Omeprazole Bicarb 40-1680mg Pwdr Pk

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 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 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, changes in urine output, blood in the urine, or sudden weight gain.
High Blood Sugar: Confusion, drowsiness, 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.
Blood Pressure Changes: Severe headache or dizziness, fainting, or changes in vision.
Neurological Symptoms: Confusion, shakiness, dizziness or fainting, twitching, or abnormal sensations such as burning, numbness, or tingling.
Other Serious Symptoms: Bone pain, fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Swelling or Weight Gain: Sudden or severe swelling, or unexplained weight gain.

Additional Serious Side Effects:

C. diff-associated Diarrhea (CDAD): Stomach pain or cramps, watery or bloody stools. Do not attempt to 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, changes in skin color, 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), or other serious reactions, which can be life-threatening. Seek immediate medical attention 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:

Headache
Stomach pain or diarrhea
Gas
Upset stomach or vomiting

If these side effects or any others bother you or do not subside, consult your doctor. Not all side effects are listed here. If you have questions or concerns about side effects, contact your doctor or report them 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 potential gastrointestinal 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 inform your doctor about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.

To ensure safe use, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Do not initiate, discontinue, 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. 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 lab 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, 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 (at least 3 months) may lead to rare but potentially serious 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 1 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 it is essential to use it with caution and under close medical supervision. If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to discuss the potential benefits and risks of this medication to you and your baby.

• Rilpivirine (due to reduced absorption)
• Nelfinavir (due to reduced absorption)

• Clopidogrel (reduced antiplatelet effect)
• Methotrexate (increased methotrexate levels)
• Atazanavir (reduced atazanavir levels)
• Digoxin (increased digoxin levels)
• Tacrolimus (increased tacrolimus levels)
• Warfarin (increased INR/bleeding risk)
• Mycophenolate Mofetil (reduced mycophenolic acid exposure)

• Iron salts (reduced absorption)
• Ketoconazole, Itraconazole, Posaconazole (reduced absorption)
• Erlotinib (reduced absorption)
• Dasatinib, Nilotinib (reduced absorption)
• Citalopram (increased citalopram levels)
• Diazepam (increased diazepam levels)
• Phenytoin (increased phenytoin levels)
• Cilostazol (increased cilostazol levels)
• Saquinavir (reduced saquinavir levels)
• Diuretics (especially loop and thiazide diuretics, increased risk of hypomagnesemia and metabolic alkalosis with sodium bicarbonate)
• Corticosteroids (increased risk of metabolic alkalosis with sodium bicarbonate)

• Sucralfate (may reduce omeprazole absorption, administer at least 30 minutes apart)
• Theophylline (minor increase in theophylline levels)

• Resolution of GERD/ulcer symptoms (e.g., heartburn, regurgitation, dyspepsia)
• Signs of hypomagnesemia (e.g., muscle cramps, tremors, tetany, arrhythmias, seizures)
• Signs of metabolic alkalosis (e.g., confusion, muscle twitching, weakness, arrhythmias)
• Signs of fluid overload (e.g., edema, weight gain, shortness of breath) due to sodium content
• New or worsening gastrointestinal symptoms (e.g., severe diarrhea, abdominal pain)
• Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)

Omeprazole is generally considered low risk in pregnancy (Category B). Sodium bicarbonate is Category C due to potential for electrolyte imbalance and fluid retention. Use the combination only if clearly needed and the potential benefits outweigh the potential risks.

Omeprazole is excreted in breast milk in small amounts; generally considered compatible with breastfeeding (L2). Sodium bicarbonate is a natural component of breast milk and generally considered safe (L3), but large doses could theoretically alter milk pH or electrolyte balance. Use with caution, monitor infant for adverse effects.

Approved for GERD in children 1 year and older. Dosing is weight-based. Long-term use in children should be carefully considered due to potential risks (e.g., bone fractures, hypomagnesemia, C. difficile infection).

No overall differences in safety or effectiveness observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Due to the sodium bicarbonate component, elderly patients, especially those with renal impairment, heart failure, or on sodium-restricted diets, should be monitored closely for fluid overload and electrolyte imbalances (e.g., metabolic alkalosis). Lower doses may be considered for omeprazole in severe hepatic impairment.

• This formulation (powder packet with sodium bicarbonate) is designed to protect omeprazole from acid degradation, allowing for rapid absorption and onset of action. It is distinct from delayed-release omeprazole formulations.
• Always administer on an empty stomach, at least 1 hour before a meal, for optimal efficacy.
• The sodium bicarbonate content is significant (e.g., 1680 mg sodium bicarbonate contains approximately 460 mg sodium). This must be considered for patients on sodium-restricted diets, those with hypertension, heart failure, or renal impairment.
• Long-term use of PPIs (including omeprazole) has been associated with increased risks of bone fractures, C. difficile-associated diarrhea, hypomagnesemia, and vitamin B12 deficiency. Periodically reassess the need for continued therapy.
• Patients should be advised not to crush or chew the powder, but to mix it completely with water and drink immediately.

• Other Proton Pump Inhibitors (e.g., Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
• H2 Receptor Antagonists (e.g., Famotidine, Ranitidine [historical], Cimetidine)
• Antacids (e.g., Calcium Carbonate, Aluminum Hydroxide/Magnesium Hydroxide)
• Prokinetics (e.g., Metoclopramide, for specific motility disorders)
• Sucralfate (for ulcer treatment)

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, and do not take medication prescribed to someone else. This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is important to read this guide carefully and review it again whenever your prescription is refilled. 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.