TEDO 20/MG FC TAB 8/FC TAB

Indications

Approved Uses

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

Off-Label Uses

Raynaud’s phenomenon; prevention/treatment of high-altitude pulmonary edema (HAPE) in selected cases.

Dosage & Administration

Dosing by Condition

ED (as needed): 10 mg prior to sexual activity; may adjust to 5 mg or 20 mg; maximum once daily. ED (once daily): 2.5 mg once daily, may increase to 5 mg once daily. BPH (once daily): 5 mg once daily. PAH: 40 mg once daily (given as two 20 mg tablets).

Initial Dose

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

Maintenance Dose

5-20mg as needed; 2.5-5mg once daily.

Maximum Dose

Erectile Dysfunction: 20mg as needed. BPH/ED daily: 5mg daily. Pulmonary Arterial Hypertension: 40mg daily (using 20mg tablets

Children's Dosage

Not approved for children for ED/BPH. Used in pediatric patients for PAH under specialist supervision.

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. Once-daily tadalafil is not recommended when CrCl <30 mL/min. Hepatic impairment: mild-moderate (Child-Pugh A/B): max 10 mg once daily for ED as-needed; severe (Child-Pugh C): not recommended. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): for ED as-needed, max 10 mg every 72 hours; avoid/limit with daily regimens per labeling.

How to Take

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

Safety & Warnings

Contraindications

Contraindicated with any form of organic nitrates or nitric oxide donors; contraindicated with guanylate cyclase stimulators (e.g., riociguat); contraindicated in patients with hypersensitivity to tadalafil/excipients.

Warnings & Precautions

Assess cardiovascular status before prescribing and avoid use when sexual activity is inadvisable; caution with alpha-blockers/other BP-lowering drugs and alcohol (hypotension); caution with anatomical penile deformation and conditions predisposing to priapism; discontinue and seek urgent care for sudden vision/hearing changes or priapism; not indicated for women for ED.

Age Restriction

Not approved for patients <18 years for this product (tadalafil 20 mg oral tablet for ED); pediatric use is not indicated.

Drug Interactions

Drug Interactions

Major/contraindicated: nitrates/NO donors; riociguat. Clinically significant: alpha-blockers and other antihypertensives (additive BP lowering), substantial alcohol (hypotension), potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) increase tadalafil exposure, CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin) decrease exposure/efficacy.

Interaction Severity

MAJOR/Contraindicated: nitrates (any form) and riociguat (risk of profound hypotension). MAJOR: strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) markedly increase tadalafil exposure-dose limits/avoid daily use depending on regimen. MODERATE: alpha-blockers and other antihypertensives (additive BP lowering), substantial alcohol intake (hypotension). MINOR: CYP3A4 inducers (e.g., rifampin, carbamazepine) may reduce efficacy.

Special Populations

Children

Not approved for children for ED/BPH. Used in pediatric patients for PAH under specialist supervision.

Storage & Patient Advice

Missed Dose

As-needed ED use: not applicable (take only when needed; do not exceed one dose in 24 hours). Once-daily regimens (ED daily/BPH/PAH): take as soon as remembered the same day; if close to next dose, skip the missed dose-do not double doses.

Stopping the Medicine

Safe to stop anytime.

Pharmacology

Mechanism of Action

Selective phosphodiesterase type 5 (PDE5) inhibitor that increases cGMP by preventing its degradation, causing smooth muscle relaxation and vasodilation (corpus cavernosum for erection with sexual stimulation; pulmonary vasculature for PAH).

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

Approximately 17.5 hours.

Bioavailability

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

Metabolism

Hepatic metabolism predominantly via CYP3A4 to inactive metabolites (with subsequent conjugation).

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 20 mg tadalafil

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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