Zegerid 40mg-1100mg 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, activated in the acidic environment of the parietal cell canaliculus, where it is converted to the active sulfenamide form. This active form then irreversibly binds to and inactivates the proton pump, leading to profound and long-lasting inhibition of acid secretion. Sodium bicarbonate is an antacid that neutralizes gastric acid, thereby increasing intragastric pH. This increased pH protects the acid-labile omeprazole from degradation in the stomach, allowing it to pass into the small intestine for absorption.

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 reactions: 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 problems: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance changes, 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.
High blood sugar: Confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Pancreatitis: Severe stomach pain, severe back pain, or severe nausea and vomiting.
Liver problems: Dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes.
High or low blood pressure: Severe headache or dizziness, fainting, or changes in vision. Confusion, shakiness, dizziness, or fainting. Twitching or abnormal sensations (burning, numbness, or tingling).
Bone pain, fever, chills, or sore throat. Unexplained bruising or bleeding, or feeling extremely tired or weak.
Swelling or weight gain.
C. diff-associated diarrhea (CDAD): Stomach pain, cramps, very loose or watery stools, or bloody stools. Do not attempt to treat diarrhea without consulting your doctor first.
Low vitamin B-12 levels (rarely occurs with long-term treatment, typically more than 3 years): Shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms or legs.
Lupus: If you have lupus, inform your doctor. Seek medical attention immediately if you experience a rash on the cheeks or other body parts, skin color changes, easy sunburning, muscle or joint pain, chest pain, shortness of breath, or swelling in the arms or legs.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can 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.

Other Side Effects

Most people do not experience side effects or only have mild side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Headache
Stomach pain or diarrhea
Gas
* Nausea or vomiting

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 visit 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. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Bartter's syndrome
+ Low calcium or potassium levels
+ Acid-base problems in the blood
Symptoms of potentially serious health issues, such as:
+ 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
* Concurrent use of certain medications, including:
+ Atazanavir
+ Clopidogrel
+ Methotrexate
+ Nelfinavir
+ Rifampin
+ Rilpivirine
+ St. John's wort
+ Warfarin
+ Note: This is not an exhaustive list of interacting drugs and health conditions

To ensure safe use, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Always verify that it is safe to take this medication with your existing medications and health conditions before starting, stopping, or changing the dose of any drug.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. The full effect of this drug may not be apparent for a few days. Be sure to follow your doctor's instructions regarding the duration of treatment, as taking this medication for longer than prescribed can have adverse effects.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you are on a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.

If you have diabetes, you will need to closely monitor your blood sugar levels, as this medication may increase the risk of elevated blood sugar. Additionally, this medication may increase the risk of hip, spine, and wrist fractures in individuals with osteoporosis (weak bones). This risk may be higher if you take high doses of this medication, use it for more than a year, or are over 50 years old.

If you have risk factors for osteoporosis, such as a history of alcohol consumption, smoking, steroid use, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor. Certain medications, including those used to treat seizures, may also increase the risk of osteoporosis.

Prolonged use of this medication (typically more than 3 months, often after 1 year of treatment) may lead to low magnesium levels, which can cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels.

Although rare, this medication has been associated with severe pancreas, liver, and white blood cell problems, which can be fatal. If you have any questions or concerns, discuss them with your doctor. Long-term use of this medication (more than 1 year) may also increase the risk of developing stomach growths called fundic gland polyps. If you have questions, consult with your doctor.

Individuals of Asian descent should use this medication with caution, as they may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to you and your baby.

• Nelfinavir
• Rilpivirine

• Clopidogrel (reduced antiplatelet effect)
• Warfarin (increased INR/bleeding risk)
• Methotrexate (increased methotrexate levels/toxicity)
• Digoxin (increased digoxin levels)
• Tacrolimus (increased tacrolimus levels)
• Diazepam (increased diazepam levels)
• Cilostazol (increased cilostazol levels)
• Phenytoin (increased phenytoin levels)
• Saquinavir (decreased saquinavir levels)
• Iron salts (decreased absorption)
• Ketoconazole, Itraconazole, Posaconazole, Erlotinib (decreased absorption due to increased gastric pH)
• Mycophenolate mofetil (reduced exposure of active metabolite)
• Atazanavir (decreased atazanavir levels)
• Dasatinib, Nilotinib, Pazopanib (decreased absorption due to increased gastric pH)
• Sodium polystyrene sulfonate (risk of metabolic alkalosis and intestinal necrosis with sodium bicarbonate)

• Voriconazole (increased omeprazole exposure)
• Citalopram (increased citalopram levels)
• Escitalopram (increased escitalopram levels)
• Theophylline (increased theophylline levels)
• Sucralfate (delays omeprazole absorption, administer Zegerid at least 30 minutes before sucralfate)
• Diuretics (increased risk of hypokalemia with sodium bicarbonate)
• Corticosteroids (increased risk of hypokalemia with sodium bicarbonate)
• Lithium (increased lithium levels due to sodium bicarbonate effect on renal excretion)
• Quinidine (increased quinidine levels due to sodium bicarbonate effect on renal excretion)
• Amphetamines (increased amphetamine levels due to sodium bicarbonate effect on renal excretion)

• Antacids (additive effect, but Zegerid already contains sodium bicarbonate)
• Food (may delay absorption, but not clinically significant)

• Persistent or worsening heartburn
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• Recurrent vomiting
• Black, tarry stools (melena)
• Coffee-ground emesis
• Signs of electrolyte imbalance (e.g., muscle weakness, cramps, irregular heartbeat, confusion, excessive thirst, dry mouth)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Omeprazole is generally considered low risk, but Zegerid is Pregnancy Category C due to limited human data for the combination and potential for electrolyte disturbances from sodium bicarbonate.

Omeprazole is excreted into breast milk in small amounts. Sodium bicarbonate is also excreted. The potential for adverse effects on the breastfed infant is considered low, but caution is advised. Lactation Risk L3 (Moderate Concern). Consider alternative agents or monitor infant for adverse effects (e.g., diarrhea, drowsiness).

Safety and effectiveness in pediatric patients have not been established for Zegerid. Other omeprazole formulations are approved for pediatric use in specific conditions. Use of Zegerid in children is generally not recommended.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to electrolyte imbalances (due to sodium bicarbonate) and bone fractures (with long-term PPI use). Use with caution in elderly patients with renal or cardiac impairment. Consider lower doses for omeprazole in severe hepatic impairment.

• Zegerid combines a PPI (omeprazole) with an immediate-release antacid (sodium bicarbonate) to provide rapid onset of acid suppression and protect the omeprazole from gastric acid degradation.
• It should be taken on an empty stomach, at least one hour before a meal, for optimal absorption and efficacy.
• The sodium bicarbonate component can lead to electrolyte imbalances (e.g., hypernatremia, metabolic alkalosis, hypokalemia), especially in patients with renal impairment, heart failure, or those on diuretics.
• Long-term use of PPIs like omeprazole has been associated with increased risks of C. difficile infection, hypomagnesemia, bone fractures, and possibly kidney disease.
• Patients should be advised not to chew or crush the capsules, but they can be opened and mixed with applesauce if swallowing is difficult.
• Due to the sodium bicarbonate content, Zegerid is not interchangeable with delayed-release omeprazole formulations.

• Other Proton Pump Inhibitors (e.g., Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
• H2 Receptor Antagonists (e.g., Famotidine, Ranitidine [withdrawn], Cimetidine, Nizatidine)
• Antacids (e.g., Calcium Carbonate, Aluminum Hydroxide/Magnesium Hydroxide)
• Sucralfate

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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 medication taken, the amount, and the time it occurred.