Sunpraz, pills 40mg, 30pcs

Composition

1 tablet contains:  

Active ingredient:

pantoprazole 40 mg;

Auxiliary substances:

magnesium oxide-18 mg,

calcium carbonate-81.4 mg,

crospovidone-35 mg,

sodium lauryl sulfate-5 mg,

calcium stearate-3 mg,

colloidal silicon dioxide-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 (E 171) – 0.8 mg, iron oxide yellow (E 172) – 0.2 mg, macrogol 6000-0.35 mg

Pharmacological action

Inhibitor of H+ – K+ – ATPASE. Sunpraz blocks the final stage of hydrochloric acid secretion, reduces the level of basal and stimulated (regardless of the type of stimulus) secretion of hydrochloric acid in the stomach.

In Helicobacter pylori-associated duodenal ulcer, a decrease in gastric secretion increases the sensitivity of microgranismus to antibiotics.

Pharmacokinetics

Absorption After oral use, pantoprazole is rapidly absorbed from the gastrointestinal tract. Cmax is reached in 2.5 hours and is 2-3 mg / l, while the Cmax value remains unchanged with repeated use. Bioavailability is 65-77%.

Vydaveniyet1 / 2-about 1 hour.

Indications

• peptic ulcer of the stomach or duodenum in the acute phase;
• erosive gastritis (including associated with Helicobacter pylori);
• erosive and ulcerative lesions of the stomach and duodenum associated with NSAID use;
• reflux esophagitis.

Use during pregnancy and lactation

Experience of using the drug during pregnancy and lactation is limited. The drug can be used during pregnancy only if the benefit to the mother exceeds the possible risk to the fetus.

There are no data on the excretion of pantoprazole in breast milk. You should stop breastfeeding while taking the drug.

In experimental studies of reproductive function, minor embryotoxicity was noted at doses exceeding 5 mg / kg.

Contraindications

• dyspepsia of neurotic origin;
• malignant diseases of the gastrointestinal tract;
• childhood (due to the lack of data on the use of the drug in pediatric practice);
• hypersensitivity to pantoprazole.

With caution, the drug is prescribed for hepatic insufficiency.

Side effects

When taking Sunpraz in accordance with the indications and in the recommended doses, side effects are extremely rare.

From 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; very rarely-hepatocellular insufficiency, leading to jaundice with or without liver failure, increased activity of liver enzymes (transaminases, glutamyltranspeptidases).

From the musculoskeletal system: rarely-arthralgia; in isolated cases-myalgia.

From the hematopoietic system: very rarely – leukopenia, thrombocytopenia.

Allergic reactions: very rarely – anaphylactic reactions, including anaphylactic shock, urticaria, angioedema.

Interaction

Concomitant use of Sunpraz may reduce the absorption of drugs whose bioavailability depends on the pH of the stomach environment (including ketoconazole, iron salts, ritonavir).

When Sunpraz is co-administered with atazanavir, plasma concentrations of atazanavir decrease and its therapeutic effect decreases.

When performing specific Sunpraza tests with such drugs as digoxin, nifedipine, metoprolol, amoxicillin, clarithromycin, oral contraceptives (levonorgestrel/ethinyl estradiol), diclofenac, phenazone, naproxen, piroxicam, glibenclamide, levothyroxine sodium, diazepam, carbamazepine, phenytoin, cyclosporine, tacrolimus, cisapride, midazolam, metronidazole, theophylline, caffeine, ethanol no clinically significant interaction was found.

According to post-marketing data, when the drug is co-administered with warfarin, the prothrombin time increases, which can lead to bleeding, up to a fatal outcome. It is recommended to determine the prothrombin time.

How to take, course of use and dosage

For peptic ulcer of the stomach and duodenum, erosive gastritis, the drug is prescribed at 40-80 mg / day. The course of treatment for acute duodenal ulcer is 2 weeks, and gastric ulcer-4-8 weeks.

For the prevention of exacerbations of peptic ulcer of the stomach and duodenum,20 mg/day is prescribed.

To eliminate Helicobacter pylori, take 40 mg 2 times a day in combination with antimicrobial agents. The course of therapy is 7-14 days.

For erosive and ulcerative lesions of the stomach and duodenum associated with taking 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 long-term 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.

Special instructions

The use of pantoprazole in neurogenic dyspepsia is not effective.

In the presence of any of the disturbing symptoms (e. g. significant unintended weight loss, recurrent vomiting, dysphagia, anemia, or melena) and in the case of suspected or present stomach ulcers, the possibility of malignancy should be excluded, as treatment with pantoprazole may reduce symptoms and delay the correct diagnosis. If symptoms persist despite adequate treatment, then a further examination should be performed.

Before and after treatment, endoscopic monitoring is required to exclude the possibility of malignant diseases of the stomach or esophagus, since treatment can mask the symptoms and delay the correct diagnosis.

Use in pediatrics

There are not enough data on the use of the drug in children under 18 years of age.

Influence on the ability to drive motor vehicles and manage mechanisms

The use of the drug does not affect the patient’s ability to perform work that requires increased attention and speed of psychomotor reactions.

Form of production

Enteric coated tablets.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Pantoprazole

Conditions of release from pharmacies

By prescription

Dosage form

Tablets