Patient Medication Information: uses, side effects, how to take - Teva-Doxazosin
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed TEVA-DOXAZOSIN because you either have a medical condition called benign prostatic hyperplasia (BPH) or Hypertension.
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:
TEVA-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 TEVA-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 TEVA-DOXAZOSIN helps your condition, it is not known whether TEVA-DOXAZOSIN reduces the need for surgery.
- TEVA-DOXAZOSIN will not cure your benign prostatic hyperplasia (BPH). TEVA-DOXAZOSIN 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 TEVA-DOXAZOSIN therapy.
Similarly, TEVA-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:
TEVA-DOXAZOSIN should not be used if you have a known allergy to TEVA-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 nonmedicinal ingredients are:
Microcrystalline cellulose, lactose, pregelatinized starch, sodium starch glycolate, magnesium stearate, and sodium lauryl sulphate
What dosage forms it comes in:
Tablets: 1, 2, and 4 mg (doxazosin)
WARNINGS AND PRECAUTIONS
BEFORE you use TEVA-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.
TEVA-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 TEVA-DOXAZOSIN due to the risks of developing serious hypotension (low blood pressure).
Your doctor has prescribed TEVA-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 TEVA-DOXAZOSIN. TEVA-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 TEVA-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 TEVA-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
TEVA-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 TEVA-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 TEVA-DOXAZOSIN with anyone else; it was prescribed only for you.
Notify your doctor about any illness which may develop during your treatment with TEVA-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 TEVA-DOXAZOSIN.
You can take TEVA-DOXAZOSIN either in the morning or at bedtime, with or without food. If you take TEVA-DOXAZOSIN 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 TEVA-DOXAZOSIN. 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 TEVA-DOXAZOSIN: You should take TEVA-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.
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications, some patients may experience side effects with TEVA-DOXAZOSIN.
Side effects you could have while taking TEVA-DOXAZOSIN 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, TEVA-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 TEVA-DOXAZOSIN and contact your doctor immediately.
| 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 seek medical assistance immediately | |
| Only if severe | In all cases | ||
| Dizziness, faint, light-headed | √ | ||
| 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 TEVA-DOXAZOSIN, contact your doctor or pharmacist.
HOW TO STORE IT
Store your tablets at room temperature (15°C – 30°C).
REPORTING SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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.
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com