Pantoprazole Sodium Sesquihydrate

Indications

Pantoprazole Sodium Sesquihydrate is used for: Peptic ulcer disease, H. pylori infection, Gastro-oesophageal reflux disease, Zollinger-Ellison syndrome, Oesophagitis, Acid-related dyspepsia, NSAID-associated ulceration, ulcer resistant to H2 receptor antagonists, Gastrointestinal (GI) bleeding from stress, Prophylaxis for acid aspiration syndrome during induction of anaesthesia

Adult Dose

Erosive Esophagitis Associated With GERD Treatment: 40 mg PO qDay for 8-16 weeks Maintenance of healing: 40 mg PO qDay Alternatively, 40 mg IV qDay for 7-10 days Short-term Treatment of GERD Oral therapy inappropriate or not possible: 40 mg IV infusion over 15 minutes qDay for 7-10 days; switch to PO once patient able to swallow Zollinger-Ellison Syndrome 40 mg PO qDay; up to 240 mg/day administered in some patients 80 mg IV infusion q8-12hr up to 7 days; switch to PO once patient able to swallow Peptic Ulcer Disease Duodenal ulcer: 40 mg PO qDay for 2-4 weeks Gastric ulcer: 40 mg PO qDay for 4-8 weeks Elderly: No dosage adjustment needed. Hepatic impairment: Max: 20 mg/day or 40 mg on alternate days.

Child Dose

Erosive Esophagitis Associated With GERD <5 years: Safety and efficacy not established >5 years 15 kg to <40 kg: 20 mg PO qDay for up to 8 weeks 40 kg or greater: 40 mg PO qDay for up to 8 weeks

Renal Dose

Renal impairment: No dosage adjustment needed.

Administration

Controlled-release: Should be taken on an empty stomach. Take 1 hr before meals. Swallow whole, do not chew/crush. Normal release: May be taken with or without food. IV Preparation GERD with a history of erosive esophagitis 15-min infusion: Reconstitute with 10 mL NS, THEN further dilute with 100 mL D5W, NS, or LR to final concentration of 0.4 mg/mL Zollinger-Ellison syndrome 15-min infusion: Reconstitute each vial with 10 mL NS, THEN Combine 2 vials and further dilute with 80 mL D5W, NS, or LR to total volume of 100 mL (concentration 0.8 mg/mL) 2-min injection: Reconstitute with 10 mL NS to final concentration of 4 mg/mL IV Administration Infuse over 15 min no more than 3 mg/min (7 mL/min) for GERD and 6 mg/min (7 mL/min) for pathologic hypersecretory conditions

Contra Indications

Concomitant use w/ rilpivirine, atazanavir and nelfinavir. Lactation.

Precautions

Gastric malignancy should be ruled out. Consider Zn++ supplementation during IV therapy in patients who are prone to Zn++ deficiency. Pregnancy. Monitoring Parameters Monitor Mg levels prior to initiation and periodically during prolonged use. Lactation: Not known whether pantoprazole is distributed into breast milk; not recommended

Pregnancy-Lactation

Interactions

Increased risk of digoxin-induced cardiotoxic effects. Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time of warfarin. May increase serum concentration of methotrexate and saquinavir. Delayed absorption and decreased bioavailability w/ sucralfate. Decreased absorption of ketoconazole, itraconazole. Potentially Fatal: May decrease serum levels and pharmacological effects of rilpivirine, atazanavir and nelfinavir.

Adverse Effects

Side effects of Pantoprazole Sodium Sesquihydrate : 1-10% Headache (>4%),Abdominal pain (4%),Facial edema (<4%),Generalized edema (<2%),Chest pain (4%),Diarrhea (4%),Constipation (<4%),Pruritus (4%),Rash (4%),Flatulence (<4%),Hyperglycemia (1%),Nausea (1%),Vomiting (>4%),Photosensitivity (<2%) Frequency Not Defined Angioedema,Atrophic gastritis,Anterior ischemic optic neuropathy,Hepatocellular damage leading to hepatic failure,Interstitial nephritis,Pancreatitis,Pancytopenia,Rhabdomyolysis,Risk of anaphylaxis,Stevens-Johnson syndrome,Fatal toxic epidermal necrolysis,Erythema multiforme

Mechanism of Action

Pantoprazole is a substituted benzimidazole, and also known as PPI due to its property to block the final step of acid secretion by inhibiting H+/K+ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.