TAMSULOSIN XR capsules and sprinkles
TAMSULOSIN XR capsules and sprinkles are new proprietary slow release granule formulations containing the active pharmaceutical ingredient in FLOMAX® (tamsulosin HCL) capsules which is a commonly used medicine for the treatment of BPH, also known as enlargement of the prostate. FLOMAX® is indicated for the treatment of the signs and symptoms of BPH. Tamsulosin is a selective alpha1 adrenergic receptor blocking drug that is specific for the alpha1 adrenergic receptors located in the smooth muscle of the prostate and bladder neck. Symptoms associated with BPH typically occur as a result of increased smooth muscle tone of the prostate and bladder which leads to constriction of urinary flow, urinary retention, urinary infection, kidney damage and life threatening blood infection called urosepsis. Blocking these alpha1 adrenergic receptors relaxes the smooth muscles of the prostate and bladder neck resulting in the improvement of urinary flow rate and reduction in the symptoms of BPH.
FLOMAX® capsules are required to be taken with food since taking the drug on an empty stomach also results in high drug levels that also results in higher risks for the postural hypotension (sudden drop in blood pressure upon standing that can lead to fainting). The FDA approved dosing instructions for Flomax also state that the capsules should not be crushed, chewed or opened because men will have drug levels that are too high and are placed at higher risk for postural hypotension. Tablets and capsules are problematic for 15% of men over the age of 60 who have difficulty swallowing tablets and capsules and the up to 60% of men in long term facilities who have difficulty swallowing tablets and capsules because of certain medical conditions, including degenerative neurological diseases like Parkinson’s or having suffered a stroke. Not being able to take alpha blocker drugs for BPH, like FLOMAX®, because of difficulty swallowing tablets and capsules may lead to the increased risk of acute urinary retention, urinary catheterization, urosepsis and death. Because TAMSULOSIN XR capsules and sprinkles are new proprietary granule formulations containing the active pharmaceutical ingredient in FLOMAX®, it would provide a more convenient and reliable way to deliver therapeutic levels of tamsulosin to men who have difficulty swallowing tablets and capsules.