Levitra®

Levitra is a prescription-only medication for the treatment of erectile dysfunction, originally developed by Bayer and GSK. Like sildenafil and tadalafil, its active ingredient vardenafil belongs to the group of PDE-5 inhibitors.

Levitra was approved in 2003 and offers an alternative for men in whom other PDE-5 inhibitors do not work optimally or are not well tolerated.

The medication is available in tablet form and as an orally disintegrating tablet (Levitra ODT). The orally disintegrating tablet dissolves in the mouth and does not have to be taken with water – convenient when you are on the go.

The active ingredient vardenafil is now also available as a generic.

Levitra contains the active ingredient vardenafil, a second-generation PDE-5 inhibitor. Its mode of action is similar to that of other medications in this class, but with some special features.

The mechanism: During sexual arousal, nitric oxide (NO) is released in the penis. It activates the production of cGMP, a messenger substance that relaxes the muscles of the blood vessels. As a result, more blood flows into the penis and an erection develops.

The enzyme PDE-5 breaks down cGMP and thereby ends the erection. Vardenafil selectively inhibits this enzyme, allowing cGMP to act for longer.

Special features of vardenafil:

• High selectivity for PDE-5 – less effect on other enzymes
• Fast onset of action – sometimes after just 25 minutes
• Duration of action of 4-5 hours
• Less affected by food intake (with moderate fat intake)

Important: Like all PDE-5 inhibitors, Levitra only works when sexual stimulation is present.

Levitra is suitable for adult men with erectile dysfunction of various causes:

Particularly suitable for:

• Men who want a fast onset of action
• Patients who do not tolerate sildenafil well
• Men with diabetes mellitus – in studies, Levitra showed good efficacy in diabetic ED
• Men after radical prostatectomy (nerve-sparing surgery)

Advantages of the orally disintegrating tablet (Levitra ODT):

• Can be taken without water
• Discreet use possible
• Convenient on the go
• Dissolves quickly in the mouth

Typical situations of use:

• Erectile dysfunction with a predominantly organic cause
• Psychologically caused erection problems
• Mixed forms of both causes
• Intolerance or insufficient effect of other PDE-5 inhibitors

Levitra film-coated tablets:

• 5 mg – Lowest dose, for certain patient groups
• 10 mg – Recommended starting dose
• 20 mg – If 10 mg is not sufficiently effective

Levitra ODT (orally disintegrating tablets):

• 10 mg – Only available strength

Dosage recommendations:

• Standard start: 10 mg, about 25-60 minutes before sexual intercourse
• Dose increase: To 20 mg if 10 mg is not sufficiently effective
• Dose reduction: To 5 mg in case of severe side effects or certain concomitant conditions

Adjustment for special patient groups:

• Men aged 65 and over: No routine adjustment necessary; however, an increase to 20 mg should be considered carefully, as tolerability may be lower
• Mild to moderate liver impairment: Starting dose 5 mg
• Kidney impairment: Starting dose 5 mg if impairment is severe

Maximum dose: 20 mg per day, no more than once daily

Levitra film-coated tablets:

• Take about 25 to 60 minutes before planned sexual intercourse
• Swallow with a glass of water
• Can be taken with or without food
• A moderately high-fat meal has no significant effect
• Very high-fat meals can slightly delay absorption

Levitra ODT (orally disintegrating tablets):

• Place the tablet on the tongue
• Dissolves within seconds
• Can be taken without water
• Do not wash down with liquid
• Can also be taken with food

Duration of action: The effect of Levitra lasts about 4 to 5 hours. During this time, erections are possible with sexual stimulation.

Frequency: No more than one dose per 24 hours. Not intended for daily use (unlike Cialis 5 mg).

Alcohol: Moderate alcohol consumption is possible. Larger amounts can reduce effectiveness and increase side effects.

Levitra must not be taken in case of:

Use of nitrates: Absolute contraindication! Combination with nitrates (nitroglycerin spray, isosorbide) or amyl nitrite (poppers) can cause a life-threatening drop in blood pressure.

Severe heart disease:

• Heart attack within the last 6 months
• Unstable angina pectoris
• Severe heart failure
• Life-threatening heart rhythm disorders
• Stroke within the last 6 months

Other contraindications:

• Low blood pressure (below 90/50 mmHg)
• Uncontrolled high blood pressure
• Severe liver disease
• End-stage kidney failure requiring dialysis
• Hereditary retinal diseases (e.g., retinitis pigmentosa)
• Concomitant use of HIV protease inhibitors (e.g., ritonavir, indinavir)
• Concomitant use of riociguat or other guanylate cyclase stimulators
• Recent loss of vision due to NAION

Caution in case of:

• Anatomical deformities of the penis
• Conditions with a risk of priapism
• Blood clotting disorders
• Active stomach ulcer
• Congenital QT prolongation, low potassium levels (hypokalemia) or use of class IA or class III antiarrhythmics (avoid use if possible)

Very common side effects (more than 10%):

• Headache

Common side effects (1-10%):

• Facial redness (flushing)
• Stuffy nose
• Indigestion
• Dizziness

Uncommon side effects (0.1-1%):

• Nausea
• Increased sensitivity to light
• Blurred vision
• Watery eyes
• Skin rash
• Muscle pain
• Back pain
• Increased intraocular pressure

Rare but serious side effects:

• Priapism: Painful erection lasting more than 4 hours – seek medical help immediately
• Sudden loss of vision: Very rare, but see a doctor immediately
• Sudden hearing loss: Very rare, immediate medical evaluation necessary

Compared with other PDE-5 inhibitors: Headache and flushing occur about as often as with other medications in this class.

Absolutely contraindicated:

• Nitrates and NO donors: Life-threatening drop in blood pressure possible
• Ritonavir and indinavir: Potent HIV protease inhibitors raise vardenafil levels extremely
• Riociguat and other guanylate cyclase stimulators: Symptomatic drop in blood pressure possible

Important interactions:

• Other HIV protease inhibitors: Also contraindicated, as HIV protease inhibitors are very potent CYP3A4 inhibitors

• CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin): Increase the vardenafil concentration. Dose reduction required.

• Alpha blockers: Increased lowering of blood pressure possible. Only start Levitra once alpha-blocker therapy is stable. A time interval of 6 hours is recommended.

• Class IA or class III antiarrhythmics (e.g., quinidine, procainamide, amiodarone, sotalol): Vardenafil can prolong the QT interval; the use of Levitra should be avoided if possible

• Other PDE-5 inhibitors: Do not combine

• Grapefruit juice: Can increase vardenafil levels