Composition, form of production and packaging
The tablets covered with an enteric coating of yellow color, round, biconcave.
1 tab.
pantoprazole sodium sesquihydrate 45.1 mg,
which corresponds to the content of pantoprazole 40 mg
[PRING] magnesium oxide - 18 mg, calcium carbonate - 81.4 mg, crospovidone - 35 mg, sodium lauryl sulfate - 5 mg, calcium stearate - 3 mg, silicon dioxide colloid - 5 mg.
The composition of the shell: a copolymer of methacrylic acid and ethyl acrylate (1: 1) 11 mg, triethyl citrate 1.1 mg, kopividone 7 mg, talc 10.7 mg, titanium dioxide (E171) 0.8 mg, iron oxide yellow (E172) 0.2 mg , macrogol 6000 - 0.35 mg.
10 pieces. - Strips aluminum (1) - packs cardboard.
10 pieces. - Strips aluminum (2) - packs cardboard.
10 pieces. - Strips aluminum (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
H + -K + -ATPase inhibitor. It blocks the final stage of the secretion of hydrochloric acid (hydrochloric acid), reduces the level of basal and stimulated (regardless of the type of stimulus) secretion of hydrochloric acid (hydrochloric acid) in the stomach. In duodenal ulcer associated with Helicobacter pylori, a decrease in gastric secretion increases the sensitivity of microorganism 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
After taking the drug, pantoprazole is rapidly absorbed from the digestive tract. C max is achieved in 2.5 hours and is 2-3 mg / l, while the value of C max remains unchanged with multiple reception. Bioavailability of 65-77%.
Excretion
T 1/2 - about 1 hour.
INDICATIONS
- Stomach ulcer or duodenal ulcer in the phase of exacerbation;
- erosive gastritis (including associated with Helicobacter pylori);
- erosive and ulcerative lesions of the stomach and duodenum, associated with the intake of NSAIDs;
- reflux esophagitis.
DOSING MODE
With peptic ulcer of stomach and duodenum, erosive gastritis, the drug is prescribed for 40-80 mg / day. The course of treatment for exacerbation of peptic ulcer of the duodenum is 2 weeks, and gastric ulcer is 4-8 weeks.
For prevention of exacerbations of peptic ulcer of the stomach and duodenum , 20 mg / day are prescribed.
For the eradication of Helicobacter pylori take 40 mg 2 times / day in combination with antimicrobial agents. The course of therapy is 7-14 days.
With erosive and ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs, 40-80 mg / day is prescribed. The course of treatment is 4-8 weeks. For the prevention of erosive lesions against the background of prolonged use of NSAIDs - 20 mg / day.
When reflux-esophagitis is prescribed for 20-40 mg / day. The course of therapy is 4-8 weeks. For the prevention of exacerbations take 20 mg / day.
In patients with severe impairment of liver function, the dose should be reduced to 40 mg once every 2 days, while biochemical blood counts should be monitored.When the activity of hepatic enzymes is increased, the drug should be discontinued.
Tablets are taken internally as a whole (without crushing or dissolving), with a sufficient amount of liquid. The drug is recommended to take 1 hour before breakfast, with the frequency of reception 2 times / day the second dose - 1 hour before dinner.
SIDE EFFECT
From the side of the central nervous system: headache; very rarely - depression, weakness, dizziness, impaired vision.
From the digestive system: diarrhea, nausea, pain in the upper abdomen, constipation, flatulence; in isolated cases (1 case for 10 6 patients) - severe hepatocellular liver damage with jaundice, liver function disorders.
Allergic reactions: skin rash, itching, skin hyperemia, anaphylactic reactions (up to shock).
Other: painful tension of mammary glands, hyperthermia.
CONTRAINDICATIONS
- dyspepsia of neurotic genesis;
- malignant diseases of the digestive tract;
- Children's age (due to lack of data on the use of the drug in pediatric practice);
- Hypersensitivity to pantoprazole.
With caution appoint a drug for liver failure.
PREGNANCY AND LACTATION
With caution appoint the drug during pregnancy and lactation (breastfeeding).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with severe impairment of liver function, the dose should be reduced to 40 mg once every 2 days, while biochemical blood counts should be monitored.When the activity of hepatic enzymes is increased, the drug should be discontinued.
APPLICATION FOR CHILDREN
Contraindication: children's age (due to lack of data on the use of the drug in pediatric practice).
SPECIAL INSTRUCTIONS
Before and after the end of therapy, endoscopic control (if necessary with biopsy) is necessary to exclude a malignant neoplasm of the stomach or esophagus, becauseThe use of the drug may delay the formulation of the correct diagnosis.
OVERDOSE
Data on the overdose of Sunpras is not available.
DRUG INTERACTION
With the simultaneous use of pantoprazole can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach (for example, ketoconazole).
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light and out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
