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. Tell your doctor if you develop any new symptoms. 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.
Deger G "Comparison of the safety and efficacy of once-daily terazosin versus twice-daily prazosin for the treatment of mild to moderate hypertension. While syncope is the most severe orthostatic effect of Hytrin 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.
Doses of 10 mg once daily are generally required for the clinical response. Caution should be observed when Hytrin 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 tablets and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary see PRECAUTIONS. Hypotension has been reported when Hytrin has been used with phosphodiesterase-5 PDE-5 inhibitors. The adverse reactions were usually mild or moderate in intensity but sometimes were serious enough to interrupt treatment.
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
If Hytrin is helping you, you should notice an effect on your particular symptoms in 2 to 4 weeks of starting to take the medication. Hytrin may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens. 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. 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. If you miss a dose of Hytrin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist. Includes weakness, tiredness, lassitude and fatigue. 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. Most reports were in patients treated with an alpha-1 blocker at the time IFIS occurred, but in some instances the alpha-1 blocker had been stopped prior to surgery. The manufacturer recommends that patients be questioned to determine whether or not they have taken alpha-1 blockers prior to being considered for cataract surgery. If it is determined that the patient has taken an alpha-1 blocker, the patient's ophthalmologist should be prepared for possible modifications to their surgical technique that may be necessary should IFIS be observed during the procedure. Hernandez RH, Angeligreaves M, Carvajal AR, Pajuelo JG, Padilla MCA, Armashernandez MJ "Terazosin: ex vivo and in vitro platelet aggregation effects in patients with arterial hypertension. At first, 1 mg taken at bedtime. Then, 1 to 5 mg once a day.
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. 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. 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. Bottles of 100 NDC 0074-3324-13. 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.
In this long-term trial, both symptom scores and peak urinary flow rates showed statistically significant improvement suggesting a relaxation of smooth muscle cells. Terazosin is available only with your doctor's prescription. 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. Tell your doctor or dentist that you take Hytrin before you receive any medical or dental care, emergency care, or surgery including eye surgery. Store Hytrin at room temperature, between 68 and 77 degrees F 20 and 25 degrees C. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hytrin out of the reach of children and away from pets. 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. Syncope has occurred in less than 1% of patients. Palpitations have been reported in 5% of patients, but are much less likely than with some other alpha-adrenergic blockers. Peripheral edema, cold extremities, and chest pain have been reported in up to 6%, 12%, and 5% of patients, respectively. Atrial fibrillation has been reported incidence not given. 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. 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 therapy to rule out the presence of carcinoma of the prostate. At first, 1 milligram mg taken at bedtime. Then, 5 to 10 mg once a day. Musculoskeletal complaints of pain or cold extremities have been reported in up to 17% and 12% of patients, respectively. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. 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. Do not keep outdated medicine or medicine no longer needed. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. 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. 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. 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. 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. 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. Both differences were statistically significant. Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. 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. 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. Koh MJ, Seah PP, Tay YK, Mancer K "Lichenoid drug eruption to terazosin. 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.
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. Terazosin helps to lower blood pressure by relaxing blood vessels so that blood passes through them more easily. Lowe FC "Safety assessment of terazosin in the treatment of patients with symptomatic benign prostatic hyperplasia - a combined analysis. Use and dose must be determined by your doctor. 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.
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. 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. 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. There was a tendency for patients to gain weight during terazosin therapy. Respiratory system side effects have been limited to nasal congestion in 2% to 12% of patients. Similar adverse reaction rates were observed in placebo-controlled monotherapy trials. Only 4% of 354 patients from a multicenter trial complained of general abdominal pain or diarrhea within the first 90 days of therapy. 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. 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. It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Bottles of 100 NDC 0074-3323-13. Yellow No. 6, lactose, magnesium stearate, povidone and talc. 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. Hytrin relaxes the tightness of a certain type of muscle in the prostate and at the opening of the bladder. 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.
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. 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. Medication. There are different kinds of medication used to treat BPH. Your doctor has prescribed Hytrin for you. See "What Hytrin does to treat BPH" below. 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. 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. If Hytrin administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen. Your doctor has prescribed Hytrin 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. Hytrin is not a treatment for prostate cancer.
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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. Hytrin is used to treat high blood pressure hypertension. Hytrin is also used to treat benign prostatic hyperplasia BPH in men. This leaflet describes Hytrin as a treatment for hypertension or BPH. What Is Hypertension High Blood Pressure? Hematologic side effects have included thrombocytopenia.
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. These adverse effects all occurred within 90 minutes of dosing. 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. 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.
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. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459. 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.
Take Hytrin by mouth with or without food. Lepor H, Jones K, Williford W "The mechanism of adverse events associated with terazosin: An analysis of the Veterans Affairs cooperative study. If using Hytrin for an extended period of time, obtain refills before your supply runs out.