Zegerid 40mg-1680mg Powder Packets
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Take your medication at least 1 hour before a meal.
To prepare your dose, mix the powder with 1 or 2 teaspoons (5 or 10 mL) of water in a cup. Use only water to mix with the powder. Drink the mixture immediately after preparation, then rinse the cup with more water and drink. Do not store the mixed medication for future use.
If you have a feeding tube, you can also use the powder after mixing. However, you must stop feeding for 3 hours before and 1 hour after giving the medication. Before and after administering the medication through the feeding tube, flush the tube with water.
Before taking antacids with this medication, consult your doctor. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Important Dosage Information
If your doctor increases your dose, do not take two capsules of a lower dose to achieve the higher dose. This can lead to excessive sodium bicarbonate intake.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take on an empty stomach, at least 1 hour before your first meal of the day.
- Do not crush, chew, or open the powder packets. Mix the entire contents of the packet with 1-2 tablespoons of water and stir well. Drink immediately.
- Avoid trigger foods that worsen heartburn (e.g., spicy foods, fatty foods, caffeine, chocolate, peppermint, citrus).
- Eat smaller, more frequent meals.
- Avoid lying down for at least 3 hours after eating.
- Elevate the head of your bed.
- Avoid alcohol and smoking.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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 attention immediately:
Allergic reactions: 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 problems: 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, changes in urine output, blood in the urine, or significant weight gain.
High blood sugar: Confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Pancreas problems (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.
Low vitamin B-12 levels: 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. Seek medical attention 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. These reactions can be fatal. 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 Side Effects
Most people do not experience side effects or only have mild side effects. However, if you are concerned about any of the following side effects or if they persist, contact your doctor or seek medical attention:
Headache
Stomach pain or diarrhea
Gas
* Upset stomach or vomiting
This is not an exhaustive list of possible side effects. If you have questions or 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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent abdominal pain
- Black, tarry stools or vomiting blood (signs of bleeding)
- Difficulty or pain swallowing
- Unexplained weight loss
- Persistent diarrhea (may indicate C. difficile infection)
- Muscle cramps, weakness, dizziness, or irregular heartbeat (signs of electrolyte imbalance like low magnesium or high sodium)
- New or worsening skin rash (rare, but can be severe)
Before Using This Medicine
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 list is not exhaustive, and you should discuss all your medications and health conditions with your doctor.
To ensure safe treatment, inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins. Verify that it is safe to take this medication with your existing medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.
Precautions & Cautions
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 following a low-sodium or sodium-free diet, consult 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 fractures in the hip, spine, and wrist, particularly in individuals with osteoporosis (weak bones). This risk may be higher if you take this medication in high doses, for longer than a year, or if you are over 50 years old.
If you have risk factors for osteoporosis, such as 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 3 months, often after 1 year of treatment) may lead to rare cases of low magnesium levels, which can cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your condition.
In rare instances, this medication has been associated with severe pancreas, liver, and white blood cell problems, which can be fatal. If you have questions or concerns, discuss them 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, consult 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.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Confusion
- Lethargy
- Tachycardia
- Blurred vision
- Metabolic alkalosis (due to sodium bicarbonate)
- Hypernatremia (due to sodium bicarbonate)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive and symptomatic. May involve correction of electrolyte imbalances and fluid status.
Drug Interactions
Contraindicated Interactions
- Rilpivirine (decreased absorption of rilpivirine)
Major Interactions
- Clopidogrel (decreased antiplatelet effect due to CYP2C19 inhibition)
- Methotrexate (increased methotrexate levels, potential toxicity)
- Tacrolimus (increased tacrolimus levels)
- Digoxin (increased digoxin absorption and levels)
- Iron salts (decreased iron absorption)
- Mycophenolate mofetil (decreased mycophenolic acid exposure)
- Tyrosine Kinase Inhibitors (e.g., Erlotinib, Dasatinib, Nilotinib, Pazopanib - decreased absorption)
- Atazanavir, Nelfinavir (decreased antiretroviral absorption)
Moderate Interactions
- Warfarin (increased INR, bleeding risk)
- Diazepam (increased diazepam levels)
- Phenytoin (increased phenytoin levels)
- Cilostazol (increased cilostazol levels)
- Voriconazole (increased omeprazole levels)
- St. John's Wort (decreased omeprazole levels)
- Ketoconazole, Itraconazole, Posaconazole (decreased antifungal absorption)
- Cefpodoxime, Cefuroxime (decreased antibiotic absorption)
- Sucralfate (delays omeprazole absorption; administer Zegerid at least 30 minutes before sucralfate)
Minor Interactions
- Not typically categorized as minor for PPIs, but general caution with drugs requiring acidic environment for absorption.
Monitoring
Baseline Monitoring
Rationale: To assess baseline electrolyte status, especially due to sodium bicarbonate component and potential for metabolic alkalosis or hypernatremia.
Timing: Prior to initiation, especially in patients with renal or cardiac impairment.
Rationale: To assess baseline kidney function, as sodium bicarbonate requires renal excretion and caution is needed in impaired function.
Timing: Prior to initiation, especially in patients with renal impairment.
Rationale: Omeprazole is metabolized hepatically; baseline assessment for patients with suspected hepatic impairment.
Timing: Prior to initiation in patients with suspected hepatic impairment.
Routine Monitoring
Frequency: Periodically, as clinically indicated
Target: Resolution or improvement of symptoms
Action Threshold: Persistent or worsening symptoms may indicate need for dose adjustment, alternative therapy, or further diagnostic workup.
Frequency: Periodically, especially with long-term use or in patients with renal/cardiac impairment
Target: Within normal limits
Action Threshold: Abnormal levels (e.g., hypernatremia, metabolic alkalosis) may require dose adjustment, discontinuation, or specific management.
Frequency: Periodically with long-term use (âĨ3 months), especially if on diuretics or other magnesium-lowering drugs
Target: Within normal limits
Action Threshold: Hypomagnesemia may require supplementation or discontinuation of PPI.
Frequency: Consider with long-term use (e.g., >2-3 years)
Target: Within normal limits
Action Threshold: Deficiency may require supplementation.
Symptom Monitoring
- Persistent or worsening heartburn
- Dysphagia (difficulty swallowing)
- Odynophagia (painful swallowing)
- Unexplained weight loss
- Black, tarry stools (melena)
- Vomiting blood (hematemesis)
- Severe abdominal pain
- Signs of electrolyte imbalance (e.g., muscle weakness, cramps, confusion, irregular heartbeat, excessive thirst, dry mouth)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Omeprazole alone is Category B, but the combination with sodium bicarbonate makes it Category C.
Trimester-Specific Risks:
Lactation
L3 (Moderately Safe). Omeprazole is excreted in human milk in small amounts. Sodium bicarbonate is a natural component of milk. Use with caution; monitor infant for adverse effects (e.g., diarrhea, drowsiness).
Pediatric Use
Safety and efficacy have not been established for Zegerid powder packets in pediatric patients. Omeprazole alone is used in pediatric populations for certain conditions, but the sodium bicarbonate component in this formulation makes it generally not recommended for routine pediatric use due to potential for electrolyte imbalances and lack of specific studies.
Geriatric Use
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. Increased risk of adverse effects associated with long-term PPI use (e.g., bone fractures, C. difficile infection, hypomagnesemia). Caution with sodium load from sodium bicarbonate in elderly patients with cardiovascular disease, renal impairment, or those on sodium-restricted diets.
Clinical Information
Clinical Pearls
- Zegerid combines a PPI (omeprazole) with an antacid (sodium bicarbonate) to provide both immediate acid neutralization and sustained acid suppression.
- The sodium bicarbonate component protects omeprazole from gastric acid degradation, allowing for faster and more consistent absorption compared to delayed-release omeprazole formulations.
- It is crucial to take Zegerid on an empty stomach, at least 1 hour before a meal, for optimal effectiveness.
- Do not substitute Zegerid for other omeprazole formulations without consulting a healthcare professional, as the dosing and absorption characteristics differ.
- Long-term use of PPIs, including Zegerid, has been associated with increased risks of C. difficile infection, hypomagnesemia, bone fractures, and vitamin B12 deficiency. Periodically assess the need for continued therapy.
- Patients with significant renal or cardiac impairment should use Zegerid with caution due to the sodium bicarbonate content and potential for fluid retention or electrolyte imbalances.
Alternative Therapies
- Other Proton Pump Inhibitors (e.g., Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
- H2-receptor antagonists (e.g., Famotidine)
- Antacids (e.g., Calcium Carbonate, Aluminum Hydroxide/Magnesium Hydroxide)
- Prokinetics (e.g., Metoclopramide - for specific motility disorders)
- Lifestyle modifications alone for mild symptoms