability to influence the reaction rate when driving vehicles or other mechanisms

There are no special studies of the effect of the drug on the ability to drive a car or work with mechanisms. However, on the basis of the pharmacodynamic profile and the observed adverse reactions, meloxicam is not likely to influence or have a negligible effect on this activity. However, patients with visual impairment, including blurred vision, dizziness, drowsiness, vertigo or other disorders of the central nervous system, are advised to refrain from driving or working with other mechanisms.

Posology and method of administration

Intramuscular application.

One injection of 15 mg once a day.

Intramuscular application.

One injection of 15 mg once a day.

DO NOT EXCEED THE DOSAGE of 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 are not possible). Adverse reactions can be minimized by applying the lowest effective dose during the shortest treatment period necessary to control the symptoms (see section "Precautions for use").

The patient's need for symptomatic relief and his response to treatment should be evaluated periodically.

Special categories of patients.

Elderly patients and patients with an increased risk of adverse reactions development.

The recommended dose for elderly patients is 7.5 mg per day. Patients with an increased risk of adverse reactions development should begin treatment with 7.5 mg per day (half an ampoule 1.5 ml) (see section "Precautions for use").

Renal failure.

For patients with severe renal failure who are on dialysis, the dose should not exceed 7.5 mg per day (half-ampule 1.5 ml).

Patients with restrained and moderate renal failure (namely, patients with a creatinine clearance greater than 25 mL / min) do not need a dose reduction. For patients with severe renal failure without dialysis, see the section “Contraindications”.

Liver failure.

Patients with mild to moderate hepatic impairment are not required to dose reduction. For patients with severe hepatic impairment, see the section “Contraindications”.

Application method.

The drug should be entered slowly, by deep intramuscular injection into the upper outer quadrant of the buttocks, adhering to strict aseptic technique. In case of repeated administration, it is recommended to alternate the left and right buttocks. Before injection, it is important to check that the tip of the needle is not in the vessel.

Injection should be stopped immediately in case of severe pain during injection.

In the case of a hip joint prosthesis, the injection should be made into the other buttock.

Instruction for use of  ampule.

  1. Separate one ampoule from the block and shake the contents gently, holding the ampoule by its neck.
  2. Squeeze the ampoule in your hand (the product leakage shall not occur) and remove the cap by rotating it..
  3. Immediately put a syringe in the ampoule through the obtained hole.
  4. Turn the ampoule over and slowly suck the liquid in the syringe.
  5. Put a needle on the syringe.

Children.

Meloxikam-H, solution for injection 15 mg / 1.5 ml, is contraindicated to children.

Overdose

Symptoms of an acute overdose of NSAIDs are usually limited by lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible in case of maintenance therapy. Gastrointestinal bleeding may occur. Severe poisoning can lead to hypertension, acute kidney failure, liver dysfunction, respiratory depression, coma, convulsions, cardiovascular failure and cardiac arrest. Anaphylactoid reactions have been reported in the therapeutic use of NSAIDs, which can also occur with an overdose.

In case of an overdose by NSAIDs, symptomatic and supportive measures are recommended. Studies have shown accelerated excretion of meloxicam with 4 oral doses of cholestyramine 3 times a day.

Adverse reactions

Research data and epidemiological data suggest that the use of certain NSAIDs (especially in high doses and within long-term treatment) may be associated with a slight increase in the risk of vascular thrombotic events (such as myocardial infarction or stroke) (see section "Precautions for use”).

Edema, arterial hypertension and heart failure were observed during the treatment by NSAIDs.

Most of the observed side effects are of gastrointestinal origin. Possible peptic ulcer, perforation or gastrointestinal bleeding, which is sometimes lethal, especially in case of elderly patients (see section "Precautions for use"). After the application, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, vomiting of blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease were observed (see section "Precautions for use"). With a lower incidence of gastritis.

Blood and lymphatic system: anemia, abnormalities in indexes of blood analysis from normal (including changes in the number of leukocytes), leukopenia, thrombocytopenia, cases of agranulocytosis (see "Selected serious and / or common adverse reactions").

Immune system: allergic reactions, which differ from anaphylactic or anaphylactoid; anaphylactic shock, anaphylactic reactions, anaphylactoid reactions, including shock.

Mental disorders: mood changes, nightmares; confusion, disorientation, insomnia.

Nervous system: headache, dizziness, drowsiness.

Visual system: impaired vision, including blurred vision; conjunctivitis.

Hearing and the vestibular apparatus: dizziness, tinnitus.

Cardiac disorders: a feeling of heartbeat, heart failure associated with the use of NSAIDs.

Vascular disorders: increased blood pressure (see section "Precautions for use"), flushes.

Respiratory system, the organs of the thorax and the mediastinum: asthma in case patients have an allergy to aspirin and other NSAIDs; infection of the upper respiratory tract, cough.

Digestive tract: dyspepsia, nausea, vomiting, abdominal pain, diarrhea; latent or macroscopic gastrointestinal bleeding, stomatitis, gastritis, constipation, flatulence, belching, colitis, gastroduodenal ulcer, esophagitis; gastrointestinal perforation.

Gastrointestinal bleeding, ulcers or perforation can be severe and potentially lethal, especially in case of elderly patients (see section "Precautions for use").

Disorders of the hepatobiliary system: liver indicators’ dysfunction (for example, increased transaminases or bilirubin); hepatitis, jaundice, liver failure.

Skin and subcutaneous tissue: angioedema, itching, rashes; Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, bullous dermatitis, multi-formal erythema; Photosensitivity, exfoliative dermatitis.

Urinary system: sodium and water retention, hyperkalemia (see section "Precautions for use" and "Interaction with other drugs and other interactions"), changes in renal function (increased serum creatinine and / or urea serum); acute renal failure, in particular at patients with risk factors (see section "Application features"); urinary tract infection, disorder of frequency of urination.

General disorders and reaction at the injection place: compaction at the injection site; pain at the injection site; edema, including edema of the lower limbs; influenza-like symptoms.

Muscular and skeletal system: arthralgia, back pain, signs and symptoms associated with joints.

Separate serious and/or common adverse reactions.

It was reported about the rare cases of agranulocytosis in case of application of meloxicam and other potentially myelotoxic drugs (see the section "Interaction with other drugs and other interactions").

Adverse reactions, which are not associated with the use of the drug, but which are generally accepted as specific for other class compounds.

Organic renal failure, which probably leads to acute renal failure: it was reported about the rare cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome and papillary necrosis (see section "Application features").

Shelf life

2 years.

Shelf life after opening the ampoule: unused content of the ampoule should be destroyed, it can not be stored for further use.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ° C.

Keep away from children.

Incompatibility

Because of possible incompatibility, Meloxicam-N, solution for injection, should not be mixed with other drugs in the same syringe.

Packaging

1.5 ml in polyethylene ampoules № 5.

Prescription category

Following the doctor’s prescription.

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Materials on the medicine

No materials available.

Calculation of dose

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