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TERAZOSIN is a brand name for Terazosin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Orally administered terazosin is indicated: (i) for the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). Terazosin is a selective post synaptic alpha-1- adrenoreceptor antagonist. Antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Only:
The dose of terazosin should be adjusted according to the patient's response.
The following is a guide to administration:
Initial dose 1 mg before bedtime is the starting dose for all patients and should not be exceeded. Strict compliance with this recommendation should be observed to minimise acute first-dose hypotensive episodes. Therefore, use of an alternative preparation will be necessary for initiation of therapy.
Subsequent dose In the treatment of BPH:
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 10 mg once daily. Improvements in symptoms have been detected as early as two weeks after starting treatment with terazosin.
At present there are insufficient data to suggest additional symptomatic relief with doses above 10 mg once daily. Transient side effects may occur at each titration step. If any side effects persist, consideration should be given to reducing the dose In the treatment of hypertension: 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. Use with thiazide diuretics and other antihypertensive agents When adding a thiazide diuretic or another antihypertensive agent to a patient's treatment regimen, the dose of terazosin should be reduced and retitration carried out if necessary.
Caution should be observed when terazosin is administered with thiazides or other antihypertensive agents as hypotension may develop. Use in renal insufficiency Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended dosages.
Use in patients with hepatic insufficiency The terazosin dose 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, in common with other alpha-adrenoreceptor antagonists, may cause syncope. 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 agent.
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 tachycardia with heart rates of 120 to 160 beats per minute.
If syncope occurs the patient should be placed in a recumbent position and given supportive treatment as necessary. Dizziness, light-headedness or fainting may occur when standing up quickly from a lying or sitting position. Patients should be advised of this possibility and instructed to lie down if these symptoms appear and then sit for a few minutes before standing to prevent recurrence.
These adverse effects are self limiting and, in most cases, do not recur after the initial period of therapy or during subsequent re-titration. Adverse events reported with terazosin from multiple sources including clinical trials and spontaneous reports: Blood and lymphatic system disorder Thrombocytopenia Immune system disorders Anaphylactoid reaction Psychiatric disorders Depression, nervousness, anxiety, insomnia Nervous system disorders Dizziness, somnolence, headache, paraesthesia, vertigo Eye disorders Blurred vision, amblyopia, visual impairment, conjunctivitis Ear and labyrinth disorders Tinnitus Cardiac disorders Palpitations, tachycardia, arrhythmia, atrial fibrillation Vascular disorders Postural hypotension, syncope, vasodilatation Respiratory, thoracic and mediastinal disorders Nasal congestion, rhinitis, dyspnoea, sinusitis, bronchitis, epistaxis, flu symptoms, pharyngitis, cold symptoms, cough Gastrointestinal system disorders Nausea, abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, flatulence, vomiting Skin and subcutaneous tissue disorders Pruritus, rash, hyperhidrosis, angioedema Musculoskeletal and connective tissue disorders Back pain, pain in extremity, neck pain, shoulder pain, gout, arthralgia, arthritis, joint disorders, myalgia Renal and urinary disorders Pollakiuria, urinary tract infection and urinary incontinence (primarily reported in post-menopausal women).
Terazosin hydrochloride, like other alpha-adrenoceptor blockers, can cause marked lowering of blood pressure, especially postural hypotension and syncope in association with the first dose or first few doses of therapy. A similar effect can be anticipated if therapy is interrupted for more than a few doses and then re-started.
Syncope has also been reported with other alpha-adrenoceptor blockers 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.
In clinical trials, the incidence of postural hypotension was greater in BPH patients than in those with hypertension. 6%). If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.
Before treating the symptoms of benign prostatic hyperplasia (BPH) with alpha- blockers, other causes of impaired urinary flow or urinary symptoms should be excluded. Also, where the diagnosis of BPH has been established, it should be confirmed that there is no concomitant obstruction of the upper urinary tract or any signs of infection before treating with terazosin.
Patients with benign prostatic hyperplasia, who simultaneously suffer from congestion of the upper urinary tract, chronic urinary tract infection or bladder stones, should not be treated with terazosin. Terazosin should not be given to patients with bladder overflow, anuria or advanced renal failure.
Due to the risk of an excessive decrease in blood pressure, caution is advised for the concomitant administration of terazosin and thiazides or other antihypertensive medications. If a thiazide diuretic or another antihypertensive medication is added during treatment with terazosin, the terazosin dose must be reduced or the drug discontinued.
1. Known sensitivity to other alpha-adrenoceptor blockers. Patients with a history of micturition syncope.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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As no clinical experience is available in patients with severe hepatic impairment, the use of terazosin is not recommended in these patients. Use in Children Terazosin Tablets are not recommended for use in children. Safety and efficacy in children has not been established.
Use in the Elderly Pharmacokinetic studies in the elderly indicate that no alteration in dosage recommendation is required. Postural Hypotension Postural hypotension has been reported to occur in patients receiving terazosin for the symptomatic treatment of urinary obstruction caused by BPH.
6%) Method of Administration For oral administration. Response to treatment to be reviewed at four weeks. If administration is discontinued for more than several days, therapy should be re- instituted using the initial dose titration regimen.
Reproductive system and breast disorders Libido decreased, erectile dysfunction, priapism General disorders and administration site conditions Asthenia, peripheral oedema, oedema, chest pain, face oedema, pyrexia Investigations Weight increased.
Decreased haematocrit, decreased haemoglobin, decreased white blood cell count, decreased total protein and decreased blood albumin (suggestive of haemodilution) Treatment with terazosin for up to 24 months had no significant effect on prostate specific antigen (PSA) levels.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
A new dose-titration is essential. When administering terazosin in addition to other antihypertensives, the dose of the other antihypertensives should 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: • Pulmonary oedema due to aortic or mitral valve stenosis • High output cardiac insufficiency • Right-sided cardiac insufficiency due to pulmonary embolism or pericardial effusion • Left-sided cardiac insufficiency with low filling pressure In patients with severe coronary heart disease, a very rapid or excessive decrease in blood pressure can lead to an exacerbation of angina pectoris.
Laboratory Tests:
Small but statistically significant decreases in haematocrit, haemoglobin, white blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggest the possibility of haemodilution.
Treatment with terazosin for up to 24 months had no significant effect on Prostate Specific Antigen (PSA) levels. Caution is also recommended, when terazosin is administered concomitantly with drugs, which may influence hepatic metabolism.
g. sildenafil, tadalafil, verdenafil) and terazosin may lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phophodiesterase-5- inhibitors.
The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha- adrenoceptor blockers and the possibility of 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. Terazosin 2mg Tablets contain lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Terazosin 2mg Tablets contain colouring agent quinoline yellow lake E104 May cause allergic reactions. Terazosin 2mg Tablets contain sodium This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.