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Drug Details

Pantoprazole 40 mg Powder for Solution for Injection

• Drug Class Description
  Proton pump inhibitors - ATC code: A02BC02
• Generic Name
  pantoprazole sodium sesquihydrate
• Presentation
  Powder for solution for injection. A white to yellowish powder.
• Description
  One vial contains 40 mg pantoprazole (as pantoprazole sodium sesquihydrate).
• Indications
  

  − Reflux oesophagitis.

  − Gastric and duodenal ulcer.

  − Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.

• Adult Dosage
  

  This medicine should be administered by a healthcare professional and under appropriate medical supervision.

  Intravenous administration of Pantoprazole 40 mg Powder for Solution for Injection is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, treatment with Pantoprazole 40 mg Powder for Solution for Injection i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.

  Recommended dose

  Gastric and duodenal ulcer, reflux oesophagitis

  The recommended intravenous dose is one vial of Pantoprazole 40 mg Powder for Solution for Injection (40 mg pantoprazole) per day.

  Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions

  For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg Pantoprazole 40 mg Powder for Solution for Injection. Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.

  In case a rapid acid control is required, a starting dose of 2 x 80 mg Pantoprazole 40 mg Powder for Solution for Injection is sufficient to manage a decrease of acid output into the target range (< 10 mEq/h) within one hour in the majority of patients.

  Special populations

  Hepatic Impairment

  A daily dose of 20 mg pantoprazole (half a vial of 40 mg pantoprazole) should not be exceeded in patients with severe liver impairment .

  Renal Impairment

  No dose adjustment is necessary in patients with impaired renal function.

   

• Child Dosage
  

  The experience in children is limited. Therefore, Pantoprazole 40 mg Powder for Solution for Injection 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age until further data become available.

• Elderly Dosage
  

  No dose adjustment is necessary in elderly patients.

• Contra Indications
  

  Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients.

• Special Precautions
  

  n presence of alarm symptoms

  In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with pantoprazole may alleviate symptoms and delay diagnosis.

  Further investigation is to be considered if symptoms persist despite adequate treatment.

  Hepatic Impairment

  In patients with severe liver impairment, the liver enzymes should be monitored during therapy. In the case of a rise of the liver enzymes, the treatment should be discontinued.

  Co-administration with atazanavir

  Co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir. A pantoprazole dose of 20 mg per day should not be exceeded.

  Gastrointestinal infections caused by bacteria

  Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with Pantoprazole 40 mg Powder for Solution for Injection may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.

• Interactions
  

  Effect of pantoprazole on the absorption of other medicinal products

  Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may reduce the absorption of drugs with a gastric pH dependent bioavailability, e.g. some azole antifungals as ketoconazole, itraconazole, posaconazole and other medicine as erlotinib.

  HIV medications (atazanavir)

  Co-administration of atazanavir and other HIV medications whose absorption is pH-dependent with proton-pump inhibitors might result in a substantial reduction in the bioavailability of these HIV medications and might impact the efficacy of these medicines. Therefore, the co-administration of proton pump inhibitors with atazanavir is not recommended.

  Coumarin anticoagulants (phenprocoumon or warfarin)

  Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing period. Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time / INR is recommended after initiation, termination or during irregular use of pantoprazole.

  Other interactions studies

  Pantoprazole is extensively metabolized in the liver via the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by CYP2C19 and other metabolic pathways include oxidation by CYP3A4.

  Interaction studies with drugs also metabolized with these pathways, like carbamazepine, diazepam, glibenclamide, nifedipine, and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions.

  Results from a range of interaction studies demonstrate that pantoprazole does not effect the metabolism of active substances metabolised by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol) or does not interfere with p-glycoprotein related absorption of digoxin.

  There were no interactions with concomitantly administered antacids.

  Interaction studies have also been performed administering pantoprazole concomitantly with the respective antibiotics (clarithromycin, metronidazole, amoxicillin). No clinically relevant interactions were found.

   

   

   

• Adverse Drug Reactions
  

  Approximately 5% of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhoea and headache, both occurring in approximately 1% of patients.

  The table below lists adverse reactions reported with pantoprazole, ranked under the following frequency classification:

  Very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

  For all adverse reactions reported from post-marketing experience, it is not possible to apply any Adverse Reaction frequency and therefore they are mentioned with a “not known” frequency.

  Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

  Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience

  Frequency	Common	Uncommon	Rare	Very rare	Not known
  System Organ Class
  Blood and lymphatic system disorders				Thrombocytopenia; Leukopenia
  Immune system disorders			Hypersensitivity (including anaphylactic reactions and anaphylactic shock)
  Metabolism and nutrition disorders			Hyperlipidaemi as and lipid increases (triglycerides, cholesterol); Weight changes		Hyponatraemia
  Psychiatric disorders		Sleep disorders	Depression (and all aggravations)	Disorientation (and all aggravations)	Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence)
  Nervous system disorders		Headache; Dizziness
  Eye disorders			Disturbances in vision / blurred vision
  Gastrointestinal disorders		Diarrhoea; Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth; Abdominal pain and discomfort
  Hepatobiliary disorders		Liver enzymes increased (transaminases, γ-GT)	Bilirubin increased		Hepatocellular injury; Jaundice; Hepatocellular failure
  Skin and subcutaneous tissue disorders		Rash / exanthema / eruption; Pruritus	Urticaria; Angioedema		Stevens-Johnson syndrome; Lyell syndrome; Erythema multiforme; Photosensitivity
  Musculoskeletal and connective tissue disorders			Arthralgia; Myalgia
  Renal and urinary disorders					Interstitial nephritis
  Reproductive system and breast disorders			Gynaecomastia
  General disorders and administration site conditions	Injection site thrombophlebitis	Asthenia, fatigue and malaise	Body temperature increased; Oedema peripheral