TADANERFI — Tadalafil Oral Dissolvable Films

Active ingredient: Tadalafil | Dosage form: Oral dissolvable films | Available strengths: 5 mg and 20 mg

Medical Description

TADANERFI contains tadalafil, a medication belonging to the phosphodiesterase type 5 (PDE5) inhibitor class. It is primarily used for the treatment of erectile dysfunction (ED), helping improve erectile function by enhancing blood flow to the penile tissues.

Tadalafil works by inhibiting the PDE5 enzyme, which increases cyclic guanosine monophosphate (cGMP) levels and promotes relaxation of smooth muscles in blood vessels. This facilitates increased blood flow to the penis in response to sexual stimulation.

Tadalafil has a prolonged duration of action, with effects that may last up to 36 hours following administration. Sexual stimulation is still required for an erection to occur.

Tadalafil is also approved for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), including urinary hesitancy, weak urinary stream, and frequent urination.

The oral dissolvable film formulation provides an alternative dosage form for administering tadalafil. It is designed to dissolve in the mouth, offering a convenient administration option for patients who prefer an alternative to conventional tablets.

Composition

Each oral dissolvable film contains:

Pack size: As specified on the product packaging.

Mechanism of Action

Tadalafil selectively inhibits the PDE5 enzyme, preventing the breakdown of cGMP in smooth muscle cells. This enhances nitric oxide-mediated smooth muscle relaxation and increases blood flow to the penile tissues during sexual stimulation.

It also relaxes smooth muscle in the prostate and bladder, helping improve urinary symptoms associated with benign prostatic hyperplasia.

Indications and Potential Benefits

• Treatment of Erectile Dysfunction: Helps achieve and maintain an erection sufficient for satisfactory sexual activity.
• Improves Erectile Function: Enhances penile blood flow in response to sexual stimulation.
• Prolonged Duration of Action: Provides an extended therapeutic window, with effects lasting up to 36 hours.
• Supports Prostate Health: Helps relieve lower urinary tract symptoms associated with benign prostatic hyperplasia.
• Improves Urinary Symptoms: May reduce urinary frequency, urgency, and difficulty initiating urination in men with BPH.

Dosage should be individualized according to the indication, patient response, tolerability, and physician assessment.

• The 5 mg daily regimen should be taken at approximately the same time each day.
• For as-needed treatment, tadalafil is generally started at 10 mg, with adjustment to 5 mg or 20 mg according to efficacy and tolerability.
• Do not take tadalafil more than once daily.
• Tadalafil can be administered with or without food.
• Follow the manufacturer's instructions for placing and dissolving the oral film in the mouth.

The 20 mg strength should not be interpreted as a recommended daily dose.

• Nitrates: Tadalafil is strictly contraindicated with nitrate medications, including nitroglycerin and isosorbide, because the combination can cause a potentially life-threatening drop in blood pressure.
• Cardiovascular conditions: Patients with significant heart disease or those for whom sexual activity is medically inadvisable should undergo medical evaluation before use.
• Blood pressure: Caution is required when tadalafil is used with antihypertensive medications or alpha-blockers due to the risk of hypotension.
• Alcohol: Excessive alcohol consumption may increase the risk of dizziness, headache, and low blood pressure.
• Kidney and liver impairment: Dose adjustment or avoidance may be necessary depending on the severity of impairment.
• Drug interactions: Avoid concomitant use with riociguat and other PDE5 inhibitors. Certain medications, particularly strong CYP3A4 inhibitors, may require dosage adjustment.

Common adverse effects include:

• Headache.
• Facial flushing.
• Nasal congestion.
• Indigestion or dyspepsia.
• Back pain.
• Muscle aches.
• Dizziness.

Serious adverse reactions requiring immediate medical attention:

• An erection lasting more than 4 hours (priapism).
• Sudden loss or deterioration of vision.
• Sudden hearing loss.
• Chest pain or severe cardiovascular symptoms.

Patients experiencing chest pain after taking tadalafil should seek emergency medical assistance and inform healthcare professionals about the tadalafil dose and timing. They must not self-administer nitrates.

Store according to the manufacturer's instructions. Keep the oral films in their original protective packaging, away from moisture, excessive heat, and direct sunlight. Keep out of reach of children.

References

The following trusted medical and governmental resources provide evidence-based information about tadalafil:

1. U.S. National Library of Medicine – DailyMed: Tadalafil Full Prescribing Information. View medical reference.
2. U.S. Food and Drug Administration (FDA): Cialis (Tadalafil) Prescribing Information. View FDA reference.
3. FDA – DailyMed: Tadalafil indications, dosage, contraindications, and safety information. Visit DailyMed.

Patient Disclaimer

TADANERFI is a prescription medication containing tadalafil and should be used only under the supervision of a qualified healthcare professional. It is intended for the treatment of approved medical conditions and is not intended to enhance sexual performance in individuals without an appropriate medical indication. Do not use this medication with nitrate-containing medicines, as this combination can cause a dangerous decrease in blood pressure. Do not exceed the prescribed dose. Consult your physician or pharmacist before use, particularly if you have cardiovascular disease, kidney or liver problems, or are taking other medications.