Composition, form of production and packaging
Tablets, covered with an enteric coating of light yellow to yellow, round, biconvex.
1 tab.
pantoprazole sodium sesquihydrate 45.1 mg,
which corresponds to the content of pantoprazole 40 mg
Excipients: crospovidone, calcium stearate, mannitol, povidone, sodium carbonate anhydrous, sodium hydroxide, simethicone emulsion (30%), Opadry YS-1R-7006 transparent dye (hypromellose 5cp, macrogol 400, macrogol 6000), Opadry acrylic yellow dye 93O92052 (methacrylic acid copolymer (type C), talc, titanium dioxide, triethyl citrate, silicon dioxide colloid, sodium bicarbonate, iron oxide yellow, sodium lauryl sulfate).
10 pieces. - blisters of aluminum foil (1) - packs of cardboard.
10 pieces. - blisters of aluminum foil (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
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. In duodenal ulcer associated with Helicobacter pylori, a decrease in gastric secretion increases the sensitivity of microorganisms to antibiotics. Does not affect the 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 those associated with Helicobacter pylori;
- erosive gastritis;
- gastroesophageal reflux disease;
- reflux esophagitis;
- Zollinger-Ellison syndrome;
- Stress ulcers of the gastrointestinal tract
DOSING MODE
It is applied inside. The tablet is not chewed, washed down with a small amount of liquid.
With gastric ulcer and duodenal ulcer, gastroesophageal reflux disease, the daily dose is 40 mg once, possibly increasing the dose to 80 mg / day. The 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 disease - 4 weeks (in some cases, the drug is used for 4 more weeks).
With combined eradication anti-helicobacter therapy in patients with peptic ulcer of the stomach or duodenum, the drug is prescribed at 40 mg 2 times / day (before breakfast and before dinner or during meals) in combination with amoxicillin, azithromycin, clarithromycin, metronidazole. The duration of eradication therapy is 7 days (maximum - 2 weeks).
SIDE EFFECT
On the part of the digestive system: diarrhea; rarely dry mouth, increased appetite, nausea, belching, vomiting, flatulence, abdominal pain, constipation, increased activity of transaminases.
From the side of the central nervous system and sensory organs: headache; rare plant, dizziness, drowsiness, insomnia; in some cases - nervousness, depression, tremor, paresthesia, photophobia, visual disturbances, tinnitus.
From the genitourinary system: in isolated cases - hematuria, swelling, impotence.
From the skin: in isolated cases - alopecia, acne, exfoliative dermatitis.
Allergic reactions: rarely - rashes, hives, itching, angioedema.
Other: rarely - hyperglycemia, myalgia; in isolated cases - fever, eosinophilia, hyperlipoproteinemia, hypercholesterolemia.
CONTRAINDICATIONS
- dyspepsia of neurotic genesis;
- malignant diseases of the digestive tract;
severe hepatic impairment;
- Hypersensitivity to the components of the drug.
With caution appoint pantoprazole in patients with impaired liver function, in childhood (experience of using the drug in children under 6 years is 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.
APPLICATION FOR FUNCTIONS OF THE LIVER
In case of impaired renal function, do not exceed the dose of 40 mg / day.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution appoint pantoprazole in patients with impaired liver function.
Contraindicated in severe hepatic insufficiency.
In severe hepatic insufficiency, the dosing regimen should 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).
APPLICATION FOR CHILDREN
Be wary appoint pantoprazole in childhood (experience of using the drug in children under 6 years is absent).
APPLICATION IN ELDERLY PATIENTS
In elderly patients it is not recommended to exceed the dose of 40 mg / day.
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.
At elderly patients and at disturbance of function of kidneys it is not recommended to exceed a dose of 40 mg / sut.
In severe hepatic insufficiency, the dosing regimen should 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).
OVERDOSE
Symptoms of an overdose of pantoprazole are not described.
DRUG INTERACTION
Pantoprazole reduces the effect of drugs that are absorbed at acidic pH values ​​(including ketoconazole).
Does not affect the pharmacokinetic parameters of drugs metabolized by 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.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. Keep in a place inaccessible to children at a temperature of no higher than 30 В° C in a dry, sheltered from the world. Shelf life - 3 years.
