TADALAFIL EVA 20 MG 4 TAB

Indications

Approved Uses

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

Dosage & Administration

Initial Dose

10 mg taken prior to anticipated sexual activity (on-demand); or 2.5 mg once daily for daily dosing regimen

Maintenance Dose

10-20 mg as needed (on-demand); 5 mg once daily (daily dosing); 40 mg once daily (PAH)

Maximum Dose

20 mg per dose (not to exceed once daily) for erectile dysfunction (on-demand); 40 mg once daily for PAH

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment (ED/BPH): CrCl 30-50 mL/min-start 5 mg, max 10 mg every 48 hours (on-demand); CrCl <30 mL/min or hemodialysis-max 5 mg every 72 hours (on-demand); once-daily use for ED/BPH is not recommended when CrCl <30 mL/min. Hepatic impairment: mild-moderate (Child-Pugh A/B)-max 10 mg (on-demand) and use caution; severe (Child-Pugh C)-not recommended. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): max 10 mg every 72 hours (on-demand); for once-daily regimens, avoid or use lowest dose with caution per labeling.

How to Take

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

Side Effects

Common Side Effects

Headache, Flushing, Dyspepsia, Back pain, Myalgia, Nasal congestion, Nasopharyngitis, Limb pain

Side Effect Frequency

Very common: headache. Common: flushing, dyspepsia, nasal congestion, back pain, myalgia, pain in extremity, dizziness. Rare/serious: hypotension/syncope (especially with interacting drugs), priapism, sudden hearing loss, and non-arteritic anterior ischemic optic neuropathy (NAION).

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 excipients. Other items listed by Model A (e.g., recent MI/stroke, unstable angina, uncontrolled hypertension, severe hepatic impairment, retinitis pigmentosa) are generally warnings/precautions or situations where use is not recommended rather than absolute contraindications.

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status before initiating because sexual activity increases cardiac workload; avoid all nitrates/NO donors and riociguat; caution with alpha-blockers and other antihypertensives (risk of symptomatic hypotension-ensure stable therapy and start low); counsel to seek urgent care for priapism (>4 hours); discontinue and seek care for sudden vision or hearing changes; use caution in patients with anatomical penile deformity or conditions predisposing to priapism (e.g., sickle cell disease, leukemia, multiple myeloma); caution in severe hepatic/renal impairment; not indicated for women/children for ED.

Age Restriction

Not approved under 18 years

Drug Interactions

Drug Interactions

Clinically significant interactions include: nitrates/NO donors (contraindicated), riociguat (contraindicated), alpha-blockers (additive hypotension-caution; ensure stable alpha-blocker therapy), other antihypertensives (additive BP lowering), potent CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, ritonavir/cobicistat, clarithromycin-↑ tadalafil exposure; dose limits/avoid high doses), potent CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin-↓ exposure/efficacy), and substantial alcohol (additive hypotension).

Interaction Severity

MAJOR/Contraindicated: Nitrates (e.g., nitroglycerin, isosorbide) and riociguat-risk of profound hypotension. MODERATE: Alpha-blockers (especially nonselective), antihypertensives, substantial alcohol intake-additive blood-pressure lowering; strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin)-increased tadalafil exposure; CYP3A4 inducers (e.g., rifampin)-reduced effect. MINOR: Antacids may slightly delay absorption (minimal clinical impact).

Food Interaction

No clinically significant food interaction; may be taken with or without food (high-fat meals do not meaningfully affect exposure).

Special Populations

Children

Not approved for children.

Storage & Patient Advice

Missed Dose

On-demand use: skip the missed dose (take only when needed); do not double. Once-daily use: take as soon as remembered the same day; if close to the next dose, skip; do not take two doses in one day.

Stopping the Medicine

Safe to stop anytime - no tapering required

Pharmacology

Mechanism of Action

Selectively inhibits phosphodiesterase type 5 (PDE5), preventing degradation of cyclic guanosine monophosphate (cGMP) in smooth muscle cells of the corpus cavernosum, leading to smooth muscle relaxation, increased blood flow, and penile erection in response to sexual stimulation

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

17.5 hours.

Bioavailability

Absolute bioavailability: not established; food does not produce a clinically meaningful effect on exposure.

Metabolism

Hepatic metabolism predominantly via CYP3A4 to metabolites (primarily inactive), followed by further conjugation.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: Tadalafil 20 mg

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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