Europe — EMA
Gluintol
Gluintol contains glucose monohydrate, an oral excipient used as a filler, sweetener, and stabilizer in EU pharmaceutical products.
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What is Glucose Monohydrate?
Gluintol is a pharmaceutical-grade product that contains glucose monohydrate as its sole active ingredient. It is supplied in an oral dosage form, with strength and specific formulation not publicly disclosed, and is marketed within the European Union. Classified as an excipient, Gluintol is used primarily as an inert carrier or filler in various medicinal preparations, providing a source of simple carbohydrate for pharmaceutical applications and.
What is Glucose Monohydrate used for?
Gluintol is employed in pharmaceutical manufacturing where glucose monohydrate serves as an inert carrier or functional additive.
- As a filler or diluent in tablets, capsules and oral powders. - To provide a readily soluble source of carbohydrate in liquid formulations. - As a sweetening agent that improves palatability of pediatric medicines. - To aid in the preparation of oral rehydration solutions and electrolyte mixes. - As a stabilizing excipient that supports the integrity of biologic products. - In compounding of custom formulations where a neutral carbohydrate base is required.
What are the side effects of Glucose Monohydrate?
When taken orally, glucose monohydrate is generally well tolerated, but some individuals may experience mild or, rarely, serious adverse effects.
Common: - Mild gastrointestinal discomfort such as bloating or flatulence. - Transient increase in thirst or mild dry mouth. - Slight rise in blood glucose levels that normalizes quickly. - Nausea or mild stomach upset after ingestion.
Serious: - Allergic reactions including rash, itching or swelling of the face and throat. - Severe hyperglycemia leading to symptoms such as rapid breathing or confusion. - Anaphylactic shock, a rare but life‑threatening allergic response. - Osmotic diuresis causing excessive urination and electrolyte imbalance.
What precautions apply to Glucose Monohydrate?
Because glucose monohydrate can affect blood sugar and fluid balance, certain precautions are recommended before using Gluintol.
- Assess blood glucose levels in patients with diabetes or impaired glucose tolerance. - Use caution in individuals prone to dehydration or with renal insufficiency. - Avoid excessive dosing in children, as rapid glucose spikes may occur. - Monitor for signs of allergic reaction, especially in those with known carbohydrate sensitivities. - Store the product in a cool, dry place to prevent microbial growth. - Keep out of reach of infants and pets to prevent accidental ingestion.
What does Glucose Monohydrate interact with?
Glucose monohydrate may interact with certain medications or medical conditions, influencing absorption or metabolic response.
Avoid: - Concurrent use with high‑dose insulin or other potent hypoglycemic agents, which may cause severe hypoglycemia. - Co‑administration with medications that contain carbohydrate‑based excipients, potentially leading to cumulative glucose load.
Use with caution: - Antidiabetic drugs such as metformin, sulfonylureas, or GLP‑1 agonists, requiring closer glucose monitoring. - Diuretics that affect electrolyte balance, as glucose can influence fluid shifts. - Medications that slow gastric emptying, which may alter glucose absorption rates.
Frequently asked questions
What is Gluintol and what does it contain?+
Is Gluintol considered a medication or an excipient?+
In which market is Gluintol available?+
Can Gluintol be used as a sweetener in pediatric formulations?+
What role does glucose monohydrate play in tablet manufacturing?+
Is there a known mechanism of action for glucose monohydrate?+
Are there any common side effects associated with oral glucose monohydrate?+
What serious adverse reactions should be monitored when using Gluintol?+
Should patients with diabetes take Gluintol?+
How should Gluintol be stored?+
Can Gluintol be combined with insulin therapy?+
Is Gluintol available over the counter?+
Product details
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