Omeprazole 20mg Capsules

Omeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase (proton pump) in the gastric parietal cells. It is a weak base that is activated in the acidic secretory canaliculi of the parietal cells, where it is converted to its active sulfenamide form. This active form then irreversibly binds to the sulfhydryl groups of the H+/K+-ATPase, leading to irreversible inhibition of acid secretion. Because the binding is irreversible, new proton pumps must be synthesized for acid secretion to resume, explaining its prolonged duration of action despite a short plasma half-life.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or unhealing wounds.
Liver Problems: Dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellowing of the skin and eyes.
Pancreatitis: Severe stomach pain, back pain, or nausea and vomiting.
Other Serious Symptoms: Severe dizziness or fainting, bone pain, significant weight loss, or extreme fatigue and weakness.

Severe Skin Reactions: This medication can cause rare but serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe reactions. These conditions can affect other organs and be life-threatening. Seek medical help immediately if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever, chills, body aches, shortness of breath, or swollen glands

Other Side Effects

Most people taking this medication do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Headache
Nausea or vomiting
Stomach pain or diarrhea
* Gas

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health issues, including:
+ Black or bloody stools
+ Heartburn accompanied by lightheadedness, sweating, dizziness, or wheezing
+ Chest pain
+ Shoulder pain with shortness of breath
+ Pain that radiates to the arms, neck, or shoulders
+ Lightheadedness
+ Excessive sweating
+ Vomiting blood
+ Difficulty or pain when swallowing food
A history of kidney problems caused by this medication or similar drugs
If you are taking any of the following medications:
+ Atazanavir
+ Clopidogrel
+ Methotrexate
+ Nelfinavir
+ Rifampin
+ Rilpivirine
+ St. John's wort
+ Warfarin
Note: This list is not exhaustive, and you should inform your doctor about all medications you are taking.

To ensure your safety, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial because it may affect certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug.

People with weak bones (osteoporosis) may have a higher risk of fractures in the hip, spine, and wrist while taking this medication. This risk may increase if you take high doses, use the medication for more than a year, or are over 50 years old. If you have risk factors for osteoporosis, such as consuming alcohol, smoking, taking steroids, using seizure medications, or having a family history of osteoporosis, exercise caution and discuss your risks with your doctor.

This medication may also increase the risk of developing a severe form of diarrhea known as C. diff-associated diarrhea (CDAD). If you experience stomach pain, cramps, very loose or watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.

Long-term use of this medication (typically more than 3 months) may lead to rare cases of low magnesium levels, which can cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your condition. Additionally, prolonged treatment (usually more than 3 years) may result in low vitamin B-12 levels. Be aware of symptoms such as shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness and tingling in the arms and legs, and notify your doctor promptly if you experience any of these signs.

Do not take this medication for an extended period beyond what your doctor has prescribed. There have been cases of lupus, as well as worsening of existing lupus, associated with this medication. If you have lupus, inform your doctor and seek medical attention immediately if you notice symptoms such as a rash on your cheeks or other body parts, changes in skin color, easy sunburning, muscle or joint pain, chest pain, shortness of breath, or swelling in the arms or legs.

Rare but severe problems, including pancreas, liver, and white blood cell disorders, have occurred in people taking this medication, and in some cases, these conditions have been fatal. Discuss any concerns you may have with your doctor. Furthermore, long-term use (more than 1 year) may increase the risk of developing stomach growths called fundic gland polyps. If you have questions or concerns, consult your doctor.

If you are of Asian descent, use this medication with caution, as you may be more prone to side effects. It is also essential to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both you and your baby.

• Rilpivirine (decreased rilpivirine absorption due to increased gastric pH)

• Clopidogrel (reduced antiplatelet effect of clopidogrel due to CYP2C19 inhibition)
• Nelfinavir, Atazanavir (decreased antiviral absorption due to increased gastric pH)
• Methotrexate (increased methotrexate levels, especially with high-dose methotrexate, due to inhibition of renal tubular secretion)

• Warfarin (increased INR/bleeding risk due to CYP2C19 inhibition)
• Diazepam (decreased diazepam clearance due to CYP2C19 inhibition)
• Phenytoin (increased phenytoin levels due to CYP2C19 inhibition)
• Tacrolimus (increased tacrolimus levels due to CYP3A4 inhibition)
• Digoxin (increased digoxin absorption due to increased gastric pH)
• Citalopram (increased citalopram exposure due to CYP2C19 inhibition)
• Cilostazol (increased cilostazol exposure due to CYP2C19 inhibition)
• Iron salts (decreased iron absorption due to increased gastric pH)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)

• Ketoconazole, Itraconazole, Posaconazole (decreased antifungal absorption due to increased gastric pH)
• Erlotinib (decreased erlotinib absorption due to increased gastric pH)

• Persistent or worsening heartburn
• Difficulty swallowing (dysphagia)
• Painful swallowing (odynophagia)
• Unexplained weight loss
• Vomiting (especially bloody or 'coffee-ground' emesis)
• Black, tarry stools (melena)
• Chest pain
• New or unusual muscle cramps or weakness (signs of hypomagnesemia)
• Fatigue, pallor, numbness/tingling (signs of B12 deficiency)

Omeprazole has been widely studied in pregnant women and is generally considered low risk. While historically classified as Category C, newer data suggest it is unlikely to cause major birth defects or adverse pregnancy outcomes. Use during pregnancy should be based on a clear clinical need where benefits outweigh potential risks.

Omeprazole is excreted into breast milk in small amounts. The amount ingested by the infant is very low and unlikely to cause adverse effects. It is generally considered compatible with breastfeeding, but caution is advised, especially in preterm or very young infants.

Approved for use in children 1 year and older for GERD and erosive esophagitis. Dosing is weight-based. Long-term safety data in pediatric populations is less extensive than in adults; monitor for potential long-term adverse effects (e.g., B12 deficiency, hypomagnesemia, bone health).

No specific dose adjustment is required based on age alone. However, elderly patients may have reduced hepatic function, which could lead to slightly increased exposure. Monitor for adverse effects and drug interactions, as polypharmacy is common in this population. Increased risk of C. difficile infection and bone fractures may be more pronounced in the elderly.

• Omeprazole is a prodrug that requires an acidic environment for activation; therefore, it should be taken 30-60 minutes before a meal to maximize its effect on active proton pumps.
• Despite a short plasma half-life, its duration of action is long due to irreversible binding to the proton pump.
• Long-term use (especially >1 year) is associated with an increased risk of hypomagnesemia, Vitamin B12 deficiency, and possibly bone fractures and C. difficile infection.
• Avoid concomitant use with clopidogrel due to reduced antiplatelet effect; consider alternative PPIs (e.g., pantoprazole) or H2RAs if acid suppression is necessary.
• Patients should be advised not to crush or chew delayed-release capsules, as this will destroy the enteric coating and lead to premature degradation by stomach acid.

• H2 Receptor Antagonists (H2RAs): Famotidine (Pepcid), Ranitidine (Zantac - largely withdrawn), Cimetidine (Tagamet)
• Antacids (e.g., Tums, Maalox, Mylanta)
• Sucralfate (Carafate)
• Prokinetics (e.g., Metoclopramide - for specific motility disorders)
• Lifestyle modifications (dietary changes, weight loss, elevating head of bed)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable patient fact sheet. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.