Description
Latin name
Sunpras
Release form
Enteric coated tablets
packaging 30 pcs
Pharmacological action of
Sanpraz is an inhibitor of H + -K + -ATPase. Sanpraz blocks the final stage of the secretion of hydrochloric (hydrochloric) acid, reduces the level of basal and stimulated (regardless of the type of stimulus) secretion of hydrochloric (hydrochloric) acid in the stomach. In case of duodenal ulcer associated with Helicobacter pylori, a decrease in gastric secretion increases the sensitivity of the microorganism to antibiotics.
Pharmacokinetics
Absorption
After oral administration, pantoprazole is rapidly absorbed from the gastrointestinal tract. Cmax is reached after 2.5 hours and amounts to 2-3 mg / l, while the Cmax value remains unchanged with repeated administration. Bioavailability of 65-77%.
Withdraw
T1 / 2 – about 1 hour.
Indications
peptic ulcer of the stomach or duodenum in the acute phase
erosive gastritis (incl. associated with Helicobacter pylori)
erosive and ulcerative lesions of the stomach and duodenum associated with NSAIDs
reflux esophagitis.
Contraindications
dyspepsia of neurotic origin
malignant gastrointestinal tract
childhood (due to lack of data on the use of the drug in pediatric practice)
hypersensitivity to pantoprazole.
With caution, the drug is prescribed for liver failure.
Use during pregnancy and lactation
Experience with the drug during pregnancy and lactation is limited. The drug can be used during pregnancy only if the benefit to the mother outweighs the possible risk to the fetus.
There is no data on the release of pantoprazole with breast milk. You should stop breastfeeding while taking the drug.
In experimental studies of reproductive function, slight embryotoxicity was observed in doses exceeding 5 mg / kg.
Composition
1 tablet contains:
Active ingredient: pantoprazole 40 mg
Excipients: magnesium oxide – 18 mg, calcium carbonate – 81.4 mg, crospovidone – 35 mg, sodium lauryl sulfate – 5 mg, calcium stearate – 3 mg, silicon colloidal – 5 mg
Shell composition: copolymer of methacrylic acid and ethyl acrylate (1: 1) – 11 mg, triethyl citrate – 1.1 mg, copovidone – 7 mg, talc – 10.7 mg, titanium dioxide (E171) – 0.8 mg, iron oxide yellow ( E172) – 0.2 mg, macrogol 6000 – 0.35 mg.
Dosage and administration of
In case of peptic ulcer of the stomach and duodenum, erosive gastritis, the drug is prescribed at 40-80 mg / day. The course of treatment for exacerbation of duodenal ulcer is 2 weeks, and gastric ulcer – 4-8 weeks.
To prevent exacerbations of peptic ulcer of the stomach and duodenum, 20 mg / day are prescribed.
To eradicate 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 NSAIDs, appoint 40-80 mg / day. 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.
For reflux esophagitis, 20 40 mg / day is prescribed. The course of therapy is 4-8 weeks. To prevent exacerbations, take 20 mg / day.
Side effects
When taking Sanpraz in accordance with the indications and in the recommended doses, side effects are extremely rare.
From the side of the central nervous system: sometimes – headache rarely – depression, hallucinations (especially in predisposed patients), disorientation and confusion in isolated cases – dizziness or visual impairment.
From the digestive system: sometimes – pain in the upper abdomen, diarrhea, constipation, flatulence rarely – nausea, vomiting, dry mouth is very rare – hepatocellular insufficiency, leading to jaundice with or without liver failure, increased activity of liver enzymes (transaminases, glutamyl transpeptidases).
From the musculoskeletal system: rarely – arthralgia in isolated cases – myalgia.
From the hemopoietic system: very rarely – leukopenia, thrombocytopenia.
Allergic reactions: very rarely – anaphylactic reactions, including anaphylactic shock, urticaria, angioedema.
Drug Interaction
Concomitant administration of Sanpraz may reduce the absorption of drugs whose bioavailability depends on the pH of the gastric medium (including ketoconazole, iron salts, ritonavir).
When combined with Sanpraz with atazanavir, plasma concentrations of atazanavir are reduced and its therapeutic effect is reduced. srdl srpl srpl With the specific tests of Sanprazip with drugs such as digoxin, nifedipine, metoprolol, amoxicillin, clarithromycin, oral contraceptives (levonorgestrel / etinilestradiol), diclofenac, pheroxaprox, pirox, pirox , cisapride, midazolam, metronidazole, theophylline, caffeine, ethanol no clinically relevant interaction was found.
According to post-marketing data, when co-administered with warfarin, prothrombin time increases, which can lead to bleeding up to death. It is recommended to determine prothrombin time.
Storage Conditions
In a dark place at 10 – 25 ° C.
Shelf life
3 years.
Active ingredient
Pantopr sol
tablet dosage form of tablets
Possible product names
SANPRAZ 0.04 N10 TABLE P / O
SANPRAZ 0.04 N30 TABLE P / O
Sanpraz 40mg Tab. cover intestines. pl. about. X30
Sanpraz 40mg No. 30
SANPRAZ 40MG. No. 30 TAB. P / O
San Pharmaceutical Industries Ltd, India
