Vardenafil Orally Disintegrating Tabs Dosage & Rx Info

Vardenafil Orally Disintegrating Tabs Generic Name & Formulations

Legal Class

General Description

Vardenafil (as HCl) 10mg; peppermint flavor; contains phenylalanine, sorbitol.

Pharmacological Class

Phosphodiesterase type 5 inhibitor (cGMP-specific).

How Supplied

Contact supplier

Manufacturer

Various generic manufacturers

Mechanism of Action

The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most abundant PDE in the human corpus cavernosum is the cGMP-specific PDE5; therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.

Vardenafil Orally Disintegrating Tabs Indications

Indications

Erectile dysfunction.

Vardenafil Orally Disintegrating Tabs Dosage and Administration

Adult

Not interchangeable with vardenafil 10mg film-coated tabs. Take without liquid. Place one tab on tongue, approx. 1hr before sexual activity; max 1 tab/day. Concomitant α-blockers (patients should be stable on α-blocker therapy before starting): use lower doses of vardenafil film-coated tabs as initial therapy.

Children

Not established.

Vardenafil Orally Disintegrating Tabs Contraindications

Contraindications

Concomitant nitrates, or nitric oxide donors. Concomitant guanylate cyclase (GC) stimulators (eg, riociguat).

Vardenafil Orally Disintegrating Tabs Boxed Warnings

Not Applicable

Vardenafil Orally Disintegrating Tabs Warnings/Precautions

Warnings/Precautions

Not for use in women. Confirm diagnosis before therapy. Congenital QT prolongation: avoid use. Cardiovascular disease (eg, MI, stroke or life-threatening arrhythmia within 6 months; systolic BP <90 or BP >170/110; unstable angina, LV outflow obstruction, severe cardiac failure), moderate or severe hepatic impairment, on renal dialysis, hereditary degenerative retinal disorders and retinitis pigmentosa: not recommended. Anatomical penile deformation. Predisposition to priapism. History of non-arteritic anterior ischemic optic neuropathy (NAION) or those with "crowded" optic disc. Advise patients to discontinue if sudden vision or hearing loss occurs. Patients for whom sexual activity is inadvisable or contraindicated. Bleeding disorders. Active peptic ulcer. Phenylketonuria. Fructose intolerance.

Vardenafil Orally Disintegrating Tabs Pharmacokinetics

Distribution

Plasma protein bound: ~95%.

Metabolism

Hepatic (CYP3A4).

Elimination

Fecal (major). Half-life: 4–6 hours.

Vardenafil Orally Disintegrating Tabs Interactions

Interactions

See Contraindications. Hypotension with nitrates, GC stimulators. Avoid Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics, others that cause QT prolongation. Additive hypotensive effects with concomitant α-blockers, other antihypertensives; caution. Concomitant moderate or potent CYP3A4 inhibitors (eg, erythromycin, grapefruit juice, clarithromycin, ketoconazole, itraconazole, indinavir, saquinavir, atazanavir, ritonavir), or other erectile dysfunction treatments: not recommended.

Vardenafil Orally Disintegrating Tabs Adverse Reactions

Adverse Reactions

Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain, sudden vision or hearing loss, cardiovascular effects (eg, hypotension, tachycardia), QT prolongation; rare: priapism, prolonged erection.

Vardenafil Orally Disintegrating Tabs Clinical Trials

See Literature

Vardenafil Orally Disintegrating Tabs Note

Notes

Formerly known under the brand name Staxyn.

Vardenafil Orally Disintegrating Tabs Patient Counseling