What are the precautions for using Vardenafil (Levitra) with Metoprolol (beta-blocker) in patients with risk of hypotension?

From the Guidelines

Vardenafil can be used with metoprolol, but with caution and careful monitoring of blood pressure, due to the risk of significant hypotension, as recommended by the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA guideline 1. When using vardenafil (Levitra) with metoprolol, it is essential to consider the potential risks and take necessary precautions. The primary concern is the risk of significant hypotension, as both medications can lower blood pressure.

• Patients should start with the lowest effective dose of vardenafil (5mg) and avoid taking it within 4 hours of metoprolol.
• The mechanism behind this interaction involves vardenafil's inhibition of PDE5, increasing nitric oxide and causing vasodilation, while metoprolol reduces cardiac output and blood pressure through beta-receptor blockade, creating an additive hypotensive effect when used together.
• Patients should monitor their blood pressure regularly and report any symptoms of hypotension such as lightheadedness, dizziness, or fainting to their healthcare provider immediately.
• It's advisable to take vardenafil when lying down to minimize orthostatic hypotension risk.
• Patients should avoid alcohol and grapefruit juice, which can worsen hypotensive effects.
• Those with uncontrolled hypertension, recent stroke, heart attack, or severe heart failure should not use this combination, as stated in the 2023 guideline 1. The 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA guideline recommends that phosphodiesterase type 5 inhibitors, such as vardenafil, should not be used concomitantly with nitrate medications, but does not explicitly mention beta-blockers like metoprolol 1. However, the guideline does emphasize the importance of careful consideration and monitoring when using these medications together.
• The half-life of vardenafil is approximately 4 hours, and patients on this medication should avoid taking nitroglycerine for at least 24 hours, as recommended in the guideline 1. In summary, vardenafil can be used with metoprolol, but with careful monitoring and precautions to minimize the risk of significant hypotension, as recommended by the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA guideline 1.

From the FDA Drug Label

The evaluation of erectile dysfunction should include a determination of potential underlying causes, a medical assessment, and the identification of appropriate treatment. Before prescribing LEVITRA, it is important to note the following: Alpha-blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers Phosphodiesterase Type 5 (PDE5) inhibitors, including LEVITRA, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects. Concomitant treatment with vardenafil and alpha-blockers should be initiated only if the patient is stable on his alpha-blocker therapy. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at the lowest recommended starting dose

Vardenafil and Metoprolol Interaction:

• There is no direct information in the provided drug labels about the interaction between vardenafil and metoprolol.
• However, beta-blockers like metoprolol are not explicitly mentioned as having a direct interaction with vardenafil in the provided labels.
• Caution is advised when using vardenafil with other medications that can lower blood pressure, as additive effects may occur.
• Patients should be stable on their current medication regimen before initiating vardenafil, and the lowest recommended dose should be used.
• It is essential to consider the potential risk of hypotension when combining vardenafil with other medications that can lower blood pressure, such as beta-blockers.
• The FDA drug label does not provide explicit guidance on the concomitant use of vardenafil and metoprolol; therefore, clinical judgment and caution are necessary when considering this combination.
• Monitoring of blood pressure is recommended when using vardenafil with other medications that can lower blood pressure.
• Patients with risk factors for hypotension should be closely monitored when using vardenafil with metoprolol. The FDA drug label does not answer the question.

From the Research

Precautions for Using Vardenafil with Metoprolol

• The use of Vardenafil (Levitra) with Metoprolol (beta-blocker) requires caution, especially in patients with a risk of hypotension 2, 3.
• Phosphodiesterase-5 (PDE5) inhibitors, such as Vardenafil, can reduce blood pressure in healthy patients, with Vardenafil 20 mg causing a decline of -7.5/-8 mm Hg 2.
• The additive effect of PDE5 inhibitors with one or multiple antihypertensive drugs, including beta-blockers like Metoprolol, is modest 2.
• However, the combination of PDE5 inhibitors with alpha(1)-blockers may result in larger declines in blood pressure and cause orthostatic hypotension, emphasizing the need for caution when using Vardenafil with other medications that affect blood pressure 2, 3.
• Nitrates in combination with PDE5 inhibitors are contraindicated due to the risk of profound decline in blood pressure 2, 3.

Considerations for Patients with Risk of Hypotension

• Patients with a risk of hypotension should be closely monitored when using Vardenafil with Metoprolol, as the combination may increase the risk of hypotension 3.
• The lowest doses of Vardenafil and other medications that affect blood pressure should be used in combination to minimize the risk of hypotension 2.
• Patients should be advised to report any symptoms of hypotension, such as dizziness or lightheadedness, to their healthcare provider promptly 3.

Clinical Evidence and Guidelines

• Clinical trials have demonstrated the efficacy and safety of Vardenafil in the treatment of erectile dysfunction, but the evidence for its use with Metoprolol is limited 4, 5, 6.
• Healthcare providers should consider the individual patient's profile and medical history when choosing a PDE5 inhibitor, including Vardenafil, and use caution when combining it with other medications that affect blood pressure 5.