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Merazodel 40 mg
Merazodel 40 mg
Esomeprazole sodium injection 42.5 mg eq. to Esomeprazole 40 mg.
ADDITIONAL INFORMATION
| Mechanism of Action: | Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+- ATPase in the gastric parietal cell. The S- and R-isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion. |
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| Indications: | Treatment of Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis MERAZODEL for Injection is indicated for the short-term treatment of GERD with erosive esophagitis in adults and pediatric patients 1 month to 17 years, inclusively as an alternative to oral therapy when oral Esomeprazole is not possible or appropriate. GERD with Erosive Esophagitis Adult Patients The recommended adult dose is either 20 mg or 40 mg MERAZODEL given once daily by intravenous injection (no less than 3 minutes). Safety and efficacy of MERAZODEL for Injection as a treatment of GERD patients with erosive esophagitis for more than 10 days have not been demonstrated. Dosage adjustment is not required in patients with mild to moderate liver impairment (Child Pugh Classes A and B). For patients with severe liver impairment (Child Pugh Class C), a maximum dose of 20 mg once daily of MERAZODEL should not be exceeded Pediatric Patients The recommended doses for children ages 1 month to 17 years, inclusive, are provided below. 1 year to 17 years: Body weight less than 55 kg: 10 mg Body weight 55 kg or greater: 20 mg 1 month to less than 1 year of age: 0.5 mg/kg |
| Preparation and Administration Instructions: | General Information The reconstituted solution of Merazodel should be stored at room temperature not exceeding 30°C and administered within 12 hours after reconstitution. No refrigeration is required Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis Preparation Instructions for Adult Patients Intravenous Injection (20 mg or 40 mg vial) over no less than 3 minutes The freeze-dried powder should be reconstituted with 5 mL of 0.9% Sodium Chloride Injection, USP. Withdraw 5 mL of the reconstituted solution and administer as an intravenous injection over no less than 3 minutes. |
| DOSAGE FORMS AND STRENGTHS: | MERAZODEL 40 mg vial for Injection contains 42.5 mg of esomeprazole sodium equivalent to 40 mg Esomeprazole |
| DOSAGE FORMS AND STRENGTHS: | MERAZODEL 40 mg vial for Injection contains 42.5 mg of esomeprazole sodium equivalent to 40 mg Esomeprazole |
| DOSAGE FORMS AND STRENGTHS: | MERAZODEL 40 mg vial for Injection contains 42.5 mg of esomeprazole sodium equivalent to 40 mg Esomeprazole |
| DOSAGE FORMS AND STRENGTHS: | MERAZODEL 40 mg vial for Injection contains 42.5 mg of esomeprazole sodium equivalent to 40 mg Esomeprazole |
| CONTRAINDICATIONS: | MERAZODEL is contraindicated in patients with known hypersensitivity to substituted
Benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include Anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and Urticaria |
| WARNINGS AND PRECAUTIONS: | Presence of Gastric Malignancy In adults, symptomatic response to therapy with MERAZODEL does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adults patients who have suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients also consider an endoscopy. Acute Interstitial Nephritis Acute interstitial nephritis has been observed in patients taking PPIs including MERAZODEL Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue MERAZODEL if acute interstitial nephritis develops Adverse reactions in adults with Symptomatic GERD and Erosive Esophagitis Adverse Reactions occurring at an Incidence ≥ 1% in the patients treated with
Intravenous treatment with esomeprazole 20 and 40 mg-administered as an |
| Pregnancy: | There are no adequate and well-controlled studies with Esomeprazole in pregnant women. Esomeprazole is the s-isomer of omeprazole. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. |
| Lactation: | Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk. There are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should beconsidered along with the mother’s clinical need for MERAZODEL and any potential adverse effects on the breastfed infant from MERAZODEL or from the underlying maternal condition. |
| Pediatric Use: | The safety and effectiveness of Esomeprazole for Injection have been established in pediatric patients 1 month to 17 years of age for short-term treatment of GERD with Erosive Esophagitis However, effectiveness has not been established in patients less than 1 month of age. Neonates 0 to 1 month of age The safety and effectiveness of Esomeprazole in neonates have not been established. |
| Geriatric Use: | No overall differences in safety and efficacy were observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. |
Additional Information
| human | human |
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DELTA PHARMA is a leading pharmaceutical company in the Egyptian market aiming to step up its rank among all other Arabian pharmaceutical manufacturers, to be one of the top ten generic companies in the region within the upcoming years.
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