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  • Hytrin
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    Active Ingredient
    Terazosin (as monohydrochloride dihydrate) 2 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    Stater pack: 7 X 1 mg + 7 X 2 mg

    partial basket chart 9564 8130

    Tablets

    28 X 5 mg

    partial basket chart 9536 8004

    Tablets

    28 X 10 mg

    partial basket chart 9563 8099

    Related information


    Dosage

    1 mg before bedtime is the starting dose for all patients and should not be exceeded. Compliance with this initial dosage recommendation should be strictly observed to minimise potential for acute first-dose hypotensive episodes.
    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.
    BPH
    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.
    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. At present there are insufficient data to suggest additional symptomatic relief with doses above 10mg once daily. Treatment should be initiated using the BPH Starter Pack and response to treatment reviewed at four weeks. Transient side effects may occur at each titration step. If any side effects persist, consideration should be given to reducing the dose.
    Use in renal insufficiency:
     Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended dosages.
    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: has been reported to occur in patients receiving terazosin for the symptomatic treatment of urinary obstruction caused by BPH. In these cases, the incidence of postural hypotensive events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%).
    Use with thiazide diuretics and other antihypertensive agents: When adding a thiazide diuretic or another antihypertensive agent to a patient’s regimen the dose of Hytrin should be reduced and retitration carried out if necessary. Caution should be observed when Hytrin is administered with thiazides or other antihypertensive agents as hypotension may develop.
    For full details see prescribing information.


    Indications

    Symptomatic treatment of urinary obstruction caused by benign prostatic hypertrophy (BPH), mild to moderate hypertension.


    Contra-Indications

    Hypersensitivity.


    Special Precautions

    As with other alpha adrenoreceptor antagonists, terazosin is not recommended in patients with a history of micturition syncope. In clinical trials, the incidence of postural hypotension was greater in BPH patients than those with hypertension. In these cases, the incidence of postural hypotension events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%). If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen. There have been reports of hypotension following the use of a phosphodiesterase-5 (PDE-5) inhibitor and terazosin. Concomitant treatment with tadalafil is not recommended and caution is advised when sildenafil or vardenafil is administered with terazosin 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-1 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-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.


    Side Effects

    Hytrin in common with other alpha-adrenoceptor 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 supportive treatment applied 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 their 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: The most common events were asthenia, palpitations, nausea, peripheral oedema, dizziness, somnolence, nasal congestion/rhinitis and blurred vision/amblyopia.In addition, the following have been reported: back pain; headache; tachycardia; postural hypotension; syncope; oedema; weight gain; pain in extremities; decreased libido; depression; nervousness; paraesthesia; vertigo; dyspnoea; sinusitis and impotence. Additional adverse reactions reported in clinical trials or reported during marketing experience but not clearly associated with the use of terazosin include the following: chest pain; facial oedema; fever; abdominal pain; neck pain; shoulder pain; vasodilation; arrhythmia; constipation; diarrhoea; dry mouth; dyspepsia; flatulence; vomiting; gout; arthralgia; arthritis; joint disorders; myalgia; anxiety; insomnia; bronchitis; epistaxis; flu symptoms; pharyngitis; rhinitis; cold symptoms; pruritis; rash; increased cough; sweating; abnormal vision; conjunctivitis; tinnitus; urinary frequency; urinary tract infection and urinary incontinence primarily reported in post-menopausal women. At least two cases of anaphylactoid reactions have been reported with the administration of terazosin.
    Post marketing experience: Thrombocytopenia and priapism have been reported. Atrial fibrillation has been reported: however, a cause and effect relationship has not been established. 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.


    Drug interactions

    In patients receiving terazosin plus ACE inhibitors or diuretics the proportion reporting dizziness or related side effects was greater than in the total population of terazosin treated patients from clinical trials. 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.Terazosin has been given without interaction with analgesics/anti-inflammatories, cardiac glycosides, hypoglycemics, antiarrhythmics, anxiolytics/sedatives, antibacterials, hormones/steroids and drugs used for gout. Hypotension has been reported when terazosin has been used with phosphodiesterase-5 (PDE-5) inhibitors. Concomitant treatment with terazosin and sildenafil or vardenafil should only be initiated if the patient is stabilised on terazosin. In addition, vardenafil should not be administered within 6 hours of terazosin, and sildenafil should not be initiated within 4 hours of terazosin therapy.


    Pregnancy and Lactation

    Although no teratogenic effects were seen in animal testing, the safety of Hytrin use during pregnancy or during lactation has not yet been established. Hytrin should not be used therefore in pregnancy unless the potential benefit outweighs the risk.
    For full details see prescribing information.


    Manufacturer
    Aesica Queenborough
    Licence holder
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