Composition, form of production and packaging
The tablets covered with an enteric-soluble coating of yellow color, round, biconcave, with the inscription "RA 783" green on one side.
1 tab.
Pantoprazole (in the form of pantoprazole sodium sesquihydrate) 20 mg
Excipients: mannitol, crospovidone, giprolose, sodium lauryl sulfate, silicon dioxide colloid, talc, magnesium stearate.
Composition of the film shell: opadrai AMV yellow 80W32009 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow (E172), lacquer based on quinoline yellow (E104) and aluminum, lecithin (soybean), xanthan gum).
Ingredients of the enteric coating: eukrazhet L30D-55 (copolymer of methacrylic acid and ethyl acrylate (1: 1), sodium lauryl sulfate, polysorbate 80, water), glyceryl monostearate, triethyl citrate, polysorbate 80; 5312 food coloring for the inscription (diamond blue FCF, ethanol).
14 pcs. - blisters (2) - packs of cardboard.
The tablets covered with an enteric-soluble coating of yellow color, round, biconcave, with the inscription "RA 784" green on one side.
1 tab.
pantoprazole (in the form of pantoprazole sodium sesquihydrate) 40 mg
Excipients: mannitol, crospovidone, giprolose, sodium lauryl sulfate, silicon dioxide colloid, talc, magnesium stearate.
Composition of the film shell: opadrai AMV yellow 80W32009 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow (E172), lacquer based on quinoline yellow (E104) and aluminum, lecithin (soybean), xanthan gum).
Ingredients of the enteric coating: eukrazhet L30D-55 (copolymer of methacrylic acid and ethyl acrylate (1: 1), sodium lauryl sulfate, polysorbate 80, water), glyceryl monostearate, triethyl citrate, polysorbate 80; 5312 food coloring for the inscription (diamond blue FCF, ethanol).
14 pcs. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Proton pump inhibitor (H + -K + -ATPase). It blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus. The selectivity of the therapeutic effect of pantoprazole is manifested in the fact that it acts in an acidic medium at pH <3, for large pH values ​​pantoprazole is practically inactive.
In duodenal ulcer associated with Helicobacter pylori, normalization of secretion in the stomach increases the sensitivity of microorganisms to antibiotics. Does not affect the motility of the gastrointestinal tract. Secretory activity is normalized 3-4 days after the end of the drug intake.
PHARMACOKINETICS
Suction
Quickly absorbed from the digestive tract. Bioavailability is about 77%. Eating does not affect bioavailability. C max in plasma is 2-3 mcg / ml, achieved after 2.5 h and does not change with repeated admission.
Distribution and Metabolism
V d is about 0.15 l / kg. Metabolism of pantoprazole occurs mainly in the liver.
Excretion
It is excreted mainly by the kidneys (about 80%) in the form of metabolites. T 1/2 - about 1 hour.
INDICATIONS
- gastroesophageal reflux disease;
- Stomach ulcer and duodenal ulcer in the phase of exacerbation;
- Zollinger-Ellison syndrome and other pathological conditions associated with increased secretion;
- stress ulcers of the stomach and duodenum;
- erosive and ulcerative lesions of the stomach and duodenum, associated with the intake of NSAIDs;
- eradication of Helicobacter pylori in combination with two antibiotics for peptic ulcer of stomach and duodenum, gastritis.
DOSING MODE
The drug is taken orally, squeezed with liquid and swallowed whole (tablets can not be ground or dissolved).
The drug should be taken before breakfast or during it. When applying the drug 2 times / day the second dose is recommended before supper.
In gastroesophageal reflux disease , 20-80 mg / day is prescribed (depending on the severity of the pathological process). The course of treatment is 4-8 weeks.
With peptic ulcer of the stomach and duodenum, erosive gastritis - 40-80 mg / day. The course of treatment for exacerbation of duodenal ulcer is 2 weeks, with peptic ulcer exacerbation 4-8 weeks.
To eradicate Helicobacter pylori - 40 mg 2 times / day in combination with two antibacterial agents for 7-14 days (depending on the treatment regimen used).
With erosive and ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs, 40-80 mg / day. The course of treatment is 4-8 weeks.
For the prevention of erosive and ulcerative lesions of the stomach and duodenum against the background of NSAIDs, - 20 mg / day.
In patients with severe impairment of liver function, the dose of the drug should not exceed 20 mg / day. In this case it is necessary to control the biochemical parameters of the blood. With an increase in the level of liver enzymes should stop using the drug.
Elderly patients, as well as patients with impaired renal function , can not exceed a daily dose of 40 mg. An exception is the use of combined antibacterial therapy for Helicobacter pylori, when elderly patients should take pantoprazole at a dose of 40 mg 2 times / day.
SIDE EFFECT
From the side of the central nervous system: headache, dizziness.
From the digestive system: diarrhea, nausea, pain in the upper abdomen, constipation, flatulence.
Allergic reactions: skin rash, itching and flushing of the skin, anaphylactic reactions, including anaphylactic shock.
Other: painful tension of the mammary glands, hyperthermia; very rarely - depression after depression, myalgia, weakness, dizziness, visual acuity.
During the application of pantoprazole, severe hepatocellular damage with jaundice or a dysfunction of the liver, severe skin lesions, photosensitivity is extremely rare.
CONTRAINDICATIONS
- dyspepsia of neurotic genesis;
- Hypersensitivity to the components of the drug.
It should be used with caution in pregnancy, during lactation, with liver failure.
PREGNANCY AND LACTATION
It should be used with caution in pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with impaired renal function should not exceed a daily dose of 40 mg.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with severe impairment of liver function, the dose of the drug should not exceed 20 mg / day. In this case it is necessary to control the biochemical parameters of the blood. With an increase in the level of liver enzymes should stop using the drug.
APPLICATION FOR CHILDREN
The drug should not be given to children; there are no data on its clinical application in pediatric practice.
APPLICATION IN ELDERLY PATIENTS
Elderly patients should not exceed a daily dose of 40 mg. An exception is the use of combined antibacterial therapy for Helicobacter pylori, when elderly patients should take pantoprazole at a dose of 40 mg 2 times / day.
SPECIAL INSTRUCTIONS
Before and after treatment, endoscopic control should be performed to exclude the possibility of having malignant diseases of the stomach or esophagus. treatment with pantoprazole may mask symptoms and delay correct diagnosis.
Use in Pediatrics
The drug should not be given to children; there are no data on its clinical application in pediatric practice.
OVERDOSE
To date, there have been no overdose events of Zipantol.
DRUG INTERACTION
The simultaneous use of pantoprazole may reduce the absorption of drugs whose bioavailability depends on the pH of the stomach environment (eg, ketoconazole).
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 2 years.
