COMPOSITION :
Pantoprazole Sodium Sesquihydrate Powder for Injection 40 mg, each vial contains : Pantoprazole sodium sesquihydrate equivalent to Pantoprazole 40 mg.
DESCRIPTIONS :
Pantoprazole Sodium Sesquihydrate containing Pantoprazole sodium sesquihydrate (equivalent to Pantoprazole) is available in 40 mg powder for injection.
INDICATIONS :
- Duodenal ulcer.
- Gastric ulcer.
- Moderate and severe cases of inflammation of the esophagus (reflux esophagitis).
- Treatment of pathological hypersecretory conditions associated with Zollinger-Ellison-syndrome or other neoplastic conditions.
DOSAGE AND ADMINISTRATIONS :
Recommeded dosage :
- Duodenal ulcer, gastric ulcer, moderate and severe reflux esophagitis :
The recommended IV dosage is : One vial of Pantoprazole Sodium Sesquihydrate IV (40 mg Pantoprazole) daily.
- Long-term management of Zollinger-Ellison-syndrome and other pathological hypersecretory conditions :
Patients should start their treatment with a daily dose of 80 mg Pantoprazole Sodium Sesquihydrate IV. 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 in long-term therapy. Transition from oral to IV and from IV to oral should be performed in such manner to ensure continuity of effect of suppression of acid secretion. Thereafter, the dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide.
In case a rapid acid control is required, a starting dose of 2 x 80 mg Pantoprazole Sodium Sesquihydrate IV is sufficient to manage a decrease of acid output into target range (< 10 mEq/hour) within 1 hour in majority of patients.
Instruction for use :
- A ready-to-use solution is prepared by injecting 10 ml of 0.9% NaCl solution into the vial containing the dry substance. After preparation the solution must be used within 12 hours. If not used immediately, in-use storage times and conditions would normally not be longer than 12 hours at not more than 25°C.
- The prepared Pantoprazole should be administered intravenously over 2 – 15 minutes.
- As soon as oral therapy is possible, treatment with Pantoprazole Sodium Sesquihydrate IV should be discontinued and 40 mg Pantoprazole per oral should be administered instead.
- The contents of the vial is for single use only.
OVERDOSAGE :
There are no known symptoms of overdosage in human. Doses up to 240 mg IV were administered over two minutes and were well tolerated. In the case of overdosage with clinical signs of intoxication, the usual rules of intoxication therapy apply.
CONTRAINDICATION :
Patients with known hypersensitivity to the constituent.
WARNINGS AND PRECAUTIONS :
- Administration of Pantoprazole sodium sesquihydrate IV 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 and the liver enzymes should be monitored during Pantoprazole IV therapy.
- Pantoprazole should only be used when the benefit to the mother is considered greater than the potential risk to the foetus/baby.
DRUG INTERACTIONS :
- Pantoprazole is metabolized in the liver via the cytochrome P450 enzym system. An interaction of Pantoprazole with other drugs 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 with Carbamazepine, Caffeine, Diazepam, Diclofenac, Digoxin, Ethanol, Glibenclamide, Metoprolol, Naproxen, Nifedipine, Phenytoin, Piroxicam, Theophylline, Warfarin and oral contraceptive.
- Monitoring of prothrombine time in patients being treated with Pantoprazole and Coumarin anticoagulants.
- There were no interactions concomitantly use Pantoprazole with Antacids.
ADVERSE REACTIONS :
| Organ System | Frequency | |||
| Common
(>1/100, <1/10) |
Uncommon
(>1/1000, <1/100) |
Rare
(<1/1000, >1/10.000) |
Very Rare
(<1/10.000, include Isolated reports) |
|
| Blood and lymphatic system | Leukopenia; thrombocytopenia | |||
| Gastrointestinal disorders | Upper abdominal pain; diarrhea; 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 (transminases, 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 Steven-Johnson syndrome, erythema multiforme, Lyell-syndrome; photosensitivity | ||
PRESENTATIONS :
| Pantoprazole Sodium Sesquihydrate Powder for Injection 40 mg | Box, 1 vial @ 40 mg |
Reg. No. GKL1102344244A1
| Pantoprazole Sodium Sesquihydrate Powder for Injection 40 mg | Box, 10 vial @ 40 mg |
Reg. No. …
STORAGE :
STORE BELOW 25°C AND DRY PLACE, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
