Nolpaza 40mg tablets 14 (Pantoprazole)

Country

Slovenia

INN

Pantoprazole

Dosage

40mg

Composition

Active ingredients: Pantoprazole sodium sesquihydrate 45.1 mg, which corresponds to the content of pantoprazole 40 mg.

Excipients: mannitol, crospovidone, sodium carbonate anhydrous, sorbitol, calcium stearate.

Shell composition: hypromellose, povidone, titanium dioxide (E171), iron dye yellow oxide (E172), propylene glycol, dispersion Eudragite L30D (copolymer of methacrylic acid and ethyl acrylate (1: 1) dispersion 30%, water, sodium lauryl sulfate, polysorbate-80), talc, macrogol 6000.

Pharmacological properties

H inhibitor ⁺ -K ⁺ -ATP-basics. Blocks the final stage of secretion of hydrochloric acid, reduces the level of basal and stimulated (regardless of the type of irritant) secretion of hydrochloric acid in the stomach. With ulcerative duodenal disease associated with Helicobacter pylori, such a decrease in gastric secretion increases the sensitivity of micro-organisms to antibiotics. Pantoprazole has its own antimicrobial activity against Helicobacter pylori.

Pharmacokinetics

Pantoprazole is rapidly absorbed after ingestion. With _max after taking the first dose, 20 mg is about 1.0-1.5 μg / ml.

The pharmacokinetics of pantoprazole after single and repeated use are the same. In the dose range of 10-80 mg, the pharmacokinetics of pantoprazole in the blood plasma remain linear both with oral and intravenous use.

The absolute bioavailability of pantoprazole when taken orally is about 77%. Binding to blood plasma proteins - 98%. V _d is 0.15 l/kg.

It is metabolized mainly in the liver. The main metabolic pathway is demethylation with CYP2C19 with subsequent sulfate conjugation. Other metabolic pathways include oxidation by CYP3A4.

Final T _1/2 is approximately 1 h, ground clearance - about 0.1 l / h / kg.

The main route of excretion is through the kidneys (about 80%) in the form of metabolites of pantoprazole, the rest is excreted with feces.

Indications for use

• gastroesophageal reflux disease (GERD), incl. erosive-ulcerative reflux esophagitis and symptoms associated with GERD: heartburn, regurgitation sour, pain when swallowing;
• erosive-ulcerative lesions of the stomach and duodenum associated with taking NSAIDs;
• peptic ulcer of the stomach and duodenum (treatment and prevention);
• eradication of Helicobacter pylori in combination with two antibiotics;
• Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

Contraindications

• hypersensitivity to pantoprazole or other components of the drug;
• the drug contains sorbitol, so it is not recommended for persons with rare hereditary intolerance to fructose;
• dyspepsia of neurotic genesis;
• children's age up to 18 years (efficacy and safety have not been studied).

With caution: pregnancy, lactation, liver failure, risk factors for cyanocobalamin deficiency (vitamin B) ₁₂ ), especially against the background of hypo- and achlorhydria

Use in pregnancy and lactation

Nolpase is contraindicated in pregnancy and lactation

Special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant neoplasm (endoscopic control, if necessary with a biopsy - especially with a stomach ulcer), because treatment, masking the symptoms, can postpone the correct diagnosis. If after 4 weeks of therapy with pantoprazole the patient does not have the desired therapeutic effect, he must undergo a second examination. Like other proton pump inhibitors, pantoprazole may reduce the absorption of cyanocobalamin (vitamin B) ₁₂ ) against the background of hypo- and achlorhydria. This should be especially taken into account during long-term treatment and in patients with risk factors for vitamin B deficiency. ₁₂ .

Long-term therapy, especially lasting more than 1 year, requires regular monitoring of the patient.

Effect on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. The drug does not affect the ability to drive a car or other technical means.

Dosage and Administration

Inside, the tablet should not be chewed and broken. Swallow the tablet whole, washed down with a small the amount of liquid before meals, usually before breakfast. With double intake, the second dose of the drug is recommended to be taken before dinner.

GERD, incl. erosive-ulcerative reflux esophagitis and associated symptoms: heartburn, regurgitation sour, pain when swallowing:

- mild degree: the recommended dose is 1 table. Nolpase 20 mg per day;

- moderate and severe: the recommended dose is 1-2 tablets. Nolpase at 40 mg per day (40-80 mg / day). Relief of symptoms usually occurs within 2-4 weeks. The course of therapy is 4-8 weeks. For prevention, as well as as a supportive long-term therapy, take 20 mg / day (1 tablet. Nolpase 20 mg), if necessary, the dose is increased to 40-80 mg / day. It is possible to take the drug "on demand" when symptoms occur.

Erosive-ulcerative lesions of the stomach and duodenum associated with taking NSAIDs: the recommended dosage is 1-2 tablets. Nolpase 40 mg (40–80 mg/day). Course of therapy — 4–8 weeks. For the prevention of erosive lesions against the background of prolonged use of NSAIDs - 20 mg each.

Peptic ulcer of the stomach and duodenum (treatment and prevention) - prescribe 40-80 mg / day. The course of treatment for exacerbation of duodenal ulcer is usually 2 weeks, gastric ulcer - 4-8 weeks. If necessary, the duration of therapy is increased.

Eradication of Helicobacter pylori (in combination with antibiotics): the recommended dose is 1 tablet. Nolpase (40 mg) 2 times a day in combination with two antibiotics, usually the course of anti-Helicobacter therapy is 7-14 days.

Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion: the recommended starting dose of long-term therapy with pantoprazole is 80 mg (2 tablets of Nolpase of 40 mg) per day, divided into 2 doses. In the future, the daily dose can be titrated depending on the initial level of gastric secretion. Possibly temporary increasing the daily dose of pantoprazole to 160 mg in order to adequately control gastric secretion. The duration of therapy is selected individually.

In patients with severe impairment of liver function, the dose of pantoprazole should not exceed 40 mg / day and it is recommended to regularly monitor the activity of "liver" enzymes, especially with long-term treatment with pantoprazole. With an increase in the activity of "liver" enzymes, it is recommended to cancel the drug.

In the elderly and patients with kidney disease, the maximum daily dose of pantoprazole is 40 mg. In elderly persons receiving eradication therapy with Helicobacter pylori, the duration of therapy usually does not exceed 7 days.

Side effects

From the organs of hematopoiesis: very rarely - leukopenia, thrombocytopenia.

From the digestive system: often - abdominal pain, diarrhea, constipation, flatulence; infrequently - nausea, vomiting; rarely - dry mouth; very rarely - increase activity of hepatic transaminases and gamma-glutamine transferase (GGT), severe liver damage leading to jaundice with or without hepatic insufficiency.

From the immune system: very rarely - anaphylactic reactions, including anaphylactic shock.

From the musculoskeletal system: rarely - arthralgia; very rarely - myalgia.

From the central and peripheral nervous system: often - headache; infrequently - dizziness, visual impairment (blurred vision).

Mental disorders: very rarely - depression.

From the genitourinary system: very rarely - interstitial nephritis.

Allergic reactions: infrequently - itching and rash; very rarely - urticaria, angioedema, Stevens-Johnson syndrome, polymorphic erythema or Lyell's syndrome, photosensitivity.

General disorders: very rarely - peripheral edema, hyperthermia, weakness, painful tension of the mammary glands, increased triglyceride levels.

Storage conditions

Store at a temperature not exceeding 30 ° C.

Shelf life: 3 years.

Keep out of reach of children.