Terazosin

• Hytrin^®

Yes

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.

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.

Terazosin may be found in some form under the following brand names:

• Hytrin

Serious side effects have been reported. See "Drug Precautions" section.

Common ide effects you could have while taking terazosin include:

• drowsiness
• blurred or hazy vision
• nausea
• swelling of the feet or hands

This is not a complete list of terazosin side effects. Ask your doctor or pharmacist for more information.

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

Before taking terazosin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to terazosin or any inactive ingredient in terazosin
• have or have ever had prostate cancer
• have or have ever had liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take terazosin exactly as prescribed. Follow the directions on your prescription label carefully. Your doctor will likely start you on a low dose and gradually increase the dose as necessary.

The terazosin dose range is 1 mg to 20 mg taken once daily.

If you take too much terazosin, call your local Poison Control Center or seek emergency medical attention right away.

It is important that your doctor check your progress at regular visits to make sure that terazosin is working properly.

For patients taking terazosin for high blood pressure :

• Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Dizziness, lightheadedness, or sudden fainting may occur after you take terazosin, especially when you get up from a lying or sitting position. These effects are more likely to occur when you take the first dose of terazosin. Taking the first dose at bedtime may prevent problems. However, be especially careful if you need to get up during the night. These effects may also occur with any doses you take after the first dose. Getting up slowly may help lessen this problem. If you feel dizzy, lie down so that you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

The dizziness, lightheadedness, or fainting is more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking terazosin, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Terazosin may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to terazosin before you drive, use machines, or do anything else that could be dangerous if you are dizzy, drowsy, or are not alert. After you have taken several doses of terazosin, these effects should lessen.

• It is used to treat high blood pressure.
• In men, it is used to treat the signs of an enlarged prostate.
• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Stuffy nose.
• Runny nose.
• Upset stomach.
• Feeling tired or weak.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Syncope and "First-Dose" Effect

Terazosin capsules, 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 to 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 Terazosin, given at bedtime. The 2 mg, 5 mg and 10 mg capsules 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 Terazosin at doses of 2.5 mg, 5 mg 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 light-headedness 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 Terazosin, 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 Terazosin 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).

• Alpha1 Blocker
• Antihypertensive

Usual Adult Dose for Hypertension:

Initial dose: 1 mg orally once a day at bedtime
Maintenance dose: 1 to 5 mg orally once a day.
Maximum dose: 20 mg per day.

Usual Adult Dose for Benign Prostatic Hyperplasia:

Initial dose: 1 mg orally once a day at bedtime.
Maintenance dose: Increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once a day to achieve desired improvement of symptoms.