Generic Name and Formulations:
Pantoprazole (as sodium) 40mg; per packet; e-c delayed-release granules.

Company:
Pfizer Inc.
Indications for PROTONIX for ORAL SUSP:
Short-term treatment (up to 8 weeks) and maintenance of healing of erosive esophagitis (EE). Pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome).

Adult:
Swallow whole. Do not crush or chew granules. Susp: Take 30 mins before a meal. Mix contents of packet in 5mL of apple juice or applesauce (do not mix in water, other liquids or foods); then swallow. May give via NG tube (see full labeling). Treatment of EE: 40mg once daily for ≤8 weeks; if not healed, may repeat for 8 more weeks. Maintenance of EE healing: 40mg once daily. Pathological hypersecretory conditions: initially 40mg twice daily; max 240mg/day.

Children:
Swallow whole. Do not crush or chew granules. Susp: Take 30 mins before a meal. Mix contents of packet in 5mL of apple juice or applesauce (do not mix in water, other liquids or foods); then swallow. May give via NG tube (see full labeling). <5yrs: not recommended. Treatment of EE: Give once daily for up to 8 weeks. ≥5yrs: (≥15kg to <40kg): 20mg; (≥40kg): 40mg.

Warnings/Precautions:
Gastric malignancy. Discontinue if acute interstitial nephritis occurs. Long-term therapy may lead to malabsorption/deficiency of Vit. B12 or atrophic gastritis. Increased risk of osteoporosis-related fractures (hip, wrist or spine) with long-term and multiple daily dose PPI therapy. Monitor magnesium levels with long-term therapy. Use lowest effective dose for shortest duration. Reeva luate periodically. IV: consider zinc supplementation in those prone to zinc deficiency. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:
Concomitant atazanavir or nelfinavir: not recommended. May alter absorption of gastric pH-dependent drugs (eg, ketoconazole, iron, atazanavir, erlotinib, mycophenolate mofetil, ampicillin). Concomitant digoxin or drugs that may cause hypomagnesemia (eg, diuretics); consider monitoring magnesium levels. Monitor warfarin. May give antacids concomitantly. IV: caution with concomitant other EDTA-containing products. May potentiate methotrexate. May cause false (+) urine THC test.

See Also:
PROTONIX TABLETS

PROTONIX I.V.

Pharmacological Class:
Proton pump inhibitor.

Adverse Reactions:
Headache, diarrhea, nausea, vomiting, flatulence, dizziness, arthralgia, inj site reactions; also children: fever, rash, abdominal pain; hypomagnesemia (w. prolonged PPI therapy), possible C. difficile-associated diarrhea.

Metabolism:
Hepatic (CYP2C19, 3A4). 98% protein bound.

Elimination:
Renal (primarily), fecal.

Generic Availability:
Tabs, IV (YES); oral soln (NO)

How Supplied:
Tabs—90; Susp—30 packets/box; Vials (40mg)—1, 10, 25