Omeprazole 10mg Capsules

Omeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase (proton pump) at the secretory surface of the gastric parietal cell. It is a weak base, which is concentrated and converted to its active form in the highly acidic secretory canaliculi of the parietal cell. The active sulfenamide metabolite then forms a stable covalent bond with sulfhydryl groups of the H+/K+-ATPase, irreversibly inactivating the enzyme and blocking the final step in acid production.

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 immediate medical attention:

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 a wound that won't heal.
Liver Problems: Dark urine, fatigue, decreased appetite, nausea and stomach pain, light-colored stools, vomiting, or yellowing of the skin and eyes.
Pancreatitis: Severe stomach pain, severe back pain, or severe nausea and vomiting.
Other Serious Side Effects: 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 immediate medical help 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

Common Side Effects

Most people taking this medication will not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Headache
Nausea and vomiting
Stomach pain or diarrhea
* Gas

Reporting Side Effects

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact 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 you experienced, including any symptoms that occurred.
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 currently taking any of the following medications:
+ Atazanavir
+ Clopidogrel
+ Methotrexate
+ Nelfinavir
+ Rifampin
+ Rilpivirine
+ St. John's wort
+ Warfarin
Note: This is not an exhaustive list of interacting medications, and it is crucial to discuss all your medications with your doctor.

To ensure your safety, it is vital to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.

Important Warnings and Cautions

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 lab workers about your medication.

Risk of Fractures

This medication may increase the risk of hip, spine, and wrist fractures, particularly in individuals with weak bones (osteoporosis). The risk may be higher if you take this medication in high doses or for an extended period (more than a year), or if you are over 50 years old. If you have risk factors for osteoporosis, such as drinking alcohol, smoking, taking steroids, or having a family history of osteoporosis, exercise caution. Discuss your risks with your doctor.

Diarrhea and Infection

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

Electrolyte and Vitamin Deficiencies

Rarely, long-term use of this medication (at least 3 months) has been associated with low magnesium levels, which may lead to other electrolyte problems. Your doctor may recommend regular blood tests to monitor your magnesium levels. Additionally, long-term treatment (more than 3 years) has been linked to low vitamin B-12 levels. Be aware of signs of low vitamin B-12 levels, such as shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs. If you experience any of these symptoms, contact your doctor promptly.

Duration of Treatment

Do not take this medication for longer than prescribed by your doctor.

Lupus and Other Serious Conditions

This medication has been associated with the development or worsening of lupus. If you have lupus, inform your doctor. Be aware of signs of lupus, such as a rash on the cheeks or other body parts, changes in skin color, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs. Contact your doctor immediately if you experience any of these symptoms.

Very rare but serious pancreas, liver, and white blood cell problems have occurred in individuals taking this medication, and in some cases, have been fatal. Discuss any concerns with your doctor.

Stomach Growth Risk

The risk of stomach growths called fundic gland polyps may be higher in individuals taking this medication for more than a year. If you have questions or concerns, discuss them with your doctor.

Special Populations

If you are of Asian descent, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of this medication for you and your baby.

• Rilpivirine (concurrent use with PPIs is contraindicated due to significant reduction in rilpivirine absorption)

• Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition)
• Methotrexate (increased methotrexate levels, especially high-dose)
• Warfarin (increased INR/bleeding risk)
• Tacrolimus (increased tacrolimus levels)
• Digoxin (increased digoxin levels)
• Atazanavir, Nelfinavir (reduced antiretroviral absorption)
• Erlotinib, Dasatinib, Nilotinib (reduced tyrosine kinase inhibitor absorption)
• Citalopram (increased citalopram levels, QT prolongation risk)

• Diazepam (prolonged elimination)
• Phenytoin (increased phenytoin levels)
• Cilostazol (increased cilostazol levels)
• Voriconazole (increased omeprazole exposure)
• St. John's Wort (decreased omeprazole exposure)
• Iron salts (reduced iron absorption)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)

• Ketoconazole, Itraconazole (reduced antifungal absorption)
• Ampicillin esters (reduced absorption)

• Resolution of GERD symptoms (heartburn, regurgitation)
• Resolution of ulcer symptoms (abdominal pain)
• Signs of adverse effects (headache, nausea, diarrhea, abdominal pain)
• Signs of hypomagnesemia (tetany, arrhythmias, seizures)
• Signs of C. difficile infection (persistent diarrhea, fever, abdominal pain)
• Signs of kidney problems (changes in urination, swelling)

Generally considered low risk. Studies in pregnant women have not shown an increased risk of major birth defects or other adverse outcomes. Use only if clearly needed.

Omeprazole is present in human milk. The amount is small, and adverse effects on the breastfed infant are not expected. Considered compatible with breastfeeding (LactMed L2).

Safety and efficacy not established for infants under 1 year of age. Dosing for children 1 year and older is weight-based and should be carefully determined by a physician. Long-term use in children should be avoided if possible due to potential risks (e.g., bone fractures, B12 deficiency).

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, due to potential for polypharmacy and comorbidities, monitor for drug interactions and adverse effects. No dose adjustment is typically needed based on age alone.

• Omeprazole is a prodrug that requires activation in an acidic environment; therefore, it should be taken 30-60 minutes before a meal to maximize its effect on active proton pumps.
• The delayed-release formulation is crucial for omeprazole to pass through the stomach acid intact and be absorbed in the intestine.
• Long-term use (>1 year) of PPIs, including omeprazole, has been associated with increased risks of C. difficile infection, hypomagnesemia, bone fractures, and vitamin B12 deficiency. Periodically reassess the need for continued therapy.
• For patients on clopidogrel, consider alternative PPIs (e.g., pantoprazole) or H2RAs if acid suppression is necessary, due to the CYP2C19 interaction, although the clinical significance of this interaction is debated.
• Omeprazole is available over-the-counter (Prilosec OTC) for frequent heartburn, but self-treatment should not exceed 14 days without consulting a doctor.

• Other Proton Pump Inhibitors (PPIs): Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole
• Histamine-2 Receptor Antagonists (H2RAs): Famotidine, Ranitidine (withdrawn in some regions), Cimetidine, Nizatidine
• Antacids (e.g., calcium carbonate, aluminum hydroxide/magnesium hydroxide)
• Prokinetics (e.g., Metoclopramide - for specific motility disorders)
• Sucralfate (for ulcer treatment)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe and effective use. It is important to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek emergency medical attention right away. When reporting the overdose, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care.