Food and Drug Administration. WebMD does not endorse any specific product, service, or treatment. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. Hytrin works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure. What is BPH?
At first, 1 mg taken at bedtime. Then, 1 to 5 mg once a day. About Prostate Specific Antigen PSA. Your doctor may have done a blood test called PSA. Your doctor is aware that Hytrin does not affect PSA levels. You may want to ask your doctor more about this if you have had a PSA test done. Lepor H, Jones K, Williford W "The mechanism of adverse events associated with terazosin: An analysis of the Veterans Affairs cooperative study. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
There was a tendency for patients to gain weight during terazosin therapy. The information contained in the Truven Health Micromedex products as delivered by Drugs. In a study of 226 patients on terazosin the active ingredient contained in Hytrin for up to 2 years, only 2 discontinued therapy due to rash. Rarely, probably less than once in every several thousand patients terazosin and other α 1-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.
Only 4% of 354 patients from a multicenter trial complained of general abdominal pain or diarrhea within the first 90 days of therapy. Hytrin 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. This may not be a complete list of all interactions that may occur. Ask your health care provider if Hytrin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Remember that terazosin will not shrink the size of your prostate but it does help to relieve the symptoms. Doses of 10 mg once daily are generally required for the clinical response. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hytrin while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Hytrin, check with your doctor. Discuss any possible risks to your baby. If you have any questions about Hytrin, please talk with your doctor, pharmacist, or other health care provider. Some MEDICINES MAY INTERACT with Hytrin. Statistically significant differences were not found in the verapamil level with and without terazosin. Tell your doctor or dentist that you take Hytrin before you receive any medical or dental care, emergency care, or surgery including eye surgery.
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. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs. 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. Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of terazosin in children with use in other age groups. In multiple dose clinical trials involving nearly 2000 hypertensive patients treated with Hytrin tablets, syncope was reported in about 1% of patients. Syncope was not necessarily associated only with the first dose. Hytrin may cause a sudden drop in blood pressure after the first dose. Take your first dose at bedtime. If you get up during the night, sit up slowly, then stand slowly. In a short term study Study 1 patients were randomized to either 2, 5 or 10 mg of Hytrin or 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. The rash was accompanied by mild fever, asthenia, and intense pruritus. The patient was on no other medications. Hematologic and histopathologic studies suggested a drug reaction. Terazosin was discontinued. Two weeks following oral methylprednisolone 40 mg daily and emollients, symptoms had resolved completely. Hypersensitivity reactions have been reported, including anaphylaxis and rashes. Bottles of 100 NDC 0074-3325-13. Take Hytrin by mouth with or without food. 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. Testicular weights and morphology were unaffected by treatment.
Bottles of 100 NDC 0074-3324-13. Bottles of 100 NDC 0074-3323-13. This information should not be used to decide whether or not to take Hytrin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Hytrin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Hytrin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Hytrin. In all three studies, both symptom scores and peak urine flow rates showed statistically significant improvement from baseline in patients treated with Hytrin from week 2 or the first clinic visit and throughout the study duration. Analysis of the effect of Hytrin on individual urinary symptoms demonstrated that compared to placebo, Hytrin 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. 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 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. 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. The classifications below are a general guideline only. It is difficult to determine the relevance of a particular drug interaction to any individual given the large number of variables. Because of this effect, your doctor may have told you to take Hytrin at bedtime. If you take Hytrin 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. 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. 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.
To decrease the likelihood of syncope or excessive hypotension, treatment should always be initiated with a 1 mg dose of Hytrin 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. Oddly enough, though, I think this has led to another problem. Do not consider WebMD User-generated content as medical advice. Never delay or disregard seeking professional medical advice from your doctor or other qualified healthcare provider because of something you have read on WebMD. You should always speak with your doctor before you start, stop, or change any prescribed part of your care plan or treatment. WebMD understands that reading individual, real-life experiences can be a helpful resource but it is never a substitute for professional medical advice, diagnosis, or treatment from a qualified health care provider. If you think you may have a medical emergency, call your doctor or dial 911 immediately. Respiratory system side effects have been limited to nasal congestion in 2% to 12% of patients. Use and dose must be determined by your doctor.
Terazosin may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine 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 this medicine, these effects should lessen. In this long-term trial, both symptom scores and peak urinary flow rates showed statistically significant improvement suggesting a relaxation of smooth muscle cells. The presence of other medical problems may affect the use of this medicine. 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 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. Hytrin 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. Do NOT take more than the recommended dose without checking with your doctor.
Hematologic side effects have included thrombocytopenia. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Terazosin helps relax the muscles in the prostate and the opening of the bladder. Cardiovascular side effects have included orthostatic hypotension, which generally occurs within 30 to 60 minutes after the first dose. For this reason, it is recommended that the first dose be administered at bedtime. Other symptoms of hypotension, such as mild to moderate dizziness, lightheadedness, palpitations and weakness have occurred in 1% to 30% of patients. Some cardiovascular side effects, particularly dizziness, have been more prevalent among persons greater than 65 years old. The opinions expressed in WebMD User-generated content areas like communities, reviews, ratings, or blogs are solely those of the User, who may or may not have medical or scientific training. These opinions do not represent the opinions of WebMD. User-generated content areas are not reviewed by a WebMD physician or any member of the WebMD editorial staff for accuracy, balance, objectivity, or any other reason except for compliance with our Terms and Conditions. If your symptoms do not improve or if they become worse, check with your doctor. Hytrin may cause a sudden drop in blood pressure after the first dose. Take your first dose at bedtime. If you get up during the night, sit up slowly, then stand slowly. This will help to reduce your lightheadedness or dizziness. These effects are more likely to occur after the first few doses or if your dose has increased, but can occur at any time while you are taking the medicine. It can also occur if you stop taking the medicine and then restart treatment. Similar adverse reaction rates were observed in placebo-controlled monotherapy trials. Female rats were unaffected. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Itskovitz HD "Alpha-1-blockade for the treatment of hypertension - a megastudy of terazosin in 2214 clinical practice settings. 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. Check with your pharmacist about how to dispose of unused medicine. It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly.
Do not drink alcohol or use medicines that may cause drowsiness eg, sleep aids, muscle relaxers while you are using Hytrin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459. Tell your doctor if you develop any new symptoms. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease. Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. 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. Lab tests, including blood pressure, may be performed while you use Hytrin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. 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. Nervous system side effects, such as dizziness 5% to 30% of patients and blurred vision 2% of patients may be related to hypotension. Headaches 2% to 10% asthenia 8% and somnolence 6% have occurred following long-term use. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs including any herbal medicines or supplements or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. Oddly enough, though, I think this has led to another problem. I've developed nocturia and often have to get up from bed to urinate. Now that my flow is strengthened due to this med, I often have incontinence if I'm in a deep sleep and the urge doesn't wake me up in time. Not sure of this, of course, but it seems logical. Follow your doctor's instructions about how to take Hytrin. 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 with anyone else; it was prescribed only for you.
Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. This can cause problems in urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely. Elhilali MM, Ramsey EW, Barkin J, Casey RW, Boake RC, Beland G, Fradet Y, Trachtenberg J, Orovan WL, Schick E, Klotz LH "A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of terazosin in the treatment of benign prostatic hyperplasia. 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 for up to 24 months had no significant effect on prostate specific antigen PSA levels. Some medical conditions may interact with Hytrin. 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 substances you are taking, check with your doctor, nurse, or pharmacist. Hytrin 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. You will start with a 1 mg dose of Hytrin. Then the dose will be increased as your body gets used to the effect of the medication. Patients should also be told that drowsiness or somnolence can occur with Hytrin tablets, requiring caution in people who must drive or operate heavy machinery. Hytrin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. 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.
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. Musculoskeletal complaints of pain or cold extremities have been reported in up to 17% and 12% of patients, respectively. Cohen J "Long-term efficacy and safety of terazosin. Should overdosage of Hytrin 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 is highly protein bound; therefore, dialysis may not be of benefit. Highest dose 10 mg shown. Deger G "Comparison of the safety and efficacy of once-daily terazosin versus twice-daily prazosin for the treatment of mild to moderate hypertension.
Terazosin helps to lower blood pressure by relaxing blood vessels so that blood passes through them more easily. Hytrin is to be used only by the patient for whom it is prescribed. Do not share it with other people. Do not use it for other health conditions. Remember that terazosin will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. 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 for you. Blue No. 2, lactose, magnesium stearate, povidone and talc. Keep Hytrin and all medicines out of the reach of children. The dose of Hytrin and the dose interval 12 or 24 hours should be adjusted according to the patient's individual blood pressure response. Keep out of the reach of children. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.
Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response. Both differences were statistically significant. 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 this medicine, 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. Bottles of 100 NDC 0074-3322-13. This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects. Dermatologic side effects of skin rash have been reported rarely. Lichenoid drug eruption has been associated with terazosin the active ingredient contained in Hytrin therapy. 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. Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal. Dizziness, lightheadedness, or fainting especially when getting up from a lying or sitting position may be more likely to occur in the elderly, who are more sensitive to the effects of terazosin. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. Cohen J "Long-term efficacy and safety of terazosin alone and in combination with other antihypertensive agents. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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Koh MJ, Seah PP, Tay YK, Mancer K "Lichenoid drug eruption to terazosin. Shionoiri H, Gotoh E, Ito T, Hata T, Iwatsubo H, Takegawa K, Ogihara T, Mikami H, Ikegami H, Otsuka A, Katahira K, Kawaguchi Y "Long-term therapy with terazosin may improve glucose and lipid metabolism in hypertensives - a multicenter prospective study. 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.
If using Hytrin for an extended period of time, obtain refills before your supply runs out. Mersey JH "Long-term experience with terazosin for treatment of mild to moderate hypertension. Terazosin is available only with your doctor's prescription. However, terazosin will not help shrink the prostate. The prostate may continue to grow. This may cause the symptoms to become worse over time. Therefore, even though terazosin may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future.
VERY weak urine stream. I find that, as long as I take it on schedule, and don't forget doses, my urine stream has improved a great deal, almost to the level of what I considered normal. Extremely rarely, Hytrin 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. 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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. 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.