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Drug Details

Pantoprazole 20 mg Gastro-resistant Tablets

• Drug Class Description
  Proton pump inhibitors (PPI's)
• Generic Name
  pantoprazole sodium sesquihydrate
• Presentation
  Gastro-resistant tablet A yellow, oval coated tablet imprinted 20 in black
• Description
  Each gastro-resistant tablet contains: 20 mg of pantoprazole (equivalent to 22.6 mg pantoprazole sodium sesquihydrate) Also contains maltitol and soya lecithin.
• Indications
  

  Adults and adolescents 12 years of age and above

  Symptomatic gastro-oesophageal reflux disease

  • For long-term management and prevention of relapse in reflux oesophagitis.

   

  Adults

  Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment (see section 4.4).

• Adult Dosage
  

  Tablets should not be chewed or crushed and should be swallowed whole, with some water, 1 hour before a meal.

   

  Recommended dose

  Adults and adolescents 12 years of age and above

  Symptomatic gastro-oesophageal reflux disease

  The recommended oral dose is one pantoprazole 20 mg gastro-resistant tablet per day. Symptom relief is generally accomplished within 2-4 weeks. If this is not sufficient, symptom relief will normally be achieved within a further 4 weeks.

  When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, when required. A switch to continuous therapy maybe considered in case satisfactory symptom control cannot be maintained with on-demand treatment.

   

  Long-term management and prevention of relapse in reflux oesophagitis:

  For long-term management, a maintenance dose of one Pantoprazole 20 mg gastro-resistant tablet per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Pantoprazole 40 mg is available in this case. After healing of the relapse, the dose can be reduced again to 20 mg pantoprazole.

   

  Adults

  Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment

  The recommended oral dose is one Pantoprazole 20 mg gastro-resistant tablet per day.

   

  Special populations

  Children below 12 years of age

  Pantoprazole 20mg is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group.

  Hepatic Impairment:

  A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment (see section 4.4).

   

  Renal impairment:

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

   

  Elderly:

  No dose adjustment is necessary in elderly patients.

• Child Dosage
  

   

  Adults and adolescents 12 years of age and above

  Symptomatic gastro-oesophageal reflux disease

  The recommended oral dose is one pantoprazole 20 mg gastro-resistant tablet per day. Symptom relief is generally accomplished within 2-4 weeks. If this is not sufficient, symptom relief will normally be achieved within a further 4 weeks.

  When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, when required. A switch to continuous therapy maybe considered in case satisfactory symptom control cannot be maintained with on-demand treatment.

  Children below 12 years of age

  Pantoprazole 20mg is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group.

   

• Elderly Dosage
  

  Elderly:

  No dose adjustment is necessary in elderly patients.

• Contra Indications
  

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

• Special Precautions
  

   

  Hepatic impairment

  In patients with severe liver impairment, the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly with long-term use. In the event of a rise in liver enzymes, Pantoprazole 20 mg should be discontinued.

   

  Co-administration with NSAIDs.

  The use of Pantoprazole 20 mg as prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk of developing gastrointestinal complications. The increased risk should be assessed according to individual risk factors, e.g. advanced age (>65 years), history of gastric or duodenal ulcers or upper gastrointestinal bleeding.

   

  In the presence of alarm symptoms

  In the presence of any alarm symptoms (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.

   

  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.

   

  Influence on vitamin B12 absorption

  Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

   

  Long term treatment

  In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

   

  Gastrointestinal infections caused by bacteria

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

   

  Soya lecithin

  This medicinal product contains soya lecithin. If the patient is allergic to peanut or soya, do not use this medicinal product.

  This medicinal product contains maltitol.

  Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.

   

• 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 medicines such 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 (see section 4.4).

   

  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 affect 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	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		Hyperlipidaemias and lipid increases (triglycerides, cholesterol); Weight changes		Hyponatraemia
  Psychiatric disorders	Sleep disorders	Depression (and all aggravations)	Disorientation (and all aggravations)	Hallucination; Confusion (especially in predisposed 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 sub-cutaneous 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	Asthenia, fatigue and malaise	Body temperature increased; Oedema peripheral