Pantoprazole Sodium (Pantobbas) 40mg Lyophilized Powder for Injection I.M/I.V Vial 1's

40mg Lyophilized Powder for Injection I.M/I.V

Below is the detailed product description, indications, dosages, side effects, and contraindications for Pantoprazole Sodium (Pantobbas) 40mg Lyophilized Powder for Injection (IM/IV) Vial 1's:

Product Description:

Pantobbas (Pantoprazole Sodium 40mg Lyophilized Powder for Injection) is a proton pump inhibitor (PPI) used to reduce the production of stomach acid. It is available as a 40mg lyophilized powder for injection, which can be administered either intravenously (IV) or intramuscularly (IM). The product comes in a vial containing the powdered form of Pantoprazole Sodium, which is reconstituted and administered by a healthcare professional.

Pantoprazole works by specifically inhibiting the proton pump (H+/K+ ATPase) in the stomach lining, which is responsible for the final step of acid production. By reducing stomach acid, Pantobbas helps to alleviate symptoms associated with acid-related diseases such as gastric ulcers, GERD, and other conditions involving excessive acid production.

Indications:

Pantobbas (Pantoprazole Sodium) is indicated for the treatment of conditions where reduction of gastric acid is beneficial. These include:

1. Gastroesophageal Reflux Disease (GERD):

   • Treatment of symptomatic GERD (heartburn and acid reflux), as well as in patients with erosive esophagitis due to GERD.

2. Gastric Ulcers:

   • Treatment of gastric ulcers (stomach ulcers), including those caused by Helicobacter pylori infection when used in combination with appropriate antibiotics.

3. Duodenal Ulcers:

   • Treatment of duodenal ulcers, particularly in cases where the ulcer is resistant to other treatments.

4. Helicobacter pylori Eradication:

   • As part of a combination therapy regimen to eradicate H. pylori infection in patients with ulcers, usually in combination with antibiotics.

5. Zollinger-Ellison Syndrome:

   • Management of conditions like Zollinger-Ellison syndrome, which causes excessive acid secretion.

6. Prophylaxis of Gastric Ulcers:

   • Pantoprazole may also be used to prevent gastric ulcers in patients who are receiving NSAIDs (non-steroidal anti-inflammatory drugs) for long periods of time.

Dosages:

The dosage of Pantobbas (Pantoprazole Sodium 40mg Powder for Injection) depends on the condition being treated and the patient's response. Typical dosages are as follows:

For Adults:

• Gastroesophageal Reflux Disease (GERD) and Erosive Esophagitis:

  • 40mg once daily for 7 to 10 days by IV or IM injection. If necessary, treatment may be extended depending on the patient's condition and clinical response.

• Peptic Ulcers (Gastric or Duodenal):

  • 40mg once daily via IV or IM injection for up to 4 to 8 weeks, depending on the severity of the ulcer and the patient's response.

• Helicobacter Pylori Eradication (used in combination with antibiotics):

  • 40mg once daily via IV or IM injection, typically for 7 to 14 days, in combination with antibiotics like clarithromycin and amoxicillin.

• Zollinger-Ellison Syndrome:

  • 80mg initially, given twice daily. The dose may be adjusted based on the severity of acid secretion, but it can go up to 240mg per day in divided doses for patients with more severe conditions.

For Renal Impairment:

• No dose adjustment is necessary for patients with mild to moderate renal impairment.

• However, in cases of severe renal impairment, caution should be exercised, and regular monitoring is recommended.

For Hepatic Impairment:

• In patients with liver disease (e.g., cirrhosis), Pantoprazole should be used with caution, and the dosing frequency may need to be adjusted based on liver function.

Side Effects:

Pantobbas (Pantoprazole Sodium) is generally well-tolerated, but like all medications, it may cause side effects. Common side effects include:

Common Side Effects:

• Headache or dizziness.

• Gastrointestinal symptoms like nausea, vomiting, diarrhea, or constipation.

• Injection site reactions (pain, redness, or swelling) at the site of IV or IM administration.

• Flatulence (gas).

• Abdominal discomfort or bloating.

Serious Side Effects:

• Allergic reactions such as rash, itching, or difficulty breathing (may indicate anaphylaxis).

• Severe skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (though rare).

• Liver problems: Symptoms such as yellowing of the skin or eyes, dark urine, or unexplained fatigue may indicate liver dysfunction.

• Low magnesium levels (hypomagnesemia), which may cause muscle cramps, arrhythmias, or seizures.

• Bone fractures: Long-term use of PPIs like Pantoprazole has been associated with an increased risk of bone fractures, particularly in older adults.

• Clostridium difficile-associated diarrhea: A risk for patients on long-term PPI therapy, as it may disrupt normal gut flora and lead to overgrowth of C. difficile bacteria.

Contraindications:

Pantobbas (Pantoprazole Sodium) should be avoided in the following cases:

1. Hypersensitivity to Pantoprazole or Other PPIs:

   • If a patient is allergic to Pantoprazole, other proton pump inhibitors, or any components of the product, they should not use this medication.

2. Severe Liver Impairment:

   • Patients with severe hepatic impairment should use Pantoprazole with caution, as the drug is metabolized in the liver, and accumulation may occur in these individuals. Dosage adjustments may be required.

3. Pregnancy and Breastfeeding:

   • Pantoprazole should be used during pregnancy only if the benefits outweigh the potential risks. There is insufficient evidence to confirm its safety in pregnancy.

   • While Pantoprazole is excreted into breast milk, the amount is small. It should be used during lactation only if deemed absolutely necessary by a healthcare provider.

4. Children:

   • Pantoprazole is typically not recommended for use in children under the age of 18 unless directed by a physician, as its safety and effectiveness have not been well-established in this population.

5. Combination with Certain Medications:

   • Pantoprazole may interact with certain medications, such as clopidogrel (a blood thinner), and should be used with caution in patients on these drugs.

Precautions:

1. Long-Term Use:

   • Pantoprazole should not be used for prolonged periods unless recommended by a healthcare provider. Extended use may increase the risk of side effects, such as bone fractures, low magnesium levels, or gastric cancer.

2. Vitamin B12 Deficiency:

   • Long-term use of Pantoprazole may interfere with the absorption of Vitamin B12, potentially leading to deficiency. This should be monitored if treatment extends beyond one year.

3. Monitoring:

   • Pantoprazole therapy should be monitored, especially in patients with existing liver disease or renal impairment. Routine monitoring of liver function and serum magnesium levels may be necessary with long-term use.

4. Discontinuation:

   • If a patient experiences severe side effects or symptoms like unexplained weight loss, difficulty swallowing, or vomiting blood, they should seek immediate medical attention. Pantoprazole may mask symptoms of more serious conditions, such as gastric cancer.

Summary:

Pantobbas (Pantoprazole Sodium 40mg Lyophilized Powder for Injection) is a proton pump inhibitor (PPI) used to treat conditions such as GERD, gastric ulcers, and Zollinger-Ellison syndrome by reducing stomach acid production.

• Indications: Treatment of GERD, gastric/duodenal ulcers, H. pylori eradication, and Zollinger-Ellison syndrome.

• Dosage: Usually 40mg once daily; in severe cases, the dose may be increased or used in combination with antibiotics.

• Side Effects: Common effects include headache, nausea, and injection site reactions; serious side effects can include liver issues, bone fractures, and low magnesium levels.

• Contraindications: Avoid in patients with hypersensitivity to PPIs, severe liver disease, and use with caution in pregnancy, lactation, and children.

Pantobbas should be used as directed by a healthcare provider, and the risks of long-term therapy should be carefully weighed.