Prilosec OTC

Generic Name: omeprazole (Oral route)

oh-MEP-ra-zole

Commonly used brand name(s)

In the U.S.

• Prilosec


• Prilosec OTC

Available Dosage Forms:

• Tablet, Delayed Release


• Capsule, Delayed Release


• Packet

Pharmacologic Class: Proton Pump Inhibitor

Uses For Prilosec OTC

Omeprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. Sometimes omeprazole is used in combination with antibiotics (e.g., amoxicillin, clarithromycin) to treat ulcers associated with infection caused by the H. pylori bacteria (germ).

Omeprazole is also used to treat Zollinger-Ellison syndrome, a condition where the stomach produces too much acid.

Omeprazole is also used to treat dyspepsia, a condition that causes sour stomach, belching, heart burn, or indigestion.

In addition, omeprazole is used to prevent upper gastrointestinal tract bleeding in seriously ill patients.

Omeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Prilosec OTC

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of omeprazole in children 1 to 16 years of age. Safety and efficacy have not been established in children younger than 1 year of age. .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omeprazole in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir


• Bendamustine


• Citalopram


• Clopidogrel


• Clorazepate


• Dasatinib


• Delavirdine


• Erlotinib


• Indinavir


• Methotrexate


• Mycophenolate Mofetil


• Nelfinavir


• Nilotinib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Armodafinil


• Carbamazepine


• Cilostazol


• Cranberry


• Digoxin


• Disulfiram


• Fluconazole


• Ginkgo Biloba


• Iron


• Raltegravir


• Saquinavir


• St John's Wort


• Tipranavir


• Triazolam


• Voriconazole


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypomagnesemia (low magnesium in the blood), history of or


• Osteoporosis (bone problem) or


• Seizures, history of—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of omeprazole

This section provides information on the proper use of a number of products that contain omeprazole. It may not be specific to Prilosec OTC. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you are using this medicine without a prescription, follow the instructions on the medicine label.

Take omeprazole capsules or delayed-release capsules before a meal, preferably in the morning. Omeprazole tablets may be taken with food or on an empty stomach. Take omeprazole powder for oral suspension on an empty stomach at least 1 hour before a meal. For patients receiving continuous feeding through a tube, feeding should be temporarily stopped about 3 hours before and 1 hour after administration of omeprazole powder for oral suspension.

It may take several days before this medicine begins to relieve stomach pain. To help relieve this pain, antacids may be taken with omeprazole, unless your doctor has told you not to use them.

If you are taking this medicine to treat an ulcer that is associated with an H. pylori infection, take it together with the antibiotics (e.g., amoxicillin, clarithromycin) at the same time of day.

Swallow the capsule and tablet forms of omeprazole whole. Do not open the capsule. Do not crush, break, or chew the capsule or the tablet.

If you cannot swallow the omeprazole delayed-release capsules, you may open it and sprinkle the pellets contained in the capsule on one tablespoon of applesauce. This mixture must be swallowed immediately with a glass of cool water. The applesauce should not be hot and should be soft enough to be swallowed without chewing. Do not chew or crush the pellets.

To use the powder for oral suspension:

• Empty packet of powder into a small cup containing 2 tablespoons of water.


• Do not use other liquids or foods.


• Stir well and drink immediately.


• Refill cup with water and drink.

To use the delayed-release oral suspension:

• Empty the contents of a 2.5 milligrams (mg) packet of powder into a container containing 5 mL of water.


• Empty the contents of a 10 mg packet of powder into a container containing 15 mL of water.


• Do not use other liquids or foods.


• Stir and leave it for 2 to 3 minutes to thicken.


• Stir well and drink within 30 minutes.


• If any medicine remains after drinking, add more water, stir, and drink immediately.

If you are using the delayed-release oral suspension with a nasogastric or gastric tube:

• Add 5 mL to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet).


• Shake the syringe right away and leave it for 2 to 3 minutes to thicken.


• Shake the syringe and give the medicine through the nasogastric or gastric tube into the stomach with 30 minutes.


• Refill the syringe with an equal amount of water.


• Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, delayed-release capsules or suspension, or tablets):
  
  • To treat duodenal ulcers:
    
    • Adults—20 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat duodenal ulcers with H. pylori:
    
    • Adults—20 or 40 milligrams (mg) one or two times a day before a meal. The dose is usually taken together with clarithromycin or clarithromycin plus amoxicillin. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat erosive esophagitis:
    
    • Adults—20 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat gastric ulcers:
    
    • Adults—40 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat gastroesophageal reflux disease (GERD):
    
    • Adults—20 milligrams (mg) once a day before a meal. Your doctor may tell you to take 40 mg a day for certain conditions. Also, your doctor may want you to take omeprazole for more than 8 weeks for certain conditions.
    
    
    • Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 20 mg once a day before a meal.
    
    
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat Zollinger-Ellison syndrome:
    
    • Adults—60 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage forms (powder for suspension):
  
  • To prevent upper gastrointestinal tract bleeding in seriously ill patients:
    
    • Adults—The first day: 40 milligrams (mg) for the first dose; then after 6 to 8 hours, a second 40 mg dose. After the first day: 40 mg once a day for up to 14 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat duodenal ulcer:
    
    • Adults—20 milligrams (mg) once a day for 4 to 8 weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat gastric ulcers:
    
    • Adults—40 milligrams (mg) once a day for 4 to 8 weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat gastroesophageal reflux disease (GERD) for erosive esophagitis:
    
    • Adults—20 milligrams (mg) once a day for 4 to 8 weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Prilosec OTC

It is important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, check with your doctor.

Tell your doctor if you or your child have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine to treat erosive esophagitis.

This medicine is sometimes given together with other medicines to treat ulcers. Be sure you understand about the risks and proper use of any other medicine your doctor gives you or your child together with omeprazole.

Omeprazole may cause a serious type of allergic reaction when used in patients with conditions treated with antibiotics. Call your doctor right away if you or your child have itching; trouble breathing or swallowing; or any swelling of your hands, face, or mouth while you or your child are using this medicine.

Serious stomach conditions may occur while taking this medicine with antibiotics. Stop using this medicine and check with your doctor immediately if you or your child are having more than one of these symptoms: abdominal or stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, unusual tiredness or weakness.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Prilosec OTC Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Back, leg, or stomach pain


• bleeding or crusting sores on the lips


• blisters


• bloody or cloudy urine


• chills


• continuing ulcers or sores in the mouth


• difficult, burning, or painful urination


• fever


• frequent urge to urinate


• general feeling of discomfort or illness


• joint pain


• loss of appetite


• muscle aches or cramps


• pain


• red or irritated eyes


• redness, tenderness, itching, burning, or peeling of the skin


• skin rash or itching


• sore throat


• sores, ulcers, or white spots on the lips, in the mouth, or on the genitals


• unusual bleeding or bruising


• unusual tiredness or weakness

Incidence not known

• Drowsiness


• fast, racing, or uneven heartbeat


• mood or mental changes


• muscle spasms (tetany) or twitching seizures


• nausea or vomiting


• trembling

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision


• confusion


• dryness of the mouth


• flushing


• headache


• increased sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Body aches or pain


• chest pain


• constipation


• cough


• diarrhea or loose stools


• difficulty with breathing


• dizziness


• ear congestion


• gas


• heartburn


• loss of voice


• muscle pain


• nasal congestion


• runny nose


• sneezing


• unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Prilosec OTC side effects (in more detail)

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More Prilosec OTC resources

• Prilosec OTC Side Effects (in more detail)
• Prilosec OTC Use in Pregnancy & Breastfeeding
• Prilosec OTC Drug Interactions
• Prilosec OTC Support Group
• 7 Reviews for Prilosec OTC - Add your own review/rating

• Prilosec OTC Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Omeprazole Prescribing Information (FDA)


• Omeprazole Professional Patient Advice (Wolters Kluwer)


• Omeprazole Monograph (AHFS DI)


• Omeprazole Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Prilosec Prescribing Information (FDA)


• Prilosec Consumer Overview

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