Fedcerine Medisun treat ulcerative colon (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Mesalazin

Ingredient

Composition information	Content
Mesalazin	500mg

Uses

Indications

Fedcerine 500mg drug indicated for acute and treatment treatment maintenance of ulcerative colon disease.

Pharmacology

Pharmacological group: Anti -inflammatory intestinal inflammation.

ATC code: A07EC02.

Masalazin anti-inflammatory mechanism (5-aminosalicylic, 5-ASA) has not been clearly studied. The results from in-vitro data showed that mesalazin inhibits lipoxygenase, while reducing prostaglandin concentration in the intestinal mucosa.

Mesalazin acts as a substance that recovers free radicals from oxygen reaction compounds in the body. The drug has anti -inflammatory effects.

Using oral masalazin is more local than anti -inflammatory effects. Therefore, the good weak determination of anti -inflammatory effect is the concentration of masalazin at the inflammatory position.

Mesalazin's bioavailability is not proportional to the effectiveness of treatment, but only related to safety when using the drug.

Dynamic pharmacokinetics

Mesalazin pharmacokinetic characteristics.

absorption:

Mesalazin is the highest absorption of the first and lowest bowel section at the end of the small intestine.

Mesalazin metabolizes step 1 in the liver thanks to the liver cycle to form N-acetyl-5-Aminosalicylic without pharmacological activity (N-AC-5-ASA). The ratio of Mesalazin and N-AC-5-ASA is linked to plasma proteins, respectively 43% and 78%.

Mesalazin and its metabolites are excreted mainly through feces and kidneys (about 20-50%) depending on the form of preparation, sugar and a small part through biliary tract. About 1% of Mesalazin is secreted into breast milk in the form of N-AC-5-ASA.

absorption:

Release Mesalazin from the intestinal tablet after 3-4 hours of medication.

Combining dynamic studies, after 3-4 hours of taking the drug in the ileum, and the head of the colon after 4-5 hours.

The total time of the drug in the colon is 17 hours.

The ratio of masalazin and its metabolites N-AC-5-ASA excreted the kidney after 24 hours when using multiple doses (3 x 500 mg/day for the first 2 days and 1 x 500 mg/day, also the test date) is 60%.

Before taking Fedcerine Medisun treat ulcerative colon (3 blisters x 10 tablets)

How to use

should use Fedcerine 500mg in the morning, noon and evening 1 hour before meals.

Take the tablet with a large amount of water, no chewing, no pills.

Recommended patients using Fedcerine 500mg at the right and regular dose, in the case of acute treatment of ulcerative colitis and the remission treatment of ulcerative colon. In case of remission of colon ulcers: The dosage is usually reduced to 1.5 mg of mesalazin/day (for adults and children of puberty, weighing over 40 kg) and 0.75 mg of Mesalazin/day (for children and children at puberty under 40 kg).

Dosage

Adult adults and the elderly

Depending on the clinical situation in each case, the daily use dose is as follows:

Treatment of acute phase of ulcerative colon: 1-2 tablets/time x 3 times/day.

Do not use drugs for children under 6 years old.

Children over 6 years old

Exacection of ulcerative colon:

is determined depending on the condition, with an average dose of 30-50 mg/kg/day.

Maximum dose of 75 mg/kg/day.

is determined depending on the specific object, starting with an average dose of 15-30mg/kg/day.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

There is no specific antidote in case of overdose. Symptomatic treatment and patient support.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Modalazin may be associated with the severe symptoms of colitis for patients who had previously had similar problems with sulphasalazin.

Common: ADR> 1/100:

Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain.

Blood disorders: leukopenia (leucopenia), neutropenia (notRepenia), Agroculocytosis (Agroculocytosis), Anemia, thrombocytopenia. Pulmonary allergies (including shortness of breath, cough, alveoli, lung hyperburgery, pulmonary infection, pneumonia). Urine.

Blood disorders: Anemia, Eosin hyperactivity (as part of an allergic reaction) and reducing all bloody global. joints.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Fedcerine 500mg drug contraindicated in the following cases:

Patients with a history of allergies to salicylate.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Serious hematopathy has been reported when using Mesalazin at a rare frequency.

It is necessary to perform hematurian testing if the patient has unknown bleeding, bruising, hemorrhage, anemia, fever or sore throat. Treatment should be stopped if there is doubt or evidence of hematopoietic disorders.

Most patients are intolerant or sensitive to sulphasalazin may use masalazin without the same risk of reaction. However, be careful when treated in the case of patients allergic to sulphasalazin (risk of allergies to salicylate).

Be cautious in patients with impaired liver function.

mesalazin should be used very carefully in patients with mild to moderate renal failure.

Patients using mesalazin by oral should be monitored with kidney function.

Check serum creatinine levels before starting treatment, every 3 months of the first year, then every 6 months in the next 4 years and each year later. Mesalazin should be discontinued if the renal function is impaired.

If a patient has dehydration during treatment with Mesalazin, normal electrolytes and liquid balance should be restored as soon as possible.

Mesalazin causes heart -hypersensitivity reactions (myocarditis and pericarditis) that has been reported rare frequency.

Should stop taking the drug if suspected or there is evidence of this reaction.

For patients with lung disease, especially bronchial asthma, closely monitoring during treatment.

used for pregnant and lactating women

Mesalazin should be used cautiously in pregnant women and nursing women and only used when benefits exceed the risk possible, in the opinion of the doctors.

mesalazin passes the placenta, but the limited data on drug use in pregnant women does not allow evaluation of possible side effects.

No monster effects have been recorded in animal studies.

Blood disorders (leukopenia, thrombocytopenia, anemia) have been reported in the newborns of mothers treated with Mesalazin.

There have been reports on some cases of kidney failure in newborns with mothers who take high doses of Mesalazin (2-4g) that lasts for pregnancy.

Research on animals shows that the use of oral masalazin does not directly or indirectly to the cases of pregnancy, the development of embryos, fetal and postpartum children.

Only use Fedcerine 500mg in pregnant and lactating women in case of benefits is greater than risk.

affects the ability to drive and operate machinery

does not affect or affect the ability to drive and operate machinery.

Drug interaction

Concomitant use of Mesalazin with known toxic kidney agents, such as NSAID and Azathioprine nonsteroidal anti -inflammatory drugs, can increase the risk of toxicity to the kidneys.

Simultaneously used with Mesalazin with azathioprin or 6-mercaptopurin may increase the risk of hematopoietic disorders.

There is evidence that using mesalazin can reduce Warfarin's anticoagulant activity.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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