Esomeprazole Injection

Description

Product Description: Esomeprazole Injection is a sterile, intravenous solution containing the proton pump inhibitor (PPI) esomeprazole. It is used for the treatment of gastroesophageal reflux disease (GERD) and other acid-related conditions.

Indications and Usage: Esomeprazole Injection is indicated for the short-term treatment of GERD with erosive esophagitis in adults and pediatric patients aged 1 month and older. It is also prescribed for the maintenance of healing of erosive esophagitis and for reducing the risk of re-bleeding in adults after initial control of bleeding caused by ulcers.

Dosage and Administration: The recommended dosage of Esomeprazole Injection depends on the indication, patient age, weight, and severity of the condition. It is administered intravenously over a specific duration determined by the healthcare provider, typically ranging from 10 minutes to 30 minutes.

Dosage Forms and Strengths: Esomeprazole Injection is available as a sterile solution in single-dose vials. The concentration of esomeprazole in the solution is typically 20 mg or 40 mg per vial.

Contraindications: Esomeprazole Injection is contraindicated in patients with known hypersensitivity to esomeprazole or any component of the formulation. It should not be co-administered with drugs that are known to be strong CYP2C19 inhibitors, such as voriconazole and fluvoxamine.

Warnings and Precautions: Before administering Esomeprazole Injection, healthcare providers should evaluate patients for risk factors associated with gastric malignancy, C. difficile-associated diarrhea, and hypomagnesemia. Long-term use may increase the risk of osteoporosis-related fractures and vitamin B12 deficiency.

Adverse Reactions/Side Effects: Common adverse reactions associated with Esomeprazole Injection include headache, diarrhea, abdominal pain, nausea, and vomiting. Other potential side effects may include hypomagnesemia, vitamin B12 deficiency, and osteoporosis-related fractures.

Drug Interactions: Esomeprazole Injection may interact with certain medications, including digoxin, warfarin, and ketoconazole. Concomitant use with drugs that require acidic pH for absorption may reduce their efficacy. Healthcare providers should carefully evaluate patients for potential drug interactions before administering Esomeprazole Injection.

Use In Specific Populations Description: Esomeprazole Injection is generally considered safe for use in pregnant and lactating women, although caution should be exercised, especially during the first trimester of pregnancy. It should be used with caution in pediatric patients, particularly those younger than 1 month old, due to limited safety data in this population.

How Supplied/Storage and Handling: Esomeprazole Injection is supplied as a sterile solution in single-dose vials. It should be stored at controlled room temperature between 20°C to 25°C (68°F to 77°F), protected from light and moisture. Unused portions should be discarded according to local regulations for biohazardous waste disposal.