TANDO 20 MG 4 TAB

Indications

Approved Uses

Erectile dysfunction, Pulmonary arterial hypertension (PAH), Benign prostatic hyperplasia (BPH) with or without erectile dysfunction

Dosage & Administration

Dosing by Condition

Erectile dysfunction (as-needed): 10 mg prior to sexual activity; adjust to 5-20 mg; maximum once daily. Erectile dysfunction (once daily): 2.5 mg once daily, may increase to 5 mg. BPH (with or without ED): 5 mg once daily. Pulmonary arterial hypertension: 40 mg once daily (two 20 mg tablets) (note: indication depends on local product authorization).

Initial Dose

10 mg taken at least 30 minutes before 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 regimen); 40 mg once daily for PAH

Maximum Dose

20mg per day for as-needed use (ED); 5mg per day for daily use (ED/BPH); 40mg per day for PAH

Children's Dosage

Not approved for children.

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. Renal impairment (once-daily ED/BPH): not recommended if CrCl <30 mL/min; if CrCl 30-50 mL/min, start 2.5 mg daily and may increase to 5 mg based on response. Hepatic impairment: mild-moderate-use with caution (as-needed max 10 mg; once-daily use generally not recommended); severe hepatic impairment-avoid. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): as-needed max 10 mg every 72 hours; once-daily max 2.5 mg daily. Alpha-blockers: risk of hypotension-patient should be stable on alpha-blocker; use lowest tadalafil dose and avoid combination for BPH unless clearly needed.

How to Take

Swallow the 20 mg film‑coated tablet whole with water; may be taken with or without food. For erectile dysfunction (as‑needed), 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, Back pain, Myalgia, Nasal congestion, Nasopharyngitis, Limb pain

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: Priapism; sudden decrease/loss of vision (NAION) and sudden hearing loss (post-marketing).

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any form of organic nitrates or nitric oxide donors (e.g., nitroglycerin, isosorbide, amyl nitrite), (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat), (3) known hypersensitivity to tadalafil or any excipients. Additionally, tadalafil should not be used in patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina or severe cardiac disease).

Warnings & Precautions

Warnings/precautions: assess cardiovascular status before prescribing because sexual activity increases cardiac workload; avoid use if sexual activity is inadvisable. Risk of hypotension-use caution with alpha-blockers/antihypertensives and advise on dizziness/syncope. Priapism risk-caution with penile anatomical deformity or conditions predisposing to priapism (e.g., sickle cell disease, leukemia, multiple myeloma) and seek urgent care for erection >4 hours. Visual/hearing symptoms-stop and seek urgent evaluation for sudden vision or hearing loss. Consider left ventricular outflow obstruction/autonomic dysfunction as higher-risk for hypotension. Not indicated for women for ED; use only for approved indications.

Age Restriction

Not approved under 18 years.

Driving Warning

Use caution when driving or operating machinery; dizziness may occur

Drug Interactions

Drug Interactions

Major interactions: (1) Nitrates/NO donors-contraindicated (profound hypotension), (2) riociguat-contraindicated (marked hypotension), (3) alpha-blockers and other antihypertensives-additive BP lowering (start low, separate dosing/monitor), (4) potent CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, ritonavir/cobicistat, clarithromycin)-increase tadalafil exposure (dose limitation/avoid depending on regimen), (5) potent CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)-decrease exposure/efficacy, (6) substantial alcohol-additive hypotension/dizziness. Amlodipine is not a unique interaction beyond general additive hypotension with antihypertensives.

Interaction Severity

MAJOR/Contraindicated: nitrates (any form) and riociguat (profound hypotension). MODERATE: alpha-blockers and other antihypertensives (additive BP lowering), strong CYP3A4 inhibitors (↑ tadalafil exposure), excessive alcohol (↑ orthostatic symptoms), CYP3A4 inducers like rifampin (↓ efficacy). MINOR: antacids may slightly delay absorption without major clinical impact.

Food Interaction

May be taken with or without food; food (including high-fat meals) does not meaningfully affect overall exposure. Grapefruit/grapefruit juice may increase tadalafil concentrations (CYP3A4 inhibition) and should be used cautiously.

Alcohol Interaction

Use with caution; substantial alcohol consumption may increase risk of orthostatic hypotension

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 and concomitant medications

Kidney Impairment

As-needed ED dosing: CrCl 30-50 mL/min: max 10 mg no more frequently than every 48 hours; CrCl <30 mL/min or on hemodialysis: max 5 mg no more frequently than every 72 hours. Once-daily use: not recommended when CrCl <30 mL/min or on hemodialysis; if CrCl 30-50 mL/min, use reduced daily dose with caution per product labeling.

Liver Impairment

Hepatic impairment: Mild-moderate (Child-Pugh A or B): use with caution; for as-needed erectile dysfunction dosing, maximum 10 mg once daily; once-daily chronic dosing is not well studied/should be used cautiously. Severe (Child-Pugh C): not recommended (avoid).

Storage & Patient Advice

Missed Dose

As-needed ED use: not applicable-take only when needed; do not take extra doses to make up for a missed dose. Once-daily regimens (ED/BPH/PAH): take as soon as remembered the same day; if close to the next dose, skip-do not double doses.

Stopping the Medicine

Safe to stop anytime; no tapering is required.

Overdose

Overdose: Expected effects are exaggerated adverse reactions (e.g., headache, flushing, dizziness, hypotension, dyspepsia, back pain/myalgia); management is supportive/symptomatic with vital sign and hemodynamic monitoring. Consider GI decontamination only if very recent ingestion per toxicology practice; hemodialysis is unlikely to be helpful due to high protein binding.

Patient Counseling

Take exactly as prescribed (either as-needed before sexual activity or once daily at the same time); swallow whole with water; do not exceed one dose per day. Do not use with nitrates or riociguat; tell your clinician about all medicines (especially alpha-blockers, antihypertensives, and strong CYP3A4 inhibitors). Limit excessive alcohol; seek urgent care for chest pain after dosing (do not take nitrates), erection >4 hours, or sudden vision/hearing loss.

Monitoring Requirements

Assess cardiovascular status and contraindications before initiation; monitor blood pressure and symptoms of hypotension when used with antihypertensives/alpha-blockers or in patients at risk; monitor for vision/hearing changes and priapism symptoms clinically.

Pharmacology

Mechanism of Action

Selective PDE5 inhibitor that increases cGMP by preventing its breakdown, causing smooth-muscle relaxation and increased blood flow in the corpus cavernosum (erection with sexual stimulation); also relaxes smooth muscle in lower urinary tract/prostate and pulmonary vasculature.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours. [2, 4]

Half-Life

Terminal half-life ~17.5 hours.

Bioavailability

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

Metabolism

Hepatic metabolism predominantly via CYP3A4 (minor CYP2C9) to metabolites with reduced/inactive PDE5 inhibitory activity; excreted mainly as metabolites in feces and urine.

Excretion

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

Protein Binding

Approximately 94% protein bound.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: Tadalafil 20 mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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