Ulter (Ultera)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspTabletki, covered with enteric film membrane.
Composition:

1 tablet, coated with enteric coating, contains:

active substance: S (-) pantoprazole sodium trihydrate 23.964 mg, corresponding S(-) pantoprazole 20 mg;

Excipients: Mannitol 43.838 mg, sodium carbonate 20 mg, povidone 4 mg, crospovidone 40 mg, calcium stearate 3.20 mg;

insulating sheath: hypromellose (hydroxypropylmethylcellulose) 2.75 mg; enteric membrane: methacrylic acid and ethyl acrylate copolymer [1: 1] [dispersion 30%] (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, iron iron oxide yellow (E 172) 0.475 mg, iron oxide red (E 172) 0.103 mg.

Description:

Round, biconvex tablets, covered with an enteric-soluble coat of yellow-orange color.

On the cross section, the core is from almost white to cream colored. Presence of marble is admissible.

Pharmacotherapeutic group:glands of the stomach secretion-lowering agent - proton pump inhibitor
ATX: & nbsp
  • Pantoprazole
    • Pharmacodynamics:

    S-Pantoprazole sodium-chirally pure Senantiomer of racemic pantoprazole. S-Pantoprazole is a proton pump inhibitor that inhibits the final stage of hydrochloric acid secretion 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.

    Pharmacokinetics:

    Pills S-pentoprazole are coated with an enteric-soluble coat, so that the release of the active substance begins after the drug has left the stomach. Absorption S-pentoprazole does not depend on the joint application with antacids.

    The maximum concentration in plasma (CmOh) - 1.85 ± 0.66 μg / ml reaches its value after 2.96 ± 0.736 hours. Taking the drug with food can slow its absorption; while the maximum plasma concentration (CmOh) and the area under the "concentration-time" curve (AUC) remain unchanged. Thus, the drug can be taken regardless of food intake.

    Metabolised in the liver.

    The half-life (T1/2) - 2.341 ± 0.908 h.

    Indications:

    - 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);

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - dyspepsia of neurotic genesis;

    - pregnancy and lactation (safety and efficacy not established);

    - Children under 18 years of age (efficacy and safety in pediatrics not established).

    Carefully:PEF deficiency.
    Dosing and Administration:

    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.

    Recommended reception mode for Ulter with peptic ulcer - 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.

    At 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.

    With 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.

    Side effects:

    From 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.

    Interaction:

    Reduces the effect of drugs that are absorbed at acidic pH values ​​(including ketoconazole).

    Special instructions:

    Before and after Ultera, endoscopic control is necessary to exclude malignant growth, treatment can mask the symptoms and delay correct diagnosis.

    Effect on the ability to drive transp. cf. and fur:

    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.

    Form release / dosage:

    Tablets coated with enteric coating, 20 mg.

    Packaging:

    For 10 or 14 tablets per strip of aluminum foil, 7 tablets per blister, aluminum foil / aluminum foil.

    2 blisters for 7 tablets, 10 strips of 10 tablets or 1 strip for 14 tablets with instructions for use in a cardboard box.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:PL-000708
    Date of registration:29.09.2011 / 03.02.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia
    Information update date: & nbsp04.01.2017
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