Omeprazole 40mg 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, where it irreversibly binds to and inactivates the proton pump, leading to profound and long-lasting inhibition of acid secretion.

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 immediately or seek emergency medical attention:

Allergic Reaction: Rash, hives, itching, redness, swelling, blistering, 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 (jaundice).
Pancreatitis: Severe stomach pain, back pain, or 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 potentially life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions. These reactions can affect not only the skin but also other organs. If you experience any of the following symptoms, seek medical help immediately: 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 Possible Side Effects

Most people taking this medication do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor:

Headache
Nausea or vomiting
Stomach pain or diarrhea
* Gas

This is not an exhaustive list of possible side effects. If you have 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 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 you should discuss all your medications with your doctor.

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

Do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.

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 the results of certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug.

This medication may increase the risk of fractures in the hip, spine, and wrist, particularly in individuals with osteoporosis (weak bones). 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 a history of alcohol consumption, smoking, steroid use, seizure medication, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor.

There is a potential increased risk of developing a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) while taking this medication. 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 first consulting your doctor.

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

Do not take this medication for an extended period beyond what your doctor has prescribed.

This medication has been linked to the development or worsening of lupus. If you have a history of lupus, inform your doctor. Be aware of the 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, and contact your doctor immediately if you experience any of these symptoms.

Rare but severe pancreas, liver, and white blood cell problems have been reported in individuals taking this medication, and in some cases, these have been fatal. If you have any questions or concerns, discuss them with your doctor.

The risk of developing stomach growths called fundic gland polyps may be higher in individuals who take this medication for more than a year. If you have any questions or concerns, consult your doctor.

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

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the benefits and risks of this medication to both you and your baby.

• Rilpivirine (due to significant reduction in rilpivirine exposure)

• Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition)
• Nelfinavir (reduced nelfinavir exposure)
• Atazanavir (reduced atazanavir exposure)
• Methotrexate (increased methotrexate levels, especially with high doses)
• Tacrolimus (increased tacrolimus levels)
• Warfarin (increased INR/bleeding risk, especially with initial co-administration)

• Digoxin (increased digoxin absorption/levels)
• Citalopram (increased citalopram levels)
• Diazepam (prolonged diazepam half-life)
• Phenytoin (increased phenytoin levels)
• Cilostazol (increased cilostazol levels)
• Iron salts (reduced absorption of iron)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)
• Drugs requiring acidic gastric pH for absorption (e.g., ketoconazole, itraconazole, erlotinib, nelfinavir, atazanavir, dasatinib, nilotinib, pazopanib)

• Not available (most minor interactions are related to pH changes or CYP inhibition, covered in moderate/major)

• Persistent or worsening heartburn
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• Anemia
• Black, tarry stools (melena)
• Vomiting blood (hematemesis)
• Severe diarrhea (especially watery or bloody, suggestive of C. difficile infection)
• Muscle cramps, weakness, tremors, or irregular heartbeats (signs of hypomagnesemia)
• New or worsening joint pain (possible lupus erythematosus)

Omeprazole is generally considered safe for use during pregnancy when clinically indicated. While older classifications listed it as Category C, current data from observational studies and meta-analyses suggest no increased risk of major congenital malformations or other adverse pregnancy outcomes.

Omeprazole is excreted into breast milk in small amounts. The amount is considered clinically insignificant and unlikely to cause adverse effects in a breastfed infant. Generally considered compatible with breastfeeding (Lactation Risk Category L2).

Approved for the treatment of GERD and erosive esophagitis in pediatric patients 1 year of age and older. Dosing is weight-based. Long-term safety data in children are limited; use lowest effective dose for shortest duration possible.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is required based on age alone, but consider potential for polypharmacy and increased risk of long-term adverse effects (e.g., bone fractures, C. difficile infection, hypomagnesemia).

• Instruct patients to take omeprazole 30-60 minutes before the first meal of the day to maximize efficacy, as the proton pumps are most active after a period of fasting.
• Omeprazole is a prodrug and requires activation in an acidic environment; its effect is irreversible, leading to prolonged acid suppression despite a short plasma half-life.
• Not for immediate relief of heartburn; full effect may take several days.
• Long-term use (especially >1 year) has been associated with increased risk of bone fractures, C. difficile-associated diarrhea, hypomagnesemia, and vitamin B12 deficiency.
• Patients should be advised not to stop PPIs abruptly, as this can lead to rebound acid hypersecretion and worsening symptoms. Tapering may be necessary for long-term users.
• Consider alternative therapies or lower doses for patients with severe hepatic impairment.

• Other Proton Pump Inhibitors (e.g., Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
• H2 Receptor Antagonists (e.g., Famotidine, Ranitidine [historical], Cimetidine)
• Antacids (e.g., Calcium carbonate, Aluminum hydroxide/Magnesium hydroxide)
• Prokinetics (e.g., Metoclopramide - for specific motility disorders)
• Sucralfate (for ulcer protection)

If your symptoms or health issues persist or worsen, it's 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 provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.