Sanpras, 40 mg 30 pcs.

H+-K+-ATPase inhibitor. Sanpraz blocks the final stage of chlorohydric (hydrochloric) acid secretion, reduces the level of basal and stimulated (regardless of the type of irritant) chlorohydric (hydrochloric) acid secretion in the stomach.

In duodenal ulcer associated with Helicobacter pylori, decreased gastric secretion increases the sensitivity of the micro-organism to antibiotics.

Pharmacokinetics

Absorption
After oral administration pantoprazole is rapidly absorbed from the GI tract. Cmax is reached after 2.5 hours and is 2-3 mg/l, herewith Cmax value remains unchanged after multiple administration. Bioavailability is 65-77%.

Elimination
T1/2 is about 1 hour.

Indications

Active ingredient

Composition

1 tablet contains:

The active ingredient:

Pantoprazole 40 mg;

Associates:

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;

Composition of the shell:

Methacrylic acid and ethyl acrylate copolymer (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.

How to take, the dosage

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

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

For eradication of Helicobacter pylori it is prescribed in combination with antimicrobial agents for 40 mg 2 times per day. The course of therapy is 7-14 days.

In erosive-ulcerative lesions of the stomach and duodenum associated with taking NSAIDs, it is prescribed in 40-80 mg per day. The course of treatment is 4-8 weeks. For prophylaxis of erosive lesions at a background of long-term use of NSAIDs – 20 mg/day.

In case of reflux esophagitis, 20-40 mg/day are prescribed. The course of therapy makes up 4-8 weeks. For prevention of exacerbations 20 mg/day are taken.

Interaction

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

The co-administration of Sanprase with atazanavir decreases the plasma concentrations of atazanavir and reduces its therapeutic effect.

. In specific tests of Sanprase with drugs such as digoxin, nifedipine, metoprolol, amoxicillin, clarithromycin, oral contraceptives (levonorgestrel/ethinylestradiol), 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, prothrombin time increases when concomitant use of the drug with warfarin, which may lead to bleeding, up to and including death. It is recommended that prothrombin time be determined.

Special Instructions

The use of pantoprazole in dyspepsia of neurogenic genesis is not effective.

In the presence of any of the alarming symptoms (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, anemia, or melena) and if gastric ulcer is suspected or present, the possibility of malignancy should be excluded, as treatment with pantoprazole may reduce symptoms and delay correct diagnosis. If symptoms persist despite adequate treatment, further evaluation should be performed.

Endoscopic evaluation is necessary before and after treatment to exclude the possibility of gastric or esophageal malignancies, as treatment may mask symptoms and delay correct diagnosis.

Pediatric use

There are insufficient data on the use of the drug in children under 18 years of age.

Impact on ability to drive and operate machinery

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

Contraindications

With caution, the drug is prescribed in hepatic insufficiency.

Side effects

When taking Sanprase according to the indications and in the recommended doses, adverse events are extremely rare.

CNS disorders: sometimes headache; rarely – depression, hallucinations (especially in predisposed patients), disorientation and confusion; in single cases – dizziness or visual disturbances.

The digestive system: sometimes – upper abdominal pain, diarrhea, constipation, flatulence; rarely – nausea, vomiting, dry mouth; very rarely – hepatocellular failure leading to jaundice with or without liver failure, increased liver enzyme activity (transaminase, glutamyl transpeptidase).

Muscular system disorders: rare – arthralgia; in single cases – myalgia.

Hematopoietic system: very rare – leukopenia, thrombocytopenia.

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

Pregnancy use

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

There are no data on excretion of pantoprazole with breast milk. Breast-feeding should be stopped while taking the drug.

In experimental fertility studies, minor embryotoxicity has been noted in doses greater than 5 mg/kg.

Similarities