Zotonix Tab 40 Mg 14’s

Potential Overview:

Generic Name:Pantoprazole

Brand Name:Zotonix

Pack Size:14 tablets (40 mg each)

Mechanism of Action (MOA):

• Pantoprazole is a proton pump inhibitor (PPI) that works by irreversibly inhibiting the H+/K+ ATPase enzyme (also known as the proton pump) in the parietal cells of the stomach. This enzyme is responsible for secreting gastric acid. By inhibiting this pump, Pantoprazole reduces the production of gastric acid, leading to a decrease in stomach acidity and an increase in the pH of the stomach.
• This mechanism helps in the treatment of conditions related to excessive gastric acid production, such as acid reflux, peptic ulcers, and Zollinger-Ellison syndrome.

Indications:

Zotonix (Pantoprazole) is used to treat the following conditions:

• Gastroesophageal Reflux Disease (GERD): To relieve symptoms of heartburn and to heal erosive esophagitis caused by acid reflux.
• Peptic Ulcers: Treatment and prevention of duodenal and gastric ulcers.
• Zollinger-Ellison Syndrome: A condition where the stomach produces excessive acid.
• Helicobacter pylori eradication: As part of a combination therapy for the treatment of H. pylori infections in peptic ulcer disease.
• Non-Erosive GERD: Used in the management of non-erosive GERD symptoms.

Dosage:

• Adults:
  • GERD: 40 mg once daily for 4 to 8 weeks.
  • Peptic Ulcers: 40 mg once daily for 4 to 8 weeks.
  • Zollinger-Ellison Syndrome: The dose is typically 40 mg twice daily, and it may be adjusted based on clinical response.
  • H. pylori Eradication: Typically used in combination with other antibiotics like clarithromycin or amoxicillin.
• Children: The use of Pantoprazole in children is usually determined by a healthcare provider based on the condition being treated. It’s less commonly used in children under 12 years old.

Note: Always follow your healthcare provider’s instructions for the precise dosage.

Side Effects:

Common side effects of Zotonix (Pantoprazole) include:

• Gastrointestinal: Nausea, vomiting, diarrhea, constipation, flatulence, or abdominal pain.
• Headache.
• Dizziness or lightheadedness.
• Fatigue.
• Rash.

Serious side effects may include:

• Bone fractures: Long-term use of PPIs may increase the risk of bone fractures.
• Kidney problems: Pantoprazole may cause interstitial nephritis (kidney inflammation).
• Low magnesium levels: This can cause muscle spasms, arrhythmias, and seizures.
• Clostridium difficile infection: Long-term use may increase the risk of this infection in the colon.
• Severe allergic reactions: Rarely, some individuals may develop a severe allergic reaction (anaphylaxis).

Precautions:

• Liver Function: Pantoprazole should be used with caution in patients with liver disease. Dose adjustments may be necessary in cases of severe liver impairment.
• Kidney Function: As Pantoprazole can affect renal function, monitor kidney function in long-term therapy.
• Bone Health: Long-term use of PPIs, including Pantoprazole, has been linked to an increased risk of bone fractures, particularly in older adults. Consider calcium and vitamin D supplementation.
• Magnesium Levels: Long-term use of PPIs may lead to hypomagnesemia, which can result in muscle spasms, arrhythmias, and seizures. Monitoring magnesium levels is recommended for prolonged treatment.
• C. difficile Infection: Prolonged use may increase the risk of Clostridium difficile-associated diarrhea (CDAD).
• Pregnancy and Lactation: Pantoprazole is generally considered safe during pregnancy (Category B), but should be used only if clearly needed. It is excreted in breast milk, so use caution when administering it during breastfeeding.

Contraindications (CI):

• Hypersensitivity: Contraindicated in patients who are allergic to Pantoprazole or any of its components.
• Severe Liver Impairment: Patients with severe liver disease should use Pantoprazole with caution, and the dose may need to be adjusted. It may not be recommended in such cases.

Pharmacist Related Data

Chemical Name and Formula:

• Chemical Name: Pantoprazole sodium sesquihydrate
• Molecular Formula: C16H15F2N3O4S
• IUPAC Name: 5-(Difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridinyl)methylthio]-1H-benzimidazole

Half-Life:

• Half-Life: Approximately 1 hour.
  However, the pharmacodynamic effect (reduced acid secretion) lasts much longer than the half-life of the drug in plasma.

Metabolism:

• Pantoprazole is metabolized in the liver, primarily by CYP2C19 and CYP3A4 enzymes.
• The drug undergoes extensive hepatic metabolism to produce inactive metabolites.
• Excretion: The drug is predominantly excreted in the urine (about 80%), with the rest excreted in the feces.

Drug Interactions with Food and Medicine:

Drug Interactions:

• Clopidogrel: Pantoprazole can reduce the effectiveness of clopidogrel, an anti-platelet drug, by inhibiting the enzyme CYP2C19, which is responsible for converting clopidogrel to its active form.
• Warfarin: Pantoprazole may increase the anticoagulant effect of warfarin, requiring more frequent monitoring of prothrombin time (PT/INR).
• Methotrexate: When used with high doses of methotrexate, Pantoprazole can increase the levels of methotrexate, leading to potential toxicity.
• Antifungals: Some azole antifungals like ketoconazole and itraconazole may have reduced absorption when taken with pantoprazole, as the drug decreases stomach acidity.
• Digoxin: Pantoprazole can increase digoxin serum concentrations, potentially leading to digoxin toxicity.
• Rifampin: Rifampin may decrease the serum concentration of pantoprazole, as it induces hepatic enzymes involved in its metabolism.
• HIV medications: Atazanavir and delavirdine may have reduced bioavailability with Pantoprazole due to the reduced stomach acidity.

Food Interactions:

• Food does not significantly affect the absorption of Pantoprazole. It can be taken with or without food, but it is generally recommended to take it before meals for optimal effect.
• Alcohol: While no significant interaction has been found, excessive alcohol can exacerbate acid-related conditions like GERD, potentially reducing Pantoprazole’s effectiveness.

Pharmacodynamics:

• Mechanism of Action:
  Pantoprazole is a proton pump inhibitor (PPI). It inhibits the H+/K+ ATPase enzyme, also known as the proton pump, located on the parietal cells of the stomach. This enzyme is responsible for the final step of gastric acid secretion. By blocking this pump, Pantoprazole significantly reduces the production of gastric acid, helping to heal ulcers, reduce symptoms of acid reflux, and manage conditions like GERD and Zollinger-Ellison Syndrome.
• Clinical Effects:
  It provides relief from symptoms of heartburn, gastric ulcers, and acid reflux, as well as promoting healing of esophageal mucosa damaged by acid reflux.

Pharmacokinetics:

1. Absorption:
   • Pantoprazole is well absorbed after oral administration, with a bioavailability of approximately 77%.
   • Peak plasma concentrations occur approximately 2.5 to 3.5 hours after oral administration.
2. Distribution:
   • Pantoprazole is extensively bound to plasma proteins (approximately 98%).
   • It is widely distributed throughout the body, including the gastric parietal cells, where its therapeutic effects occur.
3. Metabolism:
   • Pantoprazole is metabolized in the liver via the cytochrome P450 system, specifically CYP2C19 and CYP3A4 enzymes.
   • It undergoes extensive hepatic metabolism and is converted into inactive metabolites.
4. Excretion:
   • Pantoprazole is primarily excreted via the kidneys (about 80%), with the rest excreted through the feces.
   • It has a half-life of about 1 hour, but its effect lasts much longer due to the irreversible inhibition of the proton pump.