Omeprazole (Ome Bop 40) 40mg Delayed Release Capsule 30's

Product Description:

Omeprazole (Ome Bop 40) 40mg Delayed Release Capsule is a medication that belongs to a class of drugs known as proton pump inhibitors (PPIs). The active ingredient, Omeprazole, works by inhibiting the proton pump in the stomach lining, which is responsible for secreting gastric acid. This leads to a decrease in stomach acid production, which helps treat acid-related gastrointestinal disorders. The delayed-release formulation allows the capsule to be absorbed in the small intestine rather than the stomach, reducing irritation and increasing effectiveness.

Each Omeprazole (Ome Bop 40) capsule contains 40 mg of Omeprazole and is available in a pack of 30 capsules.

Indications:

Omeprazole (Ome Bop 40) is indicated for the treatment of a variety of gastrointestinal disorders related to excessive stomach acid production, including:

1. Gastroesophageal Reflux Disease (GERD):

   • Used to treat and manage symptoms of GERD, where acid from the stomach frequently flows back into the esophagus, causing symptoms like heartburn and potential damage to the esophagus lining.

2. Peptic Ulcers:

   • Treats gastric ulcers and duodenal ulcers by reducing stomach acid, allowing ulcers to heal and preventing further damage.

3. Helicobacter pylori Eradication:

   • Used in combination with antibiotics to eradicate H. pylori infection, which is a major cause of peptic ulcers.

4. Zollinger-Ellison Syndrome:

   • A rare condition involving tumors in the pancreas or duodenum that cause excessive stomach acid production, which can be controlled with Omeprazole.

5. Prevention of NSAID-Induced Ulcers:

   • Prevents gastric ulcers in patients who require long-term use of NSAIDs (nonsteroidal anti-inflammatory drugs), which can irritate the stomach lining and cause ulcers.

Dosage:

The recommended dose of Omeprazole (Ome Bop 40) varies based on the condition being treated. The capsules should be taken oral and should not be crushed or chewed to maintain the delayed-release formulation.

For Adults:

1. Gastroesophageal Reflux Disease (GERD):

   • Initial dose: 40 mg once daily, taken in the morning before a meal, for 4 to 8 weeks.

   • Maintenance dose: Once symptoms are controlled, the dose may be reduced to 20 mg once daily.

2. Peptic Ulcer Disease:

   • Gastric Ulcers: 40 mg once daily for 4 to 8 weeks.

   • Duodenal Ulcers: 20 mg once daily for 4 to 6 weeks.

3. Helicobacter pylori Eradication:

   • Typically used in combination with antibiotics like clarithromycin and amoxicillin. The typical dose is 40 mg twice daily for 10 to 14 days.

4. Zollinger-Ellison Syndrome:

   • 60 mg once daily, which can be increased up to 120 mg daily as needed, depending on the patient's response. This should be divided into two doses.

5. Prevention of NSAID-Induced Ulcers:

   • 20 mg once daily for prevention of ulcers in patients who are at risk of developing them due to long-term NSAID use.

For Elderly and Patients with Renal or Hepatic Impairment:

• Omeprazole can be used in elderly patients and those with mild to moderate renal impairment without the need for dosage adjustments. However, caution is needed in patients with severe hepatic impairment, and the dose may need to be reduced.

Side Effects:

Common side effects associated with Omeprazole (Ome Bop 40) include:

Common Side Effects:

• Headache.

• Abdominal pain, bloating, or discomfort.

• Diarrhea or constipation.

• Nausea or vomiting.

• Flatulence (gas).

• Dizziness.

Serious Side Effects (less common, but require immediate medical attention):

• Severe allergic reactions: Symptoms like rash, itching, swelling of the face or throat, and difficulty breathing (anaphylaxis).

• Severe gastrointestinal problems: Persistent diarrhea, abdominal pain, or blood in the stool, which could indicate an infection like Clostridium difficile.

• Liver damage: Symptoms such as yellowing of the skin or eyes (jaundice), dark urine, or persistent abdominal pain.

• Low magnesium levels: Symptoms such as muscle cramps, seizures, dizziness, or irregular heartbeats (hypomagnesemia).

• Bone fractures: Long-term use has been associated with an increased risk of fractures, especially in older adults.

• Kidney problems: Changes in urine output, painful urination, or swelling.

Other Potential Side Effects:

• Fatigue or weakness.

• Mental confusion or mood changes.

• Hair loss (rare).

Contraindications:

Omeprazole (Ome Bop 40) is contraindicated in the following situations:

1. Hypersensitivity:

   • Should not be used in patients with known allergy to Omeprazole, other PPIs, or any of the excipients in the formulation.

2. Severe Hepatic Impairment:

   • Omeprazole should be used with caution in patients with severe liver disease, as the drug is primarily metabolized by the liver. In these patients, the dose may need to be reduced.

3. Pregnancy:

   • Omeprazole is classified as Pregnancy Category C (FDA), which means it should only be used during pregnancy if the potential benefits justify the risks to the fetus. Pregnant women should only take Omeprazole under the advice and supervision of a healthcare provider.

4. Breastfeeding:

   • Omeprazole is excreted into breast milk in small amounts. It should be used with caution in breastfeeding mothers, and the benefits should be weighed against any potential risks.

5. Children:

   • Omeprazole is generally not recommended for children under 1 year of age unless specifically prescribed by a doctor.

Precautions:

• Long-term Use: Prolonged use (especially beyond 1 year) can lead to an increased risk of bone fractures, low magnesium levels, and Clostridium difficile infections. Regular monitoring is recommended for patients requiring long-term therapy.

• Kidney and Liver Function: Caution should be used in patients with kidney disease or liver dysfunction, as adjustments to the dose may be necessary.

• B12 Absorption: Long-term use of Omeprazole can interfere with vitamin B12 absorption, leading to deficiency. Patients on prolonged therapy should be monitored for B12 levels.

• Gastrointestinal Infections: Omeprazole may increase the risk of gastrointestinal infections, especially Clostridium difficile in hospitalized patients.

Drug Interactions:

Omeprazole can interact with several medications, including:

• Clopidogrel: Omeprazole may reduce the effectiveness of clopidogrel, a drug used to prevent blood clots.

• Warfarin: Omeprazole may increase the effect of warfarin, increasing the risk of bleeding.

• Methotrexate: Concurrent use with methotrexate may increase the risk of methotrexate toxicity.

• Diazepam and Phenytoin: Omeprazole may increase the blood levels of diazepam and phenytoin, requiring careful monitoring.

• Antifungals and Antiretrovirals: Omeprazole may alter the absorption of certain antifungal medications (e.g., ketoconazole) and antiretrovirals, reducing their effectiveness.

Conclusion:

Omeprazole (Ome Bop 40) is a highly effective proton pump inhibitor (PPI) used to treat conditions caused by excess stomach acid, such as GERD, peptic ulcers, Helicobacter pylori infections, and Zollinger-Ellison syndrome. While it is generally well-tolerated, long-term use should be monitored for potential side effects, such as bone fractures and B12 deficiency. Always follow the prescribed dosage and consult your healthcare provider for any concerns.