Patient Medication Information: uses, side effects, how to take - Hytrin-7 Tabs 1mg-7 Tabs 2mg-14 Tabs 5mg
ABOUT THIS MEDICATION
What the medication is used for:
HYTRIN® is used to treat:
$ Hypertension (high blood pressure)
$ Benign prostatic hyperplasia (enlargement of the prostate
gland)
HYTRIN® is for symptomatic benign prostatic hyperplasia (BPH) and not for prostate cancer. It is possible for men to have both BPH and prostate cancer at the same time. HYTRIN® is not a treatment for prostate cancer.
Doctors usually recommend that men be checked for prostate cancer once a year when they turn 50 (or 40 if a family member has had prostate cancer). These checks, including Prostate Specific Antigen (PSA), should continue while you are taking HYTRIN®.
What it does:
HYTRIN works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.
HYTRIN® also blocks smooth muscle receptors of the bladder neck and the prostate called alpha-1 adrenoceptors. This blockade causes the smooth muscles of the bladder neck and prostate to relax and decreases muscle tone. This can lead to a rapid improvement in urine flow and symptoms within a 2 week period.
When it should not be used:
HYTRIN® should not be used if you are allergic to any component of HYTRIN®, including active ingredient and non-active ingredients.
What the medicinal ingredient is:
Terazosin hydrochloride
What the important nonmedicinal ingredients are:
Corn starch, lactose, magnesium stearate, povidone (for 1, 2, 5 mg only), pregelatinized starch (for 10 mg only) and talc. Also contains FD&C yellow No. 6 (for 2 mg), iron oxide (for 5 mg) and FD&C blue No. 2 (for 10 mg).
What dosage forms it comes in:
If your doctor prescribed the Starter Pack, it is important to complete the Starter Pack as indicated before starting your HYTRIN® prescription.
HYTRIN® is a tablet and is available in the following four strengths: 1 mg, 2 mg, 5 mg and 10 mg.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
$ HYTRIN® should not be used if you have been diagnosed with micturition syncope.
BEFORE you use HYTRIN® talk to your doctor or pharmacist if:
$ you have low blood pressure.
$ you are using VIAGRA® (sildenafil), CIALIS®
(tardenafil) or LEVITRA® (vardenafil). $ you have liver problems.
$ you have kidney problems.
$ you have had or will have prostate surgery. $ you have pancreatic cancer.
$ you are pregnant or nursing.
You should not drive, operate heavy machinery, or do any hazardous task, until you are used to the effects of the medication. You should also avoid situations where injury could result should syncope occur during initiation of terazosin therapy. If you begin to feel dizzy, sit or lie down until you feel better.
INTERACTIONS WITH THIS MEDICATION
In general, you should avoid the use of phosphodiesterase (PDE5) inhibitors such as VIAGRA® (sildenafil), CIALIS® (tadalafil) or LEVITRA® (vardenafil) when taking HYTRIN® due to the risks of developing serious hypotension (low blood pressure).
Administration of HYTRIN® with verapamil (i.e., ISOPTIN®, TARKA® or CHRONOVERA®) to hypertensive patients may result in low blood pressure and/or a rapid heart beat.
Do not take these drugs with HYTRIN® without your doctor’s advice.
PROPER USE OF THIS MEDICATION
Usual dose:
Follow your doctor’s instructions very carefully about how to take HYTRIN®. The starting dose is 1 mg at bedtime. The 1 mg dose should be maintained during the first week of treatment, and should be taken every day as prescribed by your doctor. Your doctor will then gradually increase the strength of your prescription to 2 mg, 5 mg, or 10 mg depending on how well you respond. The maximum recommended daily dose is 20 mg per day.
You should see an effect on your symptoms in 2 to 4 weeks. While taking HYTRIN®, you should have regular check-ups to evaluate your progress regarding your BPH and to monitor your blood pressure.
Overdose:
If you or someone you know accidentally takes more than stated dose, contact your doctor immediately or go to the nearest hospital with the tablets. Tell your doctor or hospital how much was taken. Treat even small overdoses seriously.
Missed Dose:
If you forget to take one tablet, take another as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed tablet at all.
Never double-up on a missed dose.
Talk to your doctor if you have not taken HYTRIN® for a few days. You may have to restart at the 1 mg dose. Be cautious about possible dizziness.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Along with its needed effects, a medicine may cause some unwanted effects. These are referred to as “side effects”. Although not all of these side effects may occur, if they do occur they may need medical attention.
HYTRIN® can cause a sudden drop in blood pressure after the very first dose. You may feel dizzy, faint, or "light-headed", particularly after you get up from bed or from a chair. This is more likely to occur after you have taken the first few doses, but can occur at any time while you are
taking the drug. It can also occur if you stop taking the drug and then restart treatment.
Because of this effect, your doctor may have told you to take HYTRIN® at bedtime. If you take HYTRIN® at bedtime but need to get up from bed to go to the bathroom, get up slowly and cautiously until you are sure how the medicine affects you. It is also important to get up slowly from a chair or bed at anytime until you learn how you react to HYTRIN®.
Other side effects with HYTRIN® include back pain, constipation, diarrhea, drowsiness or sleepiness, dry mouth, flatulence, headache, impotence, indigestion, libido decreased, nasal congestion, nausea, “puffiness” of the feet or hands, swelling, urinary frequency, urinary incontinence primarily reported in postmenopausal women, urinary tract infection, weakness or weight gain.
Discontinue your medication and inform your physician if you experience any of the following: anxiety, difficulty breathing/shortness of breath, heart palpitations, rash, drowsiness/sleepiness sweating, vomiting, blurred or hazy vision, weakness, allergic reaction, chest pain, decreased blood pressure or low blood pressure, permanent erection, unknown bruising or increased bleeding after a cut.
Check with your physician or pharmacist if you experience any unexpected effects, or are concerned by the above side effects.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Abnormal, Irregular or Rapid Heartbeat (Palpitation) | a | ||
| Allergic Reaction | a | ||
| Anxiety | a | ||
| Blurred or Hazy Vision | a | ||
| Chest pain | a | ||
| Decreased Blood Pressure or Low Blood Pressure | a | ||
| Depression | a | ||
| Difficulty breathing or Shortness of Breath | a | ||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Drowsiness or Sleepiness | a | ||
| Fainting | a | ||
| Joint Inflammation or Joint Pain | a | ||
| Permanent Erection | a | ||
| Rash | a | ||
| Sweating | a | ||
| Unknown Bruising or Increased Bleeding after a Cut | a | ||
| Vomiting | a | ||
| Weakness | a | ||
Check with your pharmacist or doctor immediately, if you experience any of the above symptoms of the serious side effects.
HOW TO STORE IT
Keep HYTRIN® and all other medicines out of reach of children.
HYTRIN® tablets should be stored at 15°C to 25°C.
Do not take your tablets after the expiry date shown on the label.
It is important to keep the HYTRIN® in the original package.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at: http://www.abbott.ca
or by contacting the sponsor, Abbott Laboratories, Limited, at: 1-800-361-7852