Patient information: uses, side effects, how to take - Tezruly
What is TEZRULY?
TEZRULY is a prescription medicine that contains terazosin hydrochloride and is called an “alpha-blocker”. TEZRULY is used to treat:
- the symptoms of benign prostatic hyperplasia (BPH)
- high blood pressure (hypertension)
It is not known if TEZRULY is safe and effective in children.
Do not take TEZRULY if you:
are allergic to terazosin or any of the ingredients in TEZRULY. See the end of this Patient Information leaflet for a complete list of ingredients in TEZRULY.
Before taking TEZRULY, tell your healthcare provider about all of your medical conditions, including if you:
- have had low blood pressure, especially after taking other medicine. Signs of low blood pressure include fainting, dizziness, and lightheadedness.
- have any planned eye surgery.
- have prostate cancer or a history of prostate cancer. Your healthcare provider may have you checked for prostate cancer before you start taking and while you take TEZRULY.
are pregnant or plan to become pregnant. It is not known if TEZRULY will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if TEZRULY passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take TEZRULY.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TEZRULY may affect the way other medicines work, and other medicines may affect the way TEZRULY works causing side effects.
Especially tell your healthcare provider if you take:
- other medicine for high blood pressure, particularly the calcium channel blocker verapamil. The use of TEZRULY with verapamil can lead to a drop in blood pressure or to fainting.
- medicines to treat erectile dysfunction (ED) called phosphodiesterase type 5 (PDE-5) inhibitors. The use of TEZRULY with PDE-5 inhibitors can lead to a drop in blood pressure or to fainting.
Know your medicines. Keep a list to show your healthcare providers or pharmacist when you get a new medicine.
How should I take TEZRULY?
Take TEZRULY by mouth with or without food.
- The starting dose of TEZRULY is 1 mg (1 mL) at bedtime. Do not take more than 1 mg as your starting dose. This is to reduce the chance of a sudden drop in blood pressure which can cause fainting, dizziness, and lightheadedness. Your healthcare provider will then increase your dose of TEZRULY as needed.
- Your healthcare provider will tell you how much TEZRULY to take and when to take it.
- Your healthcare provider may need to change your dose of TEZRULY until it is the right dose for you.
- Take TEZRULY using a marked (calibrated) measuring device, such as an oral syringe or oral dosing cup. Ask your pharmacist for a measuring device and instructions on how to measure and take the correct dose of medicine. A household measuring cup, teaspoon, or tablespoon is not an adequate measuring device.
What should I avoid while taking TEZRULY?
Do not drive or perform any hazardous task until at least 12 hours after you have taken TEZRULY if you are taking:
- your first dose of TEZRULY
- TEZRULY for the first time after your healthcare provider has increased your dose of TEZRULY
- TEZRULY for the first time after any breaks (interruptions) in your treatment with TEZRULY
What are the possible side effects of TEZRULY?
TEZRULY may cause serious side effects, including:
- A sudden drop in blood pressure, especially when you first start treatment or when there is an increase in your dose of TEZRULY, is common but can also be serious. This may cause you to have a feeling that your heart is pounding or racing (palpitations), faint, have a spinning feeling (vertigo), or to feel dizzy or lightheaded. If you have a spinning feeling, dizziness or lightheadedness, you should sit or lie down and be careful when rising from a sitting or lying position. Your risk of having this problem may be increased if you take TEZRULY with certain other medicines that lower blood pressure including verapamil and PDE-5 inhibitors. Your healthcare provider may monitor your blood pressure while you take TEZRULY. See “What should I avoid while taking TEZRULY?”
- A painful erection that will not go away. TEZRULY can cause a painful erection (priapism), which cannot be relieved by having sex or masturbation. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future
- Eye problems during cataract surgery. A condition called Intraoperative Floppy Iris Syndrome (IFIS) can happen during cataract surgery if you take or have taken alpha-blockers such as TEZRULY. If you need to have cataract surgery, be sure to tell your ophthalmologist (eye doctor) if you take or have taken TEZRULY.
The most common side effects of TEZRULY include:
- weakness
- dizziness
- puffy feet or hands
- lack of energy
- nasal congestion
- drowsiness
These are not all the possible side effects of TEZRULY.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of TEZRULY.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TEZRULY for a condition for which it was not prescribed. Do not give TEZRULY to other people, even if they have the same symptoms you have. It may harm them.
You can ask your healthcare provider or pharmacist for information that is written for health professionals.
What are the ingredients in TEZRULY?
Active ingredient: terazosin hydrochloride
Inactive ingredients: artificial cherry flavor, citric acid anhydrous, glycerin, methylparaben, propylparaben, purified water, sodium citrate dihydrate and sucralose.
Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
TEZRULYTM is a pending trademark of ANI Pharmaceuticals, Inc.
For more information, call 1-855-204-1431.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Issued: 07/2024
LB4752-01