Lyophilized powder, intravenous or infusion: 40 mg.
Indication & Usage:
Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis:
Remeflux is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of Remeflux as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.
Pathological Hyper secretion Including Zollinger-Ellison Syndrome:
Remeflux is indicated for the treatment of pathological hyper secretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
Dosage & Administration:
- GERD Associated with EE:
The recommended adult dosage is 40 mg given once daily by intravenous infusion for 7 to 10 days.
- Pathological Hypersecretion Conditions, Including ZE Syndrome:
The recommended adult dosage is 80 mg administered every 12 hours by intravenous infusion.
- Only for intravenous infusion.
- The intravenous infusion can be administered over 2 minutes or 15 minutes.
Most common adverse reactions (>2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.
The following serious adverse reactions are described below and elsewhere in labeling:
Hypersensitivity and Severe Skin Reactions, Injection Site Reactions, Potential for Exacerbation of Zinc Deficiency, Acute Interstitial Nephritis, Clostridium Difficile-Associated Diarrhea, Bone Fracture, Cutaneous and Systemic Lupus Erythematosus, Hepatic Effects, Hypomagnesaemia, Fundic Gland Polyps
- Remeflux is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria.
- Proton pump inhibitors (PPIs), including Remeflux, are contraindicated in patients receiving Rilpivirine-containing products
- Decreased exposure of some antiretroviral drugs (e.g., Rilpivirine, Atazanavir, and Nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance.
- Increased exposure of other antiretroviral drugs (e.g., Saquinavir) when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drugs.
- Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
- Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite Hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted. A temporary withdrawal of Remeflux may be considered in some patients receiving high-dose methotrexate.
- Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH.
- CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.
- There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.
Warning & Precautions:
- Gastric Malignancy: In adults, symptomatic response to therapy with Remeflux does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
- Hypersensitivity and Severe Skin Reactions: Anaphylaxis has been reported.
- Injection Site Reactions: Thrombophlebitis is associated with the administration of intravenous pantoprazole.
- Potential Exacerbation of Zinc Deficiency: Consider zinc supplementation in patients who are prone
- to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously.
- Acute Interstitial Nephritis: Observed in patients taking PPIs.
- Clostridium Difficile-Associated Diarrhea: PPI therapy may be associated with increased risk.
- Bone Fracture: Long term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
- Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Remeflux and refer to specialist for evaluation.
- Hepatic Effects: Elevations of transaminases observed. (5.9) Hypomagnesemia: Reported rarely with prolonged treatment with PPIs.
- Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the
- shortest duration of therapy.
Pregnancy & Lactation:
Pregnancy Category C
Lactation: Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
Carton containing 1 vial of 40 mg sterile lyophilized powder.
Storage & condition:
Keep out of reach of children.
Store dry product below 25°C and protect from light and moisture.
Single use only, throwaway the rest of reconstituted solution.