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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Viola Tricolor
Brand Name
Viola Tricolor
Generic Name
Viola Tricolor
Active Ingredient
Viola Tricolor WholeCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
10
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 6 [hp_C]/1 | PELLET | ORAL | 37662-2017 |
| 200 [hp_C]/1 | PELLET | ORAL | 37662-2021 |
| 30 [hp_C]/1 | PELLET | ORAL | 37662-2019 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Viola Tricolor, you must consult a qualified healthcare professional.
| 1 [hp_M]/1 | PELLET | ORAL | 37662-2023 |
| 6 [hp_C]/6[hp_C] | PELLET | ORAL | 0220-5274 |
| 12 [hp_C]/1 | PELLET | ORAL | 37662-2018 |
| 10 [hp_M]/1 | PELLET | ORAL | 37662-2024 |
| 1 [hp_Q]/1 | PELLET | ORAL | 37662-2025 |
| 100 [hp_C]/1 | PELLET | ORAL | 37662-2020 |
| 500 [hp_C]/1 | PELLET | ORAL | 37662-2022 |
Detailed information about Viola Tricolor
Viola Tricolor Whole is a botanical drug substance classified as a non-standardized food allergenic extract and associated with adrenocorticotropic hormone pathways, primarily used in diagnostic allergy testing and specific immunotherapy.
The dosage of Viola Tricolor Whole is highly individualized, particularly when used as an allergenic extract. There is no 'one-size-fits-all' dose, as the patient's sensitivity level dictates the starting point.
Viola Tricolor Whole is generally not recommended for children under the age of 5 for immunotherapy due to the difficulty in communicating early symptoms of systemic reactions.
No specific dosage adjustments are provided in the manufacturer's labeling for renal impairment. However, since metabolites are excreted renally, clinicians should monitor for increased sensitivity or side effects in patients with a GFR below 30 mL/min.
Caution is advised in patients with severe hepatic dysfunction, as the metabolism of the flavonoid and phenolic components may be delayed, potentially increasing the risk of systemic toxicity.
Geriatric patients may have a higher prevalence of cardiovascular disease, which increases the risk associated with epinephrine use if an allergic reaction occurs. Dosing should be conservative, and the 'build-up' phase may be extended.
If a dose is missed during the build-up phase, the next dose may need to be reduced to ensure safety. If a dose is missed during the maintenance phase by more than one week, your doctor may revert to a previous, lower dose. Do not double the dose to catch up.
An overdose of Viola Tricolor Whole extract typically manifests as a severe systemic allergic reaction.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or frequency without medical guidance, as this significantly increases the risk of a life-threatening reaction.
Most patients receiving Viola Tricolor Whole as an allergenic extract will experience local reactions at the site of administration. These are generally considered a normal part of the immune response.
Viola Tricolor Whole must be used with extreme caution. It is a biological product that directly interacts with the immune system. Patients must be fully aware that every dose carries a small but significant risk of a systemic allergic reaction. It is not a 'simple' herbal supplement when used in a clinical extract form.
Class Warning Text: "Allergenic extracts can cause severe life-threatening systemic reactions, including anaphylaxis. Patients should be observed for at least 30 minutes after receiving an injection. Those with severe or unstable asthma are at increased risk for fatal reactions. Epinephrine must be available for immediate use."
Viola Tricolor Whole must NEVER be used in the following circumstances:
There are no adequate and well-controlled studies of Viola Tricolor Whole in pregnant women. Animal reproduction studies have not been conducted.
It is not known whether the components of Viola Tricolor Whole are excreted in human milk. Because many drugs and proteins are excreted in milk, caution should be exercised. However, since the allergens are proteins that would likely be digested in the infant's stomach, the risk is generally considered low. The mother should be monitored for any signs that the infant is developing a new allergy or rash.
Viola Tricolor Whole functions as a biological response modifier. The primary active constituents are cyclotides, specifically kalata-type peptides. These peptides possess a unique cyclic cystine knot (CCK) motif, which provides extraordinary stability against thermal, chemical, and enzymatic degradation.
In the immune system, these cyclotides interact with the phospholipid bilayer of T-lymphocytes. Research indicates they can inhibit the proliferation of activated T-cells by interfering with IL-2 expression. This suppresses the overactive Th2 immune response characteristic of allergic disease. Simultaneously, the extract provides a controlled 'antigenic challenge' that re-trains B-cells to produce IgG4 instead of IgE.
Common questions about Viola Tricolor
Viola Tricolor Whole is primarily used as a non-standardized allergenic extract for the diagnosis and treatment of specific allergies. In a clinical setting, healthcare providers use it for skin prick testing to identify if a patient is allergic to the Wild Pansy plant or its relatives. It is also used in allergen immunotherapy, commonly known as 'allergy shots,' to help the immune system become less sensitive to the allergen over time. Additionally, it has a history in traditional medicine for treating inflammatory skin conditions like eczema and respiratory issues. Its classification also links it to the modulation of certain hormonal pathways related to ACTH, though this is a secondary area of study.
The most frequent side effects are localized to the site of administration, especially when given as an injection. Patients often experience redness, swelling, and itching at the injection site, which usually resolves within 24 to 48 hours. Some people may also feel a sense of fatigue or have a mild headache following their treatment. If taken orally as a botanical supplement, mild stomach upset or nausea can occur. While these are common, it is vital to distinguish them from serious systemic reactions like hives all over the body or difficulty breathing, which require immediate medical attention.
It is strongly advised to avoid alcohol consumption on the days you receive a Viola Tricolor Whole injection. Alcohol can cause your blood vessels to dilate, which may lead to faster absorption of the allergen into your bloodstream, significantly increasing the risk of a systemic allergic reaction or anaphylaxis. Furthermore, alcohol can mask some of the early warning signs of an allergic reaction, such as flushing or dizziness. To ensure maximum safety during your immunotherapy, refrain from drinking alcohol for at least 24 hours around your scheduled dose. Always discuss your lifestyle habits with your allergist to ensure your treatment plan is as safe as possible.
The safety of Viola Tricolor Whole during pregnancy has not been established through rigorous clinical trials. Most healthcare providers recommend against starting a new course of immunotherapy while pregnant because of the risk that a systemic reaction could cause harm to the fetus by reducing oxygen levels. However, if a patient is already on a stable maintenance dose and is tolerating it well, the doctor may decide to continue the treatment at the same or a reduced dose. The decision is always based on a careful risk-benefit analysis between the mother's allergic symptoms and the potential risks of the treatment. Consult your obstetrician and allergist if you become pregnant while using this medication.
The timeline for Viola Tricolor Whole depends on the intended use. For diagnostic skin testing, the results are visible within 15 to 20 minutes. For allergen immunotherapy, the process is much slower and requires patience. Most patients begin to see a reduction in their allergy symptoms during the 'maintenance phase,' which typically occurs 3 to 6 months after starting the treatment. Significant and long-lasting immune system changes usually require a commitment of 3 to 5 years of regular injections. It is not a 'quick fix' but rather a long-term strategy to modify the underlying cause of your allergies.
Yes, you can stop taking Viola Tricolor Whole injections suddenly without experiencing physical withdrawal symptoms like those seen with some other medications. However, stopping the treatment prematurely will likely result in the return of your original allergy symptoms over time, as the immune system has not fully developed long-term tolerance. If you stop for more than a few weeks and then decide to restart, you cannot simply resume at your previous dose; you must start back at a much lower dose to prevent a dangerous allergic reaction. Always consult your doctor before discontinuing your immunotherapy to discuss the best path forward for managing your symptoms.
If you miss a dose of Viola Tricolor Whole, contact your healthcare provider's office immediately for instructions. Do not attempt to 'double up' on your next dose, as this significantly increases the risk of a life-threatening allergic reaction. Depending on how many days or weeks have passed since your last injection, your doctor may need to repeat your last dose or even reduce the dose slightly to safely get you back on schedule. Consistency is key to the success of immunotherapy, so try to keep all scheduled appointments. If you miss doses frequently, the treatment may not be effective in reducing your allergies.
There is no clinical evidence to suggest that Viola Tricolor Whole causes weight gain when used as an allergenic extract or in standard botanical doses. While it is classified under the Adrenocorticotropic Hormone [EPC] category, which relates to hormones that can influence weight (like cortisol), the amounts used in allergy treatments are generally too low to cause systemic metabolic changes. If you experience unexpected weight gain while on this treatment, it is more likely due to other factors, such as the use of oral corticosteroids for allergy flares or other lifestyle changes. Discuss any concerns about weight with your healthcare provider to identify the underlying cause.
Viola Tricolor Whole can interact with several other medications, some of which are very serious. The most critical interaction is with beta-blockers, which are often used for heart conditions or high blood pressure; these drugs can prevent life-saving epinephrine from working if you have a severe allergic reaction. Other medications like ACE inhibitors and MAOIs also require caution. It is generally safe to take your standard allergy medications like antihistamines or nasal sprays, but you should inform your doctor of everything you are taking. Your healthcare provider will review your full medication list to ensure there are no contraindications before starting treatment.
Viola Tricolor Whole is a non-standardized biological extract rather than a traditional chemical drug, so the concept of 'generic' vs. 'brand name' is slightly different. Different manufacturers may produce their own versions of Viola Tricolor extract, but because they are non-standardized, one company's extract may not be identical in potency or composition to another's. For this reason, doctors generally recommend staying with the same manufacturer's product throughout your course of treatment to ensure consistency in dosing. These extracts are typically only available through specialized allergy clinics and are not sold as over-the-counter generic medications.
> Warning: Stop taking Viola Tricolor Whole and call your doctor immediately or seek emergency care if you experience any of the following:
With prolonged use of Viola Tricolor Whole in immunotherapy, some patients may develop 'serum sickness-like' symptoms, characterized by fever, joint pain, and rashes. This is due to the chronic stimulation of the immune system. Additionally, because of its classification under Adrenocorticotropic Hormone [EPC], there is a theoretical (though clinically unverified at standard doses) risk of mild HPA axis suppression if extremely high doses are used over many years.
While Viola Tricolor Whole may not have a specific individual black box warning for the plant itself, all Non-Standardized Allergenic Extracts carry a general class warning regarding the risk of severe non-fatal and fatal systemic allergic reactions.
Summary of Warning: This product can cause severe life-threatening systemic reactions, including anaphylaxis. It should only be administered by physicians who are exceptionally experienced in the treatment of systemic allergic reactions and in facilities equipped with the necessary equipment and medication (including epinephrine) to treat such reactions. Patients with unstable asthma are at a higher risk for fatal reactions.
Report any unusual or persistent symptoms to your healthcare provider immediately. Documenting the size and duration of local reactions can help your doctor adjust your treatment plan safely.
While Viola Tricolor Whole does not typically cause sedation, a systemic reaction or the subsequent administration of antihistamines/epinephrine can significantly impair your ability to drive. It is recommended to wait at least 30 minutes to ensure you feel stable before operating a vehicle.
Alcohol consumption should be avoided for several hours before and after an injection. Alcohol causes vasodilation (widening of blood vessels), which can speed up the absorption of the allergen and increase the risk of a systemic reaction.
If you decide to stop Viola Tricolor Whole immunotherapy, you can typically do so without a tapering period. However, the 'allergic protection' provided by the extract will gradually fade over several months. If you stop for a period and then wish to restart, you MUST start back at the lowest possible dose to avoid anaphylaxis.
> Important: Discuss all your medical conditions, especially respiratory and heart problems, with your healthcare provider before starting Viola Tricolor Whole.
For each major interaction, the mechanism typically involves either pharmacodynamic interference (preventing emergency drugs from working) or immunological synergy (increasing the risk of a cytokine storm or anaphylaxis).
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, especially if you have been prescribed a new heart or blood pressure medication.
Conditions requiring a careful risk-benefit analysis by a specialist:
Patients who are allergic to other members of the Violaceae family may experience cross-allergic reactions. There is also a known cross-reactivity between Viola species and certain salicylates. If you have a known 'Aspirin Triad' (aspirin sensitivity, nasal polyps, and asthma), use Viola Tricolor Whole with extreme caution.
> Important: Your healthcare provider will evaluate your complete medical history, including a physical exam and lung function tests, before prescribing Viola Tricolor Whole.
Clinical studies of Viola Tricolor Whole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
In patients with chronic kidney disease (CKD), the clearance of the small-molecule bioactive components (flavonoids, salicylates) may be reduced. While the protein allergens are not cleared by the kidneys, the systemic 'inflammatory load' should be monitored. No specific GFR-based adjustments are published, but clinical vigilance is required.
Patients with Child-Pugh Class B or C cirrhosis may have altered protein synthesis and metabolism. This could theoretically affect how the body processes the immunomodulatory cyclotides. Use with caution and monitor for signs of systemic toxicity.
> Important: Special populations require individualized medical assessment and often a slower titration of the medication.
| Parameter | Value |
|---|---|
| Bioavailability | Low (Oral) / High (Subcutaneous) |
| Protein Binding | Variable (approx. 60-80% for flavonoids) |
| Half-life | 4–12 hours (small molecules); Weeks (immunological) |
| Tmax | 1–2 hours (phenolics); 30 mins (local allergen) |
| Metabolism | Hepatic (Phase II conjugation) |
| Excretion | Renal (Primary) |
Viola Tricolor Whole is part of the Allergenic Extracts therapeutic class. It is grouped with other non-standardized extracts like dandelion or ragweed (non-standardized versions). Its secondary classification as an Adrenocorticotropic Hormone [EPC] relates to its potential to influence the endocrine system, though this is less common in modern Western clinical practice than its use in allergy.