AUP Tablet (Enteric Coated)

Introduction

AUP Tablet (Enteric Coated) 20 mg is a proton pump inhibitor (PPI) used to treat conditions related to excessive stomach acid production, such as gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and erosive esophagitis. By inhibiting gastric acid secretion, it helps heal acid-related damage to the esophagus and stomach.

Uses

AUP Tablet (Enteric Coated) 20 mg is used in the treatment of:

• Gastroesophageal reflux disease (GERD)
• Erosive esophagitis
• Duodenal and gastric ulcers
• Zollinger-Ellison syndrome (pathological hypersecretory conditions)
• Helicobacter pylori eradication therapy (in combination with antibiotics)

Mechanism of Action

Pantoprazole works by selectively inhibiting the H⁺/K⁺ ATPase pump, also known as the proton pump, located on the parietal cells of the stomach lining. This pump is responsible for the final step in the production of gastric acid. By blocking this pump, pantoprazole significantly reduces gastric acid secretion, allowing for the healing of acid-induced damage in the gastrointestinal tract.

How Long Does It Take to Work?

Pantoprazole typically begins to reduce stomach acid within 2 to 4 hours of oral administration. However, maximum relief and healing effects may take several days to manifest. Symptomatic improvement in conditions like GERD usually occurs within a few days, though full therapeutic effects may take 1 to 2 weeks.

Absorption

Pantoprazole is absorbed rapidly after oral administration. The drug has a bioavailability of approximately 77%, and its absorption is not significantly affected by food intake. Peak plasma concentrations are reached within 2.5 hours after oral administration.

Route of Elimination

Pantoprazole is primarily metabolized in the liver via the cytochrome P450 system (mainly CYP2C19 and CYP3A4). The inactive metabolites are excreted predominantly through the urine (approximately 80%), with a smaller portion (around 20%) excreted via feces.

Dosage

Common dosages of AUP Tablet (Enteric Coated) 20 mg include:

• GERD and erosive esophagitis: 40 mg once daily for up to 8 weeks, which may be extended if necessary.
• Zollinger-Ellison syndrome: Initial dose of 40 mg twice daily, with dosage adjustments based on patient response.
• Helicobacter pylori eradication: 40 mg twice daily in combination with antibiotics (amoxicillin and clarithromycin) for 7 to 14 days.

Administration

AUP Tablet (Enteric Coated) 20 mg is available in both oral (delayed-release tablets) and intravenous formulations. The oral tablets should be swallowed whole without crushing, splitting, or chewing, as they are enteric-coated to prevent degradation by stomach acid. It can be taken with or without food.

Side Effects

Common side effects of pantoprazole include:

• Headache
• Diarrhea
• Nausea
• Abdominal pain
• Flatulence

• Hypomagnesemia (low magnesium levels)
• Bone fractures (with long-term use)
• Clostridium difficile-associated diarrhea
• Kidney inflammation (interstitial nephritis)

Toxicity

Pantoprazole overdose is rare, but excessive doses may cause symptoms such as confusion, headache, dizziness, nausea, and tachycardia. In cases of overdose, symptomatic and supportive care is recommended. There is no specific antidote for pantoprazole overdose.

Precautions

Caution should be exercised when using pantoprazole in patients with:

• Liver disease, as it is metabolized by the liver
• Osteoporosis, due to the potential for increased fracture risk with long-term use
• Magnesium deficiency, as prolonged use may lower magnesium levels
• Kidney disease, due to the risk of interstitial nephritis

Interaction

Pantoprazole may interact with:

• Warfarin, increasing the risk of bleeding
• Clopidogrel, potentially reducing its antiplatelet effects
• Drugs requiring an acidic pH for absorption, such as ketoconazole or atazanavir
• Iron supplements, as pantoprazole may reduce iron absorption

Disease Interaction

Pantoprazole should be used with caution in patients with:

• Liver disease
• Osteoporosis
• Renal impairment
• Hypomagnesemia

Drug Interaction

Pantoprazole can interact with several medications, including:

• Clopidogrel: Pantoprazole may reduce the effectiveness of clopidogrel by inhibiting CYP2C19.
• Warfarin: Co-administration may increase the risk of bleeding due to elevated INR (International Normalized Ratio).
• Digoxin: Pantoprazole may increase digoxin levels, leading to potential toxicity.

Food Interactions

Pantoprazole can be taken with or without food, as food does not significantly affect its absorption. However, prolonged suppression of stomach acid may interfere with the absorption of nutrients such as vitamin B12, calcium, and magnesium.

Pregnancy Use

Pantoprazole is classified as pregnancy category B. Animal studies have not shown any harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should only be used during pregnancy if clearly needed.

Lactation Use

Pantoprazole is excreted in breast milk, but its effects on nursing infants are unknown. Caution should be exercised when pantoprazole is administered to breastfeeding women. The benefits and potential risks should be considered before continuing therapy during lactation.

Acute Overdose

In the event of an overdose, symptoms may include confusion, dizziness, and gastrointestinal disturbances such as nausea and vomiting. Treatment is supportive, as there is no specific antidote for pantoprazole overdose. Activated charcoal and gastric lavage may be considered in acute cases.

Contraindication

Pantoprazole is contraindicated in individuals with:

• Known hypersensitivity to pantoprazole or any of its components
• Severe liver impairment, in cases of high-dose or long-term therapy

Use Direction

Pantoprazole should be taken exactly as prescribed by the healthcare provider. The delayed-release tablets should be swallowed whole and should not be chewed or crushed. Patients should be instructed to complete the full course of treatment, even if they feel better before the prescribed duration is over.

Storage Conditions

Pantoprazole should be stored at room temperature (20-25°C), protected from moisture and light. Keep it out of reach of children and avoid using after the expiration date.

Volume of Distribution

The volume of distribution of pantoprazole is approximately 11.0 to 23.6 L, indicating that it is distributed moderately in body tissues.

Half-Life

The elimination half-life of pantoprazole is approximately 1 to 2 hours in healthy individuals. However, in patients with liver impairment, the half-life may be extended.

Clearance

Pantoprazole is cleared primarily through hepatic metabolism via the CYP2C19 and CYP3A4 pathways. Its systemic clearance is approximately 7-9 L/h in healthy adults. Reduced clearance is seen in patients with liver disease.

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