What is omeprazole?

oh-MEP-ra-zole

Commonly used brand name(s)

In the U.S.

First - Omeprazole
PriLOSEC
PriLOSEC OTC

Available Dosage Forms:

Tablet, Delayed Release
Capsule, Delayed Release
Powder for Suspension
Packet

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

Uses For omeprazole

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 (eg, 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.

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

Before Using omeprazole

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 omeprazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to omeprazole 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 omeprazole, 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 omeprazole 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 omeprazole 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
Bosutinib
Cilostazol
Citalopram
Clopidogrel
Clorazepate
Clozapine
Dabrafenib
Dasabuvir
Dasatinib
Delavirdine
Erlotinib
Eslicarbazepine Acetate
Indinavir
Ketoconazole
Ledipasvir
Methotrexate
Mycophenolate Mofetil
Nelfinavir
Nilotinib
Ombitasvir
Paritaprevir
Pazopanib
Ritonavir
Saquinavir
Tacrolimus
Topotecan
Vismodegib

Using omeprazole 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
Cranberry
Digoxin
Disulfiram
Fluconazole
Ginkgo Biloba
Iron
Levothyroxine
Raltegravir
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.

Proper Use of omeprazole

Take omeprazole 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 omeprazole without a prescription, follow the instructions on the medicine label.

omeprazole should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 omeprazole 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 omeprazole to treat an ulcer that is associated with an H. pylori infection, take it together with the antibiotics (eg, 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 omeprazole 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 omeprazole. 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, two, or three 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 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 form (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 omeprazole, 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 omeprazole

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, urine, and other laboratory 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 omeprazole to treat erosive esophagitis.

omeprazole 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 omeprazole.

Atrophic gastritis (inflammation in the stomach) may occur, especially if you take omeprazole for a long time. Talk with your doctor if you or your child have concerns about this.

Check with your doctor right away if you or your child have a fever, joint pain, skin rash, swelling of the body, feet, or ankles, or unusual weight gain after receiving omeprazole. These could be symptoms of acute interstitial nephritis.

Taking omeprazole for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you or your child have concerns about vitamin B12 deficiency.

Serious stomach conditions may occur while taking omeprazole alone or together with antibiotics. 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, or unusual tiredness or weakness.

omeprazole 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 omeprazole, or use it for one year or more.

omeprazole may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking omeprazole for more than one year, or if you are taking omeprazole together with digoxin (Lanoxin®) or certain diuretics or "water pills". 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 omeprazole without first checking with your doctor, or unless told to do so by your doctor.

Make sure any doctor or dentist who treats you knows that you are using omeprazole. You may need to stop using omeprazole several days before you have medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

omeprazole 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.

How to use omeprazole?

Usual Adult Dose for Duodenal Ulcer

20 mg orally once a day before a meal. Most patients heal within 4 to 8 weeks.

Usual Adult Dose for Helicobacter pylori Infection

Dual therapy: omeprazole 40 mg orally once a day in the morning plus clarithromycin 500 mg orally 3 times a day on days 1 to 14. Beginning on day 15, omeprazole 20 mg orally once a day in the morning on days 15 to 28.

Triple therapy: omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg all given orally twice a day for 10 days. If an ulcer is present at the initiation of therapy, continue omeprazole 20 mg orally once a day for an additional 18 days.

Study (n=294) - Canadian Adult Dyspepsia Empiric Treatment-Helicobacter pylori positive (CADET-Hp): omeprazole 20 mg, metronidazole 500 mg, and clarithromycin 500 mg, twice daily for 7 days.

Usual Adult Dose for Gastric Ulcer

40 mg orally once a day before a meal for 4 to 8 weeks.

Usual Adult Dose for Erosive Esophagitis

20 mg orally once a day before a meal. This dosage may be increased to 40 mg per day based on desired clinical response and patient tolerance. Studies have been completed up to 12 months for maintenance therapy of erosive esophagitis.

Usual Adult Dose for Zollinger-Ellison Syndrome

Initial: 60 mg orally once a day. Dosage should be individualized to patient's needs.

Maintenance: doses up to 120 mg 3 times a day have been administered. Daily doses greater than 80 mg should be divided.

Usual Adult Dose for Gastroesophageal Reflux Disease

Initial: 20 mg orally once a day before a meal for 4 to 8 weeks. This dosage may be increased to 40 mg per day if needed.

Maintenance: long-term treatment with doses of 10 to 20 mg per day may be required for maintenance therapy of refractory disease and appears to be safe.

Usual Adult Dose for Multiple Endocrine Adenomas

Initial: 60 mg orally once a day before a meal. This dosage may be titrated based on desired clinical response and patient tolerance.

Maintenance: doses up to 120 mg 3 times a day have been administered. Daily doses greater than 80 mg should be divided.

Usual Adult Dose for Systemic Mastocytosis

Usual Adult Dose for Dyspepsia

Prevention of frequent heartburn: 20 mg orally once daily, before a meal, for 14 days.

Usual Pediatric Dose for Erosive Esophagitis

Oral:
Infants:
GERD: 0.7 mg/kg/dose once daily reduced the percentage of time gastric and esophageal pH less than 4, as well as the number of reflux episodes in 10 neonates [mean PMA: 36.1 weeks, (34 to 40 weeks)] in a trial. Higher doses of 1 to 1.5 mg/kg/day have been reported

Children and Adolescents 1 to 16 years:
GERD, ulcers, esophagitis:
Manufacturer recommendations:
5 kg to less than 10 kg: 5 mg once daily
10 kg to less than or equal to 20 kg: 10 mg once daily
Greater than 20 kg: 20 mg once daily

Alternate dosing:
Children 1 to 16 years:
1 mg/kg/dose once or twice daily

Adjunctive therapy of duodenal ulcers associated with Helicobacter pylori (in combination with antibiotic therapy either clarithromycin or clarithromycin and amoxicillin) in children:
15 to 30 kg: 10 mg twice daily
Greater than 30 kg: 20 mg twice daily

Comment: The safety and efficacy of omeprazole use in patients less than 1 year of age and for pediatric uses other than the treatment of GERD and maintenance of healing of erosive esophagitis has not been established.

Usual Pediatric Dose for Gastroesophageal Reflux Disease

Renal Dose Adjustments

No adjustments recommended

Liver Dose Adjustments

The manufacturer recommends dose adjustments in patients with hepatic impairment, specially where maintenance of healing of erosive esophagitis is needed.

Dose Adjustments

The manufacturer recommends dose adjustments in Asian patients, especially where maintenance of healing of erosive esophagitis is needed.

For the over-the-counter product, the manufacturer advises not to use drug for more than 14 days in a row. And, a 14-day course can be repeated only every 4 months.

Precautions

Symptomatic relief does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients on long therapy with omeprazole.

Proton pump inhibitors should be used with caution in patients who have hypocalcemia or hypoparathyroidism.

Calcium absorption is decreased in patients with achlorhydria.

Proton pump inhibitors could contribute to the development of vitamin B12 deficiency with prolonged use.

Proton pump inhibitors may interfere with the detection of H pylori by the urea breath test. Therefore, testing for H pylori with the urea breath test is not recommended in patients who have received proton pump inhibitors in the preceding two weeks.

Proton pump inhibitors should be used with caution in patients who have hypocalcemia or hypoparathyroidism.

Calcium absorption is decreased in patients with achlorhydria.

Proton pump inhibitors could contribute to the development of vitamin B12 deficiency with prolonged use.

Omeprazole powder for oral suspension contains 20 mEq of sodium bicarbonate per dose (460 mg Sodium). Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. Sodium bicarbonate should be used with caution in patients with Bartter's syndrome, respiratory alkalosis, and hypokalemia. Milk-alkali syndrome may occur on long-term administration of bicarbonate with calcium or milk.

Dialysis

Not readily dialyzable

Other Comments

Some patients with Zollinger-Ellison syndrome have been treated continuously for greater than 5 years.

The omeprazole powder for oral suspension should be taken 1 hour before a meal (on an empty stomach).

The omeprazole delayed release capsules should be taken 30 minutes before food or meals. Swallow the capsule whole; do not open, crush, or chew.

Several methods of administration have been used in patients unable to swallow the capsule: Sprinkle content of capsule (granules) onto 1 teaspoon of applesauce or yogurt, or add to fruit juice (apple, grape, grapefruit, cranberry, orange, pineapple, tomato, or V-8 juice) and give orally. Do not chew granules.

For patients fed through a nasogastric tube: open capsule and flush 6 to 10 granules with water (10 to 20 mL) at a time, until all gone (total water volume 120 to 140 mL); or place granules in 30 mL water and give through nasogastric tube, using a 30 mL syringe. Flush nasogastric tube with 15 mL water afterwards.

Omeprazole delayed-release 20 mg tablet is available over-the-counter for the treatment of frequent heartburn.

What are the side effects of omeprazole?

Prilosec Side Effects

Common Side Effects of Prilosec

You should tell your doctor if any of the following side effects are severe or don't go away:

Nausea or vomiting
Gas
Constipation
Headache

Serious Side Effects of Prilosec

You should contact your doctor immediately or seek emergency medical help if you experience any of the following severe side effects:

Rash, hives, or itching
Swelling of the face, throat, tongue, lips, eyes, hands, feet, or lower legs
Hoarseness
Breathing or swallowing difficulties
Extreme fatigue
Fast, irregular, or pounding heartbeat
Dizziness or lightheadedness
Muscles spasms
Seizures
Uncontrollable shaking of a part of the body
Diarrhea with watery stools
Fever
Stomach pain