Asakol® (Asacol®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMesalazineMesalazine
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    • Dosage form: & nbspenteric coated tablets
    Composition:

    1 tablet, coated with enteric coating, contains:

    Active substance: mesalazine 400 mg or 800 mg, respectively.

    Excipients: lactose monohydrate 76.4 / 152.8 mg, sodium carboxymethyl starch (type A) 18.3 / 36.6 mg, magnesium stearate 6.2 / 12.4 mg, talc 10.4 / 20.8 mg, povidone K25 8 , 7 / 17.4 mg;

    enteric membrane: methacrylic acid and methacrylate copolymer (1: 2) 16,806 / 33,277 mg, talc 4,507 / 8,924 mg, triethyl citrate 3,362 / 6,656 mg, iron oxide dye yellow 0.382 / 0.756 mg, iron oxide red 2,215 / 4,387 mg; Macrogol 6000 0.60 mg.

    Description:Oval tablets covered with a shell, reddish-brown color with a glossy surface.
    Pharmacotherapeutic group:Antimicrobial and anti-inflammatory intestinal
    ATX: & nbsp

    A.07.E.C.02   Mesalazine

    A.07.E.C   Aminosalicylic acid and its analogues

    Pharmacodynamics:

    Asakol® contains mesalazine, which is 5-aminosalicylic acid, which has an anti-inflammatory effect, the mechanism of which has not been fully understood to date. Mesalazine suppresses the migration of polymorphonuclear leukocytes, as well as the activity of lipoxygenase. As a result, the synthesis of proinflammatory leukotrienes in macrophages of the intestinal wall is suppressed. Mesalazine inhibits the synthesis of the platelet-activating factor (PAP), in addition, it is also an antioxidant: reduces the synthesis of substances containing active oxygen, and binds free radicals.

    It has antibacterial action against Escherichia coli and some cocci (manifested in the large intestine).

    It has good tolerability, reduces the risk of recurrence in Crohn's disease, especially in patients with ileitis and a long duration of the disease.

    Pharmacokinetics:Asakol® tablets are coated with a coating that provides release of the active substance in the lower part of the ileum and the large intestine, which are the main sources of inflammation. The composition of the tablets is selected in such a way as to minimize the absorption of mesalazine in the digestive tract. Absorption after oral administration is about 26%. Accordingly, 74% of the administered dose remains in the lower part of the ileum and the large intestine, as well as in the rectum, thus having an anti-inflammatory effect. Metabolism is carried out in the liver and intestinal mucosa, an inactive metabolite N-acetyl-5-aminosalicylic acid is formed. Half-life is less than 1 hour. It is excreted mainly by the kidneys and through the intestine in an unchanged form and as a metabolite of N-acetyl-6-aminosalicylic acid.
    Indications:

    - Nonspecific ulcerative colitis (treatment of mild and moderate disease, supporting treatment in remission);

    - Crohn's disease (prevention and treatment of exacerbations).

    Contraindications:

    - Hypersensitivity to mesalazine or other components of the drug;

    - hypersensitivity to salicylates;

    - severe violations of the liver and kidneys;

    - Stomach ulcer and duodenal ulcer;

    - increased tendency to bleeding;

    - Children's age up to 3 years.

    Carefully:Hepatic and renal failure, pregnancy (I trimester), deficiency of glucose-6-phosphate dehydrogenase.
    Pregnancy and lactation:

    The use of Asakola® in pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

    The drug is excreted in breast milk, so when taking the drug during lactation should resolve the issue of ending breastfeeding.

    Dosing and Administration:

    Inside. Tablets are taken after meals, not breaking and not chewing, with plenty of water.

    Nonspecific ulcerative colitis. With an exacerbation, the daily dose is 2.4 - 4.8 g divided into several doses. To prevent relapse, the daily dose is 1.2-2.4 g (ie 400-800 mg 3 times a day).

    Crohn's disease.In case of exacerbation, the daily dose is up to 4 g / day, with maintenance treatment in the remission phase, the daily dose is 2.4 g divided into several doses.

    Use in children is possible only with a body weight of more than 40 kg: 20-30 mg / kg / day, divided into several receptions.

    If the disease worsens, the duration of treatment is 8-12 weeks, with the goal of preventing relapses - several years.

    Side effects:

    Gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea, pancreatitis, hepatitis, increased activity of "liver" transaminases.

    The cardiovascular system: tachycardia, chest pain, shortness of breath, increase or decrease in blood pressure.

    Nervous system: headache, dizziness, polyneuropathy.

    Allergic reactions: skin rash, skin itching, bronchospasm, eosinophilic pneumonia.

    urinary system: proteinuria, hematuria, oliguria, interstitial nephritis, nephrotic syndrome, crystalluria.

    Musculoskeletal system: myalgia, arthralgia.

    Hematopoiesis: leukopenia, neutropenia, thrombocytopenia, eosinophilia, anemia (aplastic), agranulocytosis, hypoprothrombinemia.

    Other: alopecia (1 case per 1000 - 10,000 patients), lupus-like syndrome.

    Overdose:

    In general, symptoms of an overdose of mesalazine are similar to symptoms of salicylate overdose: headache, weakness, increased sweating, nausea, vomiting, dehydration, hyperventilation, acid-base balance (acidosis-alkalosis).

    Treatment: gastric lavage, stimulation of diuresis, compensation of fluid loss, restoration of acid-base balance, symptomatic therapy.

    There is no specific antidote.

    Interaction:

    Mesalazine in combination therapy can reduce the effects of probenecid and sulfinpyrazone, furosemide and spironolactone.

    The severity of the side effects of glucocorticoids in relation to the gastrointestinal tract when combined with mesalazine increases.

    With the simultaneous use of mesalazine and digoxin, digoxin absorption is reduced. Under the action of mesalazine, the immunosuppressive activity of azathioprine and 6-mercaptopurine may increase.

    Strengthens the hypoglycemic effect of sulfonyl urea derivatives, toxicity of methotrexate, weakens the activity of rifampicin, enhances the effect of anticoagulants,increases the effectiveness of uricosuric drugs (tubular secretion blockers).

    Special instructions:

    Caution should be given to patients with high urea concentration in the blood and proteinuria. If, during treatment with mesalazine, renal dysfunction is noted, it may be a manifestation of the nephrotoxic effect of the drug. It is recommended to monitor the function of the kidneys and the blood formula for all patients before starting treatment with Asakol® and then following the scheme: 14 days after the start of therapy, and then 2-3 more times with 4-week intervals. Under normal control results, the test is repeated once every 3 months. If there are signs of impaired renal function, additional research is needed.

    It is especially important to monitor the blood picture when the following symptoms appear in the patient during treatment: bleeding of unknown origin, hematomas, purpura, anemia, prolonged persistent fever, and complaints of pain in the throat. Careful monitoring of the patient's condition is necessary for violations of respiratory function, especially when asthmatic attacks occur, as well as signs of acute intolerance of the drug (cramps, abdominal pain, severe headaches, rashes on the skin).In such cases, treatment should be immediately stopped and the patient should receive the necessary medical care.

    Patients in the older age group of the drug is prescribed only with normal kidney function.

    It can be observed staining of urine and tears in yellow-orange color, staining of soft contact lenses.

    Effect on the ability to drive transp. cf. and fur:Asakol® does not affect the ability to drive and machines.
    Form release / dosage:Tablets coated with enteric coating 400 mg, 800 mg.
    Packaging:For 10 tablets in a blister, 10 blisters together with instructions for medical use in a pack of cardboard. Tablets coated with enteric-coated 800 mg; 10 tablets in a blister, 5 or 6 blisters together with instructions for medical use in a pack of cardboard.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-010502/09
    Date of registration:23.12.2009 / 09.06.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Tillotts Pharma AGTillotts Pharma AG Switzerland
    Manufacturer: & nbsp
    Representation: & nbspPharma International Ltd.Pharma International Ltd.
    Information update date: & nbsp14.09.2017
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