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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Phosphoric Acid, Angostura Bark, Ferula Assa-foetida Resin, Bellis Perennis, Bryonia Dioica Root, Guaiacum Officinale Resin, Ruta Graveolens Flowering Top, And Equisetum Arvense Top
Brand Name
Oss-regen
Generic Name
Phosphoric Acid, Angostura Bark, Ferula Assa-foetida Resin, Bellis Perennis, Bryonia Dioica Root, Guaiacum Officinale Resin, Ruta Graveolens Flowering Top, And Equisetum Arvense Top
Active Ingredient
Angostura BarkCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 4 [hp_X]/100mL | SOLUTION/ DROPS | ORAL | 59469-153 |
Detailed information about Oss-regen
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Oss-regen, you must consult a qualified healthcare professional.
Angostura Bark (Galipea officinalis) is a botanical substance utilized clinically as a non-standardized food and plant allergenic extract for diagnostic testing and immunotherapy, belonging to the Rutaceae family.
Dosage for Angostura Bark allergenic extract is not measured in milligrams like standard drugs but is instead expressed as a weight/volume (w/v) ratio or Protein Nitrogen Units (PNU/mL).
Angostura Bark extracts can be used in children, but the procedure must be performed with extreme caution.
No specific dosage adjustments are required for renal impairment, as the systemic exposure during diagnostic skin testing is minimal. However, patients with end-stage renal disease may have altered skin reactivity (uremic pruritus), which can make test interpretation difficult.
No dosage adjustments are necessary for hepatic impairment. The local nature of the diagnostic test bypasses primary hepatic metabolism.
Elderly patients may exhibit reduced skin reactivity due to age-related changes in skin elasticity and mast cell density. This may result in smaller wheal sizes, potentially leading to false-negative results. Clinicians may need to rely more heavily on the histamine control for comparison.
Angostura Bark extract is for diagnostic use only and must be administered by a healthcare professional.
In the context of diagnostic testing, a 'missed dose' refers to a cancelled or skipped appointment. Since this is not a daily medication, there is no schedule to maintain. If an immunotherapy dose is missed, contact your allergist immediately, as the dose may need to be reduced to prevent a reaction upon restarting.
An overdose of an allergenic extract occurs if too much is injected or if the concentration is too high for the patient's sensitivity level.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Because Angostura Bark extracts are designed to provoke a response, 'side effects' at the site of administration are expected and common.
> 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 associated with a one-time diagnostic use of Angostura Bark extract. If used in long-term immunotherapy, the primary risk is the development of increased sensitivity or the rare occurrence of serum sickness (a Type III hypersensitivity reaction), though this is not well-documented for Angostura Bark specifically.
While non-standardized extracts like Angostura Bark may not always carry an individual 'Black Box' on the label in the same way as a high-risk pharmaceutical, the Allergenic Extract Class Warning is effectively a black box warning. It states that these products can cause severe life-threatening systemic reactions, including anaphylaxis. They must only be administered by clinicians trained in the treatment of anaphylaxis and in facilities where emergency equipment (epinephrine, oxygen, airway management) is immediately available.
Report any unusual symptoms to your healthcare provider.
Angostura Bark allergenic extract must be used with extreme caution. It is intended for diagnostic use by specialists (Allergists/Immunologists). The most significant risk is a systemic allergic reaction. Before testing, a thorough medical history must be taken to ensure the patient is not currently experiencing an asthma exacerbation or other acute illness that would make a reaction more difficult to treat.
No specific FDA black box warning exists uniquely for Angostura Bark; however, it falls under the General Black Box Warning for Allergenic Extracts:
Generally, diagnostic testing does not affect the ability to drive. However, if a systemic reaction occurs or if the patient receives antihistamines or epinephrine, they should not drive until they are fully recovered and cleared by a physician.
Alcohol should be avoided for 24 hours before and after testing. Alcohol can increase peripheral blood flow and potentially enhance the rate of allergen absorption or exacerbate a mild reaction.
If a patient experiences a systemic reaction to Angostura Bark extract, further testing with that specific extract is usually contraindicated. There is no 'withdrawal' or 'tapering' required for diagnostic extracts.
> Important: Discuss all your medical conditions with your healthcare provider before starting Angostura Bark.
Angostura Bark extract testing does not interfere with standard blood chemistries. However, it will obviously affect the results of an Allergy Skin Test Panel. It may also cause a transient rise in peripheral eosinophil counts if a systemic reaction occurs.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Patients with known allergies to other members of the Rutaceae family (including Rue, Citrus fruits, and Sichuan pepper) may experience cross-allergic reactions. Caution should be exercised if the patient has a known severe allergy to these related plants.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Angostura Bark.
Angostura Bark extracts are classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. The primary risk is not teratogenicity (birth defects) but rather the risk of maternal anaphylaxis. If the mother experiences a drop in blood pressure or respiratory distress, it can lead to fetal hypoxia (lack of oxygen to the baby). Most allergists recommend postponing diagnostic skin testing until after delivery unless the information is critical for immediate management.
It is unknown if the components of Angostura Bark extract are excreted in human milk. However, because the amount used in diagnostic testing is so small and localized, it is highly unlikely to affect a nursing infant. The risk-benefit profile is generally favorable for breastfeeding mothers, provided they are monitored for systemic reactions.
Angostura Bark extract is used in children as young as infants for diagnostic purposes. However, the skin of infants is less reactive, and the risk of systemic reactions may be harder to monitor. Children with a history of severe food allergies or multiple environmental allergies should be tested with extra caution. Dosing remains the same (one drop for prick tests), but the number of antigens tested at one time should be limited.
In patients over 65, the skin's reactivity to histamine and allergens decreases. This can lead to smaller wheal sizes, which may be misinterpreted as a negative result. Furthermore, elderly patients are more likely to have underlying cardiovascular disease or be taking medications like beta-blockers or ACE inhibitors, which increases the risk of a complicated systemic reaction.
No adjustments are needed for renal impairment. The local administration and minimal systemic absorption mean that kidney function does not significantly impact the safety of the diagnostic procedure.
No adjustments are needed for hepatic impairment. The liver is not significantly involved in the clearance of the small amounts of protein used in a skin test.
> Important: Special populations require individualized medical assessment.
Angostura Bark extract contains various proteins and alkaloids that act as antigens. Upon introduction into the skin, these antigens bind to IgE antibodies on the surface of mast cells. This triggers a signaling cascade involving tyrosine kinases (such as Syk), leading to an influx of calcium and the subsequent exocytosis of pre-formed granules. These granules contain histamine, heparin, and proteases. Histamine binds to H1 receptors on vascular endothelial cells, causing the 'wheal' (edema) and 'flare' (erythema) diagnostic response.
| Parameter | Value |
|---|---|
| Bioavailability | Negligible (Local) |
| Protein Binding | N/A |
| Half-life | 15-30 minutes (Local mediators) |
| Tmax | 15-20 minutes |
| Metabolism | Local Proteolysis |
| Excretion | Renal (as peptide fragments) |
Angostura Bark is a Non-Standardized Allergenic Extract. It belongs to the broader category of Biological Diagnostic Agents. Related medications include other food extracts (e.g., Peanut Extract, Almond Extract) and plant extracts (e.g., Ragweed Extract, Oak Extract).
Common questions about Oss-regen
In a medical context, Angostura Bark is primarily used as an allergenic extract for diagnostic skin testing. Healthcare providers use it to determine if a patient has a specific allergy to the bark or to products that contain it as a flavoring agent. By applying a small amount to the skin and observing the reaction, an allergist can confirm a Type I hypersensitivity. It is also historically known for its use in traditional medicine as a digestive tonic, though this is not its primary clinical use today. It is a key ingredient in some traditional bitters, which is why testing may be necessary for people with unexplained reactions to flavored beverages.
The most common side effects are localized to the site of the skin test and include itching, redness, and a raised bump known as a wheal. These symptoms are actually the intended result of a positive test and indicate that the body's immune system has recognized the allergen. Most of these local symptoms disappear within an hour or two after the test is completed. Some patients may also experience a 'delayed' reaction where the area becomes red or swollen several hours later. While uncomfortable, these common local reactions are generally not dangerous.
Alcohol should be avoided for at least 24 hours before and after undergoing a skin test with Angostura Bark extract. Alcohol can increase blood flow to the skin and may either mask a reaction or make a systemic reaction more severe. Furthermore, many alcoholic 'bitters' actually contain botanical extracts, and consuming them while being tested could complicate the diagnostic process. If you have had a systemic reaction to the test, your doctor will likely advise you to avoid alcohol for several days. Always follow the specific pre-test instructions provided by your allergy clinic.
Angostura Bark extract is generally avoided during pregnancy unless the diagnostic information is absolutely essential. While the extract itself is not known to cause birth defects, the risk of a systemic allergic reaction (anaphylaxis) poses a significant danger to the fetus by potentially reducing oxygen supply. If a pregnant woman requires testing, it must be done under strict medical supervision in a high-risk setting. Most doctors prefer to wait until after the baby is born to perform allergy skin tests. Always inform your allergist if you are or could be pregnant before the procedure begins.
When used for diagnostic skin testing, Angostura Bark extract works very quickly. A visible 'wheal and flare' reaction typically begins to appear within 5 to 10 minutes of the skin being pricked. The reaction usually reaches its peak size at approximately 15 to 20 minutes, which is when the healthcare provider will measure the results. If you are being tested for a delayed-type hypersensitivity (which is rare for this extract), the doctor may ask you to return 24 to 48 hours later. For standard IgE-mediated allergy testing, the entire process is completed in under half an hour.
Since Angostura Bark extract is used as a one-time diagnostic tool rather than a daily medication, there is no need to 'stop' taking it or worry about withdrawal symptoms. If you are undergoing a series of immunotherapy injections that include Angostura Bark, you should not stop the schedule without consulting your allergist, as this could affect your level of desensitization. However, for the vast majority of patients who only encounter this substance during a diagnostic panel, it is a single-exposure event. There are no long-term dependencies associated with allergenic extracts.
If you miss an appointment for an allergy skin test involving Angostura Bark, simply reschedule with your healthcare provider at your earliest convenience. There is no medical harm in delaying a diagnostic test. If you are on an immunotherapy 'build-up' phase and miss an injection, you must contact your allergist. Depending on how long it has been since your last dose, the doctor may need to maintain your current dose or even reduce it to ensure safety when you resume. Do not attempt to 'double up' or change your immunotherapy schedule on your own.
There is no clinical evidence to suggest that Angostura Bark extract causes weight gain. As a diagnostic agent used in minute quantities, it has no metabolic effect on body fat or muscle mass. Even if consumed as a flavoring agent in foods or bitters, the quantities are far too small to contribute significant calories or affect the hormones that regulate weight. If you are experiencing unexplained weight gain, it is likely due to other factors and should be discussed with your primary care physician. Angostura Bark is purely an immunological or flavoring agent.
Angostura Bark extract can interact with several medications, but primarily by interfering with the accuracy of the test or the safety of treating a reaction. Antihistamines, for example, will block the 'wheal and flare' and must be stopped before testing. More seriously, beta-blockers can make it difficult to treat a severe allergic reaction if one occurs during the test. You must provide your doctor with a full list of all medications, including over-the-counter drugs and supplements, before the test. Your doctor will tell you which medications need to be temporarily paused.
Angostura Bark extract is a non-standardized biological product, so the term 'generic' does not apply in the same way it does to chemical drugs like ibuprofen. Different biological manufacturers may produce their own versions of *Galipea officinalis* extract, and while they are essentially the same product, they are not considered interchangeable 'generics.' Each manufacturer's extract may have slightly different protein concentrations. Your allergist will typically use a consistent supplier to ensure that the results of your tests are as reproducible as possible.
Other drugs with the same active ingredient (Angostura Bark)