Pentas pills 500mg №100
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Tradename:
Pentasa
INN:
mesalazine
Dosage Form:
long acting tablets
The composition of 1 tablet:
active substance - mesalazin 500 mg,
Excipients - microcrystalline cellulose 207 mg, povidone 25 mg, talc 9 mg, ethyl cellulose 6-9 mg, Magnesium stearate 1 mg.
Description
pills are round-shaped, white with a grayish shade of color with numerous patches of light brown with a bevel, drawing and engraving “500 mg” on one side and “Pentasa” on the other.
Pharmacotherapeutic group:
anti-inflammatory and antimicrobial intestinal agent.
Pharmacological properties
Pharmacodynamics
Mesalazine - 5-aminosalicylic acid - is the active component of Sulfasalazine. The therapeutic effect of mesalazine after oral or rectal 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: after taking the tablet, the drug Pentasa breaks up 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 pill. The time of passage of the drug through the small intestine averages 3 to 4 hours.
Distribution: about 30-50% of the dose taken is absorbed mainly in the small intestine. The maximum concentration of mesalazine in plasma is reached 1 hour after administration and lasts up to 4 hours, gradually decreasing.
Metabolism: mesalazine undergoes acetylation in the intestinal mucosa and in the liver, as well as enterobacteria to a small extent, forming the main metabolite of N-acetyl-5-aminosalicylic 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. Mesalazine clearance is 18 l / h. When taking high doses (up to 1500 mg / day), a cumulative effect may be observed.
Excretion: the half-life of mesalazine from plasma 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 (exacerbation of mild to moderate ulcerative colitis, maintenance of remission and / or long-term therapy of ulcerative colitis),
Crohn's disease.
Contraindications
- Hypersensitivity to mesalazine and other components of the drug,
- Severe damage to the liver and / or kidneys,
- Peptic ulcer or duodenal ulcer,
- Hemorrhagic diathesis,
- The last 2-4 weeks of pregnancy and lactation,
- Children age up to 2 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 who have an allergy to salicylates, since hypersensitivity reactions to sulfasalazine are possible, as well as 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
The drug is allowed to use during pregnancy, when the potential benefits of its use for the mother outweigh the possible risk of adverse effects on 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 the drug Pentasa ® breastfeeding should be stopped.
Dosage and administration
Tablets are recommended to be taken after food without chewing.To facilitate swallowing, the pill can be divided into several parts or dissolved in water or juice immediately before ingestion.
Ulcerative colitis
Acute period: 2 pills 2-4 times a day.
Maintenance Therapy: 1 pill 2 - 3 times a day.
Crohn's disease
Acute period: 2 - 4 pills 4 times a day.
Maintenance Therapy: 2 to 4 pills 2 times a day or 2 to 3 pills 3 times a day,
Children
The dose is selected individually, usually 20-30 mg of mesalazine per 1 kg of body weight per day in several doses.
Side effect
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% and <10%) | Rarely (> 0.01% and <1.0%) | Very rarely (<0.01%, including isolated cases) | |
From the side of blood formation organs | Eosinophilia, anemia, leukopenia, granulocytopenia, agranulocytosis, | ||
The immune system | Hypersensitivity reactions, drug fever, angioedema | ||
The nervous system | Dizziness | Peripheral neuropathy, benign intracranial | |
Since the cardiovascular system * | Myocarditis, pericarditis | Shortness of breath, cough, allergic alveolitis, pulmonary eosinophilia, | |
On the part of the respiratory system * | |||
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, eczema | Photosensitization, let's turn 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.
Overdose
Pentas® overdose is rare. Specific antidotes are absent. It is recommended to wash the stomach and take measures to increase diuresis. In the event of acidosis, alkalosis or dehydration, it is necessary to restore the acid-base and water-electrolyte balance. With signs of hypoglycemia, the introduction of dextrose is recommended.
Interaction with other drugs
With the simultaneous appointment of the drug Pentasa with azathioprine or mercaptopurine increases the risk of suppression of bone marrow function (leukopenia, thrombocytopenia, erythrocytopenia / anemia or pancytopenia). The simultaneous appointment of the drug Pentas® and other drugs with nephrotoxicity,For example, nonsteroidal anti-inflammatory drugs (NAPs) the effectiveness of uricosuric drugs (canalicular secretion blockers).
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 Pentas®, the creatinine index in the blood should be regularly monitored.
In the case of side effects (dizziness, nausea) it is not recommended to drive a car and other mechanisms that require increased concentration and psychomotor speed.
Release form
pills of the prolonged action of 500 mg.
On 10 pills in the blister from aluminum foil. On 5 or 10 blisters with the application instruction in a cardboard pack.
On 50 pills in a plastic bottle, with the screwed cap, soldered by a thermofilm, in a cardboard pack with the instruction for application.Stickers can be applied to the carton to control the first opening.
Storage conditions
At a temperature not higher than 25 ° С.
Keep out of the reach of children.
Shelf life
3 years.
Do not use after expiration date.
Vacation conditions
On prescription.