Omeprazole Sodium (Africid) 40mg Luophilized Powder for IV Injection 1 Vial + 10ml Ampoules

Product Description:

Omeprazole Sodium (Africid) 40mg is a lyophilized powder for IV injection designed for the treatment of various gastrointestinal conditions. Omeprazole is a proton pump inhibitor (PPI) that works by reducing the amount of stomach acid produced. It is commonly used in patients who require rapid, effective management of acid-related disorders when oral administration is not possible or practical.

Each vial contains 40mg of Omeprazole Sodium, which is reconstituted with 10ml of sterile water to create a solution for intravenous injection. It is typically administered in a hospital or clinical setting under the supervision of a healthcare professional.

Indications:

Omeprazole Sodium (Africid) 40mg IV is used in the treatment of the following conditions:

1. Gastroesophageal Reflux Disease (GERD):

   • For the treatment of severe GERD and other conditions where reducing gastric acid is required.

2. Peptic Ulcer Disease:

   • To promote healing of peptic ulcers and prevent their recurrence, especially in cases complicated by Helicobacter pylori infection when used with antibiotics.

3. Zollinger-Ellison Syndrome:

   • A condition characterized by excessive stomach acid production, and Omeprazole helps reduce acid secretion.

4. Acid-related Gastric Bleeding:

   • Used in patients with upper gastrointestinal bleeding (e.g., ulcers) to reduce gastric acid secretion and promote healing.

5. Stress Ulcer Prophylaxis:

   • In critically ill patients to prevent stress-related mucosal damage in the stomach.

Dosage and Administration:

• Dosage:

  • For GERD, Peptic Ulcers, and Zollinger-Ellison Syndrome:

    • The recommended dose for adults is 40mg intravenously once daily, depending on the severity of the condition. In some cases, higher doses may be required.

  • For Stress Ulcer Prophylaxis:

    • The typical dosage is 40mg IV once daily.

  • Reconstitution:

    • The 40mg of Omeprazole Sodium powder should be reconstituted with 10ml of sterile water to make a solution.

    • The solution should be injected slowly over a 2-minute period.

  • Administration:

    • IV infusion is preferred in a hospital setting. Direct intravenous bolus administration may be used, especially for patients who require quick action for controlling acid secretion.

• Duration:

  • Treatment duration can vary based on the clinical indication, and the doctor will determine the exact length of time based on the patient’s response.

Side Effects:

While Omeprazole Sodium (Africid) is generally well-tolerated, it can cause side effects, especially when administered intravenously. Common and serious side effects include:

Common Side Effects:

1. Headache: One of the most commonly reported side effects.

2. Nausea and Vomiting: May occur, although less common.

3. Abdominal Pain: Discomfort in the stomach or abdominal area.

4. Diarrhea: A common gastrointestinal issue.

5. Flatulence: Bloating or gas.

6. Dizziness: Especially when standing up quickly, may cause lightheadedness.

Serious Side Effects:

1. Allergic Reactions: Symptoms such as swelling of the face, lips, throat, or tongue, which can cause difficulty breathing (anaphylaxis).

2. Severe Diarrhea: This could be due to Clostridium difficile infection associated with prolonged PPI use.

3. Kidney Problems: Symptoms like swelling of the feet or ankles, and changes in urination (acute kidney injury).

4. Liver Dysfunction: Symptoms like yellowing of the skin or eyes (jaundice), dark urine, or unexplained fatigue.

5. Low Magnesium Levels: Can lead to symptoms such as muscle cramps, seizures, or abnormal heart rhythms.

6. Bone Fractures: Prolonged use of PPIs has been associated with an increased risk of fractures, especially in the spine, wrist, or hip.

Contraindications:

Omeprazole Sodium (Africid) should not be used in the following situations:

1. Hypersensitivity to Omeprazole or other PPIs:

   • Contraindicated in patients who have a known allergy to Omeprazole, esomeprazole, or any other PPI.

2. Severe Liver Impairment:

   • In patients with severe hepatic impairment or liver failure, Omeprazole use should be avoided due to the risk of drug accumulation and toxicity.

3. Pregnancy:

   • Omeprazole should be used with caution during pregnancy, particularly in the first trimester, as there may be a potential risk to the fetus. It is recommended only if the benefit outweighs the risk, and it should be prescribed only when absolutely necessary.

4. Breastfeeding:

   • Omeprazole is excreted in breast milk, and caution should be exercised if the medication is given to nursing mothers. It should be used only if the benefit outweighs the potential risk to the infant.

5. Patients with Gastric Cancer:

   • If gastric cancer is suspected, Omeprazole should not be used as a test for the presence of malignancy, as it can mask symptoms or delay diagnosis.

Precautions:

1. Long-Term Use:

   • Long-term use of Omeprazole may increase the risk of bone fractures, kidney disease, low magnesium levels, and Clostridium difficile infection. It should be used at the lowest effective dose and for the shortest duration necessary.

2. Renal and Hepatic Impairment:

   • Patients with renal or hepatic impairment should be monitored closely. Dosage adjustments may be necessary for patients with moderate to severe hepatic dysfunction.

3. Magnesium Levels:

   • Regular monitoring of serum magnesium levels is advised, especially for long-term users of PPIs. Hypomagnesemia can cause serious complications, including muscle spasms, arrhythmias, or seizures.

4. Vitamin B12 Deficiency:

   • Long-term use of PPIs can interfere with vitamin B12 absorption, leading to deficiency. This may require supplementation over time.

5. Clostridium difficile Infection:

   • Omeprazole Sodium should be used cautiously in patients with a history of Clostridium difficile-associated diarrhea or other gastrointestinal infections, as PPIs have been associated with an increased risk of such infections.

Drug Interactions:

• Clopidogrel:

  • Omeprazole may reduce the effectiveness of clopidogrel (a blood thinner), leading to an increased risk of cardiovascular events. Other PPIs like esomeprazole should be avoided in patients on clopidogrel.

• Other Medications Metabolized by Cytochrome P450:

  • Omeprazole can inhibit CYP2C19, an enzyme that metabolizes certain drugs, which may affect the levels of warfarin, phenytoin, or diazepam.

• Drugs that increase gastric pH:

  • The absorption of azole antifungals (e.g., ketoconazole, itraconazole) and iron supplements may be reduced due to the reduced stomach acid.

• Antacids:

  • Concurrent use of antacids with Omeprazole may interfere with its effectiveness.

Summary:

Omeprazole Sodium (Africid) 40mg is a lyophilized powder for IV injection used in the management of various acid-related gastrointestinal disorders. It works by inhibiting the proton pump in the stomach, reducing the production of gastric acid. This medication is especially useful in critically ill patients or those who cannot take oral medications.

The typical dose is 40mg intravenously once daily, and it is reconstituted with 10ml of sterile water before administration. It is essential to be cautious with its long-term use due to the potential for side effects such as hypomagnesemia, bone fractures, and gastrointestinal infections.

Contraindications include severe liver disease, pregnancy, and hypersensitivity to omeprazole. It should be used with caution in patients with renal impairment, and monitoring is required for serum magnesium levels in long-term use.