Proksium
Producer: Universal agency "Pro-Pharma" Ukraine
Code of automatic telephone exchange: A02BC02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: pantoprazola of 0,04 g;
excipients: lactose pharmaceutical, starch corn, polyvinylpirrolidone low-molecular medical, magnesium stearate, oydragit, talc, poly(ethylene oxide), titanium dioxide pigmental, евросерт sunst yellow.
Pharmacological properties:
The therapeutic effect after a single dose develops quickly and remains within 24 hours.
Pharmacokinetics. Pantoprazol acid is unstable, is soaked up almost completely only in the alkaline environment of a small intestine and comes to a system blood stream. Bioavailability makes 70-80%. Presence of food and a concomitant use antacids does not influence bioavailability of drug. The maximum concentration in blood after internal reception of 40 mg of a pantoprazol makes 1,1-3,1 mg/l and is reached in 2-4 h Pantoprazol well gets into fabrics, including in covering cells of a stomach. Linkng with proteins of plasma makes 98%. Distribution volume - 0,16 l/kg, an elimination half-life - 0,9-1,9 h, the general clearance - 0,1 l/h/kg. Drug is metabolized in a liver with the participation of fermental system of P450 cytochrome by oxidation, dealkylation and conjugation. The main metabolites - деметилпантопразол and two sulphated conjugates. It is excreted from an organism by kidneys (71%) and intestines (18%). Drug does not kumulirut in an organism, poorly gets through a blood-brain barrier, is excreted in breast milk.
At patients of advanced age bioavailability and the maximum concentration of a pantoprazol increases a little. At patients with cirrhosis the elimination half-life increases up to 7-9 h, at a renal failure increases slightly.
Indications to use:
Peptic ulcer of a stomach and 12-perstny gut in aggravation stages, a reflux esophagitis, Zollingera-Ellison's syndrome, and also as a part of a combination therapy for the purpose of Helicobacter piroli eradikation
Route of administration and doses:
To adults and children 14 years are more senior appoint on 1 tablet (40 mg) a day to or during food, without chewing and washing down with liquid. At erozivno and ulcer forms a reflux esophagitis increase in a dose up to 2 tablets is possible (80 mg - the maximum daily dose).
Duration of therapy is established individually depending on indications: at an ulcer of a 12-perstny gut - 2-4 weeks, at stomach ulcer, a reflux esophagitis of-4-8 weeks.
As a part of the combined eradikatsionny antikhelikobakternoa of therapy - on 1 tablet (40 mg) 2 times a day. Duration of a course eradikatsionny therapy-7-14dney.
At patients of advanced age and at patients with an impaired renal function the daily dose should not exceed 40 mg of a pantoprazol. At heavy abnormal liver functions the dose of drug can be lowered to 1 tablet (40 mg) of 1 times 2 days.
Features of use:
It is not recommended to appoint to patients with not ulcer dyspepsia.
Before the beginning and after the end of treatment control for an exception of malignant new growths as it пантопразол can mask symptoms is obligatory endoscopic and otstrachivat establishment of the diagnosis. The diagnosis a reflux esophagitis demands obligatory endoscopic confirmation.
At purpose of drug patients with the broken function of a liver in the course of treatment should control activity of liver enzymes. In case of its increase пантопразол it is necessary to cancel.
Pregnancy and lactation.
Use of drug is possible only when the expected advantage for mother exceeds potential risk for a fruit or the child.
During treatment pantoprazoly it is necessary to stop feeding by a breast.
There is no experience of use of a pantoprazol for children up to 14 years.
Influence on control of vehicles or other difficult mechanisms. At use of drug it is necessary to abstain from control of vehicles and work with potentially dangerous mechanisms.
Side effects:
From the alimentary system: diarrhea; occasionally - nausea, an eructation,
vomiting, abdominal pain, meteorism, dryness in a mouth, the increased appetite.
From the central nervous system: headache; seldom - dizziness, weakness, drowsiness, sleeplessness, in isolated cases - initial displays of depressions, nervousness, a tremor, paresthesias, photophobia, vision disorders, a sonitus.
From integuments: in isolated cases - an alopecia, an acne, eksfoliativny dermatitis.
Allergic reactions: is rare-pour, an itch, a Quincke's disease.
Others: seldom - a hyperglycemia, a mialgiya.
Interaction with other medicines:
Pantoprazol influences rn-dependent absorption, slowing down it for weak acids and accelerating for alkali. Let's combine with drugs which метаболизуються with the participation of fermental system of P450 cytochrome. Clinically significant interaction пантопразолп is not revealed at co-administration with carbamazepine, caffeine, diazepam, diclofenac, ditoxin, ethanol, glibenclamide, metoprololy, nifedipine, Phenytoinum, theophylline, warfarin, oral contraceptives.
Contraindications:
Digestive tract malignancies, heavy liver failure. Hypersensitivity to drug components. Pregnancy and lactation. Children up to 14 years.
Overdose:
At overdose strengthening of side effect is possible.
Treatment: drug withdrawal, the symptomatic therapy directed to maintenance of the vital functions of an organism. Hemodialysis not effectively. There is no specific antidote.
Storage conditions:
To store in the unavailable to children, dry, protected from light place at a temperature from 15 °C to +25 °C.
Issue conditions:
According to the recipe
Packaging:
On 10 tablets in a blister strip packaging, on 1 strip packaging in a pack, on 3 strip packagings in a pack.
