CIALIS 5/MG FC TAB 28/FC TAB

Indications

Approved Uses

Erectile dysfunction (ED); benign prostatic hyperplasia (BPH); and ED with BPH (concomitant).

Off-Label Uses

Raynaud’s phenomenon/digital ischemia and other peripheral vasospastic disorders; high‑altitude pulmonary edema prevention/treatment (limited evidence). PAH is not off‑label for tadalafil as a molecule but is a different labeled product/brand than Cialis.

Dosage & Administration

Dosing by Condition

ED (once‑daily): 2.5 mg once daily, may increase to 5 mg once daily. ED (as‑needed): 10 mg prior to sexual activity, may adjust to 20 mg or 5 mg; not more than once daily. BPH: 5 mg once daily. ED + BPH: 5 mg once daily.

Initial Dose

5 mg once daily (for once-daily dosing regimen)

Maintenance Dose

5 mg once daily; may be adjusted to 2.5 mg once daily based on individual response and tolerability

Maximum Dose

5 mg per day for once-daily regimen; 20 mg per day for on-demand use

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment (once‑daily use): CrCl 30-50 mL/min-start 2.5 mg once daily and may increase to 5 mg based on response; CrCl <30 mL/min or on hemodialysis-once‑daily use not recommended. Hepatic impairment: mild-moderate (Child‑Pugh A/B)-use with caution (once‑daily use generally not recommended); severe (Child‑Pugh C)-not recommended. Strong CYP3A4 inhibitors-avoid once‑daily tadalafil; if using as‑needed, reduce frequency/dose per labeling.

How to Take

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

Side Effects

Common Side Effects

Headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (limb pain).

Side Effect Frequency

Common (≥1%): headache, dyspepsia, back pain, myalgia, flushing, nasal congestion, pain in extremity. Less common/uncommon: dizziness, hypotension, blurred vision. Rare but serious: priapism, non-arteritic anterior ischemic optic neuropathy (sudden vision loss), sudden hearing loss, hypersensitivity reactions.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any nitrates or nitric oxide donors in any form; (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat); (3) known hypersensitivity to tadalafil or any component of the product.

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status and avoid use in patients for whom sexual activity is inadvisable; risk of hypotension (especially with alpha-blockers/antihypertensives/alcohol-ensure stable alpha-blocker therapy and start low); priapism risk (higher in anatomical penile deformity or predisposition such as sickle cell disease, leukemia, multiple myeloma); discontinue and seek urgent care for sudden vision loss (NAION) or sudden hearing loss; use caution with substantial CYP3A4 inhibitors; not indicated for use in women and not for pediatric use.

Age Restriction

Not approved under 18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: nitrates (contraindicated-profound hypotension), guanylate cyclase stimulators/riociguat (contraindicated), alpha-blockers (additive hypotension-caution and ensure stable alpha-blocker therapy), antihypertensives (additive BP lowering), alcohol in substantial amounts (orthostatic hypotension), strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat, clarithromycin-↑ tadalafil exposure; dose limitation/avoid higher doses), strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin-↓ exposure/efficacy).

Interaction Severity

MAJOR/CONTRAINDICATED: nitrates (any form) and riociguat. MODERATE: alpha‑blockers and other antihypertensives (additive hypotension), strong CYP3A4 inhibitors (↑ tadalafil), strong CYP3A4 inducers (↓ tadalafil), substantial alcohol (hypotension).

Food Interaction

May be taken with or without food; avoid grapefruit/grapefruit juice (especially large amounts) due to CYP3A4 inhibition potentially increasing tadalafil exposure.

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; however, greater sensitivity to hypotensive effects may occur - assess cardiovascular status carefully

Kidney Impairment

Once-daily use (ED/BPH): CrCl 30-50 mL/min: start 2.5 mg once daily; may increase to 5 mg based on response. CrCl <30 mL/min or on hemodialysis: once-daily use not recommended. On-demand ED dosing: CrCl 30-50 mL/min: 5 mg with max 10 mg no more frequently than every 48 hours; CrCl <30 mL/min or on hemodialysis: max 5 mg every 72 hours

Liver Impairment

Mild to moderate hepatic impairment (Child-Pugh A or B): use with caution; for once-daily use, consider 2.5 mg daily and may increase to 5 mg based on response/tolerability; for on-demand ED dosing, do not exceed 10 mg once daily. Severe hepatic impairment (Child-Pugh C): not recommended (avoid use).

Storage & Patient Advice

Missed Dose

For once‑daily use: take the missed dose as soon as remembered the same day; if it is close to the next dose, skip it; do not take more than one dose in a day.

Stopping the Medicine

Safe to stop anytime.

Overdose

Overdose may cause exaggerated PDE5-inhibitor effects (e.g., headache, flushing, dizziness, hypotension/syncope, tachycardia, priapism); management is supportive/symptomatic with monitoring of vital signs and cardiovascular status; hemodialysis is not effective due to high protein binding.

Patient Counseling

Take 1 tablet (tadalafil 5 mg) by mouth once daily at about the same time each day, with or without food; sexual stimulation is required for effect. Do NOT use with any nitrates (e.g., nitroglycerin/isosorbide) or guanylate cyclase stimulators (riociguat) due to risk of profound hypotension; use caution with alpha-blockers and other antihypertensives. Limit alcohol (can worsen dizziness/low BP). Avoid grapefruit/grapefruit juice (may increase tadalafil levels). Seek urgent care for chest pain after taking tadalafil (do not self-treat with nitrates), an erection lasting >4 hours, or sudden vision or hearing loss. This medication does not protect against STIs; tell your prescriber about all medicines and significant heart/liver/kidney disease.

Monitoring Requirements

Assess cardiovascular status and blood pressure at baseline and clinically as needed; monitor for symptomatic hypotension especially with antihypertensives/alpha‑blockers and for vision/hearing changes or priapism symptoms.

Pharmacology

Mechanism of Action

Selective PDE5 inhibition increases cGMP by reducing its breakdown, enhancing nitric‑oxide-mediated smooth‑muscle relaxation and blood flow (e.g., corpus cavernosum; also vascular smooth muscle).

Onset of Action

As‑needed: typically ~30-60 minutes. Once‑daily: clinical readiness is maintained with daily dosing; steady state is reached by about day 5.

Duration of Effect

Up to ~36 hours after a single dose (as‑needed use).

Half-Life

Terminal half-life: approximately 17.5 hours (healthy subjects).

Bioavailability

Absolute oral bioavailability: not determined (no IV comparator); tadalafil is well absorbed with median Tmax ~2 hours.

Metabolism

Metabolism: hepatic, predominantly via CYP3A4 to a catechol metabolite, then methylated and glucuronidated (metabolites essentially inactive).

Excretion

Excretion: primarily as metabolites-about 61% in feces and about 36% in urine.

Protein Binding

94%

Product Information

Available Dosage Forms

Film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: 5 mg tadalafil

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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