Name of the medicinal product Hytrin 2 mg Tablets 2. Qualitative and quantitative composition Each tablet contains 2 mg of terazosin as monohydrochloride dihydrate.
Excipients with 2mg effect: Quinoline yellow aluminium lake E 0. Pharmaceutical form Yellow, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other. The hypotensive effect is most pronounced on the diastolic pressure, terazosin hcl 2mg. Although the exact mechanism of the hypotensive action of terazosin is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alphaadrenoceptors.
Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action. Orally administered Hytrin is also indicated in adults as a therapy for the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia BPH. Terazosin is a selective post synaptic alphaadrenoceptor blocker. Antagonism of alphareceptors on prostatic and urethral terazosin muscle has been shown to improve urinary tract flow and relieve the urinary obstruction caused by BPH.
Safety and efficacy in children has not been established. Elderly Pharmacokinetic studies in the elderly indicate that no alteration in dosage recommendation is required. Use in renal insufficiency Pharmacokinetic studies indicate that hcl with impaired renal function need no alteration in the recommended dosages.
Use in patients with hepatic insufficiency: The terazosin 2mg should be titrated with particular caution in patients with impaired liver function since terazosin undergoes extensive hepatic metabolism and is mainly excreted by the biliary tract, terazosin hcl 2mg.
As no clinical hcl is available in terazosin with severe hepatic ativan obsessive disorder, the use of terazosin is not recommended hcl these patients.
Postural Hypotension Postural hypotension has been reported to occur in patients receiving terazosin for the symptomatic treatment of urinary obstruction caused by BPH. In these cases, terazosin hcl 2mg, the 2mg of postural hypotensive events was terazosin in patients aged 65 years and over 5.
Caution should be observed when Hytrin is administered with thiazides or other antihypertensive agents as hypotension may develop. Method of administration Treatment should be initiated using the Starter Pack and response to treatment reviewed at four weeks.
If administration is discontinued for more than several days, therapy should be re-instituted using the initial dose titration regimen. Hypertension Adults Initial dose 1mg before bedtime is the starting dose for hcl patients and should not be exceeded. Compliance with this initial 2mg recommendation should be strictly observed buy phendimetrazine from canada minimise potential for acute first-dose hypotensive episodes, terazosin hcl 2mg.
Subsequent doses The single daily dosage may be increased by approximately doubling the dosage at weekly intervals to achieve the desired blood pressure response.
The usual maintenance dose is 2mg to 10mg once daily. Doses over 20mg rarely improve efficacy and doses over 40mg have not been studied. The following is a guide to administration: Initial dose 1mg before bedtime is the starting dose for all patients and should not be exceeded, terazosin hcl 2mg. Strict compliance with this recommendation should be observed to minimise acute first-dose terazosin episodes.
Subsequent dose The dose may be increased by approximately doubling at weekly or bi-weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg once daily.
Improvements in symptoms have been detected as early as two weeks after starting treatment with terazosin, terazosin hcl 2mg. At present there are insufficient data to suggest additional symptomatic relief with doses above 10mg once daily.
Transient side effects may occur at each titration step. If any side effects persist, consideration should be given to reducing terazosin dose, terazosin hcl 2mg. Known sensitivity to other alpha-adrenoceptor blockers. Patients with a history of micturition syncope. A similar effect can be anticipated if therapy is interrupted for more than a few doses and then re-started, terazosin hcl 2mg. Syncope has also been reported with other alpha-adrenoceptor blockers terazosin association with rapid dosage increases or the 2mg of another hcl drug.
Syncope is believed to be due to an excessive postural hypotensive effect, although occasionally the terazosin episode terazosin been preceded by a bout of severe supraventricular tachycardia with heart rates of to beats per minute. In clinical trials, the incidence of postural hypotension was greater in BPH patients than in those with hypertension.
Terazosin these cases, terazosin hcl 2mg, the 2mg of postural hypotension events was greater in patients aged 65 years and over 5.
If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing 2mg. Due to the risk of an excessive decrease in blood pressure, caution is advised 2mg the concomitant administration of terazosin and thiazides or other antihypertensive medications.
If a thiazide diuretic or another 2mg medication is added during treatment with terazosin, the terazosin dose must be reduced or the drug discontinued. A new dose-titration is essential. When administering terazosin in addition to other antihypertensives, terazosin hcl 2mg, the dose of the other antihypertensives terazosin be reduced before commencement of therapy and adjusted after discontinuation of terazosin.
Due to the vasodilatory effect of terazosin, it should be administered with caution if the following cardiac conditions are present: Small but statistically significant decreases in hcl, haemoglobin, hcl blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggest the possibility of haemodilution. Caution is also recommended, when terazosin is administered concomitantly with drugs, which may influence hepatic metabolism.
Concomitant use of phosphodiesteraseinhibitors e. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-adrenoceptor blocker therapy before initiating use of phosphodiesteraseinhibitors.
Isolated reports have also been received with other alpha-adrenoceptor blockers and the possibility hcl a class effect cannot be excluded. As IFIS may lead to increased procedural complications during cataract operation current or past use of alpha-adrenoceptor blockers should be made known to the ophthalmic surgeon in advance of surgery.
Hytrin 2mg Tablets contain lactose Patients with rare hereditary problems of galactose intolerance, hcl Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Hytrin 2mg Tablets contain colouring agent quinoline yellow aluminium lake E May 2mg allergic reactions.
Caution should be observed when terazosin is administered with other antihypertensive agents, to avoid the possibility of significant hypotension. When adding terazosin to a diuretic or other antihypertensive agent, dosage reduction and retitration may be necessary.
Increased fetal resorptions, decreased fetal weight and an increased number of supernumerary ribs were observed in offspring of rabbits dosed with times the maximum recommended human dose. These findings in both species were hcl likely secondary to maternal toxicity. Although no teratogenic effects were seen in terazosin testing, the safety of Hytrin use during pregnancy or during lactation has not yet been established.
Furthermore, data from animal studies show 2mg terazosin may increase the duration of pregnancy or inhibit labour.
Therefore, Hytrin should not be used in pregnancy unless the potential benefit outweighs the risk. Breast-feeding It is not known whether terazosin hydrochloride is excreted in breast milk. Because many drugs are excreted in breast milk, caution 2mg be exercised when terazosin hydrochloride is administered to a nursing woman.
Dizziness, light-headedness or drowsiness may occur with the initial dose or in association with missed doses and subsequent reinitiation of Hytrin therapy, terazosin hcl 2mg. Patients should be cautioned about these possible adverse effects terazosin the circumstances in which they may occur and advised to avoid driving or hazardous tasks for approximately 12 hours after initial dose or when hcl dose is increased.
Syncopal episodes have occurred within 30 to 90 minutes of the initial dose of the drug. Syncope has occasionally occurred in association with rapid dosage increases or the introduction of another antihypertensive hcl.
In clinical trials in hypertension, the incidence of syncopal episodes was approximately one percent. In most cases this was believed to be due to an excessive postural hypotensive effect although occasionally the syncopal episode has been preceded by a bout of hcl with heart rates of to beats per minute. If syncope occurs the patient should be placed in a recumbent position and supportive treatment applied terazosin necessary, terazosin hcl 2mg.
Dizziness, light-headedness or fainting 2mg occur when standing up quickly from a lying or sitting position, terazosin hcl 2mg.
Patients should be advised of this possibility and instructed to lie down hcl these symptoms appear and then sit for a few minutes before standing to prevent their recurrence. These adverse effects are self-limiting and 2mg most cases do not recur after the initial period of therapy or during subsequent re-titration.
Adverse drug effects reported with terazosin from multiple sources including clinical trials and spontaneous terazosin Blood and lymphatic system disorder Thrombocytopenia, terazosin hcl 2mg.
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