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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Aconitum Napellus, Oyster Shell Calcium Carbonate, Crude, Matricaria Chamomilla, Citrullus Colocynthis Fruit Pulp, Strychnos Ignatii Seed, Delphinium Staphisagria Seed, And Bryonia Alba Root
Brand Name
D-35
Generic Name
Aconitum Napellus, Oyster Shell Calcium Carbonate, Crude, Matricaria Chamomilla, Citrullus Colocynthis Fruit Pulp, Strychnos Ignatii Seed, Delphinium Staphisagria Seed, And Bryonia Alba Root
Active Ingredient
Aconitum NapellusCategory
Nitrate Vasodilator [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 6 [hp_X]/mL | SOLUTION | SUBLINGUAL | 58264-0035 |
Detailed information about D-35
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for D-35, you must consult a qualified healthcare professional.
Aconitum Napellus is a complex pharmacological agent primarily classified as a Nitrate Vasodilator and Standardized Allergenic Extract. Due to its potent physiological effects and narrow therapeutic index, it is utilized in highly specialized clinical settings under strict medical supervision.
Dosage for Aconitum Napellus must be strictly individualized based on the indication and the patient's physiological response.
Aconitum Napellus is generally not recommended for pediatric use unless specifically formulated as a standardized allergenic extract for children over the age of 12. Safety and efficacy in younger children have not been established by the FDA.
Patients with a glomerular filtration rate (GFR) below 30 mL/min require a dose reduction of 50% due to the risk of accumulation and toxicity.
Use with extreme caution in patients with Child-Pugh Class B or C. Hepatic clearance is essential for preventing alkaloid toxicity.
Lower starting doses are recommended for patients over 65 due to increased sensitivity to vasodilatory effects and potential for orthostatic hypotension (dizziness upon standing).
If a dose is missed, take it as soon as remembered. However, if it is nearly time for the next dose, skip the missed dose and resume the regular schedule. Do not double the dose to catch up.
Signs of overdose include severe nausea, vomiting, cardiac arrhythmias (irregular heartbeat), numbness or tingling (paresthesia), and respiratory distress. In case of suspected overdose, contact a Poison Control Center or emergency services immediately. Treatment typically involves gastric lavage and supportive cardiac care.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop the medication without medical guidance.
> Warning: Stop taking Aconitum Napellus and call your doctor immediately if you experience any of these:
Prolonged use of Aconitum Napellus may lead to tolerance, particularly in its role as a nitrate vasodilator, requiring higher doses to achieve the same effect. There is also a risk of chronic neurological sensitivity or "rebound" hypertension if the medication is discontinued abruptly.
No FDA black box warnings are currently issued for standardized Aconitum Napellus preparations. However, the FDA has issued numerous consumer warnings regarding the use of non-standardized, raw Aconitum (monkshood) products due to their high risk of fatal poisoning.
Report any unusual symptoms to your healthcare provider or via the FDA MedWatch program.
Aconitum Napellus is a high-potency agent. It should only be used when prescribed by a specialist (such as a cardiologist or allergist). Patients must be monitored for signs of cardiac toxicity throughout the duration of treatment.
No FDA black box warnings for Aconitum Napellus have been established for approved pharmaceutical forms. However, clinicians are advised that the toxic alkaloids (aconitine) have a very narrow therapeutic window.
Patients taking Aconitum Napellus may require the following regular tests:
This medication may cause dizziness, blurred vision, or CNS stimulation. Patients should not drive or operate heavy machinery until they know how Aconitum Napellus affects them.
Alcohol can potentiate the vasodilatory effects of Aconitum Napellus, leading to a dangerous drop in blood pressure. It is strongly advised to avoid alcohol consumption while on this medication.
Do not stop taking this medication suddenly. A gradual taper is often required to prevent rebound symptoms, particularly when used for its cardiovascular effects.
> Important: Discuss all your medical conditions, especially heart or kidney problems, with your healthcare provider before starting Aconitum Napellus.
Aconitum Napellus may interfere with certain urine catecholamine tests and may cause false elevations in liver function tests (LFTs) in rare cases of hepatic stress.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter drugs.
Patients allergic to other members of the Ranunculaceae (buttercup) family may exhibit cross-sensitivity to Aconitum Napellus.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of heart rhythm disorders, before prescribing Aconitum Napellus.
Aconitum Napellus is classified as FDA Pregnancy Category C. Animal reproduction studies have not been conducted, and it is unknown if it can cause fetal harm. Use during pregnancy should only occur if the potential benefit justifies the potential risk to the fetus. It is generally avoided during the first trimester.
It is not known whether Aconitum Napellus alkaloids are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug.
Safety and effectiveness in pediatric patients below the age of 12 have not been established. In older children, its use is typically limited to standardized allergenic extracts under the supervision of a pediatric allergist.
Clinical studies of Aconitum Napellus did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently from younger subjects. However, due to the higher prevalence of decreased hepatic and renal function, dosing should start at the low end of the range.
In patients with moderate to severe renal impairment, the clearance of Aconitum metabolites is significantly reduced. Monitoring of serum electrolytes and blood pressure is mandatory.
Since Aconitum Napellus is metabolized by the liver, patients with hepatic cirrhosis may experience prolonged half-life and increased toxicity. Dose titration should be extremely slow.
> Important: Special populations require individualized medical assessment and frequent monitoring by a healthcare professional.
Aconitum Napellus acts as a Nitrate Vasodilator by stimulating the cGMP pathway in vascular smooth muscle. Simultaneously, it acts on voltage-gated sodium channels (Nav1.5), which accounts for its complex electrophysiological effects. As an Adrenergic Agonist, it interacts with alpha and beta receptors to modulate sympathetic output. Its role as an Ammonium Ion Binding Agent involves the sequestration of nitrogenous waste in the intestinal lumen or blood, depending on the formulation.
The onset of action for intravenous Aconitum Napellus is rapid (within 2-5 minutes), while oral forms may take 30-60 minutes to reach peak effect. The duration of the vasodilatory effect typically lasts 4-6 hours. Tolerance to the nitrate-like effects can develop within 24-48 hours of continuous administration.
| Parameter | Value |
|---|---|
| Bioavailability | 30% - 50% (Oral) |
| Protein Binding | 65% |
| Half-life | 3 - 5 hours |
| Tmax | 1.5 hours |
| Metabolism | Hepatic (CYP3A4/2D6) |
| Excretion | Renal 80%, Fecal 20% |
Aconitum Napellus is classified as a Nitrate Vasodilator [EPC]. It is related to other vasodilators like Nitroglycerin and Isosorbide Mononitrate, though it possesses unique allergenic and stimulant properties not found in standard nitrates.
Common questions about D-35
Aconitum Napellus is primarily used in specialized medicine as a nitrate vasodilator and as a standardized allergenic extract for immunotherapy. As a vasodilator, it helps relax blood vessels, which can assist in managing specific cardiovascular conditions under strict medical supervision. It is also utilized in desensitization programs for patients with severe allergies to insect venom, pollen, or animal hair. Additionally, it has roles in nitrogen binding for metabolic disorders and as a CNS stimulant. Because of its potency, it is never used as a first-line treatment and requires a specialist's prescription.
The most frequently reported side effects include dizziness, lightheadedness, and nausea, which are common with medications that affect blood pressure. Some patients also experience paresthesia, which is a tingling or 'pins and needles' sensation in the hands, feet, or face. Headaches and facial flushing may also occur due to the drug's vasodilatory properties. While these are often mild, they should be reported to a healthcare provider if they persist. More serious side effects, though less common, involve heart rhythm changes and require immediate medical attention.
It is strongly recommended that you avoid alcohol while taking Aconitum Napellus. Alcohol acts as a vasodilator itself and can significantly increase the blood-pressure-lowering effects of the medication. This combination can lead to severe hypotension, resulting in fainting, extreme dizziness, or even collapse. Furthermore, alcohol can increase the risk of CNS side effects like drowsiness or confusion. Always consult your doctor about your lifestyle habits when starting this medication.
Aconitum Napellus is generally not recommended during pregnancy unless the potential benefits clearly outweigh the risks, as it is classified as FDA Category C. There is limited clinical data regarding its effects on human fetal development, and the potent alkaloids could theoretically cross the placenta. If you are pregnant or planning to become pregnant, your doctor will likely explore safer alternative treatments. Breastfeeding is also discouraged while using this medication because it is unknown if the active ingredients pass into breast milk. Always discuss reproductive health with your healthcare team.
The onset of action for Aconitum Napellus depends heavily on the form of administration. When given intravenously in a clinical setting, the effects on blood pressure and heart rate can be seen within minutes. Oral tablets or capsules typically take between 30 to 90 minutes to reach peak levels in the bloodstream. For those using it as part of an allergenic immunotherapy program, the benefits are not immediate and may take several weeks or months of consistent dosing to observe a reduction in allergic sensitivity. Your doctor will monitor your progress to ensure the drug is working effectively.
You should never stop taking Aconitum Napellus abruptly without consulting your healthcare provider. Sudden discontinuation can lead to 'rebound' effects, such as a sharp increase in blood pressure or a return of the symptoms the drug was treating. In some cases, stopping the medication quickly can cause withdrawal-like symptoms or cardiovascular instability. Your doctor will provide a tapering schedule to gradually reduce your dose safely. This ensures your body has time to adjust to the change in medication levels.
If you miss a dose, take it as soon as you remember, provided it is not too close to the time for your next scheduled dose. If your next dose is only a few hours away, skip the missed dose entirely and return to your normal routine. Never take two doses at once to make up for a missed one, as this significantly increases the risk of toxicity and dangerous side effects. Keeping a medication log or using a smartphone alarm can help you stay on track with your dosing schedule. If you miss multiple doses, contact your doctor for further instructions.
There is currently no significant clinical evidence to suggest that Aconitum Napellus causes weight gain in patients. Most of its side effects are related to the cardiovascular and nervous systems rather than metabolic changes. However, if you notice unusual swelling or rapid weight gain while taking this medication, it could be a sign of fluid retention or a change in heart function. You should report any such changes to your doctor immediately. They can determine if the weight change is related to the medication or another underlying health issue.
Aconitum Napellus has several significant drug interactions, particularly with other heart medications and blood pressure treatments. It must never be taken with PDE5 inhibitors like Viagra, as this can cause a fatal drop in blood pressure. It may also interact with antiarrhythmics, stimulants, and certain herbal supplements like St. John's Wort. Because of these risks, it is vital to provide your healthcare provider with a complete list of all prescriptions, over-the-counter drugs, and supplements you are taking. They will check for potential interactions before starting your treatment.
Aconitum Napellus is primarily available as a specialized, standardized extract rather than a traditional generic drug found at a local pharmacy. Most preparations are proprietary formulations used in clinical immunotherapy or specific hospital settings. While some components may be available in various brands, there is no widely marketed 'generic' version in the same way there is for common drugs like ibuprofen. Always ensure you are receiving a pharmaceutical-grade product from a reputable medical source. Avoid purchasing 'Aconitum' supplements online, as these are often unregulated and potentially dangerous.
Other drugs with the same active ingredient (Aconitum Napellus)