Eupantol Uses, Dosage, Side Effects, Precautions & Warnings
Eupantol drug Generic drug of the Therapeutic class: Gastro-Entero-Hepatology
active ingredients: Pantoprazole
This drug is indicated for the treatment of an ulcer of the stomach or duodenum, whether or not associated with the presence of a bacterium (Helicobacter pylori) , or esophagitis (inflammation of the esophagus) or for the long-term treatment of Zollinger-Ellison syndrome.
Table of Contents
Eupantol indication and Uses
- Gastroresistant tablet:
- Eupantol is indicated in adults and adolescents aged 12 and over for:
-
- Oesophagitis by gastroesophageal reflux.
- Eupantol is indicated in adults for:
- Eradication of Helicobacter pylori ( H. pylori ) in combination with appropriate antibiotic therapy in patients with H. pylori- related ulcer .
- Gastric and duodenal ulcer.
- Zollinger-Ellison syndrome and other pathological hypersecretory conditions.
- Powder for solution for injection:
-
- Esophagitis by gastro-oesophageal reflux.
- Gastric and duodenal ulcer.
- Zollinger-Ellison syndrome and other pathological hypersecretory conditions.
Eupantol Dosage
adults
The tablets will not be crunched or crushed, but swallowed whole with a little water before a meal.
Eradication of Helicobacter pylori in case of peptic ulcer disease:
The following dosing regimens are recommended:
- 1 tablet of pantoprazole 40 mg morning and evening with clarithromycin 500 mg morning and evening and amoxicillin 1000 mg morning and evening for 7 days;
- 1 tablet of pantoprazole 40 mg morning and evening with clarithromycin 500 mg morning and evening and metronidazole or tinidazole 500 mg morning and evening for 7 days;
- Alternatively to the above regimens, 1 tablet of pantoprazole 40 mg morning and evening combined with amoxicillin 1000 mg morning and evening and metronidazole or tinidazole 500 mg morning and evening for 7 days.
- The effectiveness of treatment depends on compliance with the dosing regimen, including taking the therapy for 7 days .
Evolutionary duodenal ulcer
- 1 tablet daily for 4 weeks.
Evolutionary gastric ulcer
- 1 tablet daily for 4 to 8 weeks.
Gastroesophageal reflux esophagitis
1 tablet daily for 4 weeks with a possible second period of 4 weeks at the same dosage.
Long-term treatment of Zollinger-Ellison syndrome
The initial dosage is 2 tablets per day (ie 80 mg).
This can be increased or decreased depending on the needs, depending on the results of the acid flow measurements. In the case of a dosage higher than 80 mg / day, the dose will be divided into two doses. A temporary increase in dosage above 160 mg per day is possible but should not exceed the time required to control acid secretion.
Adults and children 12 years and older
- Maintenance treatment and prevention of recurrence of oesophagitis by gastroesophageal reflux.
- The recommended dose is 1 tablet at 20 mg daily, with an increase to 40 mg pantoprazole daily for recurrence. EUPANTOL 40 mg can be used in this case.
- After healing, the dose will be reduced to 20 mg per day.
Children under 12 years
- As the available data are limited in this age group, EUPANTOL 40 mg should not be given to children under 12 years of age.
Contraindications
- Pantoprazole hypersensitivity
- Benzimidazoles hypersensitivity
- Child under 6
- Feeding with milk
- Child from 6 to 12 years old
- Pregnancy
Hypersensitivity to the active substance, to substituted benzimidazoles or to any of the excipients listed in the Composition section.
How it works Eupantol
Pharmacotherapeutic group: proton pump inhibitors, ATC code: A02BC02
Action mechanism
- Pantoprazole is a substituted benzimidazole that inhibits the gastric secretion of hydrochloric acid from the stomach by specific blockage of parietal cell proton pumps.
- Pantoprazole is converted into its active form in the acid environment of parietal cells where it inhibits the enzyme H + / K + -ATPase, that is to say at the terminal phase of secretion of hydrochloric acid in the stomach.
- Inhibition is dose-dependent and affects both basal acid secretion and stimulated acid secretion.
- In most patients, the disappearance of symptoms is obtained in 2 weeks. Like other proton pump inhibitors and H2 receptor blockers, treatment with pantoprazole results in a reduction in stomach acidity and therefore an increase in gastrin proportional to the decrease in acidity. This increase in gastrin is reversible.
- Since pantoprazole binds to enzyme located posteriorly at the cellular receptors, it can inhibit the secretion of hydrochloric acid, whatever the nature of the stimulus (acetylcholine, histamine, gastrin).
- The effect is the same whether the product is administered orally or intravenously.
Pharmacodynamic effects
- Fasting gastrinemia values increase with pantoprazole. In most cases, in short-term treatment, gastrinemia values do not exceed the upper limits of normal.
- These values most often double during long-term treatments. However, the increase is excessive only in isolated cases.
- As a result, a slight to moderate increase in the number of endocrine cells in the stomach (ECL cells) can be observed in a minority of cases during long-term treatment (from simple to adenomatoid hyperplasia).
- However, based on studies to date (see Preclinical safety data section).), the formation of carcinoid precursors (atypical hyperplasia) or gastric carcinoids, as described in animals has not been observed in humans.
- In view of the results of the animal studies, it is not possible to completely exclude an influence on the endocrine parameters of the thyroid during long-term treatment with pantoprazole for more than one year.
Eupantol Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking these tablets and tell your doctor immediately or contact the emergency department at the nearest hospital:
- · Serious allergic reactions (rare frequency: may affect up to 1 in 1000 people ): swelling of the tongue and / or throat, difficulty swallowing, hives (redness similar to that caused by nettles), difficulty breathing, allergic facial demes (Quincke’s angina), severe vertigo with increased heart rate and profuse sweating.
- · Serious skin manifestations (frequency not known): frequency can not be estimated based on available data): blistering and rapid deterioration of your general condition, erosion (including slight bleeding) of the eyes, nose, nose mouth / lips or genitals (Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme) and sensitivity to light.
- · Other serious manifestations (frequency not known: frequency can not be estimated based on available data ): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, redness and enlargement of the kidneys sometimes accompanied painful urination and low back pain (severe renal inflammation), which can lead to kidney failure.
Other side effects are:
- · Frequent (may affect up to 1 in 10 people)
Benign polyps of the stomach.
- · Uncommon (may affect up to 1 in 100 people)
Headache ; vertigo; diarrhea; bad heart, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin redness; eruption; itching; feeling of weakness, exhaustion or general malaise; sleeping troubles ; fracture of the hip, wrist or vertebrae.
· Rare (may affect up to 1 in 1,000 people)
Distortion or lack of taste, visual disturbances such as blurred vision; urticaria; joint pain ; muscle pain, weight changes; elevation of body temperature, high fever, swelling of the extremities (peripheral edema); allergic reactions; depression, hypertrophy of mammary glands in man.
· Very rare (may affect up to 1 in 10,000 people)
Disorientation.
· Undetermined (whose frequency can not be estimated from the available data)
Hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood; decreased levels of magnesium in the blood , tingling sensation, tingling, pinching and stinging, burning or numbness skin rash, possibly with joint pain
Adverse reactions identified by blood tests:
- · Uncommon (may affect up to 1 in 100 people)
Elevation of liver enzymes.
- · Rare (may affect up to 1 in 1,000 people)
Elevation of bilirubin; increase of fats in the blood, sudden drop of a certain type of circulating white blood cells (granulocytes) associated with a high fever.
- · Very rare (may affect up to 1 in 10,000 people)
Decreased platelet count that may result in bleeding or hematoma beyond normal; decrease in the number of white blood cells that can cause an increase in the frequency of infections. Abnormal simultaneous decrease in the number of white and red blood cells and platelets.
Eupantol Interactions
Drugs with pH-dependent absorption
- Because of a significant and long-lasting inhibition of gastric secretion, pantoprazole may interfere with the absorption of other drugs, for which gastric pH is a determinant of their oral bioavailability, for example ketoconazole, azole antifungals, such as, itraconazole, posaconazole and other medications such as erlotinib.
HIV protease inhibitors
- Concomitant administration of pantoprazole and HIV protease inhibitors, whose absorption depends on gastric pH, such as atazanavir, is not recommended, as this may significantly reduce their bioavailability. Warnings and precautions for use ).
- If the combination of an HIV protease inhibitor and a proton pump inhibitor is considered essential, regular clinical monitoring (eg viral load monitoring) is recommended. The dose of 20 mg pantoprazole daily should not be exceeded. The dosage of HIV protease inhibitor could be adjusted.
Coumarin anticoagulants (phenprocoumon or warfarin)
- The combination of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon, or INR. However, cases of increased INR and prothrombin time have been reported in patients receiving PPI and concomitant warfarin or phenprocoumon.
- An increase in INR and prothrombin time can cause bleeding, potentially fatal. In patients treated concurrently with pantoprazole and warfarin or phenprocoumon, monitoring of INR and prothrombin time is recommended.
methotrexate
- An increase in blood levels of methotrexate has been reported in some patients when concomitant use of high doses of methotrexate (eg, 300 mg) and proton pump inhibitors is used. Therefore, in situations where high doses of methotrexate are used, such as in cancer and psoriasis, temporary discontinuation of pantoprazole should be considered.
Other studies of kinetic interactions
- Pantoprazole is metabolized in the liver by the enzymatic system of cytochrome P450. The main metabolic pathway is demethylation by CYP2C19 and other metabolic pathways include CYP3A4 oxidation.
- No clinically significant interactions were observed in specific studies including carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline, and an oral contraceptive containing levonorgestrel and ethinyl estradiol.
- The interaction of pantoprazole with other drugs or compounds metabolized by the same enzyme system can not be ruled out.
- The results of a series of kinetic interaction studies showed that pantaprozole did not influence the metabolism of CYP1A2 metabolized active substances (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol). Pantoprazole does not interfere with the absorption of digoxin bound to P-glycoprotein.
- There are no interactions with concomitantly administered antacids.
- Interaction studies were conducted on the concomitant administration of pantoprazole and various antibiotics (clarithromycin, metronidazole, amoxicillin). No clinically significant interactions have been shown.
Medicinal products that inhibit or induce CYP2C19:
- Inhibitors of CYP2C19 such as fluvoxamine may increase systemic exposure to pantoprazole. For patients taking long-term pantoprazole at high doses, or for patients with hepatic impairment, dose reduction may be considered.
- Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St. John’s wort ( Hypericum perforatum) can reduce the plasma levels of IPPs, which are metabolized by these enzyme systems.
Eupantol Warnings and Precautions
In patients with severe hepatic impairment, a review of liver enzymes should be performed regularly during treatment especially in case of long-term treatment. If they are elevated, treatment should be discontinued .
Therapeutic Association
In case of therapeutic combinations, it is necessary to respect the summaries of the product characteristics of the drugs involved.
Malignant gastric tumor
- The symptomatic response to pantoprazole treatment may mask the symptoms of a malignant gastric tumor and delay its diagnosis. In the presence of any alarming symptom (eg significant involuntary weight loss, recurrent vomiting, dysphagia, hematemesis, anemia or melena) and, where a gastric ulcer is suspected or present, a malignant condition should be ruled out.
- Further examinations should be considered if symptoms persist despite appropriate treatment.
Concomitant administration of HIV protease inhibitors The concomitant administration of pantoprazole and HIV protease inhibitors, the absorption of which depends on gastric pH (such as atazanavir), is not recommended as this may to significantly reduce their bioavailability (see section Interactions with other medicinal products and other forms of interaction ).
Influence on the absorption of vitamin B12
- In patients with Zollinger-Ellison syndrome and other hypersecretory pathological conditions requiring long-term treatment, pantoprazole, like any gastric anti-secretory drug, may decrease the absorption of vitamin B12 (cyanocobalamin) by hypo- or achlorhydria.
- This should be considered in patients with reduced reserves or risk factors for decreased vitamin B12 absorption during long-term treatment or if clinical symptoms are observed.
Long-term treatment
In the context of long-term treatment, especially when it lasts more than 1 year, patients will have to undergo regular clinical monitoring.
Gastrointestinal bacterial infections
- Eupantol treatment may lead to a slight increase in the risk of gastrointestinal infections due to bacteria such as Salmonella, Campylobacter , and C.difficile.
- Pantoprazole, like all proton pump inhibitors (PPIs), may increase the number of bacteria normally present in the upper gastrointestinal tract. Treatment with Eupantol may lead to a slight increase in the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.
hypomagnesemia
- Cases of severe hypomagnesemia have been reported in patients treated with proton pump inhibitors (PPIs) such as pantoprazole for at least three months and in most cases for one year. Hypomagnesemia can manifest as severe clinical signs such as fatigue, tetany, delirious flushes, convulsions, dizziness, ventricular arrhythmia, but it can start insidiously and go unnoticed. In most patients, hypomagnesemia improved after magnesium supplementation and discontinuation of PPI.
- In patients requiring prolonged treatment or in combination of PPIs with digoxin or with drugs that may induce hypomagnesaemia (eg diuretics), blood magnesium levels should be considered by health professionals before start treatment with IPP and then regularly during treatment.
Bone fracture
- Proton pump inhibitors, particularly if used in high doses over a prolonged period (> 1 year), may increase the risk of hip, wrist and vertebral fracture, mainly in patients aged or in the presence of other identified risk factors. Observational studies suggest that proton pump inhibitors can increase the overall risk of fracture by 10-40%.
- This increase may be due in part to other risk factors. Patients at risk for osteoporosis should be managed according to the recommendations in force, and receive appropriate vitamin D and calcium intake.
Subacute cutaneous lupus erythematosus (LECS)
- Proton pump inhibitors (PPIs) are associated with very occasional cases of LECS. If lesions develop, especially on sun-exposed skin areas, and if they are accompanied by arthralgia, the patient should consult a doctor promptly and the health care provider should consider stopping Eupantol.
- The occurrence of a LECS after treatment with a proton pump inhibitor may increase the risk of LECS with other proton pump inhibitors.
Drive and use machines
PREGNANCY / BREAST FEEDING / FERTILITY
eupantol during pregnancy
- A moderate number of data in the pregnant woman (between 300 and 1000 pregnancies) did not reveal any malformative effect, nor toxic for the fetus or the newborn of Eupantol.
- Studies in animals have shown reproductive toxicity ( see Preclinical Safety ).
- As a precaution, it is best to avoid the use of Eupantol during pregnancy.
Breastfeeding
- Studies in animals have shown that pantoprazole passes into breast milk.
- There is insufficient data on the excretion of pantoprazole in breast milk, but the passage into breast milk in humans has been reported.
- A risk for newborns / infants can not be ruled out. Therefore, the decision to stop breastfeeding or to stop / abstain from treatment with Eupantol must take into account the benefit of breastfeeding for the child and the benefit of Eupantol treatment for the woman.
Fertility
- Studies in animals have not shown signs of impaired fertility following the administration of pantoprazole ( see Preclinical Safety ).
What happens if I overdose from Eupantol ?
What is Forms and Composition?
| FORMS and PRESENTATIONS |
40 mg gastro-resistant coated tablet (oval and biconvex, on one side “P40” printed in brown ink, yellow):
- Box of 28, under blister packs.
Hospital model: Box of 50, under pads. Powder for solution for injection (IV) 40 mg (white to off-white):
- Bottle, unit box.
| COMPOSITION |
| Gastroresistant tablet: | p cp |
| Pantoprazole sodium sesquihydrate expressed as pantoprazole | 40 mg |
- Excipients: Core: anhydrous sodium carbonate, mannitol (E 421), crospovidone, povidone K 90, calcium
- stearate. Coating: hypromellose, povidone K 25, titanium dioxide (E 171), yellow ferric oxide (E 172), propylene glycol, methacrylic acid / ethyl acrylate copolymer (1: 1), polysorbate 80, lauryl sulphate sodium,
- triethyl citrate. Printing ink: shellac, red iron oxides, black and yellow (E 172), concentrated ammonia solution.
| Powder for solution for injection: | p bottle |
| Pantoprazole sodium sesquihydrate expressed as pantoprazole | 40 mg |
- Excipients: disodium edetate, sodium hydroxide (for pH adjustment).
- Excipients with known effect: edetate disodium (1 mg / vial); sodium hydroxide (0.24 mg / vial).
- This medicine contains less than 1 mmol sodium (23 mg) per vial, ie it is essentially “sodium-free”.
NOT’s
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- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
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- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
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