Nolpaz - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspenteric coated tablets

Composition:

1 tablet, coated with enteric coating, contains:

Core:

Active substance:

Pantoprazole sodium sesquihydrate 22.55 mg or 45.10 mg (corresponding to pantoprazole 20 mg or 40 mg)

Excipients:

Mannitol 5.95 mg or 11.90 mg, crospovidone 32.50 mg or 65.00 mg, sodium carbonate, anhydrous 5.00 mg or 10.00 mg, sorbitol 18.00 mg or 36.00 mg, calcium stearate 1.00 mg or 2.00 mg

Sheath:

Hypromellose 8.13 mg or 16.26 mg, povidone 0.20 mg or 0.40 mg, titanium dioxide, E171 0.15 mg or 0.30 mg, ferric oxide yellow oxide, E172 0.02 mg or 0.04 mg, propylene glycol 2.00 mg or 4.00 mg, methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion (dispersion of Eudragit L30D, besides methacrylic acids and ethyl acrylate copolymer and water, contains as sodium emulsifiers lauryl sulfate (0.7% calculated by dry matter in dispersion) and polysorbate 80 (2,3 %, calculated by dry matter in the dispersion)) 10.00 mg or 16.00 mg, talc 3.70 mg or 6.00 mg, macrogol 6000 1.00 mg or 1.60 mg.

Description:

Oval, slightly biconvex tablets, covered with a film coating of light yellowish-brown color.

View of the fracture: mass from white to light yellowish brown with a rough surface with a coat layer of light yellowish brown color.

Pharmacotherapeutic group:glands of the stomach secretion-lowering agent - proton pump inhibitor

Pharmacodynamics:

Inhibits the enzyme H + K + -ATP-asu ("proton pump") in parietal cells of the stomach and blocks, thus, the final stage of the synthesis of hydrochloric acid. This leads to a decrease in the level of basal and stimulated secretion of hydrochloric acid, regardless of the nature of the stimulus. After a single admission of 20 mg of pantoprazole, the action of pantoprazole occurs within the first hour, the maximum effect is achieved in 2-2.5 hours. Does not affect the motility of the gastrointestinal tract (GIT). After discontinuation of the drug secretory activity is completely restored after 3-4 days.

Pharmacokinetics:Pantoprazole quickly absorbed from the gastrointestinal tract, the maximum concentration in the plasma (C_mOh) (1-1.5 μg / ml) is achieved after 2-2,5 hours after ingestion, with the value of C_max remains constant with multiple reception. Bioavailability of the drug is 77%. Simultaneous food intake does not affect the indicator area under the concentration-time curve (AUC), FROM_max, and bioavailability; there is only a change in the beginning of the drug.

The connection with plasma proteins is about 98%. The distribution volume is approximately 0.15 l / kg, and the clearance is 0.1 l / h / kg. Pantoprazole almost completely metabolized in the liver. It is an inhibitor of the enzyme system CYP2C19. The half-life (T1/2) - 1 hour. Due to the specific binding of pantoprazole to the proton pump of parietal cells, T1 / 2 does not correlate with the duration of the therapeutic effect. Excretion of metabolites (80%) mainly through the kidneys; the remainder is excreted with bile. The main metabolite, determined in serum and urine, desmethylpentoprazole, which is conjugated with sulfate. T1/2 desmethylpentoprazole, the main metabolite (about 1.5 hours) is much more than T1 / 2 most pantoprazole. In chronic renal failure (at including the who are on hemodialysis) no change in the dose of the drug is required. T1 / 2 - short, as in healthy individuals. Very small amounts of pantoprazole can be dialyzed.

Have patients with cirrhosis of the liver (Classes A and B by classification Child, Pugh) when taking pantoprazole 20 mg / day T1 / 2 increases to 3-6 hours, AUC increased by 3-5 times, a CW - in 1,3 times in comparison with healthy persons.

A small increase AUC and an increase in C_maxthe elderly patients compared with the corresponding data in young patients are not clinically significant.

Indications:

- Gastroesophageal reflux disease (GERD), including erosive-ulcerative reflux esophagitis and associated with GERD symptoms: heartburn regurgitation acidic, pain when swallowing;

- Erosive-ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);

- Stomach ulcer and duodenal ulcer, treatment and prevention;

- Eradication 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;

- Nolpaz contains sorbitol, so the drug is not recommended for individuals with a rare hereditary intolerance to fructose;

- Dyspepsia of neurotic genesis;

- Children under 18 years of age (efficacy and safety not studied).

Carefully:

Pregnancy, lactation, liver failure, risk factors for cyanocobalamin deficiency (vitamin B12) (especially against the background of hypo- and achlorhydria).

Pregnancy and lactation:

The experience with pantoprazole in pregnant women is limited. During pregnancy and during lactation, you can only use it if the positive effect for the mother justifies the possible risk to the fetus and the baby. There is no data on the isolation of pantoprazole with breast milk.

Dosing and Administration:Inside, the tablet should not be chewed and broken. The tablet should be swallowed whole, with a small amount of liquid, before meals, usually before breakfast. When taking twice a second dose of the drug is recommended before dinner.

GERD, including erosive-ulcerative reflux esophagitis and associated symptoms: heartburn, acid regurgitation, pain when swallowing:

- light degree: the recommended dose is 1 tablet of Nolpase (20 mg) per day.

- moderate and severe: the recommended dose is 1-2 tablets Nolpase 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 supporting long-term therapy, take 20 mg / day (1 tablet Nolpazy 20 mg), if necessary, increase the dose 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 the intake of NSAIDs:

The recommended dosage is 40-80 mg / day (1-2 tablets Nolpase 40 mg). The course of therapy is 4-8 weeks. For the prevention of erosive lesions against the background of prolonged use of NSAIDs

- on 20 mg.

Stomach ulcer and duodenal ulcer, treatment and prevention:

Assign 40-80 mg / day. The course of treatment for exacerbation of duodenal ulcer is usually 2 weeks, peptic ulcer of the stomach - 4-8 weeks. If necessary, the duration of therapy is increased.

Eradication Helicobacter pylori (in combination with antibiotics):

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

Zollinger's Syndrome - Ellison and others pathological conditions associated with increased gastric secretion:

The recommended starting dose of prolonged therapy with pantoprazole: 80 mg (2 tablets Nolpaz 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. Perhaps a temporary increase in the daily dose of pantoprazole to 160 mg with the aim of adequate control of gastric secretion.The duration of therapy is selected individually.

Patients with severe impairment of liver function the dose of pantoprazole should not exceed 40 mg per day and it is recommended to regularly monitor the activity of "liver" enzymes, especially with prolonged treatment with pantoprazole. When increasing the activity of "liver" enzymes, it is recommended to cancel the drug.

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

Side effects:

The side effects of the WHO classification are listed:

On the part of 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 - increased activity of "hepatic" transamine and gamma-glutamytransferase (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; infrequent - 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 - hives, angioedema, Stevens-Johnson syndrome, polymorphic erythema or Lyell syndrome, photosensitivity.

General disorders: very rarely - peripheral edema, hyperthermia, weakness, painful tension of the mammary glands, increase in the level of triglycerides.

With the development of severe adverse effects, drug treatment should be discontinued.

Overdose:

Symptoms overdoses in humans are not known.

Treatment: there is no specific antidote. In the case of an overdose of the drug, accompanied by the usual signs of intoxication, detoxification measures are used. Treatment is symptomatic.

Interaction:

Nolpase® reduces the absorption of drugs whose bioavailability depends on the pH of the stomach and is absorbed at acidic pH values (for example, ketoconazole). Pantoprazole is metabolized in the liver by the enzymatic system of cytochrome P450. It is impossible to exclude interactions of pantoprazole with drugs that are metabolized by the same system. Nevertheless, in clinical studies, no significant interactions with digoxin, diazepam, diclofenac, ethanol, phenytoin, glibencloid, carbamazepine, caffeine, metoprolol, naproxen, nifedipine, piroxicam, theophylline, and oral contraceptives. While using simultaneously with warfarin in clinical pharmacokinetic studies, no significant interactions were detected, several separate reports on the change in the international normalized relationship (INR) were noted. In patients receiving coumarin anticoagulants, simultaneously with pantoprazole, it is recommended that monitor prothrombin time or INR.

With the simultaneous administration of pantoprazole with antacids no drug interactions have been reported.

Special instructions:

Before the start of therapy, it is necessary to exclude the presence of malignant neoplasm (endoscopic control,if necessary with a biopsy - especially with a stomach ulcer), because the treatment, masking the symptomatology, can delay the formulation of the correct diagnosis. If, after 4 weeks of pantoprazole therapy, the patient does not have the desired curative effect, he should undergo a second examination.

Like other proton pump inhibitors, pantoprazole can reduce the absorption of cyanocobalamin (vitamin B12) against hypo- and achlorhydria. Especially it should be considered in long-term treatment and in patients with risk factors for vitamin B12 deficiency.

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

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive a car or other technical means.

Form release / dosage:

Tablets, coated with enteric coating, 20 mg, 40 mg.

Packaging:

14 tablets per blister from the combined material OPA / Al / PVC-aluminum foil.

By 1, 2 or 4 blisters in a pack of cardboard along with instructions for use.

Storage conditions:

When temperature not higher than 25 ° С, in the original packaging.

Keep out of the reach of children.

Shelf life:

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-009049/08

Date of registration:19.11.2008

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp29.08.2015

Illustrated instructions

Instructions

Nolpaz® (Nolpaza®)