Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. Before taking this medicine You should not use Nexium if you are allergic to esomeprazole or to similar medicines such as lansoprazole Prevacid , omeprazole Prilosec, Zegerid , pantoprazole Protonix , or rabeprazole AcipHex. Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.
To make sure Nexium is safe for you, tell your doctor if you have: Taking a proton pump inhibitor such as Nexium may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medicine long term or at high doses, and in those who are age 50 and older.
It is not clear whether Nexium is the actual cause of an increased risk of fracture. It is not known whether Nexium will harm an unborn baby.
Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether esomeprazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. How should I take Nexium? Take Nexium exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger or smaller amounts or for longer than recommended.
This medicine is usually given for 4 to 8 weeks only. Your doctor may recommend a second course of treatment if you need additional healing time. Take each dose with a full glass 8 ounces of water. Nexium should be taken at least one hour before a meal.
Do not crush or chew a delayed-release capsule. Vimovo is available in two dosage strengths: Essentially, the capsule consists of extremely small enteric-coated granules pellets of the esomeprazole formulation inside an outer shell. When the capsule is immersed in an aqueous solution, as happens when the capsule reaches the stomach, water enters the capsule by osmosis. The contents swell from water absorption, causing the shell to burst, and releasing the enteric-coated granules.
For most patients, the multiple-unit pellet system is of no advantage over conventional enteric-coated preparations.
AstraZeneca's marketing of Nexium There has been some controversy about AstraZeneca 's behaviour in creating, patenting, and marketing of the drug.
Esomeprazole's successful predecessor, omeprazole , is a mixture of two mirror-imaged molecules esomeprazole which is the S-enantiomer, and R-omeprazole ; critics said the company was trying to " evergreen " its omeprazole patent by patenting the pure esomeprazole and aggressively marketing to doctors that it is more effective than the mixture. Generally, positive antinuclear antibodies ANA and histological findings were observed, consistent with a diagnosis of CLE.
Organ involvement was not typically seen. Complete recovery generally has occurred within 12 weeks after discontinuation of the drug. Onset of SLE typically occurred within 30 days after initiating PPI treatment, but some cases occurred days or years after initiating treatment.
SLE occurred primarily in older patients, although cases also occurred in young adults. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported. Antibody testing for lupus, including ANA and antihistone antibodies, may be positive. Clinical symptoms generally resolved within 8 weeks. Elevated serological test results may take longer to resolve than clinical manifestations.
Avoid administration of PPIs for longer than medically indicated. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as esomeprazole, that inhibit CYP2C19 activity.
Concomitant use of clopidogrel with 40 mg esomeprazole reduces the pharmacological activity of clopidogrel. Cyanocobalamin Vitamin B Deficiency Daily treatment with any acid-suppressing medications over a long period of time e. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Hypomagnesemia Hypomagnesemia , symptomatic and asymptomatic , has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany , arrhythmias, and seizures.
In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia e.
John's Wort or rifampin. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.
Healthcare providers should temporarily stop esomeprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed e. Adverse Reactions Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: Use with other foods has not been evaluated and is not recommended.
Instruct patients to rinse the syringe with water after each use. For patients who are prescribed NEXIUM For Delayed-Release Oral Suspension and need to use more than one packet for their dose, instruct them regarding the correct amount of water to use when mixing their dose.
In two month oral carcinogenicity studies in rats, omeprazole at daily doses of 1. Gastric carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia was present in all treated groups of both sexes. In one of these studies, female rats were treated with No carcinoids were seen in these rats.
No similar tumor was seen in male or female rats treated for 2 years. For this strain of rat no similar tumor has been noted historically, but a finding involving only one tumor is difficult to interpret. A week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence, but the study was not conclusive.
Esomeprazole was negative in the Ames mutation test, in the in vivo rat bone marrow cell chromosome aberration test, and the in vivo mouse micronucleus test. Esomeprazole, however, was positive in the in vitro human lymphocyte chromosome aberration test. Omeprazole was positive in the in vitro human lymphocyte chromosome aberration test, the in vivo mouse bone marrow cell chromosome aberration test, and the in vivo mouse micronucleus test.
The potential effects of esomeprazole on fertility and reproductive performance were assessed using omeprazole studies. 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.
Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg based on a body surface area basis for a 60 kg person.
However, changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg see Animal Data.
Because of the observed effect at high doses of esomeprazole magnesium on developing bone in rat studies, NEXIUM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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