Registered South Africa · SAHPRA

ADCO PANTOPRAZOLE IV

Pantroprazole Sodium Sesquihydrate equivalent to Pantroprazole

44/11.4.3/0981

What it does

Pantoprazole is a medication that reduces stomach acid, helping to treat various digestive issues.

Commonly used for: stomach ulcers, gastroesophageal reflux disease (GERD), excess stomach acid conditions

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
44/11.4.3/0981
Registration date
2013/05/12
Expiry date
-
Status
Registered
Active ingredient
Pantroprazole Sodium Sesquihydrate equivalent to Pantroprazole
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:12:36 · updated 2026-09-23 04:10:46

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About pantroprazole

Pantoprazole is a medication that reduces stomach acid, helping to treat various digestive issues.

What it treats

  • stomach ulcers
  • gastroesophageal reflux disease (GERD)
  • excess stomach acid conditions

How it works

It works by blocking the pumps in the stomach that produce acid, leading to less acid and relief from symptoms.

Who it's for

This medicine is for adults and children over 12 who need help with acid-related stomach problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About sesquihydrate

Sesquihydrate is a compound often used in various formulations, but specific information about its uses and interactions is limited.

How it works

The exact mechanism of how sesquihydrate works is not well-defined, but it is often included in formulations to improve texture or stability.

Who it's for

Sesquihydrate is generally used in products for individuals needing certain formulations, but specific patient groups are not identified.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: pantroprazole

Pantoprazole is a proton pump inhibitor (PPI) that decreases stomach acid production. It is commonly used to treat gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. By inhibiting the H+/K+ ATPase enzyme in the gastric parietal cells, pantoprazole effectively reduces the secretion of gastric acid.

Indications

  • Gastroesophageal reflux disease (GERD)
  • Peptic ulcer disease
  • Zollinger-Ellison syndrome
  • Prevention of stress ulcer bleeding

Dosage

Children: Refer to the BNF for Children for specific dosing information.

Adults: Refer to the BNF for specific dosing information.

Mechanism of action

Pantoprazole works by irreversibly binding to the H+/K+ ATPase enzyme, also known as the gastric proton pump, located on the luminal surface of the gastric parietal cells. This action inhibits the final step of gastric acid secretion, leading to a significant reduction in gastric acidity.

Pharmacodynamics

Pantoprazole exhibits a dose-dependent inhibition of gastric acid secretion. The onset of action is typically within 1 hour, with peak effects observed around 2 to 4 hours post-administration. The duration of action can last up to 24 hours. Pantoprazole is more effective in inhibiting gastric acid secretion in a stimulated state, such as after meal intake.

Pharmacokinetics

Pantoprazole is well absorbed from the gastrointestinal tract, with bioavailability being around 77% when taken orally. It undergoes extensive hepatic metabolism, primarily via the cytochrome P450 system, particularly CYP2C19 and CYP3A4. The elimination half-life is approximately 1 hour, but its effects on acid secretion can last much longer due to the irreversible action on the proton pump. Excretion occurs mainly via the urine, with around 80% of the drug being eliminated as metabolites.

Contra-indications

  • Hypersensitivity to pantoprazole or any component of the formulation
  • Concomitant use with nelfinavir

Adverse effects

  • Headache
  • Diarrhea
  • Nausea
  • Vomiting
  • Abdominal pain
  • Flatulence
  • Constipation
  • Rash
  • Dizziness
  • Fatigue

Interactions

  • May reduce the effectiveness of drugs that require an acidic gastric pH for absorption (e.g., ketoconazole, atazanavir)
  • May interact with warfarin and increase the risk of bleeding
  • Concomitant use with methotrexate may increase the risk of toxicity

Precautions

  • Use with caution in patients with hepatic impairment
  • Long-term use may lead to vitamin B12 deficiency
  • Monitor for signs of Clostridium difficile-associated diarrhea
  • Consider potential risk of gastric cancer in long-term use

Pregnancy

Pantoprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data on human use.

Breast-feeding

Pantoprazole is excreted in human milk, caution should be exercised when administering to nursing women.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets (Enteric-coated)
  • Injection (Powder for solution)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: sesquihydrate

Sesquihydrate refers to a hydrate form of a compound that contains one and a half molecules of water for every molecule of the compound. It is commonly associated with various medications that may appear in this hydrated form. The specific pharmacological properties and clinical applications depend on the base compound of the sesquihydrate form, which can vary widely.

Dosage

Children: For paediatric dosing information, refer to the specific drug associated with the sesquihydrate form, as dosages will vary based on the active ingredient.

Adults: For dosing information, refer to the specific drug associated with the sesquihydrate form, as dosages will vary based on the active ingredient.

Mechanism of action

The mechanism of action of a sesquihydrate compound is dependent on the active ingredient it is associated with. Generally, hydrated forms of drugs may influence solubility and bioavailability, affecting how the drug interacts with biological systems.

Pharmacodynamics

Pharmacodynamics will vary significantly according to the specific sesquihydrate compound. Typically, the pharmacodynamic profile would include the drug's effects on the body, the relationship between drug concentration and effect, and the duration of action, which are influenced by its chemical structure and interactions with target receptors or enzymes.

Pharmacokinetics

Pharmacokinetics of a sesquihydrate compound is influenced by its solubility, absorption, distribution, metabolism, and excretion (ADME). The presence of water molecules in the sesquihydrate form can enhance solubility, potentially improving absorption. The specific pharmacokinetic parameters would need to be referenced from studies of the particular drug associated with the hydrated form.

Pregnancy

Consult a healthcare provider before use.

Breast-feeding

Consult a healthcare provider before use.

Storage

Store in a cool, dry place away from direct sunlight.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.