HEROX 5/MG 30/FC TAB

Indications

Approved Uses

Erectile dysfunction (ED), Benign prostatic hyperplasia (BPH), ED and BPH, Pulmonary arterial hypertension (PAH).

Dosage & Administration

Initial Dose

5 mg once daily (for daily dosing regimen for ED or BPH)

Maintenance Dose

5 mg once daily

Maximum Dose

5 mg per day (for once-daily dosing); 20 mg per dose (for on-demand dosing)

Safety & Warnings

Contraindications

Concomitant use of any nitrates or nitric oxide donors; concomitant use of guanylate cyclase stimulators (e.g., riociguat); hypersensitivity to tadalafil

Warnings & Precautions

Assess cardiovascular status and avoid use when sexual activity is inadvisable; avoid/contraindicated with nitrates or riociguat; caution with alpha-blockers/other antihypertensives and with substantial alcohol (hypotension); counsel to seek urgent care for priapism and for sudden vision/hearing changes; caution in anatomical penile deformity or conditions predisposing to priapism; generally not indicated for women

Drug Interactions

Drug Interactions

Nitrates/NO donors (contraindicated-severe hypotension); riociguat (contraindicated); alpha-blockers (additive hypotension-caution); antihypertensives (additive BP lowering-monitor); potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/boosted protease inhibitors-↑ tadalafil exposure); potent CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin-↓ exposure); alcohol (additive hypotension)

Interaction Severity

"MAJOR/Contraindicated: ["Nitrates (e.g., nitroglycerin, isosorbide) - profound hypotension
Riociguat - symptomatic hypotension"], "MODERATE: ["Alpha-blockers and other antihypertensives - additive BP lowering (risk higher with non-selective alpha-blockers)
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - increased tadalafil levels
Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - reduced tadalafil levels/efficacy
Alcohol (substantial intake) - additive hypotension/dizziness"]

Pharmacology

Mechanism of Action

Selective phosphodiesterase type 5 (PDE5) inhibitor that increases cGMP by preventing its breakdown, enhancing nitric-oxide-mediated smooth muscle relaxation and blood flow (e.g., corpus cavernosum; also vascular smooth muscle).

Half-Life

Approximately 17.5 hours (terminal half-life) in healthy subjects.

Metabolism

Hepatic metabolism predominantly via CYP3A4 to metabolites with minimal pharmacologic activity.

Product Information

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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