Protas (Esomeprazole)

Class: Proton pump inhibitors

Manufacturer: Square pharmaceuticals Kenya EPZ Ltd, Athi River, Machakos, Kenya

Dosage Form: Tablet, Injection

Similar Brands:

Uses:

Treatment of gastroesophageal reflux disease (GERD). Healing of erososive esophagitis. Maintenance of healing of erosive esophagitis. Symptomatic gastroesophageal reflux disease (GERD).

Risk reduction of NSAID associated ulcer.

H.pylori eradication (triple therapy).

Dosage:

Tablet and capsule: recommended adult dosage schedule of esomeprazole

Indication	Dose	Frequency
Gastroesophageal Reflux Disease (GERD)
Healing of erosive esophagitis	20mg or 40mg	Once daily for 4 to 8 weeks*
Maintenance of healing of erosive esophagitis.	20mg	Once daily**
Symptomatic GERD	20mg	Once daily for 4 weeks***
Risk reduction of NSAID associated ulcer	20mg or 40mg	Once daily for up to 6 months**
H.pylori eradication (triple therapy).
Esomeprazole	20mg	Twice daily for 10 days
Amoxicillin	1000mg	Twice daily for 10 days
Clarithromycin	500mg	Twice daily for 10 days

 

Paediatric use (12 years and older)

Short term treatment of GERD: 20mg or 40mg once daily for up to 8 weeks.

*the majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks treatment may be considered.

**controlled studies did not extend beyond six months.

***if symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

Injection

Duodenal ulcer, gastric ulcer, gastrointestinal lesions refractory to h2 blockers, zollinger-ellison syndrome	40mg per day intravenously
Reflux esophagitis	20-40mg per day intravenously

 

Special population

Getriatric: no dosage adjustment is necessary.

Renal insufficiency: no dosage adjustment is necessary.

Hepatic insufficiency: no dosage adjustment is necessary in patients with mild to moderate liver impairment. For patients with severe liver impairment a dose of 20mg should not be exceeded.

Gender: no dosage adjustment is necessary.

Direction for use of iv injection

Esomeprazole lyophilized powder and 0.9% Sodium Chloride injection is for intravenous administration only and must not be given by any other route. Esomeprazole injection 40mg should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 5ml 0.9% sodium chloride injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 3 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30 °C) for a maximum of 12 hours. Half of the IV injection should be used when 20mg is to be administered.

Direction for use of iv infusion

Esomeprazole IV 40mg should be given as an intravenous infusion over a period of 10 to 30 minutes. Esomeprazole IV should be reconstituted with 5ml of 0.9% sodium chloride injection and further diluted (admixed) with 5% dextrose injection or 0.9% sodium chloride injection or lacteted ringer’s injection to a final volume of 50ml. The reconstituted solution may be stored at room temperature (up to 30 °C) for a maximum of 12 hours prior to dilution. The admixed solution may be stored at room temperature (up to 30 °C) and must be used within 12 hours when reconstituted with 0.9% sodium chloride injection or lactated ringer’s injection and within 6 hours when reconstituted with 5% dextrose injection.

Side Effects:

Side effect reported with esomeprazole include; headache, diarrhea, and abdominal pain.

Warnings & Precautions:

Exclude the possibility of malignancy when gastric ulcer is suspected and before treatment for dyspepsia. When using in combination with antibiotic, refer to the prescribing information of the respective antibiotics.

Pregnancy & Lactation:

US FDA pregnancy category “B”

Teratology studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to esomeprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Because esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Drug Interactions:

Esomeprazole appears to be a selective inhibitor of the cytochrome p450 monooxygenase system, there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of esomeprazole on the oral combined contraceptive pill. Further assessment is currently underway. Physiological changes similar to those found with omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin b12 absorption.

Contraindications:

Esomeprazole is contraindicated in those patients who have known hypersensitivity to any other components of the formulation.

Price: Ksh 600

Notes:

Pack Size: 30s