Inipomp Uses, Dosage, Side Effects, Precautions &Warnings
Inipomp indication and Uses
- Gastroresistant tablet:
- Inipomp is indicated in adults and adolescents aged 12 and over for:
- Oesophagitis by gastroesophageal reflux.
- Inipomp 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.
The tablets will not be crunched or crushed, but swallowed whole with a little water before a meal.
– Eradication of Helicobacter pylori in cases of peptic ulcer disease :
Recommended are following schedules:
- . 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.
- . either 1 tablet of pantoprazole 40 mg morning and evening combined 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 .
– Progressive 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 dose.
– 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.
- Pantoprazole hypersensitivity
- Benzimidazoles hypersensitivity
- Feeding with milk
- Child under 6
- Child from 6 to 12 years old
Hypersensitivity to the active substance, to substituted benzimidazoles or to any of the excipients listed in the Composition section.
How it works Inipomp?
- 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 responsible for the terminal phase of acid production, 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.
- Fasting gastrinemia values increase with pantoprazole. In most cases, during short-term treatments, they do not exceed the upper limits of normal. These values most often double during long-term treatments. However, an excessive increase is reported only in isolated cases. As a result, a slight to moderate increase in the number of endocrine cells in the stomach (ECL cells) is observed only 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 animal studies, it is not possible to totally exclude an influence on the endocrine parameters of the thyroid during long-term treatment with pantoprazole for more than one year.
- During treatment with antisecretory drugs, serum gastrin concentration increases in response to decreased acid secretion. Similarly, the level of CgA increases because of the decrease in gastric acidity. Increased levels of CgA may interfere with tests performed for the exploration of neuroendocrine tumors.
- Based on published data, proton pump inhibitors should be discontinued for 5 days to 2 weeks before measuring CgA. The goal is to allow a return to normal levels of CgA that would have been artificially increased by taking PPIs.
Inipomp Side Effects
Like all medicines, INIPOMP 40 mg gastro-resistant tablets can cause side effects, although not everybody gets them, such as:
- headache, abdominal pain, diarrhea, constipation, flatulence;
- allergic reactions such as itching, rash (and in isolated cases urticaria, angioedema, anaphylactic reactions up to anaphylactic shock), very rarely photosensitivity and severe skin reactions of bullous appearance (Stevens-Johnson syndrome, erythema multiforme) , Lyell’s syndrome.)
- rare cases of nausea, vomiting, dry mouth, dizziness or blurred vision, joint pain;
- isolated cases of edema, fever or muscle pain were observed, as well as elevated liver enzymes (gamma-GT, transaminases) and triglycerides;
- rare cases of depression, hallucination, disorientation and confusion, especially in predisposed patients, and worsening of these symptoms, if pre-existing;
- severe liver injury with jaundice and / or liver failure has been reported very rarely,
- very rare cases of interstitial nephritis (renal damage) and decreased levels of white blood cells or platelets have been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
- 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, such as some azole antifungals, such as ketoconazole, 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 (see section 5.2). caution 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.
- 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 interaction studies
- Pantoprazole is extensively metabolized in the liver by the cytochrome P450 enzyme system. 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, diazepam, glibenclamide, nifedipine, and an oral contraceptive composed of 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 interaction studies showed that pantaprozole did not affect the metabolism of active substances metabolized by CYP1A2 (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, a 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.
Warnings and Precautions
- In patients with severe hepatic insufficiency, liver enzymes should be monitored regularly during pantoprazole treatment, especially in long-term use. If hepatic enzymes are increased, treatment should be discontinued .
- In the case of therapeutic associations, it is necessary to follow 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, haematemesis, anemia or melena), and when a gastric ulcer is suspected or present, a malignant condition should be ruled out.
- Further examinations should be considered if the symptoms persist despite appropriate treatment.
- Concomitant administration of HIV protease inhibitors
- Concomitant administration of pantoprazole and HIV protease inhibitors, whose absorption depends on gastric pH, such as latazanavir, is not recommended as this may significantly reduce their bioavailability (see section 4.5).
- Influence on the absorption of vitamin B12
- In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, pantoprazole, like any gastric secretory inhibitor, 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.
- In the context of long-term treatment, especially when its duration exceeds 1 year, patients should be monitored regularly.
Gastrointestinal bacterial infections
- Treatment with Inipomp may lead to a slight increase in the risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter , or C.difficile.
- Severe hypomagnesemic cases 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 IPP discontinuation.
- In patients requiring prolonged therapy or when PPIs are combined with digoxin or with drugs that may induce hypomagnesaemia (eg diuretics), blood magnesium levels should be considered by health professionals before starting treatment with IPP and regularly during treatment.
- Proton pump inhibitors, particularly if they are used in high doses over a prolonged period (> 1 year), may moderately increase the risk of hip, wrist and vertebral fractures, mainly in elderly or elderly patients. 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 of osteoporosis should be managed according to the recommendations in force, and receive an appropriate intake of vitamin D and calcium.
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 accompanied by arthralgia, the patient should consult a physician promptly and the health care provider should consider stopping Inipomp. The occurrence of LECS after treatment with a proton pump inhibitor may increase the risk of LECS with other proton pump inhibitors.
Interference with laboratory tests
- Increased levels of Chromogranin A (CgA) may interfere with tests performed for the exploration of neuroendocrine tumors. To avoid this interference, treatment with Inipomp should be stopped for at least 5 days before measuring the level of CgA (see section 5.1). If CgA and gastrin levels have not normalized after the initial measurement, the measurements should be repeated 14 days after discontinuation of proton pump inhibitor therapy.
Drive and use machines
- Pantoprazole has no or negligible effect on the ability to drive and use machines.
- Adverse effects such as dizziness and visual disturbances may occur (see section 4.8). Patients with this type of adverse effect should not drive or use machinery.
PREGNANCY / BREAST FEEDING / FERTILITY
inipomp 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 Inipomp.
- Studies in animals have shown reproductive toxicity ( see Preclinical Safety ).
- As a precaution, it is best to avoid the use of Inipomp during pregnancy.
- 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 Inipomp must take into account the benefit of breastfeeding for the child and the benefit of Inipomp treatment for the woman.
- Studies in animals have not shown signs of impaired fertility following the administration of pantoprazole ( see Preclinical Safety ).
- What happens if I overdose from Inipomp ?
- The symptoms of overdose in humans are not known.
- Doses up to 240 mg administered by injection for two minutes were well tolerated. Since pantoprazole is largely protein bound, it is not dialysable.
- In case of overdose with clinical signs of intoxication, no specific therapeutic recommendations can be given, with the exception of symptomatic treatment and support.
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): Boxes of 14 and 28, under blister packs.
- Hospital model: Box of 50. Powder for solution for injection IV 40 mg (white to off-white): Bottle, unit box.
|Gastroresistant tablet:||p cp|
|(as pantoprazole sodium sesquihydrate)|
- Excipients: Core: anhydrous sodium carbonate, mannitol (E 421), crospovidone, povidone K 90, calcium stearate. Coating: hypromellose, povidone K 25, titanium dioxide (E 171), yellow iron oxide (E 172), propylene glycol, copolymer of methacrylic acid and ethyl acrylate (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|
|(as pantoprazole sodium sesquihydrate)|
- Excipients: disodium edetate, sodium hydroxide (for pH adjustment).
- Excipients with known effect: edetate disodium (1 mg / vial) and sodium hydroxide (0.24 mg / vial).
- This medicine contains less than 1 mmol sodium (23 mg) per vial, ie it is essentially “sodium-free”.
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