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Vitaros Cream


Method of administration:

It is recommended to urinate before applying the drug. After removing the cap, apply all the contents of Vitaros into the opening at the tip of the penis (meatus) 5 to 30 minutes before attempting intercourse by following the instructions below:

1. Wash your hands before applying Vitaros. Remove the AccuDose container from the sachet by tearing fully down the seal from the middle of the top edge. Save the sachet for discarding the used AccuDose container later.

2. Bring the contents of the single-dose container to room temperature by rolling the container between your hands. This step can be avoided if the sachet was removed from the refrigerator earlier (within the time limits stated in Section 6.4 Special precautions for storage) and the contents have already reached room temperature.

3. Twist the plunger several times to make sure it will glide easily. Then remove the cap from the tip of the AccuDose container.



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.

Patients should be given instruction on proper administration technique, information on possible side effects (e.g., dizziness, fainting) and the need to avoid operating machinery until one is aware of their tolerance to the drug. In the clinical trial there was a higher withdrawal rate in the 300 mcg treated group compared to the 200 mcg group, 30% compared to 20% respectively.