Consumer Information for: APO-DOXAZOSIN
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Your doctor has prescribed APO-DOXAZOSIN because you either have a medical condition called benign prostatic hyperplasia (BPH) or Hypertension. This leaflet describes APO-DOXAZOSIN as a treatment for BPH.
What is BPH?
BPH is an enlargement of the prostate gland. After age 50, most men develop enlarged prostates. The prostate is located below the bladder and surrounds the urethra which is a tube that drains urine from the bladder. The symptoms of BPH, however, can be caused by an increase in the tightness of muscles in the prostate. If the muscles inside the prostate tighten, they can squeeze the urethra and slow the flow of urine. This can lead to symptoms such as:
- weak or interrupted urinary stream
- sensation that you cannot completely empty your bladder
- sensation of delay or hesitation when you start to urinate
- need to urinate often, especially at night, or
- sensation that you must urinate immediately.
Hypertension is the medical term for high blood pressure (HBP). When blood flows through the blood vessels, it pushes against their walls, almost like water pushing against the sides of a hose. Blood pressure is like that “push”. When blood pressure is high (like the water pressure in a hose when the nozzle is partially shut), damage can occur to the heart and blood vessels.
Although you may not feel any symptoms for years, hypertension can lead to stroke, heart attack, kidney disease and other serious conditions.
What it does
APO-DOXAZOSIN blocks smooth muscle receptors of the bladder neck and the prostate called alpha1- 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 1 to 2 weeks period. However, not all patients respond in the same way, and since each case of BPH is different, you should keep in mind the following:
- Prior to treatment with APO-DOXAZOSIN, you should have a thorough urological evaluation to determine the severity of your condition, and to exclude the need for immediate surgery or the possibility of carcinoma of the prostate.
- Even if taking APO-DOXAZOSIN helps your condition, it is not known whether APODOXAZOSIN reduces the need for surgery.
- APO-DOXAZOSIN will not cure your benign prostatic hyperplasia (BPH). APODOXAZOSIN will make your urine flow better and improve the symptoms of BPH. In some patients, bothersome adverse effects may occur as a result of the APO-DOXAZOSIN therapy.
Similarly, APO-DOXAZOSIN lowers blood pressure by relaxing the blood vessels so that blood can flow more easily through the body.
When it should not be used
APO-DOXAZOSIN should not be used if you have a known allergy to APO-DOXAZOSIN (doxazosin mesylate) or any or the non-medicinal ingredients (see list below).
It is also contraindicated in patients with a known sensitivity to quinazoline (such as prazosin and tetrazosin)
What the medicinal ingredient is
doxazosin mesylate
What the non-medicinal ingredients are
croscarmellose sodium, lactose, magnesium stearate, and microcrystalline cellulose.
What dosage form it comes in
Tablets: 1, 2, and 4 mg (doxazosin)
Warnings and precautions
BEFORE you use APO-DOXAZOSIN talk to your doctor or pharmacist if:
- You take phosphodiesterase (PDE-5)- inhibitor such as sildenafil, tadalafil or vardenafil, due to the risk of developing low blood pressure.
- you take other medications, including those you can buy without prescription and herbal products, or if you drink alcohol;
- you have or have had heart or blood vessel diseases;
- you have heart problems;
- you have or have had kidney and liver disease;
- you have or have had stomach or intestinal problems;
- you suffer from muscular dystrophy or other neuromuscular disorder;
- You are pregnant or plan to get pregnant;
- You are breastfeeding or plan to breastfeed.
APO-DOXAZOSIN can cause a sudden drop in blood pressure after the first dose or first few doses. 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. If you feel very dizzy, faint or "light-headed" you should contact your doctor. Your doctor will discuss with you how often you need to visit and how often your blood pressure should be checked.
In general, you should be cautious when using a phosphodiesterase (PDE-5) inhibitor such as sildenafil, tadalafil or vardenafil when taking APODOXAZOSIN due to the risks of developing serious hypotension (low blood pressure).
Your doctor has prescribed APO-DOXAZOSIN for symptomatic BPH or High blood pressure and not for prostatic cancer. It is possible for men to have both BPH and prostate cancer at the same time. 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 should continue while you are taking APODOXAZOSIN. APO-DOXAZOSIN is not a treatment for prostate cancer.
About Prostate Specific Antigen (PSA). Your doctor may have done a blood test called PSA. Your doctor is aware that APO-DOXAZOSIN does not affect PSA levels. You may want to ask your doctor more about this if you have a PSA test done.
You should see an effect on your symptoms in 1 to 2 weeks. While taking APO-DOXAZOSIN, you must have regular check-ups to evaluate your progress regarding your BPH and to monitor your blood pressure. Follow your doctor's advice about when to have these check-ups.
If you drink alcohol the effects of the alcohol may be increased and prolonged. You should be aware of that and be more cautious with alcohol or you may wish to avoid alcohol altogether.
If you’re seeing more than one doctor make sure that each one knows about all the medicines you are taking.
Interactions with this medication
The following list includes drugs that may interact with APO-DOXAZOSIN:
- drugs to treat erectile dysfunction (sildenafil, tadalafil, vardenafil)
- drugs to treat hypertension, including diuretics (“water pills”) and other classes of medications
- drugs to treat infections (clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole)
- drugs to treat HIV infections (indinavir, nelfinavir, ritonavir, saquinavir)
- drugs to treat depression (nefazodone)
Talk to your doctor or pharmacist if you drink alcohol.
Proper use of this medication
Follow your doctor's instructions very carefully about how to take APO-DOXAZOSIN.
For the treatment of Hypertension:
Usual Adult Dose: Start with 1 mg once daily.
Maximum recommended daily dose is 16 mg once
daily.
For the treatment of Benign Prostatic Hyperplasia:
Usual Adult Dose: Start with 1 mg once daily.
Maximum recommended daily dose is 8 mg once
daily.
Dose increase should be done gradually with caution due to consideration of possible dizziness/vertigo effect.
Do not share APO-DOXAZOSIN with anyone else; it was prescribed only for you.
Notify your doctor about any illness which may develop during your treatment with APO-DOXAZOSIN and about any new prescription or non-prescription medication you may take. If you require medical help for other reasons, inform the attending physician that you are taking APO-DOXAZOSIN.
You can take APO-DOXAZOSIN either in the morning or at bedtime, with or without food. If you take APODOXAZOSIN 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 medication affects you. It is important to get up slowly from a chair or bed at any time until you learn how you react to APODOXAZOSIN. You should not drive or do any hazardous tasks until you are used to the effects of the medication. If you begin to feel dizzy, sit or lie down until you feel better.
If you miss a dose: Talk with your doctor if you don't take it for a few days for some reason; you may then need to restart the medication at a 1 mg dose, increase your dose gradually and again be cautious about possible dizziness.
How long to take APO-DOXAZOSIN: You should take APO-DOXAZOSIN as long as your doctor thinks it is necessary.
Overdose
If you take too many tablets by accident, call a poison control center immediately.
Side effects and what to do about them
Like all medications, some patients may experience side effects with APO-DOXAZOSIN.
Side effects you could have while taking APODOXAZOSIN include drowsiness, fatigue (tiredness), swelling of the feet, shortness of breath, weight gain, headache, and a decrease in your white blood cell count.
You may also experience dry or reduced or other kinds of ejaculation disorders. This condition may be harmless but can lead to temporary infertility during the medication usage.
Most side effects are mild. Discuss any unexpected effects you notice with your doctor.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Extremely rarely, APO-DOXAZOSIN and similar medications have caused painful erection of the penis, sustained for hours and unrelieved by sexual intercourse or masturbation. This condition is serious, and if untreated it can be followed by permanent inability to have an erection. If you have a prolonged abnormal erection, call your doctor, or go to an emergency room as soon as possible.
If you notice any of the following potentially serious side effects, please stop taking APO-DOXAZOSIN and contact your doctor immediately:
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek medical assistance immediately |
|---|---|---|---|
| Dizziness | ✔ | ||
| Faint | ✔ | ||
| lightheaded | ✔ | ||
| Painful erection/ sustained erection for hours | ✔ | ||
| Chest pain | ✔ | ||
| Rapid, pounding, or irregular heartbeat | ✔ | ||
| Allergic Reaction: Rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing. | ✔ |
This is not a complete list of side effects. If you have any unexpected effects after receiving APODOXAZOSIN, contact your doctor or pharmacist.
How to store
Store at room temperature (15°C to 30°C).
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
Keep out of sight and reach of children.
If you want more information about APODOXAZOSIN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Date of Revision: October 29, 2018
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