Nexium IV

What Is Nexium IV?

Nexium I.V. (esomeprazole sodium) is a proton pump inhibitor that inhibits gastric acid secretion used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Nexium I.V. is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid), and may also be given to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

What Are Side Effects of Nexium IV?

Common side effects of Nexium I.V. include:

• headache,
• diarrhea,
• nausea,
• stomach pain,
• gas,
• constipation,
• dry mouth, or
• drowsiness

Dosage for Nexium IV

The recommended adult dose of Nexium I.V. is either 20 mg or 40 mg given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes). Pediatric dose is determined by the child's weight.

What Drugs, Substances, or Supplements Interact with Nexium IV?

Nexium I.V. may interact with clopidogrel, digoxin, diazepam, ketoconazole, HIV or AIDS medications, iron, or blood thinners. Tell your doctor all medications and supplements you use.

Nexium IV During Pregnancy or Breastfeeding

During pregnancy, Nexium I.V. is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Nexium I.V. (esomeprazole sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Nexium IV Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• seizure (convulsions);
• kidney problems-- fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
• low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking esomeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use esomeprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

• headache;
• diarrhea;
• nausea, stomach pain, gas, constipation; or
• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nexium IV (Esomeprazole Sodium)

 

Nexium IV Professional Information

SIDE EFFECTS

Clinical Trials Experience With Intravenous NEXIUM

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

The safety of intravenous esomeprazole is based on results from clinical trials conducted in four different populations including patients having symptomatic GERD with or without a history of erosive esophagitis (n=199), patients with erosive esophagitis (n=160), healthy subjects (n=204) and patients with bleeding gastric or duodenal ulcers (n=375).

Symptomatic GERD and Erosive Esophagitis Trials

The data described below reflect exposure to NEXIUM I.V. for Injection in 359 patients. NEXIUM I.V. for Injection was studied only in actively-controlled trials. The population was 18 to 77 years of age; 45% Male, 52% Caucasian, 17% Black, 3% Asian, 28% Other, and had either erosive reflux esophagitis (44%) or GERD (56%). Most patients received doses of either 20 or 40 mg either as an infusion or an injection. Adverse reactions occurring in ≥ 1% of patients treated with intravenous esomeprazole (n=359) in clinical trials are listed below:

Table 2 : Adverse reactions occurring at an incidence ≥ 1% in the NEXIUM I.V. group

Adverse Reactions	% of patients Esomeprazole Intravenous (n=359)
Headache	10.9
Flatulence	10.3
Nausea	6.4
Abdominal pain	5.8
Diarrhea	3.9
Mouth dry	3.9
Dizziness/vertigo	2.8
Constipation	2.5
Injection site reaction	1.7
Pruritus	1.1

Intravenous treatment with esomeprazole 20 and 40 mg administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of esomeprazole.

Pediatric

A randomized, open-label, multi-national study to evaluate the pharmacokinetics of repeated intravenous doses of once daily esomeprazole in pediatric patients 1 month to 17 years old, inclusive was performed. The safety results are consistent with the known safety profile of esomeprazole and no unexpected safety signals were identified. [See CLINICAL PHARMACOLOGY]

Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers in Adults

The data described below reflect exposure to NEXIUM I.V. for Injection in 375 patients. NEXIUM I.V. for Injection was studied in a placebo-controlled trial. Patients were randomized to receive NEXIUM I.V. for Injection (n=375) or placebo (n=389). The population was 18 to 98 years old; 68% Male, 87% Caucasian, 1% Black, 7% Asian, 4% other, who presented with endoscopically confirmed gastric or duodenal ulcer bleeding. Following endoscopic hemostasis, patients received either 80 mg esomeprazole as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg per hour or placebo for a total treatment duration of 72 hours. After the initial 72-hour period, all patients received oral proton pump inhibitor (PPI) for 27 days.

Table 3 : Incidence (%) of adverse reactions that occurred in greater than 1% of patients within 72 hours after start of treatment*

	Number(%)of patients
	Esomeprazole (n=375)	Placebo (n=389)
Duodenal ulcer haemorrhage	16 (4.3%)	16 (4.1%)
Injection site reaction#	16 (4.3%)	2 (0.5)
Pyrexia	13 (3.5%)	11 (2.8%)
Cough	4 (1.1%)	1 (0.3%)
Dizziness	4 (1.1%)	3 (0.8%)
*Incidence ≥ 1% in the esomeprazole group and greater than placebo group safety population #Injection site reactions included erythema, swelling, inflammation, pruritus, phlebitis, thrombophlebitis and superficial phlebitis.

With the exception of injection site reactions described above, intravenous treatment with esomeprazole administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of esomeprazole.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of NEXIUM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing Reports - There have been spontaneous reports of adverse events with postmarketing use of esomeprazole. These reports occurred rarely and are listed below by body system:

Blood And Lymphatic System Disorders: agranulocytosis, pancytopenia;

Eye Disorders: blurred vision;

Gastrointestinal Disorders: pancreatitis; stomatitis; microscopic colitis;

Hepatobiliary Disorders: hepatic failure, hepatitis with or without jaundice;

Immune System Disorders: anaphylactic reaction/shock;

Infections and Infestations: GI candidiasis;

Metabolism and nutritional disorders: hypomagnesemia;

Musculoskeletal And Connective Tissue Disorders: muscular weakness, myalgia, bone fracture;

Nervous System Disorders: hepatic encephalopathy, taste disturbance;

Psychiatric Disorders: aggression, agitation, depression, hallucination;

Renal and Urinary Disorders: interstitial nephritis;

Reproductive System and Breast Disorders: gynecomastia;

Respiratory, Thoracic and Mediastinal Disorders: bronchospasm;

Skin and Subcutaneous Tissue Disorders: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal).

Other adverse events not observed with NEXIUM, but occurring with omeprazole can be found in the omeprazole package insert, ADVERSE REACTIONS section.

Read the entire FDA prescribing information for Nexium IV (Esomeprazole Sodium)