Pentasa Sachet 2g Ferring nuggets to treat ulcerative colitis, Crohn's disease (60 packs)

Dosage form Box of 60 packs
Specifications Mesalazine

Ingredient

Composition informationContent
Mesalazine2000mg

Uses

Indications

Pentasa 2 g Ferring 60 packs are specified in case

  • Used to treat colon ulcer and medium and mild Crohn disease.

    Mechanism of impact and pharmacological properties

    Mesalasine has been shown to be the active ingredient of sulfasalazine, used in the treatment of ulcerative colitis and Crohn's disease.

    Based on clinical results, Mesalazine's treatment value after drinking as well as rectal sugar seems to be due to the local effect on the intestinal tissue rather than the body effect.

    In patients with inflammatory infections, there are manifestations such as increased migration of leukocytes, abnormal cytokine production, hyperlem of arachidonic acid metabolism (especially leucotriene B4) and increased free radical formation in inflamed intestinal tissue.

    Mesalazine has the effect of In vitro and in vivo inhibiting leukemia, reducing the production of cytokine and leucotriene and removing free radicals. Currently the mechanisms play a major role in the clinical effect of Mesalazine has not been determined.

    pharmacokinetics

    The general characteristics of the active ingredient

    Effects on the spot and arrangement: Mesalazine's treatment activity almost depends on the medication's local contact with the infected intestinal mucosa.

    Pentasa long -lasting launcher contains mesalazine micro -micro -micro -micro -micro -micro -micro -seeds. After drinking, Mesalazine is released continuously from individual particles into the digestive tract at any pH condition in the intestine. The micro -seeds enter the duodenum within 1 hour after drinking, regardless of the use in combination with food. The average transition time through the small intestine is about 3-4 hours in healthy volunteers.

    Biological Change

    Mesalazine is metabolized by the intestinal mucosa before the circulating and after the periodic circulation is metabolized by the liver into N-acetyl-Mesalazine (Acetyl-Mesalazine). Some acetylation reactions also occur thanks to the effects of bacteria in the colon.

    Acetylation reaction does not depend on the patient's acetylator phenotype. Acetyl Mesalazine is said to have no clinical activity, but this still has to be proven.

    absorption

    Based on the data on the amount of drug found in urine in healthy volunteers, about 30-50% of oral dose is absorbed, mainly from the small intestine. Mesalazine discovered in plasma after drinking 15 minutes. The maximum concentration in plasma is recorded after taking 1-4 hours. Mesalazine concentration decreases and is not detected after drinking 12 hours.

    The curve shows the concentration of blood in acetyl-mesalazine according to the same model, but the concentration is usually higher and the elimination is slower. The metabolic rate of acetyl -mesalazine for Mesalazine in plasma after taken from 3.5 to 1.3 after taking the corresponding dose of 500 mg x 3 times and 2 g x 3 times daily, showing the acetylation depends on the dose depends on saturation.

    Average Mesalazine concentration in plasma is about 2 µmol/l, 8 µmol/l and 12 µmol/l after the corresponding dose of 1.5 g/day, 4 g/day and 6 g/day. For acetyl-mesalazine, the corresponding concentrations are 6 µmol/l, 13 µmol/l and 16 µmol/l. Mesalazine's transition and release after drinking does not depend on use with food, while the body absorption is reduced.

    Distribution

    The cohesion to the protein of Mesalazine is about 50% and of AceYTLMESALAZINE about 80%.

    Elimination

    Mesalazine's plasma sale time is about 40 minutes and of acetylmesalazine about 30 minutes. Due to the continuous release of Mesalazine from Pentasa, it is impossible to determine the duration of elimination after drinking. However, the stable state is achieved after the treatment period of 5 days after drinking.

    Both Mesalazine and Acetyl-Mesalazine are eliminated through urine and feces. The excretion in urine is mainly acetyl-mesalazine.

    The characteristics in patients

    The distribution of mesalazine to the small intestine mucosa after drinking is only slightly affected by pathological changes such as diarrhea and increased intestinal acidity in patients with active intestinal inflammation. The body's body absorption reduction has been recorded by 20-25% daily, the corresponding daily dose increases in the elimination in the fertilizer.

    In patients with liver and kidney failure, leading to reducing the rate of elimination and toxicity to the kidneys.

  • Before taking Pentasa Sachet 2g Ferring nuggets to treat ulcerative colitis, Crohn's disease (60 packs)

    How to use

    Take oral use. Do not chew pentasa*. Pour the rice powder into the tongue and drink with water or juice.

    Dosage

    ulcerative colitis

    Treatment is progressing

    Adults: Dosage for each patient, maximum 4 g per day divided into several times.

    Children 6 years of age: The dose is determined for each child, starting at a dose of 30-50 mg/kg/day is divided into several times. Maximum dose: 75 mg/kg/day is divided into several times. The total dose does not exceed 4 g/day (maximum dose of adults).

    Maintain treatment

    Adults: Dosage for each patient. The recommended dose of 2 g Mesalazine once a day. Can also be divided into several times.

    Children 6 years and older: The dose is determined for each child, starting with 30 mg/kg/day divided into several times. The total dose does not exceed 2 g/day (adult's recommended dose)

    In general, the dosage for children weighing 40 kg is recommended by half a dose of adults, and children weighing over 40 kg are recommended by the usual dose of adults.

    Pediatric patients: There are little data on children's effectiveness.

    Crohn's disease

    Treatment is progressing

    Adults: Dosage for each patient, maximum 4 g per day divided into several times.

    Children 6 years and older: The dose is determined for each child, starting with a dose of 30-50 mg/kg/day divided into several times. Maximum dose: 75 mg/kg/day divided into several times. The total dose does not exceed 4 g/day (maximum dose of adults).

    Maintain treatment

    Adults: Dosage for each patient, maximum 4 g per day divided into several times.

    Children 6 years of age: The dose is determined for each child, starting at a dose of 15 - 30 mg/kg/day is divided into several times. The total dose does not exceed 4 g/day (recommended dose for adults).

    In general, the dosage for children weighing 40 kg is recommended by half a dose of adults, and children weighing over 40 kg are recommended by the usual dosage of adults

    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?

    Symptomatic treatment at the hospital. Closely monitor kidney function.

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

    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. Do not drink twice as prescribed.

    Side Effects

    When using Pentasa 2 g Ferring 60 packs, you may experience unwanted effects (ADR).

    The most common hypersensitivity reactions in clinical trials are diarrhea, vomiting, abdominal pain, headache, vomiting and rash. Hypersensitivity reactions and fever due to drug can occur.

    Frequency of side effects, based on clinical studies and reports from after -sales monitoring.

    Common (≥ 1/100 to

  • Nervous system disorders: headache.
  • Disorders of digestive disorders: diarrhea, abdominal pain, nausea, vomiting.

  • Skin and subcutaneous disorders: rash (including floating, rash).
  • Rare (≥ 1/10,000 to ≤ 1/1,000)

  • Nervous system disorders: Dizziness.
  • Heart disorders: myocarditis*, pericarditis*.
  • Pepper chemical disorders: Acute pancreatic*, increase amylase (blood and/or urine), flatulence.
  • Very rare (≤ 1/10,000)

  • Blood system disorders and lymphatic systems: Eosin hypernagus (part of allergic reactions), the number of changing blood cells (anemia, anemia), leukemia (including granulocytopenia and neutropenia), thrombocytopenia, loss of granulocytes, reducing all blood allows.
  • Immune system disorders: Hypersensitivity reactions such as rash allergies, pancolitis.

  • Nervous system disorders: peripheral neuropathy, hyperplanded intracranial pressure among teenagers.
  • Heart disorders: pericardial effusion.

    Respiratory, chest and mediastinum disorders: allergic reactions and pulmonary fibrosis (including shortness of breath, cough, bronchospasm, allergic alveoli, eosinophilia preferred eosine in the lungs, interstitial lung disease, pneumonia, pneumonia, pleura).

  • Liver disorders, bile: increase liver enzyme, bile parameters and bilirubin, liver poisoning (including hepatitis*, cholestatic hepatitis, cirrhosis, liver failure).
  • Skin and subcutaneous tissue disorders: hair loss (temporary), edema.
  • musculoskeletal disorders, connective tissue and bone: muscle pain, joint pain, red erythema reactions.
  • Renal and urinary disorders: renal function (including interstitial nephritis* (acute and chronic), nephrotic syndrome, acute and chronic renal failure); Dark discoloration.

  • Reproductive disorders: Sperm reduction (temporary).
  • Systemic symptoms and local disorders: Fever.

    (*) It is unclear the mechanism of myocarditis, pericarditis, pancreatitis, renal inflammation, mesalazine, but may have allergic origin.

    It is important to note that some of these disorders may also be caused by inflammatory infections.

    Notify the doctor with unwanted effects when using the drug.

    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 2 g Ferring 60 Package in the following cases:

  • Too hypersensitivity to Mesalazine, any excipient ingredients or salicylate substances.
  • Hepatic failure or severe kidney failure.

    Caution when using

    Read the instructions carefully before use. If you need more information, please consult your doctor. This drug is only used by a doctor. Caution should be careful when treated in patients allergic to sulphasalasine (due to the risk of allergies to salicylate). In case of non -tolerant reactions such as abdominal pain, acute abdominal pain, fever, severe headache and rash, should stop taking the drug immediately.

    Be cautious when treating in patients with liver failure. Liver function parameters should be checked like ALT or AST before or during treatment as directed by the doctor.

    It is not recommended to use drugs for patients with renal impairment and in internal hemorrhage patients. Kidney function should be monitored regularly (for example: serum creatinine), especially in the early stages of treatment. The state of the urinary tract should be tested before and during treatment by the doctor.

    Should suspect toxicity to the kidneys caused by mesalazine in patients with abnormal kidney function during treatment. It is necessary to increase the number of kidney function monitoring when using the same substances that are known to be toxic to the kidneys, such as NSAIDs and Azathioprine, which can increase the risk of the kidneys. Caution should be careful with patients with progressive gastrointestinal ulcer. Patients with lung diseases, especially asthma should be monitored carefully during treatment.

    There have been a few reports on hypersensitivity reactions in the heart (myocarditis and pericarditis) caused by Mesalazine. Very few reports on severe blood cell abnormalities to Mesalazine. Check blood to determine the total number of different blood cells should be conducted before or during treatment as directed by the doctor. Treatment should be stopped when there is doubt or evidence of these harmful reactions.

    According to the instructions, it is advisable to do 14 -day monitoring tests after starting treatment, then add 2 to 3 tests for about 4 weeks. If the results are normal, monitoring tests should be done 3 months. If the symptoms occur, it is necessary to perform these tests immediately.

    The ability to drive and operate machinery

    No report.

    Pregnancy

    pentasa should be used cautiously in pregnant women and only if the expected benefits exceed the risk of harmful harm may have a doctor's opinion. Mesalazine is known to go through the placenta and the concentration of umbilical plasma plasma is 1/10 of the mother's plasma concentration. Uu

    Acetyl-mesalazine metabolites show the same concentration in the umbilical plasma and mother's plasma plasma. Many monitoring studies show that no monster effects have been reported and there is no evidence of clear risks when used in humans.

    Animal studies do not show directly or indirectly the harmful effects on pregnant women, the development of fetus and embryo, birth and postpartum development. Blood disorders (reducing all blood, leukopenia, thrombocytopenia, anemia) have been reported in newborns of mothers treated with Pentasa.

    The period of breastfeeding

    pentasa should be used cautiously in breastfeeding women and only if the benefits are expected to exceed the risk of harmful harm can be in the doctor's opinion. Mesalazine is secreted into breast milk. Mesalazine concentration in breast milk is lower than in the mother's blood, while acetyl-mesalazine metabolites are similar or increased. Experience in using mesalazine orally in breastfeeding women is limited. Can not exclude hypersensitivity reactions such as diarrhea in children.

    Drug interaction

    simultaneous treatment of pentasa with azathioprine, or 6-mercaptopurine in many studies shows that the frequency of bone marrow inhibitors increases higher and the interaction seems to exist. However, the rear mechanism of interaction is not fully proven. Should regularly monitor leukemia and adjust the dosage regime thiopurine appropriately.

    Cavalry has not been recorded.

    Storage

    Store less than 30 ° C in the original packaging, due to light sensitivity to light. Leave the medicine out of reach of children.

    Expiry date: 24 months from the date of manufacture. Do not use overdue drugs stated on the packaging.

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