REXOFIL 20/MG FC TAB 4/FC TAB

Indications

Approved Uses

Erectile Dysfunction (ED), Benign Prostatic Hyperplasia (BPH), Pulmonary Arterial Hypertension (PAH) (PAH approved for 40mg formulation as Adcirca

Off-Label Uses

Raynaud’s phenomenon and other peripheral vasospastic disorders; prevention/treatment of high-altitude pulmonary edema (HAPE) in select cases.

Dosage & Administration

Dosing by Condition

Erectile dysfunction (as needed): 10 mg at least 30 minutes before sexual activity; may increase to 20 mg or decrease to 5 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) or BPH with ED: 5 mg once daily.
Pulmonary arterial hypertension (PAH): 40 mg once daily (two 20 mg tablets) per PAH-specific labeling.

Initial Dose

10mg taken approximately 30-60 minutes before sexual activity (on-demand dosing for ED)

Maintenance Dose

10-20mg as needed for ED; 2.5-5mg once daily for daily dosing regimen

Maximum Dose

20mg per dose as needed for ED; 40mg once daily for PAH (Adcirca formulation

Children's Dosage

Safety and efficacy not established.

Dose Adjustment Notes

Renal impairment (ED as-needed): CrCl 30-50 mL/min: max 10 mg every 48 hours; CrCl <30 mL/min or on hemodialysis: max 5 mg every 72 hours. Hepatic impairment: mild-moderate (Child-Pugh A/B): max 10 mg once daily (as-needed use); severe (Child-Pugh C): not recommended/avoid. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): max 10 mg every 72 hours (as-needed) and avoid once-daily tadalafil regimens.

How to Take

Swallow tablet whole with water; may be taken with or without food. For erectile dysfunction (on-demand), take at least 30 minutes before sexual activity; do not take more than one dose in 24 hours.

Side Effects

Common Side Effects

Headache, dyspepsia, back pain, myalgia, flushing, nasopharyngitis, nasal congestion, pain in limb.

Side Effect Frequency

Very common (≥10%): Headache. Common (1-10%): Flushing, Dyspepsia, Nasal congestion, Back pain, Myalgia, Pain in extremity. Uncommon (0.1-1%): Dizziness. Rare/very rare (≤0.1%) or frequency not known: Priapism, Non-arteritic anterior ischemic optic neuropathy (NAION)/sudden vision loss, Sudden hearing loss, Hypersensitivity reactions.

Safety & Warnings

Contraindications

Concurrent use of any form of organic nitrates (or nitric oxide donors) and concurrent use of guanylate cyclase stimulators (e.g., riociguat); hypersensitivity to tadalafil.

Warnings & Precautions

Avoid all nitrates/NO donors and GC stimulators; assess cardiovascular fitness for sexual activity before prescribing; use caution with alpha-blockers/other antihypertensives and advise on hypotension risk; use caution in patients predisposed to priapism (e.g., sickle cell disease, leukemia, myeloma) or with penile deformity; counsel to stop and seek urgent care for chest pain, sudden vision/hearing loss, or erection lasting >4 hours; caution in hereditary retinal disorders.

Age Restriction

Not approved for use in individuals under 18 years.

Driving Warning

Caution; dizziness may occur

Drug Interactions

Drug Interactions

Contraindicated: nitrates/nitric oxide donors; riociguat (GC stimulators). Clinically significant: alpha-blockers and other antihypertensives (additive hypotension), substantial alcohol (additive hypotension), strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat) increase tadalafil exposure, strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) decrease exposure.

Interaction Severity

"MAJOR/Contraindicated: Nitrates (e.g., nitroglycerin, isosorbide) and riociguat-risk of profound hypotension.
MODERATE: Alpha-blockers and other antihypertensives (additive BP lowering); strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) increase exposure; alcohol can increase orthostatic symptoms/hypotension risk.
MINOR: CYP3A4 inducers (e.g., rifampin) may reduce efficacy; grapefruit is best considered a moderate interaction/caution rather than a formal contraindication."

Food Interaction

May be taken with or without food; food does not meaningfully affect absorption. Avoid/limit grapefruit or grapefruit juice (especially large amounts) due to potential CYP3A4-mediated increase in tadalafil exposure.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Safety and efficacy not established.

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: max 10 mg every 48 hours; CrCl <30 mL/min or on hemodialysis: max 5 mg every 72 hours. Once-daily ED/BPH regimens: not recommended when CrCl <30 mL/min.

Liver Impairment

Mild-to-moderate hepatic impairment (Child-Pugh A/B): use with caution; for as-needed ED dosing, maximum 10 mg once daily. Severe hepatic impairment (Child-Pugh C): not recommended (avoid use).

Storage & Patient Advice

Storage Conditions

Store below 30°C

Missed Dose

On-demand ED use: no missed dose concept-take only when needed and do not take extra doses. Once-daily regimens (ED daily/BPH/PAH): take as soon as remembered the same day; if near the next dose, skip and resume regular schedule; do not double.

Stopping the Medicine

Safe to stop anytime.

Overdose

Symptoms: exaggerated adverse effects (e.g., headache, flushing, dizziness, hypotension, tachycardia) and risk of priapism. Management: supportive care with vital-sign/hemodynamic monitoring; treat hypotension with standard measures; hemodialysis is unlikely to be helpful due to high protein binding.

Patient Counseling

Take at least 30 minutes before sexual activity if used as needed; sexual stimulation is required. Do not take more than one dose in 24 hours. Do not use with nitrates or riociguat; tell your clinician about alpha-blockers/antihypertensives and CYP3A4 inhibitors. Seek urgent care for chest pain after dosing (do not take nitrates), erection >4 hours, sudden vision loss, or sudden hearing loss; limit alcohol and use caution with grapefruit.

Monitoring Requirements

Assess cardiovascular status and contraindications before initiation; monitor blood pressure and symptoms of hypotension when starting or when combined with antihypertensives/alpha-blockers; monitor for vision/hearing changes and priapism symptoms.

Pharmacology

Mechanism of Action

Selectively inhibits phosphodiesterase type 5 (PDE5), which increases levels of cyclic guanosine monophosphate (cGMP). This leads to smooth muscle relaxation and increased blood flow to the corpus cavernosum of the penis during sexual stimulation, and vasodilation in the pulmonary vasculature.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

Terminal half-life ~17.5 hours (may be prolonged in older adults).

Bioavailability

Absolute oral bioavailability: not determined/unknown.

Metabolism

Predominantly hepatic metabolism via CYP3A4 to metabolites (circulating metabolites are not clinically active).

Excretion

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

Protein Binding

94%.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: Tadalafil 20mg

Generic Availability

Yes

OTC Alternatives

No true OTC equivalent to tadalafil in Saudi Arabia; PDE5 inhibitors (including tadalafil and sildenafil) are generally prescription-only.

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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