Umepenta

Description

About Umepenta Injection

Umepenta Injection, manufactured by Umedica and available in Nepal, contains the active ingredient Pantoprazole Sodium Sesquihydrate. This medication is a proton pump inhibitor (PPI). It works by blocking the final step of acid production in the stomach’s parietal cells, effectively reducing both normal (basal) and stimulated acid secretion.

What is Umepenta Injection Used For?

Umepenta Injection is prescribed to manage conditions caused by excessive stomach acid, including:

• Peptic ulcer disease
• H. pylori infection
• Gastro-oesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome
• Oesophagitis (inflammation of the esophagus)
• Acid-related dyspepsia (indigestion)
• NSAID-associated ulceration (ulcers caused by non-steroidal anti-inflammatory drugs)
• Ulcers that are resistant to H2 receptor antagonists
• Gastrointestinal (GI) bleeding due to stress
• Prophylaxis for acid aspiration syndrome during the induction of anesthesia

Dosage Information

The appropriate dosage of Umepenta Injection varies depending on the condition being treated, as well as the patient’s age and overall health.

Adult Dosing

• Erosive Esophagitis Associated with GERD:
  • Treatment (Oral): 40 mg by mouth (PO) once daily for 8-16 weeks.
  • Maintenance of healing (Oral): 40 mg PO once daily.
  • Alternatively (IV): 40 mg intravenously (IV) once daily for 7-10 days.
• Short-term Treatment of GERD (when oral therapy is not appropriate or possible): 40 mg as an IV infusion over 15 minutes once daily for 7-10 days. Patients should switch to oral therapy once they are able to swallow.
• Zollinger-Ellison Syndrome:
  • Oral: 40 mg PO once daily; some patients may receive up to 240 mg/day.
  • IV: 80 mg as an IV infusion every 8-12 hours for up to 7 days. Patients should switch to oral therapy once they are able to swallow.
• Peptic Ulcer Disease:
  • Duodenal ulcer: 40 mg PO once daily for 2-4 weeks.
  • Gastric ulcer: 40 mg PO once daily for 4-8 weeks.
• Elderly Patients: No dosage adjustment is typically needed.
• Hepatic Impairment: The maximum dose is 20 mg/day or 40 mg on alternate days.

Child Dosing (for Erosive Esophagitis Associated with GERD)

• Under 5 years: The safety and efficacy of Umepenta have not been established in this age group.
• 5 years and older:
  • 15 kg to less than 40 kg: 20 mg PO once daily for up to 8 weeks.
  • 40 kg or greater: 40 mg PO once daily for up to 8 weeks.

Renal Impairment

• No dosage adjustment is needed for patients with renal impairment.

Administration Guidelines

• Oral Tablets (if applicable, though this is an injection):
  • Controlled-release: Take on an empty stomach, ideally 1 hour before meals. Swallow the tablet whole; do not chew or crush it.
  • Normal release: Can be taken with or without food.

IV Preparation

• For GERD with a history of erosive esophagitis (15-minute infusion): Reconstitute the vial with 10 mL of normal saline (NS). Then, further dilute this solution with 100 mL of D5W, NS, or Lactated Ringer’s (LR) solution to achieve a final concentration of 0.4 mg/mL.
• For Zollinger-Ellison syndrome:
  • 15-minute infusion: Reconstitute each vial with 10 mL of NS. Combine two vials and further dilute with 80 mL of D5W, NS, or LR to a total volume of 100 mL, resulting in a concentration of 0.8 mg/mL.
  • 2-minute injection: Reconstitute with 10 mL of NS to a final concentration of 4 mg/mL.

IV Administration

• Infuse over 15 minutes.
• The maximum infusion rate should not exceed 3 mg/minute (7 mL/minute) for GERD and 6 mg/minute (7 mL/minute) for conditions involving pathologic hypersecretion.

Important Considerations

Contraindications

Do not use Umepenta Injection if you are taking rilpivirine, atazanavir, or nelfinavir. It is also contraindicated during lactation.

Precautions

• Your doctor should rule out gastric malignancy before initiating treatment with Umepenta.
• Consider zinc supplementation during IV therapy for patients who are prone to zinc deficiency.
• Use with caution during pregnancy.
• Monitoring: Your doctor will likely monitor your magnesium levels before starting and periodically during prolonged use of Umepenta.

Interactions with Other Medications

Umepenta Injection can interact with various other medications, potentially altering their effects:

• Increased risk: Digoxin-induced cardiotoxic effects, hypomagnesaemia with diuretics, increased INR and prothrombin time with warfarin, and increased serum concentrations of methotrexate and saquinavir.
• Decreased absorption/bioavailability: Sucralfate can delay absorption and decrease bioavailability. It can also decrease the absorption of ketoconazole and itraconazole.
• Potentially Fatal: Umepenta may significantly decrease the serum levels and pharmacological effects of rilpivirine, atazanavir, and nelfinavir.

Possible Side Effects

Common side effects (1-10% of patients) include:

• Headache (>4%)
• Abdominal pain (4%)
• Diarrhea (4%)
• Constipation (<4%)
• Pruritus (itching) (4%)
• Rash (4%)
• Flatulence (<4%)
• Hyperglycemia (1%)
• Nausea (1%)
• Vomiting (>4%)
• Facial edema (<4%)
• Generalized edema (<2%)
• Chest pain (4%)
• Photosensitivity (<2%)

Serious but less frequent side effects (frequency not defined) include:

• Angioedema
• Atrophic gastritis
• Anterior ischemic optic neuropathy
• Hepatocellular damage, potentially leading to hepatic failure
• Interstitial nephritis
• Pancreatitis
• Pancytopenia
• Rhabdomyolysis
• Risk of anaphylaxis
• Stevens-Johnson syndrome
• Fatal toxic epidermal necrolysis
• Erythema multiforme

Important Note

This information about Umepenta Injection is for general knowledge and is not intended as medical advice, diagnosis, or treatment. It should not replace the professional judgment of a healthcare provider. Always consult with your doctor or pharmacist for any health concerns or before making decisions about your medication.