Consumer Information for: JAMP-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 JAMP-DOXAZOSIN because you either have a medical condition called benign prostatic hyperplasia (BPH) or Hypertension. This leaflet describes JAMP-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

JAMP-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 patientsrespond in the same way, and since each case of BPH is different, you should keep in mind the following:

  • Prior to treatment with JAMP-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 JAMP-DOXAZOSIN helps your condition, it is not known whether JAMP-DOXAZOSIN reduces the need for surgery.
  • JAMP-DOXAZOSIN will not cure your
  • benign prostatic hyperplasia (BPH). JAMP-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 JAMP-DOXAZOSIN therapy.

Similarly, JAMP-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

JAMP-DOXAZOSIN should not be used if you have a known allergy to JAMP-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

microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate,sodium lauryl sulphate, colloidal silicone Dioxide and colouring agents (FD&C Red No. 40, Alum lake the 2 mg and for the 4 mg).

What dosage form it comes in

Tablets: 1, 2, and 4 mg (doxazosin)

Warnings and precautions

BEFORE you use JAMP-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 alchohol;
  • 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.

JAMP-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 JAMP-DOXAZOSIN due to the risks of developing serious hypotension (low blood pressure).

Your doctor has prescribed JAMP-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 JAMP-DOXAZOSIN. JAMP-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 JAMP-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 JAMP-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 JAMP-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

Usual Dose

Follow your doctor's instructions very carefully about how to take JAMP-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 JAMP-DOXAZOSIN with anyone else; it was prescribed only for you.

Notify your doctor about any illness which may develop during your treatment with JAMP-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 JAMP-DOXAZOSIN.

You can take JAMP-DOXAZOSIN either in the morning or at bedtime, with or without food. If you take JAMP-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 JAMP-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 JAMP-DOXAZOSIN: You should take JAMP-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.

If you think you have taken too much JAMP-DOXAZOSIN, contact your healthcare professional, 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 JAMP-DOXAZOSIN.

Side effects you could have while taking JAMP-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, JAMP-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 JAMP-DOXAZOSIN and contact your doctor immediately:

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and seek medical assistance immediately
Faint    
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 JAMP-DOXAZOSIN, contact your doctor or pharmacist.

How to store

Store at room temperature (15°C - 30°C).

Keep out of sight and reach of children.

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
  • Call 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

If you want more information about JAMP-DOXAZOSIN

  • Talk to your doctor or pharmacist.
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; or by calling 1-866-399-9091.

This leaflet was prepared by Jamp Pharma Corporation.

Last Prepared: June 28, 2019