ترازوسین
Terazosin Hcl (Hytrin)
ترازوسین

نام ژنریک

Terazosin Hcl

شکل دارویی

اشكال دارويي:


Tablet: 2, 5, 10mg

موارد مصرف

موارد و مقدار مصرف


الف) افزايش فشار خون متوسط و خفيف :


بزرگسالان: با mg 1 خوراكي هنگام خواب شروع شود و بر اساس پاسخ بيمار ميزان دارو تنظيم گردد. محدوده پيشنهاد شده mg 5-1 روزانه و يا به صورت منقسم دو بار در روز مي‌باشد.


در صورتي كه درمان به مدت چند روز قطع شود با دوز اوليه مجدداً شروع گردد و سپس به آرامي افزايش داده شود. دوزهاي بالاتر از mg/d 20 مؤثرتر در دوزهاي پائين‌تر نمي‌باشد.


ب) هيپرتروفي خوش‌خيم پروستات ( BPH) :


مردان : ابتدا با mg 1 خوراكي هنگام خواب شروع شود، مي‌توان ميزان مصرف را بر اساس پاسخ‌دهي بيمار افزايش داد. دارو به تدريج تا 2، 5 و mg 10 مي‌تواند افزايش يابد. به طور معمول بيمار به mg/d 10 نياز دارد.


مكانيسم اثر


اثر ضد فشار خون: ترازوسين از طريق مهار اختصاصي رسپتورهاي آلفا يك در عروق عضلات صاف، مقاومت عروقي محيطي را كاهش مي‌دهند. به دليل اين مكانيسم، اين دارو بر تعداد ضربان قلب اثر بسيار كمي دارد.


در حين درمان احتمال كاهش شديد كلسترول سرم، LDL و VLDL وجود دارد. اما مكانيسم اين واقعه و قابل توجه بودن آن از نظر باليني ناشناخته است.


ترازوسين سطح پتاسيم و قند را تغيير نمي‌دهد و در نتيجه به خوبي به همراه ديورتيكها، بتابلاكرها و ساير داروهاي كاهش‌دهنده فشار خون استفاده مي‌گردد.


اثر ضد هيپرتروفي ـ مهار آلفا در عضلات صاف غيرعروقي بخصوص در پروستات باعث كاهش علائم BPH مي‌گردد.

موارد منع مصرف

تداخل دارويي


مصرف ساير آلفابلاكرها باعث كاهش شديد فشار خون بخصوص در اوايل درمان مي‌گردد. مصرف همزمان ساير داروهاي كاهنده فشار خون و كلونيدين باعث كاهش بيشتر فشار خون مي‌گردد.

عوارض جانبی دارو

ملاحظات اختصاصي


فشار خون بيمار بايد مانيتور گردد.


نكات قابل توصيه به بيمار


1ـ بهتر است اولين دوز دارو هنگام خواب مصرف شود.


2ـ توصيه‌هاي تامسولوسين مراجعه گردد.


مصرف در سالمندان: سالمندان به عوارض دارويي حساس‌ تر هستند.


مصرف در شيردهي: ترشح دارو در شير مشخص نيست. مصرف ترازوسين در دوران شيردهي توصيه نمي‌شود.

موارد قابل توجه

-

تداخل دارویی

اثر بر آزمايشهاي تشخيصي


ترازوسين مي‌تواند باعث كاهش پروتئين تام، آلبومين، هموگلوبين، هماتوكريت، پلاكت و WBC‌ گردد.

مکانیزم اثر

اثر بر آزمايشهاي تشخيصي


ترازوسين مي‌تواند باعث كاهش پروتئين تام، آلبومين، هموگلوبين، هماتوكريت، پلاكت و WBC‌ گردد.

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: حساسيت به دارو و يا ساير مشتقات كوتينازولين.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: آلفا يك بلاكر.


طبقه‌بندي درماني: كاهش‌دهنده فشار خون.


طبقه‌بندي مصرف در بارداري: رده C


نام‌هاي تجاري: Apo - Terazosin


عوارض جانبي


اعصاب مركزي: آستنيا، گيجي، سردرد، اضطر اب، پاراستزي، خواب‌آلودگي.


قلبي ـ ‌عروقي: فيبريلاسيون دهليزي، افت فشار خون وضعيتي، افزايش ضربان نبض، ادم محيطي، سنكوپ، تاكي‌كاردي.


چشم، گوش، حلق و بيني: تاري ديد، احتقان بيني، سينوزيت.


دستگاه گوارش: تهوع.


ادراري - تناسلي : ناتواني جنسي، پرياپيسم.


خون: ترومبوسيتوپني.


عضلاني ـ اسكلتي: درد كمر، درد عضلات.


تنفسي: ديسپنه.


مسموميت و درمان


مصرف بيش از حد دارو باعث تشديد عوارض جانبي بخصوص افت فشار و شوك مي‌گردد. درمان علامتي و حمايتي است. دياليز به دليل اتصال پروتئيني بالا كمك‌كننده نمي‌باشد.

Terazosin Hcl (Hytrin)

HYTRIN®
(terazosin hydrochloride)

DRUG DESCRIPTION

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.

HYTRIN®
  (terazosin hydrochloride)  Structural Formula Illustration

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.

What are the possible side effects of terazosin (Hytrin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeats or fluttering in your chest;
  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • mild dizziness;
  • weakness, drowsiness;
  • blurred...

Read All Potential Side Effects and See Pictures of Hytrin »

What are the precautions when taking terazosin hcl (Hytrin)?

Before taking terazosin, tell your doctor or pharmacist if you are allergic to it; or to other alpha-blockers (e.g., doxazosin, prazosin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure/fainting, prostate cancer, other prostate/bladder problems, liver disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. You should avoid driving or hazardous tasks for 12 hours after the first dose, after your dose is...

Read All Potential Precautions of Hytrin »

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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 AND ADMINISTRATION

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.

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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).

Read the Hytrin (terazosin hcl) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

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).

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

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

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.

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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

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

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

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

Mean Changes - Study 1 - illustration

+ 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)

Mean Change in Total Symptom Score from Baseline Long-term, Open-label, Non-placebo Controlled Study - Illustration

* 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)

Mean Change in Peak Flow Rate from Baseline Long-term, Open-label, Non-placebo Controlled Study - Illustration

* 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.

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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.

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

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.

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Hytrin Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TERAZOSIN CAPSULE - ORAL

(teh-RAY-zoh-sin)

COMMON BRAND NAME(S): Hytrin

USES: Terazosin is used alone or in combination with other drugs to treat high blood pressure. It works by relaxing blood vessels so blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

This medication is also used to treat an enlarged prostate (benign prostatic hyperplasia or BPH) in men. Terazosin does not shrink the prostate, but it helps relax the prostate and bladder neck muscles to improve urine flow and emptying of the bladder. It also reduces other symptoms such as excessive urination at night.

Terazosin belongs to a class of medications called alpha-blockers.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Terazosin may also be used to help your body "pass," or get rid of, kidney stones through urination. It has also been used to help treat bladder problems in women.

HOW TO USE: Take this medication by mouth, usually once daily at bedtime or as directed by your doctor. If stomach upset occurs, you may take it with food or milk.

Dosage is based on your medical condition, use of other medications, and response to therapy.

If you are taking this drug for the first time, do not take more than 1 milligram to start. To avoid injury related to dizziness or fainting, take your first dose of terazosin at bedtime. Your dose may be gradually increased. You should take your first new dose at bedtime when your dose is increased unless directed otherwise by your doctor.

Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day as directed.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. If you have not taken this medication for several days, consult your doctor or pharmacist before restarting it. Follow your doctor's instructions carefully.

If you are taking this medication for high blood pressure, it is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. Inform your doctor if your routine blood pressure readings increase.

If you are taking this drug for an enlarged prostate, it may take four to six weeks before you notice the full benefit of the drug. Inform your doctor if your condition persists or worsens.

Disclaimer

Hytrin Consumer (continued)

SIDE EFFECTS: Fatigue, nausea, drowsiness, blurred vision, headache, or stuffy nose may occur. Lightheadedness or dizziness upon standing may also occur, especially after the first dose, and shortly after taking the drug during the first week of treatment. To minimize dizziness and the risk of fainting, get up slowly when rising from a seated or lying position. If dizziness occurs, sit or lie down. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/irregular heartbeat, burning/tingling in the hands/feet, sexual function problems, swelling of the ankles/hands/feet, unexpected weight gain.

Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, mental/mood changes.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Hytrin (terazosin hcl) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking terazosin, tell your doctor or pharmacist if you are allergic to it; or to other alpha-blockers (e.g., doxazosin, prazosin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure/fainting, prostate cancer, other prostate/bladder problems, liver disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. You should avoid driving or hazardous tasks for 12 hours after the first dose, after your dose is increased, and when this medication is restarted after it has been stopped. Limit alcoholic beverages.

To reduce the risk of dizziness and fainting, caution is advised when standing for long periods. Avoid getting overheated during exercise or hot weather. If dizziness occurs, sit or lie down.

Before having surgery (including cataract eye surgery), tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and fainting.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Hytrin Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs for male erectile problems (e.g., sildenafil, tadalafil, vardenafil), medications for high blood pressure (e.g., verapamil), other alpha-blockers (e.g., alfuzosin, tamsulosin), sildenafil.

If you are also taking sildenafil and your dose is more than 25 milligrams, you can reduce your risk of fainting by taking your doses of sildenafil and terazosin more than 4 hours apart. Consult your doctor or pharmacist if you have any questions.

Tell your doctor or pharmacist if you also take drugs that may lower blood pressure, cause drowsiness or urination problems such as: certain antihistamines (e.g., diphenhydramine), muscle relaxants (e.g., carisoprodol), narcotic pain relievers (e.g., codeine, morphine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclic antidepressants such as amitriptyline).

Check the labels on all your medicines (such as cough-and-cold products, diet aids, NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could make you drowsy or dizzy, or increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness, fainting.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you are taking this medication for high blood pressure, it is important to have your blood pressure checked regularly. Learn how to monitor your own blood pressure. Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Ask your doctor what you should do if you miss 2 or more doses.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Capsules stored at higher than recommended temperatures may soften or melt.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.

Hytrin Patient Information Including Side Effects

Brand Names: Hytrin

Generic Name: terazosin (Pronunciation: ter AY zo sin)

What is terazosin (Hytrin)?

Terazosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Terazosin relaxes your veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Terazosin is used to treat hypertension (high blood pressure), or to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Terazosin may also be used for other purposes not listed in this medication guide.

Hytrin 1 mg

spherical, gray, imprinted with a, HH

Hytrin 10 mg

spherical, blue, imprinted with a, HN

Hytrin 2 mg

spherical, yellow, imprinted with a, HY

Hytrin 5 mg

spherical, red, imprinted with a, Hk

Terazosin 1 mg NEW-TEV

white, imprinted with 4336, 1 mg

Terazosin 1 mg-APO

beige, imprinted with APO, 115

Terazosin 1 mg-GG

white, imprinted with GG 621

Terazosin 1 mg-MYL

lavender/yellow, imprinted with MYLAN 2260

Terazosin 1 mg-TEV

oval, white, imprinted with 60

Terazosin 10 mg NEW-TEV

blue/white, imprinted with 4339, 10 mg

Terazosin 10 mg-APO

blue, imprinted with APO, 118

Terazosin 10 mg-GG

green, imprinted with GG 624

Terazosin 10 mg-MYL

lavender, imprinted with MYLAN 1570

Terazosin 10 mg-TEV

oval, blue, imprinted with 63

Terazosin 2 mg NEW-TEV

white/yellow, imprinted with 4337, 2 mg

Terazosin 2 mg-APO

yellow, imprinted with APO, 116

Terazosin 2 mg-GG

yellow, imprinted with GG 622

Terazosin 2 mg-MYL

black/lavender, imprinted with MYLAN 2264

Terazosin 2 mg-TEV

oval, yellow, imprinted with 61

Terazosin 5 mg cap-GEN

pink, imprinted with GG 623

Terazosin 5 mg NEW-TEV

orange/white, imprinted with 4338, 5 mg

Terazosin 5 mg-APO

red, imprinted with APO, 117

Terazosin 5 mg-MYL

gray/lavender, imprinted with MYLAN 2268

Terazosin 5 mg-TEV

oval, red, imprinted with 62

What are the possible side effects of terazosin (Hytrin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeats or fluttering in your chest;
  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • mild dizziness;
  • weakness, drowsiness;
  • blurred vision;
  • nausea; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Hytrin (terazosin hcl) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about terazosin (Hytrin)?

You should not use this medication if you are allergic to terazosin.

Terazosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. You may wish to take this medication only at bedtime if it causes you to feel light-headed. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

If you stop taking terazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Terazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using terazosin before surgery unless your surgeon tells you to.

Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills).

Side Effects Centers

Hytrin Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking terazosin (Hytrin)?

You should not use this medication if you are allergic to terazosin.

If you have a history of prostate cancer, you may need a dose adjustment or special tests to safely take terazosin.

Terazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using terazosin before surgery unless your surgeon tells you to.

FDA pregnancy category C. It is not known whether terazosin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether terazosin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take terazosin (Hytrin)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Terazosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. You may wish to take this medication only at bedtime if it causes you to feel light-headed. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking terazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure or prostate will need to be checked often. Visit your doctor regularly.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture, heat, and light.

Side Effects Centers

Hytrin Patient Information including If I Miss a Dose

What happens if I miss a dose (Hytrin)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose (Hytrin)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking terazosin (Hytrin)?

Terazosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of terazosin.

What other drugs will affect terazosin (Hytrin)?

Tell your doctor about all other medications you use, especially:

  • sildenafil (Viagra, Revatio);
  • tadalafil (Cialis);
  • vardenafil (Levitra);
  • verapamil (Calan, Covera, Isoptin, Verelan); or
  • other blood pressure medications, including diuretics (water pills).

This list is not complete and other drugs may interact with terazosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about terazosin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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