Aciban

Description

Aciban Tablet (Pantoprazole Sodium Sesquihydrate)

Manufacturer: Cadila Pharmaceuticals Limited.Generic Name: Pantoprazole Sodium Sesquihydrate Availability: Nepal

Overview: Aciban Tablet, containing Pantoprazole Sodium Sesquihydrate, is a proton pump inhibitor (PPI) that effectively reduces stomach acid production. It achieves this by blocking the final step of acid secretion in the gastric parietal cells, thereby inhibiting both basal and stimulated acid output. It is used for various acid-related gastrointestinal conditions.

Indications for Use

Aciban Tablet is used for the treatment and management of:

• Peptic Ulcer Disease (PUD), including duodenal and gastric ulcers.
• H. pylori infection (as part of combination therapy).
• Gastro-Oesophageal Reflux Disease (GERD).
• Zollinger-Ellison Syndrome and other hypersecretory conditions.
• Oesophagitis (especially erosive oesophagitis).
• Acid-related Dyspepsia.
• NSAID-associated ulceration (both treatment and prevention).
• Ulcers resistant to H2 receptor antagonists.
• Gastrointestinal (GI) bleeding from stress (prophylaxis).
• Prophylaxis for acid aspiration syndrome during induction of anesthesia.

Dosage Information

Adults (Oral):

• Erosive Esophagitis Associated With GERD:
  • Treatment: 40 mg orally once daily for 8-16 weeks.
  • Maintenance of Healing: 40 mg orally once daily.
  • Alternatively, for initial treatment if oral therapy is inappropriate or not possible: 40 mg IV once daily for 7-10 days, then switch to oral once able to swallow.
• Zollinger-Ellison Syndrome:
  • Oral: Initially 40 mg orally once daily; doses up to 240 mg/day may be administered in some patients.
  • IV: 80 mg IV infusion every 8-12 hours for up to 7 days; switch to oral once able to swallow.
• Peptic Ulcer Disease:
  • Duodenal ulcer: 40 mg orally once daily for 2-4 weeks.
  • Gastric ulcer: 40 mg orally once daily for 4-8 weeks.

Elderly:

• No dosage adjustment is typically needed.

Hepatic Impairment:

• Maximum dose: 20 mg/day or 40 mg on alternate days.

Pediatric Dosage (Oral)

• Erosive Esophagitis Associated With GERD:
  • <5 years: Safety and efficacy have not been established.
  • >5 years:
    • 15 kg to <40 kg: 20 mg orally once daily for up to 8 weeks.
    • 40 kg or greater: 40 mg orally once daily for up to 8 weeks.

Renal Impairment

• No dosage adjustment is typically needed.

Administration

• Controlled-release tablets: Should be taken on an empty stomach, 1 hour before meals. Swallow whole; do not chew or crush.
• Normal release tablets: May be taken with or without food.

IV Preparation and Administration:

• GERD with a history of erosive esophagitis (15-minute infusion): Reconstitute with 10 mL Normal Saline (NS), then further dilute with 100 mL Dextrose 5% in Water (D5W), NS, or Lactated Ringer’s (LR) to a final concentration of 0.4 mg/mL. Infuse over 15 minutes, not exceeding 3 mg/min (7 mL/min).
• Zollinger-Ellison Syndrome:
  • 15-minute infusion: Reconstitute each vial with 10 mL NS. Combine 2 vials and further dilute with 80 mL D5W, NS, or LR to a total volume of 100 mL (concentration 0.8 mg/mL). Infuse over 15 minutes, not exceeding 6 mg/min (7 mL/min).
  • 2-minute injection: Reconstitute with 10 mL NS to a final concentration of 4 mg/mL.

Contraindications

Aciban Tablet is contraindicated with concomitant use of:

• Rilpivirine
• Atazanavir
• Nelfinavir
• It is also contraindicated during lactation.

Precautions

• Gastric malignancy should be ruled out before initiating treatment, as symptom improvement might mask an underlying serious condition.
• Consider zinc supplementation during intravenous therapy in patients prone to zinc deficiency.
• Pregnancy: Use with caution.
• Monitoring Parameters: Monitor magnesium levels prior to initiation of therapy and periodically during prolonged use.
• Lactation: It is not known whether pantoprazole is distributed into breast milk; therefore, it is generally not recommended during breastfeeding.

Interactions

• Increased risk of digoxin-induced cardiotoxic effects.
• Increased risk of hypomagnesaemia with concomitant use of diuretics.
• May increase INR and prothrombin time in patients on warfarin.
• May increase serum concentration of methotrexate and saquinavir.
• Delayed absorption and decreased bioavailability when taken with sucralfate; separate administration times.
• Decreased absorption of ketoconazole and itraconazole.
• Potentially Fatal: May significantly decrease serum levels and pharmacological effects of rilpivirine, atazanavir, and nelfinavir, leading to loss of antiviral efficacy.

Adverse Effects

Common (1-10%):

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

Frequency Not Defined (Serious/Rare):

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

Mechanism of Action

Pantoprazole is a substituted benzimidazole, classified as a proton pump inhibitor (PPI). Its mechanism of action involves irreversibly binding to and inhibiting the H+/K+ ATPase enzyme system (the proton pump) in the gastric parietal cells. By blocking this final step of acid secretion, pantoprazole effectively inhibits both basal (resting) and stimulated acid production in the stomach.

Important Note: This information regarding Aciban Tablet is sourced from the Farmaco Nepal drug index and is intended for general informational purposes only. It should not be used for self-diagnosis, medical advice, or treatment, and does not substitute for the professional judgment of a qualified healthcare provider. Always consult with a doctor or pharmacist for personalized medical advice regarding your condition and treatment.