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Protonix For Oral Susp Generic Name & Formulations
Legal Class
Rx
General Description
Pantoprazole (as sodium) 40mg; per pkt; e-c del-rel granules.
Pharmacological Class
Proton pump inhibitor.
See Also
How Supplied
Tabs—90; Susp—30 packets; Vials—1, 10, 25
Manufacturer
Generic Availability
YES
Protonix For Oral Susp Indications
Indications
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).
Protonix For Oral Susp Dosage and Administration
Adult
Swallow whole. Do not crush or chew granules. Susp: Take 30mins 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 30mins 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.
Protonix For Oral Susp Contraindications
Contraindications
Concomitant rilpivirine-containing products.
Protonix For Oral Susp Boxed Warnings
Not Applicable
Protonix For Oral Susp Warnings/Precautions
Warnings/Precautions
Symptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). 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. Nursing mothers.
Protonix For Oral Susp Pharmacokinetics
See Literature
Protonix For Oral Susp Interactions
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.
Protonix For Oral Susp Adverse Reactions
Adverse Reactions
Headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, arthralgia; possible C. difficile-associated diarrhea, inj site reactions (IV); rare: hypomagnesemia and mineral metabolism. Also children: URI, fever, rash.
Protonix For Oral Susp Clinical Trials
See Literature
Protonix For Oral Susp Note
Not Applicable
Protonix For Oral Susp Patient Counseling
See Literature
