Pantaz - instructions for use, doses, side effects, contraindications

Sheath: methacrylic acid and methyl methacrylate copolymer [1: 1], dibutyl phthalate, talc purified, hypromellose (hydroxypropylmethylcellulose), macrogol 6000, titanium dioxide, iron oxide yellow oxide.

Description:

Round, biconvex tablets, covered with enteric-coated shell of light yellow color. At the break: the core is white.

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

ATX: & nbsp

A.02.B.C Proton pump inhibitors

A.02.B.C.02 Pantoprazole

Pharmacodynamics:

Inhibits the enzyme H + / K + -ATP-asu ("proton pump") in parietal cells of the stomach and blocks, therefore, the final stage of synthesis of hydrochloric acid. This leads to a decrease in 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 is rapidly 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 area indicator under the concentration-time curve (AUC), FROM_maxand 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 h. 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 in urine, desmtilpanoprazole, which is conjugated with sulfate. T1/2 desmethylpentoprazole, the main metabolite (about 1.5 hours) is much larger than T1/2 most pantoprazole. In chronic renal failure (including patients 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, and C_max- in 1,3 times in comparison with healthy persons.

A small increase AUC and an increase in C_max in 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, acid regurgitation, pain when swallowing;

- Stomach ulcer and duodenal ulcer (treatment and prevention);

- Eradication Helicobacter pylori in combination therapy;

- Zollinger-Ellison syndrome.

Contraindications:

- Hypersensitivity to pantoprazole or other components of the drug;

- 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 eating, usually before breakfast. When taking twice a second dose of the drug is recommended before dinner.

With peptic ulcer of the stomach and duodenum, Zollinger-Ellison syndrome - 40-80 mg / day.

When reflux-esophagitis - 20-40 mg / day.

In elderly patients and with chronic renal failure - no more than 40 mg / day. With hepatic insufficiency, 40 mg once every 2 days.

The course of treatment for scarring of the ulcer of the duodenum is 2 weeks, stomach ulcers and reflux esophagitis - 4-8 weeks.

Eradication Helicobacter pylori:

pantoprazole by 20 mg 2 once a day, amoxicillin by 1000 mg 2 once a day, clarithromycin 500 mg twice a day; pantoprazole 20 mg twice a day, metronidazole 500 mg twice a day, clarithromycin 500 mg twice a day; pantoprazole 20 mg each 2 once a day, amoxicillin by 1000 mg 2 once a day, metronidazole 500 mg each 2 times a day. The treatment is carried out for 7-14 days.

Side effects:

There are side effects according to WHO classification: often (1-10%), infrequently (0.1-1%), rarely (0.1-0.01%), very rarely (less than 0.01%).

From the 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 "liver" transaminases and gamma-glutamyltransferase (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, hallucinations, disorientation, confusion (especially in predisposed individuals).

From the genitourinary system: very rarely - interstitial nephritis. Allergic reactions: infrequently - itching and rash; very rarely - urticaria, angioedema, Stevens-Johnson syndrome, erythema polymorph, Lyell's syndrome, photosensitivity.

General disorders: very rarely - peripheral edema, hyperthermia, weakness, painful tension of the mammary glands, increased concentration 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 case of an overdose of the drug, symptomatic and supportive treatment is performed.

Interaction:

Pantoprazole reduces the absorption of drugs whose bioavailability depends on the pH of the stomach and is absorbed at acidic pH values (for example, ketoconazole, gland preparations).

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 dIGOSIN, DIAZEPAM, DICLOFENAC, ethanol, phenytoin, glibenclamide, 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 to monitor prothrombin time or MNO on a regular basis.

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

It is not recommended simultaneous administration of atazanavir and nelfinavir with proton pump inhibitors (including pantoprazole), as they can reduce the concentration of atazanavir and nelfinavir in blood plasma and lead to a decrease in the therapeutic effect of antiretroviral therapy.

Special instructions:

Before the start of therapy, it is necessary to exclude the presence of malignant neoplasm (endoscopic control, if necessary with biopsy - especially with stomach ulcer), since treatment, masking the symptoms, can delay the setting 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.

It can lead to false-positive results in the test for determination of tetrahydrocannabinol in urine.

Effect on the ability to drive transp. cf. and fur:

Studies on the effect of the drug on the ability to drive a car or other technical means have not been carried out, however, some side effects (blurred vision, dizziness) can affect the performance of classes,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, coated with enteric coating, 40 mg.

Packaging:

10 tablets in Al/ Al blister.

For 1, 3.10 blisters in a cardboard box together with instructions for use.

Storage conditions:

Store at a temperature of no higher than 25 ° C, in a dry place.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006687/10

Date of registration:15.07.2010

The owner of the registration certificate:Medley Pharmaceuticals, Ltd. Medley Pharmaceuticals, Ltd. India

Manufacturer: & nbsp

MEDLEY PHARMACEUTICALS, Ltd. India

Information update date: & nbsp29.08.2015

Illustrated instructions

Instructions

Pantaz (Pantaz)