Zegerid 20mg-1100mg Capsules

Omeprazole is a proton pump inhibitor (PPI) that irreversibly binds to and inhibits the H+/K+-ATPase (proton pump) in the secretory canaliculi of parietal cells, thereby blocking the final step in gastric acid production. Sodium bicarbonate is an antacid that neutralizes existing gastric acid and also protects omeprazole from acid degradation in the stomach, allowing for its absorption.

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble 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, change in balance, abnormal heartbeat, seizures, loss of appetite, or severe upset stomach or vomiting.
Kidney Problems: Inability to pass urine, change in urine output, blood in the urine, or significant weight gain.
High Blood Sugar: Confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Liver Problems: Dark urine, fatigue, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
High or Low Blood Pressure: Severe headache or dizziness, fainting, or changes in vision. Confusion, shakiness, dizziness, or fainting. Twitching. Abnormal sensations such as burning, numbness, or tingling. Bone pain. Fever, chills, or sore throat; unexplained bruising or bleeding; or feeling extremely tired or weak. Swelling. Weight gain.
C. diff-associated Diarrhea (CDAD): Stomach pain or cramps, very loose or watery stools, or bloody stools. Do not attempt to treat diarrhea without consulting your doctor first.
Vitamin B12 Deficiency: Shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms or legs. This can occur with long-term treatment (more than 3 years).
Lupus: If you have lupus, inform your doctor. Call your doctor immediately if you experience 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.
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur, potentially affecting internal organs. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most people do not experience severe side effects, and some may only have mild or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Headache
Stomach pain or diarrhea
Gas
* Upset stomach or vomiting

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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 you experienced, including any symptoms that occurred.
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
* Use of certain medications, including:
+ Atazanavir
+ Clopidogrel
+ Methotrexate
+ Nelfinavir
+ Rifampin
+ Rilpivirine
+ St. John's wort
+ Warfarin

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.

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, particularly if taken in high doses or for an extended period (more than one 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.

Prolonged use of this medication (at least three months, often after one year of treatment) may lead to rare but potentially severe side effects, including low magnesium levels, which can cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels and overall health.

In rare cases, this medication has been associated with severe and potentially life-threatening pancreas, liver, and white blood cell problems. If you have any concerns or questions, discuss them with your doctor. Long-term use of this medication (more than one year) may also increase the risk of developing stomach growths called fundic gland polyps.

If you are of Asian descent, you may be more susceptible to side effects from this medication, so use it with caution and under close medical supervision. If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to you and your baby.

• Nelfinavir (decreased nelfinavir exposure)
• Rilpivirine (decreased rilpivirine exposure)

• Clopidogrel (decreased antiplatelet effect of clopidogrel via CYP2C19 inhibition)
• Methotrexate (increased methotrexate levels, especially high-dose)
• Tacrolimus (increased tacrolimus levels)
• Digoxin (increased digoxin levels)
• Iron salts (decreased absorption of iron)
• Ketoconazole, Itraconazole, Posaconazole (decreased absorption due to increased gastric pH)
• Mycophenolate mofetil (decreased mycophenolic acid exposure)
• Warfarin (increased INR/bleeding risk, monitor closely)
• Phenytoin (increased phenytoin levels)
• Diazepam (increased diazepam levels)
• Cilostazol (increased cilostazol and active metabolite levels)
• Voriconazole (increased omeprazole exposure)

• Atazanavir (decreased atazanavir exposure)
• Erlotinib (decreased erlotinib exposure)
• Dasatinib, Nilotinib (decreased absorption)
• Citalopram (increased citalopram exposure, consider dose reduction)
• Escitalopram (increased escitalopram exposure)
• St. John's Wort (decreased omeprazole exposure)
• Diuretics (especially loop and thiazide, may increase risk of hypomagnesemia)
• Corticosteroids (may increase risk of sodium retention with sodium bicarbonate)

• Sucralfate (may decrease omeprazole absorption, administer Zegerid at least 30 minutes before sucralfate)
• Food (take at least 1 hour before a meal)

• Persistent or worsening heartburn
• Regurgitation
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• Black, tarry stools (melena)
• Vomiting blood (hematemesis)
• New or worsening abdominal pain
• Diarrhea (especially persistent or severe, may indicate C. difficile infection)
• Muscle cramps or weakness (signs of hypomagnesemia)
• Fatigue, dizziness, irregular heartbeat (signs of electrolyte imbalance)

Category C. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Omeprazole crosses the placenta. Sodium bicarbonate can cause fluid retention and metabolic alkalosis.

Omeprazole is excreted in human milk in small amounts (L2 - probably compatible). Sodium bicarbonate is a natural component of breast milk, but large doses could theoretically alter milk pH or sodium content (L3 - moderately safe). Use with caution. Monitor infant for adverse effects (e.g., diarrhea, drowsiness).

Safety and effectiveness of Zegerid capsules have not been established in pediatric patients. Omeprazole alone is approved for certain pediatric indications, but the sodium bicarbonate component in Zegerid makes it less suitable for routine pediatric use due to potential for sodium overload and metabolic alkalosis, especially in infants and young children.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Due to the sodium bicarbonate component, use with caution in elderly patients with pre-existing cardiovascular disease (e.g., heart failure, hypertension) or renal impairment, as they may be more susceptible to fluid overload and electrolyte imbalances. Monitor for adverse effects and electrolyte status.

• Zegerid combines a PPI (omeprazole) with an immediate-release antacid (sodium bicarbonate), which allows for rapid onset of acid neutralization and protects omeprazole from gastric acid degradation, leading to faster and more consistent absorption compared to delayed-release omeprazole.
• Always take Zegerid at least one hour before a meal, preferably in the morning, to maximize its effectiveness.
• Due to the sodium bicarbonate component, Zegerid provides an immediate antacid effect in addition to the sustained acid suppression from omeprazole.
• Caution is advised in patients with heart failure, renal impairment, or those on a sodium-restricted diet due to the significant sodium load from sodium bicarbonate (1100 mg sodium bicarbonate contains approximately 300 mg of sodium).
• Long-term use of PPIs like omeprazole has been associated with potential risks including C. difficile infection, hypomagnesemia, bone fractures, and kidney problems. Periodically reassess the need for continued therapy.
• Patients should be advised not to crush or chew the capsules, as this can affect the stability and absorption of omeprazole.

• Other Proton Pump Inhibitors (PPIs): Esomeprazole (Nexium), Lansoprazole (Prevacid), Pantoprazole (Protonix), Rabeprazole (Aciphex), Dexlansoprazole (Dexilant)
• H2 Receptor Blockers (H2RAs): Famotidine (Pepcid), Ranitidine (Zantac - largely withdrawn), Cimetidine (Tagamet), Nizatidine (Axid)
• 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 is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others or take medication prescribed to someone else. 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 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 details about the medication taken, the quantity, and the time it occurred.