Asacol 800mg 60 tablets — Made in Switzerland — Free Delivery
(Asacol )
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Description Asacol 800mg 60 tablets — Made in Switzerland — Free Delivery
Pharmacological properties
Pharmacodynamics. mechanism of action. Asakol tablets and suppositories contain mesalazine, which is a 5-pasque, which has an anti-inflammatory effect. the mechanism of action has not yet been fully elucidated. mesalazine inhibits the migration of polymorphonuclear leukocytes, as a result of which inflammation in the intestine is stopped by limiting the migration of macrophages to the inflamed areas. as a result, the synthesis of anti-inflammatory leukotrienes (ltb4 and 5-hete) in macrophages of the intestinal wall is inhibited. recent studies have shown that mesalazine activates ppar-γ receptors, which counteract nuclear activation of inflammatory responses in the intestine.
Pharmacodynamic effects. During studies, it was found that mesalazine also inhibits the action of COX, and, consequently, the release of thromboxane B2 and prostaglandin E2, however, the clinical significance of this effect has not yet been established. Mesalazine inhibits the synthesis of platelet activating factor. In addition, mesalazine is also an antioxidant: it reduces the synthesis of substances containing active oxygen and binds free radicals.
Meta-analysis data from 9 studies (3 cohort studies, 6 case-control studies) involving 1932 patients with ulcerative colitis (334 cases of colorectal cancer and 140 cases of dysplasia) confirmed a 49% reduction in the risk of colorectal cancer in those patients who regularly took mesalazine. This effect was absent in patients with ulcerative colitis who did not receive mesalazine or took it irregularly.
Clinical efficacy and safety. Induction of remission in patients with mild to moderate proctitis or proctosigmoiditis.
Maintenance treatment in remission in patients with mild to moderate proctitis.
Clinical studies of Asakol suppositories included: one comparative bioavailability study, one small-scale tolerability study, and four double-blind clinical studies. Bioavailability study data confirmed an acceptable profile compared to another licensed mesalazine formulation in suppository form. During tolerance studies and clinical studies, data have been obtained confirming the safety and efficacy of this preparation. Evidence for clinical efficacy lies in statistically significant improvement in clinical, sigmoidoscopic, and histological disease parameters.
When administered orally, mesalazine acts mainly locally on the intestinal mucosa and on the submucosa from the side of the intestinal cavity. Hence, it is important that mesalazine is available in areas of inflammation. Systemic bioavailability and plasma concentration are not essential for the therapeutic effect, but most likely act as a harmless factor.
Pharmacokinetics. Absorption. Only part of the mesalazine contained in the suppository is absorbed and circulates in the systemic circulation. The mechanism of action of mesalazine is local, not systemic. After using one suppository of Asakol at a dose of 500 mg in healthy volunteers, the mean values of Cmax and Tmax were 211 ng / ml and 2.0 h for mesalazine and 443 ng / ml and 3.0 h for N-acetyl-mesalazine, respectively. Mesalazine and N-acetyl-mesalazine bind to blood plasma proteins by 43 and 78%, respectively.
Distribution. Low concentrations of mesalazine and its metabolite N-acetyl have been found in human breast milk. The clinical significance of this phenomenon has not been determined.
Biotransformation. Metabolism of mesalazine is carried out in the intestinal mucosa and liver, resulting in the formation of an inactive metabolite N-acetyl-mesalazine.
Excretion of mesalazine occurs mainly with feces and urine unchanged and in the form of the N-acetyl metabolite. After using one suppository Asakol at a dose of 500 mg in healthy volunteers, the biological T½ of mesalazine and N-acetyl-mesalazine were 4.97 and 8.32 hours, respectively.
Asakol enteric-coated tablets are resistant to gastric juice. The polymer shell of the tablets provides the release of the active substance depending on the pH of the medium in the lower ileum and large intestine, which are the main foci of inflammation. The composition of the tablets is selected in such a way as to minimize the absorption of mesalazine in the digestive tract. The absorption of mesalazine is highest in the proximal intestine and lower in the distal part. Absorption after oral administration is about 24%. Accordingly, 76% of the administered dose remains in the lower ileum and large intestine, as well as in the rectum, providing a local anti-inflammatory effect.
Linearity / non-linearity. Special studies have not been carried out.
Relationship between pharmacokinetic / pharmacodynamic data. Special studies have not been carried out.
Indications
Tablets. ulcerative colitis of mild to moderate severity; maintenance treatment in remission. Crohn's disease.
Suppositories. This medicinal product is intended for use in adults:
for the treatment of proctitis and proctosigmoiditis of mild to moderate severity;
in severe forms of total ulcerative colitis, which affects the rectum or rectosigmoid rectum, as an additional therapy to oral treatment.
Application
Tablets
Adults. Ulcerative colitis. When treating a disease in an exacerbation phase, the dose is selected individually and is up to 4 g of mesalazine per day, which is divided into several doses.
With maintenance treatment in remission, the recommended dose is up to 2 g of mesalazine 1 time per day, selected individually. It is also possible to divide the dose into several doses.
Crohn's disease. When treating a disease in an exacerbation phase and maintenance therapy, the dose is selected individually and is up to 4 g of mesalazine per day, which is divided into several doses.
Elderly patients do not require dose adjustment if renal function is not impaired.
Children over the age of 6
In the treatment of ulcerative colitis and Crohn's disease in the acute stage, the dose is selected individually, starting from 30-50 mg / kg / day, it is divided into several doses.
The maximum dose is 75 mg / kg / day, which is divided into several doses. The total daily dose should not exceed 4 g of mesalazine.
With maintenance therapy, the dose is selected individually, starting from 15-30 mg / kg / day, divided into several doses. The total daily dose should not exceed 2 g of mesalazine.
Typically, children weighing 40 kg are given half the adult dose, and children weighing 40 kg are given the full dose.
The tablets should be taken whole, without chewing, with a sufficient amount of liquid, 1 hour before meals. Both with an exacerbation of the disease and with maintenance treatment in remission, to achieve the desired therapeutic effect, Asakol tablets should be taken regularly and continuously. The duration of use is determined by the doctor. Usually, exacerbation in ulcerative colitis and Crohn's disease disappears after 8-12 weeks.
Suppositories. Suppositories are for rectal use only.
Dosage. Adults. Induction of remission: 1 suppository 3 times a day after a bowel movement.
In severe forms of total ulcerative colitis, which affects the rectum or rectosigmoid section of the rectum, as well as in the case of a slow response to oral therapy - 1 suppository in the morning and in the evening as an additional therapy to oral treatment.
Maintenance treatment in remission: the dosage depends on the severity of the disease and can be reduced if the patient's condition improves.
Elderly patients can use the usual adult dose if they do not have renal impairment. Studies in a group of elderly patients have not been conducted.
Contraindications
Hypersensitivity to the active substance, any other component of the preparation or salicylates; severe impairment of liver and kidney function (creatinine clearance 30 ml / min); ulcers of the stomach and duodenum; hemorrhagic diathesis.
Side effects
The clinical trial database includes 246 patients who used asacol, 500 mg suppositories. the range of mesalazine doses ranged from 1.0 to 1.5 g / day, the duration of treatment ranged from 4 weeks to 12 months.
With the use of oral or combined oral and rectal therapy with mesalazine, organ-specific side effects have been reported, in particular from the heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissues. Most of these side effects were noted precisely during oral mesalazine therapy and did not occur in patients receiving Asakol monotherapy, 500 mg suppositories. However, such effects cannot be excluded when using rectal mesalazine monotherapy.
Treatment should be stopped immediately if the patient has signs of acute intolerance to sulfasalazine, such as abdominal colic, acute abdominal pain, fever, severe headache or rash.
Side effects reported in two double-blind clinical trials and one open clinical study, as well as in spontaneous reports or literature sources, the occurrence of which may be associated with the use of mesalazine or cannot be excluded, are presented below according to the class of the organ system: often ( ≥1 / 100, 1/10), infrequently (≥1 / 1000, 1/100), rarely (≥1 / 10,000, 1/1000), very rarely (1/10 000).
On the part of the blood and lymphatic system: very rarely - deviations in blood test parameters (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia).
From the immune system: very rarely - hypersensitivity reactions such as allergic rashes, preparation fever, systemic lupus erythematosus, pancolitis.
From the nervous system: rarely - headache, dizziness; very rarely - peripheral neuropathy.
From the side of the cardiovascular system: rarely - myocarditis, pericarditis.
From the respiratory system, chest and mediastinal organs: very rarely - allergic and fibrotic reactions from the lungs (including shortness of breath, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis).
From the digestive system: rarely - abdominal pain, diarrhea, flatulence, nausea, vomiting; very rarely - acute pancreatitis.
On the part of the hepatobiliary system: very rarely - liver dysfunction (increased levels of transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis.
On the part of the skin and subcutaneous tissues: very rarely - alopecia.
From the musculoskeletal system and connective tissue: bone damage; very rarely - myalgia, arthralgia.
From the urinary system: very rarely - impaired renal function, including acute and chronic interstitial nephritis and renal failure.
On the part of the reproductive system and mammary glands: very rarely - oligospermia (reversible).
Systemic disorders: infrequently - no preparation effect.
Description of selected side effects. Some (unknown) of the above side effects are likely related to the underlying medical condition (inflammatory bowel disease) and not to Asakol. This is especially true for disorders of the digestive system.
Patients should be closely monitored to avoid blood dyscrasia, which may be caused by bone marrow suppression.
Concomitant use of myelosuppressive preparations such as azathioprine, 6-mercaptopurine, or thioguanine can cause leukopenia.
With simultaneous use with NSAIDs, azathioprine or methotrexate, the risk of adverse reactions from the kidneys may increase.
Children. There are limited safety data when using Asakol suppositories in pediatric practice. In children, it is expected that the same organs as in adults (heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissues) may be affected.
Other special patient groups. Patients with impaired renal function. There have been rare reports of acute renal dysfunction. Consideration should be given to the possibility of mesalazine-induced nephrotoxicity in patients who develop renal dysfunction during treatment. This nephrotoxicity usually disappears after treatment is discontinued.
Patients with impaired liver function. There are reports of increased levels of liver enzymes and the occurrence of hepatitis. In some patients, these symptoms disappeared after discontinuation of mesalazine.
Elderly patients. For elderly patients, Asakol suppositories are prescribed with caution. Asakol can be prescribed only when the patient does not have renal impairment.
special instructions
Impaired renal function. To assess the functional state of the kidneys, the doctor may prescribe a urine test (using a test strip) before and during treatment. with caution, this preparation should be prescribed to patients with increased plasma creatinine concentration and proteinuria. if during treatment with mesalazine, renal dysfunction is noted, this may be a manifestation of the nephrotoxic effect of mesalazine.
It is recommended to monitor kidney function for all patients before starting treatment with Asakol, as well as during therapy. It is also recommended to conduct control tests 14 days after the start of treatment, and then every 4 weeks for the next 12 weeks. With the help of monitoring, which is performed at short intervals after the start of therapy with Asakol, it is possible to identify rare acute renal reactions. In the absence of acute renal reactions, the intervals between tests can be increased up to 3 months, and then up to 1 time per year for the next 5 years. In the presence of additional laboratory or clinical signs of renal failure, these tests should be performed immediately. If there are signs of impaired renal function, the patient should immediately discontinue therapy with Asakol and immediately consult a doctor.
Blood dyscrasia. Cases of severe blood dyscrasia are very rare. If dyscrasia is suspected or reliable (signs of bleeding of unknown origin, bruising, purpura, anemia, persistent fever or sore throat), the patient should immediately stop treatment with Asakol and immediately consult a doctor. Before and during therapy, it is recommended to conduct hematological studies (counting individual types of leukocytes), the date of which is determined by the doctor. It is recommended to carry out control tests 14 days after the start of treatment, and then 2-3 more times at 4-week intervals. If the test results are normal, it is sufficient to carry out such tests every 3 months. If additional symptoms are present, these tests should be performed immediately.
Liver dysfunction. Among patients taking preparations containing mesalazine, cases of increased levels of liver enzymes have been reported. Care should be taken to prescribe Asakol to patients with impaired liver function. Blood tests (liver function parameters such as ALT or AST) are recommended before and during treatment. The time of these analyzes is determined by the doctor. It is recommended to carry out control tests 14 days after the start of treatment, and then 2-3 more times at 4-week intervals. If the test results are normal, it is sufficient to carry out such tests every 3 months. If additional symptoms are present, these tests should be performed immediately.
Hypersensitivity reactions from the heart. Cases of hypersensitivity reactions from the heart caused by mesalazine (myocarditis or pericarditis) are very rare in patients taking Asakol. In the event of hypersensitivity reactions from the heart caused by mesalazine, patients should not use Asakol a second time. The preparation is used with caution in patients with a history of allergic myocarditis or pericarditis, regardless of which preparation caused such a reaction.
Diseases of the lungs. Patients who have lung diseases, in particular asthma, should be closely monitored during treatment with Asakol.
Hypersensitivity to sulfasalazine. If the patient has a hypersensitivity to sulfasalazine, treatment is carried out only under constant medical supervision. Treatment should be stopped immediately if there are signs of acute preparation intolerance, such as abdominal colic, acute abdominal pain, fever, severe headache or rash.
Ulcers of the stomach and duodenum. Based on theoretical knowledge, care should be taken when starting treatment for patients with gastric or duodenal ulcers.
Elderly patients. Care should be taken to prescribe the preparation to elderly patients and only if normal renal function is maintained and there are no severe renal dysfunctions.
Children. The experience of using the preparation in the pediatric group is insignificant, and therefore there is a limited number of documents on the effectiveness of the preparation when used in children.
Use during pregnancy and lactation. Pregnancy. There is insufficient data on the use of Asakol in pregnant women. Limited data (627 pregnant women) indicate the absence of an undesirable effect of mesalazine on the course of pregnancy or the health of the fetus and / or newborn. However, anecdotal evidence suggests an increased risk of preterm birth and a decrease in newborn body weight in women who received mesalazine during pregnancy. No relevant epidemiological data are available to date.
One case of renal failure has been reported in a newborn whose mother has been using high-dose mesalazine (2–4 g orally) for a long time during pregnancy.
Data from animal studies on oral administration of mesalazine do not indicate its direct or indirect adverse effects on pregnancy and childbirth, embryofetal or postnatal development.
Thus, Asakol can be prescribed during pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus.
Breast-feeding. N-acetyl-5-aminosalicylic acid and, to a lesser extent, mesalazine are excreted in breast milk. The clinical significance of this excretion has not been established. To date, there is only limited experience with the preparation during breastfeeding. Hypersensitivity reactions such as diarrhea cannot be ruled out in newborns. So, Asakol can be used during breastfeeding only when the potential benefit outweighs the possible risk. If the infant develops diarrhea, breastfeeding should be discontinued.
Reproductive function. The effect on reproductive function has not been established.
The ability to influence the reaction rate when driving or operating other mechanisms. Asakol does not affect or may have a slight effect on the ability to drive vehicles and operate machinery. If dizziness occurs during treatment, you should refrain from driving.
Interactions
Preparation interaction studies have not been conducted.
There is some evidence of the possibility of reducing the effect of the anticoagulant action of warfarin when used simultaneously with mesalazine.
Under the influence of mesalazine, the immunosuppressive activity of azathioprine, 6-mercaptopurine or thioguanine may increase. As a result, a life-threatening infection may develop. Patients should be closely monitored for the timely detection of signs of infectious diseases or immunosuppression. Before starting combination therapy, hematological parameters should be monitored, especially the number of leukocytes, platelets and lymphocytes, periodically conducting a blood test (weekly) during treatment. If the white blood cell count remains stable for 1 month, the analysis can be performed at 4-week intervals over the next 12 weeks, and then at 3-month intervals.
With simultaneous use with preparations that have a nephrotoxic effect, such as NSAIDs, azathioprine or methotrexate, the risk of adverse reactions from the kidneys may increase. However, no side effects have been reported that provide evidence of such an interaction.
Overdose
There is insufficient evidence of overdose (eg, suicide by oral administration of high doses of mesalazine) that does not indicate possible nephrotoxicity or hepatic toxicity. there is no specific antidote. symptomatic and supportive treatment is recommended.
Storage conditions
At a temperature not exceeding 25 ° c. suppositories - in a dark place at a temperature not exceeding 25 ° C. do not refrigerate or freeze.
Tags: Asacol
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