HEROX 20/MG FC TAB 8/FC TAB

Indications

Approved Uses

Erectile dysfunction, Pulmonary arterial hypertension (PAH), Benign prostatic hyperplasia (BPH) symptoms

Dosage & Administration

Dosing by Condition

Erectile dysfunction (as-needed): Initial 10 mg prior to anticipated sexual activity; may increase to 20 mg or decrease to 5 mg based on efficacy/tolerability; maximum 20 mg per dose and not more than once daily.
Erectile dysfunction (once daily): 2.5 mg once daily at approximately the same time; may increase to 5 mg once daily.
Benign prostatic hyperplasia (BPH) or ED/BPH: 5 mg once daily.
Pulmonary arterial hypertension (PAH): 40 mg once daily (two 20 mg tablets) under specialist direction.

Initial Dose

10 mg taken at least 30 minutes before anticipated sexual activity (on-demand); 2.5 mg once daily for daily dosing regimen

Maintenance Dose

5mg to 20mg as needed, or 2.5mg to 5mg once daily.

How to Take

Oral use: swallow the film‑coated tablet whole with water; may be taken with or without food. For erectile dysfunction (as needed), take prior to anticipated sexual activity (onset may be ~30 minutes). Do not take more than one dose in 24 hours.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any form of organic nitrates or nitric oxide donors; (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat); (3) known hypersensitivity to tadalafil or any excipients. Additionally, tadalafil should not be used in men for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina or severe cardiac disease).

Warnings & Precautions

Key warnings/precautions: avoid all nitrates and riociguat; assess cardiovascular status and avoid use when sexual activity is inadvisable; caution with alpha-blockers and other antihypertensives (risk of symptomatic hypotension); counsel to seek urgent care for priapism, sudden vision loss (NAION), or sudden hearing loss; use caution in anatomical penile deformation or conditions predisposing to priapism (e.g., sickle cell disease, leukemia, multiple myeloma); consider bleeding risk in patients with bleeding disorders/active peptic ulcer; caution with substantial alcohol intake.

Drug Interactions

Drug Interactions

Clinically significant interactions: (1) Nitrates/NO donors-contraindicated (profound hypotension); (2) Riociguat/GC stimulators-contraindicated (additive hypotension); (3) Alpha-blockers-additive BP lowering (use caution; ensure patient is stable on alpha-blocker and start PDE5 inhibitor at lowest dose); (4) Antihypertensives-additive BP lowering (monitor); (5) Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat, clarithromycin)-increase tadalafil exposure (dose limitation/avoid high doses); (6) Potent CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)-reduce exposure/efficacy; (7) Excess alcohol-may increase orthostatic symptoms/hypotension.

Interaction Severity

"MAJOR/Contraindicated: Nitrates (including nitroglycerin/isosorbide) and riociguat-risk of profound, potentially life‑threatening hypotension.
MODERATE: Alpha‑blockers and other antihypertensives (additive BP lowering); potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) increase tadalafil exposure requiring dose limitation; substantial alcohol intake increases risk of symptomatic hypotension.
MINOR: CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) may reduce tadalafil effect."

Food Interaction

No restriction.

Pharmacology

Mechanism of Action

Selective phosphodiesterase‑5 (PDE5) inhibition increases cGMP in smooth muscle, enhancing NO‑mediated vasodilation (corpus cavernosum for erection with sexual stimulation; also pulmonary vasculature and lower urinary tract/prostate effects).

Duration of Effect

Up to 36 hours.

Product Information

Composition per Dose

Each film-coated tablet: 20 mg tadalafil

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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