Pentasa granules teabags 1g №50
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Trade name of the drug:
Pentasa
MHH:
mesalazine
Dosage Form:
granules of prolonged action for oral administration
Ingredients for 1 bag:
dosage 1.0 g:
active substance - mesalazine 1000 mg; excipients - ethylcellulose 4 mg - 15 mg, povidone 50 mg.
dosage of 2.0 g:
active substance - Mesalazine 2000 mg; excipients: ethyl cellulose 8 mg - 30 mg, povidone 100 mg.
Description
Cylindrical granules from light gray to light brown.
Pharmacotherapeutic group:
antimicrobial and anti-inflammatory intestinal agent
Pharmacological properties
Mesalazine - 5-aminosalicylic acid - is the active component of Sulfasalazine.
Pentasy® granules are mesalazine microgranules coated with ethylcellulose. The therapeutic effect of mesalazine after oral administration is largely due to a local effect on the inflamed intestinal tissue, rather than a systemic effect.
The therapeutic effect of mesalazine is manifested by local contact with the affected intestinal mucosa.
Mesalazine inhibits leukocyte chemotaxis, reduces the production of cytokines and leukotriene, and also reduces the formation of free radicals in the inflamed intestinal tissue.But the exact mechanism of action of mesalazine is not fully understood.
Pharmacokinetics:
- suction: when administered orally, Pentas® granules break down into microgranules, which act as independent forms of the drug with a slow release. This provides the therapeutic effect of the drug Pentas® all the way from the duodenum to the rectum at any pH values. Microgranules reach the duodenum within an hour after taking the drug. The time of passage of the drug through the small intestine is on average 3-4 hours.
- distribution: about 30-50% of the dose taken is absorbed mainly in the small intestine. Mesalazine is determined in the plasma within 15 minutes after administration, the maximum concentration is reached 1 hour after administration and lasts up to 4 hours, gradually decreasing over 12 hours.
- metabolism: mesalazine undergoes acetylation in the intestinal mucosa and in the liver, as well as enterobacteria to a small extent, forming the main metabolite, N-acetyl-5-amino salicylic acid. 43% of mesalazine and 73-83% of the metabolite binds to plasma proteins. Mesalazine and its metabolite do not penetrate the blood-brain barrier, but penetrate into breast milk.
- elimination: Mesalazine clearance is 18 l / h. When taking high doses (up to 1500 mg / day), a cumulative effect may be observed. The half-life of mesalazine is approximately 40 minutes, the metabolite is about 70 minutes.
Mesalazine and its metabolites are excreted in the urine and feces.
Indications for use
- Ulcerative colitis
Crohn's disease
Contraindications
- Hypersensitivity to salicylates and other components of the drug
- Severe hepatic or renal failure
- Peptic ulcer or duodenal ulcer
- Hemorrhagic diathesis
- Children's age up to 6 years
If you have one of these diseases, be sure to consult with your doctor before taking the drug.
Carefully
With caution, the drug should be prescribed to patients with impaired lung function, in particular, with bronchial asthma.
Care must be taken when prescribing Pentas® to patients with mild to moderate renal / hepatic insufficiency, since a decrease in the rate of elimination and an increase in the systemic concentration of mesalazine increases the risk of kidney damage.
Use during pregnancy and during breastfeeding
Pentasa® is allowed to be used during pregnancy only if the expected benefit to the mother prevails over the potential risk to the fetus. In the last 2 - 4 weeks of pregnancy, the drug should be canceled.
Mesalazine penetrates the placental barrier and is excreted in breast milk. Therefore, at the time of taking Pentasy®, breastfeeding should be discontinued.
Dosage and administration
Granules are recommended to be taken after meals without chewing.The contents of one sachet pour on the tongue and drink with water or juice.
Children over 6 years old and teenagers: dosage is selected individually. The recommended dose during the exacerbation period is 20–30 mg of mesalazine per kilogram of body weight per day in several doses, the maximum single dose is not more than 75 mg / kg, the maximum daily dose is not more than 4 g. The recommended maintenance dose is 20 to 30 mg / kg / day, the maximum daily dose of not more than 2 g. Children weighing more than 40 kg are recommended to prescribe a dose for adults.
Adults: dosage is selected individually. The recommended dose in the period of exacerbation is up to 4 g per day, divided into several doses, supportive therapy of 2 - 4 g per day, divided into several doses.
The duration of therapy is determined by the attending physician.
Side effects
Most often, when using the drug Pentasa, diarrhea (3%), nausea (3%), abdominal pain (3%), headache (3%), vomiting (1%) and skin rashes (1%) are observed.
Often (> 1/100 and <1/10) | Seldom (> 1/10000 and <1/1000) | Very rarely (<1/10000, including isolated cases) | |
From the side of blood formation organs | Eosinophilia, anemia (including aplastic), leukopenia, | ||
The immune system | Hypersensitivity reactions, drug fever, angioedema | ||
The nervous system | Dizziness | Peripheral neuropathy, benign intracranial | |
Since the cardiovascular system * | Myocarditis, pericarditis | ||
On the part of the respiratory system * | Shortness of breath, cough, allergic alveolitis, pulmonary eosinophilia, | ||
From the digestive system | Diarrhea, abdominal pain, nausea, vomiting, flatulence | Increased amylase, pancreatitis * | Exacerbation of colitis symptoms |
From the hepatobiliary system | Increased liver enzymes and bilirubin, | ||
On the part of the skin | Urticaria, erythema | Photosensitization, reversible alopecia | |
From the musculoskeletal system | Myalgia, arthralgia | ||
On the part of the urinary system | Interstitial nephritis *, nephrotic syndrome, color changes | ||
Other | Headache fever |
(*) The mechanism for the development of adverse reactions is presumably allergic.
If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects that are not indicated in the instruction, inform your doctor.
Overdosage
Pentas® overdose is rare. Specific antidotes are absent. It is recommended to wash the stomach and take measures to increase diuresis. In the case of acidosis, alkalosis, dehydration, hyperventilation, or pulmonary edema, it is necessary to restore the acid-base and water-electrolyte balance.With signs of hypoglycemia, you need to take glucose.
Interaction with other drugs
With the simultaneous appointment of the drug Pentasa with azathioprine or 6-mercaptopurine increases the risk of suppression of bone marrow function (leukopenia, thrombocytopenia, erythrocytopenia / anemia or pancytopenia). The simultaneous appointment of the drug Pentasa® and other drugs that have nephrotoxicity, for example, nonsteroidal anti-inflammatory drugs (NSAIDs) and azathioprine, increases the risk of adverse reactions from the kidneys.
Slows down the absorption of cyanocobalamin (vitamin B12) With simultaneous use of drugs mesalazine and Digoxin digoxin absorption decreases.
special instructions
In the event of acute symptoms of intolerance to the drug (muscle spasms, abdominal pain, fever, severe headache and skin rashes) or signs of abnormal liver function and / or kidneys, Pentas® should be stopped.
During the entire course of treatment with Pentasa®, the concentration of creatinine in the blood should be regularly monitored.
Influence on ability to steer vehicles, mechanisms
Care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed, as the drug can cause dizziness and other side effects that can affect these abilities.
Release form
Granules of prolonged action for oral administration of 1 g and 2 g.
On 1 g or 2 g of granules in a bag from polyester / aluminum foil / polyethylene of low density.
1 g: 50, 60, 100, 120 or 150 bags in a carton box with instructions for use.
2 g: on 30, 50, 60 or 120 bags in a cardboard pack with the application instruction.
Storage
At a temperature not higher than 25 ° С.
Keep out of the reach of children.
Shelf life
Do not use after expiration date.
Vacation conditions
On prescription.