PROTOM
-
Chemical Name:
Pantoprazole Sodium -
Therapeutic Category:
Gastro-intestinal drugs -
Pharmacologic Category:
Proton Pump Inhibitor - Substituted Benzimidazole -
Pharmaceutical Form:
Tablets -
Composition:
Pantoprazole Sodium 40mg
PROTOM
Enteric Coated Tablets
Pantoprazole (Sodium)
1. PHARMACOLOGICAL PROPERTIES:
Pantoprazole is considered one of the most potent inhibitor of proton pump. It inhibits the secretion of gastric acid, thus reducing its concentration. So, it leads to limit the ulceration and the cure of the ulcer.
2. INDICATIONS:
PROTOM-Enteric coated tablets is indicated in the following cases:
1-Gastro-duodenal ulcers, whether these are associated or not with the bacteria (Helicobacter pylori).
2-Short term treatment of erosive esophagitis associated with gastroesophageal reflux disease.
3-Maintenance of healing of erosive esophagitis
4-Long term treatment of Zollinger-Ellison syndrome.
3. CONTRAINDICATIONS:
Known hypersensitivity to pantoprazole or any other product components.
4. PRECAUTIONS:
- As with other gastric anti-secretory agents, there is a risk of malabsorption of vitamin B12 during long term treatment.
- This medicine should be used with care in case of hepatic insufficiency.
5. DRUG INTERACTIONS:
- Pantoprazole interferes with drugs in which pH adjustment is essential for its bioavailability (Ketoconazole - Ampicillin citrate - ferric salts).
- Pantoprazole absorption is not affected when administered concomitantly with antacids.
6. PREGNANCY AND LACTATION:
Pregnancy: Category B. This drug should be used during pregnancy only by medical prescription.
Pantoprazole should not be given during lactation.
7. SIDE EFFECTS:
Pantoprazole may cause the following side effects:
Abdominal pain, itching and skin rash, headache, nausea, diarrhea, vomiting, dizziness, flatulence, insomnia, hyperglycemia.
8. DOSAGE & ADMINISTRATION:
PROTOM-Enteric coated tablets:
General case: 40 to 80 mg per day, depending on the therapeutic indication.
Long-term treatment of Zollinger-Ellison syndrome: 80 mg per day. This initial dosage may be increased or decreased, depending on requirements, based on the results of acid output measurements.
Tablets should not be chewed or crushed, but swallowed whole with a little water.
Treatment duration: 4 to 8 weeks, depending on your doctor’s prescription. A longer treatment period may be prescribed during long-term treatment of Zollinger-Ellison syndrome.
9. PACKAGING & COMPOSITION:
PROTOM 40 – Enteric Coated Tablets: A pack of 20 enteric coated tablets. Each tablet contains Pantoprazole (Sodium) 40 mg.
10. STORAGE CONDITIONS:
Store PROTOM– Enteric Coated Tablets at temperature between (15-30)°C.
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