SANPRAZ

Active material: Pantoprazole
When ATH: A02BC02
CCF: Inhibitor N⁺-K⁺-ATPase. Anti-ulcer drug
ICD-10 codes (testimony): K21.0, K25, K26, K27, K29
When CSF: 11.01.03
Manufacturer: Sun Pharmaceutical Industries Ltd. (India)

Pharmaceutical form, composition and packaging

Pills, enteric coated yellow color, round, lenticular.

Excipients: magnesium oxide, calcium carbonate, krospovydon, sodium lauryl, calcium stearate, colloidal silicon dioxide, polymethacrylate type C, triэtiltsitrat, kopovydon, Talcum cleared, Titanium dioxide, iron oxide yellow, polyethylene glycol 6000, isopropyl alcohol, acetone, Purified water.

10 PC. – aluminum strips (1) – packs cardboard.
10 PC. – aluminum strips (2) – packs cardboard.
10 PC. – aluminum strips (3) – packs cardboard.

Pharmacological action

Inhibitor H⁺-K⁺-ATPase. Blocking the final stage of secretion of hydrochloric (salt) acid, reduces basal and stimulated (regardless of the type razdrazhitelya) secretion of hydrochloric (salt) acid stomach. When duodenal ulcer, associated with Helicobacter pylori, reduction of gastric secretion increases the sensitivity to antibiotics mikroogranizma.

No effect on the motility of the gastrointestinal tract. Secretory activity normalized by 3-4 the day after taking the drug.

Pharmacokinetics

Absorption

After oral administration of pantoprazole is rapidly absorbed from the gastrointestinal tract. C_max achieved through 2.5 h and is 2-3 mg / l, wherein the C_max It remains unchanged after repeated admission. Bioavailability 65-77%.

Deduction

T_1/2 – about 1 no.

Testimony

- A stomach ulcer or duodenal ulcer in the acute phase;

- Erosive gastritis (incl. associated with Helicobacter pylori);

- Erosive and ulcerative lesions of the stomach and duodenum, associated with taking NSAIDs;

- Reflux esophagitis.

Dosage regimen

At gastric ulcer and duodenal ulcer, erosive gastritis the drug is prescribed for 40-80 mg / day. The course of treatment during exacerbation of duodenal ulcer is 2 of the week, and gastric ulcer – 4-8 weeks.

To prevention of relapse of gastric ulcer and duodenal ulcer appoint 20 mg / day.

To eradication of Helicobacter pylori Take 40 mg 2 times / day in combination with antimicrobial agents. The course of therapy – 7-14 days.

At erosive and ulcerative lesions of the stomach and duodenum, associated with taking NSAIDs, appoint 40-80 mg / day. A course of treatment – 4-8 weeks. To prevention of erosive lesions on the background of the prolonged use of NSAIDs – by 20 mg / day.

At reflux esophagitis appoint 20-40 mg / day. The course of therapy is 4-8 weeks. To prevention of exacerbations Take 20 mg / day.

In Patients with severe hepatic impairment the dose should be reduced to 40 mg 1 once every 2 day, It is necessary to monitor the biochemical parameters of blood. An increase in liver enzymes drug should be discontinued.

The tablets are taken orally entirely (do not crush or dissolve), drinking plenty of fluids. The drug is recommended to take over 1 hours before breakfast, at a multiplicity of reception 2 times / day second dose – for 1 hours before dinner.

Side effect

CNS: headache; rarely – depression, weakness, dizziness, blurred vision.

From the digestive system: diarrhea, nausea, pain in the upper abdomen, constipation, flatulence; in a few cases (1 case of 10⁶ patients) – severe hepatocellular liver damage with jaundice, abnormal liver function.

Allergic reactions: skin rash, itch, dermahemia, anaphylactic reactions (up to the shock).

Other: painful tension of the mammary glands, hyperthermia.

Contraindications

- Dyspepsia nevroticheskogo genesis;

- Malignant gastrointestinal diseases;

- Children's age (due to lack of data on the use of drugs in pediatric practice);

- Hypersensitivity to pantoprazole.

FROM caution prescribe the drug for liver failure.

Pregnancy and lactation

With care prescribe a drug during pregnancy and lactation (breast-feeding).

Cautions

Before and after the treatment required endoscopic control (if necessary – with biopsy) to exclude malignancy of the stomach or esophagus, tk. use of the drug may delay the correct diagnosis.

Overdose

Data on drug overdose Sanpraz not provided.

Drug Interactions

With 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

The drug should be stored in a dry, protected from light and away from children at a temperature no higher than 25 ° C. Shelf life – 3 year.