Esomeprazole

Nexium

• Maintenance of healing of EE in adults.
• Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age.
• Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers.
• Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin.
• Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. NEXIUM for delayed-release oral suspension is indicated for the:
• Short-term treatment in the healing of EE in pediatric patients 1 year to 11 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.

Nexium 24HR

• Acid reducer
• treats frequent heartburn (occurs 2 or more days a week)
• not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Nexium

• Delayed-Release Capsules: 20 mg and 40 mg esomeprazole.
• For Delayed-Release Oral Suspension: 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg esomeprazole.

Nexium 24HR

Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

Nexium

• Population Recommended Adult and Pediatric Dosage Healing of EE (1 year and older) EE due to Acid-Mediated GERD (1 month to less than 1 year) Adults 20 mg or 40 mg A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). once daily for 4 to 8 weeks;
• Swallow capsules whole; do not crush or chew. For patients who cannot swallow intact capsule, the capsule can be opened, and the contents mixed with applesauce.
• Mix packets with water to create an oral suspension.
• Opened capsules can be administered through a nasogastric tube and oral suspension can be administered through a nasogastric or gastric tube. Recommended Dosage in Adults by Indication Table 1 shows the recommended adult dosage of NEXIUM by indication.

Nexium 24HR

• adults 18 years of age and older
• this product is to be used once a day (every 24 hours), every day for 14 days
• may take 1 to 4 days for full effect 14-Day Course of Treatment Repeated 14-Day Courses (if needed) swallow 1 capsule with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 capsule a day
• swallow whole. Do not crush or chew capsules.
• do not use for more than 14 days unless directed by your doctor
• you may repeat a 14-day course every 4 months
• do not take for more than 14 days or more often than every 4 months unless directed by a doctor
• children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Nexium

• Most common adverse reactions: • Adults (≥ 18 years) (> 1%) are: headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.
• most common adverse reactions that were reported were: diarrhea (4%), headache (4%), and abdominal pain (4%).

Nexium 24HR

• your heartburn continues or worsens
• you need to take this product for more than 14 days
• you need to take more than 1 course of treatment every 4 months
• you get diarrhea
• you develop a rash or joint pain

Nexium

• Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
• Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients.
• Clostridium difficile- Associated Diarrhea: PPI therapy may be associated with increased risk.
• Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
• Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
• Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue NEXIUM and refer to specialist for evaluation.
• Interaction with Clopidogrel: Avoid concomitant use of NEXIUM.
• Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.

Nexium 24HR

• had heartburn over 3 months. This may be a sign of a more serious condition.
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

Nexium

• Known hypersensitivity to substituted benzimidazoles or any component of the formulation.
• Patients receiving rilpivirine-containing products.
• Refer to the Contraindications section of the prescribing information for amoxicillin and clarithromycin, when administered in combination with NEXIUM.

Nexium 24HR

• trouble or pain swallowing food, vomiting with blood, or bloody or black stools
• heartburn with lightheadedness, sweating or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain

Nexium

There are other antiretroviral drugs which do not result in clinically relevant interactions with esomeprazole. Intervention: Rilpivirine-containing products: Concomitant use with NEXIUM is contraindicated. Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with NEXIUM. See prescribing information for nelfinavir.

Nexium

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 (see Data).

Nexium 24HR

If pregnant or breast-feeding, ask a health professional before use.