Zegerid 40mg-1680mg Powder Packets

Manufacturer BAUSCH HEALTH Active Ingredient Omeprazole and Sodium Bicarbonate Powder Packets(oh MEP ra zole & SOW dee um bye KAR bun ate) Pronunciation oh MEP ra zole & SOW dee um bye KAR bun ate
It is used to treat gastroesophageal reflux disease (GERD; acid reflux).It is used to treat heartburn.It is used to treat GI (gastrointestinal) ulcers.It is used to treat or prevent ulcers of the esophagus.It is used to prevent GI (gastrointestinal) bleeding in some patients.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Proton Pump Inhibitor; Antacid
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Pharmacologic Class
Proton Pump Inhibitor; Antacid
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Pregnancy Category
Category C
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FDA Approved
Jun 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Zegerid is a medication that contains two active ingredients: omeprazole and sodium bicarbonate. Omeprazole works by reducing the amount of acid your stomach makes, while sodium bicarbonate helps to quickly neutralize existing stomach acid and also protects the omeprazole so it can work effectively. It's used to treat conditions like heartburn, acid reflux (GERD), and ulcers.
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How to Use This Medicine

Taking Your Medication Correctly

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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: 40 mg omeprazole/1680 mg sodium bicarbonate orally once daily
Dose Range: 40 - 40 mg

Condition-Specific Dosing:

Erosive Esophagitis: 40 mg/1680 mg once daily for 4 to 8 weeks. Maintenance: 20 mg/840 mg once daily.
GERD (Symptomatic): 20 mg/840 mg once daily for up to 4 weeks.
Duodenal Ulcer (Active): 40 mg/1680 mg once daily for 4 weeks.
Gastric Ulcer (Active): 40 mg/1680 mg once daily for 4 to 8 weeks.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (safety and efficacy not established for this combination product)
Adolescent: Not established (safety and efficacy not established for this combination product)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary for omeprazole component. Use with caution due to sodium bicarbonate content in patients with significant renal impairment.
Moderate: No dosage adjustment necessary for omeprazole component. Use with caution due to sodium bicarbonate content in patients with significant renal impairment.
Severe: No dosage adjustment necessary for omeprazole component. Use with caution due to sodium bicarbonate content in patients with significant renal impairment; monitor electrolytes.
Dialysis: No dosage adjustment necessary for omeprazole component. Use with caution due to sodium bicarbonate content; monitor electrolytes and fluid status.

Hepatic Impairment:

Mild: No dosage adjustment necessary.
Moderate: Consider dosage reduction for omeprazole component (e.g., 20 mg/840 mg once daily) for patients with moderate to severe hepatic impairment.
Severe: Consider dosage reduction for omeprazole component (e.g., 20 mg/840 mg once daily) for patients with moderate to severe hepatic impairment.

Pharmacology

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Mechanism of Action

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 secretion. Sodium bicarbonate is an antacid that neutralizes existing gastric acid and also protects omeprazole from acid degradation in the stomach, allowing for rapid and consistent absorption.
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Pharmacokinetics

Absorption:

Bioavailability: Omeprazole bioavailability increases with repeated dosing (approx. 30-40% after single dose, up to 60% after repeated doses). Sodium bicarbonate component allows for rapid absorption of omeprazole.
Tmax: Omeprazole: Approximately 0.5 to 3.5 hours (with sodium bicarbonate, peak plasma concentrations are achieved within 30 minutes to 1 hour).
FoodEffect: Should be taken on an empty stomach, at least 1 hour before a meal. Food can delay absorption.

Distribution:

Vd: Omeprazole: Approximately 0.3 L/kg.
ProteinBinding: Omeprazole: Approximately 95-97%.
CnssPenetration: Limited

Elimination:

HalfLife: Omeprazole: Plasma half-life is approximately 0.5 to 1 hour (due to rapid metabolism), but the duration of acid suppression is much longer due to irreversible binding to the proton pump.
Clearance: Omeprazole: Approximately 500-600 mL/min.
ExcretionRoute: Renal (approximately 80%), Fecal (approximately 20%).
Unchanged: Very little (<0.1%)
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Pharmacodynamics

OnsetOfAction: Rapid, within 30 minutes (due to sodium bicarbonate).
PeakEffect: Acid suppression within 2 hours.
DurationOfAction: Up to 24 hours or more for acid suppression.

Safety & Warnings

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Side Effects

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 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.
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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)
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Before Using This Medicine

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 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.
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Precautions & Cautions

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 duration of treatment prescribed by your doctor.

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.
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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

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Contraindicated Interactions

  • Rilpivirine (decreased absorption of rilpivirine)
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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)
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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)
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Minor Interactions

  • Not typically categorized as minor for PPIs, but general caution with drugs requiring acidic environment for absorption.

Monitoring

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Baseline Monitoring

Electrolytes (Sodium, Bicarbonate)

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.

Renal Function (Creatinine, BUN)

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.

Liver Function Tests (LFTs)

Rationale: Omeprazole is metabolized hepatically; baseline assessment for patients with suspected hepatic impairment.

Timing: Prior to initiation in patients with suspected hepatic impairment.

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Routine Monitoring

Symptoms of GERD/Ulcer Healing

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.

Electrolytes (Sodium, Bicarbonate)

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.

Magnesium levels

Frequency: Periodically with long-term use (â‰Ĩ3 months), especially if on diuretics or other magnesium-lowering drugs

Target: Within normal limits

Action Threshold: Hypomagnesemia may require supplementation or discontinuation of PPI.

Vitamin B12 levels

Frequency: Consider with long-term use (e.g., >2-3 years)

Target: Within normal limits

Action Threshold: Deficiency may require supplementation.

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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

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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:

First Trimester: Limited human data, but animal studies with omeprazole have not shown teratogenicity. Sodium bicarbonate is generally considered safe in pregnancy for occasional use, but chronic high doses could lead to electrolyte imbalances.
Second Trimester: No specific risks identified beyond general pregnancy considerations.
Third Trimester: No specific risks identified beyond general pregnancy considerations. High sodium intake from sodium bicarbonate should be monitored, especially in preeclampsia or fluid retention.
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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).

Infant Risk: Low to moderate. Omeprazole levels in breast milk are low. Sodium bicarbonate is generally safe. Potential for minor gastrointestinal upset in the infant.
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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.

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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

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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.
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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
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Cost & Coverage

Average Cost: Varies widely, typically $100-$300 per 30 packets
Generic Available: Yes
Insurance Coverage: Often Tier 1 or 2 for generic omeprazole/sodium bicarbonate; Tier 3 or higher for brand Zegerid.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 refill your prescription. 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. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.