PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM
(pan-to'pra-zole)
Protonix, Protonix IV
Classifications: proton pump inhibitor;
Therapeutic: antiulcer
; proton pump inhibitor
Prototype: Omeprazole
Pregnancy Category: B

Availability

40 mg enteric coated tablets; 40 mg injection

Action

Gastric acid pump inhibitor; belongs to a class of antisecretory compounds. Gastric acid secretion is decreased by inhibiting the H+, K+-ATPase enzyme system responsible for acid production.

Therapeutic Effect

Specifically, suppresses gastric acid secretion by inhibiting the acid (proton H+) pump in the parietal cells.

Uses

Short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD), hypersecretory disease.

Unlabeled Uses

Peptic ulcer disease.

Contraindications

Hypersensitivity to pantoprazole or other proton pump inhibitors (PPIs); severe hepatic insufficiency, cirrhosis; lactation.

Cautious Use

Mild to moderate hepatic insufficiency; pregnancy (category B). Safety and effectiveness in children <18 y are not established.

Route & Dosage

Erosive Esophagitis
Adult: PO 40 mg q.d. x 8–16 wks IV 40 mg q.d. x 7–10 d

Hypersecretory Disease
Adult: PO 40 mg b.i.d. (doses up to 240 mg/d have been used) IV 80 mg b.i.d.; adjust based on acid output

Renal Impairment/Hepatic Impairment
Adjustment not needed.
Hemodialysis: Drug not removed

Administration

Oral
  • Do not crush or break in half. Must be swallowed whole.
  • Note: Therapy beyond 16 wk is not recommended.
  • Store preferably at 20°–25° C (66°–77° F), but room temperature permitted.
Intravenous

PREPARE: IV Infusion: ??Two-min infusion: Reconstitute each 40 mg vial with 10 mL NS to yield 0.4 mg/mL.??Fifteen-min infusion: Reconstitute as for 2-min infusion, then further dilute the 40 or 80 mg dose in 90 or 80 mL, respectively, of D5W, NS, or RL IV fluid. The resulting concentration will be 0.4 mg/mL or 0.8 mg/mL. 

ADMINISTER: IV Infusion: ?? Give through a dedicated line or flushed IV line before and after each dose with D5W, NS, or RL. ?? Two-min infusion: Give over at least 2 min. ?? Fifteen-min infusion: Infuse over 15 min at a rate of 6 mg/min (7 mL/min). ?? Note: Protonix IV packaged with an in-line filter must be used with the provided filter. A newer formulation does not require an in-line filter.  

INCOMPATIBILITIES Solution/additive: Solutions containing zinc. Y-site: Midazolam, zinc.

  • Reconstituted solution may be stored for up to 6 h at 15–30° C (59–86° F) before further dilution. The diluted 100 mL solution should be infused within 24 h or infused within 24 h of reconstitution.

Adverse Effects (≥1%)

GI: Diarrhea, flatulence, abdominal pain. CNS: Headache, insomnia. Skin: Rash.

Interactions

Drug: May decrease absorption of ampicillin, iron salts, itraconazole, ketoconazole; increases INR with warfarin. Herbal: Ginkgo may decrease plasma levels.

Pharmacokinetics

Absorption: Well absorbed with 77% bioavailability. Peak: 2.4 h. Distribution: 98% protein bound. Metabolism: In liver (CYP2C19). Elimination: 71% in urine, 18% in feces. Half-Life: 1 h.

Nursing Implications

Assessment & Drug Effects

  • Monitor for and immediately report S&S of angioedema or a severe skin reaction.
  • Lab tests: Urea breath test 4–6 wk after completion of therapy.

Patient & Family Education

  • Contact physician promptly if any of the following occur: Peeling, blistering, or loosening of skin; skin rash, hives, or itching; swelling of the face, tongue, or lips; difficulty breathing or swallowing.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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