HEROX 20MG 1 TAB

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Erectile dysfunction (on-demand): 10 mg prior to sexual activity; may adjust to 5 mg or 20 mg; maximum once daily. Erectile dysfunction (once daily): 2.5 mg once daily; 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) where indicated/approved.

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

20 mg per dose once daily for ED (on-demand); 40 mg once daily for PAH (Adcirca formulation

Children's Dosage

Not approved for children for ED or BPH indications.

Dose Adjustment Notes

Renal impairment: reduce dose/extend interval in moderate impairment; avoid or use lowest dose with extended interval in severe impairment (especially for on-demand use). Hepatic impairment: use lower doses in mild-moderate impairment; avoid in severe hepatic impairment. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): limit dose and/or frequency (often max 10 mg on-demand and reduced daily dosing); CYP3A4 inducers may reduce efficacy.

How to Take

Swallow tablet whole with water, with or without food. For erectile dysfunction (on-demand), take at least 30 minutes before anticipated sexual activity; sexual stimulation is required for effect; do not take more than once daily.

Side Effects

Common Side Effects

Headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, pain in extremity (limb pain), nausea, nasopharyngitis.

Side Effect Frequency

Very common (≥10%): Headache. Common (1-10%): Dyspepsia, Back pain, Myalgia, Flushing, Nasal congestion. Uncommon (0.1-1%): Dizziness. Rare/very rare (≤0.1%) or frequency not known: Priapism/prolonged erection, Hypersensitivity reactions, Sudden hearing loss, NAION/visual loss, Chest pain (often in the context of underlying cardiovascular disease).

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. Also contraindicated in patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina or severe cardiac failure) per PDE5 inhibitor labeling.

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status and avoid use when sexual activity is inadvisable; risk of hypotension (caution with alpha-blockers, antihypertensives, alcohol); discontinue and seek urgent care for sudden vision or hearing loss; counsel on priapism risk and use caution in predisposed conditions (sickle cell disease, leukemia, multiple myeloma) or penile anatomical deformation; caution with strong CYP3A4 inhibitors/inducers; not indicated for women/children for ED indication.

Age Restriction

Not approved under 18 years.

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Major interactions: (1) Nitrates/NO donors-contraindicated (profound hypotension); (2) Riociguat/GC stimulators-contraindicated (hypotension/syncope); (3) Alpha-blockers and other antihypertensives-additive BP lowering (separate dosing/titrate; avoid unstable alpha-blocker therapy); (4) Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat, clarithromycin)-increase tadalafil exposure (dose limitation/avoid high doses); (5) Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)-reduce efficacy; (6) Excess alcohol-additive orthostatic hypotension.

Interaction Severity

MAJOR/Contraindicated: nitrates (e.g., nitroglycerin, isosorbide) and riociguat (profound hypotension). MODERATE: alpha-blockers (additive hypotension), antihypertensives (additive BP lowering), strong CYP3A4 inhibitors (increased tadalafil levels), substantial alcohol intake (increased orthostatic hypotension). MINOR/Reduced efficacy: CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin).

Food Interaction

No clinically significant food effect; may be taken with or without food (including high-fat meals).

Alcohol Interaction

Use caution with excess alcohol

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children for ED or BPH indications.

Elderly

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

Kidney Impairment

As-needed ED dosing: CrCl 30-50 mL/min: 10 mg initially; maximum 10 mg every 48 hours. CrCl <30 mL/min or on hemodialysis: 5 mg initially; maximum 5 mg every 72 hours. Once-daily use: CrCl 30-50 mL/min: maximum 5 mg once daily; CrCl <30 mL/min or on hemodialysis: once-daily use not recommended.

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A or B): use with caution; for on-demand ED dosing do not exceed 10 mg once daily. Severe hepatic impairment (Child-Pugh C): not recommended (avoid use).

Storage & Patient Advice

Missed Dose

On-demand ED use: not applicable (take only when needed). Once-daily use (ED/BPH): take as soon as remembered the same day; if close to the next dose, skip; do not take more than one dose in 24 hours.

Stopping the Medicine

Safe to stop anytime.

Overdose

Overdose: adverse effects are an exaggeration of known tadalafil effects (e.g., headache, flushing, dizziness, hypotension, dyspepsia, back pain, visual symptoms); management is supportive/symptomatic with vital-sign and cardiovascular monitoring, consider GI decontamination if early, and hemodialysis is unlikely to be beneficial due to high protein binding.

Patient Counseling

Take with or without food; for on-demand ED take ≥30 minutes before sex and only once per day; sexual stimulation is needed. Avoid nitrates and riociguat; use caution with alpha-blockers, antihypertensives, and excess alcohol. Seek urgent care for chest pain requiring nitrates, erection >4 hours, or sudden vision/hearing loss; report severe dizziness/syncope.

Monitoring Requirements

Monitor blood pressure/symptoms of hypotension (especially with antihypertensives, alpha-blockers, or alcohol). Counsel/monitor for sudden vision changes (NAION) or sudden hearing loss; assess for priapism risk and seek urgent care if erection >4 hours.

Pharmacology

Mechanism of Action

Selectively inhibits PDE5, increasing cGMP by reducing its breakdown; this enhances nitric-oxide-mediated smooth-muscle relaxation and blood flow in the corpus cavernosum (and pulmonary vasculature), facilitating erection during sexual stimulation.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

Approximately 17.5 hours.

Bioavailability

Absolute oral bioavailability: not determined (no IV comparator); tadalafil is well absorbed after oral administration.

Metabolism

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

Excretion

Fecal (approximately 61%) and renal (approximately 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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