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Dietary Supplement prepared from the industrial hemp oil.
RSHO-Gold™, manufactured and distributed by HempMeds Px LLC, is a proprietary product made exclusively from industrial hemp oil. RSHO-Gold™ is rich in cannabidiol (CBD), other phyto-cannabinoids, terpenes and medium chain triglycerides (MCT).
RSHO-Gold™ may be useful as an adjunctive supplement to support healthy immune response and homeostasis, promote and maintain healthy mood, energy, sleep, pain response possibly via the modulation of endocannabinoid system (ESC), which is known as a vital factor in the regulation of homeostasis, symptomatic relief and overall metabolic functions.
Disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
RSHO-Gold™ is an oil tincture for oral and sublingual Administration.
RSHO-Gold™ is contained in an amber glass bottle covered with a polyethylene cap. Each bottle contains 120 mL of a clear, colorless to yellow solution of industrial hemp oil with a cannabidiol content at 8.3 mg/mL. The product doesn't contain any measurable amounts of psychotropic Δ⁹-tetra-hydro-cannabinol (THC).
Non-medicinal ingredients: MCT coconut oil
RSHO-Gold™ is for oral and/or sublingual use only. The dropper should be directed to below the tongue. It must not be applied into the nose. It is recommended to keep the administered sublingual dose in mouth (sublingual or buccal space) for 0.5 min or longer before the dose is swallowed.
The dosage of RSHO-Gold™ will depend on the nature of the desired health benefit. As an antioxidant RSHO-Gold™ may be effective at any dose. In order to have measurable wellness and beneficial physiologic effects, the daily intake should be at least around 30 mg (calculated based on CBD content) and then increased gradually according to the tolerance and achieved beneficial effects.
Dosage should be adjusted as needed and tolerated. Some individuals may require and may tolerate a higher number of doses. Individual should titrate to their optimal dosing regimen. They should be advised that it might take a few weeks to find the optimal dosing level.
Preferably, individual should control their daily doses of RSHO-Gold™. In case of missed dose, individuals should follow with the next dose in their dose regimen.
There is no recorded experience of deliberate overdose with RSHO-Gold™.
Despite of a good safety profile of CBD in humans [1-11, 15], RSHO-Gold™ should not be recommended for:
RSHO-Gold™ should not be used beyond its expiry date. RSHO-Gold™ should be stored upright in original container at room temperature (15°C-25°C), away from sources of heat and direct sunlight. Once opened, RSHO-Gold™ should be stored in a refrigerator (2°C-8°C).
RSHO-Gold™ has been consumed by adult individuals taking conventional pharmaceutical medications at the same time. No information from spontaneous reporting is available on any interactions resulting from simultaneous intake of conventional medicines with RSHO-Gold™.
However, since the cannabidiol (CBD) is the major ingredient of RSHO-Gold™ there may be minor drug-drug interactions due to well-known CBD driven CYP450 inhibition and induction. CBD showed to be a weak inhibitor of CYP1A2, CYP2C6, CYP2D6, CYP2C19 and CYP3A4 with an EC50 approximately two orders of magnitude greater than the plasma levels seen in clinical use [1, 2].
In preclinical studies with P-gp, BCRP, and P-gp/BCRP knockout mice, where CBD at 10 mg/kg was injected subcutaneously, showed that CBD is not a substrate of these transporters itself.
CBD is highly bound to human plasma proteins. Although this displacement has not been confirmed in vivo, the dosing should be carefully monitored when administering RSHO-Gold™ to patients who are receiving other drugs which are tightly protein-bound, such as warfarin and diclofenac [1, 2].
No interactions with food or herbs have been established.
There are two main cannabinoid (CB) receptors, CB1 which is primarily located in the central nervous system with some expression in peripheral tissues and CB2 receptors, which can be found in the periphery on cells with immune function and in the gastrointestinal tract and at low densities in the central nervous system [2-5].
CBD does not appear to act directly at CB1 receptors, with a number of studies reporting that there is no measurable response in binding assays. In studies examining potential agonist effects at CB1 receptors, most find no effect, with one report of a weak agonist and one of a weak antagonist effect, each at high concentrations (>10 μM). CBD also shows low affinity at CB2 receptors [2-10]. Across a range of measures in humans and animals, CBD had been shown to have very different effects from those of THC. In mice, CBD failed to produce the behavioral characteristics (e.g. suppression of locomotor activity, hypothermia, anti-nociception) associated with CB1 activation, whereas THC generated all of the effects which occur when CB1 is activated. Neuroimaging studies in humans and animals have shown that CBD has effects which are generally opposite to those of THC. In contrast to THC, CBD has no effect on heart rate or blood pressure under normal conditions, but in animal models of stress it reduces heart rate and blood pressure. Other differences between THC and CBD are discussed below [6-9, 11-10].
Some studies have shown that CBD may reduce or antagonize some of the effects of THC. The mechanism for this is unclear, with some suggesting that it may be a weak CB1 antagonist. Recent evidence suggests that it may be a negative allosteric modulator of the CB1 receptor, thereby acting as a noncompetitive antagonist of the actions of THC and other CB1 agonists [2- 17].
CBD may also interact with the endocannabinoid system through indirect mechanisms such as enhanced action of the endogenous cannabinoid ligand anandamide [17, 18]. This results from blockade of anandamide reuptake and the inhibition of its enzymatic degradation. CBD has been shown to modulate several non-endocannabinoid signaling systems. It is not clear which, if any, of these mechanisms are responsible for any of CBD's potential clinical or other effects. Some of these mechanisms include:
The principal pharmacological effects of CBD include analgesic, anti-convulsant, muscle relaxant, anxiolytic, neuroprotective, anti-oxidant (US Patent 6,630,507 hold by NIH), anti-inflammatory and anti-psychotic activity. The mechanisms by which the biological actions of endogenous cannabinoids are terminated, have not been fully evaluated. However, it appears likely that they are removed from the extracellular space by tissue uptake and that intracellular metabolism via an enzyme system, fatty acid amide hydrolase (FAAH), is also involved [20-21].
Although human pharmacokinetic studies with RSHO-Gold™ have not been performed yet, there exists sufficient published information on CBD (the major bio-active cannabinoid of RSHO-Gold™) to allow an assessment of the pharmacokinetic profile of RSHO-Gold™ in human.
Limited single dose pharmacokinetic data obtained from the human healthy volunteers following a under the tongue administration of EPIDIOLEX®, an oral formulation containing CBD at 100 mg/mL.
Due to its poor aqueous solubility, the absorption of CBD from the gastrointestinal tract is erratic, and the resulting pharmacokinetic profile is variable. Bioavailability from oral delivery was estimated to be 6% due to significant first-pass metabolism. Bioavailability (%F) from oral-mucosal and sublingual routes are less variable, but similar to oral delivery.
Following a daily administration of CBD 10 mg/kg in 15 neuroleptic-free patients for 6 weeks, a mean CBD plasma level ranging from 5.9–11 ng/ml. CBD is rapidly distributed into the tissues with a high volume of distribution of ~32 L/kg. It may preferentially accumulate in adipose tissues due to its high lipophilicity. It is highly bound to plasma proteins and red blood cells. The release of CBD from fatty tissue is responsible for the prolonged terminal elimination half-life [1,2, 12, 13, 19-21].
CBD is extensively metabolized in the liver . The primary route is hydroxylation to 7-OH-CBD which is then metabolized further resulting in a number of metabolites that are excreted in feces and urine. Seven human CYP450 enzymes were identified as capable of metabolizing CBD: CYP1A1, CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and CYP3A5. The two main isoforms involved are CYP3A4 and CYP2C19. CBD undergoes CYP3A- and CYP2Cdependent phase I metabolism to 7-hydroxy-CBD, which is further metabolized into 7-COOH-CBD and its glucuronide conjugated phase II metabolites and excreted, more in feces and to a lesser extent in urine. In a number of studies, CBD has been shown to inhibit CYP isozymes in vitro, but it is not clear that this occurs at concentrations achieved with doses used clinically. CBD has an estimated terminal half-life of 18–32 hours and a clearance of 57.6–93.6 L/hour [1,2, 11, 12].
RSHO-Gold™ is made from the non-genetically modified (non-GMO) cultivars of hemp grown in Europe. Only certified seeds of approved low-THC fiber hemp of the EU variety list are used for the cultivation of hemp for the extraction of CBD enriched oil. The hemp is cultivated and comply with the high internal quality standards, required for the cultivation of the medicinal plants. Farming facilities hold a special permit for the cultivation of hemp, issued by the authorities.
Our hemp plants are lawfully sourced industrial hemp originating from non-genetically modified (non-GMO) cultivars, grown by pesticide and chemical fertilizer-free farming in Europe.
Harvesting takes place at the time of the hemp plants' highest quality shortly before flowering, observing hygienic standards which are comparable to high requirements for medicinal plants. At the time of harvest a variety verification is conducted by the authority to ensure that the cultivated variety of hemp corresponds to the one registered at the authority. Only the high-quality plants containing a concentration of tetrahydrocannabinol (THC) far less than 0.3% are used for producing hemp oil. The source farm utilizes combine technology and equipment which separates the stalk from the chaff and flower of the plant. These materials do not exhibit the presence of any "resins".
A comprehensive quality control of the harvest is carried out upon arrival at the extracting facility. A comprehensive quality control of the harvest is carried out upon arrival at the extracting facility. CBD and other cannabinoids as well as other plant substances are analyzed and thoroughly documented. In addition to that, each batch is tested for conceivable germ or contaminant loads and is only accepted if it meets strict requirements. The dried harvest is stored in purpose-designed, modern warehouses in compliance with the storage of medicinal plants according to the principles of Good Manufacturing Practice (GMP). Temperature and humidity are constantly monitored.
All extraction processes of the hemp oil meet the strict requirements of the GMP. Hemp oil is extracted from the ground fibrous stalk parts of the hemp plant by supercritical CO2 fluid technique (SFT) utilizing liquefied CO2 as an extracting solvent, including a high temperature assisted decarboxylation. The extraction and decarboxylation process parameters are optimized for a higher cannabinoid yield that results in a phyto-cannabinoid rich hemp oil. The extracted hemp oil is subjected to a rigorous analytical testing to ensure the absence of pesticides, microbes and organic solvents according to established acceptance criteria.
The flow of industrial hemp manufacture is shown below. Quality control checks are indicated in purple – the reason for each of these checks can be traced back either to a risk management document or is a normal technical measurement for the process concerned.
As a final formulation step, decarboxylated and filtered hemp oil is diluted with the medium chain triglyceride (MCT) coconut oil (vehicle) to achieve a predetermined final concentration of CBD and terpenes. The final formulation is subjected to the analytical testing to verify the concentration of CBD, other cannabinoids and terpenes, as well as the metals, pesticides, microbes and organic solvents by convergence chromatography, head-space gas chromatography, ISO/IEC-17025, Liquid chromatography with mass spectrometry, respectively. The analytical testing is performed by independent qualified and certified analytical laboratory. The analysis results are documented in a corresponding Certificate of Analysis.
The efficacy of RSHO-Gold™ was not evaluated in clinical trials yet.
NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.
The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected over dosage, the drug's identity should be verified by chemical analysis.