Zegerid 20mg-1680mg Powder Packets

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

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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, 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 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 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, burning, numbness, or tingling sensations. Bone pain. Fever, chills, or sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak. Swelling or weight gain.

Additional Serious Side Effects:

C. diff-associated Diarrhea (CDAD): Stomach pain or cramps, watery or bloody stools. Do not treat diarrhea without consulting your doctor.
Vitamin B-12 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 (over 3 years).
Lupus: Rash on the cheeks or other body parts, skin color changes, easy sunburning, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs. If you have lupus, inform your doctor.
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These can be life-threatening and may affect 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.

Common Side Effects:

While many people do not experience side effects or only have mild ones, some common side effects include:

Headache
Stomach pain or diarrhea
Gas
* Upset stomach or vomiting

If these or any other side effects bother you or do not go away, contact your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or 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 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 (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use of this medication. Do not initiate, stop, or modify the dosage of any medication without 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. Do not exceed the prescribed duration of treatment, as directed by your doctor.

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

If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely, as this medication may increase the risk of elevated blood sugar. Additionally, this drug 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, or seizure medication, or if you have a family history of osteoporosis, exercise caution and discuss your risks with your doctor.

Prolonged use of this medication (at least 3 months) may lead to rare cases of low magnesium levels, often occurring after 1 year of treatment. This condition may cause other electrolyte problems, and your doctor may recommend regular blood tests to monitor your magnesium levels.

In rare instances, 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, consult with your doctor. Long-term use of this medication (more than 1 year) may also increase the risk of stomach growths called fundic gland polyps. If you have questions, discuss them 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 to discuss the potential benefits and risks to you and your baby.

• Rilpivirine (due to significant reduction in rilpivirine exposure)
• Nelfinavir (due to significant reduction in nelfinavir exposure)

• Clopidogrel (reduced antiplatelet effect)
• Methotrexate (increased methotrexate levels)
• Warfarin (increased INR/bleeding risk)
• Digoxin (increased digoxin levels)
• Tacrolimus (increased tacrolimus levels)
• Citalopram (increased citalopram levels, QT prolongation risk)
• Cilostazol (increased cilostazol levels)
• Diazepam (increased diazepam levels)
• Phenytoin (increased phenytoin levels)
• Saquinavir (reduced saquinavir levels)
• Iron salts (reduced absorption of iron)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)
• Drugs requiring acidic gastric pH for absorption (e.g., ketoconazole, itraconazole, atazanavir, erlotinib, nelfinavir, rilpivirine, dasatinib, nilotinib, pazopanib, posaconazole, iron salts)

• Voriconazole (increased omeprazole levels)
• St. John's Wort (decreased omeprazole levels)
• Dabigatran etexilate (increased dabigatran exposure)
• Theophylline (potential for increased theophylline levels)
• Sucralfate (may reduce omeprazole absorption; administer omeprazole at least 30 minutes before sucralfate)
• Diuretics (increased risk of hypomagnesemia)
• Drugs that prolong QT interval (additive risk with citalopram)

• Not available

• Persistent or worsening heartburn
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• Recurrent vomiting
• Gastrointestinal bleeding (black, tarry stools; coffee-ground emesis)
• New or worsening diarrhea (especially watery or bloody)
• Muscle cramps, weakness, tremors, or arrhythmias (signs of hypomagnesemia)
• Fatigue, pallor, shortness of breath (signs of vitamin B12 deficiency)
• Signs of kidney problems (changes in urination, swelling, fatigue)

Omeprazole is generally considered low risk during pregnancy. Studies in animals have shown no evidence of harm, and human data suggest no increased risk of major birth defects. However, sodium bicarbonate can contribute to fluid retention and metabolic alkalosis, which should be considered. Use only if clearly needed.

Omeprazole is excreted into breast milk in small amounts. Sodium bicarbonate is also excreted. While the amount of omeprazole is generally considered too low to cause adverse effects in breastfed infants, caution is advised. The L3 lactation risk rating suggests moderate concern. Monitor infant for any adverse effects (e.g., diarrhea, drowsiness).

Safety and efficacy have not been established in pediatric patients under 18 years of age for Zegerid Powder Packets. Omeprazole alone is approved for certain pediatric indications, but the combination with sodium bicarbonate is not.

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. Dosage adjustment for omeprazole is generally not needed based on age alone. However, elderly patients may be more susceptible to adverse effects of sodium bicarbonate (e.g., fluid overload, metabolic alkalosis) and long-term PPI risks (e.g., bone fractures, C. difficile infection, hypomagnesemia). Use with caution and monitor closely.

• Zegerid's sodium bicarbonate component provides immediate acid neutralization and protects omeprazole from degradation, allowing for faster and more consistent absorption compared to delayed-release omeprazole formulations.
• Always take Zegerid on an empty stomach, at least 30-60 minutes before a meal, for optimal efficacy.
• Long-term use of PPIs (including Zegerid) has been associated with increased risks of C. difficile infection, bone fractures (hip, wrist, spine), hypomagnesemia, vitamin B12 deficiency, and acute interstitial nephritis. Periodically reassess the need for continued therapy.
• The sodium bicarbonate component can be problematic in patients with renal impairment, heart failure, or those on sodium-restricted diets due to its sodium content and potential for metabolic alkalosis.
• Be aware of significant drug interactions, especially with clopidogrel, methotrexate, and certain antiretrovirals, due to omeprazole's CYP2C19 inhibition and gastric pH alteration.

• Other Proton Pump Inhibitors (PPIs): Esomeprazole (Nexium), Lansoprazole (Prevacid), Pantoprazole (Protonix), Rabeprazole (Aciphex), Dexlansoprazole (Dexilant)
• H2-receptor antagonists (H2RAs): Famotidine (Pepcid), Ranitidine (Zantac - withdrawn in some regions), Cimetidine (Tagamet), Nizatidine (Axid)
• Antacids (e.g., calcium carbonate, aluminum hydroxide/magnesium hydroxide)
• Prokinetics (e.g., metoclopramide - for specific motility disorders)
• Surgery (e.g., Nissen fundoplication for severe GERD)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information. Please read this guide carefully and review it each time you receive a refill of this medication. If you have any questions or concerns about this medication, do not hesitate to 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.