DOXAZOSIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)

Available from:

AvKARE

INN (International Name):

DOXAZOSIN MESYLATE

Composition:

DOXAZOSIN 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH. Doxazosin tablets are 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. Doxazosin tablets may be used alone or in combination with other antihypertensives. 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. Risk Summary The limited available data with doxazosin tablets 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 to 4% and 15 to 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. Risk Summary There is limited information on the presence of doxazosin in human milk [ see Data ]. There is no information on the effects of doxazosin tablets on the breastfeed infant or the effects on milk production. Data A single case study reports that doxazosin 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 doxazosin in human milk. The safety and effectiveness of doxazosin tablets have not been established in children. Benign Prostatic Hyperplasia (BPH) The safety and effectiveness profile of doxazosin tablets was similar in the elderly (age ≥ 65 years) and younger (age < 65 years) patients. Hypertension Clinical studies of doxazosin tablets 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. Doxazosin is extensively metabolized in the liver. Hepatic impairment is expected to increase exposure to doxazosin. Use of doxazosin tablets 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) ].

Product summary:

Doxazosin tablets, USP are available as white to off-white tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg or 8 mg of the active constituent, doxazosin. Doxazosin Tablets, USP are available as follows: 1 mg (white to off-white, round, scored tablets, imprinted “APO” on one side and “093” with a partial bisect on the other side). 2 mg (white to off-white, capsule shaped, scored tablets, imprinted “APO” on one side and “094” with a partial bisect on the other side), supplied as: Bottle of 1000 (NDC 42291-258-10) 4 mg (white to off-white, capsule shaped, scored tablets, imprinted “APO” on one side and “095” with a partial bisect on the other side), supplied as: Bottles of 100 (NDC 42291-259-01) Bottles of 1000 (NDC 42291-259-10) 8 mg (white to off-white, capsule shaped, scored tablets, imprinted “APO” on one side and “096” with a partial bisect on the other side), supplied as: Bottles of 100 (NDC 42291-260-01) Bottles of 1000 (NDC 42291-260-10) Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXAZOSIN- DOXAZOSIN TABLET
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
DOXAZOSIN TABLETS, USP
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXAZOSIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DOXAZOSIN
TABLETS.
DOXAZOSIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Doxazosin tablets are an alpha
adrenergic antagonist indicated for: (1)
Signs and symptoms of Benign Prostatic Hyperplasia (BPH)
Treatment of Hypertension
DOSAGE AND ADMINISTRATION
For the treatment of BPH: Initiate therapy at 1 mg once daily. Dose
maybe 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)
DOSAGE FORMS AND STRENGTHS
(3)
Tablets: 1 mg, 2 mg, 4 mg, 8 mg.
CONTRAINDICATIONS
Hypersensitivity to doxazosin, other quinazolines, or any other
ingredient in doxazosin tablets. ( 4)
WARNINGS AND PRECAUTIONS
Postural hypotension with or without syncope may occur. ( 5.1)
Risk of Intraoperative Floppy Iris Syndrome during cataract surgery. (
5.2)
Screen for the presence of prostate cancer prior to treatment for BPH
and at regular intervals
afterwards. ( 5.3)
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 CONTACT AVKARE, INC. AT
1-855-361-
3993, OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH _.
DRUG INTERACTIONS
Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to
doxazosin and increased risk of
hypotension. ( 7.1)
Concomitant administration of doxazosin tablets with a
phosphodiesterase-5 (PDE-5) inhibitor can
result in additive blood pressure lowering effects and symptomatic
hypotension. ( 7.2)
USE IN SPECIFIC POPULATIONS
Hepatic Impairment: Monitor for hypotension. ( 8.6, 12.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2017
1
FULL PRESCRIBING INFORM