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

active substance - pantoprazole 20 mg (in the form of pantoprazole sodium sesquihydrate 22.5 mg) or pantoprazole 40 mg (in the form of pantoprazole sodium sesquihydrate 45 mg);

Excipients: Mannitol 60,75 mg / 121,50 mg, croscarmellose sodium 4 mg / 8 mg, silicon dioxide colloid 0.25 mg / 0.5 mg, sodium carbonate 7 mg / 14 mg, magnesium stearate 1.5 mg / 3 mg;

composition of the shell: hypromellose-15 thousand.3.4 mg / 6.8 mg, macrogol-6000 1.371 mg / 2.742 mg; methacrylic acid and ethyl acrylate copolymer [1: 1] 7.486 mg / 14.972 mg, talc 1.506 mg / 3.012 mg, titanium dioxide (E171) 0.509 mg / 1.019 mg, iron oxide yellow oxide (E172) 0.12 mg / 0.24 mg , sodium hydroxide 0.107 mg / 0.215 mg;

composition of black ink: shellac glaze 47.5% in ethanol denatured (alcohol methylated 74 OP), iron dye oxide black (E172), butanol *, ethanol denatured (methylated alcohol 74 ODP) *, soy lecithin, defoamer (food grade).

* -Deleted in the production process.

Description:

Dosage of 20 mg: Biconvex tablets of oval form, covered with enteric coating, yellow, with the inscription "РТ20" with black ink on one side. Type of tablet on a cross-section: the shell - yellow, the core - from white to light yellow color.

Dosage of 40 mg: Biconvex tablets of oval form, covered with enteric coating, yellow, with the inscription "PT40" in black ink on one side. Type of tablet on the cross-section: the shell - yellow, the core - from white to light yellow color.

Pharmacotherapeutic group:The iron of the stomach secretion is a reducing agent - a 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). It blocks the final stage of hydrochloric acid secretion, reducing the content of basal and stimulated secretion, regardless of the nature of the stimulus. The inhibition of hydrochloric acid production is dose-dependent. Does not affect the 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 fast

is 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_max 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.

In liver failure (class A and B according to the Child-Pug 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_max) in 1.3 and 1.5 times, respectively.

A slight increase in performance AUC and C_max in the elderly is 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; malignant diseases

gastrointestinal tract; 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 peptic ulcer of the stomach 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 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 appoint 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.

Potential pantoprazole plant with antimicrobial agents for eradication Helicobacter pylori:

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

2. Pantoprazole 40 mg 2 times a day + metronidazole 400-500 mg twice a day + clarithromycin 250-500 mg twice 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 is increased, the drug should be discontinued.

Elderly patients, as well as patients with impaired renal function, Do not exceed the daily dose of 40 mg. An exception is the use of combined antimicrobial therapy in relation to Helicobacter pylori, when elderly patients should apply 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 - 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; very rarely - severe hepatocellular liver damage with jaundice, hepatic insufficiency, increased activity of "liver enzymes," hypertriglyceridemia.

Infringements from bodies of a 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, Stevens-Johnson syndrome, multi-form exudative erythema, photosensitivity, Lyell's syndrome; rarely - skin rash, itching, skin hyperemia.

Other: very rarely - the 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 and, if necessary, symptomatic therapy, in which the patient should be under medical supervision, is shown. 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:The tablets are coated with an enteric coating of 20 mg and 40 mg.

Packaging:

For 14 tablets in a blister of Al / Al foil. For 1 or 2 blisters together with instructions for use are placed in a cardboard box.

For 100 tablets in a polypropylene jar, sealed with aluminum foil and closed with polypropylene lid.

On 1 bank together with the instruction on application place in a cardboard pack.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000851

Date of registration:14.10.2011

The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India

Manufacturer: & nbsp

MICRO LABS, Limited India

Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India

Information update date: & nbsp23.08.2015

Illustrated instructions

Instructions

Crosacid (Krosacid)