Doxazosin Mesylate: Package Insert and Label Information (Page 4 of 4)

OVERDOSAGE

Experience with doxazosin mesylate overdosage is limited. Two adolescents who each intentionally ingested 40 mg doxazosin mesylate with diclofenac or acetaminophen, were treated with gastric lavage with activated charcoal and made full recoveries. A two-year-old child who accidently ingested 4 mg doxazosin mesylate was treated with gastric lavage and remained normotensive during the five-hour emergency room observation period. A six-month-old child accidentally received a crushed 1 mg tablet of doxazosin mesylate and was reported to have been drowsy. A 32-year-old female with chronic renal failure, epilepsy and depression intentionally ingested 60 mg doxazosin mesylate (blood level 0.9 mcg/mL; normal values in hypertensives = 0.02 mcg/mL); death was attributed to a grand mal seizure resulting from hypotension. A 39-year-old female who ingested 70 mg doxazosin mesylate, alcohol, and flurazepam developed hypotension which responded to fluid therapy.

The oral LD50 of doxazosin mesylate is greater than 1000 mg/kg in mice and rats. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of fluid. As doxazosin mesylate is highly protein bound, dialysis would not be indicated.

DOSAGE AND ADMINISTRATION

DOSAGE MUST BE INDIVIDUALIZED. The initial dosage of doxazosin mesylate tablets in patients with hypertension and/or BPH is 1 mg given once daily in the a.m. or p.m. This starting dose is intended to minimize the frequency of postural hypotension and first dose syncope associated with doxazosin mesylate tablets. Postural effects are most likely to occur between 2 and 6 hours after a dose. Therefore, blood pressure measurements should be taken during this time period after the first dose and with each increase in dose. If administration of doxazosin mesylate tablets is discontinued for several days, therapy should be restarted using the initial dosing regimen.

Benign Prostatic Hyperplasia 1 to 8 mg once daily.

The initial dosage of doxazosin mesylate tablets is 1 mg, given once daily in the a.m. or p.m. Depending on the individual patient’s urodynamics and BPH symptomatology, dosage may then be increased to 2 mg and thereafter to 4 mg and 8 mg once daily, the maximum recommended dose for BPH. The recommended titration interval is 1 to 2 weeks. Blood pressure should be evaluated routinely in these patients.

Hypertension 1 to 16 mg once daily.

The initial dosage of doxazosin mesylate tablets is 1 mg given once daily. Depending on the individual patient’s standing blood pressure response (based on measurements taken at 2 to 6 hours post-dose and 24 hours post-dose), dosage may then be increased to 2 mg and thereafter if necessary to 4 mg, 8 mg and 16 mg to achieve the desired reduction in blood pressure. Increases in dose beyond 4 mg increase the likelihood of excessive postural effects including syncope, postural dizziness/vertigo and postural hypotension. At a titrated dose of 16 mg once daily the frequency of postural effects is about 12% compared to 3% for placebo.

HOW SUPPLIED

Doxazosin Mesylate Tablets are available as follows:

1 mg (doxazosin as free base): white, round, unscored, biconvex tablets, debossed “DX1” on one side and “G” on the other side

bottles of 100 with a child-resistant closure NDC 55567-072-18

bottles of 1000 NDC 55567-072-35

unit dose blisters of 10, cartons of 100 NDC 55567-072-06.

2 mg (doxazosin as free base): white, capsule-shaped tablets, debossed “DX” scoreline “2” on one side and “G” on the other side

bottles of 100 with a child-resistant closure NDC 55567-073-18

bottles of 1000 NDC 55567-073-35

unit dose blisters of 10, cartons of 100 NDC 55567-073-06.

4 mg (doxazosin as free base): white, capsule-shaped tablets, debossed “DX” scoreline “4” on one side and “G” on the other side

bottles of 100 with a child-resistant closure NDC 55567-074-18

bottles of 1000 NDC 55567-074-35

unit dose blisters of 10, cartons of 100 NDC 55567-074-06.

8 mg (doxazosin as free base): white, capsule-shaped tablets, debossed “DX” scoreline “8” on one side and “G” on the other side

bottles of 100 with a child-resistant closure NDC 55567-075-18

bottles of 1000 NDC 55567-075-35

unit dose blisters of 10, cartons of 100 NDC 55567-075-06.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

[see USP Controlled Room Temperature]

PATIENT INFORMATION ABOUT DOXAZOSIN MESYLATE TABLETS FOR BENIGN PROSTATIC HYPERPLASIA (BPH)

Read this leaflet:

  • before you start taking doxazosin mesylate
  • each time you get a new prescription.

You and your doctor should discuss this treatment and your BPH symptoms before you start taking doxazosin mesylate and at your regular checkups.

This leaflet does NOT take the place of discussions with your doctor.

Doxazosin mesylate is used to treat both benign prostatic hyperplasia (BPH) and high blood pressure (hypertension). This leaflet describes doxazosin mesylate as treatment for BPH (although you may be taking doxazosin mesylate for both your BPH and high blood pressure).

What is BPH?

BPH is an enlargement of the prostate gland. This gland surrounds the tube that drains the urine from the bladder. The symptoms of BPH can be caused by a tensing of the enlarged muscle in the prostate gland which blocks the passage of urine. This can lead to such symptoms as:

  • a weak or start-and-stop stream when urinating
  • a feeling that the bladder is not completely emptied after urination
  • a delay or difficulty in the beginning of urination
  • a need to urinate often during the day and especially at night
  • a feeling that you must urinate immediately.

Treatment Options for BPH

The four main treatment options for BPH are:

  • If you are not bothered by your symptoms, you and your doctor may decide on a program of “watchful waiting”. It is not an active treatment like taking medication or surgery but involves having regular checkups to see if your condition is getting worse or causing problems.
  • Treatment with doxazosin mesylate or other similar drugs. Doxazosin mesylate is the medication your doctor has prescribed for you. See “What Doxazosin Mesylate Does”, below.
  • Treatment with the medication class of 5-alpha reductase inhibitors (e.g., Proscar® (finasteride)). It can cause the prostate to shrink. It may take 6 months or more for the full benefit of finasteride to be seen.
  • Various surgical procedures. Your doctor can describe these procedures to you. The best procedure for you depends on your BPH symptoms and medical condition.

What Doxazosin Mesylate Does

Doxazosin mesylate works on a specific type of muscle found in the prostate, causing it to relax. This in turn decreases the pressure within the prostate, thus improving the flow of urine and your symptoms.

  • Doxazosin mesylate helps relieve the symptoms of BPH (weak stream, start-and-stop stream, a feeling that your bladder is not completely empty, delay in beginning of urination, need to urinate often during the day and especially at night, and feeling that you must urinate immediately). It does not change the size of the prostate. The prostate may continue to grow; however, a larger prostate is not necessarily related to more symptoms or to worse symptoms. Doxazosin mesylate can decrease your symptoms and improve urinary flow, without decreasing the size of the prostate.
  • If doxazosin mesylate is helping you, you should notice an effect within 1 to 2 weeks after you start your medication. Doxazosin mesylate has been studied in over 900 patients for up to 2 years and the drug has been shown to continue to work during long-term treatment. Even though you take doxazosin mesylate and it may help you, doxazosin mesylate may not prevent the need for surgery in the future.
  • Doxazosin mesylate does not affect PSA levels. PSA is the abbreviation for Prostate Specific Antigen. Your doctor may have done a blood test called PSA. You may want to ask your doctor more about this if you have had a PSA test done.

Other Important Facts

  • You should see an improvement of your symptoms within 1 to 2 weeks. In addition to your other regular checkups you will need to continue seeing your doctor regularly to check your progress regarding your BPH and to monitor your blood pressure.
  • Doxazosin mesylate is not a treatment for prostate cancer. Your doctor has prescribed doxazosin mesylate for your BPH and not for prostate cancer; however, a man can have 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). A higher incidence of prostate cancer has been noted in men of African-American descent. These checks should continue even if you are taking doxazosin mesylate.

How To Take Doxazosin Mesylate and What You Should Know While Taking Doxazosin Mesylate for BPH

Doxazosin Mesylate Can Cause a Sudden Drop in Blood Pressure After the VERY FIRST DOSE. You may feel dizzy, faint or “lightheaded”, especially after you stand up from a lying or sitting position. This is more likely to occur after you’ve taken the first few doses or if you increase your dose, 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.

Your blood pressure should be checked when you start taking doxazosin mesylate even if you do not have high blood pressure (hypertension). Your doctor will discuss with you the details of how blood pressure is measured.

Blood Pressure Measurement: Whatever equipment is used, it is usual for your blood pressure to be measured in the following way: measure your blood pressure after lying quietly on your back for five minutes. Then, after standing for two minutes measure your blood pressure again. Your doctor will discuss with you what other times during the day your blood pressure should be taken, such as two to six hours after a dose, before bedtime or after waking up in the morning. Note that moderate to high-intensity exercise can, over a period of time, lower your average blood pressure.

You can take doxazosin mesylate either in the morning or at bedtime and it will be equally effective. If you take doxazosin mesylate 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 doxazosin mesylate. 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.

  • You will start with a 1 mg dose of doxazosin mesylate once daily. Then the once daily dose will be increased as your body gets used to the effects of the medication. Follow your doctor’s instructions about how to take doxazosin mesylate. You must take it every day at the dose prescribed. 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. Do not share doxazosin mesylate with anyone else; it was prescribed only for you.
  • Other side effects you could have while taking doxazosin mesylate, in addition to lowering of the blood pressure, include dizziness, fatigue (tiredness), swelling of the feet and shortness of breath. Most side effects are mild. However, you should discuss any unexpected effects you notice with your doctor.
  • WARNING: Extremely rarely, doxazosin mesylate 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.

Keep doxazosin mesylate and all medicines out of the reach of children.

FOR MORE INFORMATION ABOUT DOXAZOSIN MESYLATE AND BPH TALK WITH YOUR DOCTOR, NURSE, PHARMACIST OR OTHER HEALTH CARE PROVIDER.

Manufactured by:

Genpharm Inc.

Toronto, Ontario

Canada M8Z 2S6

Printed in Canada

005-908 REV. #05 (P4) August 2006

DOXAZOSIN MESYLATE
doxazosin mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55567-072
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doxazosin Mesylate (Doxazosin) Doxazosin 1 mg
Inactive Ingredients
Ingredient Name Strength
lactose anhydrous
magnesium stearate
microcrystalline cellulose
sodium lauryl sulphate
sodium starch glycolate
Product Characteristics
Color WHITE Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code DX1;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55567-072-18 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:55567-072-35 1000 TABLET (1000 TABLET) in 1 BOTTLE None
3 NDC:55567-072-06 100 TABLET (100 TABLET) in 1 BLISTER PACK None
DOXAZOSIN MESYLATE
doxazosin mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55567-073
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doxazosin Mesylate (Doxazosin) Doxazosin 2 mg
Inactive Ingredients
Ingredient Name Strength
lactose anhydrous
magnesium stearate
microcrystalline cellulose
sodium lauryl sulphate
sodium starch glycolate
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule shaped) Size 9mm
Flavor Imprint Code DX;2;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55567-073-18 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:55567-073-35 1000 TABLET (1000 TABLET) in 1 BOTTLE None
3 NDC:55567-073-06 100 TABLET (100 TABLET) in 1 BLISTER PACK None
DOXAZOSIN MESYLATE
doxazosin mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55567-074
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doxazosin Mesylate (Doxazosin) Doxazosin 4 mg
Inactive Ingredients
Ingredient Name Strength
lactose anhydrous
magnesium stearate
microcrystalline cellulose
sodium lauryl sulphate
sodium starch glycolate
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule shaped) Size 12mm
Flavor Imprint Code DX;4;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55567-074-18 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:55567-074-35 1000 TABLET (1000 TABLET) in 1 BOTTLE None
3 NDC:55567-074-06 100 TABLET (100 TABLET) in 1 BLISTER PACK None
DOXAZOSIN MESYLATE
doxazosin mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55567-075
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doxazosin Mesylate (Doxazosin) Doxazosin 8 mg
Inactive Ingredients
Ingredient Name Strength
lactose anhydrous
magnesium stearate
microcrystalline cellulose
sodium lauryl sulphate
sodium starch glycolate
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule-shaped) Size 12mm
Flavor Imprint Code DX;8;G
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55567-075-18 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:55567-075-35 1000 TABLET (1000 TABLET) in 1 BOTTLE None
3 NDC:55567-075-06 100 TABLET (100 TABLET) in 1 BLISTER PACK None
Labeler — Genpharm Inc.

Revised: 06/2007 Genpharm Inc.

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