Active substancePantoprazolePantoprazole
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  • Dosage form: & nbspenteric coated tablets
    Composition:

    1 tablet contains:

    Active substance:

    Pantoprazole sodium sesquihydrate ...................... 45.1 mg

    which is equivalent to pantoprazole ................................. 40 mg

    Excipients: crospovidone, calcium stearate, mannitol, povidone, sodium carbonate anhydrous; sodium hydroxide, simethicone emulsion (30%), dye Opadry YS-1R-7006 transparent (hypromellose 5sp, macrogol 400, macrogol 6000), dye Opadrai acryles yellow 93092052 (methacrylic acid copolymer type C, talc, titanium dioxide, triethyl citrate, silicon dioxide colloid, sodium bicarbonate, iron oxide yellow, sodium lauryl sulfate).

    Description:

    round biconvex tablets, covered enteric coating from light yellow to yellow.

    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). It blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus. With duodenal ulcer associated with Helicobacter pylori, decrease in gastric secretion increases the sensitivity of microorganisms to antibiotic;motility of the gastrointestinal tract. Secretory activity is normalized 3-4 days after the end of admission.

    Indications:

    - peptic ulcer of the stomach and duodenum (in the phase of exacerbation), including associated with Helicobacter pylori,

    - erosive gastritis,

    - gastroesophageal reflux disease; reflux esophagitis,

    - Zollinger-Ellison syndrome,

    - stress ulcers of the gastrointestinal tract.

    Contraindications:

    Hypersensitivity to the components of the drug, dyspepsia of neurotic genesis, malignant diseases of the gastrointestinal tract, severe hepatic insufficiency.

    Carefully:

    FROM caution appoint pantoprazole in patients with impaired liver function, in childhood (experience of the drug in children before 6 years absent).

    Pregnancy and lactation:

    The drug can be used in pregnancy only on strict indications, if the benefit to the mother exceeds the potential risk to the fetus. When prescribing the drug during lactation, it is necessary to resolve the issue of stopping breastfeeding.

    Dosing and Administration:It is applied inside. The tablet is not chewed, washed down with a small amount of liquid. With peptic ulcer of stomach and duodenum, gastroesophageal reflux disease, the daily dose is 40 mg once, possibly increasing the dose to 80 mg per day.Duration of treatment for duodenal ulcer is 14 days (sometimes the drug is used additionally for another 2 weeks), with gastric ulcer and gastroesophageal reflux diseases - 4 weeks (in some cases, the drug is used for another 4 weeks).

    With combined eradication anti-helicobacter therapy in patients with peptic ulcer of the stomach or duodenum, the drug is prescribed 40 mg twice a day (before breakfast and before dinner or during a meal) in combination with amoxicillin, azithromycin, clarithromycin; Metronidazole. The duration of the course of eradication therapy is 7 days (maximum - 2 weeks).

    Side effects:

    On the part of the organs of the gastrointestinal tract: diarrhea; rarely dry mouth, increased appetite, nausea, belching, vomiting, flatulence, abdominal pain, constipation, increased activity of transaminases.

    From the nervous system and sensory organs: headache; rarely - asthenia, dizziness, drowsiness, insomnia; in some cases - nervousness, depression, tremor, paresthesia, photophobia, visual disturbances, tinnitus.

    From the genitourinary system: in isolated cases - hematuria, edema, impotence.

    From the skin: in isolated cases - alopecia, acne, exfoliative dermatitis.

    Allergic reactions: rarely - a rash, hives, itching, angioedema.

    Other: rarely hyperglycemia, myalgia; in isolated cases - fever, eosinophilia, hyperlipoproteinemia, hypercholesterolemia.

    Overdose:

    Symptoms of an overdose of pantoprazole are not described.

    Interaction:

    Pantoprazole reduces the effect of drugs absorbed at acidic pH values ​​(including - ketoconazole).

    Does not affect the pharmacokinetic parameters drugs, metabolized with the participation of the enzymatic system of cytochrome P450, such as phenazepam, diazepam, digoxin, theophylline, carbamazepine, diclofenac, naproxen, piroxicam, phenytoin, warfarin, nifedipine, metoprolol, ethanol. Does not affect the effectiveness of hormonal contraceptives.

    Special instructions:Before the beginning of treatment, malignant diseases of the esophagus and stomach should be excluded (symptomatic improvement may delay correct diagnosis and treatment). The diagnosis of gastroesophageal reflux disease should be confirmed endoscopically.In elderly patients and with renal dysfunction, it is not recommended to exceed the dose of 40 mg per day. In severe hepatic insufficiency, the dosing regimen must be corrected: 40 mg once every 2 days, under the control of the level of hepatic enzymes (if they are increased, drug withdrawal is indicated).

    Form release / dosage:Tablets, coated with enteric coating, 40 mg.
    Packaging:10 tablets in a blister of aluminum / aluminum foil; 1 or 2 blisters (10 or 20 tablets) are placed in a cardboard box together with instructions for use.
    Storage conditions:

    List B.

    At a temperature of no higher than 30 ° C in a dry, dark place.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001362/08
    Date of registration:29.02.2008
    The owner of the registration certificate:Unik Pharmaceutical Laboratories Unik Pharmaceutical Laboratories India
    Manufacturer: & nbsp
    Representation: & nbsp"UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")""UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")"India
    Information update date: & nbsp08.09.2015
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