Levitra and Alcohol

Generally Avoid: Additive hypotensive effects may occur when phosphodiesterase-5 (PDE5) inhibitors are used with
alcohol, as both are mild systemic vasodilators.

In clinical pharmacology studies, more subjects administered alcohol at a dose of 0.7 g/kg
(equivalent to approximately 6 ounces of 80-proof vodka in an 80-kg male; consumed within 10 minutes in study

subjects, providing blood alcohol levels of 0.08%) in combination with tadalafil 10 or 20 mg single doses had
clinically significant decreases in blood pressure than with alcohol alone.

There were reports of postural dizziness, and orthostatic hypotension was observed in some.
When tadalafil 20 mg was administered with alcohol at a lower dose of 0.6 g/kg
(equivalent to approximately 4 ounces of 80-proof vodka in an 80-kg male), orthostatic
hypotension was not observed, dizziness occurred with similar frequency relative to alcohol alone, and the hypotensive
effects of alcohol were not potentiated.

Neither tadalafil nor alcohol affected the plasma concentrations of the other.
Administration of avanafil 200 mg with alcohol at a dose of 0.5 g/kg
(equivalent to approximately 3 ounces of 80-proof vodka in a 70-kg male; consumed within 15 minutes in study

subjects, providing blood alcohol levels of 0.057%) resulted in
additional maximum supine systolic/diastolic blood pressure decreases of 3.5/4.5 mm Hg and additional maximum
pulse rate increase of 9.3 bpm compared to alcohol alone, but did not cause orthostatic hypotension or dizziness.

The plasma concentrations of alcohol were not affected.
Sildenafil 50 mg and vardenafil 20 mg reportedly did not potentiate the hypotensive effect of alcohol in healthy volunteers
with mean maximum blood alcohol levels of 0.08% and in healthy volunteers administered alcohol at a dose of 0.5 g/kg,
respectively. Alcohol and vardenafil plasma levels were not altered when dosed simultaneously.

Management: Patients taking PDE5 inhibitors should avoid consuming large amounts of alcohol, which may
increase the potential for orthostatic signs and symptoms including increase in heart rate, decrease in standing
blood pressure, dizziness, and headache.

Moderate Food Interaction

Monitor: Grapefruit juice may increase the plasma concentrations of orally administered drugs that are
substrates of the CYP450 3A4 isoenzyme.

However, the interaction seems to affect primarily those drugs that undergo significant presystemic
metabolism by CYP450 3A4 (i.e., drugs with low oral bioavailability), presumably due to the fact that grapefruit
juice inhibits intestinal rather than hepatic CYP450 3A4.

Because pharmacokinetic interactions involving grapefruit juice are often subject to a high degree of interpatient
variability, the extent to which a given patient may be affected is difficult to predict.

Management: Patients who regularly consume grapefruit or grapefruit juice
should be monitored for adverse effects and altered plasma concentrations of drugs
that undergo significant presystemic metabolism by CYP450 3A4.

Levitra grapefruit and grapefruit juice should be avoided if an interaction is suspected.
Orange juice is not expected to interact with these drugs.

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