TANDO 5/MG FC TAB 30/FC TAB

Indications

Approved Uses

Erectile Dysfunction (ED), Benign Prostatic Hyperplasia (BPH), Erectile Dysfunction with Benign Prostatic Hyperplasia (ED/BPH), Pulmonary Arterial Hypertension (PAH).

Dosage & Administration

Dosing by Condition

Erectile dysfunction (as needed): 10 mg prior to anticipated sexual activity; may adjust to 5-20 mg based on efficacy/tolerability; maximum once daily.
Erectile dysfunction (once daily): 2.5 mg once daily; may increase to 5 mg once daily; max 5 mg/day.
Benign prostatic hyperplasia (BPH) or BPH + ED: 5 mg once daily.
Pulmonary arterial hypertension (PAH): 40 mg once daily (as tadalafil PAH product); not applicable to this 5 mg ED/BPH tablet brand for PAH use.

Initial Dose

5 mg once daily (for daily dosing regimen for ED or BPH)

Maintenance Dose

For daily use ED/BPH: 5mg once daily. For as-needed ED: 5mg to 20mg.

Maximum Dose

ED/BPH once-daily: 5 mg/day; ED on-demand: 20 mg per dose (max once daily

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment: for ED as-needed-CrCl 30-50 mL/min max 10 mg every 48 hours; CrCl <30 mL/min (or hemodialysis) max 5 mg every 72 hours; once-daily use is not recommended when CrCl <30 mL/min. Hepatic impairment: mild-moderate (Child-Pugh A/B) use with caution; for ED as-needed max 10 mg; once-daily use not recommended; severe (Child-Pugh C) not recommended. Strong CYP3A4 inhibitors: limit to 10 mg every 72 hours (as-needed) and avoid/limit daily dosing (generally max 2.5 mg/day if used).

How to Take

Swallow the film-coated tablet whole with water; may be taken with or without food; for once-daily use take at approximately the same time each day.

Side Effects

Common Side Effects

Headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, pain in extremity, dizziness, nausea, nasopharyngitis.

Side Effect Frequency

"Very common/common: Headache, dyspepsia, back pain, myalgia, flushing, nasal congestion, nasopharyngitis; pain in extremity and dizziness can occur (often categorized as common depending on dataset/indication).
Uncommon/rare but serious: Hypotension/syncope, priapism, sudden decrease/loss of vision (including NAION), sudden hearing loss."

Safety & Warnings

Contraindications

Concomitant use with any nitrates or nitric oxide donors; concomitant use with guanylate cyclase stimulators (e.g., riociguat); hypersensitivity to tadalafil

Warnings & Precautions

Assess cardiovascular status and avoid use when sexual activity is inadvisable; caution with alpha-blockers/other BP-lowering drugs; caution in patients at risk for priapism or with penile anatomical deformity; discontinue and seek care for sudden vision/hearing changes; not indicated for use in women

Age Restriction

Not approved under 18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Nitrates/NO donors (contraindicated); guanylate cyclase stimulators such as riociguat (contraindicated); alpha-blockers and other antihypertensives (additive hypotension); potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat) increase tadalafil exposure; potent CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) decrease exposure; substantial alcohol may increase hypotension

Interaction Severity

"MAJOR/Contraindicated: Nitrates (including recreational nitrites) and riociguat-risk of profound hypotension/syncope.
MODERATE: Alpha-blockers and other antihypertensives-additive blood pressure lowering; strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin)-increased tadalafil exposure; substantial alcohol-greater hypotension risk.
MINOR: CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)-reduced tadalafil exposure/efficacy."

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Alcohol Interaction

Avoid

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; consider renal and hepatic function

Kidney Impairment

Once-daily (5 mg) use: CrCl 30-50 mL/min start 2.5 mg once daily; may increase to 5 mg once daily based on response/tolerability. CrCl <30 mL/min or on hemodialysis: not recommended for once-daily use.

Liver Impairment

Child-Pugh A/B: use with caution (for once-daily 5 mg, consider lower dose/avoid escalation; for on-demand ED, do not exceed 10 mg); Child-Pugh C: not recommended/avoid

Storage & Patient Advice

Overdose

Symptoms may include exaggerated adverse effects (headache, flushing, dizziness), hypotension/syncope, and priapism; management is supportive with monitoring, consider activated charcoal if recent ingestion, and dialysis is unlikely to help due to high protein binding-seek urgent medical care

Patient Counseling

Take once daily at about the same time (for BPH/ED daily therapy); sexual stimulation is required for ED effect; do not use with nitrates or riociguat; limit excessive alcohol; seek urgent care for chest pain, severe dizziness/syncope, sudden vision/hearing loss, or erection >4 hours; inform clinicians about alpha-blockers, antihypertensives, and CYP3A4 inhibitors.

Monitoring Requirements

No routine laboratory monitoring; assess cardiovascular status before initiation; monitor blood pressure and symptoms of hypotension especially when combined with antihypertensives/alpha-blockers; counsel to seek urgent care for priapism or sudden vision/hearing loss.

Pharmacology

Mechanism of Action

Selectively inhibits phosphodiesterase type 5 (PDE5), an enzyme found in the smooth muscle of the corpus cavernosum, prostate, and pulmonary vasculature. By inhibiting PDE5, it prevents the breakdown of cyclic guanosine monophosphate (cGMP), leading to smooth muscle relaxation, vasodilation, and increased blood flow.

Duration of Effect

Up to 36 hours.

Bioavailability

Absolute oral bioavailability: not determined; food does not have a clinically meaningful effect on absorption.

Metabolism

Hepatic metabolism predominantly via CYP3A4 to metabolites (largely inactive).

Excretion

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

Protein Binding

94%.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: Tadalafil 5 mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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