Omeprazole Sodium (Omefree) 40mg Lyophilized Powder for IV Injection 1 Vial + 10ml Ampoule

Here is a detailed description of Omeprazole Sodium (Omefree) 40mg Lyophilized Powder for IV Injection (1 Vial + 10ml Ampoule):

Product Description:

Omeprazole Sodium (Omefree) 40mg is a lyophilized powder for intravenous (IV) injection. Each pack contains a 40mg vial of omeprazole sodium along with a 10ml ampoule of solvent (usually sodium chloride or water for injection), which is required to reconstitute the powder before use. Omeprazole is a proton pump inhibitor (PPI) that works by blocking the production of stomach acid. It is widely used in the treatment of gastric conditions associated with excessive acid secretion, such as peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome.

Omeprazole is known for its ability to reduce gastric acid secretion, thus helping to alleviate symptoms and promote healing in the stomach and esophagus.

Indications:

Omeprazole Sodium (Omefree) is primarily used for:

1. Gastroesophageal Reflux Disease (GERD):

   • Treatment of GERD, especially in cases where symptoms are severe, such as esophagitis or when oral therapy is not effective or possible.

2. Peptic Ulcers:

   • Treatment of gastric and duodenal ulcers, and for healing and maintenance therapy to prevent recurrence of ulcers, especially when caused by Helicobacter pylori infection (often used in combination with antibiotics).

3. Zollinger-Ellison Syndrome:

   • Treatment of Zollinger-Ellison syndrome, a condition where the stomach produces excessive acid due to tumors in the pancreas or duodenum.

4. Stress Ulcer Prophylaxis:

   • Preventing the formation of stress ulcers in critically ill patients, particularly in intensive care units (ICU).

5. Prevention of NSAID-Induced Gastric Ulcers:

   • Used in patients who require nonsteroidal anti-inflammatory drugs (NSAIDs) and are at risk of gastric ulcer formation.

Dosage and Administration:

Omeprazole Sodium (Omefree) should be administered intravenously after reconstitution with the provided solvent. The dosage and administration route will depend on the patient's condition, severity, and other clinical factors. Below are general guidelines:

For GERD (Esophagitis):

• Adults:

  • 40 mg IV once daily for 1–2 weeks for erosive esophagitis or for severe GERD.

For Peptic Ulcers:

• Adults:

  • 40 mg IV once daily for 4–8 weeks for gastric ulcers or duodenal ulcers. Longer duration may be required in some cases.

For Zollinger-Ellison Syndrome:

• Adults:

  • The dose is usually 60 mg IV once daily, which may be adjusted based on the clinical response. The dose can be increased to up to 120 mg/day or more, depending on the severity of the condition.

For Stress Ulcer Prophylaxis in ICU:

• Adults:

  • 40 mg IV once daily to prevent the formation of stress ulcers in critically ill patients.

Administration:

• Reconstitution: The 40mg vial of Omeprazole Sodium is mixed with the 10ml ampoule of diluent (usually sodium chloride 0.9% or water for injection). After mixing, the solution should be injected slowly over 2 minutes via IV injection.

• It is not recommended for rapid infusion or bolus injection.

Side Effects:

Like any medication, Omeprazole Sodium (Omefree) may cause side effects. While most side effects are rare and mild, some can be serious. Common and serious side effects include:

Common Side Effects:

• Headache

• Diarrhea

• Abdominal pain

• Nausea and vomiting

• Flatulence (gas)

• Dizziness

Serious Side Effects (Require Medical Attention):

• Severe allergic reactions (e.g., rash, itching, swelling, difficulty breathing)

• Severe gastrointestinal issues, including clostridium difficile-associated diarrhea (an overgrowth of harmful bacteria in the colon)

• Kidney problems, such as acute interstitial nephritis or kidney failure

• Severe skin reactions, including blistering or peeling (such as Stevens-Johnson syndrome)

• Low magnesium levels, leading to symptoms like muscle cramps, tremors, and heart arrhythmias

• Bone fractures (long-term use may increase the risk of fractures)

• Liver damage (elevated liver enzymes)

Contraindications:

Omeprazole Sodium (Omefree) should not be used in certain situations, and caution is advised in others. Contraindications include:

1. Hypersensitivity:

   • Hypersensitivity or allergic reactions to omeprazole or any other components of the formulation. This includes any known allergy to proton pump inhibitors (PPIs).

2. Severe Liver Impairment:

   • Omeprazole should be used with caution or avoided in patients with severe liver disease or those with a history of liver cirrhosis, as liver metabolism of the drug may be impaired.

3. Pregnancy:

   • Category C for pregnancy. Omeprazole should only be used during pregnancy if the potential benefit justifies the risk to the fetus. It should not be used unless prescribed by a healthcare professional.

4. Breastfeeding:

   • Caution should be exercised when using Omeprazole Sodium (Omefree) while breastfeeding, as it may pass into breast milk. The decision should be based on a risk-benefit assessment.

5. Severe Hypomagnesemia:

   • Omeprazole can cause or worsen hypomagnesemia (low magnesium levels), which can lead to muscle spasms, arrhythmias, and seizures. It should be avoided in individuals with severe magnesium deficiency.

6. Drug Interactions:

   • Omeprazole Sodium (Omefree) may interact with other medications such as clopidogrel (a blood thinner), warfarin, ketoconazole, and digoxin. Patients taking these or other medications should inform their healthcare provider.

Precautions:

• Renal Impairment: Caution is recommended in patients with renal dysfunction, as dosing may need adjustment.

• Long-term Use: Prolonged use of Omeprazole may result in B12 deficiency, so periodic monitoring of vitamin levels is recommended for long-term therapy.

• Bone Fracture Risk: Long-term use of PPIs may increase the risk of bone fractures, particularly in older patients and those with other risk factors for bone loss.

Summary:

Omeprazole Sodium (Omefree) 40mg lyophilized powder is used as an intravenous (IV) treatment for gastric acid-related disorders such as GERD, peptic ulcers, and Zollinger-Ellison syndrome. It is also used for stress ulcer prophylaxis in critically ill patients. Omeprazole works by inhibiting the proton pump in the stomach, thus reducing acid production.

• Indications: GERD, peptic ulcers, Zollinger-Ellison syndrome, stress ulcer prophylaxis.

• Dosage: 40mg IV once daily for GERD or ulcers, up to 60mg for Zollinger-Ellison syndrome.

• Side Effects: Headache, diarrhea, abdominal pain, dizziness, and more serious reactions such as severe allergic reactions or kidney problems.

• Contraindications: Hypersensitivity, severe liver impairment, and certain drug interactions.

For safe and effective use, Omeprazole Sodium (Omefree) should be administered under medical supervision, particularly for intravenous formulations. Always follow the prescribing healthcare provider's instructions regarding dosage and administration.