Brand Name
Cardura
Generic Name
Doxazosin
View Brand Information FDA approval date: October 18, 2000
Classification: alpha-Adrenergic Blocker
Form: Tablet
What is Cardura (Doxazosin)?
Doxazosin tablets are an alpha 1 adrenergic antagonist indicated for: 3. Signs and symptoms of Benign Prostatic Hyperplasia 4. Treatment of HypertensionTreatment of Hypertension.
Approved To Treat
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Brand Information
Cardura (doxazosin mesylate)
1INDICATIONS AND USAGE
CARDURA
CARDURA XL is not indicated for the treatment of hypertension.
2DOSAGE FORMS AND STRENGTHS
White, round, film-coated tablets containing doxazosin mesylate equivalent to 4 mg and 8 mg doxazosin (free base).
3CONTRAINDICATIONS
CARDURA XL is contraindicated in patients with a known hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of the inert ingredients. Allergic reactions to doxazosin and other quinazolines have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms
4OVERDOSAGE
There is no experience with CARDURA XL overdosage. Overdosage experience with the doxazosin IR is limited. Two adolescents who each intentionally ingested 40 mg doxazosin IR with diclofenac or paracetamol were treated with gastric lavage with activated charcoal and made full recoveries. A two-year-old child who accidentally ingested 4 mg doxazosin IR 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 IR and was reported to have been drowsy. A 32-year-old female with chronic renal failure, epilepsy, and depression intentionally ingested 60 mg doxazosin IR (blood level 0.9 µg/mL; normal values in hypertensives = 0.02 µg/mL); death was attributed to a grand mal seizure resulting from hypotension. A 39-year-old female who ingested 70 mg doxazosin IR, alcohol, and Dalmane
The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of fluid, keeping the patient in the supine position, and in certain circumstances, the administration of vasopressors. As doxazosin is highly protein bound, dialysis would not be indicated.
5DESCRIPTION
CARDURA XL contains doxazosin which is a quinazoline compound with the chemical name 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C
CARDURA XL is an extended-release tablet for oral use and is designed to deliver 4 or 8 mg of doxazosin as the free base. Each 4 and 8 mg tablet contains 5.1 and 10.2 mg doxazosin mesylate (includes a 5% overage) to ensure the labeled dose of 4 and 8 mg doxazosin as the free base (equivalent to 4.9 and 9.8 mg of doxazosin mesylate), is delivered. The inactive ingredients for CARDURA XL are black iron oxide, cellulose acetate, hypromellose, Macrogol
CARDURA XL System Components and Performance
CARDURA XL is similar in appearance to a conventional tablet. It consists, however, of an osmotically active drug core surrounded by a semipermeable membrane. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. The membrane surrounding the tablet is permeable to water, but not to drug or osmotic excipients. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, resulting in the release of drug through a small, laser-drilled orifice in the membrane on the drug side of the tablet.
CARDURA XL utilizes GITS (Gastrointestinal Therapeutic System) which is designed to provide a controlled rate of delivery of doxazosin into the gastrointestinal lumen which is independent of pH or gastrointestinal (GI) motility. The function of CARDURA XL depends upon the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the GI tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. The biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell.
6HOW SUPPLIED/STORAGE AND HANDLING
CARDURA XL (doxazosin) extended-release tablets is available as 4 mg (white, imprinted with CXL 4) and 8 mg (white, imprinted with CXL 8) tablets.
Bottle of 30: 4 mg (NDC 58151-078-93)
Storage
Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
7PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (
7.1Postural Hypotension
Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness or syncope, when beginning therapy or when increasing dosage strength of CARDURA XL. Patients should be cautioned about driving, operating machinery, or performing hazardous tasks during this period, until the drug’s effect has been determined.
7.2Priapism
Inform the patient about the possibility of priapism as a result of treatment with CARDURA XL extended-release tablets and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction.
7.3Tablet Administration
Patients should be informed that CARDURA XL extended-release tablets should be swallowed whole. Patients should not chew, divide, cut, or crush tablets.
7.4Dosing Interval
CARDURA XL should be taken each day with breakfast.
7.5Tablet Elimination
Patients should not be concerned if they occasionally notice in their stool something that looks like a tablet. In the CARDURA XL extended-release tablet, the medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. When this process is completed, the empty tablet is eliminated from the body.
Distributed by:
© 2023 Viatris Inc.
CARDURA is a registered trademark of Viatris Specialty LLC, a Viatris Company
The brands listed are trademarks of their respective owners.
UPJ:CRDAXL:R1
8PATIENT INFORMATION
CARDURA
Read this Patient Information leaflet before you start taking CARDURA XL and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is CARDURA XL?
CARDURA XL is a prescription medicine called an “alpha-blocker”. CARDURA XL is used to treat the symptoms of benign prostatic hyperplasia (BPH). CARDURA XL may help to relax the muscles in the prostate and the bladder which may lessen the symptoms of BPH and improve urine flow.
Before prescribing CARDURA XL, your healthcare provider may examine your prostate gland and do a blood test called a prostate specific antigen (PSA) test to check for prostate cancer. Prostate cancer and BPH can cause the same symptoms. Prostate cancer needs a different treatment.
Some medicines called “alpha-blockers” are used to treat high blood pressure. CARDURA XL is not for the treatment of high blood pressure.
It is not known if CARDURA XL is safe and effective in children.
Who should not take CARDURA XL?
Do not take CARDURA XL if you are allergic to doxazosin, other medications called quinazolines, or any of the ingredients in CARDURA XL. See the end of this leaflet for a complete list of ingredients in CARDURA XL.
What should I tell my healthcare provider before taking CARDURA XL?
Before you take CARDURA XL, tell your healthcare provider if you:
- have or have had low blood pressure, especially after taking another medicine. Signs of low blood pressure are fainting, dizziness, and lightheadedness.
- plan to have cataract surgery
- have stomach problems
- have prostate cancer
- have liver problems
- have heart problems
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
CARDURA XL may affect the way other medicines work, and other medicines may affect how CARDURA XL works.
Especially tell your healthcare provider if you take:
- a medicine to treat an infection
- a medicine to treat HIV
- a medicine to treat depression
- a medicine to treat erectile dysfunction (ED)
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of those listed above.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take CARDURA XL?
- Take CARDURA XL exactly as your healthcare provider tells you to take it.
- Take CARDURA XL 1 time each day with your breakfast.
- Take CARDURA XL tablets whole.
- CARDURA XL tablets have an outside shell that helps to release the medicine inside over time. You may see the empty CARDURA XL tablet in your stool (bowel movement). This is normal.
- If you take too much CARDURA XL, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking CARDURA XL?
Do not drive, operate machinery, or do other dangerous activities until you know how CARDURA XL affects you. CARDURA XL can cause dizziness, weakness, or fainting.
What are the possible side effects of CARDURA XL?
CARDURA XL may cause serious side effects including:
- a sudden drop in blood pressure (postural hypotension). Postural hypotension can happen at any time while you take CARDURA XL. The chance of having postural hypotension is higher a few hours after you take CARDURA XL or if you start taking a higher dose.
Symptoms of postural hypotension may happen after you stand up from a lying or sitting position and may include:- dizziness or
- fainting or
- feeling light-headed
- You should get up slowly from a chair or bed until you know how CARDURA XL will affect you. If you begin to feel dizzy or lightheaded, sit or lie down with your legs and feet up. If your symptoms do not get better call your healthcare provider.
- intraoperative floppy iris syndrome (IFIS). IFIS can happen during eye surgery to people who are taking or have taken alpha-blockers such as CARDURA XL. If you have an eye surgery for a clouding of the eye (cataract) planned, tell your eye doctor that you are using CARDURA XL or have taken an alpha-blocker before.
- blockage of the digestive tract. There have been rare reports of symptoms of blockage in the digestive tract in patients with prior history of narrowing or blockage of the digestive tract. These symptoms are severe and persistent abdominal pain/cramping/bloating. If you know you have a narrowing of your digestive tract and you experience these symptoms, contact your healthcare provider.
- prolonged erection of the penis. Extremely rarely, CARDURA XL 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.
The most common side effects of CARDURA XL include:
- tiredness
- headache
- low blood pressure
- dizziness
Call your healthcare provider if you get any side effect that bothers you or that does not go away.
These are not all the possible side effects of CARDURA XL. For more information ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store CARDURA XL?
- Store CARDURA XL at 59°F to 86°F (15°C to 30°C).
Keep CARDURA XL and all medicines out of reach of children.
General information about the safe and effective use of CARDURA XL.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CARDURA XL for a condition for which it was not prescribed. Do not give CARDURA XL to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about CARDURA XL. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CARDURA XL that is written for health professionals.
For more information, call Viatris at 1-877-446-3679 (1-877-4-INFO-RX).
What are the ingredients in CARDURA XL?
Active Ingredient: doxazosin
Inactive Ingredients: black iron oxide, cellulose acetate, hypromellose, Macrogol®, magnesium stearate, pharmaceutical glaze, polyethylene oxide, red ferric oxide, sodium chloride and titanium dioxide.
Distributed by:
© 2023 Viatris Inc.
CARDURA is a registered trademark of Viatris Specialty LLC, a Viatris Company
The brands listed are trademarks of their respective owners.
UPJ:PL:CRDAXL:R1
9PRINCIPAL DISPLAY PANEL – 4 mg
NDC 58151-078-93
Cardura
30 Tablets
Store at 25ºC (77ºF);
[see USP Controlled Room
Temperature].
[see USP Controlled Room
Temperature].
PROTECT FROM MOISTURE
DOSAGE AND USE
See accompanying
prescribing information.
See accompanying
prescribing information.
*Each tablet contains 5.1 mg
Distributed by:
© 2023 Viatris Inc.
RUPJ078H
10PRINCIPAL DISPLAY PANEL – 8 mg
NDC 58151-079-93
Cardura
30 Tablets
Store at 25ºC (77ºF);
[see USP Controlled Room
Temperature].
[see USP Controlled Room
Temperature].
PROTECT FROM MOISTURE
DOSAGE AND USE
See accompanying
prescribing information.
See accompanying
prescribing information.
*Each tablet contains 10.2 mg
Distributed by:
© 2023 Viatris Inc.
RUPJ079H
