Omeprazole (Flazomel) 20mg Proton Pump Inhibitor Capsule 100's

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Product Description:

Omeprazole (Flazomel) is a proton pump inhibitor (PPI), which works by reducing the amount of gastric acid produced in the stomach. It is commonly used to treat various conditions related to acid reflux, gastric ulcers, and gastroesophageal reflux disease (GERD). Omeprazole (Flazomel) is available as 20mg capsules and is usually packaged in a bottle containing 100 capsules.

Omeprazole is effective in inhibiting the proton pump, an enzyme responsible for producing stomach acid, thereby reducing acidity. This helps to heal damage to the stomach lining or esophagus caused by acid and prevents further irritation.

Indications:

Omeprazole (Flazomel) is indicated for the following conditions:

1. Gastroesophageal Reflux Disease (GERD): To treat GERD, a condition where stomach acid frequently backs up into the esophagus, causing symptoms such as heartburn, regurgitation, and irritation.

2. Peptic Ulcers: Treatment of gastric ulcers and duodenal ulcers; it helps heal the ulcer by reducing stomach acid production.

3. Helicobacter pylori Eradication (in combination therapy): Omeprazole is often used as part of a combination therapy with antibiotics to eradicate the H. pylori bacteria, which can cause gastric ulcers and lead to stomach cancer.

4. Zollinger-Ellison Syndrome: A rare condition where the stomach produces too much acid due to tumors in the pancreas or duodenum.

5. Prevention of Ulcers: To prevent ulcers in patients using non-steroidal anti-inflammatory drugs (NSAIDs) for long-term therapy.

6. Acid-Related Indigestion: To treat indigestion or heartburn due to excess stomach acid production.

Dosage:

The standard dosage for Omeprazole (Flazomel) 20mg capsules varies based on the condition being treated, but the typical dosing regimen is as follows:

1. Gastroesophageal Reflux Disease (GERD):

   • Adults: 20mg once daily for 4-8 weeks. If symptoms persist, treatment may be extended based on the healthcare provider's recommendation.

2. Peptic Ulcers (Gastric or Duodenal Ulcers):

   • Adults: 20mg once daily for 4-8 weeks to allow the ulcer to heal. A longer course may be prescribed in some cases.

3. Helicobacter pylori Eradication (as part of combination therapy):

   • Adults: Omeprazole is commonly used in combination with antibiotics such as clarithromycin and amoxicillin. The typical dose is 20mg twice daily for 10-14 days.

4. Zollinger-Ellison Syndrome:

   • Adults: Treatment is typically started at 60mg daily, divided into two doses. The dose can be adjusted based on the patient’s acid output, and higher doses may be required.

5. Prevention of NSAID-induced Ulcers:

   • Adults: 20mg to 40mg once daily, typically for the duration of NSAID therapy, as recommended by the healthcare provider.

6. Acid-Related Indigestion/Heartburn:

   • Adults: 20mg once daily for up to 4 weeks. Treatment can be adjusted depending on the severity and response.

Important Note: Omeprazole should be taken at least 30 minutes before meals, ideally in the morning. The capsules should be swallowed whole and not crushed or chewed.

Side Effects:

Common side effects of Omeprazole (Flazomel) can include:

• Headache

• Diarrhea

• Abdominal pain or discomfort

• Nausea or vomiting

• Flatulence (gas)

• Dizziness

• Constipation

Less common but more serious side effects include:

• Severe Allergic Reactions: Symptoms such as swelling of the face, lips, tongue, or throat, which can lead to difficulty breathing. If this occurs, immediate medical attention is required.

• Bone Fractures: Long-term use of PPIs like omeprazole has been associated with an increased risk of bone fractures, especially in older adults or those on high doses.

• Clostridium difficile Infection (C. difficile): Omeprazole may increase the risk of a C. difficile infection in the colon, leading to severe diarrhea.

• Kidney Issues: Long-term use can lead to kidney problems such as acute interstitial nephritis, which can cause kidney failure if untreated.

• Vitamin B12 Deficiency: Prolonged use may reduce the absorption of vitamin B12, leading to deficiency.

• Liver Function Abnormalities: Liver problems, including jaundice and liver inflammation, may occur in rare cases.

• Low Magnesium Levels: Long-term use of omeprazole may result in hypomagnesemia, which can cause muscle cramps, irregular heart rhythms, and seizures.

If you experience any of these more serious side effects, seek immediate medical attention.

Contraindications:

Omeprazole (Flazomel) is contraindicated in the following situations:

• Hypersensitivity to Omeprazole or any component of the formulation: If you have an allergy to omeprazole or any of the capsule’s ingredients, you should not take this medication.

• Severe Liver Impairment: Omeprazole should be avoided or used with caution in patients with severe liver disease, as metabolism of the drug could be impaired.

• Pregnancy: Omeprazole should only be used during pregnancy if absolutely necessary and prescribed by a healthcare provider. It is classified as Category C, meaning it can be harmful to the fetus in some cases.

• Breastfeeding: Omeprazole passes into breast milk. It should be used with caution in nursing mothers, and alternative treatments may be considered, especially for long-term use.

• Severe Renal Impairment: Caution should be exercised when using omeprazole in individuals with severe renal impairment, although no specific dose adjustment is generally required for mild to moderate renal impairment.

Precautions:

• Bone Health: Long-term use of omeprazole may lead to a risk of bone fractures due to reduced calcium absorption. Consider using calcium and vitamin D supplements if you require prolonged therapy.

• Infections: PPIs like omeprazole may increase the risk of infections such as Clostridium difficile-associated diarrhea. It is important to report persistent diarrhea to your healthcare provider.

• Kidney Monitoring: Long-term use may lead to kidney issues. Regular monitoring of kidney function is recommended in patients who need long-term therapy.

• Magnesium Levels: Prolonged use can lower magnesium levels, so magnesium supplementation might be required for patients on long-term omeprazole therapy.

• H. pylori: While omeprazole is often used in combination with antibiotics to eradicate H. pylori, it does not treat the infection alone. Complete eradication requires antibiotic therapy.

• Vitamin B12 Deficiency: Omeprazole can decrease the absorption of vitamin B12, especially with long-term use. Periodic blood tests for vitamin B12 levels may be needed if using omeprazole long-term.

Drug Interactions:

Omeprazole (Flazomel) can interact with various drugs, including:

• Clopidogrel: Omeprazole may reduce the effectiveness of clopidogrel, a blood thinner, by inhibiting its activation in the liver. Alternatives may be considered.

• Warfarin: Omeprazole may enhance the effects of warfarin, leading to an increased risk of bleeding. Regular monitoring of the international normalized ratio (INR) is recommended.

• Antifungal Medications (e.g., Ketoconazole, Itraconazole): Omeprazole can alter the absorption of certain antifungal medications that require an acidic environment for absorption.

• Methotrexate: High doses of methotrexate combined with omeprazole can increase the toxicity of methotrexate, requiring close monitoring.

• Diazepam: Omeprazole can increase the blood levels of diazepam (a benzodiazepine), leading to increased sedation or drowsiness.

• Digoxin: Omeprazole may increase blood levels of digoxin, which can increase the risk of digoxin toxicity.

Summary:

Omeprazole (Flazomel) 20mg is a proton pump inhibitor (PPI) used to treat acid-related conditions such as GERD, gastric ulcers, and Zollinger-Ellison syndrome. It works by reducing stomach acid production, helping heal damage caused by acid and reducing symptoms of heartburn and acid reflux.

The typical dosage for adults is 20mg once daily, although higher doses may be required for certain conditions or for prolonged therapy. Common side effects include headache, gastrointestinal discomfort, and diarrhea, while serious side effects like kidney problems and bone fractures can occur with long-term use.

Omeprazole is contraindicated in patients with hypersensitivity to the drug, severe liver disease, or those who are pregnant or breastfeeding without medical supervision. Special precautions should be taken for long-term use, especially in patients with kidney disease or those on multiple medications.

As with any medication, it is important to follow the prescribed dosage and consult your healthcare provider for proper guidance on use, especially for long-term therapy.