Omeprazole Bicarb 20-1680mg 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 gastric parietal cells, thereby blocking the final step in acid production. Sodium bicarbonate is an antacid that neutralizes gastric acid, which protects omeprazole from acid degradation and allows for rapid dissolution and 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 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, 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.
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, 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 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, 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 the 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 have only mild symptoms, 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 persist, contact your doctor for advice. 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. Describe the allergic reaction you experienced, including the 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
Note: This is not an exhaustive list of interacting medications.

To ensure safe treatment, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist will help you determine whether it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust 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 (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 a history of alcohol consumption, smoking, steroid use, or a family history of osteoporosis, use caution when taking this medication. Discuss your individual risk factors 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. Most cases of low magnesium levels have occurred after 1 year of treatment. Low magnesium levels can cause other electrolyte problems, and your doctor may recommend regular blood tests to monitor your levels.

In rare cases, this medication has been associated with severe pancreas, liver, and white blood cell problems, which can be life-threatening. If you have any 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 with your doctor.

If you are of Asian descent, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication with you.

• Nelfinavir
• Rilpivirine

• Clopidogrel (reduced antiplatelet effect)
• Methotrexate (increased methotrexate levels)
• Digoxin (increased digoxin levels)
• Tacrolimus (increased tacrolimus levels)
• Warfarin (increased INR)
• Atazanavir (reduced atazanavir absorption)
• Indinavir (reduced indinavir absorption)
• Erlotinib (reduced erlotinib absorption)
• Dasatinib (reduced dasatinib absorption)
• Nilotinib (reduced nilotinib absorption)
• Pazopanib (reduced pazopanib absorption)
• Mycophenolate Mofetil (reduced mycophenolic acid exposure)

• Iron salts (reduced absorption)
• Ketoconazole (reduced absorption)
• Itraconazole (reduced absorption)
• Posaconazole (reduced absorption)
• Cilostazol (increased cilostazol exposure)
• Diazepam (increased diazepam exposure)
• Phenytoin (increased phenytoin exposure)
• Voriconazole (increased omeprazole exposure)
• Rifampin (decreased omeprazole exposure)
• St. John's Wort (decreased omeprazole exposure)
• Drugs requiring acidic gastric pH for absorption (e.g., some tyrosine kinase inhibitors, certain antifungals)
• Drugs whose absorption is affected by increased urinary pH (due to sodium bicarbonate, e.g., salicylates, quinidine, amphetamines)

• Not typically categorized as minor for this combination, but general antacid interactions may apply (e.g., temporary pH alteration affecting absorption of some drugs if taken concurrently).

• Resolution of GERD/ulcer symptoms (heartburn, regurgitation, dyspepsia)
• Signs of adverse effects (headache, nausea, diarrhea, abdominal pain)
• Signs of electrolyte imbalance (muscle weakness, cramps, fatigue, confusion, irregular heartbeat)
• Signs of C. difficile infection (persistent diarrhea, fever, abdominal cramps)
• Any new or worsening symptoms that could indicate a serious underlying condition (e.g., dysphagia, odynophagia, unexplained weight loss, GI bleeding)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Omeprazole is Category B, but sodium bicarbonate is Category C. Limited human data on the combination.

L3 (Moderately Safe). Omeprazole is excreted in breast milk in small amounts. Sodium bicarbonate is generally considered safe in usual doses, but large doses could affect infant electrolytes. Weigh the developmental and health benefits of breastfeeding against the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.

Safety and efficacy of Omeprazole Bicarb 20-1680mg Pwdr Pk have not been established in pediatric patients. Omeprazole alone is used in children for certain conditions, but this specific combination product is generally not recommended for pediatric use.

No specific dosage adjustment is required based on age alone. However, elderly patients may be at increased risk for certain adverse effects associated with long-term PPI use (e.g., C. difficile infection, bone fractures, hypomagnesemia, vitamin B12 deficiency). Caution with the sodium bicarbonate component in elderly patients with renal impairment or cardiovascular disease due to the sodium load and potential for fluid retention or metabolic alkalosis.

• This combination product provides rapid onset of action due to the immediate release of omeprazole, protected by sodium bicarbonate, making it suitable for patients needing faster acid control than traditional delayed-release PPIs.
• Always take on an empty stomach, at least 1 hour before a meal, for optimal absorption and efficacy.
• Do not substitute with enteric-coated omeprazole products without consulting a healthcare professional, as the pharmacokinetic profiles are different.
• Long-term use (beyond 8 weeks) should be carefully evaluated due to potential risks such as C. difficile infection, bone fractures, hypomagnesemia, and vitamin B12 deficiency.
• The sodium bicarbonate component contributes a significant sodium load (1680 mg sodium bicarbonate contains approximately 460 mg sodium), which should be considered in patients on sodium-restricted diets, or those with hypertension, heart failure, or renal impairment.
• Ensure patients understand how to properly mix and administer the powder packet (e.g., mix with water, drink immediately, do not chew granules).

• Other Proton Pump Inhibitors (e.g., Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
• H2-receptor antagonists (e.g., Famotidine, Ranitidine [if available])
• 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 problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, do not hesitate to discuss them 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 detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.