Pentasa 500mg Ferring tablets treat ulcerative colitis, Crohn's disease (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Mesalazine

Ingredient

Composition information	Content
Mesalazine	500mg

Uses

indications

Pentasa drugs are indicated in the following cases:

Treatment of ulcerative colitis and Crohn disease.

Mechanism of activity and pharmacological effects

Mesalazin is known as the active ingredient of sulfasalazin, the substance is used to treat ulcerative colitis and Crohn disease.

Based on clinical results, the value of Mesalazin treatment after rectal sugar seems to be due to the local effect on the inflamed intestinal tissue rather than the systemic effect, in patients with inflammatory infections with manifestations such as increased migration of leukocytes, abnormal cytokin production, hyperlieng in arachidonic acid metabolism, especially Leukotrien B4 and increase in the intestinal radicals in p>.

Mesalazin has In vitro and Vivo pharmacological effect inhibiting leukemia, reducing the production of cytokin and leucotrien, and eliminating free radicals. Currently, it is still not known the mechanism to perform this role in the clinical effect of Mesalazin.

pharmacokinetics

The general characteristics of the active ingredient

Ready to distribute on the spot: Mesalazin's treatment effect is most likely to depend on the local contact with the infected intestinal mucosa.

Slow Pentasa release tablets include Mesalazin micro -micro -micro -micro -micro -micro -micro -seeds covered with ethylcellulose.

After taking the tablet to disintegrate into microchips and go into the duodenum within an hour, regardless of the use of the same food. Mesalazin continues to be released from micro -seeds through the gastrointestinal tract at any pH condition.

absorption

The bioavailability of Pentasa is estimated to be approximately 30% based on data on the amount of drug found in urine in healthy volunteers. The maximum plasma concentration is seen at 1 - 6 hours after drinking.

Mesalazin dose regimen once a day (1 time x 4 g/day) and 2 times a day (2 times x 2 g/day) shows the equivalent body exposure (AUC) for 24 hours and shows that Mesalazin is constantly released from the formula during treatment. The stable state of concentration achieved after a period of treatment is 5 days of taking medicine.

Transition time and mesalazin release after oral use regardless of use with food, while the body exposure may increase.

Distribution

The combination with the protein of mesalazin is about 50% and of acetyl - Mesalazin is about 80%.

Metabolism

Mesalazin is converted into N - Acetyl - Mesalazin (Acetyl - Mesalazin) mainly by NAT - 1 before entering the general circulation in the intestinal mucosa and when in the general circulation in the liver.

Some acetylation reactions are also performed by the effects of bacteria at the colon. Acetylation does not depend on the patient's acetylator phenotype.

Metabolic ratio of acetyl - Mesalazin for Mesalazin in plasma after taken from 3.5 - 1.3 after taking the corresponding dose of 500 mg x 3 times and 2 g x 3, showing the dosage acetylation and may be dependent on saturation.

Elimination

Due to the continuous relief of Mesalazin throughout the stomach - intestines, the semi -waste time cannot be determined after oral use. However, once the dosage form of the drug is no longer in the gastrointestinal tract, the excretion will follow the half -life of the plasma of Mesalazin that does not drink or intravenously means approximately 40 minutes and 70 minutes with acetyl - Mesalazin.

Before taking Pentasa 500mg Ferring tablets treat ulcerative colitis, Crohn's disease (10 blisters x 10 tablets)

How to use

Pentasa is used for oral.

Do not chew Pentasa tablets. To help you swallow the tablet, you can scatter the medicine in about 50 ml of cold water. Stir and drink immediately.

Dosage

ulcerative colon

Acute disease treatment

Adults: Dosage for each patient, maximum 4 g Mesalazin/day, divided into 2-3 times.

Children 6 years and older: Dosage for each patient, starting at a dose of 30-50 mg/kg/day, divided into 2-3 times.

Maximum dose: 75 mg/kg/day divided into 2-3 times. The total dose must not exceed 4 g/day (maximum dose of adults).

Maintain treatment

Adults: Dosage for each patient. The recommended dose of 2 g Mesalazin, 1 time 1 time. Can also be divided into 2-3 times.

Children 6 years and older: Dosage for each patient, starting at a dose of 15 - 30 mg/kg/day, divided into 2-3 times. The total dose should not exceed 2 g/day (recommended dose of adults).

Crohn's disease

Acute disease treatment

Adults: Dosage for each patient, maximum 4 g Mesalazin/day, divided into 2-3 times.

Children 6 years and older: Dosage for each patient, starting at a dose of 30-50 mg/kg/day, divided into 2-3 times.

Maximum dose: 75 mg/kg/day divided into 2-3 times. The total dose must not exceed 4 g/day (maximum dose of adults).

Maintain treatment

Adults: Dosage for each patient, maximum 4 g Mesalazin, divided into 2-3 times.

Children 6 years and older: Dosage for each patient, starting at a dose of 15 - 30 mg/kg/day, divided into 2-3 times. The total dose must not exceed 4 g/day (recommended dose of adults).

Note to children's patients: There is little data on children's effectiveness. General recommendations that one half of adult dose can be used for children weighing less than 40 kg; And the normal dose of adults for children weighs over 40 kg.

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?

Because Pentasa is an amino salicylate, Salicylate poisoning may appear such as acid -base balance disorders, lung hypervolving, pulmonary edema, vomiting, dehydration and hypoglycemia. Salicylate overdose symptoms have been carefully described in literature.

Reports in patients take a dose of 8 g/day for 1 month and there is no side effects. Overdose control in patients: There is no specific antidote and treatment is symptomatic treatment and support. Treatment at the hospital attached to the kidney function closely.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Pentasa, you may experience unwanted effects (ADR).

When used at a dose of 10 mg/day, there are no unwanted effects.

When using pentasa at high doses (40 - 80 mg/day), the following side effects may occur:

Common (≥ 1/100 to

Nervous system disorders: headache.

digestive disorders: diarrhea, abdominal pain, nausea, vomiting, flatulence.

Skin and tissue disorders: rash (including urticaria, rash.

Rare (≥ 1/10,000 to

Nervous system disorders: Dizziness.

Heart disorders: myocarditis and pericarditis.

Gastrointestinal disorders: increase amylase, acute pancreatitis.

Skin and subcutaneous tissue disorders: light sensitive.

Very rare (

Blood disorders and lymphatic systems: Change of blood counts such as (anemia, anemia, granulocytes, neutrophils, leukopenia (neutrophils hypocphystic), all bloody hemolysis, thrombocytopenia and EOSIN hyperlypes (as part of allergic reactions).

The immune system disorder: Hypersensitivity reaction includes anaphylactic reaction. Drug reactions with eosin leukemia and systemic symptoms (Dress).

Nervous system disorders: peripheral neuropathy.

Respiratory, chest and medical disorders: Allergic and pulmonary fibrosis (including shortness of breath, cough, bronchospasm, allergic alveolar inflammation, eosperant hyperlemen in the lungs, interstitial lung disease, pneumonia, pneumonia).

Gastrointestinal disorders: Full colitis.

Liver -biliary disorders: increased transaminase enamel, increased cholestatic parameters (e.g. alkaline phosphatase, gamma - gliitamyltransferase and bilirubin, liver toxicity (including hepatitis, cholecystitis, cirrhosis, liver failure).

Skin and subcutaneous tissue disorders: Hair loss (recovery). Dermatitis recurres, skin allergies, diverse roses, Stevens - Johnson syndrome (SJS).

musculoskeletal disorders, connective tissue and bone: muscle pain, joint pain, erythematometical lupus syndrome (systemic lupus system).

Kidney and urinary disorders: impaired renal function (including interstitial nephritis, kidney syndrome, kidney failure) to change urine.

Silentic disorders: Sperm reduction (recovery).

Systemic disorders and local disorders: Drug fever.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Pentasa drugs are contraindicated in the following cases:

Hypersensitivity to mesalazin, with the components of excipients, or salicylat.

Hepatic failure or severe kidney failure.

Pyloric stenosis, intestinal obstruction.

Children under 2 years of age ..

Caution when using

Most patients who are intolerant or hypersensitivity to sulphasalazin can use pentasa without risk of similar reactions. However, be careful when treating patients with allergies to sulphasalazin (at risk of allergies to salicylate), the elderly. In the case of an acute non -tolerant reaction such as abdominal pain, acute abdominal pain, fever, severe headache and rash, should stop taking the drug immediately. Be careful in patients with liver function. It is necessary to evaluate the parameters of the liver like ALT or AST before and during treatment, decided by the doctor.

This drug is not recommended in patients with renal failure. Nephrotic function should be regularly monitored (for example, serum creatinine), especially during the beginning of treatment. The status of the urinary tract (DIP STICKS) should be tested before and during treatment under the decision of the doctor. It is possible to suspect toxicity for the kidneys caused by mesalazin in patients with abnormal kidney function during treatment. When used simultaneously with known drugs toxicity to the kidneys, it is necessary to regularly control the kidney function.

Patients with lung diseases, especially bronchial asthma, should be carefully monitored during treatment; Please see the unwanted effect section.

There are rare reports on mesalazin causing hypersensitivity reactions on the heart (pericarditis, pericarditis).

Rarely have serious reports on hematopoietic disorders caused by mesalzin. Blood tests should be taken to count blood before and during treatment with the decision of the treating doctor. Need to monitor hematology if the patient has unexplained bleeding, bruises, hemorrhage, anemia, fever or sore throat.Mesalazin's simultaneous use may increase the risk of hematopoietic disorders in patients treated with azathioprin, or 6 - Mercaptopurin or thioguanin stated in the interaction with other drugs and other forms of interactions. Treatment should be stopped if there are signs of increasing sensitivity, suspicion or evidence of Mesalazin adverse reactions.

According to the instructions, it is recommended to do 14 -day monitoring tests after starting treatment, then add 2 to 3 tests for a period of 4 weeks. If the test results are normal, monitoring tests should be done every 3 months. If there are additional symptoms, these strict reviews should be conducted immediately.

The ability to drive and operate machinery

Headache is reported as a side effect when using Mesalazin, so it can affect the ability to drive and use machinery when taking the drug.

Pregnancy

pentasa should be used cautiously during pregnancy and lactation and only when benefits are higher than the risk that may occur in the doctor's opinion. Many hidden diseases (bowel disease/IBD) may increase the risk for pregnancy results.

Mesalazin is known to pass through the placenta and concentration in the umbilical cord's hemorrhage lower than the concentration in the mother's plasma. Acetyl - mesalazin metabolites are noticed the same concentration in the umbilical plasma plasma with the mother's plasma. Animal studies do not show directly or indirectly the harmful effects for pregnant women, the development of fetus and embryo, birth and postpartum development.

There is no adequate and well -controlled research on the use of Pentasa in pregnant women. The limited data on the person published to Mesalazin shows that there is no increase in the rate of birth defects. Some data shows the rate of premature birth, fetal death, and birthbeat; However, the risks of this pregnancy outcome are also related to active bowelitis. Blood diseases (reducing all bloody, leukopenia, thrombocytopenia, anemia) have been reported in newborns of mothers being treated with Pentasa.

In a separate case after a high doses of Mesalazin (2 - 4G, oral) during pregnancy, there was a report on kidney failure in newborns.

Breastfeeding period

Mesalazin is secreted into breast milk. Mesalazine concentration in breast milk is lower than in the blood, while acetyl Mesalazin metabolites seem to have similar or higher concentrations. Experience in using mesalazin orally in breastfeeding women is limited. Studies are controlled when using Pentasa in women who are in breastfeeding. It is impossible to eliminate hypersensitivity reactions like diarrhea in children. If babies have diarrhea, should stop breastfeeding.

Reproduction

Animal data shows that Mesalazin does not affect the fertility of men and women.

Drug interaction

Coordinate Pentasa treatment with azathioprin, or 6 - Mercaptopurin or thioguanin in many studies showed that the frequency of influence causing higher marrow and interactions seemed to exist. However, the mechanism behind this interaction is not fully known. It is recommended to monitor the white blood cells and the thiopurin dose should be adjusted appropriately.

There is little evidence that mesalazin can cause anti -freeze -barking effect.

Concentrated with other kidney toxic drugs such as NSAID Azathioprin may increase the risk of kidney toxicity (see the warning and caution especially when used).

Storage

Store less than 30 ℃ in the original packaging because of light sensitivity.

Do not take overdue drugs stated on the packaging.

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