Esolok 20 mg

Description

Indications

Esolok 20 mg Tablet is recommended for the following conditions:

• Relief from chronic heartburn and symptoms associated with GERD (Gastroesophageal Reflux Disease).
• Healing and maintenance of erosive esophagitis.
• In combination with amoxicillin and clarithromycin for the eradication of Helicobacter pylori infection in patients suffering from duodenal ulcers.
• Zollinger-Ellison syndrome management.
• Acid-related dyspepsia.
• Treatment for duodenal and gastric ulcers.

Take this medication as prescribed by a registered physician.

Pharmacology

Esomeprazole, the active ingredient in Esolok, is a proton pump inhibitor (PPI). It works by specifically inhibiting the H+/K+-ATPase in the gastric parietal cells, thereby reducing gastric acid secretion. As the S-isomer of omeprazole, esomeprazole provides superior acid control compared to racemic proton pump inhibitors.

Absorption:
Esomeprazole capsules are formulated with enteric-coated pellets. After oral administration, peak plasma levels are achieved approximately 1.5 hours post-dose. Plasma concentration increases proportionally with dose. Notably, there is a significant rise in the area under the plasma concentration-time curve (AUC) when the dose is increased.

Dosage

Oral Dosage:

• Healing of Erosive Esophagitis:
  20 mg or 40 mg once daily for 4-8 weeks. Most patients heal within this period, but additional treatment may be considered for those who do not respond within 4-8 weeks.

• Maintenance of Erosive Esophagitis Healing:
  20 mg once daily. (Note: Clinical studies did not extend beyond 6 months).

• Symptomatic GERD:
  20 mg once daily for 4 weeks. If symptoms persist, an additional 4 weeks may be considered.

• Helicobacter Pylori Eradication (Triple Therapy for Duodenal Ulcer):
  Esomeprazole 40 mg once daily, Amoxicillin 1000 mg twice daily, Clarithromycin 500 mg twice daily, all for 10 days.

• Zollinger-Ellison Syndrome:
  20-80 mg once daily, adjusted as necessary based on individual response. Treatment should continue as long as clinically indicated.

• Acid-related Dyspepsia:
  20-40 mg once daily for 2-4 weeks, depending on response.

• Duodenal Ulcer:
  20 mg once daily for 2-4 weeks.

• Gastric Ulcer:
  20-40 mg once daily for 4-8 weeks.

IV Injection/Infusion Dosage:

• GERD with Erosive Esophagitis:
  Adult patients: 20 mg or 40 mg once daily (IV injection over 3 minutes, or IV infusion over 10-30 minutes).
  Pediatric patients (1 year to 17 years):

  • Body weight < 55 kg: 10 mg once daily
  • Body weight ≥ 55 kg: 20 mg once daily
  • 1 month to < 1 year: 0.5 mg/kg once daily
    (IV infusion duration 10-30 minutes).

• Risk Reduction of Rebleeding in Gastric or Duodenal Ulcers (following therapeutic endoscopy):
  Adult patients: 80 mg via IV infusion for 30 minutes, followed by continuous infusion of 8 mg/h for a total duration of 72 hours.

Follow the guidance of a registered physician for dosage.

Administration

• Tablets/Capsules:
  Swallow whole, at least one hour before meals.

• Oral Suspension:
  Dissolve the entire packet in 15 ml of water. Stir for 2-3 minutes to thicken, then drink within 30 minutes. If any suspension remains, add more water, stir, and consume immediately. For nasogastric or gastric tube administration, use a 15 ml syringe, shake well, and allow 2-3 minutes for thickening.

• IV Injection:
  Reconstitute the powder with 5 ml of 0.9% Sodium Chloride and administer intravenously. IV injection should last at least 3 minutes. The solution is stable for 12 hours at room temperature, away from direct light.

Interaction

Esolok is metabolized primarily in the liver by CYP2C19 and CYP3A4. It does not significantly interact with enzymes CYP1A2, 2A6, 2C9, 2D6, 2E1, or 3A4. Esolok has no major interactions with medications like phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin.

However, co-administration of Esolok with diazepam may reduce diazepam clearance by 45%. This could lead to increased plasma levels of diazepam. Esolok can also affect the absorption of drugs dependent on gastric pH, such as ketoconazole, iron salts, and digoxin.

In combination therapy with clarithromycin and amoxicillin, the plasma levels of Esolok and 14-hydroxyclarithromycin may be elevated.

Please follow the guidance of your healthcare provider when using this medication.

Contraindications

Esolok is contraindicated for individuals with known hypersensitivity to any of its ingredients.

Side Effects

Common side effects of Esolok include headache, diarrhea, nausea, abdominal pain, flatulence, constipation, and dry mouth. No significant differences in side effects are observed between short-term and long-term (up to 12 months) usage.

Pregnancy and Lactation

There are no well-controlled studies in pregnant women. While animal studies have shown no teratogenic effects, Esolok should be used during pregnancy only if absolutely necessary. It is not known whether esomeprazole is excreted in breast milk, so breastfeeding should be discontinued if Esolok is considered essential.

Precautions and Warnings

• General: Esolok’s symptomatic relief does not rule out the presence of gastric malignancy.

• Patient Information:
  Esolok capsules should be taken one hour before meals. If swallowing capsules is difficult, open the capsule and mix the pellets with applesauce (not hot) and swallow immediately.

Use in Special Populations

• Pediatric Use: The safety and efficacy of Esolok in children have not been established.

• Geriatric Use: No significant differences have been observed in safety and efficacy in elderly patients, but greater sensitivity cannot be ruled out.

• Hepatic Insufficiency:
  No dosage adjustment is required for mild to moderate hepatic insufficiency. In severe cases, the dose should not exceed 20 mg once daily.

• Renal Insufficiency:
  Esolok’s pharmacokinetics are unaffected in patients with renal impairment, as less than 1% is excreted unchanged in the urine.

Overdose Effects

A single oral dose of 510 mg/kg (about 103 times the human dose) has been lethal in rats, showing signs of toxicity like reduced motor activity, tremor, ataxia, and clonic convulsions. There is no known antidote. In case of overdose, symptomatic and supportive treatment should be provided.

Storage Conditions

Store at temperatures not exceeding 30°C, away from light and moisture. Keep out of reach of children.

Chemical Structure

• Molecular Formula: C17H19N3O3S
• Chemical Structure: As shown in the diagram below.

Frequently Asked Questions (FAQs)

• What is Esolok 20 mg Tablet?
  Esolok 20 mg Tablet is a proton pump inhibitor (PPI) that reduces stomach acid production. It is used to treat GERD, ulcers, and other acid-related conditions.

• How long does it take for Esolok 20 mg tablets to work?
  Esolok starts to work within a few hours of ingestion.

• Can I take Esolok 20 mg Tablet if I am pregnant or breastfeeding?
  Consult your doctor if you are pregnant or breastfeeding to evaluate the risks and benefits.

• What are the side effects of Esolok 20 mg tablets?
  Common side effects include headache, diarrhea, nausea, stomach pain, and dry mouth.

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