AUP

Pantoprazole Sodium Sesquihydrate is a proton pump inhibitor (PPI) used for the short-term and long-term management of acid-related gastrointestinal disorders. It acts by suppressing gastric acid secretion through specific inhibition of the proton pumps (H⁺/K⁺-ATPase) in the stomach lining.

✅ Approved & Common Indications:

🌿 Gastroesophageal Reflux Disease (GERD)

• Symptomatic GERD For the relief of heartburn, acid regurgitation, and other symptoms associated with GERD.
• Erosive Esophagitis For healing and symptomatic relief of erosive esophagitis confirmed by endoscopy, and maintenance of healing.

🌿 Peptic Ulcer Disease

• Duodenal Ulcer Short-term treatment of active duodenal ulcers.
• Gastric Ulcer For the short-term management of active benign gastric ulcers.

🌿 Zollinger-Ellison Syndrome and Other Pathological Hypersecretory Conditions

• Indicated for the long-term treatment of conditions associated with excessive gastric acid production, including Zollinger-Ellison Syndrome.

🌿 Helicobacter pylori Eradication Regimens

• As part of a combination therapy with appropriate antibiotics for the eradication of Helicobacter pylori in patients with peptic ulcer disease to reduce the risk of ulcer recurrence.

Pantoprazole Sodium Table Dosage Summary: 

Adults:

• GERD & Erosive Esophagitis: 40 mg once daily for 4-8 weeks
• Peptic Ulcer Disease: 40 mg once daily for 4-8 weeks
• Zollinger-Ellison Syndrome: 40 mg twice daily, titrate as needed
• H. pylori Eradication (Combination Therapy): 40 mg once daily for 7-14 days with antibiotics

Pediatrics:

• GERD (5-16 years): 20-40 mg once daily for up to 8 weeks
• Not recommended for children under 5 years due to limited safety data

Elderly:

• No specific dose adjustments are required, but caution in renal/hepatic impairment

Renal/Hepatic Impairment:

• Mild to moderate liver disease: No adjustment needed
• Severe hepatic impairment: 20 mg once daily recommended

Pantoprazole Sodium Injection Dosage Summary:

Adults:

• GERD/Erosive Esophagitis: 40 mg IV once daily (for 7–10 days)
• Zollinger-Ellison Syndrome: 80 mg IV every 12 hours (up to 240 mg/day)
• Continuous infusion: 80 mg bolus, then 8 mg/hour

Pediatrics: Not routinely recommended (limited data)

Elderly: No adjustment is needed

Hepatic Impairment: Severe cases may require dose reduction

Administration:

• Reconstitute 40 mg vial with 10 mL NS, dilute to 100 mL
• Infuse over 15 minutes

"রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ওষুধ সেবন করুন।"

Pantoprazole is a proton pump inhibitor (PPI) that irreversibly inhibits H+/K+ ATPase in the gastric parietal cells, reducing gastric acid secretion.

Pantoprazole Sodium is classified as FDA Pregnancy Category B, meaning animal studies show no fetal risk, but human data is limited. It should be used in pregnancy only if clearly needed. It is excreted in breast milk in small amounts and is generally considered safe during lactation, but caution is advised.

Proton Pump Inhibitor (PPI)

Absorption:

• Rapidly absorbed; peak plasma concentration within 2-3 hours
• Bioavailability: ~77% (not significantly affected by food)

Distribution:

• Plasma protein binding: ~98%

Metabolism:

• Metabolized in the liver (CYP2C19, CYP3A4 pathway)

Excretion:

• Primarily via urine (~80%), feces (~20%)
• Half-life: ~1 hour

• Known hypersensitivity to pantoprazole, substituted benzimidazoles, or any component of the formulation

• Long-term use may lead to vitamin B12 deficiency, hypomagnesemia, and bone fractures
• Risk of Clostridium difficile-associated diarrhea
• May mask symptoms of gastric malignancy
• Caution in hepatic impairment

Common:

• Headache, diarrhea, nausea, abdominal pain, dizziness

Serious:

• Anaphylaxis, Stevens-Johnson syndrome, pancreatitis, interstitial nephritis, hypomagnesemia, fractures

• May reduce absorption of drugs where gastric pH is important (e.g., ketoconazole, atazanavir)
• Increased INR/bleeding risk with warfarin
• Methotrexate toxicity potential at high doses
• CYP2C19 interactions (e.g., may reduce clopidogrel effectiveness)

Geriatrics:

• No significant differences in response; monitor long-term use effects

Pediatrics:

• Approved for use in children 5 years and older for short-term treatment of GERD

Onset:

• Within 2.5 hours (peak plasma concentration)

Duration:

• Acid suppression may last up to 24 hours after a single dose

• Primarily renal (71%) as inactive metabolites; rest via feces

Symptoms of Overdose:

• Headache, dizziness, confusion, tachycardia

Treatment:

• Supportive and symptomatic care; no specific antidote
• Dialysis is not effective due to high protein binding

• Take tablets before meals, preferably in the morning
• Do not crush or chew delayed-release tablets
• Report symptoms like persistent diarrhea, rash, or seizures
• Avoid alcohol and smoking which may worsen acid reflux
• Inform the doctor about all medications, especially antiplatelets or antifungals

• Long-term PPI use is under increased scrutiny due to associations with renal injury and infections (FDA/EMA safety communications)
• A new guideline from AGA 2023 recommends the lowest effective dose for GERD maintenance.

Pantoprazole helps reduce stomach acid and is commonly used for conditions like heartburn, GERD, and ulcers. It works best when taken before meals and should not be used for a long time without doctor supervision, as it may cause side effects like low magnesium or vitamin B12 levels.

• Store at 20° to 25°C (68° to 77°F)
• Protect from moisture and light

• FDA Approved
• No black box warning
• Available as prescription and OTC in some countries

• U.S. Food and Drug Administration (FDA) – fda.gov
• Drugs.com – drugs.com/pantoprazole.html
• WHO Model List of Essential Medicines – who.int
• MedlinePlus – medlineplus.gov
• PubMed – pubmed.ncbi.nlm.nih.gov