Raciper

Description

Raciper IV Injection (Esomeprazole Sodium)

Raciper 40mg IV Injection, manufactured by Sun Pharmaceutical Industries Ltd., is available in Nepal. Its generic name is Esomeprazole Sodium Injection.

Indications

Raciper IV Injection is used for the treatment of:

• Heartburn
• Acid-Related Dyspepsia
• Peptic Ulcer Disease
• Zollinger-Ellison Syndrome
• Gastroesophageal Reflux Disease (GERD)
• Helicobacter pylori infection
• Erosive Esophagitis
• NSAID-associated ulceration

Note: Gouty arthritis is NOT an indication for Esomeprazole; this appears to be an error in the original text.

Dosage Information

Important: Doses should be adjusted based on individual patient needs and response. Convert to oral therapy as soon as possible.

Adult Dosing (Intravenous)

• Gastro-oesophageal Reflux Disease (GERD) & NSAID-Associated Ulceration:
  • 20 mg or 40 mg administered as an injection over at least 3 minutes, or as an infusion over 10-30 minutes, once daily.
  • Treatment duration should be less than 10 days.
• Gastric and Duodenal Ulcers:
  • Initial Dose: 80 mg as an infusion over 30 minutes.
  • Follow-up: Immediately followed by a continuous infusion of 8 mg/hour for 72 hours.
  • After 72 hours, convert to oral therapy with 40 mg once daily for 4 weeks.

Specific Populations

• Elderly: No dosage adjustment is typically needed.
• Hepatic Impairment (Severe – Child-Pugh class C): Do not exceed 20 mg/day.
• Renal Impairment: No dosage adjustment is typically needed.

Pediatric Dosing (for Short-term Treatment of GERD with Erosive Esophagitis when oral therapy isn’t feasible)

• <1 month: Safety and efficacy have not been established.
• 1 month to 1 year: 0.5 mg/kg IV once daily.
• >1 year (<55 kg): 10 mg IV once daily.
• >1 year (≥55 kg): 20 mg IV once daily.

Administration

Raciper IV Injection comes as a single-use vial containing 20 mg or 40 mg of esomeprazole.

Reconstitution:

• For IV Injection: Reconstitute each vial with 5 mL of normal saline. The reconstituted solution should be consumed within 12 hours.
• For IV Infusion: Reconstitute each vial with 5 mL of normal saline, lactated Ringer’s injection, or dextrose 5% injection. Then, further dilute the resultant solution to a final volume of 50 mL.

IV Administration Methods:

• IV Injection: Administer over no less than 3 minutes.
• Intermittent IV Infusion: Infuse over 10-30 minutes, regardless of the amount.
  • Flush the IV line with Normal Saline (NS), Lactated Ringer’s (LR), or Dextrose 5% in Water (D5W) prior to and after administration.
  • Do not administer with any other drugs.
• Continuous IV Infusion:
  • Administer the initial 80 mg IV dose over 30 minutes.
  • Then, follow with a continuous IV infusion of 8 mg/hour for a total treatment duration of 72 hours.

Contraindications

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

Precautions

Use Raciper IV Injection with caution in:

• Pediatric patients
• Pregnant or lactating individuals (see detailed note below)
• Patients with malignancy
• Patients with hepatic impairment. For those with severe liver impairment, a dose of 20 mg/day should not be exceeded.
• Patients with an increased risk of developing certain infections, such as community-acquired pneumonia.

Pregnancy and Lactation

• Lactation: It is unknown whether esomeprazole is distributed into breast milk. Therefore, it’s recommended to either discontinue the drug or discontinue nursing.
• Pregnancy: Use with caution.

Drug Interactions

• Increased Risk of Cardiotoxic Effects: With digoxin.
• Increased Risk of Hypomagnesemia: With diuretics.
• May Increase INR and Prothrombin Time: With warfarin.
• May Increase Serum Concentration: Of tacrolimus, saquinavir, methotrexate.
• May Interfere with Elimination: Of drugs metabolized by CYP2C19 (e.g., diazepam).
• May Decrease Bioavailability: Of ketoconazole, erlotinib, and iron salts.
• Potentially Fatal Interactions:
  • May decrease serum concentration and pharmacological effects of rilpivirine, atazanavir, and nelfinavir.
  • May decrease the antiplatelet effects of clopidogrel.

Adverse Effects

Common (>10%): Headache (2-11%).

Less Common (1-10%): Flatulence (10%), indigestion (6%), nausea (6%), abdominal pain (1-6%), diarrhea (2-4%), xerostomia (3-4%), dizziness (2-3%), constipation (2-3%), somnolence (1-2%), pruritus (1%).

Rare (<1%):

• Blood and lymphatic system disorders: Agranulocytosis, pancytopenia.
• Ocular: Blurred vision.
• GI disorders: Pancreatitis, stomatitis, microscopic colitis.
• Hepatobiliary disorders: Hepatic failure, hepatitis with or without jaundice.
• Allergic Reactions: Anaphylactic reaction/shock, GI candidiasis.
• Electrolyte Imbalance: Hypomagnesemia.
• Musculoskeletal disorders: Muscular weakness, myalgia, bone fracture.
• Nervous system disorders: Hepatic encephalopathy, taste disturbance.
• Psychiatric disorders: Aggression, agitation, depression, hallucination.
• Renal: Interstitial nephritis.
• Endocrine: Gynecomastia.
• Respiratory: Bronchospasm.
• Skin and subcutaneous tissue disorders: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal).

Mechanism of Action

Esomeprazole is a Proton Pump Inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the H+/K+ ATPase (proton pump) in the gastric parietal cells. It is the S-isomer of omeprazole.

Disclaimer: This information is for general knowledge and is not intended for diagnosis, medical advice, or treatment. It is not a substitute for professional medical judgment. Always consult with a healthcare professional for any medical concerns.