Raceper

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Brand Name: Raceper
Generic Name: Esomeprazole USP
Therapeutic Class: Anti-Ulcerant

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Additional information

STRENGTH

20mg, 40mg

Presentation

Raceper 20 Capsule: Each capsule contains 235.294 mg enteric coated pellets of Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.

Raceper 40 Capsule: Each capsule contains 470.588 mg enteric coated pellets of Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg.

Description

Esomeprazole (Raceper) is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+K+ ATPase in the gastric parietal cell. By acting specifically on the proton pump, Raceper blocks the final steps of acid production, thus reduction gastric acidity.

Indication

  • Treatment of Gastro esophageal reflux Disease (GERD)

        – Healing of Erosive Esophagitis

        -Maintenance of healing of Erosive Esophagitis

       -Symptomatic Gastro esophageal Reflux Disease

  • H.pylori Eradication to reduce the risk of duodenal Ulcer Recurrence
  • Zollinger-Ellison Syndrome
  • Acid Related Dyspepsia
  •  Duodenal and Gastric Ulcer

Dose And Administration

The recommended adult dosages are outlines in the table below. Raceper delayed release capsule should be swallowed whole and taken at least one hour before eating.

Recommender Adult Dosage Schedule of Raceper

Indication

Dose

Frequently

Gastro esophageal reflux   Disease (GERD)

Healing of Erosive Esophagitis

Maintenance of Erosive Esophagitis

Symptomatic Gastro esophageal Reflux Disease

 

20 mg or 40 mg

20 mg

20 mg

 

 Once Daily for 4 to 8 weeks

Once Daily

Once Daily for 4 weeks

H.pylori Eradication to reduce the risk of duodenal Ulcer Recurrence

 

40 mg

 Once Daily for 10 Days

 

 

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

Side Effects

a) Common: In general, Esomeprazole was well tolerated in both short and long term clinical trials. The most frequently occurring adverse events (>1%) are headache and diarrhea, nausea, flatulence, abdominal pain, constipation.

b) Rare: Side effects that may be seen very rarely include dry mouth occurred at similar rates among patients taking Esomeprazole

Warning & Precaution

Symptomatic response to therapy with Esomeprazole 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 Esomeprazole is an enantiomer.

Contraindication

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

Use in Pregnancy and Lactation

In pregnancy: Pregnancy category B. This drugs should be used during pregnancy only if clearly needed In lactation: The excretion of Esomeprazole in milk has not been studied. As Esomeprazole is likely to be excreted in human milk. A decision should be made whether to continue the drug, taking into account the importance of the drugs to the mother.

Packaging

Raceper 20 capsules: Each box contains Alu-Alu blister strips of 5 X10’s and 10X10’s capsules.

Raceper 40 capsules: Each box contains Alu-Alu blister strips of 8 X 4’s capsules

Drug Interaction

a) With Medicine: Drug interactions studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, Warfarin, Quinidine, Clarithromycin or Amoxicillin. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. Ketaconazole, Iron salts and Digoxin). Co administration of oral contraceptives, Diazepam, Phenytoin or Quinidine did not seem to change the pharmacokinetic profile of Esomeprazole.

b) With Food and others: Taking this drug with food can decrease the absorption of esomeprazole magnesium in body. This drug should take at least one hour before meals.

Overdose

There is very limited experience to data with deliberate overdose. Single doses of 80 mg Esomeprazole were uneventful. No specific antidote is known. Esomeprazole 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 utilized.

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