Thank you for your interest in Focus Essentials ®.
Focus Essentials is a uniquely designed formula using natural ingredients. This specialized and well-researched formula is used for the treatment of anxiety, depression, and stress symptoms while enhancing mental clarity, focus throughout the day, and overall brain health.
Focus Essentials along with other supplemental nutrition formulas have demonstrated efficacy in published research as plausible interventions for symptoms associated with mental health conditions. Research evaluating these formulas includes meta-analysis, double-blind trials, and case studies. (see Published Articles).
Research regarding the efficacy of these formulations is consistent across study groups from more than a dozen institutions in various countries. Furthermore, no conflicts of interest have been reported.
Various double-blind clinical trials evaluating Focus Essentials are currently ongoing.
The precise mechanism elucidating the therapeutic effects of Focus Essentials has yet to be determined. Proposed mechanisms of its beneficial actions include the synergistic effects of the vitamin/mineral combinations and the subsequent support of neurotransmitter production and regulation.
The pharmacodynamics associated with Focus Essentials is hypothesized to consist of an intricate interplay of separate micronutrient pharmacodynamics, most of which have been independently studied.
Researchers have reported enhanced restoration of neuronal function and structural integrity following the administration of a supplemental nutrition formula comparable to Focus Essentials in animal models with lab-induced brain lesions.
Neuronal abnormalities observed in animals are similar to those in humans which are known to influence mood and cognition. It is speculated that administration of Focus Essentials in humans would provide comparable therapeutic benefits as those reported in animal models.
Publications concerning the nutrient availability of Focus Essentials after single dose administration do not yet exist.
The specific effects of concomitant administration of food and Focus Essentials on the bioavailability and absorption of Focus Essentials are currently unknown. Despite the possibility that the simultaneous intake of food and Focus Essentials may reduce absorption of Focus Essentials to a degree, it does not seem to be clinically significant.
Considering the comprehensive nutrient profile of Focus Essentials, the corresponding metabolism of these nutrients may inadvertently affect medication pharmacodynamics. It is not known what influence age differences may play in the metabolism and absorption of Focus Essentials as it has not yet been investigated. Adverse events related to age differences have not been reported in children, adolescents, or elderly individuals.
Research evaluating the impact of renal and/or liver dysfunction on the metabolism and absorption of Focus Essentials has not been conducted.
Focus Essentials is used in the treatment of a variety of mental health conditions. These include anxiety, mood, and behavioral abnormalities. Considerable evidence has concluded that the aforementioned abnormalities can result from insufficient intake of vitamins/minerals and in those who are malnourished. It has been shown that comprehensive supplemental nutrition formulations like Focus Essentials can lessen the symptoms associated with these conditions.
The recommended dosing of Focus Essentials is 8 capsules daily with food or as directed by your physician.
It has been demonstrated in clinical trials that adult and pediatric cohorts respond well when formulations akin to Focus Essentials are provided at doses similar to the recommended dosing of Focus Essentials. (see Published Articles).
Noted in clinical observations, pediatric patients aged 2-5 with a psychiatric diagnosis may need reduced doses of Focus Essentials, often lower than the standard dose. (2-4 capsules/day vs. 8 capsules/day)
Maintenance dosing of Focus Essentials may be required to effectively prevent exacerbation or return of symptoms. The most effective dosing to prevent these issues from arising will vary on a case-by-case basis.
To review other Focus Essentials dosing concerns, to include increasing/decreasing dose concentrations, please refer to the Treatment Guidelines.
Safety data evaluating the vitals, biochemical indices, and outcomes of 144 pediatric and adult subjects from eight separate datasets following the administration of a supplemental nutrition formula comparable to Focus Essentials at therapeutic doses concluded the formulation to be safe after reports to indicate a clinically meaningful adverse event were absent.
More specifically, the datasets analyzed changes in blood pressure, heart rate, serum electrolytes, liver enzymes, and kidney function. There were no statistically significant changes in any of the measured indices.
The U.S. Institute of Medicine and other international authorities have established tolerable upper limits on specific micronutrients to reduce the risk of toxicity. In addition, safe ranges have also been established for most vitamins and minerals in both adult and pediatric populations.
The most common side-effects associated with Focus Essentials at a therapeutic dose are mild gastrointestinal symptoms including diarrhea. In the rare instances, these events occur, it usually occurs in those who are sensitive to higher doses of magnesium.
Regarding this effect, the Institute of Medicine says, “Although a few studies have noted mild diarrhea and other mild gastrointestinal complaints in a small percentage of patients at levels of 360 to 380 mg (15.0 to 15.8 mml) per day, it is noteworthy that many other individuals have not encountered such effects even when receiving substantially more than this [level] of supplementary magnesium.”
The proceeding adverse events have been reported in patients with the following illnesses: Anxiety disorder, ADHD, bipolar disorder, depression, Prader Willi Syndrome, and Oppositional Defiant Disorder.
Infrequent: a headache
Frequent: change in urine color (a fluorescent yellow color due to riboflavin).
Infrequent: loose stools, nausea.
Rare: flatulence, diarrhea, stomach ache, vomiting.
Those who are undergoing anticoagulation therapy are advised to take caution when using Focus Essentials as it contains vitamin K which promotes coagulation and may therefore disrupt the effects of anticoagulation treatment.
Dosing of anticoagulation medication(s) will depend on an individual’s particular case and take into careful consideration personal prothrombin time among other lab values for the duration of Focus Essentials administration to prevent clotting issues.
Known drug interactions between Focus Essentials and psychoactive drugs have been reported during clinical trials and are well documented. A known interaction exists between Focus Essentials and lithium. In regards to this interaction, researchers noted, “Use of multi-nutrient formulations as an adjunct should be monitored closely and with full attention to the possibility that optimum dosing of psychotropic agents may require significant adjustments.”
Guidelines for those prescribed psychiatric drugs can be located section Psychiatric medications.
Various clinical observations have concluded that the drug interactions between Focus Essentials and psychoactive medications are milder than supplemental nutrition formulations containing citrus bioflavonoids. It has been reported that Furanocoumarins and other similar molecules reduce metabolism and subsequent clearance of many medications by hindering the functions of multiple cytochrome p450 enzymes, namely CYP3A4, CYP2C9, CYP1A2, and CYP2C19.
On the contrary, it appears that lithium may be metabolized in a different manner considering there are known serious interactions with Focus Essentials versus other medications acting primarily on the central nervous system. Those that prescribed lithium can find treatment guidelines located in section Psychiatric medications.
Although clinical observations have reported interactions with psychiatric medications, notably lithium, caution is advised as additional research and systematic evaluation of other interactions with related adverse events remain elusive. Other medications that act on the central nervous system may possibly interact with Focus Essentials. These include but are not limited to cold medications, theophylline, antihistamines, alcohol, marijuana, heroin, glucocorticoids, thyroid hormones, caffeine, and nicotine.
All prescribed medications should be closely monitored by a physician while undergoing Focus Essentials administration. It may be necessary to gradually wean the patient off of psychoactive medications during micronutrient therapy to avoid overdosing the patient. Clinicians should take precautions to avoid abruptly stopping psychiatric treatment or weaning too rapidly which may cause adverse effects. See Drug Interactions.
It is recommended that patients who take bioflavonoids sourced from citrus to reduce intake of these supplements slowly (approximately 10% each day) to reduce the risk of withdrawal symptoms. See Drug Interactions.
It’s imperative to monitor all patients undergoing treatment closely for changes in behavior, clinical decline, and suicidal thoughts/ideations, particularly within the first couple of months of treatment or when dosing modifications are made with either medications or Focus Essentials. Any observable changes should be reported immediately to a healthcare professional as urgent dose adjustments may be necessary. See Psychiatric medication management.
Even though the iron content of Focus Essentials is low, Focus Essentials administration in children should only be initiated under close parental supervision. In fatalities resulting from iron toxicity in pediatric populations, the U.S. Poison Control Center reports that victims took more than 60 mg/kg of iron supplements or 27.2 mg/lb.
Cases involving Focus Essentials overdose have not been reported. Should overdose be suspected, the management of such should reflect common procedures used in the overdose management of comparable formulations. Careful consideration to decrease therapy dose or terminate therapy all together is warranted in the event of a suspected overdose.
The initiation of Focus Essentials should be avoided if the individual to be treated has a known condition where specific micronutrients are contraindicated (e.g. Wilson’s disease). The avoidance of Focus Essentials therapy is also recommended in patients with a known allergy or hypersensitivity to any constituent within Focus Essentials.
Consideration to withhold initiation of Focus Essentials should be taken if there are any contraindications or precautions in which this consideration is warranted. If the aforementioned concerns are absent, Focus Essentials can be administered accordingly as summarized in this section. Case-by-case differences are inevitable and therefore health professionals should use their best clinical judgment to suit the needs of the individual patient.
Commonly, Focus Essentials concentrations can be increased steadily to therapeutic doses within four days of start date. (see Indications & Dosage)
Patients should take Focus Essentials per the instructions on the label unless instructed otherwise by a physician.
Directions for use: Take four capsules, twice daily, or at a dose determined by your healthcare professional. You may start at a reduced dose of one capsule twice daily and increase this dose steadily until you have achieved the desired dose. Focus Essentials should be taken with food.
Patients who may initially have a low tolerance to Focus Essentials may begin therapy with one capsule/day and increase dosing according to their comfort level. Those with reported insomnia should take Focus Essentials no later than 6 pm.
It is important to remember to take Focus Essentials with a meal/snack to minimize gastrointestinal side effects. Focus Essentials use in children should be supervised by an adult.
Treatment with psychiatric medications and their selected doses should be monitored cautiously throughout Focus Essentials therapy.
If side effects associated with psychiatric medications precipitate, weaning the patient off or reducing medication dose in a gradual fashion is recommended to minimize the introduction of withdrawal symptoms.
Psychiatric medications are frequently prescribed in multi-drug regimens to treat a disorder more effectively. When decreasing doses of psychiatric medications, all drugs within the regimen should be reduced at the same rate to avoid provoking instability within the central nervous system.
A physician should carefully monitor all prescription medication doses during the course of Focus Essentials therapy.
Medications prescribed to treat thyroid disorders, insulin abnormalities, hypertension, dyslipidemia, cancer, and heart conditions require attentive monitoring as dose adjustments may become necessary.
Gastrointestinal integrity and the regular health of the GI tract is necessary for optimal absorption of nutrients. Disorders affecting the gastrointestinal systems such as gut microbiota imbalances, bowel disorders including IBD, diarrhea, and constipation may reduce the absorptive capacity of the GI tract reducing Focus Essentials therapy efficacy.
Other patient specifics that may affect the use of Focus Essentials and/or additional treatments include:
- Patient history.
- Lifestyle factors.
- Recreational drug use.
- Supplement use.
- Other factors influencing nutritional requirements.
Doses of Focus Essentials may require alterations throughout the course of therapy secondary to individual patient responses and aspects that may influence the effectiveness of Focus Essentials therapy. Supplemental therapies may also be beneficial.
Physical symptoms associated with generalized anxiety may involve a feeling of lightheadedness, a “butterfly” feeling in the abdominal region, and muscle tension which may correspond with reduced concentration, increased distractibility, and worrying. The addition of inositol to Focus Essentials therapy may help to lessen these effects.
The addition of choline to Focus Essentials therapy may benefit patients displaying aggression, anger, or racing/obsessive thoughts.
It has been known since 1996 that multiple components can influence micronutrient therapy responses. These include but are not limited to: gastrointestinal integrity/health, lifestyle habits, and prescription medications. It is important to acknowledge these various components in order to tailor Focus Essentials therapy to maximize individual effectiveness.
Psychiatric medication management
Careful consideration is important prior to switching psychiatric medications during Focus Essentials therapy to prevent unnecessary variations in brain chemistry which may induce symptomology or worsen preexisting symptoms.
Abrupt cessation of psychiatric medication during Focus Essentials therapy is not recommended. The healthcare professional(s) should reduce the dose gradually to prevent adverse reactions. It is also important to consider the duration of the pharmacologic treatment prior to weaning.
The risk of drug-nutrient interactions may be enhanced if psychiatric medication doses are increased during Focus Essentials therapy.
When numerous medications are used in combination with Focus Essentials, worsening symptoms have been reported. The following medications have provoked the most noticeable responses.
Drug-drug interactions between anesthetics and psychiatric medications have been reported. Patients undergoing surgical procedures who are exposed to anesthetic agents should be monitored closely in order to rapidly identify any symptoms associated with these interactions. Medication substitutions may be necessary in these instances.
Individuals who are no longer taking psychiatric medications that have taken prior formulations of Focus Essentials therapy have complained of withdrawal-like symptoms post-surgery that has been alleviated by traditional drug withdrawal treatment options.
To most effectively digest and absorb nutrients, sufficient acidic breakdown of the stomachs contents is required. Antacids such as Tagamet, Zantac, and Prilosec can disrupt this process and may therefore decrease the overall absorption of nutrients.
The health of the intestinal microbiota is essential to optimizing nutrient uptake in the GI tract. When antibiotics are consumed, they inadvertently kill off good bacteria in addition to the bad bacteria which may adversely affect nutrient absorption.
Worsening symptoms have been reported in those taking oral antibiotic treatments simultaneously with Focus Essentials therapy. This issue does not appear to exist in those receiving intravenous antibiotics thus suggesting that the antibiotic effects on the gut are likely the cause of the amplified symptoms.
A 50% supplementary nutrient dose during the course of antibiotic treatment appears to nullify the negative effects of antibiotics on nutrient absorption. The addition of a pre/probiotic regimen administered during and post (one to two weeks afterward) treatment is recommended.
Natural compounds with anti-fungal/antimicrobial activity are also suggested during the course of antibiotic therapy. Specifically, in those who have had past infections. Natural compounds include but are not limited to garlic, oil of oregano, and caprylic acid.
Worsening psychiatric symptoms have been reported in those taking antihistamines concomitantly with Focus Essentials therapy. Consideration of these reports is necessary prior to use.
Caution is advised when taking hormone containing birth control medications with Focus Essentials therapy as birth control medicines may adversely affect depression and mood and may incite irritability and nervousness.
Caution is advised when taking HRT with Focus Essentials, as taking both together may adversely affect mood and depression, and provoke irritability and nervousness.
Caution is advised when taking opioids and Focus Essentials therapy concurrently as this combination may worsen psychiatric symptoms.
The use of illicit drugs can provoke psychiatric symptoms. When combined with Focus Essentials therapy, the frame of mind alterations has been reported. If a patient does not demonstrate progression with therapy, consideration of illicit drug use may be necessary as those who use these drugs often conceal their use. Drug addiction can be treated successfully in some instances with specialized supplemental micronutrient therapy.
Alcohol should be minimized if not avoided entirely as its use can hinder the effectiveness of Focus Essentials therapy.
In cases that involve micronutrient deficiencies and/or genetic disorders that increase specific vitamin/mineral needs, additional micronutrients may be warranted during Focus Essentials therapy to optimize outcomes.
Generally, the addition of specific minerals including calcium, zinc, copper, and magnesium is not recommended as doing so can adversely affect the intrinsic mineral balance of Focus Essentials therapy and ultimately disrupt its efficacy. However, iron can be added to Focus Essentials with no known issues. Caution need not be taken when considering micronutrient provisions of whole foods.
Over-the-counter supplements with known psychoactive ingredients can also disrupt the effects of Focus Essentials therapy. These supplements include but are not limited to St John’s Wort, Kava Kava, ginseng, valerian root, skullcap, SAM-e, and 5-Hydroxytryptophan (5-HTP). Patients using these compounds are advised to do so with caution. Healthcare professional(s) should be aware of any supplements the patient is taking and monitor carefully if any of the preceding supplements are being used.
Suboptimal absorption of micronutrients may exist in those with diarrhea and/or constipation. Patients with this issue are encouraged to increase intake of whole foods and probiotics to alleviate these symptoms. Particular focus on increasing fiber intake and ensuring proper hydration is often useful.
Disorders characterized by inflammation and irritation of the bowel, such as IBD, can significantly impact the ability to absorb micronutrients. It is known that these conditions may improve over time during Focus Essentials therapy; however other agents can be added to facilitate restoration and function of the bowel. These include but are not limited to fatty acids, restriction diets, probiotics, and digestive enzymes.
Constipation may reduce the effectiveness of Focus Essentials therapy secondary to reduced motility and subsequent absorption. Determining the etiology of constipation and treating accordingly can help restore absorptive capacity.
There are multiple options available during Focus Essentials therapy to alleviate constipation. These include: high-fiber diet, ensuring adequate hydration, consuming raw fruit and vegetables and implementing a pre/probiotic regimen to establish a healthy gut microbiota, all of which can support regularity.
Diarrhea may reduce the effectiveness of Focus Essentials therapy secondary to increased motility and subsequent malabsorption. Determining the etiology of diarrhea and treating accordingly can help to optimize absorption.
There are multiple options available during Focus Essentials therapy to alleviate diarrhea. These include: eating bananas, cheddar cheese, peanut butter, and implementing a pre/probiotic regimen to establish a healthy gut microbiota, all of which can reduce motility and enhance absorption.
Altered gut microflora can occur with the use of antibiotics, lifestyle habits, and certain infections. Therefore, therapeutic interventions are recommended in order to maximize micronutrient absorption.
If there is a slight degree of imbalance in the gut microbiota, then a product combining both probiotics and prebiotics may be beneficial for gut health restoration.
Therapy with a natural antibiotic/antifungal regimen may be indicated if there are no signs of improvement. Patients more prone to a severe imbalance in gut function are typically those with prolonged antibiotic use.
Note: Some side effects present as flu-like symptoms, such as the Herxheimer reaction, and vary in the duration and initial presentation. It is suggested to switch antibiotic/antifungal regimen (e.g. oil of oregano, garlic capsules, or caprylic acid) if patient experiences vomiting. Adjusting regimen can also aid in inhibiting adaptation of organisms to a given product. Complete the duration of course as recommended if there are no signs and symptoms of an adverse reaction.
Probiotics are recommended for chronic use of antibiotics taken by mouth and in children. Continuous probiotic intake can be transitioned to periodic use as symptoms resolve. However, if there are no signs of improvement, then further interventions may be required.
Psychiatric drug use
Medication related symptoms can persist months to years following the cessation of psychiatric medications.  These post-withdrawal side effects can be exacerbated by many factors, such as weight loss, prolonged exposure to the sun, stress, liver or bowel cleanses, physical exertion, and even some holistic approaches, such as acupuncture or massage therapy.
It has been reported that post-withdrawal reactions have such an effect that an individual may feel medicated or mistake the symptoms for a relapse of psychiatric symptoms. The symptoms include, but are not limited to: crying, depression, irritability, anxiety, agitation, and insomnia.
It is recommended that if an individual is experiencing post-withdrawal symptoms, then their known ‘triggers’ should be limited or avoided. Elemental amino acids or protein isolates are also suggested.
It is suggested that lesser concentrations are provided to sensitive individuals to promote better tolerance. Patients with have had tolerance issues in the past or those with significant medical history may be more sensitive to Focus Essentials. These individuals may experience adverse side effects after initiating formulations with micronutrients, such as becoming more irritable, agitated, or restless.
Special nutrient needs
Individuals more prone to vitamin or mineral deficiencies or those that have a preexisting deficiency may require additional supplementation of these vitamins and minerals to maximize the benefits of therapy.
The purpose of Focus Essentials is to increase the nutrient density of a pre-existing diet. Since this is providing additional supplementation, it is imperative that patients continue to consume balanced meals on a daily basis. If an individual’s gut microbiota is prone to becoming compromised, then it is recommended that diet fads and refined foods be limited or avoided while taking Focus Essentials.
Psychosis and mania symptoms are intensified considerably when there is lack of sleep. Therefore, sufficient sleep is imperative for psychiatric health. Evening doses of Focus Essentials (after 6pm) may cause insomnia in some individuals.
Adequate hydration is essential. Patients should ensure proper hydration by consuming eight cups of water/day. Adequate hydration aids in the transport of nutrients into the cell while removing waste products.
Focus Essentials is intended to be used consistently and for uninterrupted durations. Intermittent or “as needed” administration of Focus Essentials is not recommended. Steps to correct non-adherence issues may involve additional patient education.
Weight loss may provoke post-withdrawal symptoms secondary to medications being liberated from tissue stores.
During menstrual cycles, psychiatric symptoms may precipitate secondary to hormonal fluctuations. Focus Essentials should be increased by four capsules/day for approximately one week if symptoms are observed. A preventative effect may be achieved by taking additional Focus Essentials a couple days prior to subsequent menstrual cycles.
Presenting with the common cold or flu can be indicative of immune system susceptibility. Focus Essentials therapy may be increased by four capsules/day to bolster the immune system and hasten recovery.
The micronutrient and energy demands during pregnancy and breastfeeding are higher than normal. Therefore, additional Focus Essentials may be incorporated. This increase should be proportional to calories consumed. In terms of dosing, an additional four capsules per day is a reasonable starting point.
Additional Focus Essentials during puberty may be useful considering the body’s demands for micronutrients and energy are changing. Furthermore, puberty is a time of hormonal fluctuations which cause psychiatric symptoms to arise. For this reason, additional Focus Essentials may prove beneficial.
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