Doxazosin

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Doxazosin tablets USP, 1 mg are white to off-white, round biconvex scored tablets debossed with '783' on one side and score line on another side. Doxazosin tablets USP, 2 mg are light pink to pink, mottled, round biconvex scored tablets debossed with '784' on one side and score line on another side. Doxazosin tablets USP, 4 mg are light pink to pink, mottled, capsule shaped, biconvex scored tablets debossed with '785' on one side and score line on another side. Doxazosin tablets USP, 8 mg are light purple to purple, mottled, round biconvex scored tablets debossed with '786' on one side and score line on another side.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

The use of doxazosin tablets is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Experience with doxazosin overdosage is limited. Two adolescents, who each intentionally ingested 40 mg doxazosin 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 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 and was reported to have been drowsy. A 32-year-old female with chronic renal failure, epilepsy, and depression intentionally ingested 60 mg doxazosin (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, alcohol, and Dalmane ® (flurazepam) developed hypotension which responded to fluid therapy. The oral LD 50 of doxazosin 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 is highly protein bound, dialysis would not be indicated.

11 DESCRIPTION

DESCRIPTION SECTION

Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4 benzodioxan-2-ylcarbonyl)piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23 H 25 N 5 O 5 • CH 4 O 3 S and the molecular weight is 547.6. It has the following structure: Doxazosin mesylate, USP is white to off white powder. It is freely soluble in formic acid; very slightly soluble in methanol and in water. Doxazosin is available as tablets for oral use and contains 1 mg (white), 2 mg (pink), 4 mg (pink) and 8 mg (purple) of doxazosin as the free base. Each doxazosin tablet, USP for oral administration contains 1 mg or 2 mg or 4 mg or 8 mg of doxazosin as 1.213 mg or 2.426 mg or 4.852 mg or 9.703 mg of doxazosin mesylate, respectively and inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (botanical source: potato) and sodium lauryl sulphate. Additionally 8 mg tablet contains FD&C red #40 aluminum lake, FD&C blue #2 aluminum lake and 2 mg and 4 mg tablet contains ferric oxide red.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Doxazosin tablets USP, 4 mg are light pink to pink, mottled, capsule shaped, biconvex scored tablets debossed with 785 on one side and score line on another side and are supplied as: NDC 68071-4892-3 BOTTLES OF 30 NDC 68071-4892-9 BOTTLES OF 90 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Patient Information). Postural Hypotension Advise patients of the possibility of syncopal and orthostatic symptoms, especially at the initiation of therapy, and urged to avoid driving or hazardous tasks for 24 hours after the first dose, after a dosage increase, and after interruption of therapy when treatment is resumed. Advise patients to report symptoms to their healthcare provider. Priapism Advise patients of the possibility of priapism and to seek immediate medical attention if symptoms occur. Trademarks are the property of their respective owners. This product's label may have been updated. For full prescribing information, please visit www.zydususa.com.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Manufactured by: Cadila Healthcare Ltd. Matoda, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Rev.: 07/16

SPL PATIENT PACKAGE INSERT SECTION

SPL PATIENT PACKAGE INSERT SECTION

PATIENT INFORMATION Doxazosin Tablets, USP (dox AY zo sin) What are Doxazosin Tablets? Doxazosin tablets are prescription medicine that contains doxazosin mesylate and is called an "alpha-blocker". Doxazosin tablets are used to treat: the symptoms of benign prostatic hyperplasia (BPH) high blood pressure (hypertension) It is not known if doxazosin tablets are safe and effective in children. Who should not take Doxazosin Tablets? Do not take Doxazosin Tablets if you : are allergic to doxazosin, other quinazolines, or any of the ingredients in doxazosin tablets. See the end of this Patient Information leaflet for a complete list of ingredients in doxazosin tablets. What should I tell my healthcare provider before taking Doxazosin Tablets? Before taking Doxazosin Tablets, tell your healthcare provider about all of your medical conditions, including if you : have had low blood pressure, especially after taking other medicine. Signs of low blood pressure include fainting, dizziness, and lightheadedness. have any planned eye surgery have prostate cancer or a history of prostate cancer. Your healthcare provider may have you checked for prostate cancer before you start taking and while you take doxazosin tablets. have liver problems are pregnant or plan to become pregnant. It is not known if doxazosin tablets will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if doxazosin tablets passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take doxazosin tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Doxazosin tablets may affect the way other medicines work, and other medicines may affect the way doxazosin tablets works causing side effects. Especially tell your healthcare provider if you take: other medicine for high blood pressuremedicine to treat erectile dysfunction (ED) called a phosphodiesterase type 5 (PDE-5) inhibitor. The use of doxazosin tablets with PDE-5 inhibitors can lead to a drop in blood pressure or to fainting. 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 Doxazosin Tablets? Take doxazosin tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much doxazosin tablets to take and when to take it. Your healthcare provider may need to change your dose of doxazosin tablets until it is the right dose for you. What should I avoid while taking Doxazosin Tablets? Do not drive or perform any hazardous task until at least 24 hours after you have taken doxazosin tablets if you are taking: your first dose of doxazosin tablets Doxazosin tablets for the first time after your healthcare provider has increased your dose of doxazosin tablets Doxazosin tablets for the first time after any breaks (interruptions) in your treatment with doxazosin tablets What are the possible side effects of Doxazosin Tablets? Doxazosin Tablets may cause serious side effects, including : A sudden drop in blood pressure , especially when you first start treatment or when there is an increase in your dose of doxazosin tablets, is common but can also be serious. This may cause you to faint, or to feel dizzy or lightheaded. Your risk of having this problem may be increased if you take doxazosin tablets with certain other medicines that lower blood pressure including PDE-5 inhibitors. Your healthcare provider may monitor your blood pressure while you take doxazosin tablets. See "What should I avoid while taking doxazosin tablets?" Eye problems during cataract surgery . A condition called Intraoperative Floppy Iris Syndrome (IFIS) can happen during cataract surgery if you take or have taken alpha-blockers such as doxazosin tablets. If you need to have cataract surgery, be sure to tell your healthcare provider if you take or have taken doxazosin tablets. A painful erection that will not go away . Doxazosin tablets can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future. The most common side effects of doxazosin tablets are: weakness or lack of energy (asthenia) • dizziness Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of doxazosin tablets. 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. General information about the safe and effective use of Doxazosin Tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use doxazosin tablets for a condition for which it was not prescribed. Do not give doxazosin tablets 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 doxazosin tablets. For more information, ask your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals. What are the ingredients in Doxazosin Tablets? Active ingredient : doxazosin mesylate, USP Inactive ingredients : FD&C red #40 aluminum lake, FD&C blue #2 aluminum lake, ferric oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (botanical source: potato) and sodium lauryl sulphate. Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779. This product's label may have been updated. For current full prescribing information, please visit www.zydususa.com This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured by: Cadila Healthcare Ltd. Matoda, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Rev.: 07/16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL