Omeprazole

Omeprazole, approved by the FDA, is available as a prescription and over-the-counter (OTC) drug used as a treatment for frequent heartburn.

Heartburn is a very common symptom caused by acid reflux. Acid reflux is a medical condition where stomach contents and stomach acid are forced back into the esophagus. This creates a sensation of burning and pain in the chest. A doctor sees a patient who complains of suffering from acid reflux (heartburn) at least twice per week, the diagnosis of gastroesophageal reflux disease or GERD is made.

This drug is also used as a treatment of other conditions such as the management of gastric or duodenal ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis (inflammation in the esophagus), and hypersecretory conditions (conditions where your stomach makes too much acid). This drug is also used to treat stomach infections caused by the bacteria Helicobacter pylori.

Omeprazole may help your stomach symptoms related to acid, but you could still have serious stomach problems. This medication may increase your risk of severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your medical professional or seek medical help right away if you have watery stools, stomach pain, or fever.

Omeprazole is available under the following different brand names: Prilosec, and Prilosec OTC.

This drug is available as a capsule or oral liquid suspension. This drug is available by prescription as a delayed-release oral capsule or delayed-release oral suspension.

Dosages of Omeprazole include:
Adult & Pediatric Dosages:

• Tablet: Schedule IV
• Packet
  • 2.5 mg
  • 10 mg
• Suspension
  • 2 mg/ml

Tablet delayed-release (adult dosage only)

• 20 mg

Capsule delayed release

• 10 mg
• 20 mg
• 40 mg

Dosage Considerations of Omeprazole
Duodenal Ulcer

• 20 mg orally each day for 4-8 weeks
• Safety and efficacy for maintenance treatment past 1 year not established.

Helicobacter Pylori Infection

Various regimens exist of proton pump inhibitors (PPIs) combined with antibiotics for patients who have failed therapy. See the example is listed below:

• 20 mg orally every 12 hours for 10 days, WITH Amoxicillin 1000 mg orally every 12 hours, AND Clarithromycin 500 mg orally every 12 hours for 10-14 days

Gastric Ulcer

• 40 mg orally every day for 4-8 weeks

GERD

• Adult: 20 mg orally every day for 4 weeks
• Children less than 1-year-old: Safety and efficacy not established
• Children 5-10 kg: 5 mg orally once per day
• Children 10-20 kg: 10 mg orally once per day
• Children greater than 20 kg: 20 mg once per day

Erosive Esophagitis

• Adult: 20 mg orally every day for 4-8 weeks
• Adult: Maintenance: 20 mg orally daily for up to 1 year

Pediatric Treatment

Children less than 1 month: Safety and efficacy not established

• Children aged 1 month to over 1 year:
• 3 to 5 kg: 2.5 mg once daily
• 5 to 10 kg: 5 mg once daily
• 10 kg or greater: 10 mg once daily

May treat for up to 6 weeks

May treat for 4-8 weeks

Maintenance of healing

Under 1 year: Safety and efficacy not established

1 year or older: Controlled trials for maintenance do not extend beyond 12 months.

Neonates (Off-label)

Refractory duodenal ulcer or reflux esophagitis: 0.5-1.5 mg/kg orally once daily for up to 8 weeks.

Hypersecretory Condition (Zollinger-Ellison Syndrome)

60 mg orally daily (initial) up to 360 mg/day divided into every 8 hours orally.

If a dose is greater than 80 mg, divide it.

Dosage Modifications

• Hepatic impairment: Not studied; expert analysis recommends a dose reduction, especially for maintenance of healing of erosive esophagitis.
• Renal impairment: Dose adjustments are not necessary.

Common side effects of omeprazole include:

• headache
• abdominal pain
• diarrhea
• nausea
• vomiting
• gas (flatulence)
• dizziness
• upper respiratory infection
• acid reflux
• constipation
• rash
• cough

Less common side effects of Omeprazole include:

• bone fracture (osteoporosis related)
• deficiency of granulocytes in the blood
• loss of appetite
• gastric polyps
• hip fracture
• hair loss
• chronic inflammation of the stomach
• destruction of skeletal muscle
• taste changes
• abnormal dreams

Rare side effects of Omeprazole include:

• liver damage
• inflammation within the kidneys
• pancreatitis
• dermatologic disorder, potentially life threatening (toxic epidermal necrolysis)

Post marketing side effects of Omeprazole reported include:

• bone fracture

This document does not contain all possible side effects and other side effects may occur. Check with your medical professional for additional information about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

If your doctor has directed you to use this prescription medication, your doctor or pharmacist may already be aware of any possible drug interactions, health risks, and side effects, and may be monitoring you for them. Do not start, stop, or change the dosage of this drug or any medicine before checking with your doctor, health care provider, or pharmacist first.

Severe Interactions of omeprazole include:

• erlotinib
• nelfinavir
• rilpivirine

Drug Interaction with omeprazole are:

• Omeprazole has serious interactions with at least 22 different drugs.
• Omeprazole has moderate interactions with at least 75 different drugs.
• Omeprazole has minor interactions with at least 52 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your doctor if you have health questions or concerns.

Warnings

This medication contains omeprazole. Do not take Prilosec or Prilosec OTC if you are allergic to omeprazole or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to this drug or other PPIs.

Effects of Drug Abuse

• None.

Short-term Effects

• See "What Are Side Effects Associated with Using Omeprazole?"

Long-term Effects

• Increased risk for osteoporosis-related fractures of the hip, wrist, or spine with prolonged use (over 1 year) with high-dose therapy.
• Magnesium deficiency in the blood may occur with prolonged use (over 1 year); adverse effects may result and include muscle spasms, irregular heartbeat, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPIs to be discontinued.
• Daily long-term use (more than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
• See "What Are Side Effects Associated with Using Omeprazole?"

Cautions

• PPIs are possibly associated with increased incidence of Clostridium difficile-associated diarrhea; consider the diagnosis for patients taking this drug who have diarrhea that does not improve.
• May require dosage reduction with liver disease.
• Cutaneous lupus erythematosus and systemic lupus erythematosus reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with either condition are observed and refer the patient to a specialist.
• Shown to cause gastric carcinoid tumors in rats with increased doses, but the risk in humans is unconfirmed.
• Published observational studies suggest that proton pump inhibitors therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (over 1 year), high-dose therapy.
• Magnesium deficiency in the blood may occur with prolonged use (over 1 year); adverse effects may result and include muscle spasms, irregular heartbeat, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the proton pump inhibitors had to be discontinued.
• Decreased gastric acidity increases serum chromogranin A levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue proton pump inhibitors before assessing serum chromogranin A levels.
• Inhibits hepatic isoenzyme CYP2C19 and may alter the metabolism of drugs that are CYP2C19 substrates.
• PPIs may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite.
• Daily long-term use (more than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
• Acute interstitial nephritis has been observed in patients taking PPIs.
• Relief of symptoms does not eliminate the possibility of gastric malignancy.
• Therapy increases the risk of Salmonella, Campylobacter, and other infections.
• May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered together with proton pump inhibitors, possibly leading to toxicity; consider a temporary withdrawal of PPIs therapy with high dose methotrexate administration.

Pregnancy and Lactation

• Use this drug with caution in pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies are done.
• Omeprazole distributes into human breast milk; use caution if breastfeeding. Breast milk peak concentration time approximately 3 hours following 20 mg dose (peak concentration less than 7% of peak serum concentrations).
• Because of the potential for serious adverse reactions in nursing infants from omeprazole, and the potential for tumorigenicity shown in rat carcinogenicity studies, a decision should be made to discontinue nursing or to discontinue use, taking into account the importance of the drug to the mother.