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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Sambucus Nigra
Brand Name
Sambucus Nigra
Generic Name
Sambucus Nigra
Active Ingredient
Sambucus Nigra Flowering TopCategory
Non-Standardized Plant Allergenic Extract [EPC]
Variants
8
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 12 [hp_C]/1 | PELLET | ORAL | 37662-1208 |
| 500 [hp_C]/1 | PELLET | ORAL | 37662-1212 |
| 1 [hp_M]/1 | PELLET | ORAL | 37662-1213 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Sambucus Nigra, you must consult a qualified healthcare professional.
| 30 [hp_C]/1 | PELLET | ORAL | 37662-1209 |
| 6 [hp_C]/1 | PELLET | ORAL | 37662-1207 |
| 200 [hp_C]/1 | PELLET | ORAL | 37662-1211 |
| 1 [hp_Q]/1 | PELLET | ORAL | 37662-1214 |
| 100 [hp_C]/1 | PELLET | ORAL | 37662-1210 |
Detailed information about Sambucus Nigra
Sambucus Nigra Flowering Top is a non-standardized plant allergenic extract used primarily in the diagnosis and treatment of hypersensitivity to European Elder pollen. It belongs to the class of allergenic extracts used in immunotherapy and diagnostic skin testing.
Dosage for Sambucus Nigra Flowering Top is highly individualized and is not based on a standard 'one size fits all' milligram amount. Instead, it is based on 'allergy units' or weight/volume (w/v) concentrations.
For percutaneous (skin prick) testing, a single drop of a 1:20 w/v concentration is typically applied to the skin. If intradermal testing is required, the concentration is usually diluted significantly (e.g., 1:1000 w/v) to prevent a severe local reaction.
Therapeutic dosing follows two distinct phases:
Sambucus Nigra Flowering Top may be used in children, typically those aged 5 years and older. The dosing principles are similar to those for adults, but the 'build-up' phase may be more conservative. The safety and efficacy in children under the age of 5 have not been robustly established, and healthcare providers must weigh the benefits against the risk of systemic reactions in very young children who may not be able to communicate early symptoms of anaphylaxis.
No specific dose adjustments are typically required for patients with kidney disease, as the systemic load of the protein extract is very low. However, clinicians should exercise caution if the patient is on medications for renal issues that might interact with emergency treatments (like epinephrine).
There are no established guidelines for dosage adjustment in patients with liver impairment. The metabolism of the extract is primarily proteolytic and does not rely heavily on the cytochrome P450 system.
Elderly patients (over 65) should be evaluated for cardiovascular stability before starting immunotherapy. Because the treatment carries a risk of anaphylaxis, the patient must be healthy enough to tolerate a potential dose of epinephrine (adrenaline) if an emergency occurs.
This medication is never self-administered at home. It must be administered in a clinical setting (such as an allergist's office) equipped with emergency resuscitation equipment.
If a dose in the build-up phase is missed, the next dose may need to be reduced to ensure safety. If several weeks have passed since the last injection, the clinician may need to 'backtrack' several steps in the dosage schedule. Do not attempt to 'double up' on doses to catch up.
An overdose of Sambucus Nigra Flowering Top manifests as an exaggerated allergic response. Symptoms include:
In the event of an overdose or systemic reaction, emergency protocols involving epinephrine, antihistamines, and corticosteroids are initiated immediately.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or the frequency of your injections without medical guidance.
Most patients undergoing treatment with Sambucus Nigra Flowering Top will experience some form of local reaction. These are generally not dangerous but can be uncomfortable.
Sambucus Nigra Flowering Top is a potent biological substance. It is not a supplement or an over-the-counter herbal remedy. It must be treated with the same caution as any high-risk medication. Before starting treatment, ensure your provider has a complete list of your allergies and current medications.
No FDA black box warnings are uniquely assigned to Sambucus Nigra specifically, but it falls under the General Black Box Warning for Allergenic Extracts. This warning emphasizes that systemic reactions are an inherent risk of the therapy. The warning states that the extract must be used only by clinicians prepared to manage life-threatening anaphylaxis and that patients with severe, poorly controlled asthma should generally not receive this treatment.
There are few absolute contraindications for drug combinations, but the following are considered highly risky:
Sambucus Nigra Flowering Top must NEVER be used in the following situations:
Sambucus Nigra Flowering Top is generally classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. The primary risk is not the extract itself, but the potential for a systemic reaction (anaphylaxis) in the mother. Anaphylaxis can cause a sudden drop in blood pressure, leading to decreased blood flow to the placenta and potential fetal distress or death.
It is not known whether the allergenic proteins from Sambucus Nigra Flowering Top are excreted in human milk. However, because these are large proteins that are likely broken down in the mother's digestive system if they were to reach the milk, the risk to the nursing infant is considered very low. The benefit of controlling the mother's allergies often outweighs the theoretical risks.
Sambucus Nigra Flowering Top acts as a specific immunomodulator. At the molecular level, the extract contains various proteins (antigens) that are recognized by the immune system. In a sensitized individual, these antigens bind to IgE antibodies on the surface of mast cells and basophils.
When used in Immunotherapy, the repeated, low-dose exposure causes:
Common questions about Sambucus Nigra
Sambucus Nigra Flowering Top is primarily used in the medical field of allergy and immunology for both diagnosis and treatment. Clinicians use it in skin prick tests to determine if a patient is allergic to European Elder pollen, which can cause symptoms like hay fever and asthma. Additionally, it is used in allergen immunotherapy, commonly known as allergy shots, to help desensitize the patient's immune system over time. This treatment aims to reduce the severity of allergic reactions upon natural exposure to the plant. It is not the same as over-the-counter elderberry supplements used for colds.
The most frequent side effects are localized to the area where the extract was injected or applied. These include redness (erythema), itching (pruritus), and a small raised bump or swelling (wheal) at the injection site. These symptoms usually appear within minutes and typically resolve within a few hours without treatment. Some patients may also experience 'large local reactions,' where the swelling is more significant and lasts for a day or two. Because it is an allergen, there is always a small risk of more widespread symptoms like hives or tiredness.
It is strongly advised to avoid alcohol consumption on the days you receive an injection of Sambucus Nigra Flowering Top. Alcohol can cause your blood vessels to dilate (expand), which may speed up the absorption of the allergen into your bloodstream. This increased absorption rate can raise the risk of a systemic allergic reaction or anaphylaxis. Furthermore, alcohol can mask the early symptoms of an allergic reaction, making it harder for you or your doctor to identify a problem. Always wait at least several hours after your injection and ensure you feel completely well before consuming alcohol.
The use of Sambucus Nigra Flowering Top during pregnancy requires a careful discussion with your healthcare provider. It is generally not recommended to start a new course of immunotherapy while pregnant because of the risk of anaphylaxis, which can be dangerous for both the mother and the developing fetus. However, if a woman is already on a stable maintenance dose and is tolerating it well, many allergists will continue the treatment at that same dose. The extract itself is not known to cause birth defects, but the physiological stress of a potential allergic reaction is the primary concern. Always inform your doctor immediately if you become pregnant during treatment.
For diagnostic purposes, the extract works almost immediately, producing a skin reaction within 15 to 20 minutes. However, when used as a treatment (immunotherapy), the process is much slower. Most patients do not notice a significant reduction in their allergy symptoms until they have reached their maintenance dose, which usually takes 3 to 6 months of weekly injections. Full effectiveness and long-term protection are typically achieved after 12 months of consistent treatment. A full course of therapy usually lasts 3 to 5 years to ensure the immune system remains desensitized.
Yes, you can stop taking Sambucus Nigra Flowering Top injections suddenly without experiencing physical withdrawal symptoms, as it is not an addictive substance. However, stopping the treatment before the recommended 3-to-5-year course is finished will likely result in the return of your original allergy symptoms. The progress you made in desensitizing your immune system may be lost over time. If you need to stop treatment due to side effects, cost, or scheduling issues, you should discuss this with your allergist. They can help you determine the best time to stop or how to manage your allergies using alternative methods.
If you miss a scheduled immunotherapy injection, you should contact your allergist's office as soon as possible to reschedule. Do not attempt to take an extra dose later. The safety of the next dose depends on how much time has passed since your last injection. If only a few days have passed, you may be able to continue with your regular schedule. However, if you have missed several weeks, your doctor will likely need to reduce your next dose to prevent a severe reaction. Safety protocols are strictly followed to ensure that your 're-introduction' to the allergen is safe.
There is no clinical evidence to suggest that Sambucus Nigra Flowering Top allergenic extract causes weight gain. The amount of the extract injected is extremely small and does not contain calories or hormones that would affect your metabolism or appetite. If you experience weight changes while undergoing immunotherapy, it is likely due to other factors, such as changes in lifestyle, diet, or other medications you may be taking (like oral corticosteroids for asthma). Always discuss significant weight changes with your primary care physician to identify the underlying cause.
Sambucus Nigra Flowering Top can be taken with many medications, but there are important exceptions. You must tell your doctor if you are taking beta-blockers, MAO inhibitors, or tricyclic antidepressants, as these can make allergic reactions more dangerous or harder to treat. Additionally, if you are taking antihistamines, you must stop them several days before a diagnostic skin test, as they will block the reaction and lead to inaccurate results. Most other routine medications for cholesterol, diabetes, or birth control do not interact with this allergenic extract.
The concept of 'generic' vs 'brand name' is slightly different for allergenic extracts. Sambucus Nigra Flowering Top is produced by several different biological laboratories (such as Greer, ALK, or HollisterStier). While they all contain the same basic elderflower proteins, they are 'non-standardized,' meaning the exact concentration of specific allergens can vary slightly between manufacturers. Your allergist will usually stick with one manufacturer for your entire course of treatment to ensure consistency. These extracts are generally referred to by their scientific name rather than a brand name.
Other drugs with the same active ingredient (Sambucus Nigra Flowering Top)
> Warning: Stop taking Sambucus Nigra Flowering Top and call your doctor or emergency services immediately if you experience any of these symptoms of anaphylaxis.
With prolonged use (years of immunotherapy), the primary risk is the development of new sensitivities, although this is rare. Most long-term effects are positive, such as a permanent reduction in allergy symptoms. However, chronic local reactions can occasionally lead to minor skin thickening (lichenification) at the injection sites if the same area is used repeatedly without rotation.
Allergenic extracts, including Sambucus Nigra Flowering Top, can cause severe systemic reactions, including anaphylaxis, which can be fatal.
Report any unusual symptoms, especially those occurring after you leave the clinic, to your healthcare provider immediately.
During the course of treatment, your healthcare provider will monitor:
Generally, Sambucus Nigra Flowering Top does not cause drowsiness. However, if you experience a systemic reaction or are given antihistamines to treat a local reaction, your ability to drive or operate machinery may be impaired. It is often recommended to wait until you are sure you feel 100% normal before driving home from the clinic.
Alcohol consumption should be avoided for several hours before and after your injection. Alcohol can dilate blood vessels and potentially increase the rate at which the allergen is absorbed into your bloodstream, increasing the risk of a systemic reaction.
Immunotherapy is typically a 3-to-5-year commitment. Stopping treatment early will not cause 'withdrawal' in the traditional sense, but your allergy symptoms will likely return to their original severity. If you need to stop, discuss a tapering or transition plan with your allergist.
> Important: Discuss all your medical conditions, especially respiratory or heart issues, with your healthcare provider before starting Sambucus Nigra Flowering Top.
For each major interaction, the primary concern is not the drug itself, but how it affects the body's ability to handle an emergency or how it might mask symptoms that the doctor needs to see.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those for blood pressure, depression, or sleep.
Patients allergic to Sambucus nigra may also show cross-reactivity with other members of the Adoxaceae or Caprifoliaceae families. This includes certain types of honeysuckle or viburnum. If you have known allergies to these plants, inform your allergist.
> Important: Your healthcare provider will evaluate your complete medical history, including your lung function and heart health, before prescribing Sambucus Nigra Flowering Top.
Immunotherapy with Sambucus Nigra Flowering Top is generally considered safe and effective for children 5 years of age and older. It can be particularly beneficial in children as it may prevent the development of asthma later in life (the 'allergic march'). However, the child must be cooperative enough to stay for the 30-minute observation period and able to report symptoms like an itchy throat or upset stomach.
Clinical studies of allergenic extracts often do not include sufficient numbers of subjects aged 65 and over. In older adults, the decision to use this extract must take into account the higher prevalence of heart disease and the use of medications like beta-blockers or ACE inhibitors, which can complicate the management of allergic reactions.
No dosage adjustment is required for patients with renal impairment. The total protein load in a 0.5 mL injection is negligible compared to the body's daily protein turnover. However, clinicians should monitor for any signs of systemic accumulation in patients with end-stage renal disease, although this is not a documented clinical problem.
There is no evidence that liver disease affects the safety or efficacy of Sambucus Nigra Flowering Top. The allergens are primarily processed by local tissue enzymes and circulating proteases rather than the liver's metabolic pathways.
> Important: Special populations require individualized medical assessment and often a more cautious approach to dosing and monitoring.
According to its EPC classification, it also exhibits Ammonium Ion Binding Activity [MoA], suggesting it may play a role in nitrogen metabolism within the local tissue environment, though this is not its primary therapeutic use.
| Parameter | Value |
|---|---|
| Bioavailability | Low (Subcutaneous), High (Local tissue) |
| Protein Binding | N/A (Allergenic proteins) |
| Half-life | Variable (Hours to days for specific proteins) |
| Tmax | 1-2 hours (Systemic absorption) |
| Metabolism | Proteolysis (Extravascular) |
| Excretion | Renal (Metabolites) |
Sambucus Nigra Flowering Top is classified as a Non-Standardized Plant Allergenic Extract. Unlike 'standardized' extracts (like ragweed or grass), non-standardized extracts do not have a federally mandated potency test, meaning the strength is determined by the weight of the raw material per volume of solvent (w/v). It is part of a therapeutic class that includes other tree, weed, and mold extracts used in allergy medicine.