Progut 40mg

Tablet
Esomeprazole
Popular Pharmaceuticals Ltd

Other Strength:
- Progut 20mg
- Progut-N 500mg+20mg

Alternative:
- Esopra 40mg
- Esoben 40mg
- Maxima 40mg
- Esonix 40mg
- Sergel 40mg
- Nexum MUPS 40mg
- Nexum 40mg
- Maxpro 40mg



Progut
Indication

ProgutTM Capsule/tablet: ProgutTMcapsule/tablet is indicated for the relief of heartburn and other symptoms associated with gastro esophageal reflux diseases (GERD) and for the healing of erosive esophagitis, a potentially serious condition associated with GERD. The FDA approved Esomeprazole is also indicated in combination with Amoxicillin and Clarithromycin, for the eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
ProgutTM IV Injection: ProgutTM IV Injection is indicated for gastric antisecretory treatment when the oral route is not possible. Such as: Bleeding peptic ulcer, Short-term treatment of GERD (Upto 10 days), Erosive Esophagitis (EE), Pre and post operative hyperacidity and Hyperacidity in patients with non-surgical NPO status.


Dosage & Administration

Dosage and Administration





Disease





Dose





Frequency

Gastroesophageal reflux disease (GERD)



























Healing of erosive esophagitis





20 mg or 40 mg





Once daily for 4 to 8 weeks *















Maintenance of healing of erosive esophagitis





20 mg





Once daily *















Symptomatic gastro-esophageal reflux





20 mg





Once daily for 4 weeks *















H. pylori eradication to reduce the risk of duodenal ulcer recurrence















Triple therapy:



























Esomeprazole





40 mg





Once daily for 10 days















Amoxicillin





1000 mg





Twice daily for 10 days

Clarithromycin





500 mg





Twice daily for 10 days



*Depends on the severity of the disease.

ProgutTM IV Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). ProgutTM IV injection should not be administered concomitantly with any other medications through the same intravenous site.Treatment with ProgutTM IV injection should be discontinued as soon as the patient is able to resume treatment with ProgutTM delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.

Method of Administration
Injection: ProgutTM IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution the injection should be given slowly over a peroid of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30o C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.

Infusion: Reconstitute one sterile single dose vial of ProgutTM IV Injection with 5 ml of the solvent (WFI) provided and further diluting the resulting solution within 0.9% Sodium Chloride solution or 5% Dextrose solution to make a final volume of 50 ml. The resultant infusion should be given intravenously over a period of 10-30 minutes. Chemical and physical in-use stability has been demonstrated for 12 hours after reconstitution with 0.9% Sodium Chloride solution or for 6 hours after reconstitution with 5% Dextrose solution. From a microbial point of view, the product should be used immidiately. Any unused portion should be discarded.


Precautions

Symptomatic response to therapy with Esomeprazole does not preclude the presence of gastric malignancy. When using in combination with antibiotic, refer to the prescribing information of the respective antibiotics. Paediatric patient: Safety and effectiveness have not yet been established in paediatric patients. Geriatric: Dosage adjustment is not necessary. Renal insufficiency: Dosage adjustment is not necessary. Hepatic insufficiency: Dosage adjustment is not necessary in patients with mild to moderate liver impairment. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily of Esomeprazole should not be exceeded. Gender: No dosage adjustment is necessary. Use in pregnancy: This drug should be used during pregnancy only if clearly needed. Use in lactation: As Esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue the drug or nursing.

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