Omepral Capsule – Product Information and Patient Guide

Trade Name: Omepral Capsule

Generic Name: Omeprazole

---

Composition:

Each capsule contains:

• Omeprazole pellets equivalent to 20 mg Omeprazole.

Pellet Composition:

• Omeprazole, mannitol, hydroxyl propyl cellulose, microcrystalline cellulose, lactose anhydrous, sodium lauryl sulphate, disodium hydrogen phosphate dihydrate, hydroxy propyl methyl cellulose, cetyl alcohol.

---

Pharmaceutical Form:

Capsule

---

Properties:

Omeprazole belongs to a group of drugs known as proton pump inhibitors (medications that reduce the production of stomach acid). It inhibits both basal (normal) and stimulated stomach acid secretion and reduces pepsin (an enzyme that digests proteins). The effect lasts for at least 24 hours.

Omeprazole’s ability to lower acid secretion helps heal peptic ulcers (sores on the lining of the stomach or small intestine) and other gastrointestinal disorders by reducing the main cause of these issues—excess stomach acid.

---

Pharmacokinetics (How the Drug is Absorbed, Metabolized, and Excreted):

Omepral contains enteric-coated pellets (special coating that protects the drug from stomach acid, ensuring it is absorbed later in the digestive system), as omeprazole is acid-labile (easily destroyed by stomach acid). Absorption begins after the pellets leave the stomach, and peak levels in the blood occur within 0.5 to 3.5 hours after taking the medication on an empty stomach. Food can delay absorption.

Omeprazole is quickly metabolized in the liver, and most of the drug is eliminated in urine. Despite its short half-life (the time it takes for the concentration of the drug in the blood to reduce by half), which is 0.5 to 1 hour, the effects on stomach acid last much longer, making a single daily dose effective.

In patients with chronic liver disease (long-term liver problems), the drug’s half-life can increase to nearly 3 hours, and its bioavailability (the amount of drug that enters the bloodstream and has an active effect) increases to nearly 100%. In patients with chronic kidney disease (long-term kidney damage or failure), omeprazole’s elimination slows, increasing its concentration in the body.

---

Indications (What the Drug is Used For):

• Treatment of esophageal reflux disease (GERD): In cases of reflux esophagitis (inflammation of the esophagus caused by acid reflux), most patients are healed within 4 weeks, with rapid symptom relief.
• Treatment of duodenal and benign gastric ulcers: Includes those caused by NSAIDs (non-steroidal anti-inflammatory drugs such as ibuprofen).
• Eradication of Helicobacter pylori (H. pylori): Used in combination with antibiotics to treat peptic ulcer disease.
• Prophylaxis of acid aspiration: Prevents aspiration pneumonia (a lung infection that occurs after inhaling stomach contents).
• Zollinger-Ellison syndrome: A condition characterized by excessive stomach acid production.

---

Warnings and Precautions:

• Bone Fractures: Long-term or high-dose use of proton pump inhibitors (PPIs) may increase the risk of osteoporosis-related fractures (bone fractures due to weak bones) of the hip, wrist, or spine. Patients should use the lowest effective dose for the shortest time necessary.
• Gastrointestinal Infections: Reducing stomach acid with PPIs can slightly increase the risk of gastrointestinal infections such as Salmonella and Campylobacter (types of bacteria that can cause food poisoning).
• Hypomagnesemia: Long-term PPI use may lead to low serum magnesium levels (hypomagnesemia), which can cause muscle spasms, irregular heartbeat (arrhythmias), and seizures. Magnesium supplements may not correct this condition, and the PPI may need to be discontinued.

---

Side Effects:

Omepral is generally well-tolerated. Side effects are usually mild and reversible. They are categorized by how frequently they occur:

• Common (>1/100):
  • Central Nervous System: Headache
  • Gastrointestinal: Diarrhea, constipation, nausea, vomiting, abdominal pain, flatulence (excess gas)
• Uncommon (>1/1000, <1/100):
  • Central Nervous System: Dizziness, light-headedness, insomnia
  • Hepatic (Liver): Increased liver enzymes
  • Skin: Rash, dermatitis (skin inflammation), itching
• Rare (<1/1000):
  • Central Nervous System: Reversible mental confusion, agitation, depression, hallucinations (seeing or hearing things that aren’t there), predominantly in severely ill patients
  • Gastrointestinal: Dry mouth, stomatitis (inflammation of the mouth), gastrointestinal candidiasis (yeast infection in the digestive system)
  • Hematological (Blood): Leukopenia (low white blood cell count), thrombocytopenia (low platelet count)
  • Musculoskeletal: Muscle pain, arthritic symptoms
  • Skin: Severe reactions like Stevens-Johnson syndrome (a rare, serious disorder of the skin and mucous membranes) and toxic epidermal necrolysis (a life-threatening skin condition)

---

Key Recommendations:

• Patients at risk of osteoporosis should manage their condition according to standard treatment guidelines.
• Long-term PPI use should be monitored, especially for low magnesium levels.
• Consult a healthcare provider if experiencing persistent side effects or symptoms.

Always follow your doctor’s advice on dosage and duration of treatment to minimize potential risks and side effects.

Drug Interactions

Omeprazole may interact with certain medications, potentially affecting how well they work or increasing the risk of side effects. Be sure to inform your doctor if you are taking any of the following:

• Clopidogrel: Omeprazole may reduce the effectiveness of this antiplatelet drug, which is used to prevent blood clots.
• Warfarin: A blood thinner that may require close monitoring, as omeprazole can increase the risk of bleeding.
• Antifungals (e.g., Ketoconazole): Omeprazole may decrease the absorption of antifungal drugs.
• Digoxin: Used for heart conditions, omeprazole may increase digoxin levels, requiring dose adjustment.
• Diazepam: A sedative that may be metabolized more slowly when taken with omeprazole.

Always disclose all medications, including over-the-counter drugs, supplements, and herbal products, to your healthcare provider before starting omeprazole.

---

How to Use Omepral (Omeprazole)

• Dosage: Follow your doctor’s exact instructions on how much and how often to take omeprazole. The typical dosage for adults is 20 mg once daily, but this may vary based on your condition.
• Timing: Omeprazole works best when taken before a meal, preferably in the morning on an empty stomach. Avoid taking it with food, as this can slow its absorption.
• Duration: Omeprazole is usually prescribed for 4 to 8 weeks, depending on the condition being treated. However, in some cases, long-term treatment may be necessary.

Conclusion

Omepral (Omeprazole) is a highly effective proton pump inhibitor that provides relief from acid-related conditions such as GERD, peptic ulcers, and Zollinger-Ellison syndrome. While it is well-tolerated by most patients, it’s important to follow your doctor’s advice regarding dosage and duration of use. Always be mindful of potential side effects and interactions with other medications, and report any unusual symptoms to your healthcare provider promptly.

For the best results, take Omepral as directed, and discuss any concerns you may have with your doctor, especially if you have liver, kidney, or bone health issues.

Omepral is produced by Memphis Pharmaceutical Industries, an Egyptian company that distributes and exports its products to various countries in Africa and the Middle East.