Asector ®

Esomeprazole Sodium IV injection

 

Composition

Asector® 20 Capsule: Each capsule contains Esomeprazole Magnesium Trihydrate equivalent to 20 mg Esomeprazole INN as enteric coated granules.

Asector® 20 Tablet: Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate equivalent to 20 mg Esomeprazole INN .

Asector® 40 Tablet: Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate equivalent to 40 mg Esomeprazole INN .

 

Description

Esomeprazole is a proton pump inhibitor used to treat ulcers, Gastro-esophageal reflux disease (GERD), or Zollinger-Ellison syndrome. Esomeprazole is S-isomer of Omeprazole.

 

Mode of Action

Esomeprazole suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase in the gastric parietal cell. The S-isomers of Omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphonamide. By acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion.

 

Indication

1. Initial treatment for healing of reflux esophagitis.

2. Initial treatment of heartburn and other symptoms of GERD.

3. Daily treatment to prevent relapse of reflux esophagitis.

4. Long-term management of recurrent heartburn and other Symptoms of GERD with on demand treatment.

5. Healing of H. pylori associated duodenal ulcer.

6. H. pylori eradication for prevention of recurrence of H. pylori associated duodenal ulcer.

Dosage and Administration

Esomeprazole, Delayed-Release Capsules should be swallowed whole and taken at least one hour before meal. Recommended adult dosage schedule:

 

Indication

Dose

Frequency

Gastroesophageal Reflux Disease (GERD)

 Healing of Erosive  Esophagitis

20 mg or

40 mg

Once Daily for 4 to 8 Weeks*

Maintenance of Healing of Erosive Esophagitis

20 mg

Once Daily**

Symptomatic Gastro-esophageal Reflux Disease

20 mg

Once Daily for 4 Weeks***

Risk reduction of NSAIDs associated gastric ulcer

20 mg

Once daily for 4 weeks**

H. Pylori eradication to reduce the risk of the duodenal ulcer recurrence

Triple Therapy:

Esomeprazole

Amoxicillin

Clarithromycin

40 mg

1000 mg

500 mg

Once Daily for 10 Days

Twice Daily for 10 Days

Twice Daily for 10 Days

Paediatric use (12-17 years old) Short term treatment of GERD

20 mg or

40 mg

Once daily for up to 8 week

The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. **Controlled studies did not extend beyond six months. ***If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

 

Geriatric: No dosage adjustment is necessary.

Renal Insufficiency: No dosage adjustment is necessary.

Hepatic Insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment. For patients with severe liver impairment, a dose of 20 mg of Esomeprazole should not be exceeded.

Gender: No dosage adjustment is necessary.

Children: Safety and effectiveness in children have not been established.

 

Side Effect

More common side effects may include: Abdominal pain, diarrhea, headache, dermatitis ets.

Use in Pregnancy & Lactation 

The effects of Esomeprazole during pregnancy have not been adequately studied. Those who are pregnant or plan to become pregnant should consult with the doctor. Because Esomeprazole is likely to appear in breast milk and could harm a nursing infant, so need to choose between taking Esomeprazole or breastfeeding your baby.

 

Overdose

In case of overdose, seek medical attention immediately. Symptoms of overdose may include: Blurred vision, confusion, drowsiness, dry mouth, flushing, headache, nausea, rapid heartbeat and sweating etc.

 

Contraindication

Esomerpazole is contraindicated in patients with known hypersensitivity to Esomeprazole or to substituted Benzimidazoles.

 

Precaution

Before taking this medicine, tell your doctor if you have:

          a compromised immune system

          asthma

          COPD

This medicine may increase the risk of pneumonia in some patients.

 

Drug interaction 

Esomeprazole is taken with certain other drugs; the effects either could be increased, decreased, or altered. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeparzole may interfere with the absorption of drugs where gastric pH is the important determinant of bioavailability (e.g. Ketoconazole, Iron salts, and Digoxin). Co-administration of oral contraceptives, Diazepam, Phenytion, or Granidine does not seem to change the pharmacokinetic profile of Esomeprazole. Co-administration of Esomeparzole, Clarithromycin, and Amoxycillin has resulted in increase in the plasma levels of Esomeprazole and 14-hydroxclarithromycin.

 

Pharmaceutical Precaution

Store in a cool and dry place and keep away from light.

 

Availability

Asector® 20 capsule:  Each box contains 5 Alu-alu blister strips of 6 capsules each.

Asector® 20 tablet:  Each box contains 5 Alu-alu blister strips of 6 tablets each.

Asector® 40 capsule:  Each box contains 5 Alu-alu blister strips of 6 tablets each.