CIALIS 20/MG 4/FC TAB

Indications

Approved Uses

Erectile dysfunction (ED), benign prostatic hyperplasia (BPH), pulmonary arterial hypertension (PAH), concurrent ED and BPH

Dosage & Administration

Dosing by Condition

Erectile dysfunction (as-needed): 10 mg prior to anticipated sexual activity; may increase to 20 mg or decrease to 5 mg based on efficacy/tolerability; maximum once daily.
Erectile dysfunction (once-daily): 2.5 mg once daily, may increase to 5 mg once daily.
Benign prostatic hyperplasia (BPH) or BPH with ED: 5 mg once daily.
Pulmonary arterial hypertension (PAH): 40 mg once daily (two 20 mg tablets) (product-specific indication depends on local approval).

Initial Dose

10mg taken approximately 30 minutes before anticipated sexual activity

Maintenance Dose

10-20mg as needed (not more than once per day); 5mg once daily for daily dosing regimen

Maximum Dose

20mg as needed for ED; 5mg once daily for ED/BPH; 40mg once daily 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 hemodialysis: max 5 mg every 72 hours; once-daily tadalafil is not recommended when CrCl <30 mL/min. Hepatic impairment (ED as-needed): mild-moderate (Child-Pugh A/B): max 10 mg; severe (Child-Pugh C): not recommended. Strong CYP3A4 inhibitors: limit to 10 mg every 72 hours (as-needed) or avoid/limit daily dosing per labeling.

How to Take

Swallow the film-coated tablet whole with water; may be taken with or without food. For erectile dysfunction (as-needed), take at least 30 minutes before sexual activity (effect may last up to 36 hours). Do not take more than one dose in 24 hours.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (≥1%): headache, dyspepsia, back pain, myalgia, flushing, nasal congestion; other reported common effects include pain in extremity and dizziness; rare but serious: priapism, NAION, sudden hearing loss.

Safety & Warnings

Contraindications

Concomitant use with any form of organic nitrate; concomitant use with guanylate cyclase stimulators (e.g., riociguat); hypersensitivity to tadalafil or excipients

Warnings & Precautions

Assess cardiovascular status before prescribing; avoid nitrates/riociguat; caution with alpha-blockers/antihypertensives and alcohol (hypotension); caution in penile deformity or priapism risk conditions; discontinue and seek urgent care for vision/hearing changes; caution with bleeding disorders/active peptic ulcer; not indicated for women for ED

Age Restriction

Not approved under 18 years

Drug Interactions

Drug Interactions

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

Interaction Severity

"MAJOR/CONTRAINDICATED: Nitrates (any form) and riociguat (risk of profound, potentially life-threatening hypotension).
MODERATE: Alpha-blockers and other antihypertensives (additive BP lowering), strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) (increased tadalafil exposure), substantial alcohol intake (additive hypotension/dizziness).
MINOR: CYP3A4 inducers (e.g., rifampin) may reduce effect; antacids may slightly reduce/slow absorption."

Food Interaction

May be taken with or without food; food does not meaningfully affect absorption. Avoid/limit grapefruit or grapefruit juice (especially large amounts) due to CYP3A4 inhibition potentially increasing tadalafil exposure.

Special Populations

Children

Not approved for children.

Elderly

Standard adult dosing. Slower clearance may lead to longer half-life.

Kidney Impairment

As-needed ED dosing: CrCl 30-50 mL/min: max 10 mg once every 48 hours; CrCl <30 mL/min or on hemodialysis: max 5 mg once every 72 hours. Once-daily use: CrCl 30-50 mL/min: start 2.5 mg daily, may increase to 5 mg daily; CrCl <30 mL/min or on dialysis: not recommended

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A/B): max 10 mg once daily for as-needed use; use with caution. Severe hepatic impairment (Child-Pugh C): not recommended (avoid)

Storage & Patient Advice

Missed Dose

As-needed use: no missed dose concept-take only when needed and not more than once in 24 hours. Once-daily use: 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 required

Patient Counseling

Take with or without food; for ED as-needed, take at least 30 minutes before sexual activity and do not exceed one dose in 24 hours; sexual stimulation is required. Do not use with nitrates or riociguat; use caution with alpha-blockers/antihypertensives and limit alcohol. Seek urgent care for erection >4 hours or sudden vision/hearing loss; report chest pain and do not take nitrates after tadalafil without medical advice.

Monitoring Requirements

No routine laboratory monitoring is required; assess cardiovascular status before initiating for ED, and monitor blood pressure/symptoms of hypotension when used with antihypertensives or alpha-blockers and in patients at risk.

Pharmacology

Mechanism of Action

Selectively inhibits PDE5, increasing cGMP in smooth muscle (e.g., corpus cavernosum and pulmonary vasculature), leading to smooth muscle relaxation and increased blood flow; erectile response requires sexual stimulation.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

Approximately 17.5 hours (terminal half-life).

Bioavailability

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

Metabolism

Predominantly hepatic metabolism via CYP3A4 to a catechol metabolite, followed by methylation and glucuronidation (metabolites largely inactive).

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 20mg tadalafil

Generic Availability

Yes

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.