Asozit Capsule, Capsule (delayed Release)

Asozit is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell. It is the S-isomer of omeprazole.

Uses

Asozit is used for:

  • Treatment of Gastroesophageal Reflux Disease (GERD)
  • Healing of Erosive Esophagitis
  • Maintenance of Healing of Erosive Esophagitis
  • Symptomatic Gastroesophageal Reflux Disease
  • H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
  • Zollinger-Ellison Syndrome
  • Acid Related Dyspepsia
  • Duodenal and Gastric Ulcer

Asozit is also used to associated treatment for these conditions: Duodenal Ulcer, Erosive Esophagitis, Gastro-esophageal Reflux Disease (GERD), Heartburn, Helicobacter Pylori Infection, NSAID Associated Gastric Ulcers, Stress Ulcers, Upper Gastrointestinal Hemorrhage, Zollinger-Ellison Syndrome, Acute benign gastric ulcers, Maintenance of healing Erosive esophagitis, Postendoscopy Bleeding

Trade Name Asozit
Generic Esomeprazole
Other Names (S)-omeprazole, Esomeprazol, Ésoméprazole, Esomeprazole, Esomeprazolum, Perprazole
Weight 20mg, 40mg
Type Capsule, Capsule (delayed Release)
Formula C17H19N3O3S
Weight Average: 345.416
Monoisotopic: 345.114712179
Protein binding

Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 to 20 µmol/L.

Therapeutic Class Proton Pump Inhibitor
Manufacturer The White Horse Pharma
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:20 am

Dosage

Asozit dosage

Tablet:

Healing of erosive esophagitis: 20 mg or 40 mg once daily for 4 to 8 Weeks. For those patients who have not healed after 4-8 weeks of treatment, an additional 4-8 weeks course of Asozit may be considered. 

Long-term management of esophagitis: 20 mg once daily.

Symptomatic gastroesophageal reflux disease: 20 mg once daily for 4 weeks.

H. pylori eradication for treatment of duodenal ulcer

Triple therapy: 20 mg Asozit once daily with 500 mg Clarithromycin twice daily, and 1 g Amoxicillin twice daily for 7-10 days.

Injection:

The recommended adult dose in GERD with Erosive Esophagitis is either 20 or 40 mg Asozit given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 to 30 minutes). Pediatric dose (1 to 11 years old): 

  • Short term treatment of symptomatic GERD: 10 mg once daily for up to 8 weeks.

Healing of erosive esophagitis: 

  • Weight <20 kg: 10 mg once daily for up to 8 weeks.
  • Weight ≥20 kg: 10 mg or 20 mg once daily for up to 8 weeks.

Directions for reconstitution of solution: Solution for injection is prepared by adding 5 ml of 0.9% Sodium Chloride for intravenous injection into the vial containing the dry powder. The reconstituted solution for injection is clear and colorless to very slightly yellow.

Preparations for Use and Administration of Asozit 40 IV Injection: A solution for intravenous infusion is prepared by first reconstituting the contents of one vial with 5 ml of 0.9% Sodium Chloride and further diluting the resulting solution to a final volume of 50 ml. The resultant concentration after diluting to a final volume of 50 ml is 0.8 mg/ml. 

  • 20 mg dose: Withdraw 25 ml of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes.
  • 10 mg dose: Withdraw 12.5 ml of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes.

Side Effects

In general, esomeprazole is well tolerated in both short and long term use. Adverse events reported with esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth.

Precaution

Symptomatic response to therapy with Asozit does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which Asozit is an enantiomer.

Interaction

Drug interaction studies have shown that Esomeparzole does not have any clinically significant interactions with Phenytoin, Warfarin, Quinidine, Clarithromycin or Amoxicillin. Asozit inhibits gastric acid secretion. Therefore, Asozit may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, Ketoconazole, Iron salts and Dogoxin). Coadministration of oral contraceptives, Diazepam, Phenytoin or Quinidine did not seem to change the pharmacokinetic profile of Asozit.

Food Interaction

  • Take with or without food. Co-administration with food slightly alters pharmacokinetics, but not to a clinically significant extent.

Volume of Distribution

The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.

Half Life

1-1.5 hours

Pregnancy & Breastfeeding use

Pregnancy: There are no adequate and well-controlled studies on the use of Asozit in pregnant women. Therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk. Asozit should be used during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus.

Lactation: Asozit is excreted in human milk. Thus, a decision should be taken to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Contraindication

Asozit is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.

Special Warning

Geriatric: Dosage adjustment is not necessary.

Pediatric: Safety and effectiveness in pediatric patients have not been established.

Hepatic insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency a dose of 20 mg once daily should not be exceeded.

Renal insufficiency: Dosage adjustment is not necessary.

Acute Overdose

There is no experience to data with deliverate overdose. Data are limited but single doses of 80 mg Asozit were uneventful. Asozit is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.

Storage Condition

Store between 15-30°C. Protect from light.