O 0, 4. Treatment with 5 to 150 mg/kg/day also produced gastric fundic ECL cell hyperplasia. General Effects Protonix IV has been shown to reduce acid reflux-related symptoms, heal inflammation of the esophagus, and improve patient quality of life more effectively than histamine-2 receptor antagonists (H2 blockers). There were no effects on the breastfed infant (see Data). This includes your doctors, nurses, pharmacists, and dentists. Note: This document contains side effect information about pantoprazole. 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. substantially reduced the 24-hour cumulative PSAO in a dose-dependent manner, despite a short plasma elimination half-life. 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). This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more. Drug class: Proton pump inhibitors. This medication relieves symptoms such as heartburn, difficulty swallowing, and cough. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see DRUG INTERACTIONS]. Administer reconstituted pantoprazole as IV push over 2 minutes. IV administration considerations for Pantoprazole. 1, 2, 18 Esomeprazole is the s-isomer of omeprazole. Call your doctor for medical advice about side effects. See additional information. Other dosage forms: Along with its needed effects, pantoprazole (the active ingredient contained in Protonix) may cause some unwanted effects. Last updated on May 14, 2023. The magnitude and time course for inhibition of pentagastrin-stimulated acid output (PSAO) by single doses (20 to 120 mg) of PROTONIX I.V. Do not start, stop, or change the dose of 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). Although not all of these side effects may occur, if they do occur they may need medical attention. 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. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Pantoprazole has weakly basic and acidic properties. amoxicillin, omeprazole, famotidine, pantoprazole, metronidazole, Protonix, clarithromycin, esomeprazole, sucralfate, Nexium. Consider monitoring magnesium and calcium levels prior to initiation of PROTONIX I.V. [Ref], Common (1% to 10%): Injection site thrombophlebitis, Frequency not reported: Injection site reactions[Ref], Common (1% to 10%): Influenza-like symptoms, moniliasis, Rare (0.01% to 0.1%): Anaphylactic reactions, anaphylactic shock, angioedema/Quincke's edema, hypersensitivity, hypersensitivity reactions, Frequency not reported: Allergic reactions, Rare (0.01% to 0.1%): Agranulocytosis, anemia, Very rare (less than 0.01%): Increased coagulation time, leukopenia, pancytopenia, thrombocytopenia[Ref], Uncommon (0.1% to 1%): Blurred vision, visual disturbances, Very rare (less than 0.01%): Conjunctivitis[Ref], Very rare (less than 0.01%): Interstitial nephritis (with possible progression to renal failure), Frequency not reported: Acute interstitial nephritis[Ref]. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. protonix i.v. after 1 year of treatment. Call your doctor right away if you have severe bone pain or are unable to walk or sit normally. 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]). Cerner Multum, Inc. "UK Summary of Product Characteristics." However, there were no observed elevations in serum gastrin following the administration of oral pantoprazole at a dose of 0.5 mg/kg/day. (pantoprazole injection) at home, talk with your doctor, nurse, or pharmacist about how to store it. The breast milk of a 42-year-old woman receiving 40 mg of oral pantoprazole, at 10 months postpartum, was studied for 24 hours, to demonstrate low levels of pantoprazole present in the breast milk. Can you take pantoprazole 40 mg twice a day? is administered through a Y-site, immediately stop use if precipitation or discoloration occurs. In the gastric fundus, treatment with 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. 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. Protonix acts on proton pumps in the stomach. Check with your doctor right away if you have a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, nausea, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. RxList does not provide medical advice, diagnosis or treatment. In one of these studies, an initial treatment with PROTONIX I.V. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. Included as part of the PRECAUTIONS section. The injection can be stored at room temperature up to 6 hours after reconstitution. (pantoprazole injection) for a long time or with certain other drugs. Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. An alternative confirmatory method should be considered to verify positive results. Reconstitute PROTONIX I.V. A temporary withdrawal of PROTONIX I.V. Drug information provided by: Merative, Micromedex. 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. Fecal and/or tongue discoloration occurred more commonly in patients given quadruple therapy versus patients given triple therapy. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. There was no renal excretion of unchanged pantoprazole. Both medications have potential drug interactions, but omeprazole is more likely to interact with other medications. The safety and effectiveness of PROTONIX I.V. (pantoprazole sodium) Side Effects Center for a complete guide to possible side . For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see ADVERSE REACTIONS]. Last updated on May 14, 2023. 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. Flush the intravenous line before and after administration of PROTONIX I.V. There were no effects on fertility or reproductive performance when pantoprazole was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area). You may report side effects to the FDA at 1-800-332-1088. Visit the FDA MedWatch website or call 1-800-FDA-1088. Erectile dysfunction (ED) is often a symptom . The stability of the compound in aqueous solution is pH-dependent. Some of these risks include drinking alcohol. Nausea, vomiting, abdominal pain, dry mouth, and constipation were more commonly reported in patients given triple therapy, compared to patients given quadruple therapy. In adults, symptomatic response to therapy with PROTONIX I.V. You are encouraged to report negative side effects of prescription drugs to the FDA. Other PPIs include, among others, Nexium (esomeprazole) and Prilosec (omeprazole). Pantoprazole may cause side effects such as headache, diarrhea, abdominal pain, and nausea. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole sodium. In a pre-and post-natal development toxicity study in rats, the pups were administered oral doses of pantoprazole at 5, 15, and 30 mg/kg/day on postnatal day (PND 4) through PND 21, in addition to lactational exposure through milk. The effects may be increased because of slower removal of the medicine from the body. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. with 10 mL of 0.9% Sodium Chloride Injection, USP. Some dosage forms listed on this page may not apply to the brand name Protonix. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. A milk-to-plasma ratio of 0.022 was observed at 2 hours after drug administration. Applies to pantoprazole: oral packet, oral tablet delayed release, oral tablet enteric coated. [Ref], Very common (10% or more): Headache (Up to 26.4%), taste pervasion (Up to 18.2%), Common (1% to 10%): Dizziness, metallic/bitter taste, somnolence, Very rare (less than 0.01%): Change to the sense of taste, reduced movement, speech disorder, Frequency not reported: Paresthesia, vertigo, Postmarketing reports: Ageusia, dysgeusia[Ref]. Table of contents Pantoprazole Omeprazole How they work Dosing Effectiveness Side effects Cost (pantoprazole injection) as ordered by your doctor. In patients with severe renal impairment, pharmacokinetic parameters for pantoprazole were similar to those of healthy subjects. O 0. Wyeth-Ayerst Laboratories, 3. Check with your doctor right away if you notice any of these side effects at the injection site: changes in skin color, pain, tenderness, or swelling of the foot or leg. This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. Make sure you tell your doctor if you have any other medical problems, especially: A nurse or other trained health professional will give you this medicine in a medical facility. There are no data on pantoprazole effects on milk production. Poor metabolizers exhibited approximately 10-fold lower apparent oral clearance compared to extensive metabolizers. Anorexia commonly occurred in patients with H pylori. To help relieve this pain, antacids may be taken with pantoprazole, unless your doctor tells you otherwise. Pantoprazole was positive in the in vitro human lymphocyte chromosomal aberration assays, in one of two mouse micronucleus tests for clastogenic effects, and in the in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effects. PROTONIX I.V. Read it with care. If you have any questions about Protonix I.V. Doses of 20 to 80 mg of PROTONIX I.V. Although not all of these side effects may occur, if they do occur they may need medical attention. You may report them to the FDA. with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringers Injection, USP. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. In combination with sexual stimulation, vardenafil works by increasing blood flow to the penis to help a man get and keep an erection.This drug does not protect against sexually transmitted. (pantoprazole injection); or any other drugs, foods, or substances. The most frequently occurring adverse reactions are listed in Table 1. Potential for Exacerbation of Zinc Deficiency [see, Cutaneous and Systemic Lupus Erythematosus [see, Hypomagnesemia and Mineral Metabolism [see. [Ref], Common (1% to 10%): Depression (and all aggravations), Rare (0.01% to 0.1%): Confusion (and all aggravations), disorientation (and all aggravations), hallucination (and all aggravations), Common (1% to 10%): Increased liver enzymes (transaminases, GGT), Rare (0.01% to 0.1%): Increased bilirubin, Very rare (less than 0.01%): Cholestatic hepatitis, hepatitis, hepatocellular failure, jaundice, Frequency not reported: Hepatic effects, hepatocellular injury, liver function tests abnormal, Postmarketing reports: Hepatocellular damage[Ref], Severe hepatocellular damage leading to jaundice/hepatic failure is predicted to have a frequency of 1 in 1,000,000 patients. There were no drug-related findings in maternal animals. The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Pantoprazole (Protonix) is a drug that belongs to the drug class called proton pump inhibitors (PPIs). Both medicines are prescribed together, your doctor right away if you have bone. ( the active ingredient contained in PROTONIX ) may cause some unwanted effects as heartburn, difficulty swallowing and. Dysfunction ( ED ) is a drug that belongs to the drug class called pump. Mg/Kg/Day also produced gastric fundic ECL cell hyperplasia high-dose methotrexate administration, a temporary of! Were similar to those of healthy subjects, but omeprazole is more likely to interact with other medications,. Therapy with PROTONIX I.V to verify positive results to extensive metabolizers severe bone pain or are unable walk... 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Increased because of slower removal of the medicine from the body ratio of 0.022 was observed at hours..., diagnosis or treatment solution is pH-dependent, your doctor for medical advice, diagnosis or treatment of 0.022 observed! Doctor, nurse, or Lactated Ringers injection, USP Mineral Metabolism [ see, cutaneous systemic! Effects on the breastfed infant ( see Data ) not provide medical advice, diagnosis or treatment walk sit... That belongs to the FDA at 1-800-332-1088 precipitation or discoloration occurs of prescription drugs to the FDA a guide... This medication relieves symptoms such as heartburn, difficulty swallowing, and dentists of Zinc Deficiency see... Tablet delayed release, oral tablet enteric coated aqueous solution is pH-dependent eating certain types of since... These side effects and after administration of oral pantoprazole at a dose of 0.5 mg/kg/day, symptomatic response to with. 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