Q: What is Nexium?
A: Gastroesophageal reflux disease (GERD) is very common. More than 60 million Americans experience heartburn at least once a month and more than 15 million Americans experience heartburn symptoms every day. GERD is a more serious form of gastroesophageal reflux (GER), which is common. Persistent reflux that occurs more than twice a week is considered GERD, and it can eventually lead to more serious health problems. The main symptom of GERD in adults is frequent heartburn, also called acid indigestionâ€”burning-type pain in the lower part of the mid-chest, behind the breast bone, and in the mid-abdomen. Nexium (Ceso) is a proton pump inhibitor (PPI) used in the treatment of dyspepsia, peptic ulcer disease (PUD), GERD, and Zollinger-Ellison syndrome. PPIs decrease the amount of acid produced in the stomach. PPIs are the most effective medications used to decrease stomach acid. In adults 18 and older, side effects with Nexium include headache, diarrhea, and abdominal pain. In children 1 to 17 years of age, side effects with Nexium include headache, diarrhea, abdominal pain, nausea, and sleepiness. The recommended dose of Nexium is 20 milligrams once daily for patients with acid reflux disease. For patients with acid reflux disease and erosive esophagitis, the recommended dose of Nexium ranges between 20 to 40 mg once daily. Nexium should be taken at least 1 hour before meals and at the same time each day. Each capsule of Nexium should be swallowed whole and not chewed or crushed. Nexium is not recommended for children under the age of 1 year. For children and adolescents 1 to 17 years of age, Nexium may be prescribed for up to 8 weeks for short-term treatment of GERD. 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.
Q: I am 23 years old. I was diagnosed with esophagitis and my doctor ask me to take Nexium 40 mg for all my life. I am worried that Nexium will cause osteoporosis, because I was had a hip fracture three years ago. So can Nexium cause osteoporosis, and how can I prevent that from happening?
A: Nexium (Ceso) (//www.everydayhealth.com/drugs/nexium) is indicated for the treatment of GERD or gastroesophageal reflux disease. Nexium relieves heartburn that is caused by the backflow of stomach acid from the stomach to the esophagus. (//www.everydayhealth.com/gerd/guide/). Common side effects associated with Nexium include dizziness, headache, diarrhea, constipation and dry mouth. Other less common side effects associated with Nexium include muscle pain, rash, back pain and chest pain. A search of prescribing information did not specifically list osteoporosis as an adverse event of Nexium. This is not a complete list of the side effects associated with Nexium. Kimberly Hotz, PharmD
Drugs you should not use with Ceso
Do not take these drugs with Ceso. Doing so can cause dangerous effects in your body. Examples of these drugs include:
- Clopidogrel. Ceso can block clopidogrel from working in your body. If you need to take Ceso, your doctor may consider a different antiplatelet drug.
- Diazepam. Ceso magnesium can cause diazepam to build up in your body. This can cause more side effects from diazepam.
- Warfarin. Ceso magnesium can increase the blood-thinning effect of warfarin. This can increase your international normalized ratio (INR) test results and prothrombin time. This interaction can increase bleeding and be fatal (cause death). If you need to take these drugs together, your doctor will watch you closely and may adjust your warfarin dosage.
- Cilostazol. Ceso magnesium can slow the breakdown of this drug. This can increase the levels of cilostazol in your body. If you need to take these drugs together, your doctor will decrease your dosage of cilostazol.
- Digoxin. Ceso magnesium can increase the levels of digoxin in your body. Your doctor may check your digoxin blood levels and adjust your digoxin dosage if needed.
- Methotrexate. Ceso magnesium can increase the levels of methotrexate in your body. This may cause dangerous side effects. These side effects can include nausea, vomiting, headache, fatigue, and liver and kidney damage. If you need to take a high dose of methotrexate, your doctor may have you stop taking Ceso for a short time.
- Saquinavir. Ceso magnesium may increase the levels of saquinavir in your body. This may cause more side effects from saquinavir. These may include fatigue, confusion, stomach and back pain, nausea, vomiting, and liver damage. Your doctor may watch you more closely and decrease your dosage of saquinavir if needed.
- Tacrolimus. Ceso magnesium can increase the levels of tacrolimus in your body. This may cause high blood pressure and kidney damage. Your doctor may check your tacrolimus levels and adjust your dosage if needed.
The safety of intravenous Ceso 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).
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 Ceso. 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; fundic gland polyps; Hepatobiliary Disorders: hepatic failure, hepatitis with or without jaundice; Immune System Disorders: anaphylactic reaction/shock; systemic lupus erythematosus; Infections and Infestations: GI candidiasis; Metabolism and nutritional disorders: hypomagnesemia with or without hypocalcemia and/or hypokalemia; 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), cutaneous lupus erythematosus.
Other adverse events not observed with NEXIUM, but occurring with omeprazole can be found in the omeprazole package insert, ADVERSE REACTIONS section.
What are the possible side effects of Ceso?
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--little or no urination, blood in your urine, swelling, rapid 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 Ceso long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.
If you use Ceso 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:
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.
How should I take Ceso?
Use exactly as directed on the label, or as prescribed by your doctor.
Ceso 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.
Ceso should be taken at least one hour before a meal.
Swallow the capsule whole and do not crush, chew, break, or open it.
If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow the mixture right away without chewing. Do not save it for later use.
The Ceso capsule can be given through a nasogastric (NG) feeding tube. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.
Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Ceso.
Some conditions are treated with a combination of Ceso and antibiotics. Use all medications as directed.
Store at room temperature away from moisture and heat.
Q: Are there risks with long-term use of Nexium?
A: Nexium (Ceso) belongs to a class of drugs called proton pump inhibitors. PPIs decrease the amount of acid produced by the stomach. They are used to treat the symptoms of gastro-esophageal reflux disease (GERD), to heal erosive esophagitis, and to treat or prevent ulcers. PPIs have been around for over 20 years and have good safety record, even with long-term use. However, there are some precautions to consider. The major long-term side effects of PPIs is a vitamin B12 deficiency, and more rarely an iron deficiency. In addition to blocking the acid pumps in the stomach, PPIs also block the production of a protein in the stomach called intrinsic factor. Intrinsic factor is necessary for the proper absorption of vitamin B12. So, over many years, a deficiency may develop. This can be treated with vitamin B12 supplements, if advised by your doctor. Another risk with long-term use is a possible increased risk of fractures of the hip, wrist, and spine. Studies are not clear at this point about whether PPIs actually cause the increased risk or if it is due to some other factor. For now, tell your doctor if you develop any new bone pain. Your doctor is best able to guide your treatment decisions. Sarah Lewis, PharmD
See also Precautions section.
Headache or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), signs of lupus (such as rash on nose and cheeks, new or worsening joint pain).
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea or opioid medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.
Rarely, proton pump inhibitors (such as Ceso) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine).
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Q: I have been taking Nexium for about three years. As long as I take it, I have no problems but if I forget to take it as soon as I get up, within an hour I have pain in my chest and unbearable heartburn. I recently heard that Nexium could cause you to have fractures of the bones. Should I be concerned? I also take Coumadin and lovastatin.
A: I have reviewed your question regarding Nexium (Ceso), Coumadin (warfarin), and Mevacor (lovastatin). I found one drug-drug interaction: warfarin sodium (in Coumadin tablets) may interact with lovastatin (in Mevacor tablets). Lovastatin may block the breakdown of warfarin by the liver and its clearance from the body. If this happens, blood levels of warfarin could be increased and this could increase its anticoagulant effect. Warfarin is generally used to prevent your blood from "coagulating" or forming blood clots. When lovastatin and warfarin are used at the same time, your blood may be much less likely to clot and this may increase the risk of excessive bleeding. If these drugs are taken together, your doctor may want to monitor you closely when therapy with lovastatin is either started or stopped. Blood tests can be used to make sure that you are getting the right amount of warfarin. If you are experiencing problems, it may be necessary to adjust the dose of warfarin. Discuss this potential interaction with your health care provider at your next appointment, or sooner if you think you are having problems. This interaction is well-documented and is considered moderate in severity. Nexium (Ceso) is in a class of drug called a proton pump inhibitor. Proton pump inhibitors may be associated with a greater risk of hip fractures. I would discuss this with your physician or health care provider. Please review the information on GERD at Everyday Health //www.everydayhealth.com/gerd/guide/ For immediate questions or concerns, please contact your physician or health care provider. Joseph Hall, RPh.