Tezol tab 40mg #28

Tezole 40 mg Gastro-Resistant Tablets

Composition:

Each enteric-coated tablet contains:

• Active ingredient:44.50 mg of esomeprazole magnesium trihydrate, equivalent to 40 mg of esomeprazole.

• Excipients:Colloidal silicon dioxide, calcium carbonate, sodium croscarmellose, mannitol, anhydrous sodium carbonate, magnesium stearate, sodium lauryl sulfate, talc, microcrystalline cellulose, hypromellose, povidone.

• Coating materials:Diethyl phthalate, methacrylic acid copolymer, talc, titanium dioxide (E 171), erythrosine, titanium dioxide (E 171).

Indications:

Adults:
Gastroesophageal Reflux Disease (GERD):

• Treatment of erosive reflux esophagitis

• Long-term maintenance therapy to prevent relapse after healing of erosive reflux esophagitis

• Symptomatic treatment of GERD

Peptic Ulcer Disease (in combination with appropriate antibacterial therapy to eradicateHelicobacter pylori):

• Treatment ofH. pylori-associated duodenal ulcers

• Prevention of recurrence of peptic ulcers associated withH. pyloriinfection

Patients requiring long-term NSAID therapy:

• Healing of gastric ulcers associated with NSAID use

• Prevention of gastric and duodenal ulcers associated with NSAID use in at-risk patients

Zollinger-Ellison Syndrome

Dosage and Administration:

Adults:

Gastroesophageal Reflux Disease (GERD):

• Treatment of erosive reflux esophagitis: 20 mg twice daily for 4 weeks. An additional 4-week course is recommended if healing is not achieved or symptoms persist.

• Maintenance therapy after healing of erosive reflux esophagitis: 20 mg once daily.

• Symptomatic GERD treatment (without esophagitis): 20 mg once daily. If symptoms persist after 4 weeks, further investigation is recommended. Once symptoms are resolved, patients may switch to an on-demand regimen if appropriate. For patients at risk of ulcers due to NSAIDs, an on-demand regimen is not recommended.

Eradication ofHelicobacter pylori(in combination therapy):

• Duodenal ulcer healingandPrevention of recurrence of peptic ulcers:
  Tezole 20 mg + amoxicillin 1 g + clarithromycin 500 mg — all taken twice daily for 7 days.

Patients requiring long-term NSAID treatment:

• Healing of NSAID-associated gastric ulcers: 20 mg once daily for 4–8 weeks.

• Prevention of NSAID-associated ulcers in at-risk patients: 20 mg once daily.

Zollinger–Ellison Syndrome:

• Initial dose: 40 mg twice daily. The dose should be individualized, and treatment continued as needed.
  Doses of 80–160 mg/day may be required; daily doses >80 mg should be divided and administered twice daily.

Special Populations:

Pediatric patients (12 years and older):

GERD:

• Erosive reflux esophagitis: 40 mg once daily for 4 weeks. Extend for another 4 weeks if healing is not achieved.

• Long-term management post-healing: 20 mg once daily.

• Symptomatic treatment of GERD (without esophagitis): 20 mg once daily. If no control after 4 weeks, further investigation is required.

H. pylori eradication (with appropriate antibiotics):

• For body weight 30–40 kg:
  Tezole 20 mg + amoxicillin 750 mg + clarithromycin 7.5 mg/kg — all taken twice daily for 1 week.

• For body weight >40 kg:
  Tezole 20 mg + amoxicillin 1 g + clarithromycin 500 mg — all taken twice daily for 1 week.

Children under 12 years of age:
Tezole is not recommended; other formulations of esomeprazole may be more appropriate.

Patients with renal impairment:
No dose adjustment needed. Use with caution in severe renal impairment due to limited experience.

Patients with hepatic impairment:
No adjustment in mild to moderate cases. In severe hepatic impairment, the maximum dose should not exceed 20 mg per day.

Elderly patients:
No dose adjustment required.

Method of Administration:

• Tablets should be swallowed whole with water.

• Do not chew or crush the tablets.

• For patients who have difficulty swallowing: tablets can be dispersed in half a glass of still water. Stir until dispersed and drink the mixture immediately (within 30 minutes), including the granules. Rinse the glass with water and drink the remaining contents.

• Do not use other liquids as they may disrupt the enteric coating.

• For patients unable to swallow, the dispersed mixture may be administered via a gastric tube after compatibility checks with the syringe and tube.

Storage Conditions:

• Store below 25°C in the original packaging.

• Keep out of reach of children.