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Basics for everyone

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  1. 1. PANTOPRAZOLE Lakshmi Narayana M
  2. 2. Topics to follow…. Introduction Mechanism of action Pharmacokinetics Indications Recommended dosing schedule Dose adjustments Not to prescribe or take care Possible side effects of pantoprazole
  3. 3. Proton pump inhibitors (PPIs) are a group of drugs whose main action is a pronounced and long-lasting reduction of gastric acid production • Omeprazole • Lansoprazole • Dexlansoprazole • Esomeprazole • Pantoprazole • Rabeprazole • Ilaprazole INTRODUCTION
  4. 4. INTRODUCTION Pantoprazole is a substituted benzimidazole and proton pump inhibitor drug that inhibits gastric acid secretion. It is used to treat gastroesophageal reflux disease (GERD), a condition that causes gastric juices to flow upward from your stomach and into the oesophagus. It also treats conditions in which the stomach makes excess acid, such as Zollinger-Ellison syndrome. it works to shut off the acid-pumping cells in your stomach. It reduces the amount of stomach acid and helps to reduce painful symptoms related to gastroesophageal reflux disease (GERD).
  5. 5. MECHANISM OF ACTION Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding of pantoprazole to H+/K+-ATPase is irreversible in nature, and effectively inhibits acid secretion until new enzyme is synthesized. MOA
  6. 6. PHARMACOKINETICS Rapidly absorbed after oral administration. On set of action is within 2¬4 hours, duration of action is about 24 hours. Peak concentration (Cmax) is 2.5 μg/mL; the time to reach the peak concentration (tmax) is 2.5 h. The drug is subject to low first pass¬ hepatic excretion, the oral bioavailability is 77%. approximately 71% of the dose was excreted in the urine, with 18% excreted in the feces through biliary excretion. There was no renal excretion of unchanged pantoprazole.
  7. 7. Contd…. Geriatric Only slight to moderate increases in pantoprazole AUC (43%) and Cmax (26%) were found in elderly volunteers (64 to 76 years of age) after repeated oral administration, compared with younger subjects. No dosage adjustment is recommended based on age
  8. 8. Children and Adolescents 6 through 16 Years of Age Contd…. 6-11 YEARS (N=12) 12-16 YEARS (N=11) Cmax (Pg/mL)a 1.8 1.8 tmax (h)b 2.0 2.0 AUC (μg•h/mL)a 6.9 5.5 CL/F (L/h)b 6.6 6.8
  9. 9. DOSE ADJUSTMENTS Gender There is a modest increase in pantoprazole AUC and Cmax in women compared to men. However, weight-normalized clearance values are similar in women and men. No dosage adjustment is recommended based on gender. Renal Impairment In patients with severe renal impairment, pharmacokinetic parameters for pantoprazole were similar to those of healthy subjects. No dosage adjustment is necessary in patients with renal impairment or in patients undergoing hemodialysis.
  10. 10. Contd…. Hepatic Impairment No dosage adjustment is needed in patients with mild to severe hepatic impairment.
  11. 11. INDICATIONS • To treat ulcers in the stomach and the part of the gut called the duodenum. • To reduce acid reflux which may cause heartburn or inflammation of the gullet (oesophagitis). These conditions are sometimes called gastro- oesophageal reflux disease (GORD). • As one part of treatment to get rid of Helicobacter pylori - a germ (bacterium) found in the stomach, which can cause ulcers. • To help prevent and treat ulcers associated with anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs). • In a rare condition called Zollinger-Ellison syndrome. • In other conditions where it is helpful to reduce acid in the stomach.
  12. 12. RECOMMENDED DOSING SCHEDULE INDICATION DOSE FREQUENCY Short-Term Treatment of Erosive Esophagitis Associated with GERD Adults 40 mg Once daily for up to 8 weeks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily
  13. 13. NOT TO PRESCRIBE OR TAKE CARE Pregnancy: Pregnancy Category B, this drug should be used during pregnancy only if clearly needed Nursing Mothers Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants.
  14. 14. Contd…. Tumorigenicity In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown Bone Fracture Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine
  15. 15. POSSIBLE SIDE EFFECTS Common • Gastrointestinal: abdominal pain (6%), diarrhea (9%), nausea (7%), vomiting (4%) • Neurologic: headache (12%), dizziness (3%)
  16. 16. Contd…. Rare • Gastrointestinal: constipation, dry mouth, hepatitis • Blood problems: low white blood cell count, thrombocytopenia • Immunologic: Stevens-Johnson syndrome, toxic epidermal necrolysis • Metabolic: elevated creatine kinase, elevated cholesterol levels, elevated liver enzymes (AST/ALT), swelling • Musculoskeletal: Muscle disorders, bone fracture and infection, Clostridium difficile infection, osteoporosis-related hip fracture, rhabdomyolysis
  17. 17. Contd…. Long-term • Osteoporosis and bone fracture have been observed in patients on high-dose and/or long term (over 1 year) prescription proton pump inhibitors • Hypomagnesia has been observed in patients on medications like pantoprazole when taken for longer periods of time (generally 1 year or more, although cases have been reported with regimens as short as 3 months)