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PROTONIX
Hyperacidity, GERD, and ulcers
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Drug Name:

PROTONIX Rx

Generic Name and Formulations:
Pantoprazole (as sodium) 20mg, 40mg; e-c del-rel tabs.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for PROTONIX:

Short-term treatment (up to 8 weeks) and maintenance of healing of erosive esophagitis (EE). Long-term treatment of 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 or gastrostomy 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. 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 or gastrostomy 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.

Contraindications:

Concomitant rilpivirine-containing products.

Warnings/Precautions:

Symptomatic response does not preclude gastric malignancy. Discontinue if acute interstitial nephritis, cutaneous/systemic lupus erythematosus occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Use lowest dose for shortest duration appropriate to condition. Reevaluate periodically. IV: consider zinc supplementation in those prone to zinc deficiency. Pregnancy (Cat.C). Nursing mothers: not recommended.

See Also:

PROTONIX for ORAL SUSP

PROTONIX I.V.

Pharmacological Class:

Proton pump inhibitor.

Interactions:

See Contraindications. May antagonize atazanavir, nelfinavir (avoid). May potentiate saquinavir, methotrexate (at high doses, consider temporary withdrawal of the PPI); monitor. May alter absorption of gastric pH-dependent drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Caution with digoxin or drugs that may cause hypomagnesemia (eg, diuretics); monitor. Monitor warfarin. May cause false (+) results in diagnostic investigations for neuroendocrine tumors; discontinue pantoprazole 14 days prior to CgA level assessment. May cause false (+) urine THC test. IV: caution with concomitant other EDTA-containing products.

Adverse Reactions:

Headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, arthralgia; possible C. difficile-associated diarrhea, inj site reactions (IV); rare: hypomagnesemia. Also children: URI, fever, rash.

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 pkts/carton; Vials (40mg)—1, 10, 25

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