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

Excipients: Magnesium oxide - 18.00 mg, calcium carbonate - 81.40 mg, crospovidone - 35.00 mg, sodium lauryl sulfate - 5.00 mg, calcium stearate - 3.00 mg, silicon dioxide colloid - 5.00 mg; shell composition: methacrylic acid-ethyl acrylate copolymer [1: 1] - 11.00 mg triethyl citrate - 1.10 mg, copovidone - 7.00 mg talc - 10.70 mg, titanium dioxide (E171) - 0.80 mg, dye, iron oxide yellow (E172) - 0.20 mg, macrogol-6000-0.35 mg.

Description:

Yellow, round, biconvex tablets, covered enteric coating.

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:Proton pump inhibitor (H + / K + -ATPase) / Blocks the final stage cecreations of hydrochloric acid, reducing cthe maintenance of basal and stimulated secretion, irrespective of the nature of the stimulus. The inhibition of hydrochloric acid production is dose-dependent. Do not Influenceon motility of the gastrointestinal tract. Secretory activity is normalized 3-4 days after the end of admission.

Pharmacokinetics:

Suction: after taking the drug inside pantoprazole quickly absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma (C_mOh) is achieved after 2.5 hours and is 2-3 mg / l, while the value of C_mOh remains unchanged with multiple admission. Bioavailability of 65-77%.

Metabolism: The main metabolite is desmethylpentoprazole, which is then sulfated.

Excretion: Clearance - 0.1 l / h / kg. It is excreted primarily by the kidneys (80%) in the form of metabolites, in a small number - by the intestine. The half-life (T1 / 2) of pantoprazole is 1 hour, the metabolite is 1.5 hours.

With liver failure (class A and B according to the Child-Piuga classification), T1 / 2 with admission of 20 mg increases to 3-6 hours, with a dose of 40 mg - up to 7-9 hours; area under the curve "concentration-time" (AUC) increases in 3-5 and 5-7 times, respectively; and the maximum concentration in the blood plasma (C_mOh) in 1.3 and 1.5 times, respectively. A slight increase in performance AUC and C_mOh The elderly are not clinically relevant.

Indications:

- peptic ulcer of the stomach or duodenum in the phase of exacerbation;

- erosive gastritis;

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

- reflux esophagitis;

- Zollinger-Ellison syndrome;

- eradication Helicobacter pylori in combination with antibacterial agents.

Contraindications:

Dyspepsia of neurotic genesis; children's age (due to lack of data on the use of the drug in pediatric practice); increased sensitivity to pantoprazole, simultaneous reception with atazanavir.

Carefully:With caution appoint the drug to patients with hepatic insufficiency, the elderly, as well as during pregnancy and lactation.

Pregnancy and lactation:

The use of the drug during pregnancy and during lactation is possible if the expected benefit to the mother exceeds the potential risk to the fetus or the baby.

Dosing and Administration:

Inside. Tablets are taken internally as a whole (without crushing or dissolving), with a sufficient amount of liquid. The drug is recommended to take 1 hour before breakfast; at a frequency of reception 2 times / day the second dose - 1 hour before dinner.

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

For prevention of peptic ulcer and duodenal ulcer exacerbations appoint 20 mg / day.

When erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), appoint 40-80 mg / day. The course of treatment is 4-8 weeks.

For prevention of erosive lesions with long-term use of NSAIDs - 20 mg / day.

When reflux esophagitis appoint 20-40 mg / day. The course of therapy is 4-8 weeks.

When Zollinger-Ellison syndrome Pantoprazole is prescribed at 40-80 mg / day.

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

Possible combinations of pantoprazole with antimicrobial agents in eradication Helicobacter pylori:

1. Pantoprazole 40 mg 2 times a day + amoxicillin 1000 mg twice a day + clearsromycin 500 mg twice a day;

2. Pantoprazole 40 mg 2 times a day + metronidazole 400-500 mg twice a day +clarithromycin 250-500 mg 2 times a day;

3. Pantoprazole 40 mg 2 times a day + amoxicillin 1000 mg twice a day + metronidazole 500 mg twice a day.

Have patients with severe hepatic impairment dose should be reduced to 40 mg 1 time in 2 days, while it is necessary to monitor the biochemical parameters of the blood. When the activity of hepatic enzymes increasesThe drug should be discontinued.

The elderlypatients, and patients with impaired renal function, do not exceed the daily dose of 40 mg. An exception is the use of combined antimicrobial therapy for Helicobacter pylori, when elderly patients should also use pantoprazole 40 mg 2 times a day.

Side effects:

Very Frequent -> 10 %, frequent -> 1 and <10 %, not frequent -> 0.1 and <1%, rare -> 0.01 and <0.1 %, very rare - <0.01 %.

From the central nervous system: often - headache; not often, the weakness, dizziness; rarely - depression, hallucinations, disorientation, confusion (especially in predisposed individuals).

From the gastrointestinal tract: often - diarrhea, pain in the upper abdomen, constipation, flatulence; not often - nausea, vomiting; rarely dry mouth; rarely - severe hepatocellular liver damage with jaundice, liver failure, the upregulation of the activity of "liver enzymes," hypertriglyceridemia.

Violations from hand hemopoiesis: very rarely - leukopenia, thrombocytopenia.

Disorders from the side of the organ of vision: not often - impaired vision.

Disorders from the musculoskeletal system: rarely - arthralgia, very rarely - myalgia.

Disorders from the urinary system: very rarely - interstitial nephritis.

Allergic reactions: very rarely - urticaria, angioedema, syndrome Stevens-Johnson, multiforme exudative erythema, photosensitivity, Lyell's syndrome; rarely - skin rash, itching, skin hyperemia.

Other: highly rarely - painful tension of the mammary glands, hyperthermia.

Overdose:There have been no cases of overdose. But in case of taking high doses of the drug, observation is shown and, if necessary, symptomatic therapy, in which the patient must be under medical supervision. Hemodialysis is ineffective.

Interaction:

Reduces the effect of drugs that are absorbed at acidic pH values (including ketoconazole).

Slows down the elimination of drugs metabolized by microsomal enzymes of the liver (including diazepam, ibuprofen, indomethacin, clarithromycin, prednisolone, propranolol, terfenadine or warfarin, phenytoin).

Significantly reduces plasma concentrations of atazanavir and nelfinavir, concomitant use is not recommended.

With simultaneous application with warfarin, an international normalized relationship (INR) can be increased and monitoring of this indicator is necessary.

Special instructions:

Before and after treatment, endoscopic control is necessary to exclude malignant neoplasm, as treatment can mask the symptoms and delay correct diagnosis.

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

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Tablets coated with enteric film coating 40 mg.

Packaging:

10 tablets per strip of aluminum foil. For 1, 2 or 3 strips, together with the instructions for use are placed in a cardboard box.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001183

Date of registration:27.09.2011

The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India

Manufacturer: & nbsp

Sun Pharmaceutical Industries, Ltd. India

Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India

Information update date: & nbsp29.08.2015

Illustrated instructions

Instructions

SunPraz (Sunpras)