Name:
Melbek solution for intramuscular injection injections of 15mg / 1.5ml in amp. in pack. No. 3 Main active ingredient Meloxicam Release form solution Composition 1 ampoule 1.5 ml contains: meloxicam 15 mg; excipients: meglumine, glycofurol, poloxamer 188, glycine, sodium chloride, sodium hydroxide or hydrochloric acid, water for injection.
Description:
Yellow transparent solution, without particles, in 2 ml colorless glass ampoules. Dosage 15 mg / 1.5 ml Indications for use Short-term symptomatic therapy of exacerbation of rheumatoid arthritis or ankylosing spondylitis in case of oral or rectal administration. Contraindications Hypersensitivity to meloxicam or any auxiliary component of the drug. There is a possibility of developing cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs). Melbek is contraindicated in patients who have previously experienced symptoms of bronchial asthma, nasal polyps, angioedema or urticaria after taking acetylsalicylic acid or other NSAIDs. Gastrointestinal ulcer / perforation in the acute stage, recently transferred or transferred earlier (two or more confirmed episodes). Nonspecific inflammatory bowel disease in the acute stage (Crohn’s disease, ulcerative colitis). Severe liver failure. Severe renal failure without hemodialysis. Open gastrointestinal bleeding, recent cerebrovascular bleeding or other somatic disorders accompanied by bleeding. History of gastrointestinal bleeding or perforation of the gastrointestinal tract associated with previous NSAID therapy. Severe uncontrolled heart failure. Children and teenagers up to 18 years old. Pregnancy or breastfeeding. Patients with impaired hemostasis or taking anticoagulants. Contraindicated for the treatment of intraoperative pain in coronary artery bypass grafting (CABG). Use during pregnancy and lactation Melbek is contraindicated during pregnancy. Suppression of prostaglandin synthesis can have an undesirable effect on pregnancy and fetal development. Data from epidemiological studies indicate an increased risk of spontaneous abortions, heart defects and gastroschisis in the fetus after the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of developing malformations of the cardiovascular system increased from less than 1% to 1.5%. This risk increases with increasing dose and duration of therapy. In the III trimester of pregnancy, the use of any prostaglandin synthesis inhibitors can lead to the following fetal developmental disorders: premature closure of the arterial duct and pulmonary hypertension due to toxic effects on the cardiopulmonary system; kidney dysfunction, with further development, renal failure with oligohydroamniosis. During childbirth, the duration of bleeding may increase in the mother, and the antiplatelet effect may develop even at a low dosage and the contractility of the uterus may decrease, and as a result, the duration of labor may increase. Despite the lack of data on the experience of using the drug Melbek, it is known that NSAIDs penetrate into breast milk. Therefore, these drugs are contraindicated during lactation. The use of meloxicam, as well as other drugs that block cyclooxygenase / prostaglandin synthesis, can affect fertility, so this drug is not recommended for women planning pregnancy. In case of violation of the ability to conceive in women or an examination for infertility, it is necessary to consider the abolition of meloxicam. Influence on the ability to drive a car and mechanisms Studies of the effect of the drug on the ability to drive a car and mechanisms have not been conducted. However, patients should be warned that side effects such as visual disturbances, including blurred vision, dizziness, drowsiness, and other central nervous system abnormalities, may occur. Patients with the above symptoms should refrain from performing potentially hazardous activities such as driving or operating machinery. Dosage and administration The drug is administered intramuscularly. The recommended dose of Melbek, solution for intramuscular injection is 15 mg (1 ampoule of 1.5 ml) once a day. Do not exceed a dose of 15 mg/day. Treatment is usually limited to one injection, in exceptional cases, the duration of treatment using this dosage form can reach 2-3 days (ie, in cases where oral or rectal administration is not possible). Minimizing the risk of developing adverse effects is possible by using the minimum effective dose for the shortest period of time necessary to control symptoms. The need for the use of the drug in a patient to relieve symptoms and response to therapy should be periodically assessed. Elderly patients and patients at increased risk of adverse reactions The recommended dose for elderly patients is 7.5 mg per day. Patients with an increased risk of developing adverse reactions should begin treatment with a dosage of 7.5 mg per day (1/2 ampoule containing 1.5 ml). Renal insufficiency In patients with severe renal insufficiency who are on dialysis, should not exceed 7.5 mg per day (1/2 ampoule containing 1.5 ml). Dose reduction is not required in patients with mild to moderate renal insufficiency (i.e., in patients with creatinine clearance greater than 25 ml/min.) . Hepatic insufficiency In patients with mild and moderate insufficiency, a dose reduction is not required (for recommendations regarding patients with severe hepatic insufficiency, see the “Contraindications” section). Children and adolescents Melbek solution for intramuscular injection is contraindicated in children and adolescents under 18 years of age. Method of application Melbek solution for intramuscular injection should be injected deep intramuscularly, slowly, into the upper outer quadrant of the buttock, observing the rules of asepsis. In the case of repeated administration, it is recommended to alternate injections on the left and right. Before insertion, make sure that the tip of the needle is not in a blood vessel. In case of severe pain during the injection, the administration should be stopped immediately. In the case of a hip prosthesis, it is recommended to inject from the other side. Side effects Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombosis (eg, myocardial infarction or stroke). There have been reports of the development of heart failure, edema, arterial hypertension associated with the use of NSAIDs. The most common adverse reactions are gastrointestinal disorders. Complications of peptic ulcer may develop: perforation or gastrointestinal bleeding, sometimes fatal, especially in the elderly. It was reported about the development of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, vomiting with blood, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn’s disease, gastritis. Adverse reactions are presented by frequency of occurrence according to the following scale: very often (?1/10), often (?1/100 to <1/10), infrequently (?1/1000 to <1/100), rarely (?1 /10,000 to <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data). Blood and lymphatic system disorders Uncommon: anemia Rare: changes in the blood count (including changes in the leukocyte count), leukopenia, thrombocytopenia. In rare cases, agranulocytosis. A predisposing factor for the occurrence of cytopenia is the simultaneous use of potentially myelotoxic drugs, in particular, methotrexate. Immune system disorders Uncommon: allergic reactions, Frequency not known: anaphylactic shock, anaphylactic reactions, anaphylactoid reactions Psychiatric disorders Rare: mood disorders, nightmares Frequency not known: confusion, disorientation Nervous system disorders Common: headache Uncommon: dizziness, drowsiness Visual disturbances Rare: visual disturbances including blurred vision, conjunctivitis Hearing and labyrinth disorders Uncommon: dizziness Rare: ringing in the ears Cardiac disorders Rare: palpitations NSAID-related heart failure has been reported . Vascular disorders Uncommon: increased blood pressure, flushing Respiratory, chest and mediastinal disorders Rare: bronchial asthma in patients with allergic reactions to acetylsalicylic acid or other NSAIDs Gastrointestinal disorders Very common: gastrointestinal disorders such as dyspepsia , nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea Uncommon: occult or macroscopically visible gastrointestinal bleeding, stomatitis, gastritis, belching Rare: colitis, stomach ulcer, esophagitis Very rare: gastrointestinal perforation/bleeding, which may be fatal, especially in elderly patients Hepatic and biliary tract disorders Uncommon: hepatic dysfunction (eg, elevated transaminases or bilirubin) Very rare: hepatitis Skin and subcutaneous tissue disorders Uncommon: angioedema, pruritus, rash Rare : Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria a Very rare: bullous dermatitis, erythema multiforme Not known: photosensitivity reactions Renal and urinary disorders Uncommon: sodium and water retention, hyperkalemia, changes in renal function tests (increased serum creatinine and/or urea). Very rare: acute renal failure, especially in patients with risk factors. Patients with kidney disease have an increased risk of developing acute renal failure, cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome and papillary necrosis have been reported. General disorders and disorders at the injection site Often: induration at the injection site, pain at the injection site. Uncommon: edema, including edema of the lower extremities. Overdose In acute overdose of NSAIDs, the following symptoms may occur, which are usually reversible with maintenance therapy: weakness, drowsiness, nausea, vomiting and epigastric pain. Gastrointestinal bleeding may develop. Severe intoxication can lead to hypertension, acute renal failure, liver failure, respiratory depression, coma, convulsions, and cardiovascular failure. As well as when taking NSAIDs in therapeutic doses, with their overdose, there may be anaphylactoid reactions. The antidote is not known, in case of an overdose of the drug, general maintenance therapy should be carried out. Clinical studies have shown that cholestyramine accelerates the elimination of meloxicam. Interaction with other drugs Other prostaglandin synthesis inhibitors, including glucocorticoids and salicylates (acetylsalicylic acid): the simultaneous use of prostaglandin synthesis inhibitors increases the risk of gastrointestinal ulcers and gastrointestinal bleeding due to synergistic action. The combined use of meloxicam and NSAIDs is not recommended. Co-administration with acetylsalicylic acid prescribed in anti-inflammatory doses (? 500 mg single dose or ? 3 g total daily dose) is not recommended. Oral anticoagulants, antiplatelet agents, systemic heparin, thrombolytic agents and selective serotonin receptor inhibitors: increased risk of bleeding. The simultaneous use of NSAIDs and oral anticoagulants or heparin is not recommended for elderly patients. If it is impossible to avoid the simultaneous use of these drugs, careful monitoring of the effect of anticoagulants is necessary: careful monitoring of INR (international normalized ratio) is required. Lithium: NSAIDs increase the concentration of lithium in the blood plasma by reducing the renal excretion of lithium. The concentration of lithium in plasma can reach toxic values. The combined use of lithium and NSAIDs is not recommended. If such combination therapy is necessary, the plasma lithium concentration should be monitored at the beginning of treatment, when selecting a dose and canceling meloxicam. Methotrexate: NSAIDs may reduce tubular secretion of methotrexate and thus increase the plasma concentration of methotrexate. In this regard, patients receiving high doses of methotrexate (more than 15 mg per week), the simultaneous use of NSAIDs is not recommended. The risk of interaction with the simultaneous use of methotrexate and NSAIDs is also possible in patients receiving low doses of methotrexate, especially in patients with impaired renal function. If combination therapy is necessary, the blood count and kidney function should be monitored. Care must be taken if NSAIDs and methotrexate are used simultaneously for 3 days, because. plasma methotrexate concentration may increase and, as a result, toxic effects may occur. The simultaneous use of meloxicam did not affect the pharmacokinetics of methotrexate at a dose of 15 mg per week, however, it should be taken into account that the hematological toxicity of methotrexate increases with the simultaneous use of NSAIDs. Contraception: A decrease in the effectiveness of intrauterine contraceptive devices has previously been reported with the use of NSAIDs, further confirmation. Diuretics: The use of NSAIDs increases the risk of acute renal failure in dehydrated patients. In patients taking Melbek and diuretics, adequate hydration should be maintained. Before starting treatment, a study of kidney function is necessary. Antihypertensive agents (eg, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, vasodilators, diuretics): NSAIDs reduce the effect of antihypertensive agents by inhibiting prostaglandins, which have vasodilatory properties. The combined use of NSAIDs and angiotensin II receptor antagonists and ACE inhibitors enhances the effect of reducing glomerular filtration. In some patients with impaired renal function (eg, patients with dehydration or elderly patients with impaired renal function), the concomitant use of an ACE inhibitor or angiotensin-II antagonist and cyclooxygenase inhibitors may lead to further deterioration of renal function, including the possibility of developing acute renal failure, such as reversible rule. This combination should be administered with caution, especially in elderly patients. Adequate hydration of the patient and monitoring of renal function after initiation of concomitant therapy and periodically during treatment are recommended. Cholestyramine, by binding to meloxicam in the gastrointestinal tract, leads to its faster elimination. NSAIDs, by acting on renal prostaglandins, may increase the nephrotoxicity of cyclosporine and tacrolimus. In the case of combination therapy, renal function should be monitored. With the simultaneous use of meloxicam and antacids, cimetidine, digoxin, no significant pharmacokinetic interactions were identified. The possibility of interaction with oral antidiabetic agents cannot be ruled out. Risk of hyperkalemia: Some drugs or therapeutic groups may contribute to the development of hyperkalemia: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim. The development of hyperklaemia may depend on the presence of risk factors. The risk of developing hyperkalemia increases with the simultaneous use of the above drugs and meloxicam. Deferasirox: Concomitant use of meloxicam and deferasirox may increase the risk of gastrointestinal side effects. In this regard, these drugs should be taken simultaneously with caution. Pemetrexed: If meloxicam and pemetrexed are to be co-administered in patients with mild to moderate renal impairment (creatinine clearance 45-78 ml/min.), meloxicam should not be taken within 2 days of pemetrexed administration. If the combination of meloxicam and pemetrexed is necessary, careful monitoring of the patient is recommended, especially due to myelosuppression and gastrointestinal side effects. In patients with severe renal insufficiency (creatinine clearance <45 ml / min.), the simultaneous use of meloxicam and pemetrexed is not recommended. In patients with normal renal function (creatinine clearance ?80 ml/min.), the use of meloxicam at a dose of 15 mg may lead to a decrease in the clearance of pemetrexed and, consequently, an increase in its side effects. Thus, concomitant use of meloxicam 15 mg and pemetrexed in patients with normal renal function (creatinine clearance ?80 ml/min.) Should be used with caution. Precautions Undesirable effects can be minimized by administering the lowest effective dose necessary to control symptoms for the shortest period of time. In case of insufficient therapeutic effect, the recommended maximum daily dose should not be exceeded and / or an additional NSAID should be prescribed, because. this can lead to increased toxicity in the absence of therapeutic benefits. The simultaneous administration of meloxicam with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Meloxicam is not suitable for the relief of acute pain. If there is no clinical improvement after a few days of taking the drug, it is recommended to re-evaluate the appointment of treatment. Patients with a history of esophagitis, gastritis, and/or peptic ulcer should be ascertained to be cured before prescribing meloxicam. Careful monitoring of these patients receiving meloxicam is necessary in order to timely detect a relapse of the disease. Effects on the gastrointestinal tract As with other NSAIDs, potentially fatal gastrointestinal bleeding, ulceration or perforation may occur at any time during treatment with or without warning symptoms or a history of serious gastrointestinal disease. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing dose of NSAIDs in patients with a history of ulcer, especially complicated by bleeding or perforation, and in elderly patients. In such patients, treatment should be initiated at the lowest effective dose. For such patients, combination therapy with protective medicinal products (such as misoprostol or proton pump inhibitors) should be considered, as well as for patients who require concomitant use of a low dose of acetylsalicylic acid or other drugs that increase the risk of gastrointestinal damage. Patients with a history of gastrointestinal toxicity, especially elderly patients, should report all unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial stages of treatment. Caution should be exercised in patients taking concomitant drugs that may increase the risk of ulcer or bleeding, such as heparin, prescribed both for radical treatment and in geriatric practice, anticoagulants, such as warfarin, or other non-steroidal anti-inflammatory drugs, including acetylsalicylic acid in anti-inflammatory doses (≤500 mg single dose or ≥3 g total daily dose). With the development of gastrointestinal bleeding or ulcers in patients taking meloxicam, treatment should be discontinued. NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may worsen. Influence on the cardiovascular system Careful monitoring is recommended in patients with arterial hypertension and / or congestive heart failure of mild to moderate severity, since fluid retention and edema have been observed during NSAID therapy. Patients with risk factors are recommended clinical monitoring of blood pressure at the beginning of therapy, especially at the beginning of the course of treatment with meloxicam. Research and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with a slight increase in the risk of vascular thrombotic events (eg, myocardial infarction or stroke). There are insufficient data to rule out such a risk for meloxicam. Patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with meloxicam after careful assessment of their condition. Such an assessment is necessary before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smokers). Skin reactions Serious life-threatening skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with meloxicam. Patients should be aware of symptoms and signs and carefully monitored for skin reactions. The highest risk of developing Stevens-Johnson syndrome and toxic epidermal necrolysis was observed during the first weeks of treatment. Meloxicam should be discontinued at the first symptoms or signs of Stevens-Johnson syndrome or toxic epidermal necrolysis (eg, progressive skin rash, often blistering, or mucosal lesions). The best outcome in the treatment of Stevens-Johnson syndrome or toxic epidermal necrolysis was observed with early diagnosis and immediate withdrawal of the suspect drug. Early drug withdrawal was associated with a better prognosis. If Stevens-Johnson syndrome or toxic epidermal necrolysis developed during the reception, then in the future this patient should not be given meloxicam again. Hepatic and renal function tests As with most NSAIDs, elevations in serum transaminases, elevations in serum bilirubin or other liver function tests, as well as elevations in creatinine and blood urea, and other laboratory abnormalities have been reported rarely. In most cases, the violations were temporary and unexpressed. The development of a pronounced deviation of indicators from the norm or their persistence requires the cessation of the introduction of meloxicam and an appropriate examination. Functional renal failure NSAIDs, by inhibiting the vasodilating action of renal prostaglandins, can cause functional renal failure as a result of a decrease in glomerular filtration. This response is dose-dependent. It is recommended to carefully monitor diuresis and renal function at the beginning of treatment or after increasing the dose in patients with the following risk factors: advanced age; concomitant therapy with ACE inhibitors, angiotensin II antagonists, sartans, diuretics; hypovolemia (regardless of cause); heart failure; kidney failure; nephrotic syndrome; lupus nephropathy; severe hepatic impairment (serum albumin <25 g/l or Child-Pugh score ?10). In rare cases, NSAIDs can cause interstitial nephritis, glomerulonephritis, medullary necrosis of the kidney, or nephrotic syndrome. The dose of meloxicam in patients with end-stage renal disease on hemodialysis should not exceed 7.5 mg. Dose reduction is not required in patients with mild to moderate renal impairment (i.e., in patients with creatinine clearance greater than 25 ml/min). Sodium, Potassium and Water Retention The use of NSAIDs can lead to retention of sodium, potassium and water and may affect the natriuretic effect of diuretics. In addition, it is possible to reduce the antihypertensive effect of antihypertensive drugs. As a result, predisposed patients may develop or increase edema, symptoms of heart failure or hypertension. Clinical observation is recommended for these patients. Hyperkalemia The risk of developing hyperkalemia is increased in patients with diabetes mellitus or in concomitant therapy with drugs that increase the level of potassium in the blood. In such cases, it is necessary to regularly monitor the level of potassium in the blood. Co-administration with pemetrexed Patients with mild to moderate renal impairment receiving pemetrexed should not take meloxicam for at least 5 days prior to pemetrexed administration, on the day of administration, and for 2 days after pemetrexed administration. Other Warnings and Precautions Elderly, debilitated and malnourished patients are more susceptible to adverse reactions and therefore require careful monitoring. As with other NSAIDs, special care must be taken when prescribing the drug to elderly patients who often have impaired renal, hepatic and cardiac function. Elderly patients also have an increased incidence of adverse reactions with NSAIDs, especially gastrointestinal bleeding and gastrointestinal perforation, which can be fatal. Meloxicam, like other NSAIDs, may mask the symptoms of an infectious disease. The use of meloxicam may reduce fertility in women and, accordingly, is not recommended for women planning a pregnancy. In case of violation of the ability to conceive in women or an examination for infertility, it is necessary to consider the abolition of meloxicam. As with other NSAIDs administered intramuscularly, abscess and necrosis may develop at the injection site. The drug contains 0.027 mmol sodium (0.61 mg) in 1.5 ml of solution. Storage conditions Store in a place protected from light at a temperature not exceeding 25 ° C. Buy Melbek solution for intramuscular injection 15mg/1.5ml in ampoules No. 3 for Melbek solution for intramuscular injection 15mg/1.5ml in ampoules №3
Melbek solution for intramuscular injection 15mg/1.5ml in ampoules №3
$20.00
SKU: 37192
Category: Medicines for pain and inflammation
INN | MELOXICAM |
---|---|
The code | 37 192 |
Barcode | 8 699 540 754 003 |
Dosage | 15mg/1.5ml am |
Active substance | Meloxicam |
Manufacturer | Idol Ilach Dol. San. wee tick. A.S., Turkey |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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