Oleander 3 DH. Other Ingredients: Ethyl Alcohol.
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In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
This is a homeopathic preparation. Homeopathy is a system of medicine established in the 19th century by a German physician named Samuel Hahnemann. Its basic principles are that "like treats like" and "potentiation through dilution." For example, in homeopathy, diarrhea would be treated with an extreme dilution of a substance that normally causes diarrhea when taken in high doses.
Practitioners of homeopathy believe that more dilute preparations are more potent. Many homeopathic preparations are so diluted that they contain little or no active ingredient. Therefore, most homeopathic products are not expected to have any pharmacological effects, drug interactions, or other harmful effects. Any beneficial effects are controversial and cannot be explained by current scientific methods.
Dilutions of 1 to 10 are designated by an "X." So a 1X dilution = 1:10, 3X=1:1000; 6X=1:1,000,000. Dilutions of 1 to 100 are designated by a "C." So a 1C dilution = 1:100; 3C = 1:1,000,000. Dilutions of 24X or 12C or more contain zero molecules of the original active ingredient.
Homeopathic products are permitted for sale in the US due to legislation passed in 1938 sponsored by a homeopathic physician who was also a Senator. The law still requires that the FDA allow the sale of products listed in the Homeopathic Pharmacopeia of the United States. However, homeopathic preparations are not held to the same safety and effectiveness standards as conventional medicines. For more information, see the Homeopathy monograph.
Below is general information about the effectiveness of the known ingredients contained in the product Oleander (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Oleander (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY UNSAFE ...when applied topically to broken or raw skin. Topical use of a paste containing multiple ingredients including oleander on broken or raw skin has caused bradycardia (94434).
LIKELY UNSAFE ...when used orally. Ingestion of oleander leaf, oleander leaf tea, or oleander seed has led to fatal and non-fatal poisonings (9,3495,65395,65407,65409,65410,65420,65422,65436,65437),(65438,94417,94428,94429,94430,94431,94432,94433,94434,94435),(94436,94437,103238,103239,103240,103241). A safe dose has not been identified, and as few as 2 seeds can cause fatal poisoning (106426).
CHILDREN: LIKELY UNSAFE
when used orally.
Ingestion of oleander leaf, oleander leaf tea, or oleander seed has led to fatal and non-fatal poisonings (65395,65411,65419,65433,65434,65442,65444).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally.
Oleander has been reported to have abortifacient properties (5000). Also, maternal ingestion of oleander seeds during pregnancy has led to fetal toxicity (65425). There is insufficient reliable information available about the safety of topical use of oleander during pregnancy and lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Oleander (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, using oleander with prolonged corticosteroid therapy can increase the risk of oleander toxicity.
Details
Oleander contains cardiac glycosides. Concomitant use of corticosteroids with oleander can increase the therapeutic and adverse effects of long-term corticosteroid use due to potassium depletion and electrolyte imbalance (2).
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Theoretically, concomitant use of digoxin and oleander will increase the risk and severity of toxic effects.
Details
Oleander contains cardiac glycosides similar to digoxin, increasing the risk of additive effects with concomitant use (2).
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Theoretically, diuretic drugs may increase the risk of oleander toxicity.
Details
Concomitant use of potassium depleting diuretics and oleander can increase the risk of cardiac glycoside toxicity due to potassium depletion (506).
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Theoretically, macrolide antibiotics may increase the risk of oleander toxicity.
Details
Macrolide antibiotics reduce levels of bacteria in the gut that break down digoxin to inactive metabolites, increasing digoxin bioavailability (17). Theoretically, this same process could increase the bioavailability of cardiac glycosides in oleander, increasing its toxicity.
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Theoretically, quinine may increase the risk of oleander toxicity.
Details
Quinine is known to increase plasma levels of digoxin by inhibiting an efflux pump. This interaction might occur with other cardiac glycosides, including those in oleander (506).
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Theoretically, stimulant laxatives may increase the risk of oleander toxicity.
Details
Overuse or misuse of stimulant laxatives leads to potassium depletion. This might increase the risk of toxicity with cardiac glycosides, including those in oleander (2).
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Theoretically, tetracycline antibiotics may increase the risk of oleander toxicity.
Details
Tetracycline antibiotics reduce levels of bacteria in the gut that break down digoxin to inactive metabolites, increasing digoxin bioavailability (17). Theoretically, this same process might increase the bioavailability of cardiac glycosides in oleander, increasing its toxicity.
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Below is general information about the adverse effects of the known ingredients contained in the product Oleander (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Oleander can cause significant toxicity by any route of administration.
Most Common Adverse Effects:
Orally: Abdominal pain, bitter taste, diarrhea, headache, mucous membrane irritation, nausea, salivation, stupor, and vomiting.
Topically: Contact dermatitis.
Serious Adverse Effects (Rare):
Orally: Arrhythmias, cardiac arrest, cardiovascular collapse, death, hyperchloremia, hyperkalemia, metabolic acidosis, mydriasis, peripheral neuritis, and vision disturbances.
Cardiovascular
...Orally, oleander can cause malignant dysrhythmias, ventricular ectopy, cardiovascular collapse, cardiac arrest, and death (17,94437,103238,103239).
Oleander can also cause hyperkalemia (2532,3495,65419,65435,94429,94436,94437,103239,103241). Hyperkalemia after oleander ingestion is generally due to inhibition of the sodium-potassium ATPase pump. Digoxin is usually detectable by radioimmunoassay, due to the cross-reactivity between digoxin and the cardiac glycosides contained in oleander (98220).
Topically, applying an oleander paste to penile and perianal ulcers has caused asymptomatic bradycardia. The paste contained oleander bark and leaves, as well as holy basil, tamarind, onion, and neem. There is also one case report of bradycardia requiring atropine treatment and a pacemaker after application of this paste to a penile ulcer. The risk of transcutaneous absorption of oleander is increased if applied to raw or broken skin (94434).
Dermatologic ...Topically, the sap of freshly cut oleander leaves can cause contact dermatitis (5000,65432,65448). In a case report, a 5-year-old child applied oleander leaves to the face and developed skin erythema, followed by blistering, swelling and partial thickness facial burns. The condition resolved with conservative management (106425).
Gastrointestinal ...Orally, oleander leaves, flowers, and seeds have a bitter taste, and can cause a burning sensation in the mouth, nausea, vomiting, and diarrhea (17,18,3495,65395,65411,65419,65422,65423,65431,65437,94417,94430,94432,94435,94436,98220,103239,103241). Oleander can also cause mucous membrane irritation, increased salivation, abdominal pain and cramping, and buccal erythema (3495,5000,65422,94435,94436,98220,103239). In one case report, a male with schizoaffective disorder consumed the leaves of an ornamental oleander plant, resulting in severe diarrhea and diarrhea-induced hypokalemia (94430).
Hematologic ...Oleander use has been associated with thrombocytopenia. A 33-year-old female who ingested an infusion of 20 oleander leaves presented with symptoms of oleander poisoning and, 72 hours after ingestion, developed thrombocytopenia. Another case of thrombocytopenia linked to oleander intake has also been reported (103241).
Hepatic
...Two cases of jaundice, increased bilirubin, and hepatosplenomegaly have been reported after oleander ingestion (65420).
Intramuscularly, there is one case report of a patient with cancer who developed hepatotoxicity after receiving daily injections of a specific oleander extract (Anvirzel, Phoenix Biotech) 1.2 mL/m2 for 2 months. Other causes of hepatotoxicity were ruled out (94428).
Neurologic/CNS ...Orally, oleander can cause weakness, headache, giddiness, dizziness, and malaise or stupor (17,18,3495,65422,65434,65443,65444,94417,94432,94435,94436,98220,103239). It can also cause peripheral neuritis (3495,5000) and numbness of the mouth or tongue (65422,94429). There is one case report of a young child who developed irritability and seizures after ingestion of oleander (65444). In another case, a 12-year-old child developed hypertonia, neck stiffness, and flexor plantar response after ingestion of oleander seeds (65434).
Ocular/Otic ...Orally, oleander can cause visual disturbances and mydriasis (3495,5000). In one case report, a 7-year-old child experienced a change in color vision about 6 hours after ingestion of oleander seeds (65411). There is also a report of dimness of vision and tinnitus after ingesting a water extract from oleander leaves (65424).
Renal ...Orally, oleander can cause acute kidney failure characterized by dark colored, scanty urine (less than 300 mL daily) (65417,65420,106426).