Prozelax Special Precautions

Orthostatic Hypotension: Syncope is the most severe orthostatic symptom of α₁-adrenoceptor antagonists. Other symptoms such as postural hypotension, dizziness and vertigo can also occur.
Patients in occupations in which orthostatic hypotension could be dangerous should be treated with caution. Patients who experience hypotension should be placed in the supine position. If still inadequate, volume expansion with IV fluids or vasopressor therapy may be applies. A transient hypotensive response is not a contraindication to further therapy with tamsulosin.
Prostate Cancer: Carcinoma of the prostate and BPH have similar symptoms and these two diseases frequently co-exist. Evaluate patients prior to starting tamsulosin treatment and at regular intervals afterwards to rule out the presence of carcinoma of the prostate. Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed.
Priapism and Ejaculation Disorders: Tamsulosin, like other alpha₁-blockers, has been rarely (probably less than one in 50,000 patients) associated with priapism (persistent painful penile erection unrelated to sexual activity). This condition could lead to impotence if not properly treated. Patients must be advised about the seriousness of this condition.
Ejaculation disorder, retrograde ejaculation and ejaculation failure have been reported with the use of tamsulosin.
Intraoperative Floppy Iris Syndrome (IFIS): During post-marketing surveillance, IFIS has been observed during cataract and glaucoma surgery in some patients treated with alpha₁-blockers including tamsulosin. Most reports were in patients taking the alpha₁-blocker when IFIS occurred. However, some cases occurred even after the alpha₁-blocker has been discontinued before surgery.
IFIS, a variant of small pupil syndrome, manifests as a combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis even with preoperative dilation with standard mydriatic drugs and potential prolapse of the iris toward the phacoemulsification incisions. The patient's ophthalmologist should be prepared for possible modifications of their surgical technique such as utilization of iris hooks, iris dilator rings or viscoelastic substances. The benefits of stopping alpha₁-blocker therapy before cataract surgery have not been established.
The risk of eye complications during and after the operation is increased by IFIS. The benefit of stopping alpha blocker therapy before cataract or glaucoma surgery has not been established. The initiation of tamsulosin is not recommended in patients who is scheduled for cataract or glaucoma surgery.
Sulfa Allergy: Allergic reactions with tamsulosin HCl have been rarely reported in patients with sulfa allergy. Administer tamsulosin HCl with caution in patients who have serious or life threatening sulfa allergy.
Effects on Ability to Drive or Use Machines: Although there are no specific studies conducted on tamsulosin and the ability to drive vehicles or use machines, tamsulosin may cause dizziness. Patients receiving tamsulosin should be advised to take precautions while performing activities requiring mental alertness or physical coordination. It should be carefully considered whether it is advisable to drive or operate machinery under these circumstances.
Hepatic and Renal Impairment: Use with caution in patients with hepatic or renal impairment since there are no studies on the effects of tamsulosin in these populations.
Use in Children: Tamsulosin HCl is not indicated for use in children.
Use in the Elderly: No substantial differences in safety and efficacy have been demonstrated relative to younger adults, but increased sensitivity cannot be ruled out.