Contraindications of TALEGRIA

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12 Questions

What should patients be advised to do in the event of sudden loss of hearing?

Seek prompt medical attention

Why is once-a-day dosing of tadalafil not recommended in patients with severe renal impairment?

Because of increased tadalafil exposure

What should patients do if they experience erections lasting 4 hours or more?

Seek immediate medical assistance

Why should TALEGRIA be used with caution in patients with anatomical deformation of the penis?

Because it can exacerbate existing anatomical deformation

What should patients avoid taking in combination with TALEGRIA?

CYP3A4 inhibitors

Why should patients with rare hereditary problems of galactose intolerance not take TALEGRIA?

Because it contains lactose

In which patients is the use of TALEGRIA not recommended?

Those with myocardial infarction within the last 90 days

What should patients be advised to do if they experience symptoms upon initiation of sexual activity?

To refrain from further sexual activity and report the episode to their medical practitioner

What is a cause of decreased vision, including permanent loss of vision, associated with TALEGRIA?

Non-arteritic anterior ischaemic optic neuropathy (NAION)

What should patients be advised to do if they experience sudden visual defects while taking TALEGRIA?

To stop taking TALEGRIA and consult a medical practitioner immediately

What is a reported adverse effect of tadalafil?

Sudden hearing loss

Who are at increased risk of NAION?

Those who have already experienced NAION

Study Notes

Contraindications

  • myocardial infarction within the last 90 days
  • unstable angina or angina during sexual intercourse
  • New York Heart Association Class 2 or greater heart failure in the last 6 months
  • uncontrolled dysrhythmia, hypotension (< 90/50 mm Hg), or uncontrolled hypertension
  • stroke within the last 6 months

Warnings

  • patients who experience symptoms upon initiation of sexual activity should refrain from further activity and report to their medical practitioner
  • sudden visual defects, including permanent loss of vision, have been reported in connection with TALEGRIA and other PDE5 inhibitors
  • increased risk of acute NAION (non-arteritic anterior ischaemic optic neuropathy) in men with erectile dysfunction
  • patients who have already experienced NAION are at increased risk of NAION

Adverse Reactions

  • cases of sudden hearing loss have been reported after the use of tadalafil
  • patients should stop taking TALEGRIA and seek prompt medical attention in the event of sudden decrease or loss of hearing
  • events may be accompanied by tinnitus and dizziness

Special Populations

  • once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment
  • once-a-day administration has not been evaluated in patients with hepatic insufficiency
  • caution should be exercised in patients with anatomical deformation of the penis or conditions that may predispose them to priapism

Interactions

  • caution should be exercised when prescribing TALEGRIA to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin)
  • increased tadalafil exposure (AUC) has been observed when combined with potent CYP3A4 inhibitors

Other

  • patients should be informed not to take TALEGRIA in combination with other PDE5 inhibitors or treatments for erectile dysfunction
  • patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take TALEGRIA
  • TALEGRIA contains less than 1 mmol sodium (23 mg) per tablet, making it essentially sodium-free

This quiz covers the patient groups in which the use of TALEGRIA is not recommended. It includes patients with recent myocardial infarction, unstable angina, and heart failure, among others.

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