First - Omeprazole (Oral)

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 with antibiotics (for example, amoxicillin, clarithromycin) to treat ulcers linked to the infection caused by the H. pylori bacteria.

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

Omeprazole is also used to treat dyspepsia, which causes a sour stomach, belching, heartburn, or indigestion.

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

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

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

It is important for your doctor to check your or your child's progress at regular visits. This allows your doctor to see if the medicine is working properly and to decide if you should keep taking it. You may need blood, urine, and other lab tests to check for unwanted effects. If you or your child's condition does not improve or gets worse, contact your doctor.

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

Do not use omeprazole if you are also taking medicines that contain rilpivirine (Edurant®, Complera®). Using these medicines together may cause unwanted side effects.

This medicine is sometimes prescribed with other medicines to treat ulcers. Make sure you understand the risks and proper use of any other medicine your doctor gives you or your child along with omeprazole.

Omeprazole may cause a serious allergic reaction when used in patients with conditions treated with antibiotics. Call your doctor immediately if you or your child has itching, trouble breathing or swallowing, or any swelling of the hands, face, or mouth.

Contact your doctor right away if you or your child experiences a change in how often you urinate or the amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after taking this medicine. These could be signs of a serious kidney problem called acute tubulointerstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you are concerned about vitamin B12 deficiency.

Serious stomach problems may occur while taking this medicine alone or with antibiotics. Contact your doctor immediately if you or your child has stomach cramps, a bloated feeling, watery and severe diarrhea that may also be bloody, fever, nausea or vomiting, or unusual tiredness or weakness.

This medicine may increase your risk of fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age or older, if you are taking high doses of this medicine, or if you have been using it for one year or more. Call your doctor right away if you have severe bone pain or cannot walk or sit normally.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Contact your doctor immediately if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to happen if you take this medicine for more than 1 year or if you take this medicine with digoxin (Lanoxin®) or certain diuretics or "water pills." Contact your doctor right away if you have convulsions (seizures), a fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Cutaneous or systemic lupus erythematosus may occur or worsen in patients taking a Proton pump inhibitors (PPI). Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you take this medicine for more than 1 year. Talk to your doctor if you have concerns.

Do not stop taking this medicine without first checking with your doctor or unless your doctor tells you to do so.

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

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

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it may provide. Here are some important points to think about:

Allergies

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

Pediatric

Current studies have not shown any specific problems in children aged 1 to 16 years that would limit the usefulness of omeprazole. However, safety and effectiveness have not been established in children younger than 1 month.

Geriatric

Current studies have not indicated any specific problems in elderly patients that would limit the usefulness of omeprazole. However, older adults may be more sensitive to this medicine than younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are taking this medicine, it is very important for your healthcare professional to know if you are also taking any of the medicines listed below. The following interactions are significant but may not be 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 your other medicines.

• Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of use for one or both medicines.

• Abametapir
• Acalabrutinib
• Amphetamine
• Atazanavir
• Atezolizumab
• Belumosudil
• Belzutifan
• Benzphetamine
• Bosutinib
• Capecitabine
• Cefuroxime Axetil
• Cilostazol
• Citalopram
• Clopidogrel
• Clorazepate
• Conivaptan
• Dabrafenib
• Dacomitinib
• Darunavir
• Dasabuvir
• Dasatinib
• Delavirdine
• Dextroamphetamine
• Diazepam
• Digoxin
• Elagolix
• Erlotinib
• Escitalopram
• Eslicarbazepine Acetate
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Fosphenytoin
• Gefitinib
• Indinavir
• Infigratinib
• Itraconazole
• Ketoconazole
• Ledipasvir
• Levoketoconazole
• Lisdexamfetamine
• Mavacamten
• Methamphetamine
• Methotrexate
• Methylphenidate
• Mycophenolate Mofetil
• Nelfinavir
• Neratinib
• Netupitant
• Nilotinib
• Octreotide
• Olanzapine
• Omaveloxolone
• Ombitasvir
• Palbociclib
• Paritaprevir
• Pazopanib
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pirtobrutinib
• Primidone
• Rifampin
• Ritonavir
• Saquinavir
• Secretin Human
• Selpercatinib
• Sotorasib
• Sparsentan
• St John's Wort
• Sunitinib
• Tacrolimus
• Tocilizumab
• Velpatasvir
• Vismodegib
• Voriconazole
• Warfarin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Armodafinil
• Carbamazepine
• Cyanocobalamin
• Disulfiram
• Ginkgo Biloba
• Iron
• Levothyroxine
• Raltegravir
• Tipranavir
• Triazolam

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines can also cause interactions. The following interactions are significant but may not be all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects, but may be necessary in some situations. If used together, your doctor may adjust the dose or give you specific instructions regarding food, alcohol, or tobacco.

• Cranberry

Other Medical Problems

Having other medical problems may affect how this medicine is used. Be sure to inform your doctor if you have any other medical issues, especially:

• Diarrhea or
• Hypomagnesemia (low magnesium in the blood), history of or
• Osteoporosis (bone problem) or
• Seizures, history of or
• Systemic lupus erythematosus (SLE)—Use with caution. This may worsen these conditions.

• Liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away 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
• itching, skin rash
• joint pain
• loss of appetite
• muscle aches or cramps
• pain
• red or irritated eyes
• redness, tenderness, itching, burning, or peeling of the skin
• 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

• Black, tarry stools
• bleeding gums
• blindness
• blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred or decreased vision
• chest pain or tightness
• confusion
• constipation
• cough
• dark urine
• decreased urine
• difficulty swallowing
• dizziness
• drowsiness
• eye pain
• fast, racing, or uneven heartbeat
• indigestion
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• lower back or side pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms (tetany) or twitching seizures
• numbness and tingling around the mouth, fingertips, or feet
• nausea
• pain or swelling in the arms or legs without any injury
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• stomach pain
• swollen glands
• trembling
• unpleasant breath odor
• vomiting
• vomiting of blood
• yellow eyes or skin

Get emergency help right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also 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
• diarrhea or loose stools
• difficulty with breathing
• dizziness
• ear congestion
• gas
• heartburn
• loss of voice
• muscle pain
• runny or stuffy nose
• sneezing
• unusual drowsiness

Incidence not known

• Bloody nose
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased interest in sexual intercourse
• dry mouth
• hearing loss
• inability to have or keep an erection
• increased sensitivity of the skin to sunlight
• increased sweating
• loss in sexual ability, desire, drive, or performance
• redness or other discoloration of the skin
• severe sunburn
• swelling of the breasts or breast soreness in both females and males
• trouble sleeping

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.

In the U.S.

• First - Omeprazole
• PriLOSEC
• PriLOSEC OTC

Available Dosage Forms:

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

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

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.

This medicine 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 this medicine begins to relieve stomach pain. To help relieve this pain, antacids may be taken with omeprazole, unless your doctor tells you otherwise.

If you are taking this medicine to treat an ulcer that is associated with an H. pylori infection, take it together with 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 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 as 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 as 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 as needed. Children—Use and dose must be determined by your doctor. To treat erosive esophagitis caused by acid-mediated GERD: Adults and children 17 years of age and older—20 milligrams (mg) once a day before a meal. Children 1 to 16 years of age—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 1 month to younger than 1 year of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 2.5 to 10 mg once a day before a meal. Children younger than 1 month of age—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 as 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 as 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 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.

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