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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Mangifera Indica Leaf Extract,stem Banana Extract,white Mulberry (morus Alba) Leaf Extract
Brand Name
St. Paul Brands Glucotrojan
Generic Name
Mangifera Indica Leaf Extract,stem Banana Extract,white Mulberry (morus Alba) Leaf Extract
Active Ingredient
BananaCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 250 mg/1 | CAPSULE | ORAL | 13411-860 |
Detailed information about St. Paul Brands Glucotrojan
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for St. Paul Brands Glucotrojan, you must consult a qualified healthcare professional.
Banana (Non-Standardized Food Allergenic Extract) is used primarily in the diagnosis and management of IgE-mediated hypersensitivity. It contains complex proteins and catecholamines that act as adrenergic and estrogen receptor agonists.
For diagnostic skin prick testing, the dosage is not measured in milligrams but in the volume of the extract applied to the epidermis. Typically, one drop (approximately 0.05 mL) of the non-standardized extract (1:20 w/v) is applied to the volar surface of the forearm or the back. A sterile lancet is then used to prick through the drop into the skin.
In the rare instance of oral desensitization (investigational), dosages begin at microgram levels of protein and are doubled at regular intervals (e.g., every 2 weeks) under strict medical supervision. There is no established 'standard' dose for systemic administration of Banana extract, as it is primarily a diagnostic tool. If used as a source of catecholamines or vitamin C in a dietary context, the 'dosage' is typically 1 to 2 medium-sized fruits daily, which provides approximately 400-800 mg of potassium and 10-20 mg of Vitamin C.
Banana extract is generally considered safe for skin testing in children as young as 6 months of age, provided there is a clinical history of allergic reaction. The procedure for pediatric skin testing is identical to adult testing, though the number of simultaneous tests may be limited to reduce discomfort and the risk of a systemic reaction. Pediatric patients must be monitored more closely for signs of systemic distress, as their surface-area-to-volume ratio differs from adults.
No dosage adjustment is required for skin prick testing in patients with renal impairment, as systemic absorption is minimal. However, in patients with end-stage renal disease (ESRD), skin reactivity may be diminished (uremic pruritus or skin changes), potentially leading to false-negative results.
No adjustments are necessary for diagnostic use. The metabolism of biogenic amines may be slightly delayed in severe hepatic failure, but this is clinically insignificant for the amounts used in allergenic extracts.
Elderly patients may have reduced skin turgor and diminished histamine response. Healthcare providers may need to use a positive control (histamine) to validate the test results in this population. Caution is advised if the patient has underlying cardiovascular disease, as a rare systemic reaction could place more strain on the heart.
Banana extract for diagnostic purposes MUST be administered by a trained healthcare professional (usually an Allergist or Immunologist). The skin must be clean and free of topical steroids or antihistamines for at least 3 to 7 days prior to the test.
Since Banana extract is typically administered as a one-time diagnostic test or a strictly scheduled immunotherapy dose in a clinic, a missed dose simply involves rescheduling the appointment. Do not attempt to apply allergenic extracts at home.
An 'overdose' in the context of an allergenic extract is a systemic allergic reaction (anaphylaxis). Symptoms include generalized hives, swelling of the throat, wheezing, low blood pressure, and rapid heart rate. Emergency treatment requires the immediate administration of epinephrine (0.3 mg for adults, 0.15 mg for children) and emergency medical transport.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or attempt self-testing without medical guidance.
The most frequent side effect of Banana extract administration is a localized reaction at the site of the skin prick. This is actually the intended effect for a positive diagnosis.
These symptoms typically resolve within 1 to 2 hours without treatment, though topical hydrocortisone may be applied after the test is read.
> Warning: Stop the procedure and call for emergency help immediately if you experience any of the following:
There are no known long-term side effects from a single diagnostic exposure to Banana extract. In the context of long-term immunotherapy (if used), there is a theoretical risk of shifting the immune system toward a chronic inflammatory state, though the goal is typically to induce 'tolerance.' Prolonged exposure to high levels of dietary bananas (and thus their catecholamines) has been studied in the context of 'Carcinoid-like' symptoms, though this is extremely rare and requires massive consumption.
Banana extracts, like all allergenic extracts, can cause severe life-threatening systemic reactions, including anaphylaxis. Patients must be tested only in facilities equipped to handle respiratory and cardiovascular emergencies. Epinephrine must be immediately available. Patients with unstable asthma are at higher risk for severe reactions. This extract should only be administered by clinicians experienced in the diagnosis and treatment of allergic diseases.
Report any unusual symptoms to your healthcare provider.
Banana extract is intended for diagnostic use by healthcare professionals only. It is not for self-administration. Patients must inform their doctor of all current medications, especially heart or blood pressure medications, as these can interfere with the safety and accuracy of the test. If you have a history of severe reactions to bananas, latex, or other fruits, the doctor may choose to perform the test using a more dilute solution or avoid the test entirely.
FDA-Required Warning for Allergenic Extracts: Banana extract is associated with a risk of systemic anaphylaxis. This product must be administered in a clinical setting where emergency resuscitative equipment and personnel are present. Patients must be observed for at least 30 minutes post-administration. Severe reactions are more likely in patients with poorly controlled asthma or those taking beta-blockers, which may render epinephrine less effective.
Banana extract does not typically affect the ability to drive. However, if a systemic reaction occurs or if the patient experiences a vasovagal response (fainting), they should not drive until they have fully recovered and been cleared by a medical professional.
There is no direct interaction between Banana extract and alcohol. However, alcohol can cause vasodilation and may theoretically increase the rate of absorption or the severity of an allergic reaction. It is best to avoid alcohol for 24 hours before and after testing.
Since this is usually a one-time diagnostic test, 'discontinuation' is not applicable. For those in immunotherapy, stopping the treatment will result in a loss of the induced tolerance, and the patient will return to their baseline level of allergy.
> Important: Discuss all your medical conditions with your healthcare provider before starting Banana extract testing.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Patients with a known allergy to Latex have a 30-50% chance of being cross-sensitive to Banana extract due to shared proteins like class I chitinases. Similar cross-sensitivity exists with Kiwi, Avocado, and Chestnut. If you are allergic to any of these, notify your doctor, as the reaction to Banana extract may be more severe than expected.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing or administering Banana extract.
Banana extract is classified as FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. The primary concern is not the extract itself, but the potential for a systemic allergic reaction (anaphylaxis). Anaphylaxis in a pregnant woman can cause a sudden drop in blood pressure and uterine contractions, leading to fetal distress, hypoxia, or miscarriage. Diagnostic skin testing should be postponed until after delivery unless the information is vital for the immediate management of the patient.
It is not known whether the allergenic proteins or the concentrated biogenic amines from the extract pass into breast milk. However, because the amount used in skin testing is so small, it is unlikely to affect a nursing infant. The main consideration is the mother's health; if she were to have a severe reaction, the medications used to treat it (like high-dose steroids or antihistamines) might require a temporary interruption of breastfeeding.
Banana extract is safe for use in children when administered by a specialist. However, the 'wheal and flare' response may be smaller in infants than in older children. Children are also more prone to systemic reactions if they have co-existing conditions like food-induced asthma. The use of 'prick-to-prick' testing with fresh fruit is often preferred in pediatrics to ensure the most relevant allergens are captured.
In patients over 65, the skin's reactivity to histamine and allergens decreases. This can lead to smaller wheals and potential false negatives. Furthermore, elderly patients are more likely to be on medications (like ACE inhibitors or beta-blockers) that complicate the safety profile. A thorough cardiovascular assessment is recommended before testing, as the adrenergic agonist properties of the extract's components could theoretically trigger an arrhythmia in a vulnerable heart.
Patients with chronic kidney disease (CKD) often experience 'uremic pruritus' and changes in skin thickness. This can make the interpretation of a skin prick test difficult. While no dose adjustment is needed, the clinician should use a stronger positive control (histamine) to ensure the skin is capable of mounting a visible response.
There are no specific precautions for hepatic impairment regarding diagnostic skin testing. If the extract were used in a way that led to systemic absorption, the metabolism of the biogenic amines (dopamine, etc.) might be slowed, but the quantities used in standard clinical practice are far below the threshold for systemic toxicity.
> Important: Special populations require individualized medical assessment by an allergy specialist.
Banana extract functions through several pharmacological pathways. As a Non-Standardized Food Allergenic Extract [EPC], its primary mechanism is the induction of a Type I hypersensitivity reaction. The proteins in the extract bind to specific IgE antibodies on the surface of mast cells. This triggers the activation of the phospholipase C pathway, leading to an increase in intracellular calcium and the subsequent exocytosis of pre-formed inflammatory mediators like histamine.
Additionally, the extract contains significant amounts of Catecholamines, specifically dopamine, norepinephrine, and serotonin. These act as alpha-Adrenergic Agonists and beta-Adrenergic Agonists. Norepinephrine binds to alpha-1 receptors on vascular smooth muscle to cause constriction, and beta-1 receptors in the heart to increase contractility. The Estrogen Receptor Agonist [MoA] activity is attributed to sitosterols and other phytoestrogens which can modulate gene expression through nuclear estrogen receptors, although this effect is negligible in diagnostic doses.
The pharmacodynamic response to Banana extract is rapid. In a skin prick test, the 'onset of action' (the appearance of the wheal) occurs within 5 to 10 minutes. The 'peak effect' is reached at 15 to 20 minutes. The duration of the localized skin response is typically 1 to 2 hours. Systemically, the catecholamines have a very short duration of action, measured in minutes, due to rapid enzymatic degradation.
| Parameter | Value |
|---|---|
| Bioavailability | <1% (Skin Prick); ~5-10% (Oral due to first-pass) |
| Protein Binding | Variable (Allergenic proteins bind to IgE) |
| Half-life | 2-3 minutes (Catecholamines); Hours (Proteins) |
| Tmax | 15-20 minutes (Skin response) |
| Metabolism | MAO and COMT (Amines); Proteolysis (Proteins) |
| Excretion | Renal (Metabolites) |
Banana extract is a member of the Allergenic Extracts class. It is specifically grouped with other non-standardized food extracts like apple, kiwi, and pear. It is also uniquely categorized as a source of plant-derived catecholamines and vitamin C.
Common questions about St. Paul Brands Glucotrojan
In a clinical setting, Banana extract is primarily used as a diagnostic tool to identify IgE-mediated allergies. It is administered through a skin prick test where a small amount of the liquid is placed on the skin and pricked with a needle to see if a reaction occurs. This helps doctors confirm if a patient has a true food allergy or Oral Allergy Syndrome, which can cause itching or swelling in the mouth. It is also used to screen for cross-reactivity in patients who are allergic to latex. Occasionally, it is used in research for oral desensitization therapy.
The most common side effects are localized to the area where the test was performed. Most patients experience intense itching, redness, and a raised bump known as a wheal, which looks similar to a mosquito bite. These symptoms are actually a sign of a positive test result and usually appear within 15 minutes. The reaction typically fades away on its own within one to two hours. Some patients may also experience a 'late-phase' reaction where the swelling returns several hours later, but this is less common.
It is generally recommended to avoid alcohol for at least 24 hours before and after an allergy test with Banana extract. Alcohol can cause blood vessels to dilate, which might increase the size of the skin reaction and lead to a false-positive result. Furthermore, alcohol can potentially make a systemic allergic reaction more severe if one were to occur. Alcohol may also interact with the biogenic amines found in the extract, leading to headaches or flushing. Always follow the specific pre-test instructions provided by your allergist.
Banana extract testing is generally avoided during pregnancy unless it is absolutely necessary for the patient's immediate health. While the extract itself is not a toxin, the risk of a systemic allergic reaction (anaphylaxis) poses a danger to the fetus. Anaphylaxis can lead to a dangerous drop in the mother's blood pressure and reduced oxygen flow to the baby. Most doctors prefer to wait until after the baby is born to perform elective allergy testing. If testing is required, it must be done under very close medical supervision.
When used for skin testing, the reaction to Banana extract is almost immediate. A visible wheal and redness usually begin to develop within 5 to 10 minutes of the skin being pricked. The reaction reaches its maximum size at approximately 15 to 20 minutes, which is when the healthcare provider will measure the result. If the extract is being used in an investigational immunotherapy protocol, it can take several months of gradually increasing doses before the patient develops a clinical tolerance to the allergen.
Since Banana extract is typically used as a one-time diagnostic test, 'stopping' the medication is not usually a concern. However, if you are undergoing a desensitization program (immunotherapy), stopping the treatment suddenly will cause you to lose any protection you have built up against the allergy. You would once again be at risk for a severe reaction if you accidentally ate a banana. You should never stop a medically supervised allergy treatment without first discussing it with your specialist, as they may need to adjust your plan.
If you miss an appointment for a diagnostic test with Banana extract, simply call your doctor's office to reschedule. There is no harm in delaying a diagnostic test. If you are on a specific immunotherapy schedule and miss a dose, contact your allergist immediately. They will determine if you can continue with your next scheduled dose or if they need to 'backtrack' to a lower dose to ensure your safety. Never try to 'double up' on an allergy extract dose to make up for a missed one.
The amount of Banana extract used in medical testing is far too small to have any effect on body weight. In terms of dietary bananas, they are a source of carbohydrates and calories, but they do not inherently cause weight gain when eaten as part of a balanced diet. In fact, their high fiber content can help with satiety and weight management. There is no evidence that the pharmacological components of banana, such as its catecholamines or estrogens, have any significant impact on metabolic weight gain in humans.
Banana extract has several important drug interactions that your doctor must consider. Most importantly, it should not be used if you are taking beta-blockers, as these drugs can make it difficult to treat a severe allergic reaction. You must also stop taking antihistamines several days before the test, as they will block the skin's reaction and lead to a false-negative result. Other medications like MAO inhibitors can interact with the natural chemicals in the banana extract to cause blood pressure issues. Always provide a full list of your medications to your allergist.
Banana extract is a biological product, and the concept of 'generic' works differently than it does for standard pills. Various manufacturers produce 'Non-Standardized Food Allergenic Extracts' of Banana, and while they are similar, they are not always identical in their protein concentration. These are usually referred to by their manufacturer's name rather than as a generic. Because they are non-standardized, your doctor will typically stick with one brand during a course of treatment to ensure the results and effects remain consistent.