OZOLEX 20 Capsules (Hard Gelatin)

What is OZOLEX 20

OZOLEX 20 is a prescription medication that contains Omeprazole 20 mg as its active ingredient. It is supplied in the form of hard gelatin capsules, typically packaged in blister strips (14 capsules per pack: 7 capsules × 2 blisters).

Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). These are used to treat conditions involving excessive acid production in the stomach. OZOLEX 20 is primarily prescribed for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease (gastric and duodenal ulcers)
• Eradication of Helicobacter pylori (as part of combination therapy)
• Zollinger-Ellison syndrome and other hypersecretory conditions
• Prevention of NSAID-induced gastric ulcers

OZOLEX 20 is designed to reduce the amount of acid the stomach produces, thus relieving symptoms like heartburn, acid regurgitation, and epigastric pain, while promoting ulcer healing.

It is usually prescribed as a short-term treatment, but in certain chronic conditions, it may be used for longer durations under medical supervision.

How to use OZOLEX 20

OZOLEX 20 capsules should be taken exactly as prescribed by your healthcare provider. Proper administration ensures maximum effectiveness and minimizes side effects. Here’s how to use it:

• Dosage timing: Take OZOLEX 20 at least 30 to 60 minutes before a meal, preferably in the morning before breakfast.
• Swallow whole: Do not chew, crush, or open the capsule. It contains enteric-coated granules that are designed to release the medication in the intestine, not the stomach.
• With water: Swallow the capsule with a full glass of water for best results.
• Consistency matters: Take the medicine at the same time each day to maintain consistent acid suppression.

If you miss a dose:

• Take it as soon as you remember.
• If it’s close to your next dose, skip the missed one—do not double the dose.

Important considerations:

• Do not stop taking OZOLEX 20 abruptly without consulting your doctor, especially if you have been on it long term.
• If you’re taking it with antibiotics (e.g., for H. pylori), follow the complete course as directed.
• Let your doctor know if symptoms persist after 14 days or worsen during treatment.

Mode of Action OZOLEX 20

Omeprazole, the active component of OZOLEX 20, is a proton pump inhibitor (PPI) that works by blocking the final step of acid production in the stomach. Its effect is both potent and long-lasting, making it a preferred option for acid-related disorders.

• Target: Omeprazole selectively inhibits the H⁺/K⁺ ATPase enzyme, also known as the "proton pump," which is located on the surface of gastric parietal cells.
• Acid suppression: By blocking this enzyme, OZOLEX 20 effectively prevents the secretion of hydrogen ions into the stomach lumen, leading to reduced gastric acidity.
• Activation mechanism: Omeprazole is a prodrug that becomes active in the acidic environment of the stomach. Once absorbed, it accumulates in the acidic secretory canaliculi of parietal cells, where it is converted into its active form.
• Duration of action: Although it has a short half-life (1-2 hours), its inhibitory effect on acid production lasts up to 72 hours, allowing for once-daily dosing in most cases.

This acid suppression promotes:

• Healing of erosive esophagitis and peptic ulcers
• Relief from heartburn and reflux symptoms
• Improved eradication rates of H. pylori when combined with antibiotics

Omeprazole does not neutralize existing acid; it prevents new acid from being produced, which is why it’s typically taken before meals when acid secretion is about to begin.

OZOLEX 20 Interactions OZOLEX 20

OZOLEX 20 (Omeprazole) may interact with various medications, potentially altering their effectiveness or increasing the risk of side effects. It's crucial to inform your healthcare provider of all drugs you are currently taking.

• Clopidogrel:
  • Omeprazole can reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19, the enzyme needed to activate it. This may increase the risk of cardiovascular events.
• Antifungals:
  • Drugs like ketoconazole or itraconazole require an acidic stomach environment for absorption. OZOLEX may reduce their efficacy.
• Warfarin:
  • Omeprazole may increase the effect of warfarin, raising the risk of bleeding. Regular INR monitoring is advised.
• Digoxin:
  • Acid suppression may increase digoxin levels, especially in elderly patients or those with renal impairment.
• Diazepam:
  • Metabolism of diazepam may be slowed, resulting in prolonged sedation or dizziness.

Other considerations:

• Do not take OZOLEX with other PPIs or H2 receptor blockers unless directed by your doctor.
• Check with your doctor before using herbal supplements like St. John’s Wort, which may decrease Omeprazole levels.

Dosage of OZOLEX 20

Dosage of OZOLEX 20 should be individualized based on the condition being treated, the patient’s response, and other comorbidities. Below are typical dosage guidelines:

• GERD (Gastroesophageal Reflux Disease):
  • 20 mg once daily for 4 to 8 weeks.
  • For maintenance: 10–20 mg daily as needed.
• Peptic Ulcer (Gastric/Duodenal):
  • 20 mg once daily for 4–8 weeks depending on ulcer location and severity.
• H. pylori Eradication (Triple Therapy):
  • 20 mg twice daily for 7–14 days, along with amoxicillin and clarithromycin.
• Zollinger-Ellison Syndrome:
  • Initial dose of 60 mg daily; adjusted as needed up to 120 mg/day in divided doses.

Special populations:

• Renal impairment: No adjustment needed.
• Hepatic impairment: Use caution in severe cases; may need dose reduction.
• Elderly: Typically no adjustment, but monitor for side effects like dizziness or nutrient deficiencies.

Do not self-adjust dosage or discontinue without medical supervision, even if symptoms improve quickly.

Possible side effects of OZOLEX 20

OZOLEX 20 (Omeprazole) is generally well-tolerated, but like any medication, it may cause side effects. These are usually mild and temporary, but some may require medical attention.

• Common side effects (≥1 in 100):
  • Headache
  • Nausea
  • Abdominal pain
  • Constipation or diarrhea
  • Flatulence
• Less common:
  • Dizziness
  • Skin rashes or itching
  • Sleep disturbances
• Serious side effects (rare):
  • Clostridium difficile-associated diarrhea
  • Severe allergic reactions (anaphylaxis)
  • Liver function abnormalities (elevated enzymes, jaundice)
  • Vitamin B12 deficiency (with long-term use)
  • Bone fractures (hip, wrist, spine) with prolonged use, especially in elderly patients

Contact your doctor immediately if you experience: chest pain, persistent diarrhea, unexplained weight loss, dark urine, or signs of an allergic reaction (e.g., swelling of face or throat).

OZOLEX 20 Contraindications OZOLEX 20

OZOLEX 20 should not be used in certain situations due to the risk of serious complications. Key contraindications include:

• Known hypersensitivity: To Omeprazole or any other PPI (e.g., esomeprazole, lansoprazole), or to any excipients in the capsule.
• Concomitant use with nelfinavir: Omeprazole significantly reduces the effectiveness of this HIV drug.
• Unexplained weight loss, gastrointestinal bleeding, or persistent vomiting: Must be evaluated before starting treatment to rule out malignancy.
• Severe liver impairment: Use with caution; dose adjustment or alternative therapy may be needed.

Always consult your healthcare provider before starting OZOLEX, especially if you have existing liver disease, osteoporosis, or are taking multiple medications.

Storage of OZOLEX 20

Proper storage of OZOLEX 20 is essential to ensure the medication retains its effectiveness throughout its shelf life.

• Temperature: Store below 25°C (77°F).
• Moisture: Keep in the original blister packaging until use to protect from moisture.
• Light: Store in a dry, dark place away from direct sunlight.
• Keep out of reach of children: Accidental ingestion can be dangerous.

Disposal: Do not flush unused medication. Follow local guidelines for pharmaceutical waste or consult your pharmacist.