Prescribing Information

Presentation: Each single use container contains 300 micrograms of alprostadil in 100 mg of cream (3 mg/g). Vitaros® is a white to off-white cream supplied in AccuDose, a single dose container consisting of a plunger, barrel, and protective cap provided in a protective sachet.
‍List of excipients: Purified water, anhydrous ethanol, ethyl laurate, hydroxypropyl guar gum, dodecyl2 (N, N-Dimethylamine) propionate hydrochloride, potassium dihydrogen phosphate, with sodium hydroxide and phosphoric acid (for pH adjustment).
Indication: Treatment of men ≥ 18 years of age with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Dosage and administration: Vitaros® is available in two dosage strengths of 200 and 300 mcg alprostadil in 100 mg of cream. Vitaros® should be used as needed to achieve an erection. Each Vitaros® AccuDose container is for single use only and should be properly discarded after use. The onset of effect is within 5 to 30 minutes after administration. The duration of effect is approximately 1 to 2 hours. However, the actual duration will vary from patient to patient. Each patient should be instructed by a medical professional on proper technique for administration of Vitaros® prior to self-administration. The maximum frequency of use is no more than 2-3 times per week and only once per 24-hour period. The initial dose should be recommended by a physician. A starting dose with the 300-mcg dose can be considered especially in patients with serious ED, co-morbidity or failure to PDE-5 inhibitors. Those patients that do not tolerate the 300-mcg dose due to local side effects can be titrated to the lower 200 mcg dose.
‍Contraindications: Vitaros® should not be used in patients with any of the following: Underlying disorders such as orthostatic hypotension, myocardial infarction and syncope. Known hypersensitivity to alprostadil or any of the ingredients in Vitaros®. Conditions that might predispose them to priapism, such as sickle cell anaemia or trait, thrombocythemia, polycythaemia or multiple myeloma or, leukaemia. Abnormal penile anatomy such as severe hypospadias, in patients with anatomical deformation of the penis, such as curvature, and in patients with urethritis and balanitis (inflammation/infection of the glans of the penis). Prone to venous thrombosis or who have a hyperviscosity syndrome and are therefore at increased risk of priapism (rigid erection lasting 4 or more hours). Vitaros® should not be used in patients for whom sexual activity is inadvisable as in men with unstable cardiovascular or unstable cerebrovascular conditions. Vitaros® should not be used for sexual intercourse with a woman with child-bearing potential unless the couple uses a condom barrier.
Warnings and precautions for use: Special prescautions: Prolonged erections lasting > 4 hours (priapism), although rare, were observed with the use of Vitaros®. Priapism was observed in the two 3-month studies in 1 patient (0.06%) and in the > 6-month study in 5 (0.4%) patients, including 4 (0.3%) in the 200 mcg and 1 (0.1%) in the 300 mcg groups. If priapism occurs, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Symptomatic hypotension (dizziness) and syncope occurred in a small percent of patients (2/459 (0.4%), 6/1591 (0.4%), and 6/1280 (0.5%) at the 100, 200 and 300 mcg alprostadil doses, respectively, during dosing in the Phase 3 studies. Patients should be cautioned to avoid activities, such as driving or hazardous tasks, where injury could result if hypotension or syncope occurs after Vitaros® administration. Before initiation of treatment with Vitaros®, causes of erectile dysfunction, that are treatable, should be excluded by appropriate diagnostic methods. In addition, patients with underlying disorders, such as orthostatic hypotension, myocardial infarction and syncope, should not use Vitaros®. Clinical studies have not been conducted in patients with a history of neurological disease or spinal injury. The pharmacokinetics of Vitaros® has not been formally studied in patients with hepatic and /or renal insufficiency. The dose may need to be lowered in these populations due to impaired metabolism.