Precautions
Indications and Usage for Pantoprazole Injection. Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis. Pantoprazole Sodium for Injection 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).
What is a pantoprazole injection used for?
Pantoprazole sodium for injection 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).
What are the indications for pantoprazole sodium injection?
When administered through a Y-site, pantoprazole sodium for injection is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.
What solutions are compatible with pantoprazole sodium for injection?
NOTE: Pantoprazole is not approved by the FDA to be administered by continuous IV infusion, but is under FDA review. Several adult consensus guidelines recommend a pantoprazole 80 mg IV infusion bolus, followed by 8 mg/h continuous infusion in the treatment of select indications.
Can pantoprazole be given by infusion?
What is IV pantoprazole used for?
Pantoprazole injection is used to treat certain conditions in which there is too much acid in the stomach. It is used for short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) with a history of erosive esophagitis.
Can pantoprazole be given IV?
NOTE: Pantoprazole is not approved by the FDA to be administered by continuous IV infusion, but is under FDA review. Several adult consensus guidelines recommend a pantoprazole 80 mg IV infusion bolus, followed by 8 mg/h continuous infusion in the treatment of select indications. Dilute each 40-mg vial with 10 ml NS.
Is pantoprazole given IV or IM?
Pantoprazole injection comes as a powder to be mixed with liquid and given intravenously (into a vein) by a doctor or nurse in a medical facility. For the treatment of GERD, pantoprazole injection is usually given once a day for 7 to 10 days.
When do you use IV PPI?
IV PPI is indicated in the treatment of high-risk peptic ulcers, complicated gastroesophageal reflux, stress-induced ulcer prophylaxis, Zollinger–Ellison syndrome, and whenever it is impossible or impractical to give oral therapy.
How does IV PPI work?
Abstract. Intravenous (IV) administration of a proton pump inhibitor (PPI) is a faster way to achieve gastric acid suppression than oral administration of the same agent. Peak suppression after IV administration occurs within hours, compared with several days later after oral administration.
How often can you give IV pantoprazole?
The recommended adult dosage of PROTONIX I.V. is 40 mg given once daily by intravenous infusion for 7 to 10 days. Discontinue treatment with PROTONIX® I.V. as soon as the patient is able to receive treatment with PROTONIX Delayed-Release Tablets or Oral Suspension.
How do you administer pantoprazole?
PROTONIX I.V. for Injection should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min. PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL.
What injection is given for gastritis?
Proton pump inhibitors (PPIs) are the first-line therapy to treat gastritis due to H. pylori infection.
How do you dilute IV pantoprazole?
PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light.
How do you administer pantoprazole?
PROTONIX I.V. for Injection should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min. PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL.
How do you make pantoprazole infusion?
PANTOPRAZOLE (Pantoloc)Bolus: 40-80 mg in 100 mL sodium chloride 0.9%, dextrose 5% or Ringer's Lacate infused over 15-60 minutes.Infusion: 40 mg in 100 mL sodium chloride 0.9%, dextrose 5% or Ringer's Lacate. bag stable only for 6 hours; do not prepare large size bag.
How do you administer omeprazole IV?
Omeprazole, 40 mg, should be given slowly (over a period of 5 minutes) as an intravenous injection. Omeprazole powder for solution for infusion should only be dissolved in either 100 ml normal saline for infusion or 100 ml 5% dextrose for infusion. No other solutions for i.v. infusion should be used.
How much sodium chloride to inject with pantoprazole?
1. Reconstitute pantoprazole sodium for injection with 10 mL of 0.9% Sodium Chloride Injection, USP. 2. Further dilute with 100 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a final concentration of approximately 0.4 mg/mL. 3.
How much pantoprazole is in a vial?
Pantoprazole sodium for injection is supplied as a freeze-dried powder containing 40 mg of pantoprazole per vial. Pantoprazole sodium for injection is available as follows: NDC 72572-550-01 – Package of 1 vial. The vial contains pantoprazole sodium for injection equivalent to 40 mg pantoprazole.
How long does pantoprazole sodium last?
Pantoprazole sodium for injection 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 pantoprazole sodium for injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been ...
How long does it take to take 40 mg of pantoprazole?
The recommended adult dosage of pantoprazole sodium for injection is 40 mg given once daily by intravenous infusion for 7 to 10 days. Discontinue treatment with pantoprazole sodium for injection as soon as the patient is able to receive treatment with pantoprazole delayed-release tablets or oral suspension.
What is the USP test for pantoprazole?
USP test 2 is used for organic impurities test.
Is there a causal relationship between pantoprazole and sodium?
The following adverse reactions have been identified during postapproval use of pantoprazole and pantoprazole sodium for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Does pantoprazole cause diarrhea?
Published observational studies suggest that PPI therapy like pantoprazole sodium for injection 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) ].
What is pantoprazole used for?
Uses. Pantoprazole is used to treat certain stomach and esophagus problems (such as acid reflux ). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, ...
How to use Pantoprazole sodium vein?
How to use Pantoprazole SODIUM Vial. This medication is given by injection into a vein as directed by your doctor. The dosage and length of treatment are based on your medical condition and response to treatment. If you are using this medication at home, learn all preparation and usage instructions from your health care professional.
How to report pantoprazole side effects in Canada?
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Before using pantoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as lansoprazole, omeprazole ); or if you have any other allergies.
Can pantoprazole cause bone fractures?
Proton pump inhibitors (such as pantoprazole) may increase your risk of bone fractures, especially with longer use, higher doses, and in older adults.
Can drug interactions change your medication?
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist.
Does pantoprazole help with ulcers?
It helps heal acid damage to the stomach and esophagus, helps prevent ulcers , and may help prevent cancer of the esophagus. Pantoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).The injection form of this drug is used for a short time when you cannot take the medication by mouth.
How does pantoprazole work?
Mechanism of Action: Pantoprazole is a substituted benzimidazole proton-pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the gastric (H+,K+)-ATPase enzyme pump. Pantoprazole forms a covalent bond to two sites of the (H+,K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell; this binding results in antisecretory effects that persists > 24 hours, which allows for once-daily dosing. A significant increase in gastric pH and decrease in basal acid output follow oral and IV administration of pantoprazole. Pantoprazole does not antagonize H2 or cholinergic receptors.
How long does it take to take 40 mg of pantoprazole?
40 mg PO once daily after the morning meal for 2 to 4 weeks. NOTE: The safe and effective use of pantoprazole for long-term maintenance therapy (e.g., more than 16 weeks) for duodenal ulcer disease has not been established.
How long does pantoprazole last?
20 mg PO once daily for up to 4 weeks. Per clinical practice guidelines, initiate empiric therapy based on a presumptive diagnosis of GERD in the setting of typical symptoms of heartburn and regurgitation. For patients with partial response to once daily therapy, consider pantoprazole 20 mg PO twice daily, or consider a one-time switch to a different PPI. Refer non-responders for further evaluation. Consider maintenance therapy for patients who continue to have symptoms after PPI discontinuation; the lowest effective dose, including on demand or intermittent therapy should be used with regular assessment of the need for continued PPI therapy. Alternatively, step-down maintenance therapy to an H2 blocker is acceptable.
Can pantoprazole be used in pregnancy?
There are no adequate and well-controlled studies of pantoprazole in pregnant women. Although data from published observational studies in humans failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use, methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. Animal reproductive studies have been conducted in rats and rabbits using doses up to 88 and 16 times, respectively, that of humans based on body surface area; there was no evidence of fetal harm. It is not known if pantoprazole crosses the human placenta, although another PPI with a similar molecular weight, omeprazole, is known to cross the human placenta. In one study, pregnancy outcomes were reported with exposure to omeprazole (n = 295), lansoprazole (n = 62), and pantoprazole (n = 53). Compared to non-exposed control groups, there was no difference in the rate of major malformations with the use of pantoprazole (RR 0.55, 95% CI 0.8 to 3.95). However, there is a possibility that the true risk of malformation was missed due to study design and/or sample size. In another study, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births. In addition, a meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations OR = 1.12 [95% CI 0.86 to 1.45] and for spontaneous abortions OR = 1.29 [95% CI 0.84 to 1.97]). Pantoprazole likely represents a low risk in pregnancy, but should be used during pregnancy only when clearly needed. In 2009, a population-based observational cohort study explored a possible link between gastric acid suppressive therapy (e.g., proton pump inhibitors) during pregnancy and a diagnosis of allergic disease or a prescription for asthma or allergy medications in the exposed child. Among the cohort (n = 585,716), 1% of children exposed to gastric acid suppressive drugs in pregnancy received a diagnosis of allergic diease. For developing allergy or asthma, an increased OR of 1.43 and 1.51, respectively, were observed regardless of drug used, time of exposure during pregnancy, and maternal history of disease. Proposed possible mechanisms for a link include: (1) exposure to increased amounts of allergens could cause sensitization to digestion-labile antigens in the fetus; (2) the maternal Th2 cytokine pattern could promote an allergy prone phenotype in the fetus; (3) maternal allergen specific immunoglobulin could cross the placenta and sensitize fetal immune cells to food and airborne allergens. Study limitations were present and confirmation of results are necessary before further conclusions can be drawn from this data. Risk versus benefit should be considered prior to use.
Can pantoprazole cause a false positive?
Gastric acid suppression may increase serum CgA. Increased CgA concentrations may cause false positive results in diagnostic investigations for neuroendocrine tumors. To prevent this interference, temporarily stop pantoprazole at least 14 days before assessing CgA concentrations and consider repeating the test if initial concentrations are high. If serial tests are performed, ensure the same commercial laboratory is used as reference ranges may vary. Reports have suggested use of proton pump inhibitors (PPIs) may cause false positive urine screening tests for THC. If a PPI-induced false positive urine screen is suspected, confirm the positive results using an alternative testing method. PPIs may also cause a hyper-response in gastrin secretion to the secretin stimulation test, falsely suggesting gastrinoma. Health care providers are advised to temporarily stop pantoprazole at least 14 days prior to performing a secretin stimulation test to allow gastrin concentrations to return to baseline. Preparations that combine PPIs with antimicrobials and bismuth are known to suppress H. pylori; thus, ingestion of these preparations within 4 weeks of performing diagnostic tests for H. pylori may lead to false negative results. At a minimum, instruct the patient to avoid the use of pantoprazole in the 1 to 2 weeks prior to the test and the use of antimicrobials and bismuth preparations in the 4 weeks prior to the test.
Is pantoprazole excreted in milk?
According to the manufacturer, pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has also been detected, but the clinical relevance of this finding is un known. Because of the potential for tumorigenicity and carcinogenicity found in animal studies, the manufacturer suggests that a decision should be made whether to discontinue nursing or pantoprazole, taking into account the benefit of the drug to the mother. In one study, a partially breast-feeding mother was 10 months postpartum and received a single 40 mg dose of oral pantoprazole. Although small quantities of the drug were present in breast milk at 2 and 4 hours after the dose (36 mcg/L and 24 mcg/L, respectively), the drug was undetectable in expressed milk 6, 8, and 24 hours after the dose. Using the above case, authors estimated that a fully breast fed infant would receive 0.14% of the maternal weight-adjusted dosage. Because of limited human data and the potential for serious adverse reactions from pantoprazole in the breast-fed infant (including suppression of gastric acid secretion), pantoprazole should be used with caution in breast-feeding women. Alternative therapies for consideration include antacids and H2 blockers.
Can you take pantoprazole for long term?
Daily treatment with a gastric acid-suppressing medication over a long period of time (e.g., 3 months to > 1 year) may lead to hypomagnesemia; cases have been reported in patients taking pantoprazole. Generally, hypomagnesemia is corrected with magnesium supplementation; however, in cases where hypomagnesemia is observed during PPI administration, discontinuation of the PPI may also be necessary. Low serum magnesium may lead to serious adverse events such as muscle spasm (tetany), seizures, and irregular heartbeat (arrhythmias). Use PPIs with caution and, if possible, avoid long-term (> 14 days) use in patients with congenital long QT syndrome, as they may be at higher risk for arrhythmias. In pediatric patients, irregular heartbeat may cause fatigue, upset stomach, dizziness, and lightheadedness. For patients expected to be on PPI therapy for a prolonged period of time, it is prudent for clinicians to obtain serum magnesium concentrations prior to initiating PPI therapy as well as throughout treatment. Patients on concomitant medications such as digoxin or diuretics (see Interactions) may also require periodic monitoring of serum magnesium.
What are the side effects of Protonix IV?
Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes. Protonix IV side effects (more detail)
What is Protonix used for?
Uses of Protonix I.V.: It is used to treat gastroesophageal reflux disease ( GERD; acid reflux ). It is used to treat syndromes caused by lots of stomach acid. It may be given to you for other reasons. Talk with the doctor.
How long can you take Protonix?
The chance may be higher if you take Protonix I.V. (pantoprazole injection) in high doses or for longer than a year, or if you are older than 50 years old. Use care if you have risks for soft, brittle bones (osteoporosis).
What to do if you think you have an overdose?
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Can you take Protonix I.V. for longer than you were told by your doctor?
Tell all of your health care providers that you take Protonix I.V. (pantoprazole injection). This includes your doctors, nurses, pharmacists, and dentists. Do not take Protonix I.V. (pantoprazole injection) for longer than you were told by your doctor . This medicine may affect certain lab tests.
Can you take Protonix with Pantoprazole?
You must check to make sure that it is safe for you to take Protonix I.V. (pantoprazole injection) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Can you take zinc while taking Protonix?
You may need to take zinc while you take Protonix I.V. (pantoprazole injection). Talk with your doctor. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
2 DOSAGE AND ADMINISTRATION
The recommended adult dosage of PROTONIX I.V. is 40 mg given once daily by intravenous infusion for 7 to 10 days.
3 DOSAGE FORMS AND STRENGTHS
For Injection: 40 mg of pantoprazole white to off-white freeze-dried powder in a single-dose vial for reconstitution.
4 CONTRAINDICATIONS
PROTONIX I.V. is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include...
5 WARNINGS AND PRECAUTIONS
In adults, symptomatic response to therapy with PROTONIX I.V. does not preclude the presence of gastric...
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in labeling:
7 DRUG INTERACTIONS
Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PROTONIX I.V. and instructions for preventing or managing them....
10 OVERDOSAGE
Experience in patients taking very high doses of pantoprazole (greater than 240 mg) is limited. Adverse reactions seen in spontaneous reports of overdose generally reflect the known safety profile of...