Generic Name and Formulations:
Vardenafil (as HCl) 10mg; orally disintegrating tabs; peppermint flavor; contains phenylalanine, sorbitol.
Bayer and GlaxoSmithKline
Indications for STAXYN:
Not interchangeable with vardenafil (Levitra) 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.
Concomitant nitrates, or nitric oxide donors. Concomitant guanylate cyclase (GC) stimulators (eg, riociguat).
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.
Phosphodiesterase type 5 inhibitor (cGMP-specific).
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.
Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain, sudden vision or hearing loss, cardiovascular effects (eg, hypotension, tachycardia), QT prolongation; rare: priapism, prolonged erection.
Tabs (blister cards)—1 x 4
Clinical Pain Advisor Articles
- FDA Takes Steps to Reconcile Needs of Patients With Chronic Pain, Efforts to Curb Opioid Epidemic
- DFN-02 Nasal Spray Safe, Effective for Acute Treatment of Episodic Migraine
- Stat Consult: Chronic Low Back Pain
- Opioid Misuse May Help Predict Alcohol Dependence Treatment Outcomes
- Neuropathic Symptoms Worsen Quality of Life, Function in Hip, Knee Osteoarthritis
- Consensus Guidelines for the Use of Intravenous Ketamine for Chronic Pain
- Pain Societies Issue Guidelines on Use of Ketamine for the Management of Acute Pain
- Labor Epidural Analgesia Linked to Reduced Likelihood of Successful Breastfeeding
- Novel Oral Treatment Safe, Effective for Migraine Headache Relief
- Switching From Buprenorphine-Naltrexone to XR-Naltrexone as Effective as XR-Naltrexone
- History of Migraine May Be Associated With Higher Risk for Cochlear Disorders
- Symptom Severity, Sensory Sensitivity May Indicate Pain Centralization in Chronic Overlapping Pain Conditions
- Human Diagnosis Project Aims to Address Challenges Among Uninsured
- Healthcare Technology Affects Younger Patient Satisfaction
- FDA Announces New Drug Shortages Task Force