Description
ndications |
Listed in Dosage. |
Dosage |
Adult : PO Gastro-oesophageal reflux disease 20-40 mg once daily for 4 weeks (increased to 8 weeks if necessary). Maintenance: 20-40 mg daily. Peptic ulcer 40 mg for 2-4 weeks for duodenal ulcer or 4-8 weeks for benign gastric ulcer. Prophylaxis of NSAID-induced ulcers 20 mg once daily. Zollinger-Ellison syndrome 40 mg bid (adjusted up to 240 mg/day if needed). Daily doses >80 mg should be given in 2 divided doses. IV Gastro-oesophageal reflux disease, Peptic ulcer 40 mg daily until PO can be resumed. Zollinger-Ellison syndrome 80 mg once or twice daily until PO can be resumed. |
Dosage Details |
Intravenous Zollinger-Ellison syndrome Adult: 80 mg once or twice daily as slow injection or short-term infusion over 2-15 minutes. Switch to oral therapy as soon as possible.
Intravenous Adult: 40 mg daily as slow injection or short-term infusion over 2-15 minutes. Switch to oral therapy as soon as possible.
Oral Adult: 40 mg once daily (increased up to 80 mg if necessary) for 2-4 weeks for duodenal ulcer or 4-8 weeks for benign gastric ulcer.
Oral Adult: 20-40 mg once daily for 4 weeks (increased to 8 weeks if necessary). Maintenance: 20-40 mg daily. Alternatively, 20 mg daily on recurring symptoms.
Oral Adult: 20 mg once daily.
Oral Adult: 40 mg bid (adjusted up to 240 mg/day if needed). Daily doses >80 mg should be given in 2 divided doses. |
Hepatic Impairment |
Max: 20 mg daily. |
Administration |
Normal Release: May be taken with or without food. Controlled-Release: Should be taken on an empty stomach. Take 1 hr before meals. Swallow whole, do not chew/crush. |
Reconstitution |
Reconstitute 40 mg vial with 10 mL 0.9% NaCl inj to make a final concentration of approx 4 mg/mL. IV Infusion: Further dilute with 100 mL of D5W, normal saline, or Lactated Ringer’s inj to achieve a concentration of approx. 0.4 mg/mL. For an 80 mg dose: Reconstitute two 40 mg vials and dilute 10mL of the reconstituted solution in 100 mL of IV infusion solutions. |
Contraindications |
Concomitant use with rilpivirine and atazanavir. |
Special Precautions |
Patient with gastric malignancy, risk factors for reduced vitamin B12 absorption or at risk for osteoporosis. Hepatic impairment. Pregnancy and lactation. |
Adverse Drug Reactions |
Significant: Hypomagnesaemia, cutaneous lupus erythematosus, SLE, osteoporosis-related fractures, fundic gland polyp, carcinoma, Clostridium difficile-associated diarrhoea, interstitial nephritis, Vitamin B12deficiency (long-term therapy), gastrointestinal infection (e.g. salmonella, Campylobacter). Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, flatulence, abdominal pain, dyspepsia, dry mouth. General disorders and administration site conditions: Asthenia, fatigue, malaise. Hepatobiliary disorders: Increased liver enzymes. Immune system disorders: Urticaria. Metabolism and nutrition disorders: Peripheral oedema. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia. Nervous system disorders: Headache, dizziness, vertigo. Psychiatric disorders: Insomnia. Reproductive system and breast disorders: Gynaecomastia. Skin and subcutaneous tissue disorders: Rash, pruritus. |
Pregnancy Category (US FDA) |
IV/Parenteral/PO: C |
Patient Counselling |
This drug may cause dizziness or visual disturbances, if affected, do not drive or operate machinery. |
Monitoring Parameters |
Monitor bone loss, fractures, Clostridium difficile-associated diarrhoea (CDAD), serum Mg (at baseline and periodically), serum gastrin level concentrations. |
Drug Interactions |
May decrease plasma concentrations of rilpivirine and atazanavir. Increased risk of hypomagnesaemia with diuretics. Increased risk of digoxin-induced cardiotoxic effects. May increase INR and prothrombin time of warfarin. May increase plasma concentration of methotrexate. May decrease absorption of itraconazole, ketoconazole, posaconazole, erlotinib. May diminish the therapeutic effect of clopidogrel. |
Food Interaction |
St John’s wort may decrease serum levels of pantoprazole. |
Lab Interference |
May increase serum chromogranin A (CgA) levels causing false-positive result in diagnostic tests for neuroendocrine tumours and urine screening tests for tetrahydrocannabinol. |
Mechanism of Action |
Description: Pantoprazole is a substituted benzimidazole gastric antisecretory agent and is also known as proton pump inhibitor (PPI). It blocks the final step in gastric acid secretion by specific inhibition of H+/K+adenosine triphosphatase (ATPase) enzyme system present on the secretory surface of the gastric parietal cell. Both basal and stimulated acid are inhibited. Onset: 2.5 hours (oral); 15-30 minutes (IV). Duration: 24 hours. Pharmacokinetics: Absorption: Rapidly absorbed. Time to peak plasma concentration: Approx 2-2.5 hours (oral). Bioavailability: Approx 77%. Distribution: Enters breast milk. Volume of distribution: 11-23.6 L. Plasma protein binding: Approx 98% (mainly to albumin). Metabolism: Extensive hepatic metabolism, mainly by CYP2C19 isoenzyme to desmethylpantoprazole and slightly by CYP3A4, CYP2D6 and CYP2C9 isoenzymes. Excretion: Mainly via urine (approx 80%); faeces. Elimination half-life: Approx 1 hour. |
Storage |
Store between 20-25°C. |
MIMS Class |
Antacids, Antireflux Agents & Antiulcerants |
ATC Classification |
A02BC02 – pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD). |
