Vaxcel Pantoprazole

Vaxcel Pantoprazole

pantoprazole

Manufacturer:

Kotra

Distributor:

Fair Deal
Full Prescribing Info
Contents
Pantoprazole.
Description
Each vial contains Pantoprazole sodium equivalent to Pantoprazole 40mg.
Vaxcel Pantoprazole gives clear solution after reconstitution.
Action
Pharmacology: Pharmacodynamics: Pantoprazole is a selective proton pump inhibitor.
Pharmacokinetics: Peak plasma-pantoprazole concentrations are achieved about 2 to 2.5 hours after an oral dose. The oral bioavailability is about 77% with the enteric-coated tablet formulation, and does not vary after single or multiple doses. Pantoprazole is 98% bound to plasma proteins. It is extensively metabolised in the liver, primarily by the cytochrome P450 isoenzyme CYP2C19, to desmethyl pantoprazole; small amounts are also metabolised by CYP3A4, CYP2D6, and CYP2C9. Metabolites are excreted mainly (about 80%) in the urine, with the remainder being excreted in bile. The terminal elimination half-life is about 1 hour, and is prolonged in hepatic impairment; the half-life in patients with cirrhosis was 3 to 6 hours.
Indications/Uses
Short term use for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: Duodenal ulcer; Gastric ulcer; Moderate and severe reflux esophagitis; Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
Dosage/Direction for Use
The intravenous administration of Pantoprazole IV is recommended only if oral application is not appropriate.
For the long term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions the recommended daily dose at the beginning of the treatment is 80mg Pantoprazole IV.
Thereafter, the dosage can be titrated up or down as needed using measurement of gastric acid secretion to guide. With doses above 80mg daily, the dose should be divided and given twice daily. A temporary increase of the dosage above 160mg Pantoprazole is possible but should not be applied longer than required for adequate acid control. With an exception of the treatment of patients with Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions, the duration of treatment with the active ingredient pantoprazole should not exceed 8 weeks. In case a rapid acid control is required, a starting dose of 2x80mg Pantoprazole IV is sufficient to manage a decrease of acid output into the target range (<10mEq/h) within one hour in the majority of patients. Transition from Pantoprazole IV to the oral formulation of Pantoprazole should be performed as soon as it is clinically justified.
The recommended intravenous dosage is one vial (40mg Pantoprazole) IV per day.
Type and duration of treatment: As soon as oral therapy is possible, treatment with Vaxcel Pantoprazole Injection IV should be discontinued and the oral dosage form should be administered.
Route of Administration: For intravenous administration only.
Overdosage
No symptoms of overdosage have been observed in humans. The usual rules or intoxication treatment apply in the event of the overdosage with clinical signs of intoxication.
Contraindications
Pantoprazole IV should not be used in cases of known hypersensitivity to its constituents.
Pantoprazole, like other Proton Pump Inhibitors (PPIs), should not be co-administered with atazanavir.
Special Precautions
The intravenous administration of Pantoprazole IV is recommended only if oral application is not appropriate. Pantoprazole IV is not indicated for mild gastrointestinal complaints such as nervous dyspepsia.
Prior to treatment the possibility of malignancy of gastric ulcer or a malignant disease of the esophagus should be excluded as the treatment with Pantoprazole i.v. may alleviate the symptoms of malignant ulcers and can thus delay diagnosis. Diagnosis of reflux esophagitis should be confirmed by endoscopy. The daily dose of 40mg pantoprazole should not be exceeded in elderly patients or in those with impaired renal function. In patients with severe liver impairment the daily dose has to be reduced to 20mg pantoprazole. Furthermore, in these patients the liver enzymes should be monitored during Pantoprazole i.v. therapy. In case of a rise of the liver enzymes Pantoprazole IV should be discontinued.
In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with pantoprazole may alleviate symptoms and delay diagnosis. Further investigation is to be considered if symptoms persist despite adequate treatment.
There are no known effects on the ability to drive, use machines or work without a firm support.
Use in Children: To date there has been no experience with treatment in children.
Use In Pregnancy & Lactation
Clinical experience in pregnant women is limited. There is no information on the excretion of pantoprazole into human breast milk. Pantoprazole i.v. should only be used when the benefit to the mother is considered greater than the potential risk to the foetus/baby.
Side Effects
See table as follows. (See table.)

Click on icon to see table/diagram/image

If the patient experiences any side effects not mentioned in this monograph, please inform the doctor or pharmacist.
Drug Interactions
Changes in absorption should be observed when drugs whose absorption is pH dependent, e.g. ketoconazole, are taken concomitantly. Please note that this also applies to drugs taken a short time before Pantoprazole iv. The active ingredient of Pantoprazole iv is metabolized in the liver via the cytochrome P450 enzyme system. An interaction of Pantoprazole with other drugs or compounds which are metabolized using the same enzyme system cannot be excluded. However, no clinically significant interactions were observed in specific tests with a number of such drugs or compounds, namely carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and oral contraceptive.
Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in INR have been reported during concomitant treatment in the post-marketing period. Therefore, in patients being treated with coumarin anticoagulants, monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of Pantoprazole.
There were also no interactions with concomitantly administered antacids. If the patient should experience side effects, notify the doctor so that he can decide what further measure are necessary.
Co-administration or atazanavir 300mg/ritonavir 100mg with omeprazole (40mg once dally) or atazanavir 400mg with lansoprazole (60mg single dose) resulted in a substantial reduction in the bioavailability of atazanavir. The absorption of atazanavir is pH dependent. Therefore Proton Pump Inhibitors (PPls), including pantoprazole, should not be co-administered with atazanavir.
Caution For Usage
Instruction of use/handling: A ready-to-use solution is prepared by injecting 10ml of physiological sodium chloride solution into the vial containing the dry substance. This solution may be administered directly or may be administered after mixing with 100ml physiological sodium chloride solution or 5% glucose. Pantoprazole IV should not be prepared or mixed with solvents other than those stated. The solution should have a pH of 9.
After preparation the solution must be used within 12 hours. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and condition prior to use are the responsibility of the user and would normally not be longer than 12 hours at not more than 25°C.
The drug should be administered intravenously over 2-15 minutes.
Storage
Store below 25°C and protect from light.
The reconstituted solution must be used within 12 hours after preparation.
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 (white, lyophilized) x 10's.
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