Loading...
Loading...
Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Crataegus, Magnolia Grandiflora, Passiflora Incarnata, Strophanthus Gratus
Brand Name
Unda 248
Generic Name
Crataegus, Magnolia Grandiflora, Passiflora Incarnata, Strophanthus Gratus
Active Ingredient
Crataegus FruitCategory
Standardized Chemical Allergen [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 4 [hp_X]/20mL | LIQUID | ORAL | 62106-1164 |
Detailed information about Unda 248
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Unda 248, you must consult a qualified healthcare professional.
Crataegus Fruit, commonly known as Hawthorn, is a botanical substance classified as a Standardized Chemical Allergen [EPC] and used clinically for cardiovascular support and allergenic testing.
The dosage of Crataegus Fruit varies significantly based on the formulation and the condition being treated. For standardized extracts used in cardiovascular support, the following ranges are typical:
For diagnostic allergenic testing, the dosage is determined by the specific protocol of the allergist and is typically measured in protein nitrogen units (PNU) or weight/volume (w/v) concentrations applied topically or intradermally.
Crataegus Fruit is generally not recommended for use in children under the age of 18. There is insufficient clinical data to establish the safety or efficacy of hawthorn extracts in pediatric populations. If a child is undergoing allergenic testing, the allergist will use specific pediatric protocols for the diagnostic extract, but oral supplementation should be avoided unless directed by a specialist.
There are no specific guidelines for dosage adjustments in patients with renal (kidney) impairment. However, since the metabolites are primarily excreted via the kidneys, patients with significant renal dysfunction should use Crataegus Fruit with caution and under close medical monitoring.
Because the liver is responsible for the extensive metabolism of hawthorn's polyphenolic compounds, patients with hepatic (liver) impairment may experience increased plasma concentrations of the drug. Dose reductions may be necessary, and liver function should be monitored if long-term use is planned.
Elderly patients often have a higher prevalence of cardiovascular disease and are more likely to be taking multiple medications (polypharmacy). While Crataegus is generally well-tolerated in the elderly, healthcare providers should start at the lower end of the dosing range and monitor for potential interactions with other heart medications.
If you miss a dose of Crataegus Fruit, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not double the dose to catch up, as this may increase the risk of side effects such as hypotension or palpitations.
Signs of an overdose of Crataegus Fruit may include:
In the event of a suspected overdose, seek emergency medical attention immediately or contact a poison control center. Treatment is generally supportive, focusing on maintaining blood pressure and heart rate.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance, especially if you are using Crataegus Fruit for a heart condition.
Crataegus Fruit is generally considered to have a favorable safety profile when used at recommended dosages. However, some individuals may experience common side effects, which are usually mild and transient. These include:
> Warning: Stop taking Crataegus Fruit and call your doctor immediately if you experience any of these serious symptoms.
There is limited data on the effects of Crataegus Fruit use exceeding six months to one year. Long-term use appears safe in most clinical trials, but there is a theoretical risk that prolonged modulation of cardiac receptors could lead to tolerance or changes in myocardial sensitivity. Periodic evaluation by a healthcare provider is essential for anyone using this substance long-term.
No FDA black box warnings currently exist for Crataegus Fruit. However, it is critical to note that Crataegus Fruit is not an FDA-approved treatment for heart failure in the same category as pharmaceutical drugs. It is often regulated as a dietary supplement or a diagnostic allergen, meaning the rigorous safety monitoring associated with prescription drugs may not be identical for all Crataegus products.
Report any unusual symptoms to your healthcare provider. Monitoring your heart rate and blood pressure at home can provide valuable data for your doctor to review during your appointments.
Crataegus Fruit is a pharmacologically active substance that can significantly influence cardiovascular function. It should not be viewed as a 'harmless' herbal tea or supplement. Patients with pre-existing heart conditions must consult a cardiologist before starting Crataegus Fruit, as it can interact with standard therapies and potentially complicate the management of heart failure or arrhythmias.
No FDA black box warnings for Crataegus Fruit.
Because Crataegus Fruit is classified as a Standardized Chemical Allergen [EPC], individuals with known allergies to plants in the Rosaceae family (including apples, pears, cherries, and roses) are at a higher risk of hypersensitivity reactions. Symptoms can range from mild itching to life-threatening anaphylaxis. If you have a history of severe seasonal allergies or food allergies, proceed with extreme caution.
Crataegus Fruit can lower blood pressure and alter heart rhythms. While these effects are often therapeutic, they can be dangerous in patients who already have low blood pressure (hypotension) or those with complex arrhythmias. It may also mask the worsening of heart failure symptoms, leading to a delay in seeking necessary conventional medical intervention.
Due to its potential effects on blood pressure and its mild antiplatelet activity, Crataegus Fruit should be discontinued at least two weeks prior to any scheduled surgery. Failure to do so may increase the risk of bleeding or cause unpredictable fluctuations in blood pressure during anesthesia.
If you are taking Crataegus Fruit for cardiovascular support, your healthcare provider may require the following monitoring:
Crataegus Fruit may cause dizziness, vertigo, or mild sedation in some users. You should determine how you react to the supplement before driving a vehicle or operating heavy machinery. If you experience lightheadedness, avoid these activities until the symptom resolves.
Alcohol should be used with caution while taking Crataegus Fruit. Both alcohol and hawthorn can lower blood pressure and cause vasodilation. Combining the two may lead to an increased risk of dizziness, fainting, or falls.
While Crataegus Fruit does not typically cause a withdrawal syndrome, it should not be stopped abruptly if being used to manage symptoms of heart failure or hypertension. Abrupt discontinuation could lead to a 'rebound' effect where symptoms return or worsen. Always consult your doctor for a tapering schedule if you decide to stop the medication.
> Important: Discuss all your medical conditions with your healthcare provider before starting Crataegus Fruit, especially if you have a history of heart disease, kidney disease, or severe allergies.
Phosphodiesterase-5 (PDE5) Inhibitors: Drugs such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra) must not be used in combination with Crataegus Fruit. Both substances promote vasodilation through pathways that increase cGMP or cAMP. Combining them can lead to a dangerous, precipitous drop in blood pressure (severe hypotension) that can be fatal.
Digoxin (Lanoxin): Crataegus Fruit may enhance the effects and toxicity of digoxin. Both substances have positive inotropic effects. Co-administration can lead to an increased risk of digitalis toxicity, characterized by nausea, vomiting, and serious heart rhythm disturbances. If used together, digoxin levels must be monitored very closely.
Nitrates: Medications like nitroglycerin, isosorbide mononitrate, and isosorbide dinitrate also cause vasodilation. Using Crataegus Fruit with nitrates can result in excessive lowering of blood pressure and increased heart rate (reflex tachycardia).
Antihypertensives: This includes beta-blockers (e.g., metoprolol), ACE inhibitors (e.g., lisinopril), and calcium channel blockers (e.g., amlodipine). Crataegus Fruit may additive-ly increase the blood-pressure-lowering effects of these drugs, potentially leading to dizziness or fainting.
Anticoagulants and Antiplatelets: Drugs like warfarin (Coumadin), clopidogrel (Plavix), and aspirin may interact with the flavonoids in Crataegus Fruit. There is a theoretical risk of increased bleeding time, though clinical evidence is mixed. Patients on blood thinners should have their INR monitored regularly.
Crataegus Fruit may interfere with the following laboratory tests:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. A complete medication review is necessary to prevent dangerous interactions.
Crataegus Fruit must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis include:
There is a high potential for cross-sensitivity between Crataegus Fruit and other botanical allergens. Patients who react to Rowanberry, Rose hips, or Stone fruits (peaches, plums) should be tested cautiously before using standardized Crataegus extracts. As a Standardized Chemical Allergen, the potential for cross-reactivity is a primary clinical consideration.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of fainting or heart rhythm issues, before prescribing or recommending Crataegus Fruit.
Crataegus Fruit is generally assigned a Category C status (using the older FDA system) or is simply considered 'not recommended' due to a lack of human clinical trials. Animal studies have been inconclusive regarding teratogenicity (birth defects). However, historical records suggest that certain hawthorn species may have uterine-stimulating properties, which could theoretically increase the risk of miscarriage or preterm labor. Therefore, Crataegus Fruit should be avoided entirely during all trimesters of pregnancy.
It is unknown whether the active constituents of Crataegus Fruit, such as vitexin or oligomeric procyanidins, are excreted into human breast milk. Because of the potential for these compounds to affect the cardiovascular system of a nursing infant, the use of Crataegus Fruit is not recommended for breastfeeding mothers. If treatment is deemed essential by a physician, breastfeeding should be discontinued.
The safety and effectiveness of Crataegus Fruit in children under 18 years of age have not been established. Most conditions for which Crataegus is used (such as heart failure or hypertension) are rare in children and require specialized pharmaceutical intervention. Pediatric use is restricted to diagnostic allergenic testing performed by a qualified immunologist.
Geriatric patients (aged 65 and older) may be more sensitive to the effects of Crataegus Fruit. There is an increased risk of orthostatic hypotension, which can lead to falls and fractures. Furthermore, the high rate of polypharmacy in the elderly increases the likelihood of drug-drug interactions. Clinical studies on standardized extracts like WS 1442 have included elderly participants and generally show good tolerability, but dose titration should be cautious.
In patients with significant renal impairment, the clearance of flavonoid metabolites may be reduced. While no specific dose-adjustment formulas exist (like those for creatinine clearance), a reduction in frequency or dose is advisable. Patients on dialysis should avoid Crataegus Fruit as its clearance via dialysis membranes has not been studied.
Patients with Child-Pugh Class B or C hepatic impairment should use Crataegus Fruit with extreme caution. The extensive hepatic metabolism of polyphenols means that liver dysfunction can lead to significantly elevated plasma levels, increasing the risk of side effects like bradycardia and hypotension. Liver enzyme monitoring is recommended for these patients.
> Important: Special populations require individualized medical assessment. Never start an herbal extract in these groups without consulting a specialist.
Crataegus Fruit exerts its effects through several molecular mechanisms. The primary action is the inhibition of 3',5'-cyclic adenosine monophosphate phosphodiesterase (PDE3). By inhibiting this enzyme, Crataegus increases the levels of cAMP within myocardial cells. This leads to an increase in the activity of protein kinase A (PKA), which phosphorylates calcium channels, increasing the influx of calcium during systole and enhancing the force of contraction (positive inotropy).
Additionally, Crataegus Fruit increases the refractory period of the heart's conduction system and possesses mild class III antiarrhythmic properties by modulating potassium channels. Its vasodilatory effect is mediated through the stimulation of endothelial nitric oxide synthase (eNOS), leading to increased nitric oxide production and relaxation of vascular smooth muscle.
The onset of action for Crataegus Fruit is slow. Unlike pharmaceutical inotropes, the effects of oral hawthorn extracts may take 3 to 6 weeks to become clinically apparent. The duration of effect after a single dose is approximately 4 to 8 hours. Tolerance does not appear to develop with long-term use, and some studies suggest a cumulative benefit over several months.
| Parameter | Value |
|---|---|
| Bioavailability | Low to Moderate (estimated <20% for OPCs) |
| Protein Binding | 60% - 90% (for various flavonoids) |
| Half-life | 3 to 5 hours (marker: Hyperoside) |
| Tmax | 1.5 to 2.5 hours |
| Metabolism | Hepatic (Phase II glucuronidation/sulfation) |
| Excretion | Renal (primarily as metabolites) |
Crataegus Fruit contains a complex mixture of:
It is soluble in ethanol and water-ethanol mixtures, which are commonly used for extraction. The molecular weight of the primary marker, Hyperoside, is 464.38 g/mol.
Crataegus Fruit is classified as a Standardized Chemical Allergen [EPC] and a Cholinergic Nicotinic Agonist [EPC]. In a therapeutic context, it is considered a cardiotonic botanical. It is related to other Crataegus preparations, such as Crataegus Leaf with Flower, which often contains higher concentrations of flavonoids compared to the fruit.
Common questions about Unda 248
Crataegus Fruit, or Hawthorn, is primarily used as a standardized allergen for diagnostic skin testing to identify plant sensitivities. Clinically, it is also used as an adjunctive treatment for mild heart failure (NYHA Class II) to improve symptoms like fatigue and shortness of breath. It works by supporting heart muscle contraction and promoting the dilation of blood vessels. Some people also use it as a supplement to help manage mild high blood pressure. However, it should only be used for these conditions under the strict guidance of a healthcare professional.
The most common side effects reported by users of Crataegus Fruit include mild gastrointestinal issues like nausea or stomach upset, as well as dizziness and headaches. Some individuals may also experience palpitations or a feeling of a racing heart. These symptoms are usually mild and tend to go away as the body becomes accustomed to the supplement. If these effects persist or become bothersome, you should contact your doctor. Rare but serious allergic reactions can also occur in people sensitive to the Rosaceae plant family.
It is generally advised to limit or avoid alcohol consumption while taking Crataegus Fruit. Both alcohol and hawthorn have the potential to lower blood pressure and cause blood vessels to widen (vasodilation). When used together, this effect can be amplified, leading to significantly low blood pressure, increased dizziness, and a higher risk of fainting or falling. If you choose to drink alcohol, do so in moderation and be aware of how your body reacts. Always discuss your alcohol consumption with your doctor when starting a new cardiac supplement.
Crataegus Fruit is not considered safe for use during pregnancy. There is a lack of rigorous clinical data regarding its effects on developing fetuses, and some evidence suggests it may have uterine-stimulating properties that could lead to complications. Because it can also affect blood pressure and heart function, the risks to both the mother and the baby are not well-defined. Breastfeeding women should also avoid Crataegus Fruit as it is unknown if the active compounds pass into breast milk. Always consult your obstetrician before taking any herbal products during pregnancy.
Unlike many fast-acting medications, Crataegus Fruit has a slow onset of action. Most clinical studies indicate that it takes between 4 and 12 weeks of consistent, daily use before significant improvements in heart function or exercise tolerance are noticed. It is not intended for the immediate relief of symptoms like acute chest pain or severe shortness of breath. Because the effects develop gradually, it is important to take the supplement exactly as prescribed by your healthcare provider. If you do not notice any improvement after 3 months, consult your doctor.
You should not stop taking Crataegus Fruit suddenly if you are using it to manage a chronic condition like heart failure or high blood pressure. While it does not cause a typical 'addiction' or withdrawal, stopping it abruptly could cause your symptoms to return or worsen as the cardiovascular support is removed. It is always safest to talk to your healthcare provider before discontinuing any long-term treatment. They may recommend a gradual reduction in dose to ensure your heart remains stable during the transition. Never stop your standard heart medications in favor of Crataegus Fruit.
If you miss a dose of Crataegus Fruit, you should take it as soon as you remember. However, if it is nearly time for your next scheduled dose, you should skip the missed dose and simply take the next one at the regular time. Do not take two doses at once to make up for the one you missed, as this can increase the risk of side effects like low blood pressure or dizziness. Keeping a consistent schedule is key to the effectiveness of the treatment. Using a pill organizer or setting a daily reminder can help you stay on track.
There is no clinical evidence to suggest that Crataegus Fruit causes weight gain. In fact, because it is sometimes used to improve exercise tolerance in patients with mild heart failure, it might indirectly support weight management by allowing for more physical activity. Most reported side effects are related to the digestive or cardiovascular systems rather than metabolic changes. If you experience sudden or unexplained weight gain while taking this supplement, it could be a sign of worsening heart failure (fluid retention) and you should contact your doctor immediately.
Crataegus Fruit has several significant drug interactions and should be used cautiously with other medications. It can interact dangerously with ED drugs like Viagra, heart medications like Digoxin, and various blood pressure drugs or blood thinners. Because it affects heart rhythm and blood vessel diameter, combining it with other drugs that have similar effects can lead to complications. You must provide your doctor with a full list of all prescription drugs, over-the-counter medicines, and other herbal supplements you are taking. This allows them to screen for potential interactions and ensure your safety.
Crataegus Fruit is not a prescription drug with a brand-name/generic distinction in the traditional sense; it is a botanical extract. It is available under many different brand names as a dietary supplement or standardized extract. When looking for a high-quality product, you should look for one that is 'standardized' to contain a specific amount of active ingredients, such as 2.2% flavonoids or 18.75% oligomeric procyanidins. This ensures you are getting a consistent dose. Always choose products that have been third-party tested for purity and accuracy of labeling.
Other drugs with the same active ingredient (Crataegus Fruit)