Weight Management Support

The dosage of 7-keto-dehydroepiandrosterone must be individualized based on the patient's clinical needs, metabolic profile, and response to therapy.

• For Weight Management: The standard adult dosage typically ranges from 100 mg to 200 mg per day, often divided into two doses (e.g., 100 mg in the morning and 100 mg in the afternoon). Clinical trials have demonstrated efficacy at 200 mg daily when combined with a calorie-restricted diet and exercise program.
• For Cognitive Support: Some healthcare providers may recommend lower doses, starting at 25 mg to 50 mg per day, to assess neurological response and tolerance.
• For General Metabolic Support: A common maintenance dose is 50 mg to 100 mg once daily.

7-keto-dehydroepiandrosterone is not approved for use in pediatric patients (children and adolescents under the age of 18). The safety and efficacy of 7-keto in developing endocrine systems have not been established. Use in this population could potentially interfere with natural hormonal maturation, even though 7-keto is considered non-hormonal. Healthcare providers should strictly avoid prescribing this agent to minors unless part of a specialized clinical trial.

Renal Impairment

Specific dosing guidelines for patients with renal impairment have not been established. However, since the metabolites are primarily excreted via the kidneys, patients with a Glomerular Filtration Rate (GFR) below 60 mL/min should use 7-keto with extreme caution. A lower starting dose (e.g., 25 mg) may be appropriate to prevent accumulation.

Hepatic Impairment

As 7-keto-dehydroepiandrosterone undergoes significant hepatic metabolism, patients with liver cirrhosis or elevated transaminases should be monitored closely. Dose reductions may be necessary if liver function is significantly compromised.

Elderly Patients

Geriatric patients often have lower baseline levels of endogenous DHEA and its metabolites. While 7-keto may be beneficial in this population, providers should start at the lowest effective dose (25 mg) to minimize the risk of cardiovascular strain or insomnia, which are more prevalent in older adults.

To ensure maximum efficacy and safety, patients should adhere to the following administration guidelines:

• Timing: It is generally recommended to take 7-keto-dehydroepiandrosterone in the morning or early afternoon. Taking it late in the evening may cause insomnia or disrupted sleep patterns due to its thermogenic effects.
• Food: 7-keto can be taken with or without food. However, taking it with a small meal may reduce the risk of gastrointestinal upset.
• Consistency: For metabolic benefits, the medication should be taken at the same time each day to maintain stable plasma levels.
• Storage: Store the product in a cool, dry place away from direct sunlight and moisture. Keep the container tightly closed and out of reach of children.

If a dose of 7-keto-dehydroepiandrosterone is missed, it should be taken as soon as the patient remembers. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped. Do not double the dose to make up for a missed one, as this increases the risk of side effects like heart palpitations or anxiety.

Signs of an acute overdose of 7-keto-dehydroepiandrosterone may include:

• Rapid heart rate (tachycardia)
• Severe anxiety or jitteriness
• Profuse sweating
• Nausea and vomiting
• Elevated blood pressure

In the event of a suspected overdose, the patient should seek emergency medical attention or contact a poison control center immediately. Treatment is primarily supportive, focusing on cardiovascular monitoring and symptom management.

> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking 7-keto-dehydroepiandrosterone without medical guidance, as sudden changes can affect your metabolic rate and energy levels.

While 7-keto-dehydroepiandrosterone is generally better tolerated than its parent compound DHEA, it can still cause several common side effects, particularly when initiated at higher doses. These may include:

• Nausea: A feeling of sickness in the stomach, which often occurs shortly after ingestion and may subside as the body adjusts to the supplement.
• Dizziness: Some patients report a mild lightheadedness or feeling of vertigo, especially when standing up quickly.
• Insomnia: Due to its thermogenic and metabolic-stimulating properties, 7-keto can interfere with sleep onset and quality if taken too late in the day.
• Increased Perspiration: Patients may notice they feel warmer or sweat more easily during routine activities, which is a direct result of increased thermogenesis.

• Headache: Persistent or tension-type headaches may occur in some individuals.
• Irritability: A noticeable change in mood, characterized by a shorter temper or increased feelings of frustration.
• Gastrointestinal Distress: This may include abdominal cramping, bloating, or changes in bowel frequency (diarrhea or constipation).
• Skin Changes: Although 7-keto does not convert to testosterone, some users report mild acne or oily skin, possibly due to indirect effects on the sebaceous glands.

• Heart Palpitations: A sensation that the heart is racing, fluttering, or skipping beats. This requires immediate clinical evaluation.
• Elevated Blood Pressure: A transient increase in systolic or diastolic blood pressure readings.
• Hypoglycemia: In rare cases, particularly in those already taking glucose-lowering medications, 7-keto may cause blood sugar to drop too low, leading to shakiness and confusion.

> Warning: Stop taking 7-keto-dehydroepiandrosterone and call your doctor immediately if you experience any of the following serious symptoms:

• Chest Pain or Pressure: This could indicate cardiovascular strain, particularly in patients with pre-existing heart conditions.
• Severe Allergic Reaction (Anaphylaxis): Symptoms include swelling of the face, lips, or tongue; difficulty breathing; severe rash or hives; and a rapid drop in blood pressure.
• Visual Disturbances: Sudden blurring of vision or loss of peripheral vision.
• Severe Mood Swings: Development of intense anxiety, panic attacks, or depressive symptoms.
• Jaundice: Yellowing of the skin or eyes, which may indicate hepatic stress or injury.

The long-term safety profile of 7-keto-dehydroepiandrosterone beyond one year of continuous use is not fully documented in large-scale clinical trials. Potential concerns with prolonged use include:

• Thyroid Axis Alterations: There is evidence that 7-keto can increase levels of T3 (triiodothyronine). Long-term elevation of T3 without medical supervision could lead to symptoms of hyperthyroidism, such as weight loss, muscle wasting, and bone density reduction.
• Hormonal Imbalance: While 7-keto is non-hormonal, its influence on the hypothalamic-pituitary-adrenal (HPA) axis over many years is still being studied. There is a theoretical risk that it could suppress endogenous DHEA production.

At this time, there are no FDA black box warnings for 7-keto-dehydroepiandrosterone. However, because it is sold as a dietary supplement, it does not undergo the same rigorous pre-market safety review as prescription drugs. Patients should remain vigilant and report any unusual symptoms to their healthcare provider immediately. The absence of a black box warning does not imply that the substance is without risk, particularly for individuals with underlying medical conditions.

Report any unusual symptoms or persistent side effects to your healthcare provider to ensure your treatment plan remains safe and effective.

7-keto-dehydroepiandrosterone is a potent metabolic activator. It should be used with caution in individuals with a history of cardiovascular disease, thyroid disorders, or psychiatric conditions. Because it can increase the basal metabolic rate, it may place additional stress on the heart and nervous system. Patients should always inform all members of their healthcare team about their use of 7-keto to ensure coordinated and safe care.

No FDA black box warnings for 7-keto-dehydroepiandrosterone. Unlike certain prescription androgens or gonadotropins, 7-keto has not been associated with the severe risks (such as hepatic peliosis or pulmonary oil embolism) that trigger these warnings. However, patients must adhere to recommended dosages to avoid systemic toxicity.

• Allergic Reactions / Anaphylaxis Risk: While rare, hypersensitivity to 7-keto-dehydroepiandrosterone or any of the excipients in the formulation (such as cellulose or magnesium stearate) can occur. Patients with known sensitivities to DHEA should exercise extreme caution.
• Hepatotoxicity: Although 7-keto is not known to be a potent hepatotoxin, any substance metabolized by the liver carries a risk of inducing stress in susceptible individuals. Periodic liver function tests (LFTs) are recommended for those on high-dose or long-term therapy.
• Cardiovascular Effects: Because 7-keto may increase heart rate and blood pressure, it is contraindicated in patients with unstable angina, recent myocardial infarction, or uncontrolled hypertension.
• Thyroid Function: 7-keto has been shown to increase T3 levels. Patients with hyperthyroidism or Graves' disease should avoid this supplement, as it may exacerbate their condition and lead to a thyrotoxic crisis.

Healthcare providers may require the following monitoring during 7-keto-dehydroepiandrosterone therapy:

• Thyroid Panel: Regular checks of TSH, Free T3, and Free T4 to ensure the thyroid axis remains balanced.
• Blood Pressure and Heart Rate: Routine monitoring at each clinical visit.
• Lipid Profile: Monitoring of LDL, HDL, and triglycerides, as metabolic stimulants can sometimes shift lipid levels.
• Liver Function Tests: Baseline and periodic AST, ALT, and Bilirubin levels.

7-keto-dehydroepiandrosterone may cause dizziness or changes in focus in some individuals. Patients should observe how they react to the medication before driving a vehicle or operating heavy machinery. If dizziness or blurred vision occurs, these activities should be avoided.

Combining alcohol with 7-keto-dehydroepiandrosterone is not recommended. Alcohol can exacerbate the side effects of dizziness and nausea. Furthermore, alcohol may interfere with the metabolic benefits of 7-keto and place additional strain on the liver.

7-keto-dehydroepiandrosterone does not typically require a tapering schedule like corticosteroids. However, sudden discontinuation after long-term use may result in a temporary decrease in energy levels or metabolic rate. It is best to discuss a cessation plan with a healthcare provider to monitor for any rebound effects.

> Important: Discuss all your medical conditions, including any history of hormone-sensitive cancers or thyroid disease, with your healthcare provider before starting 7-keto-dehydroepiandrosterone.

7-keto-dehydroepiandrosterone should never be used in combination with the following medications due to the risk of severe adverse reactions:

• Amiodarone: Combining 7-keto with this anti-arrhythmic medication can significantly increase the risk of QT prolongation and life-threatening cardiac arrhythmias.
• Potent Thyroid Hormones (e.g., Liothyronine): Since 7-keto increases T3 levels, using it with synthetic T3 can lead to severe hyperthyroidism, heart palpitations, and potential thyroid storm.

• Antidiabetic Medications (Insulin, Sulfonylureas): As 7-keto is classified as an Antihypoglycemic Agent [EPC], it may enhance the glucose-lowering effects of these drugs, increasing the risk of hypoglycemia. Blood glucose monitoring should be intensified, and doses of diabetes medications may need adjustment.
• Warfarin and Anticoagulants: There is a theoretical risk that 7-keto may influence clotting factors or platelet aggregation. Patients on blood thinners should have their INR monitored closely.
• Corticosteroids: 7-keto may interfere with the anti-inflammatory effects of steroids by competing for metabolic enzymes or influencing cortisol levels.

• Antihypertensives: 7-keto may slightly raise blood pressure, potentially counteracting the effects of beta-blockers, ACE inhibitors, or diuretics.
• CYP3A4 Substrates: 7-keto is metabolized by liver enzymes. It may compete with other drugs metabolized by the CYP450 system, leading to altered plasma levels of either substance.

• Caffeine: High intake of caffeine (coffee, tea, energy drinks) while taking 7-keto can lead to excessive stimulation of the central nervous system, resulting in severe jitters, anxiety, and tachycardia.
• High-Fat Meals: While fat can increase absorption, extremely high-fat meals may delay the time to peak concentration (Tmax), potentially altering the onset of effect.

• St. John's Wort: This herb induces CYP3A4 enzymes, which may speed up the metabolism of 7-keto, reducing its effectiveness.
• Bitter Orange (Synephrine): Combining 7-keto with other thermogenic herbs can dangerously increase heart rate and blood pressure.
• Guggul: Guggul also affects thyroid function; taking it with 7-keto may lead to unpredictable changes in T3 levels.

7-keto-dehydroepiandrosterone may interfere with certain laboratory results:

• Thyroid Function Tests: May show falsely elevated T3 or suppressed TSH.
• Urine Steroid Screens: While 7-keto is not an anabolic steroid, it may cause cross-reactivity in some highly sensitive drug screening assays used in competitive sports.
• Glucose Tests: May result in lower-than-expected fasting glucose readings.

For each major interaction, the mechanism typically involves either pharmacodynamic synergy (e.g., both drugs increasing heart rate) or pharmacokinetic competition for hepatic enzymes. Management usually involves dose separation, dose reduction, or complete avoidance of the interacting agent.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter vitamins and weight-loss aids.

7-keto-dehydroepiandrosterone must NEVER be used in patients with the following conditions:

1. 1Hormone-Sensitive Cancers: This includes active or past history of breast cancer, prostate cancer, ovarian cancer, or uterine fibroids. Although 7-keto does not convert to estrogen or testosterone, its classification as an Androgen [EPC] and Gonadotropin [EPC] suggests potential pathways that could theoretically stimulate hormone-sensitive tissues.
2. 2Severe Hyperthyroidism: Because 7-keto increases triiodothyronine (T3) levels, it can worsen thyrotoxicosis and lead to cardiac complications.
3. 3Pregnancy and Breastfeeding: Due to the lack of safety data and the potential for altering the metabolic environment of the fetus or infant.
4. 4Hypersensitivity: Known severe allergy to 7-keto-DHEA or any component of the formulation.

The following conditions require a careful risk-benefit analysis by a healthcare provider before initiating 7-keto-dehydroepiandrosterone:

• Cardiac Arrhythmias: Patients with a history of atrial fibrillation or SVT may experience recurrences due to the stimulatory effects of the drug.
• Bipolar Disorder: Metabolic stimulants can sometimes trigger manic episodes in susceptible individuals.
• Moderate Renal or Hepatic Impairment: Requires lower dosing and frequent monitoring.
• Benign Prostatic Hyperplasia (BPH): While less risky than DHEA, any androgen-related metabolite should be used with caution in men with urinary obstruction issues.

Patients who have experienced allergic reactions to DHEA (Dehydroepiandrosterone), Prasterone, or other steroid metabolites are at a higher risk of cross-sensitivity to 7-keto-dehydroepiandrosterone. Symptoms of cross-sensitivity may include skin rash, pruritus (itching), or respiratory distress. If a patient is sensitive to soy or other plant sources from which 7-keto is synthesized (often classified under Non-Standardized Plant Allergenic Extract [EPC]), they should use the product with extreme caution.

> Important: Your healthcare provider will evaluate your complete medical history, including any family history of endocrine disorders, before prescribing 7-keto-dehydroepiandrosterone.

7-keto-dehydroepiandrosterone is classified as Pregnancy Category X (or equivalent in modern labeling). It is contraindicated during pregnancy. There is no clinical justification for its use during gestation, and the potential for disrupting the delicate hormonal and metabolic balance required for fetal development is significant. Animal studies on related DHEA metabolites have shown potential for reproductive toxicity. If a patient becomes pregnant while taking 7-keto, the medication should be discontinued immediately, and the healthcare provider should be notified.

It is unknown whether 7-keto-dehydroepiandrosterone is excreted in human milk. However, many steroid-related metabolites do pass into breast milk and could potentially affect the nursing infant's endocrine system. Because of the risk of serious adverse reactions in the infant, including altered growth and metabolic patterns, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

As previously noted, 7-keto-dehydroepiandrosterone is not recommended for pediatric use. The safety and effectiveness in children have not been established. There is a theoretical risk that metabolic stimulants could interfere with normal growth plate closure or pubertal development. Healthcare providers should monitor for accidental ingestion in households with children.

In clinical studies, elderly patients (over 65) have shown a similar response to 7-keto as younger adults, but they are at a higher risk for cardiovascular side effects and insomnia. Geriatric patients are also more likely to be taking multiple medications (polypharmacy), increasing the risk of drug interactions. Renal clearance often declines with age, which may lead to higher systemic levels of 7-keto metabolites. Starting with a 25 mg dose is advised for this population.

For patients with mild to moderate renal impairment, no specific dose adjustment is mandated, but clinical monitoring of blood pressure and electrolytes is recommended. In patients with severe renal impairment or end-stage renal disease (ESRD), 7-keto should be avoided unless the benefits clearly outweigh the risks, as the kidneys are the primary route for metabolite excretion.

Patients with hepatic impairment (Child-Pugh Class B or C) should be approached with caution. The liver is the primary site for the sulfation of 7-keto. Impaired liver function can lead to altered drug metabolism and unpredictable plasma concentrations. Liver enzymes should be monitored every 3 to 6 months in these patients.

> Important: Special populations require individualized medical assessment and more frequent clinical follow-up to ensure safety and efficacy.

7-keto-dehydroepiandrosterone functions primarily as a thermogenic inducer. Its molecular mechanism involves the induction of three key thermogenic enzymes in the liver: mitochondrial glycerol-3-phosphate dehydrogenase, malic enzyme, and catalase. By increasing the activity of these enzymes, 7-keto enhances the thermogenic process, leading to an increase in the basal metabolic rate (BMR) and the utilization of stored fat for energy. Unlike DHEA, it does not bind significantly to the estrogen receptor or the androgen receptor in a way that promotes secondary sexual characteristics, although it is classified as an Androgen Receptor Agonist [MoA] for its specific metabolic signaling pathways.

The pharmacodynamic effect of 7-keto-dehydroepiandrosterone is dose-dependent. A single 100 mg dose can significantly increase the expression of thermogenic enzymes within hours. The duration of the metabolic boost typically lasts for 8 to 12 hours. Tolerance to the thermogenic effects has not been widely reported in short-term studies (up to 8 weeks), but long-term pharmacodynamic data is limited.

| Parameter | Value |

|---|---|

| Bioavailability | Approximately 50-70% (Oral) |

| Protein Binding | 80-90% (Primarily Albumin) |

| Half-life | 2.2 to 5.0 hours |

| Tmax | 2.0 to 3.0 hours |

| Metabolism | Hepatic (Sulfation) |

| Excretion | Renal (90%), Fecal (<5%) |

• Molecular Formula: C19H26O3
• Molecular Weight: 302.41 g/mol
• Solubility: Lipophilic; poorly soluble in water, soluble in ethanol and organic solvents.
• Structure: 7-keto-dehydroepiandrosterone is a 19-carbon steroid. It is structurally identical to DHEA except for the presence of a ketone group at the C7 position of the B-ring, which prevents its conversion into sex steroids.

7-keto-dehydroepiandrosterone is classified within the Androgen [EPC] and Gonadotropin [EPC] classes. While it shares structural similarities with other androgens like testosterone or DHEA, its lack of sex-hormone conversion makes it unique. It is often grouped with other metabolic enhancers and thermogenic agents in clinical literature.