Пантап®

General characteristics. Structure:

Active ingredient: 45,3 mg of a pantoprazol of sodium of sexivihydrat (that is equivalent to 40 mg to a pantoprazol).

Excipients: sodium of a kroskarmelloz, microcrystallic PH 102 cellulose, corn starch (dry), magnesium carbonate, silica gel colloid (aerosil), talc, magnesium stearate,

Provisional cover: a gidroksipropilmetiltsellyuloza (фармакоат 603), talc, alcohol of ethyl 96% (36, 43 ml) *, the water purified *;

Kishechnorastvorimy covering: eydragit L 30 D-55 (30%), triethyl citrate (цитрофлекс), a macrogoal 6000 (PEG 6000), сеписперс AP 3232 John yellow (a gidroksipropilmetiltsellyuloza, titanium dioxide (E171), ferrous oxide yellow (Е 172), пропилпарагидроксибензоат, methylparahydroxybenzoate,  Natrium benzoicum), an emulsion of a simetikon of 30%.

Pharmacological properties:

Pharmacodynamics. Пантап® 40 contains active agent пантопразол which belongs to group of the replaced benzamidazol inhibiting a final stage in a producing hydrochloric acid by means of formation of a covalent bond with (N + - K+) ATF-aznoy fermental system on the secretory surface of covering cells.

Duration of suppression of activity of hydrochloric acid of pantoprazoly more than 24 hours. Acid secretion is normalized within 3-5 days after reception of the last dose ПАНТАП®.

At use of drug the increased level of serumal gastrin which is normalized after the treatment termination is observed.

Pharmacokinetics. Pantoprazol is quickly soaked up in digestive tract after single or repeated oral administration. Absolute bioavailability about 77%. The maximum concentration (Cmax) in blood of 2,09 mkg/ml, time of achievement of the maximum concentration (tmax) in blood 2,8 hours.

Serumal proteinaceous binding of a pantoprazol makes about 98%, mainly with albumine.

Elimination half-life of a pantoprazol about 1,2-1,3 hours. Despite a short elimination half-life after пантопразол covalently communicates with (N + - K+) ATP-ase, anti-secretory activity remains more than 24 hours.

Volume of distribution of a pantoprazol about 0,34 лкг. Pantoprazol is metabolized in the main metabolite десметилпантопразол and other substances in a liver by means of a P450 system CYP2C19 isoenzyme with the subsequent sulphation. Metabolites of a pantoprazol have no significant pharmakodinamichesky activity. About 80% of a peroral dose are removed with urine and 20% with excrements. In urine comes to light changed пантопразол.

The plasma clearance of a pantoprazol can decrease slightly or moderately at elderly people.

Indications to use:

- a peptic ulcer of a stomach and duodenum, in t. h associated with Helicobacter pylori;

- the prevention and treatment of erosive cankers of digestive tract associated with reception of non-steroidal anti-inflammatory drugs;

- gastroesophageal reflux disease;

- Zollingera-Ellison's syndrome.

Route of administration and doses:

Adult. Peptic ulcer of a stomach and duodenum. The recommended peroral dose of drug of 40 mg once a day within 4 weeks. Depending on a condition of the patient it is possible to continue a course of treatment up to 8 weeks.

Peptic ulcer of a stomach and duodenum, assotion rovanny with Helicobacter pylori.  The recommended peroral dose of drug   of 40 mg twice a day as a part of complex therapy within 7 - 14 days.

Gastroesophageal reflux disease. The recommended peroral dose of 40 mg once a day within 4 weeks. Depending on a condition of the patient it is possible to continue a course of treatment up to 8 weeks.

Prevention and treatment of erosive cankers zheludochno - an intestinal path associated with reception of non-steroidal anti-inflammatory drugs.

The recommended dose on 40 mg of 1 times a day within 4 - 8 weeks.

To accept drug to food, in the first half of day, tablets cannot be chewed or split up. To wash down each dose with a glass of water, swallowing tablets entirely.

Features of use:

Correction of doses is not required to patients with a liver failure.

Before an initiation of treatment it is necessary to exclude a possibility of a malignant new growth in a stomach and a gullet.

Use in pediatrics. Efficiency and safety of drug for children is not established.

Pregnancy and lactation. In need of use of drug at pregnancy it is necessary to estimate estimated advantage for mother and potential risk for a fruit.

It is not established whether it is allocated пантопразол with milk.

In need of purpose of drug the question of the feeding termination is raised by a breast.

Features of influence of medicine on ability to manage the vehicle or potentially dangerous mechanisms. Considering side effects of drug it is necessary to be careful during the driving and work with potentially dangerous mechanisms.

Side effects:

Seldom:

- nausea, abdominal pains, meteorism, temporary diarrhea;

- indisposition, headache, sight illegibility;

- skin rash, itch, heat, hypostasis.

The reactions observed at less than 1% of patients are included below, but connection of these reactions using Pantap® is not established:

- concern, adynamy, nervousness, sleep disorder, emotional lability, drowsiness;

- a vision disorder and hearing (an amblyopia, a diplopia, an ear-ache, a ring in ears);

- aphthous stomatitis, dryness in a mouth, a food faddism, anorexia, colitis;

- bronchitis, laryngitis, asthma, nasal bleedings, hiccups;

- retrosternal pain;

- renal pains, glucosuria, dysuria, disturbance of an urination;

- dysmenorrhea, impotence;

- alopecia, acne, exfoliative dermatitis;

- arthritises, dorsodynias.

- anemia (iron deficiency, hypochromia)

- changes of laboratory indicators (hyperbilirubinemia, increase

 alkaline phosphatase, increase in a gammaglyutamiltranspeptidaza,

 gipergastrinemiya).

Interaction with other medicines:

Let's combine with the drugs which are metabolized with the participation of fermental system of P450 cytochrome (Phenazepamum, diazepam, digoxin, theophylline, carbamazepine, diclofenac, Naproxenum, piroxicam, Phenytoinum, warfarin, nifedipine, метопролол, ethanol).

ПАНТАП® renders deep and long inhibition of secretion of hydrochloric acid therefore drug can reduce absorption of some drugs, such as кетоконазол, ethers of ampicillin, iron salt where it is necessary defined рН a stomach for their bioavailability.

Contraindications:

- hypersensitivity to any making  drug component;

- renal failure.

Overdose:

Symptoms: a vision disorder, drowsiness, excitement, a headache, increase in sweating, dryness in a mouth, nausea, tachycardia.

Treatment: symptomatic treatment.

Storage conditions:

To store at a temperature not above 25 °C in the dry, protected from light place. To store in the place, unavailable to children! Period of storage 2 years. Not to apply after a period of storage.

Issue conditions:

According to the recipe

Packaging:

The tablets covered with a kishechnorastvorimy cover of 40 mg. On 10, 14 or 28 tablets in a polyethylene bottle with the self-adhesive label.

On 14 tablets in a blister strip packaging from aluminum foil.

On 1 bottle or on 1, 2 blister strip packagings together with the instruction on a medical use in the state and Russian languages put in a cardboard pack.