Caffeine 50mg | Carnitine 150mg | Citrulline 75mg | DHEA 10mg | Methylcobalamin (B12) 1mg | Pregnenolone 10mg | Tadalafil 2.5mg

Route: Oral troche (sublingual/buccal mucosal dissolution).

• Place the troche under the tongue or between the cheek and gum.
• Allow the troche to dissolve slowly over 15–30 minutes; do not chew or swallow whole.
• Do not eat or drink during dissolution to maximize mucosal absorption.
• Take as directed by the prescriber—typically in the morning given the stimulant (caffeine) and performance-related ingredients.

Dosing is entirely prescriber-determined. Component-specific clinical reference ranges:

• Caffeine: 50 mg is a low-moderate stimulant dose; adjust based on patient tolerance and concurrent caffeine intake.
• Tadalafil: 2.5 mg daily is the FDA-approved low dose for BPH and daily ED management; titration guided by prescriber.
• DHEA: Physiologic supplementation doses typically range from 10–50 mg/day; 10 mg is a starting/low dose.
• Pregnenolone: 10 mg is a conservative supplementation dose; clinical response guides prescriber titration.
• All dosing adjustments are at prescriber discretion based on hormonal labs, symptom response, and tolerability.

• Caffeine: Non-selective competitive antagonist of adenosine A₁ and A₂A receptors; blocks adenosine-mediated CNS depression and increases cAMP via phosphodiesterase inhibition, augmenting norepinephrine and dopamine signaling.
• Carnitine: Facilitates translocation of long-chain acyl groups across the inner mitochondrial membrane via carnitine palmitoyltransferase-I and -II; essential for mitochondrial fatty acid oxidation and ATP synthesis.
• Citrulline: Undergoes conversion to arginine in the kidney via the urea cycle; arginine is the sole substrate for endothelial nitric oxide synthase (eNOS), with NO diffusing to smooth muscle to activate guanylate cyclase, increase cGMP, and produce vasodilation.
• DHEA: Converted peripherally (in adipose, liver, gonads, skin) to testosterone and estrogens via steroidogenic enzymes; supports androgen and estrogen receptor activity in tissues where age-related DHEA decline contributes to hormonal deficiency.
• Methylcobalamin: Active cobalamin form; cofactor for methionine synthase (converting homocysteine → methionine, supporting DNA methylation and myelin synthesis) and methylmalonyl-CoA mutase (branched-chain amino acid metabolism and energy production).
• Pregnenolone: Converted from cholesterol by CYP11A1 in mitochondria; the first step in steroidogenesis; serves as direct precursor to progesterone, 17-hydroxypregnenolone, DHEA, and ultimately all gonadal, adrenal, and neurosteroid hormones.
• Tadalafil: Selective inhibitor of PDE5; blocks cGMP hydrolysis in vascular smooth muscle and the corpus cavernosum; elevated cGMP sustains smooth muscle relaxation, promoting penile arterial vasodilation and erection in the context of sexual stimulation; also relaxes prostate/bladder neck smooth muscle for BPH benefit.

This multi-ingredient troche is prescribed for patients (typically adult males) experiencing age-related symptoms including fatigue, reduced libido, erectile dysfunction, and hormonal decline. It simultaneously supports energy metabolism (carnitine, citrulline, B₁₂, caffeine), steroid hormone precursor availability (DHEA, pregnenolone), and direct erectile function (tadalafil).

Prescriber monitoring:

• Baseline and periodic: serum DHEA-sulfate, testosterone (total and free), estradiol—to avoid androgen/estrogen excess with DHEA supplementation.
• PSA monitoring in men, as DHEA may increase androgen exposure with attendant prostate risk considerations.
• Cardiovascular assessment: tadalafil is contraindicated with nitrates; assess for hypotension risk.
• Blood pressure monitoring: caffeine, citrulline, and tadalafil each affect vascular tone.
• Monitor for hypersensitivity and GI tolerance.

Contraindications:

• Concomitant nitrate therapy (organic nitrates, poppers): tadalafil + nitrates causes severe, potentially fatal hypotension
• Hypersensitivity to any ingredient
• Severe hepatic or renal impairment (tadalafil clearance)
• Hormone-sensitive cancers (prostate, breast): DHEA and pregnenolone increase androgen/estrogen substrate availability

Warnings & Precautions:

• Tadalafil + nitrates: Absolute contraindication; can cause life-threatening hypotension.
• Cardiovascular disease: Sexual activity is contraindicated in patients with severe cardiovascular compromise; tadalafil lowers blood pressure.
• Hormone-sensitive conditions: DHEA and pregnenolone provide substrate for sex steroid synthesis; monitor in patients with history of hormone-sensitive cancers.
• Caffeine sensitivity: Patients with cardiac arrhythmia, anxiety disorders, or insomnia may not tolerate 50 mg caffeine.

Drug Interactions:

• Tadalafil: Nitrates (absolute contraindication); alpha-blockers (hypotension); CYP3A4 inhibitors (increase tadalafil exposure); antihypertensives (additive hypotension).
• Caffeine: Adenosine (reduced efficacy of adenosine-based cardiac procedures); CNS stimulants.
• DHEA/Pregnenolone: Anticoagulants (DHEA may alter coagulation factors); insulin/antidiabetics (DHEA may affect insulin sensitivity).

Common Side Effects: Headache, flushing, nasal congestion, dyspepsia (tadalafil); insomnia, palpitations (caffeine at higher doses); GI discomfort (carnitine at higher doses); acne or androgenic effects with DHEA; transient erythema or burning at mucosal absorption site (troche).

Store at controlled room temperature (20–25°C / 68–77°F). Protect from heat, humidity, and light. Keep troches in the sealed packaging until use. Do not refrigerate unless specifically labeled. Use before the beyond-use date assigned by Genesis Compounding. Keep out of reach of children.

Why is tadalafil included at 2.5 mg when standard doses are higher?

Tadalafil 2.5 mg daily is the FDA-approved dose for daily erectile dysfunction management and BPH symptom relief—lower than the 10–20 mg on-demand doses used for acute ED. Daily low-dose tadalafil maintains continuous PDE5 inhibition and smooth muscle relaxation with a favorable tolerability profile. The prescriber has calibrated this dose for this combination formula.

Is it safe to take caffeine and tadalafil together?

At 50 mg, caffeine is a mild stimulant dose. The primary tadalafil interaction concern is with nitrates (absolute contraindication) and antihypertensives (additive hypotension), not caffeine. However, patients with cardiovascular conditions, arrhythmia, or severe hypertension should discuss tolerance of caffeine-containing formulations with their prescriber.

What is DHEA and why is it in this troche?

DHEA (dehydroepiandrosterone) is the most abundant adrenal steroid precursor. It naturally declines with age and serves as the substrate for peripheral production of testosterone and estrogens. Supplementation with low-dose DHEA may support hormonal milieu in age-related decline, though clinical benefit is modest and individual response varies.

Is this product FDA-approved?

This is a 503A compounded preparation from Genesis Compounding, prepared for a specific patient per a prescriber's order. It is not an FDA-approved combination product. Tadalafil is FDA-approved individually; the other ingredients are dietary/hormonal supplementation agents.

How do I use a troche?

Place the troche under your tongue or between your cheek and gum. Allow it to dissolve completely over 15–30 minutes without chewing or swallowing whole. Avoid eating or drinking during dissolution to maximize mucosal absorption of all ingredients.