Dosage of Sandoz Pantoprazole in details
Sandoz Pantoprazole Dosage
Generic name: Sandoz Pantoprazole SODIUM 40mg in 10mL
Dosage form: injection, powder, for solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.
Parenteral routes of administration other than intravenous are not recommended.
Sandoz Pantoprazole I.V. for Injection may be administered intravenously through a dedicated line or through a Y-site. The intravenous line should be flushed before and after administration of Sandoz Pantoprazole I.V. for Injection with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP. When administered through a Y-site, Sandoz Pantoprazole I.V. for Injection is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.
Midazolam HCl has been shown to be incompatible with Y-site administration of Sandoz Pantoprazole I.V. for Injection. Sandoz Pantoprazole I.V. for Injection may not be compatible with products containing zinc. When Sandoz Pantoprazole I.V. for Injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.
Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis
Recommended Dosage
The recommended adult dose is 40 mg Sandoz Pantoprazole given once daily by intravenous infusion for 7 to 10 days.
Treatment with Sandoz Pantoprazole® I.V. (Sandoz Pantoprazole sodium) for Injection should be discontinued as soon as the patient is able to receive treatment with Sandoz Pantoprazole Delayed-Release Tablets or
Oral Suspension.
Administration and Preparation Instructions
Data on the safe and effective dosing for conditions other than those described such as life-threatening upper gastrointestinal bleeds, are not available. Sandoz Pantoprazole I.V. 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.
Fifteen Minute Infusion
Sandoz Pantoprazole I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, and further diluted (admixed) 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. The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.
Sandoz Pantoprazole I.V. for Injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Two Minute Infusion
Sandoz Pantoprazole I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, 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. Sandoz Pantoprazole I.V. for Injection should be administered intravenously over a period of at least 2 minutes.
Pathological Hypersecretion Including Zollinger-Ellison Syndrome
Recommended Dosage
The dosage of Sandoz Pantoprazole I.V. for Injection in patients with pathological hypersecretory conditions including Zollinger-Ellison Syndrome varies with individual patients. The recommended adult dosage is 80 mg intravenously every 12 hours. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h. Daily doses higher than 240 mg or administered for more than 6 days have not been studied. Transition from oral to intravenous and from intravenous to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with Zollinger-Ellison Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition.
Administration and Preparation Instructions
Fifteen Minute Infusion
Each vial of Sandoz Pantoprazole I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be combined and further diluted (admixed) with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL. The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.
Sandoz Pantoprazole I.V. for Injection should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Two minute Infusion
Sandoz Pantoprazole 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. The total volume from both vials should be administered intravenously over a period of at least 2 minutes.
More about Sandoz Pantoprazole (Sandoz Pantoprazole)
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Consumer resources
- Sandoz Pantoprazole
- Sandoz Pantoprazole delayed-release tablets
- Sandoz Pantoprazole suspension
- Sandoz Pantoprazole (Advanced Reading)
- Sandoz Pantoprazole
Intravenous (Advanced Reading)
Professional resources
- Sandoz Pantoprazole (AHFS Monograph)
- Sandoz Pantoprazole (FDA)
Other formulations
- Sandoz Pantoprazole IV
Related treatment guides
- GERD
- Barrett's Esophagus
- Erosive Esophagitis
- Zollinger-Ellison Syndrome
- Duodenal Ulcer
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What other drugs will affect Sandoz Pantoprazole?
Sandoz Pantoprazole should not be taken together with atazanavir (Reyataz) or nelfinavir (Viracept). Tell your doctor if you are taking either of these medications to treat HIV or AIDS.
Tell your doctor about all other medicines you use, especially:
-
ampicillin (Principen, Unasyn);
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a blood thinner such as warfarin (Coumadin, Jantoven);
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digoxin (Lanoxin, Lanoxicaps);
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a diuretic (water pill);
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ketoconazole (Nizoral);
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iron (Feosol, Mol-Iron, Fergon, Femiron, others); or
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methotrexate (Rheumatrex, Trexall).
This list is not complete and other drugs may interact with Sandoz Pantoprazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Sandoz Pantoprazole interactions
Interference With Antiretroviral Therapy
Concomitant use of atazanavir or nelfinavir with proton pump inhibitors is not recommended. Co-administration of atazanavir or nelfinavir with proton pump inhibitors is expected to substantially decrease atazanavir or nelfinavir plasma concentrations and may result in a loss of therapeutic effect and development of drug resistance.
Coumarin Anticoagulants
There have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including Sandoz Pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.
Clopidogrel
Concomitant administration of Sandoz Pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrelinduced platelet inhibition. No dose adjustment of clopidogrel is necessary when administered with an approved dose of Sandoz Pantoprazole.
Drugs For Which Gastric pH Can Affect Bioavailability
Due to its effects on gastric acid secretion, Sandoz Pantoprazole can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability. Like with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazole, ampicillin esters, atazanavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease.
Co-administration of Sandoz Pantoprazole 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. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving Sandoz Pantoprazole and MMF. Use Sandoz Pantoprazole with caution in transplant patients receiving MMF.
False Positive Urine Tests For THC
There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving proton pump inhibitors. An alternative confirmatory method should be considered to verify positive results.
Methotrexate
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of Methotrexate with PPIs have been conducted.
References
- MeSH. "Anti-Ulcer Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "2-{[(3,4-dimethoxy-2-pyridinyl)methyl]-sulfinyl}-5-methyl-1H-1,3-benzimidazole;5-difluoromethoxy-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- PubMed Health. "Pantoprazole: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology