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Dosage for Allium Sativum Whole is not standardized by a fixed milligram amount but is instead determined by the concentration of the extract, often expressed as a weight/volume (w/v) ratio or in Protein Nitrogen Units (PNU).

• Percutaneous Testing (Skin Prick): Typically, a 1:10 or 1:20 w/v glycerinated extract is used. A single drop is applied to the skin, and a sterile lancet is used to prick the epidermis.
• Intradermal Testing: If the prick test is negative but clinical suspicion remains high, a more dilute concentration (ranging from 1:100 to 1:1000 w/v) may be administered. The volume injected is usually 0.02 mL to 0.05 mL, creating a small bleb on the skin.

Allium Sativum Whole is generally considered safe for use in children, provided it is administered by a pediatric allergist.

• Infants and Children: The procedure is identical to adult testing, though fewer tests may be performed in a single session to minimize discomfort.
• Dosage Adjustments: No specific dose adjustment is required based on age, but the interpretation of the wheal size must account for the smaller surface area and different skin reactivity of pediatric patients. It is not recommended for infants under 6 months of age unless absolutely necessary, as their skin reactivity is often diminished.

Renal Impairment

No dosage adjustment is required for patients with renal impairment, as the systemic absorption of the extract is minimal during diagnostic testing. However, clinicians should monitor for any delayed clearance of systemic inflammatory mediators if a reaction occurs.

Hepatic Impairment

No dosage adjustment is required for patients with hepatic impairment. The metabolism of allergenic proteins does not rely on hepatic pathways.

Elderly Patients

In patients over 65, skin reactivity may be reduced due to age-related changes in skin turgor and mast cell density. This may lead to smaller wheal sizes, potentially resulting in false-negative results. Healthcare providers may use a positive histamine control to verify skin reactivity.

This medication is never self-administered. It is administered by a healthcare professional in a clinical setting.

• Preparation: The skin (usually the forearm or back) is cleaned with alcohol.
• Administration: The extract is applied via the percutaneous or intradermal route.
• Observation: The patient must remain in the clinic for at least 30 minutes following administration to monitor for systemic reactions or anaphylaxis.
• Storage: The extract must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). It should never be frozen, as freezing can denature the allergenic proteins, rendering the extract ineffective.

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 need to 'catch up' on doses. If a patient is undergoing immunotherapy and misses a scheduled injection, the healthcare provider will determine if the dose needs to be reduced to prevent a reaction when resuming treatment.

An overdose in the context of allergenic extracts refers to the administration of a concentration that is too high for the patient's level of sensitivity, or an accidental subcutaneous injection instead of an intradermal one.

• Signs of Overdose: Rapid onset of a very large local wheal (greater than 20mm), generalized itching, hives, swelling of the throat, wheezing, or a drop in blood pressure.
• Emergency Measures: Immediate administration of epinephrine (0.3mg for adults, 0.15mg for children) via intramuscular injection, followed by antihistamines, corticosteroids, and emergency transport to a hospital if symptoms persist.

> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or attempt to use these extracts without medical guidance.

The most frequent side effects of Allium Sativum Whole are localized to the site of administration. These are expected responses in sensitized individuals.

• Localized Wheal: A raised, pale, or skin-colored bump at the test site, appearing within 15-20 minutes. It may feel firm to the touch.
• Erythema (Flare): A redness of the skin surrounding the wheal. This is caused by the dilation of local blood vessels and can range from a few millimeters to several centimeters in diameter.
• Pruritus (Itching): Intense itching at the site of the test is very common. This usually subsides within 1 to 2 hours as the histamine is metabolized.
• Local Warmth: The area may feel warm or slightly tender for a short period.

• Delayed Local Reaction: Some patients may experience swelling or redness at the site 6 to 24 hours after the test. This is typically a Type IV hypersensitivity response and is usually managed with cold compresses.
• Lymphangitis: Occasionally, a red 'streak' may appear extending from the test site toward the nearest lymph node, indicating a localized inflammatory spread.
• Fatigue: Some patients report feeling unusually tired or 'drained' for a few hours after a significant allergic response is triggered during testing.

• Generalized Urticaria: Hives appearing on parts of the body far away from the test site.
• Angioedema: Swelling of the deeper layers of the skin, often affecting the lips, eyelids, or extremities.
• Vasovagal Reaction: Fainting or lightheadedness, often triggered by the needle prick or the sight of blood/needles rather than the extract itself.

> Warning: Stop the procedure and call for emergency assistance immediately if you experience any of the following symptoms of anaphylaxis.

• Respiratory Distress: Difficulty breathing, wheezing, or a persistent cough. This indicates airway constriction.
• Laryngeal Edema: A feeling of 'tightness' in the throat, difficulty swallowing, or a change in voice (hoarseness).
• Hypotension: A sudden drop in blood pressure, which may manifest as severe dizziness, confusion, or loss of consciousness.
• Tachycardia: A rapid or pounding heartbeat as the body attempts to compensate for systemic inflammation.
• Gastrointestinal Distress: Sudden, severe abdominal cramping, vomiting, or diarrhea can be a sign of a systemic allergic reaction.

Because Allium Sativum Whole is typically used for short-term diagnostic purposes, long-term side effects are extremely rare.

• Granuloma Formation: In very rare cases, a small, hard knot (granuloma) may form under the skin at the site of an intradermal injection. This is a chronic inflammatory response to the glycerin or the proteins in the extract.
• Skin Discoloration: Persistent hyperpigmentation or hypopigmentation at the test site may occur in individuals with certain skin types, though this usually fades over several months.

While Allium Sativum Whole may not have a specific individual black box warning for the garlic component itself, the entire class of Allergenic Extracts carries a general FDA-mandated warning regarding the risk of severe systemic reactions.

Summary of Warning: Allergenic extracts can cause severe life-threatening systemic reactions, including anaphylaxis. Patients should only be tested or treated in facilities where emergency equipment and personnel trained in treating anaphylaxis are immediately available. Patients should be observed for at least 30 minutes. Patients with unstable asthma or those taking beta-blockers may be at increased risk and may be less responsive to epinephrine.

Report any unusual symptoms to your healthcare provider immediately. Even a mild systemic reaction should be documented to prevent more severe future occurrences.

Allium Sativum Whole is a potent biological substance that must be handled with extreme caution. It is intended only for diagnostic or therapeutic use by clinicians experienced in the management of allergic diseases. Patients must provide a full medical history, including any previous reactions to garlic, onions, or other members of the Amaryllidaceae family, before the extract is used.

No specific FDA black box warning exists uniquely for Allium Sativum Whole; however, it falls under the collective class warning for all allergenic extracts. This warning emphasizes that these products can cause anaphylaxis and must be administered in a supervised medical setting. The warning also notes that the potency of non-standardized extracts can vary between manufacturers and even between different lots from the same manufacturer, necessitating careful 'bridging' or dose adjustment when switching vials.

• Anaphylaxis Risk: The primary risk is a systemic IgE-mediated reaction. This risk is higher in patients who are highly sensitive or those undergoing intradermal testing after a prick test.
• Asthma Status: Patients with poorly controlled or unstable asthma are at a significantly higher risk for severe, potentially fatal bronchospasm if a systemic reaction occurs. Testing should be postponed until asthma is well-controlled (e.g., FEV1 > 80% of predicted).
• Beta-Blocker Use: Patients taking beta-blockers (medications for blood pressure or heart conditions) may not respond effectively to epinephrine if anaphylaxis occurs. This is a critical safety consideration.
• Infection: Testing should not be performed if the patient has an active systemic infection or a severe skin condition (like widespread eczema) at the test site, as this can interfere with results and increase the risk of adverse events.

• Post-Administration Observation: A mandatory 30-minute wait period is required after any skin test or injection. Most severe reactions occur within this window.
• Vitals Monitoring: In patients with a history of severe reactions, baseline blood pressure and heart rate may be taken before and after the procedure.
• Lung Function: For patients with asthma, a peak flow or spirometry measurement may be performed prior to testing to ensure safety.

Allium Sativum Whole does not typically cause sedation or cognitive impairment. However, if a patient experiences a systemic reaction or receives epinephrine, they should not drive or operate machinery until they have fully recovered and been cleared by a physician.

Alcohol consumption should be avoided for 24 hours before and after testing. Alcohol can increase cutaneous blood flow (vasodilation), which may lead to larger-than-normal skin reactions or potentially accelerate the absorption of the extract into the bloodstream.

In the diagnostic setting, 'discontinuation' involves stopping the test if a systemic reaction begins. In an immunotherapy setting, treatment may be permanently discontinued if the patient suffers a life-threatening reaction or fails to show clinical improvement after an adequate trial period.

> Important: Discuss all your medical conditions, especially heart or lung problems, with your healthcare provider before starting Allium Sativum Whole.

While there are few absolute contraindications for drug combinations, the following should be avoided to ensure safety and accuracy:

• Beta-Blockers (e.g., Propranolol, Atenolol): These medications can block the effects of epinephrine. If a patient on a beta-blocker has an anaphylactic reaction to Allium Sativum Whole, the standard treatment (epinephrine) may fail, leading to a medical emergency. Healthcare providers will often weigh the necessity of the test against this risk.

• ACE Inhibitors (e.g., Lisinopril): Some evidence suggests that ACE inhibitors may increase the severity of anaphylactic reactions or interfere with the body's natural compensatory mechanisms during an allergic event.
• MAO Inhibitors (e.g., Phenelzine): These can potentiate the effects of epinephrine if it must be administered, leading to dangerous spikes in blood pressure.

The following drugs may interfere with the accuracy of the skin test by suppressing the wheal and flare response:

• First-Generation Antihistamines (e.g., Diphenhydramine): Must be stopped 3 to 5 days before testing.
• Second-Generation Antihistamines (e.g., Loratadine, Cetirizine): Must be stopped 7 to 10 days before testing.
• Tricyclic Antidepressants (e.g., Amitriptyline): These have potent antihistamine properties and can suppress skin reactions for up to 2 weeks.
• H2 Blockers (e.g., Famotidine): May have a minor inhibitory effect on the skin's response to histamine.

• Fresh Garlic: Consuming large amounts of fresh garlic before a test may theoretically desensitize or prime the immune system, leading to inconsistent results. It is best to avoid garlic consumption for 48 hours prior to testing.
• Caffeine: High doses of caffeine can cause mild bronchodilation and may slightly mask early respiratory symptoms of an allergic reaction.

• St. John's Wort: May affect the metabolism of other medications used to treat allergic reactions.
• High-Dose Vitamin C: Some studies suggest Vitamin C has mild antihistamine properties which could theoretically diminish the skin test response.

• Skin Testing: Allium Sativum Whole will directly interfere with any other skin tests being performed simultaneously if the sites are too close together (due to overlapping flares).
• Serum IgE: The administration of the extract for testing does not typically alter the results of blood-based allergy tests (e.g., ImmunoCAP).

For each major interaction, the mechanism involves either the pharmacological suppression of histamine (leading to false negatives) or the interference with emergency rescue medications (increasing safety risks). Management involves a 'washout' period where the interfering drug is stopped under medical supervision before the test is performed.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, especially those for allergies, depression, or blood pressure.

Allium Sativum Whole must NEVER be used in the following circumstances:

• Previous Severe Systemic Reaction: If a patient has previously experienced life-threatening anaphylaxis specifically to this extract or to garlic proteins where the risk of testing outweighs any diagnostic benefit.
• Severe, Uncontrolled Asthma: Patients with an FEV1 (Forced Expiratory Volume) consistently below 70-80% of predicted values are at an unacceptable risk for fatal bronchospasm during testing.
• Acute Infection: Testing during a fever or systemic illness can lead to unpredictable immune responses and may worsen the patient's condition.

Conditions requiring a careful risk-benefit analysis include:

• Pregnancy: While not strictly contraindicated, skin testing is usually postponed until after delivery to avoid the risk of anaphylaxis-induced uterine contractions or fetal hypoxia.
• Beta-Blocker Therapy: As noted, this complicates the treatment of potential anaphylaxis.
• Dermatographism: A condition where any pressure on the skin causes a hive. This makes interpreting the results of a skin prick test nearly impossible.
• Severe Eczema/Psoriasis: If the skin at the testing site is compromised, the extract cannot be administered safely or accurately.

Patients who are allergic to Allium Sativum Whole may also react to other members of the Alliaceae family. This is known as cross-reactivity and occurs because these plants share similar protein structures. Related substances include:

• Onions (Allium cepa)
• Leeks (Allium porrum)
• Chives (Allium schoenoprasum)
• Shallots

If you have a known severe allergy to any of these, your healthcare provider will exercise extra caution when using Allium Sativum Whole extract.

> Important: Your healthcare provider will evaluate your complete medical history and current health status before deciding to proceed with Allium Sativum Whole testing.

Allium Sativum 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 when administered to a pregnant woman. The primary concern during pregnancy is not the extract itself, but the potential for a systemic allergic reaction (anaphylaxis). Anaphylaxis can cause maternal hypotension, leading to reduced placental blood flow and fetal hypoxia (lack of oxygen). Consequently, most allergists recommend postponing diagnostic skin testing and the initiation of immunotherapy until after delivery unless the information is critical for the immediate management of the patient.

It is not known whether the antigenic components of Allium Sativum Whole are excreted in human milk. Because these are large proteins and the amount administered during skin testing is miniscule, it is highly unlikely that a nursing infant would be exposed to significant amounts. However, the decision to use the extract in a breastfeeding mother should be made by weighing the diagnostic necessity against any theoretical risk to the infant. No adverse effects in nursing infants have been documented following maternal skin testing.

Allium Sativum Whole is used in the pediatric population for the diagnosis of food allergies. The safety profile in children is generally similar to that in adults. However, clinicians must be aware that infants under the age of 2 may have lower skin reactivity, which can lead to false negatives. In children, the psychological impact of needle-based testing should be considered, and the number of tests should be limited to the minimum necessary for diagnosis. There is no evidence that skin testing with garlic extract affects growth or development in children.

In elderly patients (over age 65), the skin undergoes physiological changes, including atrophy of the dermis and a reduction in the number of mast cells. This often results in a diminished wheal and flare response. Healthcare providers should use a histamine positive control to ensure the patient's skin is capable of reacting. Additionally, older adults are more likely to be taking medications like beta-blockers or ACE inhibitors, which increases the risk profile of allergenic extract administration.

There are no specific studies of Allium Sativum Whole in patients with renal impairment. However, since the extract is used locally and in very small quantities, renal function does not typically impact the safety or efficacy of the test. No dose adjustments are required for patients with chronic kidney disease or those on dialysis.

Liver function does not affect the processing of allergenic extracts. The antigens are processed by the immune system and local proteases rather than hepatic enzymes. No dosage adjustments are needed for patients with cirrhosis or other forms of hepatic impairment.

> Important: Special populations require individualized medical assessment. Always inform your provider about pregnancy, breastfeeding, or chronic health conditions.

Allium Sativum Whole functions as a source of exogenous antigens. The primary active components are proteins, specifically alliin lyase (All s 1), which is a 54-kDa protein. When these proteins are introduced into the skin, they bind to specific IgE antibodies located on the surface of mast cells. This binding causes the IgE molecules to cluster (cross-link), which signals the mast cell to release its internal stores of inflammatory mediators. This is a classic Type I, IgE-mediated hypersensitivity reaction.

The pharmacodynamic effect is measured by the size of the wheal (edema) and flare (erythema).

• Onset: The reaction typically begins within 5 minutes of administration.
• Peak: The maximum wheal size is usually reached between 15 and 20 minutes.
• Duration: The visible reaction generally fades within 60 to 120 minutes, although the site may remain sensitive for several hours.
• Dose-Response: There is a direct correlation between the concentration of the extract and the size of the reaction, up to a 'saturation point' where all available IgE sites are occupied.

| Parameter | Value |

|---|---|

| Bioavailability | Negligible (Local administration) |

| Protein Binding | High (to IgE on mast cells) |

| Half-life | 2-4 hours (Local tissue residence) |

| Tmax | 15-20 minutes (for wheal formation) |

| Metabolism | Local Proteolysis |

| Excretion | Lymphatic clearance |

• Molecular Formula: Complex biological mixture (contains C, H, N, O, S in various protein structures).
• Molecular Weight: Ranges from 10 kDa to over 100 kDa for various garlic proteins.
• Solubility: Soluble in aqueous buffers and glycerin-saline solutions.
• Structure: The extract contains a variety of proteins, glycoproteins, and polysaccharides derived from the whole garlic bulb. The most clinically relevant allergen is the enzyme alliin lyase.

Allium Sativum Whole is classified as a Non-Standardized Food Allergenic Extract. It is grouped with other vegetable extracts like onion, asparagus, and leek extracts. Unlike 'standardized' extracts (like grass pollen or dust mites), the potency of garlic extract is not measured by bioequivalent allergy units (BAU) but by its weight/volume concentration.