Axepron

Axepron

pantoprazole

Manufacturer:

Hanlim Pharma

Distributor:

Pharma Nutria
Full Prescribing Info
Contents
Pantoprazole sodium.
Description
Each vial contains Pantoprazole (as sodium) 40 mg.
Indications/Uses
Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis: Pantoprazole 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.
Safety and efficacy of pantoprazole for injection as treatment of patients with GERD and a history or erosive esophagitis for more than 10 days have been demonstrated.
Pathological Hypersecretion including Zollinger-Ellison Syndrome: Pantoprazole for injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome in adults.
Dosage/Direction for Use
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.
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 with either 5% dextrose injection, USP, 0.9% sodium chloride injection, USP, or lactated ringer's injection, USP. When administered through a Y-site, pantoprazole for injection is compatible with the following solutions: 5% dextrose injection, USP, 09% sodium chloride injection, USP, or lactated ringer's injection, USP.
Midazolam HCl has been shown to be incompatible with Y-site administration of pantoprazole for injection. Pantoprazole for injection may not be compatible with products containing zinc. When pantoprazole for injection is administered through 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 pantoprazole given once daily by intravenous infusion for 7 to 10 days.
Administration and Preparation Instructions: Data on the safe and effective dosing for condition other than those described (see Indications) such as a 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 Minutes Infusion: PANTOPRAZOLE for injection should be reconstituted with 10 mL 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 store 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. PANTOPRAZOLE for injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Two Minutes Infusion: PANTOPRAZOLE 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 temperatures prior to intravenously infusion and does not need to be protected from light. PANTOPRAZOLE 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 PANTOPRAZOLE 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's needs based on acid output measurements. In those patient 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 acid suppression. Patients with Zollinger-Ellison syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss effective inhibition.
Administration and Preparation Instructions: Fifteen Minutes Infusion: Each vial of PANTOPRAZOLE for injection should be reconstituted with 10 mL of 0.9% sodium chloride injection, USP. The contents of 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 for 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.
PANTOPRAZOLE for injection should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Two Minutes Infusion: PANTOPRAZOLE 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.
Overdosage
Experience in patients taking very high doses of pantoprazole (>20 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 overdosage, 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
Pantoprazole is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole.
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, Stevens-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 administration of intravenous pantoprazole.
Clostridium difficile Associated Diarrhea: Published observational studies suggest that PPI therapy like pantoprazole maybe 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.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate 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 receive high-dose, define as multiple daily doses, and long-term PPI therapy (a year 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 (e.g., 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 suggest 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, possible 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 to 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 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.
Use In Pregnancy & Lactation
Use in Pregnancy: Teratogenic Effects: Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
Use in Lactation: Pantoprazole and its metabolites are excreted in milk of rats. Pantoprazole excretion in human milk has been detected in as study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this findings is not known. Many drugs which excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the benefit of the drug to the mother.
Adverse Reactions
Postmarketing Experience: The following adverse reactions have been identified during post approval use of pantoprazole. 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 casual relationship to drug exposure.
These adverse reactions are listed as follows by body system: General Disorders and Administration Conditions: Asthenia, fatigue, malaise.
Immune System Disorders: Anaphylaxis (including anaphylactic shock).
Investigations: Weight changes.
Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN), and angioedema (Quincke's edema).
Muscoskeletal Disorders: Rhabdomyolysis, bone fracture.
Renal and Urinary Disorders: Interstitial nephritis.
Hepatobiliary Disorders: Hepatocellular damage leading to jaundice and hepatic failure.
Psychiatric Disorder: Hallucinations, confusion, insomnia, somnolence.
Metabolism and Nutritional Disorders: Hyponatremia, hypomagnesemia.
Infections and Infestations: Clostridium difficile associated diarrhea.
Hematologic: Pancytopenia, agranulocytosis.
Nervous: Ageusia, dysgeusia.
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 inhibitor, 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 (e.g., ketoconazole, ampicillin esters, iron salts, and digoxin).
False Positive Urine Test for THC: There have been reports of false positive urine screening test 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 concomitantly administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Storage
Store at temperature 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 inj (vial) 40 mg x 10 mL x 1's.
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