ZIPANTOLA
Active material: Pantoprazole
When ATH: A02BC02
CCF: Inhibitor N+-K+-ATPase. Anti-ulcer drug
ICD-10 codes (testimony): E16.8, K21, K25, K26, K27
When CSF: 11.01.03
Manufacturer: PLIVA CROATIA d.o.o. (Croatia)
Pharmaceutical form, composition and packaging
Pills, enteric coated yellow color, round, lenticular, with an inscription “RA 783” green on one side.
| 1 tab. | |
| pantoprazole (in the form of pantoprazole sodium sesquihydrate) | 20 mg |
Excipients: mannitol, krospovydon, giproloza, sodium lauryl, colloidal silicon dioxide, talc, magnesium stearate.
The composition of the coating film: opadraj AMV yellow 80W32009 (partially hydrolyzed polyvinyl alcohol, Titanium dioxide, talc, iron oxide yellow (E172), Lacquer based on quinoline yellow (E104) and aluminum, lecithin (soy), xanthan gum).
The composition of the enteric coating: eudragit L30D-55 (a copolymer of methacrylic acid and ethyl acrylate (1:1), sodium lauryl, polysorbate 80, water), glyceryl monostearate, triэtiltsitrat, polysorbate 80; 5312 food color labeling (brilliant blue FCF, ethanol).
14 PC. – blisters (2) – packs cardboard.
Pills, enteric coated yellow color, round, lenticular, with an inscription “RA 784” green on one side.
| 1 tab. | |
| pantoprazole (in the form of pantoprazole sodium sesquihydrate) | 40 mg |
Excipients: mannitol, krospovydon, giproloza, sodium lauryl, colloidal silicon dioxide, talc, magnesium stearate.
The composition of the coating film: opadraj AMV yellow 80W32009 (partially hydrolyzed polyvinyl alcohol, Titanium dioxide, talc, iron oxide yellow (E172), Lacquer based on quinoline yellow (E104) and aluminum, lecithin (soy), xanthan gum).
The composition of the enteric coating: eudragit L30D-55 (a copolymer of methacrylic acid and ethyl acrylate (1:1), sodium lauryl, polysorbate 80, water), glyceryl monostearate, triэtiltsitrat, polysorbate 80; 5312 food color labeling (brilliant blue FCF, ethanol).
14 PC. – blisters (2) – packs cardboard.
Pharmacological action
Proton pump inhibitor (N+-K+-ATPase). Blocks the final stage of hydrochloric acid secretion, lowering both basal and stimulated secretion, regardless of the nature of the stimulus. The selectivity of the therapeutic effect of pantoprazole is manifested in, it acts in acidic medium at a pH < 3, at high pH values pantoprazole virtually inactive.
When duodenal ulcer, associated with Helicobacter pylori, normalization of secretion in the stomach increases the sensitivity of microorganisms to antibiotics. No effect on the motility of the gastrointestinal tract. Secretory activity normalized by 3-4 the day after taking the drug.
Pharmacokinetics
Absorption
Rapidly absorbed from the gastrointestinal tract. Bioavailability is about 77%. Eating does not affect the bioavailability of. Cmax Plasma is 2-3 ug / ml, achieved through 2.5 hours and does not change when multiple dose.
Distribution and metabolism
Vd is about 0.15 l / kg. Pantoprazole metabolism occurs primarily in the liver.
Deduction
Report mostly kidneys (about 80%) as metabolites. T1/2 – about 1 no.
Testimony
- Gastroesophageal reflux disease;
- Gastric ulcer and duodenal ulcer in the acute phase;
- 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 taking NSAIDs;
- Helicobacter pylori eradication in combination with two antibiotics for stomach ulcers and ulcer dvenadtsaperstnoy, gastric.
Dosage regimen
The drug is taken orally, with some liquid and swallowing whole (Tablets can not crush or dissolve).
The drug is recommended to take before breakfast or during. Using drugs 2 times / day is recommended to take a second dose before dinner.
At gastroesophageal reflux disease appoint 20-80 mg / day (depending on the severity of the pathological process). A course of treatment – 4-8 weeks.
At gastric ulcer and duodenal ulcer, erosive gastritis – by 40-80 mg / day. The course of treatment during exacerbation of duodenal ulcer – 2 of the week, an exacerbation of gastric ulcer – 4-8 weeks.
To eradication of Helicobacter pylori – by 40 mg 2 times / day in combination with two antibacterial agents for 7-14 days (depending on the applied treatment regimen).
At erosive and ulcerative lesions of the stomach and duodenum, associated with taking NSAIDs, – by 40-80 mg / day. A course of treatment – 4-8 weeks.
To prevention of erosive and ulcerative lesions of gastric and duodenal ulcers in patients receiving NSAIDs, – by 20 mg / day.
In Patients with severe hepatic impairment dose should not exceed 20 mg / day. In this case it is necessary to monitor the biochemical parameters of blood. An increase in liver enzymes should discontinue use of the drug.
Elderly patients, as well as in patients with impaired renal function, Do not exceed the daily dose 40 mg. An exception is the use of combination antimicrobial therapy for Helicobacter pylori, when and elderly patients should take a dose of pantoprazole 40 mg 2 times / day.
Side effect
CNS: headache, dizziness.
From the digestive system: diarrhea, nausea, pain in the upper abdomen, constipation, flatulence.
Allergic reactions: skin rash, itchiness and redness of the skin, anaphylactic reactions, including anaphylactic shock.
Other: painful tension of the mammary glands, hyperthermia; rarely – going after drug withdrawal depression, myalgia, weakness, dizziness, violation of visual acuity.
During use of pantoprazole rarely can appear heavy hepatocellular injury with jaundice or hepatic dysfunction, severe skin lesions, photosensitivity.
Contraindications
- Dyspepsia nevroticheskogo genesis;
- Hypersensitivity to the drug.
It is a caution use the drug during pregnancy, lactation, hepatic failure.
Pregnancy and lactation
Caution is advised to use the drug during pregnancy and lactation (breast-feeding).
Cautions
Before and after treatment, be sure to conduct endoscopic examinations to rule out the possibility of the presence of malignant disease of the stomach or esophagus, tk. pantoprazole treatment can mask the symptoms and delay the correct diagnosis.
Use in Pediatrics
The drug should not be prescribed to children, tk. data on its clinical application in pediatric no.
Overdose
To date, drug overdose effects were noted Zipantola.
Drug Interactions
The simultaneous use of pantoprazole may reduce the absorption of drugs, bioavailability which is dependent on the pH of the stomach (eg, ketoconazole).
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
List B. The drug should be stored out of reach of children at or above 30 ° C. Shelf life – 2 year.
