Composition, form of production and packaging
The tablets covered with an enteric-soluble coat of yellow-orange color, round, biconvex: on a cross-section - a kernel from white to cream color; the presence of marble is allowed.
pantoprazole sodium trihydrate 23.964 mg,
which corresponds to the content of (S) -pentoprazole 20 mg
Excipients: sodium carbonate - 20 mg, mannitol - 43.838 mg, povidone - 40 mg, calcium stearate - 3.2 mg.
The composition of the insulating sheath: hypromellose (hydroxypropylmethylcellulose) 2.75 mg.
Ingredients of the enteric coating: methacrylic acid and ethyl acrylate copolymer (1: 1) 30% dispersion, (Eudragit L30 D-55) 55.27 mg, sodium hydroxide 0.225 mg, macrogol 1.98 mg, talc 4.18 mg, titanium dioxide 0.825 mg , ferric iron oxide yellow (E172) - 0.475 mg, iron dye red oxide (E172) - 0.103 mg.
7 pcs. - blisters (2) - packs of cardboard.
10 pieces. - Strips (10) - packs of cardboard.
14 pcs. - Strips (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
S-pantoprazole sodium is a chirally pure S-enantiomer of racemic pantoprazole. S-pantoprazole is a proton pump inhibitor that inhibits the final stage of the secretion of hydrochloric acid by forming covalent bonds with two parts of the enzyme (H + / K + -ATPase) of parietal cells of the secretory surface of the stomach. This effect is dose-dependent and leads to inhibition of both basal and stimulated secretion, regardless of the nature of the stimulus. Inhibition of (H + / K + -ATPase) leads to a prolonged antisecretory effect, the duration of which is more than 24 hours.
The tablets of S-pantoprazole are coated with an enteric-coated membrane, so that the release of the active substance begins after the drug has left the stomach. The absorption of S-pantoprazole does not depend on the combined use with antacids. C max - 1.85 В± 0.66 Ојg / ml reaches its value after 2.96 В± 0.736 hours. Taking the drug with food can slow its absorption; while the C max and AUC remain unchanged. Thus, the drug can be taken regardless of food intake. Metabolised in the liver. T1/2 - 2.341 В± 0.908 h.
- Stomach ulcer and duodenal ulcer in the phase of exacerbation;
- gastroesophageal reflux disease;
- pathological conditions, accompanied by hypersecretion of gastric juice (for example, Zollinger-Ellison syndrome).
Inside, you can not chew or divide the pill. It should be swallowed whole, it is possible to take as with food, and without it.
The recommended mode of taking Ulter with peptic ulcer is 20-40 mg / day.
In elderly patients , with chronic renal failure (CRF) - not more than 20 mg / day.
The course of treatment for exacerbation of duodenal ulcer - 2 weeks, exacerbation of gastric ulcer and gastroesophageal reflux disease - 4-8 weeks. In conditions accompanied by hypersecretion of gastric juice, the course of treatment can be quite long, it depends on the individual characteristics of the patient's body and is established by the attending physician depending on the rate of scarring of erosive and ulcerative defects and reducing the basal secretion of hydrochloric acid to the limits of physiological norm. Based on clinical experience, the recommended initial dose of the drug is 20 mg 2 times a day.
In Zollinger-Ellison syndrome, the level of basal secretion of hydrochloric acid should be below 10 meq / h for patients without surgical treatment, this may require a dose of up to 120 mg per day and 5 meq / h in patients after surgical treatment.
With hepatic insufficiency , 20 mg once every 2 days.
From the side of the central nervous system: headache, dizziness, depression.
From the gastrointestinal tract: diarrhea, nausea, vomiting, abdominal pain.
From the skin: skin rash, itching.
Other: weakness, asthenia, pain in the chest.
- dyspepsia of neurotic genesis;
- pregnancy and lactation period (safety and efficacy not established);
- Children under 18 years of age (efficacy and safety in pediatrics not established);
hypersensitivity to the components of the drug.
With caution: liver failure.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
In chronic renal failure, a dose of no more than 20 mg / day is prescribed.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With an island with liver failure.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
APPLICATION IN ELDERLY PATIENTS
In elderly patients appoint a dose of not more than 20 mg / day.
Precautions for use
Before and after Ultera, endoscopic control is necessary to exclude malignant growth, treatment can mask the symptoms and delay correct diagnosis.
Impact on the ability to drive vehicles and manage mechanisms
Special studies studying the effect on the ability to drive a car or other mechanisms were not conducted.
It should be noted that dizziness may develop during treatment, and care must be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
Reduces the effect of drugs that are absorbed at acidic pH values вЂ‹вЂ‹(including ketoconazole).
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
In a dry, protected from light place at a temperature of no higher than 25 В° C. Keep out of the reach of children! Shelf life - 2 years.