Pantovex

Pantovex

pantoprazole

Manufacturer:

Reyoung Pharma

Distributor:

Sannovex
Full Prescribing Info
Contents
Pantoprazole sodium.
Description
Each vial contains Pantoprazole as sodium 40 mg.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Pantoprazole is a proton pump inhibitor. It accumulates in the acidic compartment of parietal cells and is converted to the active form, a sulfanilamide, which binds to hydrogen-potassium-ATPase at the secretory surface of gastric parietal cells. Inhibition of hydrogen-potassium-ATPase blocks the final step of gastric acid production, leading to inhibition of both basal and stimulated acid secretion. The duration of inhibition of acid secretion does not correlate with the much shorter elimination half-life of pantoprazole.
Indications/Uses
Pantoprazole is a proton pump inhibitor with actions and uses similar to those of omeprazole. It is given as the sodium salt but doses are expressed in terms of the base. Pantoprazole is indicated for the prevention of relapse in patients with reflux esophagitis, indicated for short-term (up to 4 weeks) treatment for symptom relief and healing in patients with active duodenal ulcer and up to 8 weeks treatment in patients with active benign gastric ulcer. Pantoprazole is indicated for short-term treatment (7 to 10 days) of adult patients with Gastroesophageal Reflux Disease (GERD) and a history of erosive esophagitis. Safety and efficacy of pantoprazole as a treatment for patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated.
In combination with clarithromycin and either amoxicillin or metronidazole, it is indicated for treatment of patients with an active duodenal ulcer who are Helicobacter pylori positive.
Pantoprazole is also indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison syndrome in adults. The drug reduces the volume of gastric acid output and hydrogen ion concentration of gastric secretions in patients with these conditions.
Dosage/Direction for Use
Pantoprazole (PANTOVEX) should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permits.
Pantoprazole routes of administration other than intravenous are not recommended. Pantoprazole 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 pantoprazole for injection.
Midazolam HCl has been shown incompatible with Y-site administration of Pantoprazole for injection. Pantoprazole for injection may be compatible with products containing zinc. When Pantoprazole for injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.
Gastroesophageal Reflux Disease (GERD) associated with a history of Erosive esophagitis: Recommended dosage: The recommended adult dose is 40 mg given once daily by intravenous infusion for 7 to 10 days.
Administration and Preparation Instructions: Data on the safe and effective dosing for conditions other than those described in the Indications such as life-threatening upper gastrointestinal bleeds, are not available. PANTOPRAZOLE 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: Pantoprazole should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, and further diluted 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 12 hours at room temperature prior to further dilution. Both the reconstituted solution and the admixed solution do not need to be protected from light.
Pantoprazole for injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Pathological Hypersecretion Including Zollinger-Ellison Syndrome: Recommended dosage: The dosage of Pantoprazole for injection in patients with pathological hypersecretory conditions including Zollinger-Ellison Syndrome varies with individual patients. The recommended adult dose 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 higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid outflow below 10 mEq/h.
Administration and Preparation Instructions: Fifteen Minute Infusion: Each vial of PANTOPRAZOLE 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 12 hours at room temperature prior to further dilution. Both the reconstituted solution and the admixed solution do not need to be protected from light.
Pantoprazole for injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Administration in Renal Impairment: Most studies have not found the pharmacokinetics of pantoprazole to be altered in patients with renal impairment and licensed drug information in the UK and US generally does not recommend dosage adjustment in this group; however some UK sources, including the British National Formulary, suggest that a maximum dose of 40 mg daily should be observed.
Administration in hepatic impairment: Dosage of pantoprazole may need to be reduced in severe hepatic impairment, or doses given only on alternate days. A maximum dose of 20 mg daily, or 40 mg on alternate days, has been suggested.
Overdosage
Experience in patients taking very high doses of pantoprazole (> 240 mg) is limited. Adverse events seen in spontaneous reports of overdose generally reflect the known safety profile of pantoprazole.
Pantoprazole is not removed by hemodialysis. In case of overdose, treatment should be symptomatic and supportive.
The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.
Contraindications
Anaphylaxis has been reported with the use of IV pantoprazole sodium. Immediate medical intervention and drug discontinuance are required if anaphylaxis or other severe hypersensitivity reactions occurs.
Special Precautions
Implications of Symptomatic response: Symptomatic response to therapy with Pantoprazole does not preclude the presence of gastric malignancy.
Hypersensitivity and Severe Skin Reactions: Anaphylaxis and other serious reactions such as erythema multiforme, Steven-Johnson syndrome, and toxic epidermal necrolysis (TEN) have been reported with use of intravenous pantoprazole. These may require emergency medical treatment.
Injection site Reactions: Thrombophlebitis was associated with the administration of intravenous Pantoprazole.
Clostridium difficile associated diarrhea: Published observational studies suggest that PPI therapy like Pantoprazole 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.
Patient should use the lowest dose and shortest duration of PPI therapy associated to the condition being treated.
Bone Fracture: Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
Hepatic Effects: Mild, transient transaminase elevations have been observed in clinical studies. The clinical significance of this finding in a large population of subjects administered intravenous Pantoprazole is unknown.
Hypomagnesemia: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (eg., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Interference with Urine Screen for THC: May produce false-positive urine screen for THC (Tetrahydrocannabinol).
Concomitant use of Pantoprazole with Methotrexate: 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. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.
Gender: No gender-related differences in the safety profile of intravenous pantoprazole were seen involving men and women with erosive esophagitis associated with GERD. The incidence rates of adverse reactions were also similar for men and women.
Hepatic Impairment: Doses higher than 40 mg/day have not been studied in patients with hepatic impairment.
Use in Children: Safety and effectiveness of pantoprazole in pediatric patients have not been established.
Use in Elderly: The incidence rates of adverse events and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.
Adverse Reactions
Adverse effects occurring in 4% or more of patients receiving IV pantoprazole and that were possibly, probably, or definitely related to treatment include abdominal pain, chest pain, rash, and pruritus. Adverse effects occurring in more than 1% of patients receiving IV pantoprazole and that generally had an unclear relationship to the drug include headache, injection site reaction, dyspepsia, diarrhea, vomiting, dizziness, and rhinitis. There have been spontaneous reports of adverse events; angioedema (Quincke's edema); anterior ischemic optic neuropathy; severe dermatologic reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN, some fatal); hepatocellular damage leading to jaundice and hepatic failure; pancreatitis; pancytopenia; and rhabdomyolysis. In addition, also observed have been confusion, hypokinesia, speech disorder, increased salivation, vertigo, nausea, tinnitus, and blurred vision.
FDA Pregnancy Risk Category: B/NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility.
Drug Interactions
Interference with Antiretroviral Therapy: Concomitant use of atazanavir or nelfinavir with proton pump inhibitors is not recommended. Coadministration 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 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 pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition. No dose adjustment of clopidogrel is necessary when administered with an approved dose of pantoprazole.
Drugs for which Gastric pH Can Affect Bioavailability: Pantoprazole causes long-lasting inhibition of gastric acid secretion, therefore pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (eg., ketoconazole, ampicillin esters, iron salts, and digoxin).
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 including pantoprazole. 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.
Caution For Usage
Direction for Reconstitution: For I.V. Administration: Add 10 mL of 0.9% Sodium Chloride Injection, USP, and further diluted 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.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Powd for infusion (vial) 40 mg x 10's.
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