Pan-Torahs 20

General characteristics. Structure:

Active ingredient: 20 mg or 40 mg of a pantoprazol in the form of a pantoprazol of sodium of sexivihydrat in 1 tablet.

Excipients: mannitol (E 421), кросповидон, sodium carbonate anhydrous, hydroxypropyl cellulose, calcium stearate, gipromelloz, titanium dioxide (Е 171), ferrous oxide yellow (Е 172), propylene glycol, methacrylate copolymer dispersion, triethyl citrate, talc.

Pharmacological properties:

Pharmacodynamics. Pantaprazol is a blocker of gastric secretion, it brakes activity N-to - ATP-ases in covering cells of a stomach and thus blocks the last phase of secretion of hydrochloric acid. It leads to decrease in level of basal secretion irrespective of the irritation nature. Has antibacterial activity concerning Helicobacter pylori and promotes manifestation of antikhelikobakterny effect of other drugs. The therapeutic effect after a single dose occurs quickly and remains within 24 hours.

Pharmacokinetics. It is quickly and completely absorbed after intake. Absolute bioavailability makes 77%. The maximum concentration is reached in 2-4 hours. Linkng with proteins of plasma makes 98%. Elimination half-life about 1 hour. Very poorly gets through a blood-brain barrier. It is metabolized in a liver. It is removed preferential with urine (82%) in the form of metabolites, in a small amount it is found in Calais. Does not kumulirut. The elimination half-life at patients with cirrhosis increases up to 7-9 h, with a liver failure – increases slightly, but the elimination half-life of the main metabolite reaches 2-3 hours.

Indications to use:

• a reflux disease of easy severity and its symptoms (such as heartburn, acid throwing, pain when swallowing),
• long treatment and prevention of a recurrence reflux esophagitis,
• prevention of ulceration of a stomach and the duodenum caused by reception of non-selective non-steroidal anti-inflammatory drugs (NPVS) in patients of risk group who have to apply NPVP long time.

Route of administration and doses:

Treatments of a reflux disease of easy severity and its symptoms (such as heartburn, acid throwing, pain when swallowing). The recommended dose for adults and children is more senior than 12 years makes 20 mg of drug a day (1 tablet). The symptomatology, as a rule, passes through 2-4 weeks of treatment. Usually the term of treatment of an esophagitis makes 4 weeks. If this term is not enough, treatment is continued within the next 4 weeks. After disappearance of symptomatology its recurrence can be controlled, applying 20 mg of drug a day depending on need.

Long treatment and prevention of a recurrence reflux esophagitis. For long-term treatment the maintenance dose makes 20 mg of drug a day (1 tablet); at the expected aggravation increase in a dose up to 40 mg a day is possible. Reception of tablets of 40 mg is in that case recommended. After improvement of a state it is possible to reduce a dose to 20 mg of drug again a day.

Prevention of the stomach ulcers and duodenum caused by reception of non-selective NPVP in patients of risk group who have to accept NPVS a long time. A pill should be taken on an empty stomach, washing down with water, not chewing and without crushing.

The recommended dose for adults makes 20 mg of drug a day (1 tablet).

Patients with heavy abnormal liver functions should not exceed a daily dose of 20 mg of drug.

For patients of advanced age and with renal failures reduction of a dose usually is not required.

Drug should be accepted in 1 hour prior to a breakfast. Swallow of tablets whole, without chewing and without crushing, washing down with water. At a combination therapy which purpose is the eradikation of H. руlori the second pill of drug should be taken before a dinner. Duration of a combination therapy, as a rule, stanovit7 days, but it can be prolonged up to 2 weeks at most. If for treatment of an ulcer further treatment pantoprazoly is shown, it is necessary to consider recommendations concerning dosing at stomach ulcer and a duodenum.

Duodenal ulcers, as a rule, recover within 2 weeks. If two weeks are not enough, treatment can be expected for further 2 weeks.

For treatment of stomach ulcers and the reflux esophagitis, as a rule, is required 4 weeks. If it is not enough, treatment can be expected for further 4 weeks.

Features of use:

Use during pregnancy or feeding by a breast. Drug should be used during pregnancy only when the expected advantage for mother exceeds potential risk for the child.

Pantoprazol gets into breast milk. At use of a pantoprazol it is necessary to stop feeding by a breast, having weighed a ratio advantage/risk for mother and the child.

Children. Do not apply to children age up to 12 years.

Features of use. At heavy abnormal liver functions during treatment by drug, especially at long use, regular control of levels of liver enzymes is necessary. In case of increase in level of enzymes treatment needs to be stopped.

Pan-Torahs it is not shown for treatment of moderate disturbances from a digestive tract (functional dyspepsia).

In case of existence of alarming symptoms (essential loss of body weight, vomiting, a dysphagy, vomiting with blood, anemia, a melena) and existence of stomach ulcer it is necessary to exclude a zlokachestvennost as treatment pantoprazoly can mask symptoms of a malignant ulcer and defer establishment of the diagnosis. Further researches have to be caused if symptoms match at adequate treatment.

When carrying out a combination therapy as a part of which it is applied пантопразол it is necessary to take into account information from safety of each drug.

Elderly patients with renal failures are not recommended to exceed a dose of 40 mg a day (see the section "Route of Administration and Doses").

Use of inhibitors of the proton pump, including пантопразол, can lead to increase in quantity of bacteria which normal exist in upper parts of a digestive tract. Use can bring the Panther to insignificant the increased risk of developing of the gastrointestinal infections caused by such bacteria as salmonellas and a kampilobakter.

At patients with Zollingera-Ellison's syndrome and in case of other diseases with a g_persekretorna of function of a stomach at which it is necessary it is long to apply пантопразол, as well as all кислотознижуючі means, пантопразол can reduce absorption of B12 vitamin (cyanocobalamine) that can lead to hypo - or achlorhydrias. It should be considered at long use of drug and to patients with an underweight of a body or with existence of risk factors for decrease in absorption of B12 vitamin or in the presence of the corresponding clinical symptoms.

At prolonged treatment, especially it is more than a year, patients have to be under constant observation.

Ability to influence speed of response at control of motor transport or work with other mechanisms. In case of developing of dizziness, a vision disorder, it is necessary to avoid control of vehicles or work with other difficult mechanisms.

Side effects:

From blood and lymphatic system: leukopenia, thrombocytopenia, eosinophilia, agranulocytosis.

From a digestive tract: pains and discomfort in a stomach, feeling of swelling in a stomach, diarrhea, a lock, nausea, vomiting, dryness in a mouth, increase in appetite.

From gepatobiliarny system: increase in level of liver enzymes (transaminases, g-GT), bilirubin, hepatocellular disturbances, jaundice, hepatocellular insufficiency.

General frustration: peripheral hypostases, adynamy, weakness, fatigue, fervescence.

From immune system: hypersensitivity reactions, including anaphylactic reactions and an acute anaphylaxis.

From a musculoskeletal system: arthralgia, mialgiya.

From skin and hypodermic cellulose: itch, skin rash, dieback, small tortoiseshell, Quincke's disease, multiformny erythema, Lyell's disease, Stephens-Johnson's syndrome, photosensitivity, alopecia, acne, dermatitis, angioedema.

From a nervous system: headache, dizziness, sonitus, tremor, paresthesias, nervousness, disorders of taste.

Mental disorders: frustration of a dream, sleeplessness, drowsiness, a depression (and deterioration in all symptoms), a disorientation (and deterioration in all symptoms), hallucinations, confusion, especially at patients who have tendency to it, and also deterioration in these symptoms in case of their existence.

From organs of sight: visual disturbances, sight illegibility, photophobia.

From kidneys and urinary system: intersticial nephrite.

Laboratory indicators: giperlipoproteinemiya and increase in level of lipids (cholesterol and triglycerides), hyperglycemia, hyponatremia, change of body weight.

From reproductive system: gynecomastia.

Interaction with other medicines:

Drug can reduce absorption of drugs which bioavailability depends from рН (for example кетоконазол, итраконазол, посаконазол and other medicines, in particular эрлотиниб).

It is proved that use of an atazanavir of 300 mg / ритонавира 100 mg with omeprazoly (40 mg once a day) or an atazanavira of 400 mg with lansoprazoly (60 mg once) causes essential decrease in bioavailability of an atazanavir in healthy volunteers. Absorption of an atazanavir depends from рН. Therefore inhibitors of the proton pump, including пантопразол, it is contraindicated to apply together with atazanaviry.

To patients who apply indirect anticoagulants фенпрокумон, warfarin, is recommended to carry out laboratory tests on coagulation of thrombocytes at the beginning, in the end and in case of irregular treatment pantoprazoly.

Pantoprazol is metabolized in a liver through system of enzymes of P450 cytochrome. Interaction of a pantoprazol with other drugs which it is metabolized through the same system is not excluded. However carrying out special researches with the majority of such means did not reveal clinically significant interactions with carbamazepine, caffeine, diazepam, diclofenac, ethanol, glibenclamide, metoprololy, Naproxenum, nifedipine, Phenytoinum, theophylline, p_roksikamy and the oral contraceptives containing levonogestret also ethinylestradiol.

Interaction with at the same time appointed antiacid drugs is not revealed.

Research of interaction of a pantoprazol with the corresponding antibiotics (кларитромицин, metronidazole, amoxicillin) did not show clinically significant data on their interaction.

Contraindications:

Hypersensitivity to a pantoprazol or to any component of drug.

Hepatitis and cirrhosis that is followed by a liver failure.

Pantoprazol, as well as other inhibitors of the proton pump, it is contraindicated to apply with atazanaviry.

Overdose:

Overdose symptoms at the person are unknown. Strengthening of manifestations of side reactions is possible.

Doses to 240 mg at intravenous administration within 2 minutes were well transferred. In case of overdose with symptoms of intoxication use the general disintoxication actions.

Storage conditions:

Period of validity - 3 years. To store at a temperature not over 25 ºС in original packaging. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in the blister, on 1 or 3 blisters in cardboard packaging.