FDA Section 5 \u2022 cited verbatim

Doxazosin - Warnings and Precautions

The following warnings and precautions are taken directly from the US FDA-approved drug label for Doxazosin. This is the same information dispensing pharmacists read.

5 WARNINGS AND PRECAUTIONS Postural hypotension with or without syncope may occur.

Risk of Intraoperative Floppy Iris Syndrome during cataract surgery.

Screen for the presence of prostate cancer prior to treatment for BPH and at regular intervals afterwards.

5.1 Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of doxazosin tablets.

However, infrequently, symptomatic postural hypotension has also been reported later than a few hours after dosing.

As with other alpha-blockers, there is a potential for syncope, especially after the initial dose or after an increase in dosage strength.

Advise patient how to avoid symptoms resulting from postural hypotension and what measures to take should they develop.

Concomitant administration of doxazosin tablets with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension.

5.2 Cataract Surgery Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha 1 blockers.

This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions.

The patient's surgeon should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.

There does not appear to be a benefit of stopping alpha 1 blocker therapy prior to cataract surgery.

5.3 Prostate Cancer Carcinoma of the prostate causes many of the symptoms associated with BPH and the two disorders frequently co-exist.

Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with doxazosin tablets for the treatment of BPH.

5.4 Priapism Alpha 1 antagonists, including doxazosin, have been associated with priapism (painful penile erection, sustained for hours and unrelieved by sexual intercourse or masturbation).

This condition can lead to permanent impotence if not promptly treated.

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