Prazole IV

Prazole IV

pantoprazole

Manufacturer:

Multicare

Distributor:

Zuellig
Full Prescribing Info
Contents
Pantoprazole.
Description
Each vial of powder for injection contains pantoprazole sodium equivalent to pantoprazole 40 mg.
Pantoprazole is sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole sesquihydrate.
Domperidone is 5-chloro-1-[1-[3-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)propyl]piperidin-4-yl]-1,3-dihydro-2H-benzimidazol-2-one.
Action
Pharmacology: Mechanism of Action: Pantoprazole is a proton-pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the H+/K+-ATPase results in a duration of antisecretory effect that persists longer than 24 hrs of all doses tested.
Pharmacokinetics: Pantoprazole does not accumulate and its pharmacokinetics are unaltered with multiple daily dosing. Following the administration of pantoprazole sodium for injection, the serum concentration of pantoprazole declines bioexponentially with a terminal elimination t½ of approximately 1 hr. In extensive metabolizers with normal liver function receiving a dose of Prazole IV 40 mg for injection by constant rate over 15 min, the peak concentration (Cmax) is 5.52 mcg/mL and the total area under the plasma concentration versus time curve (AUC) is 5.4 mcg hr/mL. The total clearance is 7.6-14 L/hr and apparent volume of distribution is 11-23.6 mL.
The serum protein-binding of pantoprazole is about 98% primarily to albumin. Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP450) system.
After administration of a single IV dose of pantoprazole to healthy, normal stabilizer subjects, approximately 71% of the dose was excreted in the urine with 18% excreted in the feces through biliary excretion. There was no renal excretion of unchanged pantoprazole.
Indications/Uses
Treatment of gastric ulcer, duodenal ulcer, moderate and severe reflux esophagitis.
Dosage/Direction for Use
Recommended Dose: 40 mg IV once daily for 7 days.
Duodenal Ulcer: Duodenal ulcers generally heal within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.
Gastric Ulcer and Gastroesophageal Reflux: A 4-week period is usually required for the treatment of gastric ulcers and gastroesophageal reflux. If this is not sufficient, healing will usually be achieved in within a further 4 weeks.
Administration: For IV administration only. Prazole IV is recommended only in cases where the oral administration is not indicated. The content of the vial needs to be reconstituted with 0.9% sodium chloride injection w/v 10 mL before injection. This freshly prepared solution should be administered IV over 2-15 min, either as a slow injection or it may be further diluted with 0.9% sodium chloride injection w/v 100 mL or 5% glucose injection and administered as a short-term infusion. The duration of administration should be 2-15 min. The reconstituted solution must be used within 12 hrs of preparation.
Overdosage
There is no known symptoms of overdosage in humans. Doses of up to 240 IV were administered without adverse effects. Apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
Contraindications
Known hypersensitivity to pantoprazole or any of the excipients of Prazole IV.
Special Precautions
Prior to the treatment of gastric ulcer, the possibility of malignancy should be excluded before treatment with pantoprazole sodium is instituted, as treatment may alleviate symptoms and delay diagnosis. Anaphylaxis has been reported with the use of pantoprazole IV. This may require emergency medical treatment. The diagnosis of an inflammation of the esophagus should be endoscopically confirmed.
Effects on the Ability to Drive or Operate Machinery: Pantoprazole IV does not affect the ability to drive and use machines.
Use in pregnancy: During pregnancy, pantoprazole IV should not be used unless the benefit exceeds the potential risk.
Use in lactation: There is no information about the safety of pantoprazole IV during breastfeeding in humans. During breastfeeding, pantoprazole IV should not be used unless the benefit exceeds the potential risk.
Use In Pregnancy & Lactation
Use in pregnancy: During pregnancy, pantoprazole IV should not be used unless the benefit exceeds the potential risk.
Use in lactation: There is no information about the safety of pantoprazole IV during breastfeeding in humans. During breastfeeding, pantoprazole IV should not be used unless the benefit exceeds the potential risk.
Adverse Reactions
Treatments with pantoprazole IV can occasionally lead to headache or diarrhea. Rarely, nausea, vomiting, abdominal pain, flatulence, constipation, allergic reactions eg, skin rash and pruritus may occur. Individual cases of edema, blurred vision, fever, dizziness, thrombophlebitis, depression or myalgia subsiding after termination of therapy have been reported.
Drug Interactions
No clinically significant interactions were observed with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, phenytoin, warfarin and concomitantly administered antacids. As with other antacid secretion inhibitors, changes in absorption may be observed with drugs whose absorption is pH dependent eg, ketoconazole are taken concomitantly.
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 inj (vial + 10 mL amp diluent) 40 mg x 1's.
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