Amelotex, 15 mg, rectal suppositories, 6 pcs.
As with the use of other NSAIDs, gastrointestinal bleeding, ulcers and perforations, which are potentially life-threatening to the patient, may occur at any time during treatment, either in the presence of warning symptoms or a history of serious gastrointestinal complications, or the absence of such. The consequences of these complications are generally more serious in older people. Caution should be exercised when using Amelotex® (as well as when using other NSAIDs) in patients with a history of gastrointestinal diseases, the elderly, and those on anticoagulant therapy. Such patients have an increased risk of erosive and ulcerative diseases of the gastrointestinal tract. In this case, as well as for the treatment of patients requiring the use of low doses of acetylsalicylic acid or other drugs that increase gastrointestinal risks, combination therapy with protective drugs (such as misoprostol or proton pump inhibitors) should be considered.
If ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding occur, treatment with Amelotex® should be discontinued.
Particular attention should be paid to patients reporting the development of adverse events from the skin and mucous membranes (itching, skin rash, urticaria, photosensitivity). In such cases, discontinuation of the use of Amelotex® should be considered.
NSAIDs inhibit the synthesis of PGs in the kidneys, which are involved in maintaining renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or reduced volume may lead to decompensation of latent renal failure. After discontinuation of NSAIDs, renal function usually recovers. Elderly patients are most at risk of developing this reaction; patients with dehydration, CHF, liver cirrhosis, nephrotic syndrome or kidney disease; patients receiving diuretics, ACE inhibitors, angiotensin II receptor antagonists, and those who have undergone major surgery leading to hypovolemia. In such patients, diuresis and renal function should be carefully monitored when initiating therapy (see Interactions). In patients with renal failure, if creatinine Cl is more than 30 ml/min, no dosage adjustment is required.
In patients with end-stage renal failure on hemodialysis, the dosage of Amelotex® should not exceed 7.5 mg/day.
If there is a persistent and significant increase in the activity of liver transaminases and changes in other indicators of liver function, the drug should be discontinued and the identified laboratory changes should be monitored.
In patients with liver cirrhosis in the compensation stage, a dose reduction of the drug is not required. Patients receiving diuretics and Amelotex® simultaneously should take sufficient fluids.
Amelotex®, like other NSAIDs, can mask the symptoms of infectious diseases.
The use of Amelotex®, like other drugs that block the synthesis of PG, can affect fertility, so it is not recommended for women planning pregnancy.
Influence on the ability to drive vehicles and machinery.
The use of the drug may cause undesirable effects such as headaches, dizziness, and drowsiness. You should refrain from driving vehicles and servicing machines and mechanisms that require concentration.
Amelotex rectal suppositories 7.5 mg No. 6
A country
Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Compound
Rectal suppositories, 6 pcs.
pharmachologic effect
NSAIDs have anti-inflammatory, antipyretic and analgesic effects. Belongs to the class of oxicams; enolic acid derivative. The mechanism of action is inhibition of Pg synthesis as a result of selective suppression of the enzymatic activity of COX2. When prescribed in high doses, long-term use and individual characteristics of the organism, COX2 selectivity decreases. Suppresses Pg synthesis in the area of inflammation to a greater extent than in the gastric mucosa or kidneys, which is associated with relatively selective inhibition of COX2. Less commonly causes erosive and ulcerative diseases of the gastrointestinal tract.
Indications for use
Rheumatoid arthritis; osteoarthritis; ankylosing spondylitis (Bechterew's disease) and other inflammatory and degenerative diseases of the joints, accompanied by pain. Intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.
Mode of application
Orally, during meals, in a daily dose of 7.5-15 mg. The maximum daily dose is 15 mg, in patients with severe renal failure on hemodialysis - 7.5 mg. With a slight or moderate decrease in renal function (creatinine clearance more than 25 ml/min), as well as with liver cirrhosis in a stable clinical condition, no dose adjustment is required. The initial dose in patients with an increased risk of side effects is 7.5 mg/day. Rectally - 15 mg (one suppository) 1 time per day.
Interaction
When taken simultaneously with other NSAIDs, the risk of developing gastrointestinal ulcers and gastrointestinal bleeding increases; increases the concentration of Li+ in plasma when used simultaneously with Li+ drugs; reduces the effectiveness of IUDs and antihypertensive drugs; indirect anticoagulants, ticlopidine, heparin, thrombolytics increase the risk of bleeding; methotrexate enhances the myelosuppressive effect; diuretics increase the risk of developing renal dysfunction; cyclosporine enhances the nephrotoxic effect; cholestyramine accelerates excretion. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.
Side effect
Frequency: often - more than 1%; infrequently - 0.1-1%; rarely - 0.01-0.1%; very rarely - less than 0.01%. From the digestive system: often - dyspepsia, incl. nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; infrequently - transient increase in the activity of “liver” transaminases, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, bleeding from the gastrointestinal tract (including hidden), stomatitis; rarely - gastrointestinal perforation, colitis, hepatitis, gastritis. From the hematopoietic organs: often - anemia; infrequently - changes in the blood formula, incl. leukopenia, thromocytopenia. From the skin: often - itching, skin rash; infrequently - urticaria; rarely - photosensitivity, bullous rashes, erythema multiforme, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis. From the respiratory system: rarely - bronchospasm. From the nervous system: often - dizziness, headache; uncommon - vertigo, tinnitus, drowsiness; rarely - confusion, disorientation, emotional lability. From the cardiovascular system: often - peripheral edema; infrequently - increased blood pressure, palpitations, “flushes” of blood to the skin of the face. From the urinary system: infrequently - hypercreatininemia and/or increased urea concentration in the blood serum; rarely - acute renal failure; The connection with taking meloxicam has not been established - interstitial nephritis, albuminuria, hematuria. From the senses: rarely - conjunctivitis, visual impairment, incl. blurred visual perception. Allergic reactions: rarely - angioedema, anaphylactoid/anaphylactic reactions.
Contraindications
Hypersensitivity (including to NSAIDs of other groups), a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to ASA and pyrazolone-type drugs; peptic ulcer of the stomach and duodenum (in the acute phase), severe liver failure, chronic renal failure in patients not undergoing dialysis (creatinine clearance less than 30 ml/min), active gastrointestinal bleeding; progressive kidney disease, severe liver failure or active liver disease, condition after coronary artery bypass surgery, confirmed hyperkalemia, inflammatory bowel disease, children (up to 12 years), pregnancy, lactation.
special instructions
If peptic ulcers or gastrointestinal bleeding occur, or side effects on the skin and mucous membranes develop, the drug should be discontinued. In patients with reduced BCC and reduced glomerular filtration (dehydration, CHF, liver cirrhosis, nephrotic syndrome, clinically significant kidney disease, taking diuretics, dehydration after major surgery), clinically significant chronic renal failure may occur, which is completely reversible after discontinuation of the drug (in such patients At the beginning of treatment, daily diuresis and renal function should be monitored). If there is a persistent and significant increase in transaminases and changes in other indicators of liver function, the drug should be discontinued and control tests should be performed. In patients with an increased risk of side effects, treatment begins with a dose of 7.5 mg. In the terminal stage of chronic renal failure in patients on dialysis, the dose should not exceed 7.5 mg/day. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions (if dizziness and drowsiness occur). To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible short course.
Dispensing conditions in pharmacies
On prescription
Amelotex, 6 pcs., 7.5 mg, rectal suppositories
As with the use of other NSAIDs, gastrointestinal bleeding, ulcers and perforations, which are potentially life-threatening to the patient, may occur at any time during treatment, either in the presence of warning symptoms or a history of serious gastrointestinal complications, or the absence of such. The consequences of these complications are generally more serious in older people. Caution should be exercised when using Amelotex® (as well as when using other NSAIDs) in patients with a history of gastrointestinal diseases, the elderly, and those on anticoagulant therapy. Such patients have an increased risk of erosive and ulcerative diseases of the gastrointestinal tract. In this case, as well as for the treatment of patients requiring the use of low doses of acetylsalicylic acid or other drugs that increase gastrointestinal risks, combination therapy with protective drugs (such as misoprostol or proton pump inhibitors) should be considered.
If ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding occur, treatment with Amelotex® should be discontinued.
Particular attention should be paid to patients reporting the development of adverse events from the skin and mucous membranes (itching, skin rash, urticaria, photosensitivity). In such cases, discontinuation of the use of Amelotex® should be considered.
NSAIDs inhibit the synthesis of PGs in the kidneys, which are involved in maintaining renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or reduced volume may lead to decompensation of latent renal failure. After discontinuation of NSAIDs, renal function usually recovers. Elderly patients are most at risk of developing this reaction; patients with dehydration, CHF, liver cirrhosis, nephrotic syndrome or kidney disease; patients receiving diuretics, ACE inhibitors, angiotensin II receptor antagonists, and those who have undergone major surgery leading to hypovolemia. In such patients, diuresis and renal function should be carefully monitored when initiating therapy (see Interactions). In patients with renal failure, if creatinine Cl is more than 30 ml/min, no dosage adjustment is required.
In patients with end-stage renal failure on hemodialysis, the dosage of Amelotex® should not exceed 7.5 mg/day.
If there is a persistent and significant increase in the activity of liver transaminases and changes in other indicators of liver function, the drug should be discontinued and the identified laboratory changes should be monitored.
In patients with liver cirrhosis in the compensation stage, a dose reduction of the drug is not required. Patients receiving diuretics and Amelotex® simultaneously should take sufficient fluids.
Amelotex®, like other NSAIDs, can mask the symptoms of infectious diseases.
The use of Amelotex®, like other drugs that block the synthesis of PG, can affect fertility, so it is not recommended for women planning pregnancy.
Influence on the ability to drive vehicles and machinery.
The use of the drug may cause undesirable effects such as headaches, dizziness, and drowsiness. You should refrain from driving vehicles and servicing machines and mechanisms that require concentration.