Arginine 150mg | DHEA 5mg | Magnesium Glycinate 200mg | Pregnenolone 15mg | Tadalafil 2.5mg

Administered orally as a capsule.

• At 2.5 mg daily, tadalafil is dosed as a once-daily preparation for continuous use (not as-needed).
• May be taken with or without food; fatty meals do not significantly affect tadalafil absorption at this low dose.
• Swallow whole with water at the same time each day.
• Consistent daily dosing is recommended for the steady-state pharmacokinetic benefits of low-dose tadalafil (half-life ~17.5 hours).

Each component is included at a low, physiologically supportive dose:

• Tadalafil 2.5 mg: the FDA-approved daily low dose for erectile dysfunction (standard daily doses are 2.5–5 mg). Steady-state plasma levels are achieved in approximately 5 days of daily dosing, supporting a state of readiness without the need for as-needed dosing.
• Arginine 150 mg: a low supplemental dose; clinical trials have used 2,500–5,000 mg/day for ED; at 150 mg, arginine provides substrate support for NO synthesis complementing the PDE5 inhibitor effect.
• DHEA 5 mg: a very low supplemental dose intended for precursor support.
• Magnesium Glycinate 200 mg: within the standard supplemental range for magnesium (200–400 mg/day elemental).
• Pregnenolone 15 mg: a moderate neurosteroid precursor dose.
• Final dosing is prescriber-determined based on symptom response, hormone levels, and clinical assessment.

• Tadalafil: Sexual stimulation triggers NO release from penile endothelium and non-adrenergic non-cholinergic (NANC) neurons, activating guanylate cyclase to generate cGMP. cGMP activates protein kinase G, relaxing corpus cavernosum smooth muscle and allowing arterial inflow. Tadalafil inhibits PDE5, the enzyme that degrades cGMP, prolonging and amplifying the vasodilatory and erectile response.
• Arginine: Substrate for endothelial nitric oxide synthase (eNOS), which oxidizes the guanidinium group of L-arginine to produce NO. Enhanced substrate availability supports NO synthesis in corpus cavernosum and vascular endothelium, complementing tadalafil's preservation of cGMP.
• DHEA: Peripherally converted to testosterone and estradiol by tissue-specific 3β-HSD, 17β-HSD, and aromatase; supports androgen precursor pool without HPG axis suppression.
• Magnesium: Cofactor for NOS activity, ATP-dependent enzymatic reactions, and inhibitor of SHBG production — lower SHBG increases free testosterone bioavailability. Magnesium deficiency is associated with reduced testosterone and poorer sexual function.
• Pregnenolone: Converted downstream to DHEA, progesterone, and ultimately testosterone and estrogens; also modulates GABA-A receptor sensitivity and NMDA receptor activity as a neurosteroid, potentially supporting libido and mood.

This preparation is designed for prescriber-directed management of male sexual health concerns, particularly erectile dysfunction with concurrent suboptimal hormonal or mineral status. Clinical contexts include:

• Erectile dysfunction — tadalafil 2.5 mg daily is FDA-approved for ED and provides continuous PDE5 inhibition. Arginine provides NO substrate support.
• Low androgen precursor status — DHEA and pregnenolone supplement the steroidogenic cascade in patients with documented suboptimal levels.
• Magnesium insufficiency — magnesium glycinate addresses a common micronutrient gap that may adversely affect free testosterone and vascular function.

Monitoring:

• Cardiovascular status assessment before tadalafil initiation (adequate cardiac reserve for sexual activity).
• Blood pressure: tadalafil is a vasodilator; monitor in patients at risk for hypotension.
• Serum total testosterone, free testosterone, DHEA-S, and estradiol at baseline and follow-up.
• Renal and hepatic function if long-term tadalafil use is planned.

Contraindications:

• Concurrent use of nitrates in any form (sublingual, oral, topical, inhaled amyl nitrite) — risk of severe, potentially fatal hypotension.
• Concurrent use of soluble guanylate cyclase (sGC) stimulators (riociguat).
• Hypersensitivity to tadalafil or any component.
• Severe hepatic impairment (Child-Pugh Class C).
• Hormone-sensitive androgen-dependent malignancy (for DHEA/pregnenolone-containing preparations).

Warnings & Precautions:

• Tadalafil causes vasodilation; use cautiously in patients with hypotension, severe aortic stenosis, or hypertrophic obstructive cardiomyopathy.
• Alpha-blocker combination: additive hypotensive effects; caution required.
• Priapism: erections lasting >4 hours require immediate medical attention.
• Non-arteritic anterior ischemic optic neuropathy (NAION): rare association with PDE5 inhibitors; use with caution in patients with prior NAION, low cup-to-disc ratio, or cardiovascular risk factors.
• Hearing loss: sudden hearing loss has been rarely reported with PDE5 inhibitors.

Drug Interactions:

• Nitrates: absolute contraindication — severe hypotension risk.
• Alpha-blockers (tamsulosin, terazosin): additive hypotension; if required, use the lowest alpha-blocker dose and allow stable tadalafil dosing before initiation.
• CYP3A4 inhibitors (ketoconazole, ritonavir): increase tadalafil exposure — dose reduction may be required.
• CYP3A4 inducers (rifampin, phenytoin): reduce tadalafil plasma levels, potentially reducing efficacy.

Common Side Effects: Headache, flushing, back pain, myalgia, dyspepsia, nasal congestion, and limb pain — generally mild to moderate and dose-dependent with tadalafil. DHEA may cause acne or oily skin at higher doses.

Store at room temperature (15–25°C), protected from heat, moisture, and direct light. Keep tightly sealed. Keep out of reach of children. Observe the beyond-use date assigned by Genesis Compounding per USP <795>.

Can I take this if I use nitroglycerin for chest pain?

No. Tadalafil (a PDE5 inhibitor) is absolutely contraindicated with all nitrate medications. The combination can cause a severe, potentially life-threatening drop in blood pressure. Inform your prescriber of all medications, including nitrates, before starting this preparation.

What does tadalafil 2.5 mg daily do differently from as-needed dosing?

Daily low-dose tadalafil maintains a continuous steady-state plasma level, allowing sexual activity to occur spontaneously without planning around a dose. It also improves penile endothelial function and has shown benefit for lower urinary tract symptoms.

Why are hormone precursors (DHEA, pregnenolone) included?

DHEA and pregnenolone support the body's natural steroidogenic pathway, providing precursor substrate for testosterone and other hormones. They are included at low doses to complement tadalafil's mechanism with supportive hormonal availability, not to replicate full testosterone replacement therapy.

Is this preparation FDA-approved?

No. This is a patient-specific, 503A compounded preparation from Genesis Compounding. Tadalafil is FDA-approved as standalone tablets; this specific multi-ingredient combination capsule is compounded to order per prescriber direction.

What monitoring is needed while taking this?

Your prescriber will assess cardiovascular fitness before initiation and may order baseline hormone levels (testosterone, DHEA-S), blood pressure, and relevant labs at follow-up. Report any vision or hearing changes, or erections lasting more than 4 hours, immediately.