Studies indicate that people who take proton pump inhibitor medications (such as Nexium) may be at an increased risk for broken bones. The risk appears to be highest for people who take such medications at high doses or for long periods (over a year). You and your healthcare provider should take this into account when deciding if the benefits of this medication outweigh the risks for your particular situation.

The use of proton pump inhibitors (including this medication) may increase the risk of a potentially serious condition known as Clostridium difficile-associated diarrhea (CDAD). If you develop diarrhea that does not seem to improve (especially if it is watery and accompanied by a fever and abdominal pain), seek immediate medical attention.

The prominent consumer watchdog group Public Citizen has filed a petition with the FDA, indicating that a new black box warning for Nexium, Prilosec and other proton pump inhibitor drugs is necessary to warn consumers and the medical community about the risk of long-term dependence and other dangerous side effects.

According to the petition (PDF) filed with the FDA on Tuesday, Public Citizen indicates that the strongest possible warning label is necessary for the widely used acid reflux drugs, which were prescribed more than 119 million times in 2009 and generated sales in the United States of $13.6 billion.

An estimated one out of every 20 people in the developed world are currently taking a proton pump inhibitor (PPI) to reduce the production of stomach acid in an attempt to alleviate symptoms of gastroesophageal reflux disease (GERD), ulcers and other stomach ailments. In addition to Nexium and Prilosec, other drugs in the same class included Prevacid, Zegerid, Protonix, Dexilant, Aciphex, Vimovo and a number of generic equivalents.

Erythromycin is used to treat a wide variety of bacterial infections. It may also be used to prevent certain bacterial infections. Erythromycin is known as a macrolide antibiotic. It works by stopping the growth of bacteria.

This antibiotic treats or prevents only bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat a certain type of stomach condition involving slowed digestion (gastroparesis).

How to use erythromycin stearate

Take this medication by mouth as directed by your doctor, usually before a meal. This medication is best absorbed when taken on an empty stomach. If nausea occurs, you may take it with food or milk.

This medication has a bitter taste if crushed. Swallow the medication whole. Do not chew or crush.

The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on age and weight.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

If you are using this medication to treat an infection, continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition persists or worsens.

If you are taking this medication to prevent certain bacterial infections, take it exactly as directed by your doctor. Do not stop taking the medication without your doctor's approval.

Nausea, vomiting, diarrhea, stomach pain/cramping, and loss of appetite may occur. Taking this medication with food may lessen these symptoms. 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: signs of liver disease (such as persistent nausea/vomiting, yellowing eyes or skin, dark urine, severe stomach/abdominal pain), unusual tiredness, muscle weakness, slurred speech, blurred vision, drooping eyelids, hearing loss.

Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, fast/irregular heartbeat.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada.

Before taking erythromycin, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (such as azithromycin, clarithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain type of muscle disease (myasthenia gravis).

Erythromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using erythromycin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using erythromycin safely.

Erythromycin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Some erythromycin products may contain sodium. Ask your doctor or pharmacist for more information if you are on a salt-restricted diet or if you have a condition such as congestive heart failure that could be worsened by an increase in salt intake.

Older adults may be more sensitive to the side effects of this drug, especially hearing loss and QT prolongation (see above).

Tell your doctor if you are pregnant before using this medication.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: clindamycin, digoxin.

Many drugs besides erythromycin may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, cisapride, pimozide, procainamide, propafenone, quinidine, sotalol, among others.

Other medications can affect the removal of erythromycin from your body, which may affect how erythromycin works. Examples include azole antifungals (such as itraconazole, ketoconazole), certain calcium channel blockers (such as diltiazem, verapamil), certain anti-seizure medications (such as carbamazepine, phenytoin), quinupristin-dalfopristin, among others.

Erythromycin can slow down the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include bromocriptine, colchicine, certain benzodiazepines (such as midazolam, triazolam), eletriptan, ergot alkaloids (such as ergotamine, dihydroergotamine), certain drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), certain "statin" drugs (such as lovastatin, simvastatin), vinblastine, among others.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This medication may interfere with certain laboratory tests (urine tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.