Esomeprazole Sod 40mg Inj, 1 Vial

Esomeprazole is a proton pump inhibitor (PPI) that specifically inhibits the H+/K+-ATPase (proton pump) in the gastric parietal cells. By irreversibly binding to and inhibiting this enzyme, it blocks the final step in gastric acid secretion, leading to a profound and long-lasting reduction in gastric acid production.

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:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Change in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Change in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Bone pain
Significant weight loss
Irritation at the injection site

This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience any of the following symptoms, contact your doctor right away:
Stomach pain or cramps
Very loose or watery stools
Bloody stools
Do not attempt to treat diarrhea without consulting your doctor first.

In rare cases, this medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can affect internal organs and be life-threatening. Seek medical help immediately if you notice:
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
Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Headache
Stomach pain or diarrhea
Constipation
Gas
Dry mouth
Upset stomach

This is not an exhaustive list of possible side effects. If you have 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.

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 you experienced, including any symptoms that occurred.
If you are currently taking any of the following medications: Atazanavir, clopidogrel, methotrexate, nelfinavir, rifampin, rilpivirine, St. John's wort, or warfarin.
* If you have a history of certain health issues, including:
+ Black or bloody stools
+ Heartburn accompanied by lightheadedness, sweating, dizziness, or wheezing
+ Chest pain
+ Shoulder pain that is associated with shortness of breath
+ Pain that radiates to the arms, neck, or shoulders
+ Lightheadedness
+ Excessive sweating
+ Vomiting blood
+ Difficulty or pain when swallowing food

Please note that this is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as taking this drug for longer than recommended by your doctor may lead to adverse effects. Additionally, this medication may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and lab personnel that you are taking this drug.

People with osteoporosis (weak bones) may be at a higher risk of fractures in the hip, spine, and wrist when taking this medication. This risk may increase with higher doses, longer treatment durations (exceeding 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, seizure medication, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor.

Prolonged use of this medication (typically three months or longer, often after one year of treatment) may lead to rare cases of low magnesium levels, which can cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your condition. Furthermore, long-term treatment (usually exceeding three years) with this type of medication has been associated with rare cases of low vitamin B-12 levels. Be aware of the signs of low vitamin B-12 levels, including shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness and tingling in the arms and legs, and contact your doctor immediately if you experience any of these symptoms.

In rare instances, this medication has been linked to the development or exacerbation of lupus. If you have lupus, inform your doctor, and seek medical attention promptly if you notice any signs of lupus, such as a rash on your cheeks or other areas, changes in skin color, increased sensitivity to sunlight, muscle or joint pain, chest pain, shortness of breath, or swelling in the arms and legs.

Taking this medication for more than one year may increase the risk of developing stomach growths called fundic gland polyps. If you have concerns, discuss them with your doctor. Lastly, if you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to weigh the benefits and risks of this medication for both you and your baby.

• Nelfinavir
• Atazanavir

• Clopidogrel
• Methotrexate (high-dose)
• Rilpivirine
• Dasatinib
• Erlotinib
• Ketoconazole
• Itraconazole
• Posaconazole
• Iron salts (oral)

• Warfarin
• Tacrolimus
• Digoxin
• Citalopram
• Diazepam
• Phenytoin
• Cilostazol
• Saquinavir
• Voriconazole
• St. John's Wort
• Rifampin

• Not specifically listed as minor, but general caution with drugs requiring acidic gastric pH for absorption.

• Resolution of GERD symptoms (heartburn, regurgitation, dysphagia)
• Improvement in symptoms related to pathological hypersecretory conditions (e.g., abdominal pain, diarrhea)
• Signs of C. difficile-associated diarrhea (CDAD) (e.g., severe diarrhea, abdominal pain, fever)
• Signs of acute interstitial nephritis (AIN) (e.g., fever, rash, nausea, malaise, oliguria, elevated creatinine)
• Signs of systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE) (e.g., new or worsening joint pain, rash on sun-exposed areas)
• Signs of hypomagnesemia (e.g., fatigue, muscle cramps, tetany, convulsions, arrhythmias)

Esomeprazole is Pregnancy Category B. Animal studies have not shown harm to the fetus, and human data from observational studies are generally reassuring. Use during pregnancy should be considered if clearly needed and the benefits outweigh the potential risks.

Esomeprazole is excreted into human milk in small amounts. The risk to the infant is considered low (Lactation Risk L2). Monitor breastfed infants for potential adverse effects such as diarrhea or drowsiness. Use with caution.

Esomeprazole IV is approved for use in pediatric patients aged 1 month to 17 years for GERD. Dosing is weight-based for younger children. Safety and effectiveness have not been established in infants younger than 1 month of age. Long-term use in pediatric patients should be carefully considered due to potential risks like bone fractures and hypomagnesemia.

No overall differences in safety or effectiveness were observed between geriatric and younger patients. No dosage adjustment is necessary based solely on age. However, elderly patients may be more susceptible to certain adverse effects (e.g., bone fractures, C. difficile infection) and may have comorbidities or be on concomitant medications that require careful monitoring.

• Esomeprazole IV is typically used for short-term treatment (7-10 days) in patients who cannot take oral PPIs, followed by transition to oral therapy.
• For pathological hypersecretory conditions, IV therapy may be prolonged, and doses can be significantly higher than for GERD.
• Administer Esomeprazole IV as an infusion over 10-30 minutes, or as a bolus injection over at least 3 minutes, depending on the indication and dose.
• Reconstitute the vial with 5 mL of 0.9% Sodium Chloride Injection, USP. Further dilute for infusion.
• Long-term PPI use (especially >1 year) has been associated with increased risk of bone fractures, hypomagnesemia, C. difficile infection, and vitamin B12 deficiency. Periodically assess the need for continued therapy.
• PPIs can mask symptoms of gastric malignancy; consider diagnostic evaluation in patients with persistent symptoms despite therapy.

• H2-receptor antagonists (e.g., Famotidine, Ranitidine [if available], Cimetidine) for less severe acid suppression.
• Antacids for immediate symptom relief.
• Prokinetics (e.g., Metoclopramide) for motility issues (less common for primary acid suppression).

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 safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by throwing them away. However, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. If you are unsure about the best method for disposing of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.