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| Product NDC Code | 0049-2716 | ||||
|---|---|---|---|---|---|
| Drug Name | Cardura |
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| Type | Brand | ||||
| Pharm Class | Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC] |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 104367, 104368, 104369, 197625, 197626, 197627, 197628, 205544 |
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| Application Number | NDA019668 | ||||
| Labeler Name | ROERIG | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Cardura
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Experience with CARDURA overdosage is limited. Two adolescents, who each intentionally ingested 40 mg CARDURA 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 CARDURA 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 CARDURA and was reported to have been drowsy. A 32-year-old female with chronic renal failure, epilepsy, and depression intentionally ingested 60 mg CARDURA (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 CARDURA, 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.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The most commonly reported adverse reactions from clinical trials are Fatigue, malaise, hypotension, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Benign Prostatic Hyperplasia (BPH) The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 2) are based on combined data from seven placebo-controlled trials involving once-daily administration of CARDURA in doses of 1 to 16 mg in hypertensives and 0.5 to 8 mg in normotensives. Adverse reactions occurring more than 1% more frequently in BPH patients treated with CARDURA vs placebo are summarized in Table 1. Table 1. Adverse Reactions Occurring more than 1% More Frequently in BPH Patients Treated with Cardura Versus Placebo BODY SYSTEM Cardura N=665 Placebo N=300 NERVOUS SYSTEM DISORDERS Dizziness Includes vertigo 15.6% 9.0% Somnolence 3.0% 1.0% CARDIAC DISORDERS Hypotension 1.7% 0% RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Dyspnoea 2.6% 0.3% GASTROINTESTINAL DISORDERS Dry Mouth 1.4% 0.3% GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue 8.0% 1.7% Oedema 2.7% 0.7% Other adverse reactions occurring less than 1% more frequently in BPH patients treated with CARDURA vs placebo but plausibly related to CARDURA include: palpitations. Hypertension CARDURA has been administered to approximately 4000 hypertensive patients in clinical trials, of whom 1679 were included in the hypertension clinical development program. In placebo-controlled studies, adverse events occurred in 49% and 40% of patients in the doxazosin and placebo groups, respectively, and led to discontinuation in 2% of patients in each group. Adverse reactions occurring more than 1% more frequently in hypertensive patients treated with CARDURA vs placebo are summarized in Table 1. . Postural effects and edema appeared to be dose-related. The prevalence rates presented below are based on combined data from placebo-controlled studies involving once-daily administration of doxazosin at doses ranging from 1 to 16 mg. Table 2. Adverse Reactions Occurring more than 1% More Frequently in Hypertensive Patients Treated with Cardura versus Placebo BODY SYSTEM Cardura N=339 Placebo N=336 NERVOUS SYSTEM DISORDERS Dizziness 19% 9% Somnolence 5% 1% RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Rhinitis 3% 1% RENAL AND URINARY DISORDERS Polyuria 2% 0% REPRODUCTIVE SYSTEM AND BREAST DISORDERS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Fatigue / Malaise 12% 6% Other adverse reactions occurring less than 1% more frequently in hypertensive patients treated with CARDURA vs placebo but plausibly related to CARDURA use include vertigo, hypotension, hot flushes, epistaxis and oedema. CARDURA has been associated with decreases in white blood cell counts Laboratory changes observed in clinical studies Leukopenia/Neutropenia: Decreases in mean white blood cell (WBC) and mean neutrophil count were observed in controlled clinical trials of hypertensive patients receiving CARDURA. In cases where follow-up was available, WBC and neutrophil counts returned to normal after discontinuation of CARDURA. No patients became symptomatic as a result of the low WBC or neutrophil counts. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of CARDURA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In post-marketing experience, the following additional adverse reactions have been reported: Blood and Lymphatic System Disorders: leukopenia, thrombocytopenia; Immune System Disorders: allergic reaction; Nervous System Disorders: hypoesthesia; Eye Disorders: Intraoperative Floppy Iris Syndrome [see Warnings and precautions (5.4) ] ; Cardiac Disorders: bradycardia; Respiratory, Thoracic and Mediastinal Disorders: bronchospasm aggravated; Gastrointestinal Disorders: vomiting; Hepatobiliary Disorders: cholestasis, hepatitis cholestatic; Skin and Subcutaneous Tissue Disorders: urticaria; Musculoskeletal and Connective Tissue Disorders: muscle cramps, muscle weakness; Renal and Urinary Disorders: hematuria, micturition disorder, micturition frequency, nocturia; Reproductive System and Breast Disorders: gynecomastia, priapism.
Cardura Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG INTERACTIONS • Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to doxazosin and increased risk of hypotension. ( 7.1 ) • Concomitant administration of CARDURA with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. ( 7.2 ) 7.1. CYP 3A Inhibitors In vitro studies suggest that doxazosin is a substrate of CYP 3A4. Strong CYP3A inhibitors may increase exposure to doxazosin. Monitor blood pressure and for symptoms of hypotension when CARDURA is used concomitantly with strong CYP3A inhibitors [ see Clinical Pharmacology (12.3) ]. 7.2 Phosphodiesterase-5 (PDE-5) inhibitors Concomitant administration of CARDURA with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. Monitor blood pressure and for symptoms of hypotension [ see Warnings and Precautions (5.1) ].
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Benign Prostatic Hyperplasia (BPH) The symptoms associated with benign prostatic hyperplasia (BPH), such as urinary frequency, nocturia, weak stream, hesitancy, and incomplete emptying are related to two components, anatomical (static) and functional (dynamic). The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate. The dynamic component of BPH is associated with an increase in smooth muscle tone in the prostate and bladder neck. The degree of tone in this area is mediated by the alpha 1 adrenoceptor, which is present in high density in the prostatic stroma, prostatic capsule and bladder neck. Blockade of the alpha 1 receptor decreases urethral resistance and may relieve the obstruction and BPH symptoms and improve urine flow. Hypertension The mechanism of action of CARDURA is selective blockade of the alpha 1 (postjunctional) subtype of adrenergic receptors. Studies in normal human subjects have shown that doxazosin competitively antagonized the pressor effects of phenylephrine (an alpha 1 agonist) and the systolic pressor effect of norepinephrine. Doxazosin and prazosin have similar abilities to antagonize phenylephrine. The antihypertensive effect of CARDURA results from a decrease in systemic vascular resistance. The parent compound doxazosin is primarily responsible for the antihypertensive activity. The low plasma concentrations of known active and inactive metabolites of doxazosin (2-piperazinyl, 6'- and 7'-hydroxy and 6- and 7-O-desmethyl compounds) compared to parent drug indicate that the contribution of even the most potent compound (6'-hydroxy) to the antihypertensive effect of doxazosin in man is probably small. The 6'- and 7'-hydroxy metabolites have demonstrated antioxidant properties at concentrations of 5 µM, in vitro . 12.2 Pharmacodynamics Benign Prostatic Hyperplasia (BPH) Administration of CARDURA to patients with symptomatic BPH resulted in a statistically significant improvement in maximum urinary flow rate [see Clinical Studies (14.1) ] . Effect on Normotensive Patients with Benign Prostatic Hyperplasia (BPH) Although blockade of alpha 1 adrenoceptors also lowers blood pressure in hypertensive patients with increased peripheral vascular resistance, CARDURA treatment of normotensive men with BPH did not result in a clinically significant blood pressure lowering effect (Table 4). The proportion of normotensive patients with a sitting systolic blood pressure less than 90 mmHg and/or diastolic blood pressure less than 60 mmHg at any time during treatment with CARDURA 1–8 mg once daily was 6.7% with doxazosin and not significantly different (statistically) from that with placebo (5%). Hypertension Administration of CARDURA results in a reduction in systemic vascular resistance. In patients with hypertension, there is little change in cardiac output. Maximum reductions in blood pressure usually occur 2–6 hours after dosing and are associated with a small increase in standing heart rate. Like other alpha 1 -adrenergic blocking agents, doxazosin has a greater effect on blood pressure and heart rate in the standing position. 12.3 Pharmacokinetics Absorption After oral administration of therapeutic doses, peak plasma levels of CARDURA occur at about 2–3 hours. Bioavailability is approximately 65%, reflecting first-pass metabolism of doxazosin by the liver. The effect of food on the pharmacokinetics of CARDURA was examined in a crossover study with twelve hypertensive subjects. Reductions of 18% in mean maximum plasma concentration (C max ) and 12% in the area under the concentration-time curve (AUC) occurred when CARDURA was administered with food. Neither of these differences is clinically significant. In a crossover study in 24 normotensive subjects, the pharmacokinetics and safety of doxazosin were shown to be similar with morning and evening dosing regimens. The AUC after morning dosing was, however, 11% less than that after evening dosing and the time to peak concentration after evening dosing occurred significantly later than that after morning dosing (5.6 vs. 3.5 hours). Distribution At the plasma concentrations achieved by therapeutic doses, approximately 98% of the circulating drug is bound to plasma proteins. Metabolism CARDURA is extensively metabolized in the liver, mainly by O-demethylation of the quinazoline nucleus or hydroxylation of the benzodioxan moiety. In vitro studies suggest that the primary pathway for elimination is via CYP 3A4; however, CYP 2D6 and CYP 2C9 metabolic pathways are also involved to a lesser extent. Although several active metabolites of doxazosin have been identified, the pharmacokinetics of these metabolites have not been characterized. Excretion Plasma elimination of doxazosin is biphasic, with a terminal elimination half-life of about 22 hours. Steady-state studies in hypertensive patients given doxazosin doses of 2 to 16 mg once daily showed linear kinetics and dose proportionality. In two studies, following the administration of 2 mg orally once daily, the mean accumulation ratios (steady-state AUC vs. first-dose AUC) were 1.2 and 1.7. Enterohepatic recycling is suggested by secondary peaking of plasma doxazosin concentrations. In a study of two subjects administered radiolabelled doxazosin 2 mg orally and 1 mg intravenously on two separate occasions, approximately 63% of the dose was eliminated in the feces and 9% of the dose was found in the urine. On average only 4.8% of the dose was excreted as unchanged drug in the feces and only a trace of the total radioactivity in the urine was attributed to unchanged drug. Specific Populations Geriatric The pharmacokinetics of CARDURA in young (<65 years) and elderly (≥65 years) subjects were similar for plasma half-life values and oral clearance. Renal Impairment Pharmacokinetic studies in elderly patients and patients with renal impairment have shown no significant alterations compared to younger patients with normal renal function. Hepatic Impairment Administration of a single 2 mg dose to patients with cirrhosis (Child-Pugh Class A) showed a 40% increase in exposure to doxazosin. The impact of moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment on the pharmacokinetics of doxazosin is not known [see Use in Specific Populations (8.6) ] . Drug Interactions There are only limited data on the effects of drugs known to influence the hepatic metabolism of doxazosin (e.g., cimetidine). Cimetidine: In healthy volunteers, the administration of a single 1 mg dose of doxazosin on day 1 of a four-day regimen of oral cimetidine (400 mg twice daily) resulted in a 10% increase in mean AUC of doxazosin, and a slight but not significant increase in mean Cmax and mean half-life of doxazosin. In vitro data in human plasma indicate that CARDURA has no effect on protein binding of digoxin, warfarin, phenytoin, or indomethacin.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Benign Prostatic Hyperplasia (BPH) The symptoms associated with benign prostatic hyperplasia (BPH), such as urinary frequency, nocturia, weak stream, hesitancy, and incomplete emptying are related to two components, anatomical (static) and functional (dynamic). The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate. The dynamic component of BPH is associated with an increase in smooth muscle tone in the prostate and bladder neck. The degree of tone in this area is mediated by the alpha 1 adrenoceptor, which is present in high density in the prostatic stroma, prostatic capsule and bladder neck. Blockade of the alpha 1 receptor decreases urethral resistance and may relieve the obstruction and BPH symptoms and improve urine flow. Hypertension The mechanism of action of CARDURA is selective blockade of the alpha 1 (postjunctional) subtype of adrenergic receptors. Studies in normal human subjects have shown that doxazosin competitively antagonized the pressor effects of phenylephrine (an alpha 1 agonist) and the systolic pressor effect of norepinephrine. Doxazosin and prazosin have similar abilities to antagonize phenylephrine. The antihypertensive effect of CARDURA results from a decrease in systemic vascular resistance. The parent compound doxazosin is primarily responsible for the antihypertensive activity. The low plasma concentrations of known active and inactive metabolites of doxazosin (2-piperazinyl, 6'- and 7'-hydroxy and 6- and 7-O-desmethyl compounds) compared to parent drug indicate that the contribution of even the most potent compound (6'-hydroxy) to the antihypertensive effect of doxazosin in man is probably small. The 6'- and 7'-hydroxy metabolites have demonstrated antioxidant properties at concentrations of 5 µM, in vitro .
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics Benign Prostatic Hyperplasia (BPH) Administration of CARDURA to patients with symptomatic BPH resulted in a statistically significant improvement in maximum urinary flow rate [see Clinical Studies (14.1) ] . Effect on Normotensive Patients with Benign Prostatic Hyperplasia (BPH) Although blockade of alpha 1 adrenoceptors also lowers blood pressure in hypertensive patients with increased peripheral vascular resistance, CARDURA treatment of normotensive men with BPH did not result in a clinically significant blood pressure lowering effect (Table 4). The proportion of normotensive patients with a sitting systolic blood pressure less than 90 mmHg and/or diastolic blood pressure less than 60 mmHg at any time during treatment with CARDURA 1–8 mg once daily was 6.7% with doxazosin and not significantly different (statistically) from that with placebo (5%). Hypertension Administration of CARDURA results in a reduction in systemic vascular resistance. In patients with hypertension, there is little change in cardiac output. Maximum reductions in blood pressure usually occur 2–6 hours after dosing and are associated with a small increase in standing heart rate. Like other alpha 1 -adrenergic blocking agents, doxazosin has a greater effect on blood pressure and heart rate in the standing position.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Absorption After oral administration of therapeutic doses, peak plasma levels of CARDURA occur at about 2–3 hours. Bioavailability is approximately 65%, reflecting first-pass metabolism of doxazosin by the liver. The effect of food on the pharmacokinetics of CARDURA was examined in a crossover study with twelve hypertensive subjects. Reductions of 18% in mean maximum plasma concentration (C max ) and 12% in the area under the concentration-time curve (AUC) occurred when CARDURA was administered with food. Neither of these differences is clinically significant. In a crossover study in 24 normotensive subjects, the pharmacokinetics and safety of doxazosin were shown to be similar with morning and evening dosing regimens. The AUC after morning dosing was, however, 11% less than that after evening dosing and the time to peak concentration after evening dosing occurred significantly later than that after morning dosing (5.6 vs. 3.5 hours). Distribution At the plasma concentrations achieved by therapeutic doses, approximately 98% of the circulating drug is bound to plasma proteins. Metabolism CARDURA is extensively metabolized in the liver, mainly by O-demethylation of the quinazoline nucleus or hydroxylation of the benzodioxan moiety. In vitro studies suggest that the primary pathway for elimination is via CYP 3A4; however, CYP 2D6 and CYP 2C9 metabolic pathways are also involved to a lesser extent. Although several active metabolites of doxazosin have been identified, the pharmacokinetics of these metabolites have not been characterized. Excretion Plasma elimination of doxazosin is biphasic, with a terminal elimination half-life of about 22 hours. Steady-state studies in hypertensive patients given doxazosin doses of 2 to 16 mg once daily showed linear kinetics and dose proportionality. In two studies, following the administration of 2 mg orally once daily, the mean accumulation ratios (steady-state AUC vs. first-dose AUC) were 1.2 and 1.7. Enterohepatic recycling is suggested by secondary peaking of plasma doxazosin concentrations. In a study of two subjects administered radiolabelled doxazosin 2 mg orally and 1 mg intravenously on two separate occasions, approximately 63% of the dose was eliminated in the feces and 9% of the dose was found in the urine. On average only 4.8% of the dose was excreted as unchanged drug in the feces and only a trace of the total radioactivity in the urine was attributed to unchanged drug. Specific Populations Geriatric The pharmacokinetics of CARDURA in young (<65 years) and elderly (≥65 years) subjects were similar for plasma half-life values and oral clearance. Renal Impairment Pharmacokinetic studies in elderly patients and patients with renal impairment have shown no significant alterations compared to younger patients with normal renal function. Hepatic Impairment Administration of a single 2 mg dose to patients with cirrhosis (Child-Pugh Class A) showed a 40% increase in exposure to doxazosin. The impact of moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment on the pharmacokinetics of doxazosin is not known [see Use in Specific Populations (8.6) ] . Drug Interactions There are only limited data on the effects of drugs known to influence the hepatic metabolism of doxazosin (e.g., cimetidine). Cimetidine: In healthy volunteers, the administration of a single 1 mg dose of doxazosin on day 1 of a four-day regimen of oral cimetidine (400 mg twice daily) resulted in a 10% increase in mean AUC of doxazosin, and a slight but not significant increase in mean Cmax and mean half-life of doxazosin. In vitro data in human plasma indicate that CARDURA has no effect on protein binding of digoxin, warfarin, phenytoin, or indomethacin.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS The use of CARDURA is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components. • Hypersensitivity to doxazosin, other quinazolines, or any other ingredient in CARDURA. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION CARDURA ® (doxazosin) 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: CARDURA (doxazosin) is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. CARDURA is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) and 8 mg (green or white) of doxazosin as the free base. The inactive ingredients for all tablets are microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg yellow tablet contains D & C yellow 10 and FD & C yellow 6; the 4 mg orange tablet contains FD & C yellow 6; the 8 mg green tablet contains FD & C blue 2 and D & C yellow 10. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION • For the treatment of BPH: Initiate therapy at 1 mg once daily. Dose may be titrated at 1 to 2-week intervals, up to 8 mg once daily. ( 2.2 ) • For the treatment hypertension: Initiate therapy at 1 mg once daily. Dose may be titrated as needed, up to 16 mg once daily. ( 2.3 ) 2.1 Dosing Information Following the initial dose and with each dose increase of CARDURA, monitor blood pressure for at least 6 hours following administration. If CARDURA administration is discontinued for several days, therapy should be restarted using the initial dosing regimen. 2.2 Benign Prostatic Hyperplasia The recommended initial dosage of CARDURA is 1 mg given once daily either in the morning or evening. Depending on the individual patient's urodynamics and BPH symptomatology, the dose may be titrated at 1 to 2 week intervals to 2 mg, and thereafter to 4 mg and 8 mg once daily. The maximum recommended dose for BPH is 8 mg once daily. Routinely monitor blood pressure in these patients. 2.3 Hypertension The initial dosage of CARDURA is 1 mg given once daily. Daily dosage may be doubled up 16 mg once daily, as needed, to achieve the desired reduction in blood pressure.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Tablets: 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) or 8 mg (green or white). Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg or 8 mg doxazosin (free base). • Tablets: 1 mg, 2 mg, 4 mg, 8 mg.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE CARDURA is an alpha 1 adrenergic antagonist indicated for: • Signs and symptoms of Benign Prostatic Hyperplasia (BPH) • Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) CARDURA is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension CARDURA is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. CARDURA may be used alone or in combination with other antihypertensives.
Spl product data elements
Usually a list of ingredients in a drug product.Cardura doxazosin mesylate DOXAZOSIN MESYLATE DOXAZOSIN MICROCRYSTALLINE CELLULOSE LACTOSE, UNSPECIFIED FORM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE SODIUM LAURYL SULFATE Cardura;1;mg Cardura doxazosin mesylate DOXAZOSIN MESYLATE DOXAZOSIN MICROCRYSTALLINE CELLULOSE LACTOSE, UNSPECIFIED FORM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE SODIUM LAURYL SULFATE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 Cardura;2;mg Cardura doxazosin mesylate DOXAZOSIN MESYLATE DOXAZOSIN MICROCRYSTALLINE CELLULOSE LACTOSE, UNSPECIFIED FORM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE SODIUM LAURYL SULFATE FD&C YELLOW NO. 6 Cardura;4;mg Cardura doxazosin mesylate DOXAZOSIN MESYLATE DOXAZOSIN MICROCRYSTALLINE CELLULOSE LACTOSE, UNSPECIFIED FORM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE SODIUM LAURYL SULFATE D&C YELLOW NO. 10 FD&C BLUE NO. 2 Cardura;8;mg Cardura doxazosin DOXAZOSIN MESYLATE DOXAZOSIN MICROCRYSTALLINE CELLULOSE LACTOSE, UNSPECIFIED FORM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE SODIUM LAURYL SULFATE CN1;Pfizer Cardura doxazosin DOXAZOSIN MESYLATE DOXAZOSIN MICROCRYSTALLINE CELLULOSE LACTOSE, UNSPECIFIED FORM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE SODIUM LAURYL SULFATE CN2;Pfizer Cardura doxazosin DOXAZOSIN MESYLATE DOXAZOSIN MICROCRYSTALLINE CELLULOSE LACTOSE, UNSPECIFIED FORM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE SODIUM LAURYL SULFATE CN4;Pfizer Cardura doxazosin DOXAZOSIN MESYLATE DOXAZOSIN MICROCRYSTALLINE CELLULOSE LACTOSE, UNSPECIFIED FORM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE SODIUM LAURYL SULFATE CN8;Pfizer
Animal pharmacology and or toxicology
Information from studies of the drug in animals, if the data were not relevant to nor included in other parts of the labeling. Most labels do not contain this field.13.2 Animal Toxicology and Pharmacology An increased incidence of myocardial necrosis or fibrosis was observed in long-term (6–12 months) studies in rats and mice (exposure 8 times human AUC exposure in rats and somewhat equivalent to human Cmax exposure in mice). Findings were not seen at lower doses. In dogs no cardiotoxicity was observed following 12 months of oral dosing at doses that resulted in maximum plasma concentrations (C max) 14 times the C max exposure in humans receiving a 12 mg/day therapeutic dose or in Wistar rats at C max exposures 15 times human C max exposure. There is no evidence that similar lesions occur in humans.
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis: Chronic dietary administration (up to 24 months) of doxazosin mesylate at maximally tolerated doses of 40 mg/kg/day in rats and 120 mg/kg/day in mice revealed no evidence of carcinogenic potential. The highest doses evaluated in the rat and mouse studies are associated with AUCs (a measure of systemic exposure) that are 8 times and 4 times, respectively, the human AUC at a dose of 16 mg/day. Mutagenicity studies revealed no drug- or metabolite-related effects at either chromosomal or subchromosomal levels. Fertility in Males : Studies in rats showed reduced fertility in males treated with doxazosin at oral doses of 20 (but not 5 or 10) mg/kg/day, about 4 times the AUC exposures obtained with a 12 mg/day human dose. This effect was reversible within two weeks of drug withdrawal. There have been no reports of any effects of doxazosin on male fertility in humans.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis: Chronic dietary administration (up to 24 months) of doxazosin mesylate at maximally tolerated doses of 40 mg/kg/day in rats and 120 mg/kg/day in mice revealed no evidence of carcinogenic potential. The highest doses evaluated in the rat and mouse studies are associated with AUCs (a measure of systemic exposure) that are 8 times and 4 times, respectively, the human AUC at a dose of 16 mg/day. Mutagenicity studies revealed no drug- or metabolite-related effects at either chromosomal or subchromosomal levels. Fertility in Males : Studies in rats showed reduced fertility in males treated with doxazosin at oral doses of 20 (but not 5 or 10) mg/kg/day, about 4 times the AUC exposures obtained with a 12 mg/day human dose. This effect was reversible within two weeks of drug withdrawal. There have been no reports of any effects of doxazosin on male fertility in humans. 13.2 Animal Toxicology and Pharmacology An increased incidence of myocardial necrosis or fibrosis was observed in long-term (6–12 months) studies in rats and mice (exposure 8 times human AUC exposure in rats and somewhat equivalent to human Cmax exposure in mice). Findings were not seen at lower doses. In dogs no cardiotoxicity was observed following 12 months of oral dosing at doses that resulted in maximum plasma concentrations (C max) 14 times the C max exposure in humans receiving a 12 mg/day therapeutic dose or in Wistar rats at C max exposures 15 times human C max exposure. There is no evidence that similar lesions occur in humans.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label - 2750-66 Pfizer NDC 0049-2750-66 Cardura ® (doxazosin mesylate) tablets 1 mg* 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label - 2750-66
PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label - 2760-66 Pfizer NDC 0049-2760-66 Cardura ® (doxazosin mesylate) tablets 2 mg* 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label - 2760-66
PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Label - 2770-66 Pfizer NDC 0049-2770-66 Cardura ® (doxazosin mesylate) tablets 4 mg* 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Label - 2770-66
PRINCIPAL DISPLAY PANEL - 8 mg Tablet Bottle Label - 2780-66 Pfizer NDC 0049-2780-66 Cardura ® (doxazosin mesylate) tablets 8 mg* 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 8 mg Tablet Bottle Label - 2780-66
PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label - 2410-10 Pfizer NDC 0049-2410-10 Cardura ® (doxazosin) tablets 1 mg* 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label - 2410-10
PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label - 2512-10 Pfizer NDC 0049-2512-10 Cardura ® (doxazosin) tablets 2 mg* 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label - 2512-10
PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Label - 2614-10 Pfizer NDC 0049-2614-10 Cardura ® (doxazosin) tablets 4 mg* 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Label - 2614-10
PRINCIPAL DISPLAY PANEL - 8 mg Tablet Bottle Label - 2716-10 Pfizer NDC 0049-2716-10 Cardura ® (doxazosin) tablets 8 mg* 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 8 mg Tablet Bottle Label - 2716-10
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.LAB-0071-10.0 Logo
Cardura: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION 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. This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 12/2020 PATIENT INFORMATION CARDURA ® (kar-DUR-a) (doxazosin tablets) What is CARDURA? CARDURA is a prescription medicine that contains doxazosin mesylate and is called an "alpha-blocker". CARDURA is used to treat: • the symptoms of benign prostatic hyperplasia (BPH) • high blood pressure (hypertension) It is not known if CARDURA is safe and effective in children. Who should not take CARDURA? Do not take CARDURA if you : • are allergic to doxazosin, other quinazolines, or any of the ingredients in CARDURA. See the end of this Patient Information leaflet for a complete list of ingredients in CARDURA. What should I tell my healthcare provider before taking CARDURA? Before taking CARDURA, 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 CARDURA. • have liver problems • are pregnant or plan to become pregnant. It is not known if CARDURA will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if CARDURA passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take CARDURA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CARDURA may affect the way other medicines work, and other medicines may affect the way CARDURA works causing side effects. Especially tell your healthcare provider if you take: • other medicine for high blood pressure or medicine to treat erectile dysfunction (ED) called a phosphodiesterase type 5 (PDE-5) inhibitor. The use of CARDURA 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 CARDURA? • Take CARDURA exactly as your healthcare provider tells you to take it. • Your healthcare provider will tell you how much CARDURA to take and when to take it. • Your healthcare provider may need to change your dose of CARDURA until it is the right dose for you. What should I avoid while taking CARDURA? Do not drive or perform any hazardous task until at least 24 hours after you have taken CARDURA if you are taking: • your first dose of CARDURA • CARDURA for the first time after your healthcare provider has increased your dose of CARDURA • CARDURA for the first time after any breaks (interruptions) in your treatment with CARDURA What are the possible side effects of CARDURA? CARDURA 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 CARDURA, 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 CARDURA with certain other medicines that lower blood pressure including PDE-5 inhibitors. Your healthcare provider may monitor your blood pressure while you take CARDURA. See " What should I avoid while taking CARDURA? " • 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 CARDURA. If you need to have cataract surgery, be sure to tell your healthcare provider if you take or have taken CARDURA. • A painful erection that will not go away . CARDURA 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 CARDURA 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 CARDURA. 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 CARDURA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CARDURA for a condition for which it was not prescribed. Do not give CARDURA 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. 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 CARDURA? The size, shape and appearance of the tablet that you receive may vary, all the tablets have the same active ingredient, and this will not affect the way that the medicine works. You can identify the tablet that you have from the following information. Strength Either Or 1 mg Tablet White, round tablet marked "CN1" on one side and "Pfizer" on the other side. White, capsule shaped tablet marked "Cardura" on one side, scored and marked "1 mg" on the other side. 2 mg Tablet White, capsule shaped tablet with break score and marked "CN2" on one side and "Pfizer" on the other side. Yellow, capsule shaped tablet marked "Cardura" on one side, scored and marked "2 mg" on the other side. 4 mg Tablet White, diamond shaped tablet with break score and marked "CN4" on one side and "Pfizer" on the other side. Orange, capsule shaped tablet marked "Cardura" on one side, scored and marked "4 mg" on the other side. 8 mg Tablet White, capsule shaped tablet with break score and marked "CN8" on one side and "Pfizer" on the other side. Green, capsule shaped tablet marked "Cardura" on one side, scored and marked "8 mg" on the other side. Active ingredient: doxazosin Inactive ingredients: microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg yellow tablet contains D & C yellow 10 and FD & C yellow 6; the 4 mg orange tablet contains FD & C yellow 6; the 8 mg green tablet contains FD & C blue 2 and D & C yellow 10. LAB-0070-6.0 For more information, go to www.Pfizer.com or call 1-800-438-1985. Logo
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Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES 14.1 Benign Prostatic Hyperplasia (BPH) The efficacy of CARDURA was evaluated extensively in over 900 patients with BPH in double-blind, placebo-controlled trials. CARDURA treatment was superior to placebo in improving patient symptoms and urinary flow rate. Significant relief with CARDURA was seen as early as one week into the treatment regimen, with CARDURA-treated patients (N=173) showing a significant (p<0.01) increase in maximum flow rate of 0.8 mL/sec compared to a decrease of 0.5 mL/sec in the placebo group (N=41). In long-term studies, improvement was maintained for up to 2 years of treatment. In 66–71% of patients, improvements above baseline were seen in both symptoms and maximum urinary flow rate. In three placebo-controlled studies of 14–16 weeks' duration, obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning) of BPH were evaluated at each visit by patient-assessed symptom questionnaires. The bothersomeness of symptoms was measured with a modified Boyarsky questionnaire. Symptom severity/frequency was assessed using a modified Boyarsky questionnaire or an AUA-based questionnaire. Uroflowmetric evaluations were performed at times of peak (2–6 hours post-dose) and/or trough (24 hours post-dose) plasma concentrations of CARDURA. The results from the three placebo-controlled studies (N=609) showing significant efficacy with 4 mg and 8 mg doxazosin are summarized in Table 3. In all three studies, CARDURA resulted in statistically significant relief of obstructive and irritative symptoms compared to placebo. Statistically significant improvements of 2.3–3.3 mL/sec in maximum flow rate were seen with CARDURA in Studies 1 and 2, compared to 0.1–0.7 mL/sec with placebo. Table 3 Table 3 In one fixed-dose study (Study 2), CARDURA therapy (4 to 8 mg, once daily) resulted in a significant and sustained improvement in maximum urinary flow rate of 2.3–3.3 mL/sec (Table 3) compared to placebo (0.1 mL/sec). In this study, the only study in which weekly evaluations were made, significant improvement with CARDURA vs. placebo was seen after one week. The proportion of patients who responded with a maximum flow rate improvement of ≥3 mL/sec was significantly larger with CARDURA (34–42%) than placebo (13–17%). A significantly greater improvement was also seen in average flow rate with CARDURA (1.6 mL/sec) than with placebo (0.2 mL/sec). The onset and time course of symptom relief and increased urinary flow from Study 1 are illustrated in Figure 1. Figure 1 – Study 1 Figure 1 – Study 1 Table 3 Figure 1 - Study 1 14.2 Hypertension In a pooled analysis of placebo-controlled hypertension studies with about 300 hypertensive patients per treatment group, doxazosin, at doses of 1 to 16 mg given once daily, lowered blood pressure at 24 hours by about 10/8 mmHg compared to placebo in the standing position and about 9/5 mmHg in the supine position. Peak blood pressure effects (1–6 hours) were larger by about 50–75% (i.e., trough values were about 55–70% of peak effect), with the larger peak-trough differences seen in systolic pressures. There was no apparent difference in the blood pressure response of Caucasians and blacks or of patients above and below age 65. In the same patient population, patients receiving CARDURA gained a mean of 0.6 kg compared to a mean loss of 0.1 kg for placebo patients. TABLE 4 Mean Changes in Blood Pressure from Baseline to the Mean of the Final Efficacy Phase in Normotensives (Diastolic BP <90 mmHg) in Two Double-blind, Placebo-controlled U.S. Studies with CARDURA 1 to 8 mg once daily. PLACEBO (N=85) CARDURA (N=183) Sitting BP (mmHg) Baseline Change Baseline Change Systolic 128.4 –1.4 128.8 –4.9 p ≤0.05 compared to placebo Diastolic 79.2 –1.2 79.6 –2.4 Standing BP (mmHg) Baseline Change Baseline Change Systolic 128.5 –0.6 128.5 –5.3 Diastolic 80.5 –0.7 80.4 –2.6
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Benign Prostatic Hyperplasia (BPH) The safety and effectiveness profile of CARDURA was similar in the elderly (age ≥ 65 years) and younger (age < 65 years) patients. Hypertension Clinical studies of CARDURA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use The safety and effectiveness of CARDURA have not been established in children.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary The limited available data with CARDURA in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. However, untreated hypertension during pregnancy can result in increased maternal risks [see Clinical Considerations ] . In animal reproduction studies, no adverse developmental effects were observed when doxazosin was orally administered to pregnant rabbits and rats during the period of organogenesis at doses of up to 41 and 20 mg/kg, respectively (exposures in rabbits and rats were 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose). A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Data Animal Data Radioactivity was found to cross the placenta following oral administration of labelled doxazosin to pregnant rats. Studies in pregnant rabbits and rats at daily oral doses of up to 41 and 20 mg/kg, respectively (plasma drug concentrations of 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose), have revealed no evidence of adverse developmental effects. A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival. In peri- and postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazosin (about 8 times human AUC exposure with a 12 mg/day therapeutic dose) was delayed, as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS • Hepatic Impairment: Monitor for hypotension. ( 8.6 , 12.3 ) 8.1 Pregnancy Risk Summary The limited available data with CARDURA in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. However, untreated hypertension during pregnancy can result in increased maternal risks [see Clinical Considerations ] . In animal reproduction studies, no adverse developmental effects were observed when doxazosin was orally administered to pregnant rabbits and rats during the period of organogenesis at doses of up to 41 and 20 mg/kg, respectively (exposures in rabbits and rats were 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose). A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Data Animal Data Radioactivity was found to cross the placenta following oral administration of labelled doxazosin to pregnant rats. Studies in pregnant rabbits and rats at daily oral doses of up to 41 and 20 mg/kg, respectively (plasma drug concentrations of 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose), have revealed no evidence of adverse developmental effects. A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival. In peri- and postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazosin (about 8 times human AUC exposure with a 12 mg/day therapeutic dose) was delayed, as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes. 8.2 Lactation Risk Summary There is limited information on the presence of CARDURA in human milk [see Data ]. There is no information on the effects of CARDURA on the breastfeed infant or the effects on milk production. Data A single case study reports that CARDURA is present in human milk, which resulted in an infant dose of less than 1% of the maternal weight-adjusted dosage and a milk/plasma ratio of 0.1. However, these data are insufficient to confirm the presence of CARDURA in human milk. 8.4 Pediatric Use The safety and effectiveness of CARDURA have not been established in children. 8.5 Geriatric Use Benign Prostatic Hyperplasia (BPH) The safety and effectiveness profile of CARDURA was similar in the elderly (age ≥ 65 years) and younger (age < 65 years) patients. Hypertension Clinical studies of CARDURA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. 8.6 Hepatic Impairment CARDURA is extensively metabolized in the liver. Hepatic impairment is expected to increase exposure to doxazosin. Use of CARDURA in patients with severe hepatic impairment (Child-Pugh Class C) is not recommended. Monitor blood pressure and for symptoms of hypotension in patients with lesser degrees of hepatic impairment (Child-Pugh Class A and B) [ see Clinical Pharmacology (12.3) ].
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING CARDURA (doxazosin) is available as tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) or 8 mg (green or white) of doxazosin as the free base. NDC and Pack Size Strength Description NDC 0049-2750-66 (Bottle of 100) NDC 0049-2750-41 (Unit dose of 100) 1 mg White, capsule shaped tablet engraved "Cardura" on one side, scored and engraved "1 mg" on the other side. NDC 0049-2410-10 (Bottle of 100) 1 mg White, round tablet engraved "CN1" on one side and "Pfizer" on the other side. NDC 0049-2760-66 (Bottle of 100) NDC 0049-2760-41 (Unit dose of 100) 2 mg Yellow, capsule shaped tablet engraved "Cardura" on one side, scored and engraved "2 mg" on the other side. NDC 0049-2512-10 (Bottle of 100) 2 mg White capsule shaped tablet with break score and engraved "CN2" on one side and "Pfizer" on the other side. NDC 0049-2770-66 (Bottle of 100) NDC 0049-2770-41 (Unit Dose of 100) 4 mg Orange, capsule shaped tablet engraved "Cardura" on one side, scored and engraved "4 mg" on the other side. NDC 0049-2614-10 (Bottle of 100) 4 mg White, diamond shaped tablet with break score and engraved "CN4" on one side and "Pfizer" on the other side. NDC 0049-2780-66 (Bottle of 100) NDC 0049-2780-41 (Unit dose of 100) 8 mg Green, capsule shaped tablet engraved "Cardura" on one side, scored and engraved "8 mg" on the other side. NDC 0049-2716-10 (Bottle of 100) 8 mg White, capsule shaped tablet with break score and engraved "CN8" on one side and "Pfizer" on the other side. Recommended Storage: Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Storage and handling
Information about safe storage and handling of the drug product.Recommended Storage: Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API