Active ingredient: Pantoprazole sodium sesquihydrate
COMPOSITION
Each vial contains 45.1 mg Pantoprazole sodium sesquihydrate (equivalent to pantoprazole 40 mg)
MECHANISM OF ACTION
Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid the stomach by specific action on the proton pumps of the parietal cells.
Pantoprazole is converted to its active form in the acidic environment in the parietal cells where its inhibits the H+, K+-ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both receptor inhibitors, treatment with pantoprazole causes a reduced acidity in the stomach and thereby an increase in gastrin in proportion to the reduction in acidity. The increase in gastrin reversible. Since pantoprazole binds to the enzyme distal to the cell receptor level, the substance can affect hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously.
INDICATIONS
- Duodenal ulcer
- Gastric ulcer
- Moderate and severe cases of inflammation of the esophagus (reflux esophagitis)
- For the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison-Syndrome or other neoplastic conditions
POSOLOGY AND METHOD OF ADMINISTRATIONS
The intravenous administration of Pantozol i.v is recommended only if oral application is not appropriate.
| - | Recommended dosage Duodenal ulcer; gastric ulcer; moderate and severe reflux esophagitis The recommended intravenous dosage is one vial (40 mg pantoprazole) Pantozol i.v. per day Long term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions Patients should start their treatment with a daily dose of 80 mg Pantozol i.v. Thereafter, the dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily, A temporary increase of the dosage above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control. In case a rapid acid control is required, a starting dose of 2 x 80 mg Pantozol i.v. is sufficient to manage a decrease of acid output into the target range (‹ 10 mEq/h) within one hour in the majority of patients. Transition from oral to i.v, and from i.v to oral formulations of gastric acid inhibitors should be performed in such manner to ensure continuity of effect of suppress on of acid secretion. |
| - | Instruction for use/ handling A ready-to-use solution is prepared by injecting 10 ml 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 100 ml physiological sodium chloride solution or 5% Glucose. 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 conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at not more than 25°C Pantozol i.v. should not be manufactured or mixed with solvents other than those stated. As soon as oral therapy is possible, treatment with Pantozol i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead. The drug should be administered intravenously over 2 - 15 minutes, Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) has to be discarded. The contents of the vial is for single use only. |
CONTRAINDICATIONS
Pantozol i.v. should generally not be used in cases of known hypersensitivity to the constituent.
WARNINGS AND PRECAUTIONS
The intravenous administration of Pantozol i.v. is recommended only if oral application is not appropriate.
Pantoprazole 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 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 40 mg 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 20 mg pantoprazole. Furthermore, In these patients the liver enzymes should be monitored during Pantozol i.v. therapy. In case of a rise of the liver enzymes Pantozol i.v. should be discontinued.
To date there has been no experience with treatment in children.
Pregnancy and Lactation
Clinical experience in pregnant women is limited in animal reproduction studies, signs of slight fetotoxicity were observed at doses above 5 mg/kg. There is no information on the excretion of pantoprazole into human breast milk. Pantoprazole should only be used when the benefit to the mother is considered greater than the potential risk to the foetus/ baby.
Effect on the ability to drive and to use machines
There are no known effects on the ability to drive and use machines.
INTERACTIONS
Changes in absorption should be observed when drugs whose absorption 15 pH-dependent e.g. ketoconazole, are taken concomitantly
The active ingredient of Pantozol i.v. 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. No clinically significant interactions were, however, 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, warfarin and an oral contraceptive.
Although no interactian 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, terminatian or during irregular use of pantoprazole.
There were also no interactions with concomitantly administered antacids.
OVERDOSAGE
There are no known symptoms of overdosage in man.
Doses up to 240 mg i.v. were administered over two minutes and were well tolerated. In the case of overdosage with clinical signs of intoxication, the usual rules of intoxicatron therapy apply.
UNDESIRABLE EFFECTS
Frequency
|
Common
(›1/100,‹1/10)
|
Uncommon
(›1/1,000,‹1/100)
|
Rare
(‹1/1,000,›1/10,000)
|
Very Rare
(‹1/10,000,incl.isolated reports)
|
| Organ System | ||||
| Blood and lymphatic system | Leukopenia; Thrombocytopenia | |||
| Gastrointestinal disorders | Upper abdominal pain; Diarrhoea; Constipation; Flatulence | Nausea/ Vomiting | Dry Mouth | |
| General disorders and administration site conditions | Injection site thrombophlebitis; Peripheral edema | |||
| Hepatobiliary disorders | Severe hepatocellular damage leading to jaundice with or without hepatic failure | |||
| Immune system disorders | Anaphylactic reactions including anaphylactic shock. | |||
| Investigations | Increased liver enzymes (transaminases, γ-GT); Elevated triglycerides; Increased body temperature | |||
| Musculoskeletal, connective tissue disorders | Arthralgia | Myalgia | ||
| Nervous system disorders | Headache | Dizziness; Disturbances in vision (blurred vision) | ||
| Psychiatric disorders | Mental depression | |||
| Renal and urinary disorders | Interstitial nephritis | |||
| Skin and subcutaneous tissue disorders | Allergic reactions such as pruritus and skin rash | Urticaria; Angioedema; Severe skin reactions such as Stevens-Johnson Syndrome, Erythema multiforme, Lyell-Syndrome; Photosensitivity | ||
PRESENTATION
PANTOZOL® i.v.
Box, 1 vial
Reg. No. DKI0253300344A1
Keep below 25°C
Keep container in the outer carton.
On Medical Prescription Only
HARUS DENGAN RESEP DOKTER
Keep medicament out of reach of children!
Imported by:
PHAROS
Jakarta-Indonesia
Under license from and manufactured by:
Nycomed GmbH
D 78467 Konstanz
Germany
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