Gelcaps

G-ZOLECAP 20/40mg (Omeprazole)

G-ZOLECAP 20/40mg (Omeprazole)

Omeprazole

  • Description: Omeprazole is the active ingredient in both 20 mg and 40 mg capsule. It is a proton pump inhibitor that reduces stomach acid production by inhibiting the H+/K+ ATPase enzyme in the gastric lining.
  • Function: Provides relief from conditions caused by excessive stomach acid, such as GERD, peptic ulcers, and Zollinger-Ellison syndrome.

1. Product Description

  • Name: G-Omozol 20/40mg (Omeprazole)
  • Type: Proton Pump Inhibitor (PPI)
  • Form: Oral capsule
  • Strength: Available in 20 mg and 40 mg per capsule

2. Chemical Information

  • Chemical Name: Omeprazole
  • Molecular Formula: C17_{17}17​H19_{19}19​N3_{3}3​O3_{3}3​
  • Molecular Weight: Approximately 345.35 g/mol

3. Indications

  • Primary Uses:
    • Treatment of gastroesophageal reflux disease (GERD)
    • Healing of erosive esophagitis caused by gastroesophageal reflux disease (GERD)
    • Management of Zollinger-Ellison syndrome (a condition where the stomach produces excessive acid)
    • Treatment of peptic ulcers, including those caused by Helicobacter pylori infection, often in combination with antibiotics

4. Dosage and Administration

  • Dosage Forms:
    • Omeprazole 20 mg: Typically used for standard indications such as GERD and peptic ulcers.
    • Omeprazole 40 mg: Used for more severe conditions or where higher doses are needed, such as Zollinger-Ellison syndrome or severe GERD.
  • Typical Dosage Schedule:
    • 20 mg: Usually once daily before a meal. Can be taken up to twice daily for severe conditions.
    • 40 mg: Typically once daily, but can be taken up to twice daily as required.
  • Administration: Swallow capsules whole with a full glass of water. Do not crush, chew, or break the capsules.

5. Pharmacokinetics

  • Absorption: Omeprazole is well absorbed from the gastrointestinal tract. Peak plasma concentrations occur approximately 1 to 2 hours after oral administration.
  • Distribution: It is extensively bound to plasma proteins.
  • Metabolism: Metabolized primarily in the liver via the cytochrome P450 enzyme system (CYP2C19 and CYP3A4).
  • Excretion: Excreted mainly in the urine, with a smaller amount eliminated via bile.

6. Side Effects

  • Common Side Effects:
    • Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)
    • Headache
    • Dizziness
  • Serious Side Effects:
    • Risk of Clostridium difficile infection in the colon
    • Risk of bone fractures with long-term use
    • Kidney issues (e.g., acute interstitial nephritis)
    • Hypomagnesemia (low magnesium levels)

7. Contraindications

  • Known Allergies: Hypersensitivity to omeprazole or other PPIs.
  • Liver Disease: Severe hepatic impairment.
  • Drug Interactions: Caution with drugs that interact with CYP2C19, such as clopidogrel.

8. Precautions

  • Caution: Use with caution in patients with a history of liver disease, renal impairment, or those who are pregnant or breastfeeding.
  • Drug Interactions: May interact with drugs metabolized by CYP2C19 and CYP3A4. Inform your healthcare provider about all medications you are taking.
  • Monitoring: Regular monitoring of magnesium levels and bone density may be necessary during long-term therapy.

9. Storage

  • Conditions: Store at room temperature, away from moisture and heat.
  • Packaging: Typically found in blister packs or bottles with child-resistant caps.

10. Patient Counseling Information

  • Adherence: Take as prescribed and do not exceed the recommended dose.
  • Timing: Best taken before a meal, usually in the morning.
  • Report Symptoms: Notify your healthcare provider if you experience severe side effects or signs of an allergic reaction, such as rash, itching, or swelling.