Pentas prolong tab. 500mg 50 pieces

Description

Composition
Active substance:
1 tablet contains: 500 mg of mesalazine ,.
Excipients:
Microcrystalline cellulose 207 mg Povidone 25 mg Talc 9 mg, ethylcellulose 6 – 9 mg magnesium stearate 1 mg.
Description:
Tablets of circular shape, white with grayish tinge of color interspersed with numerous light brown chamfered, Valium and engraving “500 mg» on one side and «Pentasa» another.
Product form:
Prolonged action tablets of 500 mg.
10 tablets in a blister of aluminum foil. 5 or 10 blisters with instructions for use in a cardboard box.
50 tablets in a plastic bottle with screw cap, sealed thermofilm in a cardboard package with instructions for use. On the cardboard box it is possible to apply stickers for tamper-evident.
Contraindications
Hypersensitivity to mesalazine and other ingredients,
Severe liver disease and / or renal,
Stomach ulcer or duodenal ulcer,
Hemorrhagic diathesis,
The last 2-4 weeks of pregnancy and lactation,
Children under 2 years old.
If you have one of these diseases, before taking this medication, you should consult with your doctor.
Carefully
With careful preparation should be administered to patients who are allergic to salicylates noted, as possible hypersensitivity reaction to sulfasalazine, and 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.
Dosage
500 mg
Indications
Ulcerative colitis (ulcerative colitis exacerbation of mild to moderate severity, maintaining remission and / or chronic treatment of ulcerative colitis), Crohn’s disease.
Interaction with other drugs
When concomitant administration of drug Pentasa® with azathioprine or mercaptopurine increased risk of bone marrow suppression (leucopenia, thrombocytopenia, erythropenia / or anemia, pancytopenia). Simultaneous administration of drug Pentasa®idrugih drugs possessing nephrotoxicity, such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, increases the risk of side slows absorption of cyanocobalamin (vitamin B12), enhances hypoglycemic effect of sulfonylurea derivatives, ulzerogennosti glucocorticosteroids, methotrexate toxicity, reduces the activity of furosemide , spironolactone, sulfonamides, rifampicin, increases the effects of anticoagulants, increases effectiveness ciency uricosuric drugs (blockers tubular secretion).
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:
Anti-inflammatory and anti-microbial intestinal agent.
Pharmacological properties:
Mesalazine – 5-aminosalicylic acid – is the active component of sulfasalazine. The therapeutic effect of mesalazine after oral or rectal administration to a greater degree 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: After receiving Pentasa® tablet formulation disintegrates in microgranules which act 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 of the tablet. 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. Maximum mesalazine concentration in plasma is achieved in 1 hour after administration and lasts up to 4 hours while gradually decreasing.
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-aminosalicylic 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. Clearance mesalazine is 18 l / h. At high doses (up to 1500 mg / day) may be a cumulative effect.
Excretion: mesalazine half-life of plasma 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 case of acute symptoms of intolerance to the drug (muscle cramps, abdominal pain, fever, severe headache and skin rash) or signs of abnormalities in the liver and / or kidney Pentasa® receiving the drug should be stopped!
During the entire course of treatment should be regularly monitored Pentasa® creatinine in the blood.
In the case of side effects (dizziness, nausea) are not recommended to drive a car and other mechanisms that require high concentration and speed of psychomotor reactions.
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Tablets are advised to take after not chewing food. For ease of swallowing the tablet can be divided into several parts or dissolved in water or juice immediately before administration.
Ulcerative colitis
Acute period: 2 tablets 2 – 4 times a day.
Maintenance therapy: 1 tablet 2 – 3 times a day.
Crohn’s disease
Acute period: 2 – 4 tablets 4 times a day.
Maintenance therapy: 2 – 4 tablets 2 times a day or 2 – 3 tablets 3 times a day.
Children
The dose is adjusted individually, normally 20-30 mg mesalazine per 1 kg of body weight per day in divided doses.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist