Loading...
Loading...
Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Non-Standardized Food Allergenic Extract [EPC]
Pulmonaria Officinalis Whole is a non-standardized food allergenic extract used primarily in the diagnosis and management of specific IgE-mediated hypersensitivity reactions. It belongs to the class of allergenic extracts regulated by the FDA Center for Biologics Evaluation and Research.
Name
Pulmonaria Officinalis Whole
Raw Name
PULMONARIA OFFICINALIS WHOLE
Category
Non-Standardized Food Allergenic Extract [EPC]
Drug Count
3
Variant Count
3
Last Verified
February 17, 2026
About Pulmonaria Officinalis Whole
Pulmonaria Officinalis Whole is a non-standardized food allergenic extract used primarily in the diagnosis and management of specific IgE-mediated hypersensitivity reactions. It belongs to the class of allergenic extracts regulated by the FDA Center for Biologics Evaluation and Research.
Detailed information about Pulmonaria Officinalis Whole
References used for this content
This page is for informational purposes only and does not replace medical advice. Consult a qualified healthcare professional before using any medication containing Pulmonaria Officinalis Whole.
Pulmonaria Officinalis Whole, commonly known as Lungwort, refers to a specific biological preparation derived from the entire plant of Pulmonaria officinalis. In a clinical and pharmacological context, this substance is classified as a Non-Standardized Food Allergenic Extract [EPC]. Unlike conventional medications such as antibiotics or antihypertensives, Pulmonaria Officinalis Whole is a complex biological mixture containing various proteins, glycoproteins, and polysaccharides that can trigger immune responses in sensitized individuals.
Historically, Pulmonaria officinalis has been used in traditional folk medicine for respiratory ailments, owing to the 'Doctrine of Signatures' (where the plant's spotted leaves resembled diseased lungs). However, in modern evidence-based medicine, its primary role is within the field of clinical immunology and allergy. As a non-standardized extract, it is used by allergists to diagnose Type I hypersensitivity (immediate-type allergy) through skin prick testing or, in specific research contexts, for allergen immunotherapy (AIT).
The FDA regulates these extracts under the Center for Biologics Evaluation and Research (CBER). Because it is 'non-standardized,' the potency of the extract is not measured against a national reference standard, unlike standardized extracts such as short ragweed or dust mites. Instead, it is typically prepared in a weight-to-volume (w/v) ratio or measured in Protein Nitrogen Units (PNU).
The mechanism of action for Pulmonaria Officinalis Whole is rooted in the pathophysiology of the human immune system, specifically the IgE-mediated allergic cascade. When the extract is introduced into the skin of a sensitized patient (via a skin prick or intradermal injection), the allergenic proteins in the extract cross-link specific Immunoglobulin E (IgE) antibodies that are bound to the surface of mast cells and basophils.
This cross-linking triggers a process called degranulation. During degranulation, mast cells release potent inflammatory mediators, most notably histamine, leukotrienes, and prostaglandins. These substances cause local vasodilation (widening of blood vessels) and increased capillary permeability, leading to the characteristic 'wheal and flare' reaction. The 'wheal' is a raised, itchy bump caused by fluid leakage, while the 'flare' is the surrounding redness caused by increased blood flow. By observing this reaction, healthcare providers can confirm if a patient has developed a specific immune sensitivity to the proteins found in Pulmonaria officinalis.
Traditional pharmacokinetic parameters (absorption, distribution, metabolism, and excretion) are applied differently to allergenic extracts compared to systemic drugs.
Pulmonaria Officinalis Whole is primarily indicated for:
Pulmonaria Officinalis Whole is typically available in the following forms:
> Important: Only your healthcare provider (typically an allergist or immunologist) can determine if Pulmonaria Officinalis Whole is right for your specific diagnostic or therapeutic needs. The use of this extract requires specialized equipment for managing potential emergency allergic reactions.
Dosage for Pulmonaria Officinalis Whole is highly individualized and depends entirely on the method of administration and the patient's sensitivity level.
For adults, the standard procedure involves applying one drop of the extract (typically at a concentration of 1:10 or 1:20 w/v) to the forearm or back. A sterile lancet is then used to prick the skin through the drop. A positive control (histamine) and a negative control (saline/glycerin) are always used simultaneously for comparison.
If the SPT is negative, an allergist may administer 0.02 mL to 0.05 mL of a highly diluted extract (e.g., 1:1000 w/v) into the intradermal layer of the skin. This is a much more sensitive test and carries a higher risk of systemic reaction.
If used for immunotherapy, the 'build-up' phase starts with extremely low doses (e.g., 0.05 mL of a 1:100,000 dilution) administered subcutaneously once or twice weekly. The dose is gradually increased over several months until a 'maintenance dose' is reached, which is then administered every 2 to 4 weeks.
Pulmonaria Officinalis Whole is generally considered safe for use in children, provided it is administered by a pediatric allergy specialist. Dosing for skin testing is identical to adult dosing, as the reaction is localized. However, healthcare providers often use fewer skin tests in very young children to minimize distress. Immunotherapy dosing for children is also similar to adults but requires even more cautious monitoring for systemic side effects.
No dosage adjustments are required for patients with renal impairment, as the systemic absorption of the allergenic proteins is negligible during standard diagnostic procedures.
No dosage adjustments are necessary for patients with liver disease.
Elderly patients may have reduced skin reactivity (reduced wheal and flare response) due to age-related changes in skin physiology. This may lead to false-negative results. Healthcare providers must interpret results cautiously in patients over age 65.
This medication is NEVER for self-administration. It must be administered by a healthcare professional in a clinical setting equipped with emergency resuscitation equipment (including epinephrine, oxygen, and IV fluids).
In the context of diagnostic testing, a missed appointment simply requires rescheduling. In the context of immunotherapy, a missed 'shot' can be problematic. If a dose is missed by more than a few days, the allergist may need to reduce the next dose to ensure safety and prevent a systemic reaction due to a loss of tolerance.
An 'overdose' in the context of allergenic extracts refers to the administration of too much allergen, leading to a systemic allergic reaction.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not attempt to use allergenic extracts outside of a supervised medical environment.
The most frequent side effects of Pulmonaria Officinalis Whole are localized to the site of administration. These are expected reactions and indicate that the test is working or that the immune system is responding.
> Warning: Stop the procedure and call for emergency help immediately if you experience any of the following symptoms of anaphylaxis. These can occur within seconds or minutes of exposure.
When used for diagnostic purposes, there are no known long-term side effects of Pulmonaria Officinalis Whole. In the context of long-term immunotherapy (3-5 years), the goal is to induce long-term immunological tolerance. There is no evidence that these extracts cause autoimmune diseases or chronic health conditions. However, repeated injections can occasionally lead to localized skin thickening (induration) at the injection site.
While non-standardized extracts like Pulmonaria Officinalis Whole may not always carry a formal 'Black Box Warning' in the same way as high-risk pharmaceuticals, the FDA requires all allergenic extracts to carry a prominent warning regarding the risk of Severe Systemic Allergic Reactions (Anaphylaxis).
Report any unusual symptoms, even if they seem mild, to your healthcare provider immediately during or after the procedure.
Pulmonaria Officinalis Whole is a biological product intended only for use by specialists. Because it contains active proteins capable of inducing an immune response, it must be handled with extreme caution. Patients should be in their baseline state of health before undergoing testing or treatment. If you are currently experiencing an asthma flare-up or a severe respiratory infection, your healthcare provider will likely postpone the administration of this extract.
No specific FDA black box warning exists uniquely for Pulmonaria Officinalis Whole beyond the general class warning for all allergenic extracts. This class warning emphasizes that allergenic extracts are not interchangeable and that the risk of anaphylaxis is ever-present. The potency of non-standardized extracts can vary between manufacturers and even between different lots from the same manufacturer, necessitating extreme care when switching vials.
Generally, Pulmonaria Officinalis Whole does not affect the ability to drive or operate machinery. However, if a patient experiences a systemic reaction or receives epinephrine, they should not drive until cleared by a medical professional. Some patients may feel lightheaded after skin testing due to anxiety or a vasovagal response.
Alcohol should be avoided for several hours before and after allergy testing. Alcohol can increase blood flow to the skin (vasodilation), which may potentially enhance the size of a skin test reaction or accelerate the systemic absorption of the allergen, increasing the risk of a reaction.
There are no 'withdrawal' symptoms associated with discontinuing Pulmonaria Officinalis Whole. If a patient stops an immunotherapy program prematurely, the primary risk is the return of allergy symptoms upon natural exposure to the plant.
> Important: Discuss all your medical conditions, especially respiratory or heart issues, with your healthcare provider before starting Pulmonaria Officinalis Whole.
While there are no absolute drug-drug contraindications that prevent the use of Pulmonaria Officinalis Whole, certain medications make its use significantly more dangerous:
There are no direct food interactions with Pulmonaria Officinalis Whole. However, if a patient has a known 'Oral Allergy Syndrome' (cross-reactivity between pollens and certain raw fruits/vegetables), they should inform their doctor, as this indicates a higher level of systemic sensitivity.
Pulmonaria Officinalis Whole does not interfere with standard blood chemistry or hematology labs. However, it is used specifically to correlate with In Vitro Specific IgE Tests (like RAST or ImmunoCAP). If a skin test is positive but the blood test is negative, the healthcare provider must use clinical judgment to determine the true allergy status.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, especially those for blood pressure, depression, or allergies.
Pulmonaria Officinalis Whole must NEVER be used in the following circumstances:
Conditions requiring a careful risk-benefit analysis include:
Pulmonaria officinalis belongs to the Boraginaceae family. Patients who are allergic to other members of this family (such as Borage, Comfrey, or Forget-me-nots) may show cross-reactivity. This means the immune system recognizes similar proteins in these different plants, potentially leading to a positive reaction even without direct prior exposure to Lungwort.
> Important: Your healthcare provider will evaluate your complete medical history and current health status before deciding to proceed with Pulmonaria Officinalis Whole testing.
Pulmonaria Officinalis Whole is classified as FDA Pregnancy Category C. This means that animal reproduction studies have not been conducted, and it is not known whether the extract can cause fetal harm. The primary risk during pregnancy is not the extract itself, but the potential for a systemic allergic reaction (anaphylaxis) in the mother. Anaphylaxis can lead to maternal hypotension and uterine contraction, which can cause fetal hypoxia or even fetal death.
Most allergists will continue maintenance doses of immunotherapy for women who become pregnant but will avoid increasing the dose or starting new diagnostic testing until after delivery.
It is not known whether the allergenic proteins or their metabolites are excreted in human milk. However, because the amount of protein administered during skin testing is extremely small and the systemic absorption is minimal, it is generally considered safe for breastfeeding mothers to undergo diagnostic testing. As always, the decision should be made in consultation with a healthcare provider.
Pulmonaria Officinalis Whole is used in the pediatric population for the diagnosis of allergic rhinitis and asthma. While there is no specific age cutoff, skin testing is rarely performed on infants under 6 months of age because their immune systems are still developing and skin reactivity is often low. In children, the psychological impact of needle-based testing must be considered, and healthcare providers often use multi-test devices to make the process faster and less painful.
In patients over age 65, the skin's reactivity to histamine and allergens tends to decrease. This can result in smaller wheal sizes, making the test harder to interpret. Furthermore, elderly patients are more likely to have co-existing cardiovascular conditions or be taking medications like beta-blockers, which increases the risk profile of allergenic extract administration.
There are no specific studies on the use of Pulmonaria Officinalis Whole in patients with renal impairment. However, given the localized nature of the administration and the proteinaceous nature of the drug (which is not cleared by the kidneys in its active form), no dosage adjustments are anticipated for patients with chronic kidney disease or those on dialysis.
Liver disease does not affect the metabolism of allergenic extracts. No dosage adjustments are required for patients with hepatic impairment or cirrhosis.
> Important: Special populations require an individualized medical assessment to ensure the benefits of testing outweigh the potential risks.
Pulmonaria Officinalis Whole acts as a biological trigger for the Type I Hypersensitivity reaction. The extract contains specific 'major' and 'minor' allergens—proteins that have been identified by the immune system as foreign. Upon contact with the skin's mast cells, these allergens bind to the Fab portion of IgE antibodies. This binding causes the IgE-FcεRI complexes to aggregate, signaling the mast cell to release its granules. The primary chemical released is histamine, which acts on H1 receptors in the local vasculature to cause the 'wheal' (edema) and 'flare' (erythema).
| Parameter | Value |
|---|---|
| Bioavailability | Negligible (Local administration) |
| Protein Binding | N/A (Drug is a protein mixture) |
| Half-life | Local degradation within hours |
| Tmax | 15-20 minutes (for skin reaction) |
| Metabolism | Local proteolytic cleavage |
| Excretion | Lymphatic clearance |
Pulmonaria Officinalis Whole extract is a complex mixture. Its chemical profile includes:
Pulmonaria Officinalis Whole is classified as a Non-Standardized Food Allergenic Extract [EPC]. It is grouped with other botanical extracts used in allergy, such as those for dandelion, goldenrod, or various tree pollens. It is distinct from 'Standardized Extracts,' which have been calibrated for specific biological potency (e.g., Bioequivalent Allergy Units - BAU).
Common questions about Pulmonaria Officinalis Whole
Pulmonaria Officinalis Whole is primarily used as a diagnostic tool in the field of allergy and immunology. Healthcare providers use this extract to perform skin prick tests or intradermal tests to determine if a patient has a specific allergy to the Lungwort plant. Identifying such an allergy helps in managing conditions like seasonal allergic rhinitis (hay fever) or allergic asthma. It is not a treatment for these conditions itself, but rather a way to identify the triggers that cause symptoms. In some specialized cases, it may be used in the formulation of allergen immunotherapy (allergy shots).
The most common side effects are localized to the area where the extract was applied to the skin. Patients typically experience a 'wheal and flare' reaction, which looks like a small, itchy, raised bump similar to a mosquito bite, surrounded by a patch of red skin. This reaction is actually the goal of a diagnostic test, as it indicates a positive result. Other common local effects include itching, mild swelling, and redness that usually resolve within a few hours. Systemic side effects are rare but can include sneezing or a mild headache.
It is generally advised to avoid alcohol consumption for at least 24 hours before and after undergoing allergy testing with Pulmonaria Officinalis Whole. Alcohol can cause vasodilation (widening of the blood vessels), which may increase the redness and swelling at the test site, potentially leading to an inaccurate reading. More importantly, alcohol could theoretically increase the speed at which the allergen is absorbed into the bloodstream, slightly increasing the risk of a systemic allergic reaction. Always follow the specific pre-test instructions provided by your allergist regarding food and drink.
The use of Pulmonaria Officinalis Whole during pregnancy is generally approached with significant caution. While the extract itself is not known to be toxic to the fetus, the risk of a systemic allergic reaction (anaphylaxis) in the mother poses a danger to the baby by potentially reducing oxygen flow. Most allergists will not start new allergy testing or increase the dose of allergy shots during pregnancy for this reason. However, if a woman is already on a stable maintenance dose of immunotherapy, it may sometimes be continued. You must inform your doctor immediately if you are pregnant or planning to become pregnant.
In the context of a diagnostic skin test, Pulmonaria Officinalis Whole works very rapidly. An immediate-type hypersensitivity reaction typically begins to appear within 5 to 10 minutes of the skin being pricked. The reaction usually reaches its maximum size (the 'peak') between 15 and 20 minutes after administration. This is why patients are required to wait in the doctor's office for a short period so the results can be accurately measured and the patient can be monitored for safety. If used in immunotherapy, the 'work' of desensitizing the immune system takes much longer, often requiring months or years of regular injections.
Since Pulmonaria Officinalis Whole is typically used for a one-time diagnostic test, 'stopping' it is not usually an issue. However, if you are receiving this extract as part of a long-term immunotherapy (allergy shot) program, you should not stop the treatment without consulting your allergist. Stopping suddenly will not cause withdrawal symptoms, but it will cause your immune system to lose the tolerance it has built up against the allergen. This means your allergy symptoms are likely to return when you are exposed to the plant in nature. Your doctor can help you decide the best way to conclude your treatment.
If you miss an appointment for a diagnostic skin test, you simply need to reschedule with your healthcare provider. If you are on an immunotherapy schedule and miss a 'shot,' it is important to contact your allergy clinic as soon as possible. Depending on how much time has passed since your last injection, your doctor may need to adjust (reduce) your next dose to ensure it is safe. Missing multiple doses can increase the risk of having a reaction when you restart, so consistency is key to both the safety and effectiveness of the treatment.
There is no clinical evidence to suggest that Pulmonaria Officinalis Whole causes weight gain. Unlike some other medications used for allergies, such as oral corticosteroids (like prednisone), allergenic extracts do not affect the body's metabolism or appetite. The amount of the substance used in testing or immunotherapy is extremely small—measured in micrograms of protein—which is not enough to have any systemic effect on body weight. If you experience unexplained weight gain while undergoing allergy treatment, you should discuss this with your primary care physician to look for other causes.
Pulmonaria Officinalis Whole can be used while taking many other medications, but there are important exceptions. Antihistamines (like Zyrtec, Benadryl, or Claritin) must be stopped several days before testing because they will block the skin reaction and lead to a false-negative result. More seriously, medications like beta-blockers (for blood pressure) can make it dangerous to receive allergenic extracts because they interfere with the treatment of a potential allergic reaction. Always provide your allergist with a complete and updated list of all medications, including over-the-counter drugs and supplements, before any procedure.
The concept of 'generic' vs. 'brand name' works differently for allergenic extracts than for standard pills. Pulmonaria Officinalis Whole is a biological product, and various laboratories may produce their own versions of the extract. These are generally considered 'non-standardized extracts' rather than generics. Because they are biological products derived from natural sources, extracts from different manufacturers may have slight variations in their protein composition. Therefore, allergists usually prefer to stay with the same manufacturer's extract during a patient's course of treatment to ensure consistency in dosing and response.