HEROX 20/MG 4/FC TAB

Indications

Approved Uses

Erectile Dysfunction (ED), Benign Prostatic Hyperplasia (BPH), Pulmonary Arterial Hypertension (PAH).

Dosage & Administration

Dosing by Condition

Erectile Dysfunction (as-needed): Initial 10 mg prior to sexual activity; may decrease to 5 mg or increase to 20 mg based on efficacy/tolerability; maximum once daily.
Erectile Dysfunction (once-daily): 2.5 mg once daily, may increase to 5 mg once daily.
Benign Prostatic Hyperplasia (BPH): 5 mg once daily.
ED and BPH: 5 mg once daily.
Pulmonary Arterial Hypertension (PAH): 40 mg once daily (two 20 mg tablets) under specialist direction (product is tadalafil; indication depends on local approval).

Initial Dose

10 mg taken at least 30 minutes before sexual activity (on-demand dosing for ED)

Maintenance Dose

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

Maximum Dose

20mg per day for as-needed use for ED; 5mg per day for daily use for ED/BPH.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment (ED as-needed): CrCl 30-50 mL/min: start 5 mg, max 10 mg no more than once every 48 hours; CrCl <30 mL/min or on hemodialysis: max 5 mg no more than once every 72 hours; once-daily use is not recommended when CrCl <30 mL/min. Hepatic impairment: mild-moderate (Child-Pugh A/B): max 10 mg as-needed; severe (Child-Pugh C): not recommended. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): limit to 10 mg every 72 hours (as-needed) and avoid/limit once-daily regimens per labeling.

How to Take

Swallow the 20 mg film-coated tablet whole with water; may be taken with or without food. For erectile dysfunction (ED) on-demand use, take prior to anticipated sexual activity (commonly at least 30 minutes before); do not take more than one dose in 24 hours.

Side Effects

Common Side Effects

Headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, nasopharyngitis, dizziness

Side Effect Frequency

"Very common (≥10%): ["Headache"], "Common (1-10%): ["Flushing
Dyspepsia
Nasal congestion
Back pain
Myalgia
Pain in extremity"], "Uncommon/Rare but serious: ["Hypotension/syncope
Priapism
Sudden decrease/loss of vision (including NAION)
Sudden decrease/loss of hearing
Severe hypersensitivity/serious skin reactions (rare)"]

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any organic nitrates or nitric oxide donors (acute or chronic), (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat), (3) known hypersensitivity to tadalafil or excipients. Also avoid/contraindicated in patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina or severe cardiac disease) per PDE5 inhibitor labeling/ED guidance.

Warnings & Precautions

Warnings/precautions: assess cardiovascular status before prescribing and avoid use when sexual activity is inadvisable; risk of symptomatic hypotension with alpha-blockers/antihypertensives/alcohol; use caution in patients with anatomical penile deformity or conditions predisposing to priapism (e.g., sickle cell disease, leukemia, multiple myeloma); discontinue and seek urgent care for sudden vision loss (NAION) or sudden hearing loss; counsel on priapism emergency; avoid concomitant nitrates/riociguat; not indicated for women/children for ED indication.

Age Restriction

Not approved under 18 years.

Driving Warning

Dizziness may occur; use caution when driving or operating machinery

Drug Interactions

Drug Interactions

Major interactions: nitrates/NO donors (contraindicated-profound hypotension), guanylate cyclase stimulators such as riociguat (contraindicated), alpha-blockers (additive hypotension-use caution and ensure stable alpha-blocker therapy), antihypertensives (additive BP lowering), potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat, clarithromycin-↑ tadalafil exposure; dose limitation/avoid depending on regimen), potent CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin-↓ exposure/efficacy), and substantial alcohol intake (↑ orthostatic symptoms/hypotension).

Interaction Severity

"MAJOR/CONTRAINDICATED: ["Nitrates (e.g., nitroglycerin, isosorbide) - profound hypotension
Riociguat - severe hypotension"], "MODERATE: ["Alpha-blockers and other antihypertensives - additive blood pressure lowering (risk higher at initiation/titration)
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - increased tadalafil exposure
Excess alcohol - additive hypotension/orthostasis"], "MINOR: ["CYP3A4 inducers (e.g., rifampin) - reduced tadalafil exposure/efficacy"]

Food Interaction

May be taken with or without food; high-fat meals do not meaningfully affect absorption. Avoid/limit grapefruit or grapefruit juice (especially large amounts) due to potential CYP3A4 inhibition increasing tadalafil exposure.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children.

Elderly

Standard adult dosing; no dose adjustment required based on age alone, but consider renal and hepatic function

Kidney Impairment

Renal impairment (erectile dysfunction, as-needed): CrCl 30-50 mL/min: start 5 mg; maximum 10 mg not more frequently than every 48 hours. CrCl <30 mL/min or on hemodialysis: maximum 5 mg not more frequently than every 72 hours. Once-daily tadalafil regimens are not recommended when CrCl <30 mL/min.

Liver Impairment

Hepatic impairment: Mild-moderate (Child-Pugh A or B): use with caution; for erectile dysfunction as-needed dosing, maximum 10 mg once daily (20 mg not recommended). Severe (Child-Pugh C): use not recommended (generally treated as a practical contraindication).

Storage & Patient Advice

Missed Dose

As-needed ED use: no missed dose concept-take only when needed and do not take more than one dose in 24 hours. Once-daily regimens (e.g., ED daily/BPH): take as soon as remembered the same day; if close to the next dose, skip and resume the next day-do not double.

Stopping the Medicine

Safe to stop anytime.

Overdose

Overdose: expected effects include exaggerated adverse reactions (headache, flushing, dizziness), hypotension/syncope, tachycardia, and prolonged erection/priapism; management is supportive (vital signs, IV fluids/positioning, treat priapism urgently), consider activated charcoal if recent ingestion, and hemodialysis is unlikely to be beneficial due to high protein binding.

Patient Counseling

Take exactly as prescribed; for ED as-needed, take before sexual activity (often ≥30 minutes) and sexual stimulation is required. Do not use with nitrates or riociguat; tell clinicians about all medicines (especially alpha-blockers, antihypertensives, and strong CYP3A4 inhibitors). Limit excessive alcohol; seek urgent care for chest pain, sudden vision/hearing loss, or an erection lasting >4 hours.

Monitoring Requirements

Assess cardiovascular status and contraindications (especially nitrate/riociguat use) before initiation; monitor blood pressure and symptoms of hypotension when starting or when combined with antihypertensives/alpha-blockers; no routine lab monitoring is required.

Pharmacology

Mechanism of Action

Tadalafil selectively inhibits phosphodiesterase type 5 (PDE5), increasing cGMP in smooth muscle and enhancing nitric-oxide-mediated vasodilation; in ED this increases penile blood flow during sexual stimulation.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

17.5 hours.

Bioavailability

Absolute oral bioavailability has not been determined in humans.

Metabolism

Hepatic metabolism predominantly via CYP3A4 to metabolites (circulating metabolite is much less active).

Excretion

Excreted mainly as metabolites: feces ~61% and urine ~36%.

Protein Binding

94%.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 20 mg tadalafil

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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