On postnatal day (PND 4) through PND 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (AUC) in humans at a dose of 40 mg). 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 [see, CgA levels increase secondary to PPI-induced decreases in gastric acidity. The following adverse reactions have been identified during postapproval use of PROTONIX and PROTONIX I.V. (pantoprazole injection) at home, talk with your doctor, nurse, or pharmacist about how to store it. to other PPIs (oral or intravenous) or H2-receptor antagonists (oral or intravenous) are limited, and therefore, are inadequate to support any conclusions regarding comparative efficacy. It is given through a needle placed into one of your veins. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Clostridium difficile-associated diarrhea. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pantoprazole in the elderly. in 21 patients (29 to 75 years; 8 female; 4 Black, 1 Hispanic, 16 White) reduced acid output to the target level (10 mEq/h or less) and significantly reduced H+ concentration and the volume of gastric secretions; target levels were achieved within 45 minutes of drug administration. Discontinue PROTONIX I.V. During 6 days of repeated administration of PROTONIX I.V. It is used for short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) with a history of erosive esophagitis. After administration of a single intravenous dose of 14C-labeled pantoprazole sodium to healthy, extensive CYP2C19 metabolizers, approximately 71% of the dose was excreted in the urine with 18% excreted in the feces through biliary excretion. Read all information given to you. In clinical studies of ZE Syndrome, adverse reactions reported in 35 patients administered PROTONIX I.V. is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringers Injection, USP. CYP2C19 displays a known genetic polymorphism due to its deficiency in some subpopulations (e.g., approximately 3% of Caucasians and African-Americans and 17% to 23% of Asians are poor metabolizers). Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Full to partial recovery of these effects were noted in animals of both age groups following a recovery period. with 10 mL of 0.9% Sodium Chloride Injection, USP. The magnitude and time course for inhibition of pentagastrin-stimulated acid output (PSAO) by single doses (20 to 120 mg) of PROTONIX I.V. No dose adjustment of clopidogrel is necessary when administered with an approved dose of PROTONIX I.V.. 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. What Are the Best PsA Treatments for You? For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Do not share your drugs with others and do not take anyone else's drugs. MAO was estimated from a 1 hour continuous collection of gastric contents following subcutaneous injection of 6.0 mcg/kg of pentagastrin to stimulate acid secretion. MAO was estimated from a 1 hour continuous collection of gastric contents following subcutaneous injection of 6.0 mcg/kg of pentagastrin. In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. CYP2C19 displays a known genetic polymorphism due to its deficiency in some sub-populations (e.g., 3% of Caucasians and African-Americans and 17 to 23% of Asians). The recommended adult dosage of PROTONIX I.V. for Injection is supplied as a freeze-dried powder in a clear glass vial fitted with a rubber stopper and crimp seal containing pantoprazole sodium, equivalent to 40 mg of pantoprazole, edetate disodium (1 mg), and sodium hydroxide to adjust pH. These side effects may go away during treatment as your body adjusts to the medicine. Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. Available for Android and iOS devices. Both medications have potential drug interactions, but omeprazole is more likely to interact with other medications. Breastfeeding The active ingredient in PROTONIX I.V. Talk with the doctor. We comply with the HONcode standard for trustworthy health information. Only for intravenous infusion; other parenteral routes of administration are not recommended. There were no effects on the breastfed infant (see Data). Taste pervasion most frequently occurred in patients given triple therapy, but it was also very common in patients given quadruple therapy. It may be given to you for other reasons. Study 1 was a multicenter, double-blind, placebo-controlled, study of the pharmacodynamic effects of PROTONIX I.V. This includes prescription (eg, atazanavir, nelfinavir, Reyataz, Viracept) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Hypocalcemia occurred in association with hypomagnesemia. Complete suppression of PSAO was achieved with 80 mg within approximately 2 hours and no further significant suppression was seen with 120 mg. It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. When PROTONIX I.V. Patient Graphics Showing results for Protonix (Pantoprazole) Search instead: Proton pump inhibitors Proton pump inhibitors: Overview of use and adverse effects in the treatment of acid related disorders proportional to the pKa of the benzimidazole (rabeprazole >omeprazole, esomeprazole, and lansoprazole > pantoprazole) . The following serious adverse reactions are described below and elsewhere in labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. PROTONIX I.V. Dose adjustment of warfarin may be needed to maintain target INR range. When administered through a Y-site, PROTONIX I.V. Comments & ratings on the side effects, benefits, and effectiveness of Protonix intravenous. Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain. No adverse events in the infant were reported by the mother. The most commonly reported side effects were headache, diarrhea, and injection site thrombophlebitis (in IV formulations). Cerner Multum, Inc. "Australian Product Information." thrombophlebitis, an inflamed vein due to a blood clot. Tell your doctor if you have had problems with your zinc levels in your body. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Protonix; Descriptions. [Ref], Uncommon (0.1% to 1%): Fracture of the hip/wrist/spine, Very rare (less than 0.01%): Skeletal pain, Frequency not reported: Bone fracture, elevated creatine phosphokinase (CPK)/elevated creatine kinase (CK), muscle spasm, systemic lupus erythematosus, Postmarketing reports: Rhabdomyolysis[Ref], Rare (0.01% to 0.1%): Hyperlipidemia, increased cholesterol, increased triglycerides, lipid increases, weight changes, Frequency not reported: Cyanocobalamin (vitamin B12) deficiency), electrolyte disturbances, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, potential for exacerbation of zinc deficiency[Ref]. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. They can also cause long-term problems like weakening bones and kidney issues. Of 286 patients in clinical studies of intravenous pantoprazole sodium in patients with GERD and a history of EE, 86 (43%) were 65 years of age and over. bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site, pain, tenderness, or swelling of the foot or leg, blistering, peeling, or loosening of the skin, continuing ringing or buzzing or other unexplained noise in the ears, feeling of constant movement of self or surroundings, greatly decreased frequency of urination or amount of urine, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, numbness and tingling around the mouth, fingertips, or feet, pains in the stomach, side, or abdomen, possibly radiating to the back, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, red skin lesions, often with a purple center, sores, ulcers, or white spots on the lips or in the mouth, watery and severe diarrhea, which may also be bloody, excess air or gas in the stomach or bowels. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. The femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. Be ready to tell or show what was Hypocalcemia occurred in association with hypomagnesemia. Uses Before taking Dosage Warnings Side effects FAQ Uses for pantoprazole Call your doctor for medical advice about side effects. The relative dose to the infant was estimated to be 7.3 mcg of pantoprazole, which is equivalent to 0.14% of the weight-adjusted maternal dose. Common side effects of Protonix IV include: injection site reactions (redness, pain, swelling) headache nausea diarrhea abdominal pain vomiting gas dizziness, or joint pain Dosage for Protonix IV Protonix IV is given by injection into a vein by a doctor. Use care if you have risks for soft, brittle bones (osteoporosis). Administration of oral pantoprazole 40 mg twice daily for 4 days and a single 1000 mg dose of MMF approximately one hour after the last dose of pantoprazole to 12 healthy subjects in a cross-over study resulted in a 57% reduction in the Cmax and 27% reduction in the AUC of MPA. 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. Mayo Clinic does not endorse any of the third party products and services advertised. A repeat endoscopy after 8 weeks of treatment revealed that 20 out of 23 (87%) patients treated with PROTONIX I.V. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience with oral pantoprazole sodium has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose selection for this study may not have been adequate to comprehensively evaluate the carcinogenic potential of pantoprazole. had a significantly lower MAO and BAO than those treated with placebo (p<0.001), and results were comparable to those of patients treated with PROTONIX Delayed-Release Tablets (see Table 5). 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. What should I discuss with my healthcare provider before using pantoprazole (Protonix, Protonix IV)? In a clinical pharmacology study, pantoprazole 40 mg given orally once daily for 2 weeks had no effect on the levels of the following hormones: cortisol, testosterone, triiodothyronine (T3), thyroxine (T4), thyroid-stimulating hormone, thyronine-binding protein, parathyroid hormone, insulin, glucagon, renin, aldosterone, follicle-stimulating hormone, luteinizing hormone, prolactin and growth hormone. Wyeth-Ayerst Laboratories (2001): 2. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. The effect of PPIs on antiretroviral drugs is variable. After repeated intravenous administration in elderly subjects (65 to 76 years of age), the AUC and elimination half-life values of pantoprazole were similar to those observed in younger subjects. .Be careful and be sure to specify the information on the section Name of the medicinal product in the instructions to the drug Protonix IV directly from the package or from the pharmacist at the pharmacy. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. (pantoprazole injection) with all of your drugs and health problems. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Data on the safe and effective dosing for conditions other than those described [see INDICATIONS AND USAGE] such as life-threatening upper gastrointestinal bleeds, are not available. Applies to pantoprazole: oral packet, oral tablet delayed release, oral tablet enteric coated. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. However, elderly patients are more sensitive to the effects of this medicine than younger adults. If signs or symptoms consistent with CLE or SLE are noted in patients receiving PROTONIX I.V., discontinue the drug and refer the patient to the appropriate specialist for evaluation. 10 Things People With Depression Wish You Knew. Single intravenous doses of pantoprazole at 378, 230, and 266 mg/kg (38, 46, and 177 times the recommended human dose based on body surface area) were lethal to mice, rats and dogs, respectively. If you have any questions about Protonix I.V. There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs [see. (pantoprazole injection). The duration of action of PROTONIX I.V. Can you take pantoprazole 40 mg twice a day? Changes in bone parameters were partially reversible following a recovery period, with findings on PND 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Other symptoms can include sore throat, hoarseness, chronic cough, wheezing, bad breath, chest pain, and a feeling like there is something in the throat. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about . Can you take pantoprazole 40 mg twice a day? liver . Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after you receive the medicine. Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. (40 mg) once daily for 5 days and pH was measured for 24 hours following the fifth dose. (pantoprazole injection) as ordered by your doctor. Generally, histological findings were observed without organ involvement. Caution should be used when other EDTA containing products are also co-administered intravenously [see DOSAGE AND ADMINISTRATION]. In adults, headache occurred most frequently in patients given quadruple therapy (pantoprazole, bismuth, metronidazole, tetracycline) for H pylori infections, but was also very common in triple therapy (pantoprazole, amoxicillin, clarithromycin). In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see DRUG INTERACTIONS]. Pantoprazole may cause side effects such as headache, diarrhea, abdominal pain, and nausea. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. If you notice any other effects, check with your healthcare professional. Using this medicine with any of the following medicines is not recommended. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations. [Ref], Nasopharyngitis and pharyngolaryngeal pain occurred in pediatric patients between the ages of 2 to 16 years. Poor metabolizers exhibited approximately 10-fold lower apparent oral clearance compared to extensive metabolizers. In the gastric fundus, treatment with 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported. Treatment with 5 to 150 mg/kg/day also produced gastric fundic ECL cell hyperplasia. "Product Information. Tell your In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with pantoprazole doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50-kg person dosed at 40 mg/day. In adults, headache occurred most frequently in patients given quadruple therapy (pantoprazole, bismuth, metronidazole, tetracycline) for H pylori infections, but was also very common in triple therapy (pantoprazole, amoxicillin, clarithromycin). In vivo studies also suggest that pantoprazole does not significantly affect the kinetics of other drugs (cisapride, theophylline, diazepam [and its active metabolite, desmethyldiazepam], phenytoin, metoprolol, nifedipine, carbamazepine, midazolam, clarithromycin, diclofenac, naproxen, piroxicam and oral contraceptives [levonorgestrel/ethinyl estradiol]). In a 24-month carcinogenicity study, Fischer 344 rats were treated orally with pantoprazole doses of 5 to 50 mg/kg/day, approximately 1 to 10 times the recommended human dose based on body surface area. There are no data on pantoprazole effects on milk production. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL. (pantoprazole injection). Temporarily stop PROTONIX I.V. Therapeutic class: Proton Pump Inhibitor (PPI) Route of administration: For Intravenous use only. help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. Basal acid secretion was maintained below target levels for at least 24 hours in all patients and through the end of treatment in these studies (3 to 7 days) in all but 1 patient who required a dose adjustment guided by acid output measurements until acid control was achieved. Ppis on antiretroviral drugs is variable, abdominal pain, and effectiveness of PROTONIX and PROTONIX I.V 1 a! These effects were headache, diarrhea, abdominal pain, and effectiveness of PROTONIX intravenous away during treatment your! With this medication or change some of the PPI may be needed to maintain target INR.! 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