Pentas prolong granules. 1g pack 50 pcs

Description

Composition
Active substance:
1 sachet contains: mesalazine 1000 mg or 2000 mg.
Excipients:
Ethyl cellulose, povidone.
Description:
Cylindrical pellets from light gray to light brown in color.
Product form:
Granules prolonged action oral 1 g and 2 g
1 g or 2 g of granules in a bag made of polyester / aluminum foil / polyethylene nizkoyplotnosti. 1 g: 50, 60, 100, 120 or 150 bags in a carton box with instructions for use. R 2: 30, 50, 60 or 120 bags in a carton box with instructions for use.
Contraindications
Hypersensitivity to salitsillatam and other ingredients
Severe hepatic or renal insufficiency
Stomach ulcer or duodenal ulcer
bleeding diathesis
Children 6 years vozrastdo
If you have one of these diseases, before taking this medication, you should consult with your doctor.
Carefully
Precautions drug should be administered to patients with impaired lung function, in particular bronchial asthma.
Care should be taken when administering the drug Pentasa® patients with renal / hepatic insufficiency mild to moderate severity, since the decrease in elimination rate and increasing the systemic concentration of mesalazine increases the risk of kidney damage.
Indications
Ulcerative colitis
Crohn’s disease.
Interaction with other drugs
When concomitant administration of drug Pentasa® with azathioprine or 6-mercaptopurine increased risk of bone marrow suppression (leucopenia, thrombocytopenia, erythropenia / or anemia, pancytopenia). Simultaneous administration of drug Pentasa® andother medicaments having nephrotoxicity, such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, increases the risk of adverse reactions by the kidneys.
Slows the absorption of cyanocobalamin (vitamin B12), enhances hypoglycemic effect of sulfonylurea derivatives, ulzerogennosti glucocorticosteroids, methotrexate toxicity, reduces the activity of furosemide, spironolactone, sulphonamides, rifampicin, probenicid and sulfinpirazona, enhances the effect of anticoagulants, increases the efficiency of uricosuric drugs (blockers tubular secretion). With simultaneous use of mesalazine drugs digoxin and digoxin absorption decreases.
Overdose
drug overdose cases Pentasa® rare. There are no specific antidotes. It is recommended to wash out the stomach and to take measures to enhance diuresis. In the case of acidosis, alkalosis, dehydration, hyperventilation, pulmonary edema, or need to restore the acid-base and water-electrolyte balance. If there are signs of hypoglycemia should take glucose.
pharmachologic effect
Pharmacological group:
Antimicrobial and anti-inflammatory intestinal agent.
Pharmacological properties:
Mesalazine – 5-aminosalicylic acid – is the active component of sulfasalazine.
Granules Pentasy® mesalazine microgranules are coated with a shell of ethyl cellulose. Mesalazine therapeutic effect after oral administration to a greater extent due to local influence on the inflamed intestinal tissue than systemic action.
The therapeutic effect of mesalazine shown at local contact with the affected intestinal mucosa.
Mesalazine inhibits leukocyte chemotaxis, cytokine production and reduces leukotriene, and also reduces the formation of free radicals in inflamed intestinal tissue. But the exact mechanism of action of mesalazine is not fully understood.
Pharmacokinetics:
Absorption: the oral application granulyPentasa® fall into microgranules acting as independent forms a sustained release preparation. It provides a therapeutic effect Pentasa® the drug all the way from the duodenum to the rectum at any pH. Microgranules reach the duodenum within an hour after ingestion. The transit time of the preparation through the small intestine is on average 3 – 4 hr.
Distribution: about 30-50% of the dose is absorbed mainly in the small intestine. Mesalazine determined in plasma in 15 minutes after administration, the maximum concentration achieved within 1 hour after administration and lasts up to 4 hours while gradually decreasing within 12 hours.
Metabolism: mesalazine subjected to acetylation in the intestinal mucosa and in the liver, as well as to a small extent, enterobacteria, forming the major metabolite N-acetyl-5-amino-salicylic acid. 43% mesalazine and 73-83% metabolite binds to plasma proteins. Mesalazine and its metabolite do not penetrate the blood-brain barrier, but penetrate into breast milk.
Excretion: mesalazine clearance is 18 l / h. At high doses (up to 1500 mg / day) may be a cumulative effect. Mesalazine half-life is approximately 40 minutes, metabolite – about 70 minutes.
Mesalazine and its metabolites are excreted in urine and feces.
Pregnancy and breast-feeding
Pentasa® drug may be used during pregnancy only if the expected benefit to the mother prevails over potential risk to the fetus. In the last 2 – 4 weeks of pregnancy the drug should be discontinued.
Mesalazine crosses the placental barrier and is excreted in breast milk. Therefore, at the time of admission Pentasy® breastfeeding should be discontinued.
Conditions of supply of pharmacies
On prescription.
side effects
Most frequently when using the drug Pentasa® observed diarrhea (3%), nausea (3%), abdominal pain (3%), headache (3%), vomiting (1%), and skin rashes (1%).
From the side of hematopoiesis: rarely, eosinophilia, anemia (including aplastic..), Leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia
Immune system: very rarely hypersensitivity reactions, drug fever, angioedema
From the nervous system: rarely, dizziness, very rarely, peripheral neuropathy, benign intracranial hypertension (in patients under the age of puberty)
Cardio-vascular system: seldom-myocarditis, pericarditis
The respiratory system: very rarely, shortness of breath, coughing, allergic alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis, bronchospasm, interstitial lung disease
From the digestive system: often, diarrhea, abdominal pain, nausea, vomiting, flatulence, rarely, elevated levels of amylase, pancreatitis, rarely, exacerbation of colitis symptoms
On the part of the hepatobiliary system: very rarely, elevated liver enzymes and bilirubin, hepatotoxicity * (hepatitis, steatosis, cirrhosis, liver failure)
For the skin: often, urticaria, erythema, photosensitivity, very rarely, reversible alopecia
On the part of musculoskeletal system: very rarely, myalgia, arthralgia
From the urinary system: very rarely, interstitial nephritis, nephrotic syndrome, change in urine color, transient renal failure
Other: often, headache, fever
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
In the case of the acute symptoms of intolerance to medication (muscle cramps, abdominal pain, fever, severe headache and skin rashes) or signs of liver dysfunction and / or renal reception Pentasy® preparation should be discontinued.
During the entire course of treatment Pentasa®, should regularly monitor the blood concentration of creatinine.
The effect on the ability to operate vehicles, machinery
Caution should be exercised when driving and busy with other potentially hazardous activities that require high concentration and speed of psychomotor reactions, because the drug can cause dizziness and other side effects that may affect these abilities.
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
The granules are recommended to take after a meal, without chewing. The contents of one sachet to pour on the tongue and then drink water or juice.
Children older than 6 years and adolescents: The dosage is adjusted individually. The recommended dose in the acute period of 20 – 30 mg mesalazine per kilogram of body weight per day in divided doses, the maximum single dose not exceed 75 mg / kg, the maximum daily dose of not more than 4, the recommended maintenance dose is 20 – 30 mg / kg / day with a maximum daily dose of no more than 2 years Children weighing more than 40 kg is recommended to prescribe the dose for adults.
Adults: The dosage is adjusted individually. The recommended dose in acute to 4 grams per day, divided into several times, maintenance therapy is 2 – 4 g per day, divided into several stages.
The duration of therapy is determined by the attending physician.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist