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HYTRIN

 * Generic Name: terazosin hcl
 * Brand Name: Hytrin
 * Drug Class: Alpha Blockers, Antihypertensives

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/15/2021

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DRUG SUMMARY

WHAT IS HYTRIN?

Hytrin (terazosin hydrochloride) is an alpha-adrenergic blocker used to treat
hypertension (high blood pressure) and benign prostatic hyperplasia (enlarged
prostate). Hytrin is available in generic form.

WHAT ARE SIDE EFFECTS OF HYTRIN?

Common side effects of Hytrin include:

 * fatigue,
 * nausea,
 * weakness,
 * drowsiness,
 * blurred vision,
 * headache,
 * stuffy nose,
 * difficulty breathing, or
 * impotence.
 * Lightheadedness or dizziness upon standing may also occur, especially after
   the first dose of Hytrin, and shortly after taking the drug during the first
   week of treatment.

Tell your doctor if you have any serious side effects of Hytrin including:

 * fainting,
 * fast or irregular heartbeat,
 * burning or tingling in the hands or feet,
 * sexual function problems,
 * swelling of the ankles/hands/feet, or
 * unexpected weight gain.

DOSAGE FOR HYTRIN

To treat benign prostatic hyperplasia, the starting dose of Hytrin is 1 mg at
bedtime, with dosage gradually increased to 10 mg. To treat hypertension, the
starting dose is 1 mg at bedtime. The usual recommended dose range is 1 mg to 5
mg administered once a day; some patients benefit from doses as high as 20 mg
per day.

WHAT DRUGS, SUBSTANCES, OR SUPPLEMENTS INTERACT WITH HYTRIN?

Hytrin may interact with sildenafil, tadalafil, vardenafil, or other blood
pressure medications.

HYTRIN DURING PREGNANCY AND BREASTFEEDING

Tell your doctor all medications you use. Hytrin should be used only when
prescribed during pregnancy. It is not known if this drug passes into breast
milk. Consult your doctor before breastfeeding.

ADDITIONAL INFORMATION

Our Hytrin (terazosin hydrochloride) Side Effects Drug Center provides a
comprehensive view of available drug information on the potential side effects
when taking this medication.


FDA DRUG INFORMATION

 * Drug Description
 * Indications
 * Dosage
 * Side Effects
 * Drug Interactions
 * Warnings
 * Precautions
 * Overdose & Contraindications
 * Clinical Pharmacology
 * Medication Guide


DESCRIPTION FOR HYTRIN

HYTRIN (terazosin hydrochloride), an alpha-1-selective adrenoceptor blocking
agent, is a quinazoline derivative represented by the following chemical name
and structural formula:

(RS)-Piperazine,
1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-,
monohydrochloride, dihydrate.







Terazosin hydrochloride is a white, crystalline substance, freely soluble in
water and isotonic saline and has a molecular weight of 459.93. HYTRIN tablets
(terazosin hydrochloride tablets) for oral ingestion are supplied in four dosage
strengths containing terazosin hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or
10 mg of terazosin.

INACTIVE INGREDIENTS

1 mg tablet: corn starch, lactose, magnesium stearate, povidone and talc.

2 mg tablet: corn starch, FD&C Yellow No. 6, lactose, magnesium stearate,
povidone and talc.

5 mg tablet: corn starch, iron oxide, lactose, magnesium stearate, povidone and
talc.

10 mg tablet: corn starch, D&C Yellow No. 10, FD&C Blue No. 2, lactose,
magnesium stearate, povidone and talc.




USES FOR HYTRIN

HYTRIN (terazosin hydrochloride) is indicated for the treatment of symptomatic
benign prostatic hyperplasia (BPH). There is a rapid response, with
approximately 70% of patients experiencing an increase in urinary flow and
improvement in symptoms of BPH when treated with HYTRIN (terazosin hcl) . The
long-term effects of HYTRIN (terazosin hcl) on the incidence of surgery, acute
urinary obstruction or other complications of BPH are yet to be determined.

HYTRIN (terazosin hcl) tablets are also indicated for the treatment of
hypertension. HYTRIN (terazosin hcl) tablets can be used alone or in combination
with other antihypertensive agents such as diuretics or beta-adrenergic blocking
agents.


DOSAGE FOR HYTRIN

If HYTRIN (terazosin hcl) administration is discontinued for several days,
therapy should be reinstituted using the initial dosing regimen.

BENIGN PROSTATIC HYPERPLASIA

INITIAL DOSE

1 mg at bedtime is the starting dose for all patients, and this dose should not
be exceeded as an initial dose. Patients should be closely followed during
initial administration in order to minimize the risk of severe hypotensive
response.

SUBSEQUENT DOSES

The dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once
daily to achieve the desired improvement of symptoms and/or flow rates. Doses of
10 mg once daily are generally required for the clinical response. Therefore,
treatment with 10 mg for a minimum of 4–6 weeks may be required to assess
whether a beneficial response has been achieved. Some patients may not achieve a
clinical response despite appropriate titration. Although some additional
patients responded at a 20 mg daily dose, there was an insufficient number of
patients studied to draw definitive conclusions about this dose. There are
insufficient data to support the use of higher doses for those patients who show
inadequate or no response to 20 mg daily.

USE WITH OTHER DRUGS

Caution should be observed when HYTRIN (terazosin hcl) tablets are administered
concomitantly with other antihypertensive agents, especially the calcium channel
blocker verapamil, to avoid the possibility of developing significant
hypotension. When using HYTRIN (terazosin hcl) tablets and other
antihypertensive agents concomitantly, dosage reduction and retitration of
either agent may be necessary (see PRECAUTIONS). Concomitant administration of
HYTRIN (terazosin hcl) with a PDE-5 inhibitor can result in additive blood
pressure lowering effects and symptomatic hypotension; therefore PDE-5 inhibitor
therapy should be initiated at the lowest dose in patients taking HYTRIN
(terazosin hcl) .

HYPERTENSION

The dose of HYTRIN (terazosin hcl) and the dose interval (12 or 24 hours) should
be adjusted according to the patient's individual blood pressure response. The
following is a guide to its administration:

INITIAL DOSE

1 mg at bedtime is the starting dose for all patients, and this dose should not
be exceeded. This initial dosing regimen should be strictly observed to minimize
the potential for severe hypotensive effects.

SUBSEQUENT DOSES

The dose may be slowly increased to achieve the desired blood pressure response.
The usual recommended dose range is 1 mg to 5 mg administered once a day;
however, some patients may benefit from doses as high as 20 mg per day. Doses
over 20 mg do not appear to provide further blood pressure effect and doses over
40 mg have not been studied. Blood pressure should be monitored at the end of
the dosing interval to be sure control is maintained throughout the interval. It
may also be helpful to measure blood pressure 2-3 hours after dosing to see if
the maximum and minimum responses are similar, and to evaluate symptoms such as
dizziness or palpitations which can result from excessive hypotensive response.
If response is substantially diminished at 24 hours an increased dose or use of
a twice daily regimen can be considered. If terazosin administration is
discontinued for several days or longer, therapy should be reinstituted using
the initial dosing regimen. In clinical trials, except for the initial dose, the
dose was given in the morning.

USE WITH OTHER DRUGS

(see above)


HOW SUPPLIED

HYTRIN tablets (terazosin hydrochloride tablets) are available in four dosage
strengths:

1  mg, white tablets (bears the Abbott “A” logo and the Abbo-Code DF): Bottles
of 100 (NDC 0074-3322-13).

2 mg, orange tablets (bears the Abbott “A” logo and the Abbo-Code DH): Bottles
of 100 (NDC 0074-3323-13).

5 mg, tan tablets (bears the Abbott “A” logo and the Abbo-Code DJ): Bottles of
100 (NDC 0074-3324-13).

10 mg, green tablets (bears the Abbott “A” logo and the Abbo-Code DI): Bottles
of 100 (NDC 0074-3325-13).

RECOMMENDED STORAGE

Store below 86°F (30°C).

Abbott Laboratories. North Chicago, IL 60064, U.S.A.




SIDE EFFECTS FOR HYTRIN

BENIGN PROSTATIC HYPERPLASIA

The incidence of treatment-emergent adverse events has been ascertained from
clinical trials conducted worldwide. All adverse events reported during these
trials were recorded as adverse reactions. The incidence rates presented below
are based on combined data from six placebo-controlled trials involving
once-a-day administration of terazosin at doses ranging from 1 to 20 mg. Table 1
summarizes those adverse events reported for patients in these trials when the
incidence rate in the terazosin group was at least 1% and was greater than that
for the placebo group, or where the reaction is of clinical interest. Asthenia,
postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and
impotence were the only events that were significantly (p ≤ 0.05) more common in
patients receiving terazosin than in patients receiving placebo. The incidence
of urinary tract infection was significantly lower in the patients receiving
terazosin than in patients receiving placebo. An analysis of the incidence rate
of hypotensive adverse events (see PRECAUTIONS) adjusted for the length of drug
treatment has shown that the risk of the events is greatest during the initial
seven days of treatment, but continues at all time intervals.

Table 1. Adverse Reactions During Placebo-controlled Trials Benign Prostatic
Hyperplasia


Body System Terazosin
(N = 636) Placebo
(N = 360) BODY AS A WHOLE   †Asthenia 7.4%* 3.3%   Flu Syndrome 2.4% 1.7%
  Headache 4.9% 5.8% CARDIOVASCULAR SYSTEM   Hypotension 0.6% 0.6%
  Palpitations 0.9% 1.1%   Postural Hypotension 3.9%* 0.8%   Syncope 0.6% 0.0%
DIGESTIVE SYSTEM   Nausea 1.7% 1.1% METABOLIC AND NUTRITIONAL DISORDERS
  Peripheral Edema 0.9% 0.3%   Weight Gain 0.5% 0.0% NERVOUS SYSTEM   Dizziness
9.1%* 4.2%   Somnolence 3.6%* 1.9%   Vertigo 1.4% 0.3% RESPIRATORY SYSTEM
  Dyspnea 1.7% 0.8%   Nasal Congestion/Rhinitis 1.9%* 0.0% SPECIAL SENSES
  Blurred Vision/Amblyopia 1.3% 0.6% UROGENITAL SYSTEM   Impotence 1.6%* 0.6%
  Urinary Tract Infection 1.3% 3.9%* † Includes weakness, tiredness, lassitude
and fatigue.
* p ≤ 0.05 comparison between groups.



Additional adverse events have been reported, but these are, in general, not
distinguishable from symptoms that might have occurred in the absence of
exposure to terazosin. The safety profile of patients treated in the long-term
open-label study was similar to that observed in the controlled studies.

The adverse events were usually transient and mild or moderate in intensity, but
sometimes were serious enough to interrupt treatment. In the placebo-controlled
clinical trials, the rates of premature termination due to adverse events were
not statistically different between the placebo and terazosin groups. The
adverse events that were bothersome, as judged by their being reported as
reasons for discontinuation of therapy by at least 0.5% of the terazosin group
and being reported more often than in the placebo group, are shown in Table 2.

Table 2. Discontinuation During Placebo-controlled Trials Benign Prostatic
Hyperplasia


Body System Terazosin
(N = 636) Placebo
(N = 360) BODY AS A WHOLE   Fever 0.5% 0.0%   Headache 1.1% 0.8% CARDIOVASCULAR
SYSTEM   Postural Hypotension 0.5% 0.0%   Syncope 0.5% 0.0% DIGESTIVE SYSTEM
  Nausea 0.5% 0.3% NERVOUS SYSTEM   Dizziness 2.0% 1.1%   Vertigo 0.5% 0.0%
RESPIRATORY SYSTEM   Dyspnea 0.5% 0.3% SPECIAL SENSES   Blurred Vision/Amblyopia
0.6% 0.0% UROGENITAL SYSTEM   Urinary Tract Infection 0.5% 0.3%



HYPERTENSION

The prevalence of adverse reactions has been ascertained from clinical trials
conducted primarily in the United States. All adverse experiences (events)
reported during these trials were recorded as adverse reactions. The prevalence
rates presented below are based on combined data from fourteen
placebo-controlled trials involving once-a-day administration of terazosin, as
monotherapy or in combination with other antihypertensive agents, at doses
ranging from 1 to 40 mg. Table 3 summarizes those adverse experiences reported
for patients in these trials where the prevalence rate in the terazosin group
was at least 5%, where the prevalence rate for the terazosin group was at least
2% and was greater than the prevalence rate for the placebo group, or where the
reaction is of particular interest. Asthenia, blurred vision, dizziness, nasal
congestion, nausea, peripheral edema, palpitations and somnolence were the only
symptoms that were significantly (p < 0.05) more common in patients receiving
terazosin than in patients receiving placebo. Similar adverse reaction rates
were observed in placebo-controlled monotherapy trials.

Table 3. Adverse Reactions During Placebo-controlled Trials Hypertension


Body System Terazosin
(N = 859) Placebo
(N = 506) BODY AS A WHOLE   †Asthenia 11.3%* 4.3%   Back Pain 2.4% 1.2%
  Headache 16.2% 15.8% CARDIOVASCULAR SYSTEM   Palpitations 4.3%* 1.2%
  Postural Hypotension 1.3% 0.4%   Tachycardia 1.9% 1.2% DIGESTIVE SYSTEM
  Nausea 4.4%* 1.4% METABOLIC AND NUTRITIONAL DISORDERS   Edema 0.9% 0.6%
  Peripheral Edema 5.5%* 2.4%   Weight Gain 0.5% 0.2% MUSCULOSKELETAL SYSTEM
  Pain-Extremities 3.5% 3.0% NERVOUS SYSTEM   Depression 0.3% 0.2%   Dizziness
19.3%* 7.5%   Libido Decreased 0.6% 0.2%   Nervousness 2.3% 1.8%   Paresthesia
2.9% 1.4%   Somnolence 5.4%* 2.6% RESPIRATORY SYSTEM   Dyspnea 3.1% 2.4%   Nasal
Congestion 5.9%* 3.4%   Sinusitis 2.6% 1.4% SPECIAL SENSES   Blurred Vision
1.6%* 0.0% UROGENITAL SYSTEM   Impotence 1.2% 1.4% † Includes weakness,
tiredness, lassitude and fatigue.
* Statistically significant at p = 0.05 level.



Additional adverse reactions have been reported, but these are, in general, not
distinguishable from symptoms that might have occurred in the absence of
exposure to terazosin. The following additional adverse reactions were reported
by at least 1% of 1987 patients who received terazosin in controlled or open,
short- or long-term clinical trials or have been reported during marketing
experience:

BODY AS A WHOLE

chest pain, facial edema, fever, abdominal pain, neck pain, shoulder pain

CARDIOVASCULAR SYSTEM

arrhythmia, vasodilation

DIGESTIVE SYSTEM

constipation, diarrhea, dry mouth, dyspepsia, flatulence, vomiting

METABOLIC/NUTRITIONAL DISORDERS

gout

MUSCULOSKELETAL SYSTEM

arthralgia, arthritis, joint disorder, myalgia

NERVOUS SYSTEM

anxiety, insomnia

RESPIRATORY SYSTEM

bronchitis, cold symptoms, epistaxis, flu symptoms, increased cough,
pharyngitis, rhinitis

SKIN AND APPENDAGES

pruritus, rash, sweating

SPECIAL SENSES

abnormal vision, conjunctivitis, tinnitus

UROGENITAL SYSTEM

urinary frequency, urinary incontinence primarily reported in postmenopausal
women, urinary tract infection.

The adverse reactions were usually mild or moderate in intensity but sometimes
were serious enough to interrupt treatment. The adverse reactions that were most
bothersome, as judged by their being reported as reasons for discontinuation of
therapy by at least 0.5% of the terazosin group and being reported more often
than in the placebo group, are shown in Table 4.

Table 4. Discontinuations During Placebo-controlled Trials Hypertension


Body System Terazosin
(N = 859) Placebo
(N = 506) BODY AS A WHOLE   Asthenia 1.6% 0.0%   Headache 1.3% 1.0%
CARDIOVASCULAR SYSTEM   Palpitations 1.4% 0.2%   Postural Hypotension 0.5% 0.0%
  Syncope 0.5% 0.2%   Tachycardia 0.6% 0.0% DIGESTIVE SYSTEM   Nausea 0.8% 0.0%
METABOLIC AND NUTRITIONAL DISORDERS   Peripheral Edema 0.6% 0.0% NERVOUS SYSTEM
  Dizziness 3.1% 0.4%   Paresthesia 0.8% 0.2%   Somnolence 0.6% 0.2% RESPIRATORY
SYSTEM   Dyspnea 0.9% 0.6%   Nasal Congestion 0.6% 0.0%



POST-MARKETING EXPERIENCE

Post-marketing experience indicates that in rare instances patients may develop
allergic reactions, including anaphylaxis, following administration of terazosin
hydrochloride. There have been reports of priapism and thrombocytopenia during
post-marketing surveillance. Atrial fibrillation has been reported.

During cataract surgery, a variant of small pupil syndrome known as
Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with
alpha-1 blocker therapy (see PRECAUTIONS).


DRUG INTERACTIONS FOR HYTRIN

Concomitant administration of HYTRIN (terazosin hcl) with a phosphodiesterase-5
(PDE-5) inhibitor can result in additive blood pressure lowering effects and
symptomatic hypotension (see DOSAGE AND ADMINISTRATION).

In controlled trials, HYTRIN (terazosin hcl) tablets have been added to
diuretics, and several beta-adrenergic blockers; no unexpected interactions were
observed. HYTRIN (terazosin hcl) tablets have also been used in patients on a
variety of concomitant therapies; while these were not formal interaction
studies, no interactions were observed. HYTRIN (terazosin hcl) tablets have been
used concomitantly in at least 50 patients on the following drugs or drug
classes: 1) analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine,
ibuprofen, indomethacin); 2) antibiotics (e.g., erythromycin, trimethoprim and
sulfamethoxazole); 3) anticholinergic/sympathomimetics (e.g., phenylephrine
hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine
hydrochloride); 4) antigout (e.g., allopurinol); 5) antihistamines (e.g.,
chlorpheniramine); 6) cardiovascular agents (e.g., atenolol,
hydrochlorothiazide, methyclothiazide, propranolol); 7) corticosteroids; 8)
gastrointestinal agents (e.g., antacids); 9) hypoglycemics; 10) sedatives and
tranquilizers (e.g., diazepam).

USE WITH OTHER DRUGS

In a study (n=24) where terazosin and verapamil were administered concomitantly,
terazosin's mean AUC0-24 increased 11% after the first verapamil dose and after
3 weeks of verapamil treatment it increased by 24% with associated increases in
Cmax (25%) and Cmin (32%) means. Terazosin mean Tmax decreased from 1.3 hours to
0.8 hours after 3 weeks of verapamil treatment. Statistically significant
differences were not found in the verapamil level with and without terazosin. In
a study (n=6) where terazosin and captopril were administered concomitantly,
plasma disposition of captopril was not influenced by concomitant administration
of terazosin and terazosin maximum plasma concentrations increased linearly with
dose at steady-state after administration of terazosin plus captopril (see
DOSAGE AND ADMINISTRATION).




WARNINGS FOR HYTRIN

SYNCOPE AND ‘‘FIRST-DOSE'' EFFECT

HYTRIN (terazosin hcl) tablets, like other alpha-adrenergic blocking agents, can
cause marked lowering of blood pressure, especially postural hypotension, and
syncope in association with the first dose or first few days of therapy. A
similar effect can be anticipated if therapy is interrupted for several days and
then restarted. Syncope has also been reported with other alpha-adrenergic
blocking agents in association with rapid dosage increases or the introduction
of another antihypertensive drug. Syncope is believed to be due to an excessive
postural hypotensive effect, although occasionally the syncopal episode has been
preceded by a bout of severe supraventricular tachycardia with heart rates of
120-160 beats per minute. Additionally, the possibility of the contribution of
hemodilution to the symptoms of postural hypotension should be considered.

To decrease the likelihood of syncope or excessive hypotension, treatment should
always be initiated with a 1 mg dose of HYTRIN (terazosin hcl) tablets, given at
bedtime. The 2 mg, 5 mg and 10 mg tablets are not indicated as initial therapy.
Dosage should then be increased slowly, according to recommendations in the
Dosage and Administration section and additional antihypertensive agents should
be added with caution. The patient should be cautioned to avoid situations, such
as driving or hazardous tasks, where injury could result should syncope occur
during initiation of therapy.

In early investigational studies, where increasing single doses up to 7.5 mg
were given at 3 day intervals, tolerance to the first dose phenomenon did not
necessarily develop and the ''first-dose” effect could be observed at all doses.
Syncopal episodes occurred in 3 of the 14 subjects given HYTRIN (terazosin hcl)
tablets at doses of 2.5, 5 and 7.5 mg, which are higher than the recommended
initial dose; in addition, severe orthostatic hypotension (blood pressure
falling to 50/0 mmHg) was seen in two others and dizziness, tachycardia, and
lightheadedness occurred in most subjects. These adverse effects all occurred
within 90 minutes of dosing.

In three placebo-controlled BPH studies 1, 2, and 3 (see CLINICAL PHARMACOLOGY),
the incidence of postural hypotension in the terazosin treated patients was
5.1%, 5.2%, and 3.7% respectively.

In multiple dose clinical trials involving nearly 2000 hypertensive patients
treated with HYTRIN (terazosin hcl) tablets, syncope was reported in about 1% of
patients. Syncope was not necessarily associated only with the first dose.

If syncope occurs, the patient should be placed in a recumbent position and
treated supportively as necessary. There is evidence that the orthostatic effect
of HYTRIN (terazosin hcl) tablets is greater, even in chronic use, shortly after
dosing. The risk of the events is greatest during the initial seven days of
treatment, but continues at all time intervals.

PRIAPISM

Rarely, (probably less than once in every several thousand patients), terazosin
and other α1-antagonists have been associated with priapism (painful penile
erection, sustained for hours and unrelieved by sexual intercourse or
masturbation). Two or three dozen cases have been reported. Because this
condition can lead to permanent impotence if not promptly treated, patients must
be advised about the seriousness of the condition (see PRECAUTIONS - Information
for Patients).


PRECAUTIONS FOR HYTRIN

GENERAL

PROSTATIC CANCER

Carcinoma of the prostate and BPH cause many of the same symptoms. These two
diseases frequently co-exist. Therefore, patients thought to have BPH should be
examined prior to starting HYTRIN (terazosin hcl) therapy to rule out the
presence of carcinoma of the prostate.

INTRAOPERATIVE FLOPPY IRIS SYNDROME (IFIS)

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract
surgery in some patients on/or previously treated with alpha-1 blockers. This
variant of small pupil syndrome is characterized by the combination of a flaccid
iris that billows in response to intraoperative irrigation currents, progressive
intraoperative miosis despite preoperative dilation with standard mydriatic
drugs, and potential prolapse of the iris toward the phacoemulsification
incisions. The patient's ophthalmologist should be prepared for possible
modifications to their surgical technique, such as the utilization of iris
hooks, iris dilator rings, or viscoelastic substances. There does not appear to
be a benefit of stopping alpha-1 blocker therapy prior to cataract surgery.

ORTHOSTATIC HYPOTENSION

While syncope is the most severe orthostatic effect of HYTRIN (terazosin hcl)
tablets (see WARNINGS), other symptoms of lowered blood pressure, such as
dizziness, lightheadedness and palpitations, were more common and occurred in
some 28% of patients in clinical trials of hypertension. In BPH clinical trials,
21% of the patients experienced one or more of the following: dizziness,
hypotension, postural hypotension, syncope, and vertigo. Patients with
occupations in which such events represent potential problems should be treated
with particular caution.

INFORMATION FOR PATIENTS

(see Patient Package Insert)

Patients should be made aware of the possibility of syncopal and orthostatic
symptoms, especially at the initiation of therapy, and to avoid driving or
hazardous tasks for 12 hours after the first dose, after a dosage increase and
after interruption of therapy when treatment is resumed. They should be
cautioned to avoid situations where injury could result should syncope occur
during initiation of HYTRIN (terazosin hcl) therapy. They should also be advised
of the need to sit or lie down when symptoms of lowered blood pressure occur,
although these symptoms are not always orthostatic, and to be careful when
rising from a sitting or lying position. If dizziness, lightheadedness, or
palpitations are bothersome they should be reported to the physician, so that
dose adjustment can be considered.

Patients should also be told that drowsiness or somnolence can occur with HYTRIN
(terazosin hcl) tablets, requiring caution in people who must drive or operate
heavy machinery.

Patients should be advised about the possibility of priapism as a result of
treatment with HYTRIN (terazosin hcl) and other similar medications. Patients
should know that this reaction to HYTRIN (terazosin hcl) is extremely rare, but
that if it is not brought to immediate medical attention, it can lead to
permanent erectile dysfunction (impotence).

LABORATORY TESTS

Small but statistically significant decreases in hematocrit, hemoglobin, white
blood cells, total protein and albumin were observed in controlled clinical
trials. These laboratory findings suggested the possibility of hemodilution.
Treatment with HYTRIN (terazosin hcl) for up to 24 months had no significant
effect on prostate specific antigen (PSA) levels.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

HYTRIN (terazosin hcl) was devoid of mutagenic potential when evaluated in vivo
and in vitro (the Ames test, in vivo cytogenetics, the dominant lethal test in
mice, in vivo Chinese hamster chromosome aberration test and V79 forward
mutation assay).

HYTRIN (terazosin hcl) , administered in the feed to rats at doses of 8, 40, and
250 mg/kg/day (70, 350, and 2100 mg/M2/day), for two years, was associated with
a statistically significant increase in benign adrenal medullary tumors of male
rats exposed to the 250 mg/kg dose. This dose is 175 times the maximum
recommended human dose of 20 mg (12 mg/M2). Female rats were unaffected. HYTRIN
(terazosin hcl) was not oncogenic in mice when administered in feed for 2 years
at a maximum tolerated dose of 32 mg/kg/day (110 mg/M2; 9 times the maximum
recommended human dose). The absence of mutagenicity in a battery of tests, of
tumorigenicity of any cell type in the mouse carcinogenicity assay, of increased
total tumor incidence in either species, and of proliferative adrenal lesions in
female rats, suggests a male rat species-specific event. Numerous other diverse
pharmaceutical and chemical compounds have also been associated with benign
adrenal medullary tumors in male rats without supporting evidence for
carcinogenicity in man.

The effect of HYTRIN (terazosin hcl) on fertility was assessed in a standard
fertility/reproductive performance study in which male and female rats were
administered oral doses of 8, 30 and 120 mg/kg/day. Four of 20 male rats given
30 mg/kg (240 mg/M2; 20 times the maximum recommended human dose), and five of
19 male rats given 120 mg/kg (960 mg/M2; 80 times the maximum recommended human
dose), failed to sire a litter. Testicular weights and morphology were
unaffected by treatment. Vaginal smears at 30 and 120 mg/kg/day, however,
appeared to contain less sperm than smears from control matings and good
correlation was reported between sperm count and subsequent pregnancy.

Oral administration of HYTRIN (terazosin hcl) for one or two years elicited a
statistically significant increase in the incidence of testicular atrophy in
rats exposed to 40 and 250 mg/kg/day (29 and 175 times the maximum recommended
human dose), but not in rats exposed to 8 mg/kg/day ( > 6 times the maximum
recommended human dose). Testicular atrophy was also observed in dogs dosed with
300 mg/kg/day ( > 500 times the maximum recommended human dose) for three months
but not after one year when dosed with 20 mg/kg/day (38 times the maximum
recommended human dose). This lesion has also been seen with Minipress®, another
(marketed) selective-alpha-1 blocking agent.

PREGNANCY

TERATOGENIC EFFECTS

Pregnancy Category C

HYTRIN (terazosin hcl) was not teratogenic in either rats or rabbits when
administered at oral doses up to 280 and 60 times, respectively, the maximum
recommended human dose. Fetal resorptions occurred in rats dosed with 480
mg/kg/day, approximately 280 times the maximum recommended human dose. Increased
fetal resorptions, decreased fetal weight and an increased number of
supernumerary ribs were observed in offspring of rabbits dosed with 60 times the
maximum recommended human dose. These findings (in both species) were most
likely secondary to maternal toxicity. There are no adequate and well-controlled
studies in pregnant women and the safety of terazosin in pregnancy has not been
established. HYTRIN (terazosin hcl) is not recommended during pregnancy unless
the potential benefit justifies the potential risk to the mother and fetus.

NONTERATOGENIC EFFECTS

In a peri- and post-natal development study in rats, significantly more pups
died in the group dosed with 120 mg/kg/day ( > 75 times the maximum recommended
human dose) than in the control group during the three-week postpartum period.

NURSING MOTHERS

It is not known whether terazosin is excreted in breast milk. Because many drugs
are excreted in breast milk, caution should be exercised when HYTRIN (terazosin
hcl) tablets are administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in children have not been determined.


OVERDOSE INFORMATION FOR HYTRIN

Should overdosage of HYTRIN (terazosin hcl) lead to hypotension, support of the
cardiovascular system is of first importance. Restoration of blood pressure and
normalization of heart rate may be accomplished by keeping the patient in the
supine position. If this measure is inadequate, shock should first be treated
with volume expanders. If necessary, vasopressors should then be used and renal
function should be monitored and supported as needed. Laboratory data indicate
that HYTRIN (terazosin hcl) is highly protein bound; therefore, dialysis may not
be of benefit.


CONTRAINDICATIONS FOR HYTRIN

HYTRIN (terazosin hcl) tablets are contraindicated in patients known to be
hypersensitive to terazosin hydrochloride.


CLINICAL PHARMACOLOGY FOR HYTRIN

PHARMACODYNAMICS

BENIGN PROSTATIC HYPERPLASIA (BPH)

The symptoms associated with BPH are related to bladder outlet obstruction,
which is comprised of two underlying components: a static component and a
dynamic component. The static component is a consequence of an increase in
prostate size. Over time, the prostate will continue to enlarge. However,
clinical studies have demonstrated that the size of the prostate does not
correlate with the severity of BPH symptoms or the degree of urinary
obstruction.1 The dynamic component is a function of an increase in smooth
muscle tone in the prostate and bladder neck, leading to constriction of the
bladder outlet. Smooth muscle tone is mediated by sympathetic nervous
stimulation of alpha-l adrenoceptors, which are abundant in the prostate,
prostatic capsule and bladder neck. The reduction in symptoms and improvement in
urine flow rates following administration of terazosin is related to relaxation
of smooth muscle produced by blockade of alpha-l adrenoceptors in the bladder
neck and prostate. Because there are relatively few alpha-l adrenoceptors in the
bladder body, terazosin is able to reduce the bladder outlet obstruction without
affecting bladder contractility.

Terazosin has been extensively studied in 1222 men with symptomatic BPH. In
three placebo-controlled studies, symptom evaluation and uroflowmetric
measurements were performed approximately 24 hours following dosing. Symptoms
were systematically quantified using the Boyarsky Index. The questionnaire
evaluated both obstructive (hesitancy, intermittency, terminal dribbling,
impairment of size and force of stream, sensation of incomplete bladder
emptying) and irritative (nocturia, daytime frequency, urgency, dysuria)
symptoms by rating each of the 9 symptoms from 0-3, for a total score of 27
points. Results from these studies indicated that terazosin statistically
significantly improved symptoms and peak urine flow rates over placebo as
follows:



  Symptom Score
(Range 0-27) Peak Flow Rate
(mL/sec) N Mean Baseline Mean (%) Change N Mean Baseline Mean (%) Change Study 1
(10 mg)a           Titration to fixed dose (12 wks)   Placebo 55 9.7 -2.3 (24)
54 10.1 +1.0 (10)   Terazosin 54 10.1 -4.5 (45) *52 8.8 +3.0 (34)* Study 2 (2,
5, 10, 20 mg)b           Titration to response (24 wks)   Placebo 89 12.5 -3.8
(30) 88 8.8 +1.4 (16)   Terazosin 85 12.2 -5.3 (43)* 84 8.4 +2.9 (35)* Study 3
(1, 2, 5, 10 mg)c (1, 2, 5, 10 mg)c           Titration to response (24 wks)
  Placebo 74 10.4 -1.1 (11) 74 8.8 +1.2 (14)   Terazosin 73 10.9 -4.6 (42)* 73
8.6 +2.6 (30)* a Highest dose 10 mg shown.
b 23% of patients on 10 mg, 41% of patients on 20 mg.
c 67% of patients on 10 mg.
* Significantly (p ≤ 0.05) more improvement than placebo.



In all three studies, both symptom scores and peak urine flow rates showed
statistically significant improvement from baseline in patients treated with
HYTRIN (terazosin hcl) from week 2 (or the first clinic visit) and throughout
the study duration.

Analysis of the effect of HYTRIN (terazosin hcl) on individual urinary symptoms
demonstrated that compared to placebo, HYTRIN (terazosin hcl) significantly
improved the symptoms of hesitancy, intermittency, impairment in size and force
of urinary stream, sensation of incomplete emptying, terminal dribbling, daytime
frequency and nocturia.

Global assessments of overall urinary function and symptoms were also performed
by investigators who were blinded to patient treatment assignment. In studies 1
and 3, patients treated with HYTRIN (terazosin hcl) had a significantly (p ≤
0.001) greater overall improvement compared to placebo treated patients.

In a short term study (Study 1), patients were randomized to either 2, 5 or 10
mg of HYTRIN (terazosin hcl) or placebo. Patients randomized to the 10 mg group
achieved a statistically significant response in both symptoms and peak flow
rate compared to placebo (Figure 1).

Figure 1. Study 1






+ for baseline values see above table
* p ≤ 0.05, compared to placebo group

In a long-term, open-label, non-placebo controlled clinical trial, 181 men were
followed for 2 years and 58 of these men were followed for 30 months. The effect
of HYTRIN (terazosin hcl) on urinary symptom scores and peak flow rates was
maintained throughout the study duration (Figures 2 and 3):

Figure 2. Mean Change in Total Symptom Score from Baseline Long-term,
Open-label, Non-placebo Controlled Study (N = 494)






* p ≤ 0.05 vs. baseline
mean baseline = 10.7

Figure 3. Mean Change in Peak Flow Rate from Baseline Long-term, Open-label,
Non-placebo Controlled Study (N = 494)






* p ≤ 0.05 vs. baseline
mean baseline = 9.9

In this long-term trial, both symptom scores and peak urinary flow rates showed
statistically significant improvement suggesting a relaxation of smooth muscle
cells.

Although blockade of alpha-1 adrenoceptors also lowers blood pressure in
hypertensive patients with increased peripheral vascular resistance, terazosin
treatment of normotensive men with BPH did not result in a clinically
significant blood pressure lowering effect:

Mean Changes in Blood Pressure from Baseline to Final Visit in all Double-blind,
Placebo-controlled Studies


    Normotensive Patients DBP
≤ 90 mm Hg Hypertensive Patients DBP
> 90 mm Hg   Group N Mean Change N Mean Change SBP Placebo 293 -0.1 45 -5.8 (mm
Hg) Terazosin 519 -3.3* 65 -14.4* DBP Placebo 293 +0.4 45 -7.1 (mm Hg) Terazosin
519 -2.2* 65 -15.1* * p ≤ 0.05 vs. placebo



HYPERTENSION

In animals, terazosin causes a decrease in blood pressure by decreasing total
peripheral vascular resistance. The vasodilatory hypotensive action of terazosin
appears to be produced mainly by blockade of alpha-1 adrenoceptors. Terazosin
decreases blood pressure gradually within 15 minutes following oral
administration.

Patients in clinical trials of terazosin were administered once daily (the great
majority) and twice daily regimens with total doses usually in the range of 5-20
mg/day, and had mild (about 77%, diastolic pressure 95-105 mmHg) or moderate
(23%, diastolic pressure 105-115 mmHg) hypertension. Because terazosin, like all
alpha antagonists, can cause unusually large falls in blood pressure after the
first dose or first few doses, the initial dose was 1 mg in virtually all
trials, with subsequent titration to a specified fixed dose or titration to some
specified blood pressure end point (usually a supine diastolic pressure of 90
mmHg).

Blood pressure responses were measured at the end of the dosing interval
(usually 24 hours) and effects were shown to persist throughout the interval,
with the usual supine responses 5-10 mmHg systolic and 3.5-8 mmHg diastolic
greater than placebo. The responses in the standing position tended to be
somewhat larger, by 1-3 mmHg, although this was not true in all studies. The
magnitude of the blood pressure responses was similar to prazosin and less than
hydrochlorothiazide (in a single study of hypertensive patients). In
measurements 24 hours after dosing, heart rate was unchanged.

Limited measurements of peak response (2-3 hours after dosing) during chronic
terazosin administration indicate that it is greater than about twice the trough
(24 hour) response, suggesting some attenuation of response at 24 hours,
presumably due to a fall in blood terazosin concentrations at the end of the
dose interval. This explanation is not established with certainty, however, and
is not consistent with the similarity of blood pressure response to once daily
and twice daily dosing and with the absence of an observed dose-response
relationship over a range of 5-20 mg, i.e., if blood concentrations had fallen
to the point of providing less than full effect at 24 hours, a shorter dosing
interval or larger dose should have led to increased response.

Further dose response and dose duration studies are being carried out. Blood
pressure should be measured at the end of the dose interval; if response is not
satisfactory, patients may be tried on a larger dose or twice daily dosing
regimen. The latter should also be considered if possibly blood pressure-related
side effects, such as dizziness, palpitations, or orthostatic complaints, are
seen within a few hours after dosing.

The greater blood pressure effect associated with peak plasma concentrations
(first few hours after dosing) appears somewhat more position-dependent (greater
in the erect position) than the effect of terazosin at 24 hours and in the erect
position there is also a 6-10 beat per minute increase in heart rate in the
first few hours after dosing. During the first 3 hours after dosing 12.5% of
patients had a systolic pressure fall of 30 mmHg or more from supine to
standing, or standing systolic pressure below 90 mmHg with a fall of at least 20
mmHg, compared to 4% of a placebo group.

There was a tendency for patients to gain weight during terazosin therapy. In
placebo-controlled monotherapy trials, male and female patients receiving
terazosin gained a mean of 1.7 and 2.2 pounds respectively, compared to losses
of 0.2 and 1.2 pounds respectively in the placebo group. Both differences were
statistically significant.

During controlled clinical trials, patients receiving terazosin monotherapy had
a small but statistically significant decrease (a 3% fall) compared to placebo
in total cholesterol and the combined low-density and very-low-density
lipoprotein fractions. No significant changes were observed in high-density
lipoprotein fraction and triglycerides compared to placebo.

Analysis of clinical laboratory data following administration of terazosin
suggested the possibility of hemodilution based on decreases in hematocrit,
hemoglobin, white blood cells, total protein and albumin. Decreases in
hematocrit and total protein have been observed with alpha-blockade and are
attributed to hemodilution.

PHARMACOKINETICS

Relative to solution, terazosin hydrochloride administered as HYTRIN (terazosin
hcl) tablets is essentially completely absorbed in man. Food had little or no
effect on the extent of absorption but food delayed the time to peak
concentration by about 1 hour. Terazosin has been shown to undergo minimal
hepatic first-pass metabolism and nearly all of the circulating dose is in the
form of parent drug. The plasma levels peak about one hour after dosing, and
then decline with a half-life of approximately 12 hours. In a study that
evaluated the effect of age on terazosin pharmacokinetics, the mean plasma
half-lives were 14.0 and 11.4 hours for the age group ≥ 70 years and the age
group of 20-39 years, respectively. After oral administration the plasma
clearance was decreased by 31.7% in patients 70 years of age or older compared
to that in patients 20-39 years of age.

The drug is highly bound to plasma proteins and binding is constant over the
clinically observed concentration range. Approximately 10% of an orally
administered dose is excreted as parent drug in the urine and approximately 20%
is excreted in the feces. The remainder is eliminated as metabolites. Impaired
renal function had no significant effect on the elimination of terazosin, and
dosage adjustment of terazosin to compensate for the drug removal during
hemodialysis (approximately 10%) does not appear to be necessary. Overall,
approximately 40% of the administered dose is excreted in the urine and
approximately 60% in the feces. The disposition of the compound in animals is
qualitatively similar to that in man.

REFERENCE

1. Lepor H. Role of alpha-adrenergic blockers in the treatment of benign
prostatic hypertrophy. Prostate 1990; 3:75-84.


PATIENT INFORMATION FOR HYTRIN

ABOUT HYTRIN® (terazosin hcl)
(HI-TRIN)

Generic Name: terazosin

(ter-A-zo-sin) hydrochloride

When used to treat HYPERTENSION or BENIGN PROSTATIC HYPERPLASIA (BPH)

Please read this leaflet before you start taking HYTRIN (terazosin hcl) . Also,
read it each time you get a new prescription. This is a summary and should NOT
take the place of a full discussion with your doctor who has additional
information about HYTRIN (terazosin hcl) . You and your doctor should discuss
HYTRIN (terazosin hcl) and your condition before you start taking it and at your
regular check-ups.

HYTRIN (terazosin hcl) is used to treat high blood pressure (hypertension).
HYTRIN (terazosin hcl) is also used to treat benign prostatic hyperplasia (BPH)
in men. This leaflet describes HYTRIN (terazosin hcl) as a treatment for
hypertension or BPH.

What Is Hypertension (High Blood Pressure)?

Blood pressure is the tension of the blood within the blood vessels. If blood is
pumped too forcefully, or if the blood vessels are too narrow, the pressure of
the blood against the walls of the vessels rises.

If high blood pressure is not treated, over time, the increased pressure can
damage blood vessels or it can cause the heart to work too hard and may decrease
the flow of blood to the heart, brain, and kidneys. As a result, these organs
may become damaged and not function correctly. If high blood pressure is
controlled, this damage is less likely to happen.

Treatment Options for Hypertension

Non-drug treatments are sometimes effective in controlling mild hypertension.
The most important lifestyle changes to lower blood pressure are to lose weight,
reduce salt, fat, and alcohol in the diet, quit smoking, and exercise regularly.
However, many hypertensive patients require one or more ongoing medications to
control their blood pressure. There are different kinds of medications used to
treat hypertension. Your doctor has prescribed HYTRIN (terazosin hcl) for you.

What HYTRIN (terazosin hcl) Does to Treat Hypertension

HYTRIN (terazosin hcl) works by relaxing blood vessels so that blood passes
through them more easily. This helps to lower blood pressure.

What is BPH?

The prostate is a gland located below the bladder of men. It surrounds the
urethra (you-REETH-rah), which is a tube that drains urine from the bladder. BPH
is an enlargement of the prostate gland. The symptoms of BPH, however, can be
caused by an increase in the tightness of muscles in the prostate. If the
muscles inside the prostate tighten, they can squeeze the urethra and slow the
flow of urine. This can lead to symptoms such as:

 * a weak or interrupted stream when urinating
 * a feeling that you cannot empty your bladder completely
 * a feeling of delay when you start to urinate
 * a need to urinate often, especially at night, or
 * a feeling that you must urinate right away.

Treatment Options for BPH

There are three main treatment options for BPH:

 * Program of monitoring or "Watchful Waiting". Some men have an enlarged
   prostate gland, but no symptoms, or symptoms that are not bothersome. If this
   applies, you and your doctor may decide on a program of monitoring including
   regular checkups, instead of medication or surgery.
 * Medication. There are different kinds of medication used to treat BPH. Your
   doctor has prescribed HYTRIN (terazosin hcl) for you. See "What HYTRIN
   (terazosin hcl) does to treat BPH" below.
 * Surgery. Some patients may need surgery. Your doctor can describe several
   different surgical procedures to treat BPH. Which procedure is best depends
   on your symptoms and medical condition.

What HYTRIN (terazosin hcl) Does to Treat BPH

HYTRIN (terazosin hcl) relaxes the tightness of a certain type of muscle in the
prostate and at the opening of the bladder. This may increase the rate of urine
flow and/or decrease the symptoms you are having.

 * HYTRIN (terazosin hcl) helps relieve the symptoms of BPH. It does NOT change
   the size of the prostate, which may continue to grow. However, a larger
   prostate does not necessarily cause more or worse symptoms.
 * If HYTRIN (terazosin hcl) is helping you, you should notice an effect on your
   particular symptoms in 2 to 4 weeks of starting to take the medication.
 * Even though you take HYTRIN (terazosin hcl) and it may help you, HYTRIN
   (terazosin hcl) may not prevent the need for surgery in the future.

Other Important Facts About HYTRIN (terazosin hcl) for BPH

 * You should see an effect on your symptoms in 2 to 4 weeks. So, you will need
   to continue seeing your doctor to check your progress regarding your BPH and
   to monitor your blood pressure in addition to your other regular check-ups.
 * Your doctor has prescribed HYTRIN (terazosin hcl) for your BPH and not for
   prostate cancer. However, a man can have BPH and prostate cancer at the same
   time. Doctors usually recommend that men be checked for prostate cancer once
   a year when they turn 50 (or 40 if a family member has had prostate cancer).
   These checks should continue even if you are taking HYTRIN (terazosin hcl) .
   HYTRIN (terazosin hcl) is not a treatment for prostate cancer.
 * About Prostate Specific Antigen (PSA). Your doctor may have done a blood test
   called PSA. Your doctor is aware that HYTRIN (terazosin hcl) does not affect
   PSA levels. You may want to ask your doctor more about this if you have had a
   PSA test done.

What You Should Know While Taking HYTRIN (terazosin hcl) for Hypertension or BPH

WARNINGS

HYTRIN (terazosin hcl) Can Cause A Sudden Drop in Blood Pressure After the VERY
FIRST DOSE. You may feel dizzy, faint, or "light-headed" particularly after you
get up from bed or from a chair. This is more likely to occur after you've taken
the first few doses, but can occur at any time while you are taking the drug. It
can also occur if you stop taking the drug and then re-start treatment.

Because of this effect, your doctor may have told you to take HYTRIN (terazosin
hcl) at bedtime. If you take HYTRIN (terazosin hcl) at bedtime but need to get
up from bed to go to the bathroom, get up slowly and cautiously until you are
sure how the medicine affects you. It is also important to get up slowly from a
chair or bed at any time until you learn how you react to HYTRIN (terazosin hcl)
. You should not drive or do any hazardous tasks until you are used to the
effects of the medication. If you begin to feel dizzy, sit or lie down until you
feel better.

 * You will start with a 1 mg dose of HYTRIN (terazosin hcl) . Then the dose
   will be increased as your body gets used to the effect of the medication.
 * Other side effects you could have while taking HYTRIN (terazosin hcl) include
   drowsiness, blurred or hazy vision, nausea, or "puffiness" of the feet or
   hands. Discuss any unexpected effects you notice with your doctor.

Extremely rarely, HYTRIN (terazosin hcl) 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.

How to take HYTRIN (terazosin hcl)

Follow your doctor's instructions about how to take HYTRIN (terazosin hcl) . You
must take it every day at the dose prescribed. Talk with your doctor if you
don't take it for a few days, you may have to restart it at a 1 mg dose and be
cautious about possible dizziness. Do not share HYTRIN (terazosin hcl) with
anyone else; it was prescribed only for you.

Keep HYTRIN (terazosin hcl) and all medicines out of the reach of children.

Store tablets below 86°F (30°C)

FOR MORE INFORMATION ABOUT HYTRIN (terazosin hcl) AND HYPERTENSION OR BPH, TALK
WITH YOUR DOCTOR, NURSE, PHARMACIST OR OTHER HEALTH CARE PROVIDER.


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   Reports can be generated based on the combination of data sets (like user
   profiles, statistics, market research, analytics data) regarding your
   interactions and those of other users with advertising or (non-advertising)
   content to identify common characteristics (for instance, to determine which
   target audiences are more receptive to an ad campaign or to certain
   contents).
   
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 * DEVELOP AND IMPROVE SERVICES 48 PARTNERS CAN USE THIS PURPOSE
   
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   Information about your activity on this service, such as your interaction
   with ads or content, can be very helpful to improve products and services and
   to build new products and services based on user interactions, the type of
   audience, etc. This specific purpose does not include the development or
   improvement of user profiles and identifiers.
   
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 * USE LIMITED DATA TO SELECT CONTENT 6 PARTNERS CAN USE THIS PURPOSE
   
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   Content presented to you on this service can be based on limited data, such
   as the website or app you are using, your non-precise location, your device
   type, or which content you are (or have been) interacting with (for example,
   to limit the number of times a video or an article is presented to you).
   
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   Object to Legitimate Interests Remove Objection

List of IAB Vendors‎

USE PRECISE GEOLOCATION DATA 15 PARTNERS CAN USE THIS PURPOSE

Use precise geolocation data

With your acceptance, your precise location (within a radius of less than 500
metres) may be used in support of the purposes explained in this notice.

List of IAB Vendors‎

ACTIVELY SCAN DEVICE CHARACTERISTICS FOR IDENTIFICATION 3 PARTNERS CAN USE THIS
PURPOSE

Actively scan device characteristics for identification

With your acceptance, certain characteristics specific to your device might be
requested and used to distinguish it from other devices (such as the installed
fonts or plugins, the resolution of your screen) in support of the purposes
explained in this notice.

List of IAB Vendors‎

ENSURE SECURITY, PREVENT AND DETECT FRAUD, AND FIX ERRORS 48 PARTNERS CAN USE
THIS PURPOSE

Always Active

Your data can be used to monitor for and prevent unusual and possibly fraudulent
activity (for example, regarding advertising, ad clicks by bots), and ensure
systems and processes work properly and securely. It can also be used to correct
any problems you, the publisher or the advertiser may encounter in the delivery
of content and ads and in your interaction with them.

List of IAB Vendors‎ | View Illustrations 

DELIVER AND PRESENT ADVERTISING AND CONTENT 41 PARTNERS CAN USE THIS PURPOSE

Always Active

Certain information (like an IP address or device capabilities) is used to
ensure the technical compatibility of the content or advertising, and to
facilitate the transmission of the content or ad to your device.

List of IAB Vendors‎ | View Illustrations 

MATCH AND COMBINE DATA FROM OTHER DATA SOURCES 39 PARTNERS CAN USE THIS PURPOSE

Always Active

Information about your activity on this service may be matched and combined with
other information relating to you and originating from various sources (for
instance your activity on a separate online service, your use of a loyalty card
in-store, or your answers to a survey), in support of the purposes explained in
this notice.

List of IAB Vendors‎

LINK DIFFERENT DEVICES 35 PARTNERS CAN USE THIS PURPOSE

Always Active

In support of the purposes explained in this notice, your device might be
considered as likely linked to other devices that belong to you or your
household (for instance because you are logged in to the same service on both
your phone and your computer, or because you may use the same Internet
connection on both devices).

List of IAB Vendors‎

IDENTIFY DEVICES BASED ON INFORMATION TRANSMITTED AUTOMATICALLY 36 PARTNERS CAN
USE THIS PURPOSE

Always Active

Your device might be distinguished from other devices based on information it
automatically sends when accessing the Internet (for instance, the IP address of
your Internet connection or the type of browser you are using) in support of the
purposes exposed in this notice.

List of IAB Vendors‎
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