Omeprazole (Omephil 20) 20mg BP Capsule 100's

Product Description:

Omeprazole (Omephil 20) 20mg BP is a proton pump inhibitor (PPI) used to reduce the amount of stomach acid produced by the stomach lining. The active ingredient, Omeprazole, works by inhibiting the H+/K+ ATPase pump (also known as the proton pump), which is the final step in the production of gastric acid. By suppressing stomach acid secretion, Omeprazole helps to alleviate conditions associated with excessive stomach acid.

Each capsule of Omeprazole (Omephil 20) 20mg contains 20 mg of Omeprazole as the active ingredient and is available in 100 capsules per pack.

Indications:

Omeprazole (Omephil 20) is indicated for the treatment and management of a range of acid-related gastrointestinal disorders, including:

1. Gastroesophageal Reflux Disease (GERD):

   • Treatment of symptomatic GERD, where stomach acid frequently flows back into the esophagus, causing heartburn and potential damage to the esophagus lining.

2. Peptic Ulcer Disease:

   • Omeprazole is used to treat gastric ulcers and duodenal ulcers, reducing stomach acid to promote healing of the ulcers.

3. Helicobacter pylori Eradication:

   • In combination with appropriate antibiotics, Omeprazole helps in the eradication of Helicobacter pylori infections, a bacteria that causes ulcers.

4. Zollinger-Ellison Syndrome:

   • A rare condition in which tumors in the pancreas or duodenum lead to excess acid production. Omeprazole is used to control acid production in these patients.

5. Prevention of NSAID-Induced Ulcers:

   • Omeprazole is used for the prevention and treatment of ulcers induced by the prolonged use of NSAIDs (nonsteroidal anti-inflammatory drugs).

Dosage:

The recommended dosage of Omeprazole (Omephil 20) will depend on the specific condition being treated and the patient's response to therapy.

For Adults:

1. Gastroesophageal Reflux Disease (GERD):

   • Initial dose: 20 mg once daily for 4 to 8 weeks.

   • Maintenance dose: If symptoms persist after initial treatment, the dose may be reduced to 10 mg once daily or continued at 20 mg as needed.

2. Peptic Ulcer Disease:

   • 20 mg once daily for 4 to 6 weeks for duodenal ulcers.

   • 40 mg once daily for 4 to 8 weeks for gastric ulcers.

3. Helicobacter pylori Eradication:

   • In combination with antibiotics such as clarithromycin and amoxicillin, the typical dose is 20 mg twice daily for 10 to 14 days.

4. Zollinger-Ellison Syndrome:

   • The dose starts at 60 mg once daily, but this can be adjusted based on the patient's response. Doses up to 120 mg daily have been used in some cases, divided into two doses.

5. Prevention of NSAID-Induced Ulcers:

   • 20 mg once daily for prevention in patients taking NSAIDs for long-term use.

For Elderly and Renal Impairment:

• Omeprazole is generally well tolerated in elderly patients and those with mild to moderate renal impairment. However, dose adjustments may be necessary in cases of severe hepatic impairment (liver dysfunction).

Side Effects:

While Omeprazole (Omephil 20) is generally well tolerated, like any medication, it can cause side effects. These include:

Common Side Effects:

• Headache.

• Nausea or vomiting.

• Diarrhea or constipation.

• Abdominal pain or bloating.

• Flatulence (gas).

• Dizziness or drowsiness.

Serious Side Effects (requiring medical attention):

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

• Severe gastrointestinal symptoms: Persistent diarrhea, abdominal pain, or blood in the stool, which could indicate Clostridium difficile-associated diarrhea.

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

• Kidney problems: Symptoms of kidney damage include changes in urine output, painful urination, or swelling.

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

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

• Vitamin B12 deficiency: Prolonged use can interfere with the absorption of vitamin B12, leading to deficiency.

Other Potential Side Effects:

• Fatigue or weakness.

• Mental confusion or mood changes.

• Hair loss (rare).

Contraindications:

Omeprazole (Omephil 20) is contraindicated in the following situations:

1. Hypersensitivity:

   • Omeprazole should not be used in individuals who have a known allergy to Omeprazole, other PPIs, or any of the inactive ingredients in the formulation.

2. Severe Hepatic Impairment:

   • In patients with severe liver disease, Omeprazole should be used with caution, and the dose may need to be reduced.

3. Pregnancy:

   • Omeprazole is classified as Pregnancy Category C (FDA), meaning that it should be used during pregnancy only if clearly needed and prescribed by a healthcare provider, weighing the potential benefits against possible risks.

4. Breastfeeding:

   • Omeprazole passes into breast milk in small amounts. It is usually considered safe for breastfeeding mothers, but it should be used with caution and under medical supervision.

5. Children:

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

Precautions:

• Long-term Use: Prolonged use of Omeprazole (beyond 1 year) may increase the 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 impairment, as adjustments to dosage may be necessary.

• Clostridium Difficile Infection: Omeprazole can alter the gut flora and increase the risk of C. difficile infection, especially in hospitalized patients.

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

Drug Interactions:

Omeprazole may interact with several medications. Some key interactions include:

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

• Warfarin: Omeprazole may increase the effect of warfarin, a blood-thinning drug, which may increase the risk of bleeding.

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

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

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

Conclusion:

Omeprazole (Omephil 20) 20mg is a highly effective proton pump inhibitor (PPI) used to treat a variety of acid-related disorders, including GERD, peptic ulcers, Zollinger-Ellison syndrome, and for the prevention of NSAID-induced ulcers. While it is generally safe and well-tolerated, long-term use may lead to certain side effects, such as bone fractures, low magnesium, and B12 deficiency. It's essential to follow the prescribed dosage and consult a healthcare provider regularly, especially when using Omeprazole for extended periods.