PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release
Wockhardt USA LLC.
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets, USP are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets, USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
Pantoprazole sodium delayed-release tablets, USP are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets, USP may be considered.
** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
*** Controlled studies did not extend beyond 12 months
|Short-Term Treatment of Erosive Esophagitis Associated With GERD|
|Adults||40mg||Once daily for up to 8 weeks*|
|Children (5 years and older)|
|≥ 15 kg to <40 kg||20 mg||Once daily for up to 8 weeks|
|≥ 40 kg||40 mg|
|Maintenance of Healing of Erosive Esophagitis|
|Adults||40 mg||Once daily***|
|Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome|
Do not split, chew, or crush pantoprazole sodium delayed-release tablets, USP.
|Delayed-Release Tablets||Oral||Swallowed whole, with or without food|
Pantoprazole Sodium Delayed-Release Tablets, USP
Swallow pantoprazole sodium delayed-release tablets, USP should be swallowed whole, with or without food in the stomach. For patients unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.
- 40 mg pantoprazole, yellow colored, biconvex oval shaped tablets plain on one side and imprinted with “W434” (brown ink) on other side.
- 20 mg pantoprazole, yellow colored, biconvex oval shaped tablets plain on one side and imprinted with “W433” (brown ink) on other side.
- Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [ see Adverse Reactions (6) ].
- Proton pump inhibitors (PPIs), including pantoprazole sodium delayed-release tablets, are contraindicated with rilpivirine-containing products [ see Drug Interactions (7) ].
In adults, symptomatic response to therapy with pantoprazole sodium delayed-release tablets does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
Acute interstitial nephritis has been observed in patients taking PPIs including pantoprazole sodium delayed-release tablets. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue pantoprazole sodium delayed-release tablets if acute interstitial nephritis develops [see Contraindications (4)].
Published observational studies suggest that PPI therapy like pantoprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)].
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.