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Presentation

Oral formulations of terazosin hydrochloride.

Drugs List

  • HYTRIN 10mg tablets
  • HYTRIN 2mg tablets
  • HYTRIN 5mg tablets
  • HYTRIN BPH starter pack
  • HYTRIN starter pack
  • terazosin 10mg tablets
  • terazosin 2mg tablets
  • terazosin 5mg tablets
  • terazosin bph starter pack
  • terazosin starter pack
  • Therapeutic Indications

    Uses

    Hypertension - mild to moderate
    Lower urinary obstruction due to benign prostatic hyperplasia

    Mild to moderate hypertension: Monotherapy or in combination with thiazide diuretics and/or other antihypertensive drugs.

    Symptomatic treatment of lower urinary obstruction caused by benign prostatic hyperplasia.

    Dosage

    Adults

    Hypertension:
    An initial dose of 1mg daily before bedtime. The daily dose can then be doubled at approximately weekly intervals to achieve the desired response.
    A typical maintenance dose is 2mg to 10mg once daily.

    Benign prostatic hyperplasia:
    An initial dose of 1mg daily before bedtime. The daily dose can then be doubled at approximately weekly or fortnightly intervals as necessary to achieve the desired response.
    A typical maintenance dose is 5mg to 10mg once daily.

    Additional Dosage Information

    If using terazosin in combination with thiazide diuretics or other antihypertensive agents, the dose of terazosin should be reduced and re-titration carried out if necessary.

    Review patient response at each dose increase as side effects may occur at each stage. If these persist, consider a dose reduction.

    Contraindications

    Children under 18 years
    Micturition syncope
    Anuria
    Congestive cardiac failure secondary to mechanical obstruction
    Galactosaemia
    History of micturition syncope - if treating benign prostatic hyperplasia
    Pregnancy

    Precautions and Warnings

    Patients over 65 years
    Predisposition to orthostatic hypotension
    Breastfeeding
    Cerebrovascular disorder
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    High output cardiac failure
    History of postural hypotension
    Hypertensive retinopathy
    Ischaemic heart disease
    Lactose intolerance
    Left ventricular failure
    Pulmonary oedema due to aortic stenosis
    Pulmonary oedema due to mitral stenosis
    Renal impairment
    Right sided cardiac insufficiency due to PE or pericardial effusion

    Advise hypotension/syncope may affect ability to drive/operate machinery
    Advise patient not to drive/operate machinery after first or dose changes
    Benign prostatic hyperplasia: Exclude prostate carcinoma before treatment
    Exclude urinary tract infection before treatment of BPH
    Not all available brands are licensed for all indications
    Contains lactose
    Some formulations contain sunset yellow (E110); may cause allergic reaction
    Monitor blood pressure after dose increases
    Profound hypotension can occur,especially after initial dose-monitor
    Review therapy after 4 weeks
    Intraoperative Floppy Iris Syndrome has been reported in cataract surgery
    May cause postural hypotension especially in elderly
    Seek immediate medical attention if priapism occurs
    Retitration of dosage required after interruption of therapy

    Exclude concomitant obstruction of the upper urinary tract before treatment.

    Pregnancy and Lactation

    Pregnancy

    Terazosin is contraindicated in pregnancy. There is insufficient study data to conclude safety of terazosin during pregnancy. Other drugs with a greater safety profile should be considered first.

    Animal studies in terazosin have shown no teratogenic effect. There have been incidence of foetal resorption in rat and rabbit studies, and low foetal weight observed in rabbits. At a dose greater than 75 times the recommended maximum human dose a significant increase in mortality in perinatal and postnatal rat pups has been seen. Terazosin may also increase the duration of pregnancy and inhibit labour.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Use terazosin with caution in breastfeeding. There is limited data to support the use of terazosin during breastfeeding.

    The molecular weight of terazosin is low enough that excretion into breast milk should be expected. The effects on the nursing infant from exposure to the drug from breast milk are unknown. An alternative antihypertensive drug may be preferred, especially while nursing a newborn or preterm infant.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Counselling

    Advise patients that their ability to drive or operate machinery may be impaired by dizziness, light-headedness or drowsiness. They should avoid driving or operating machinery for about 12 hours after the initial dose or each subsequent dose increase or if they are aware that they are affected by these effects.

    Advise patient to seek immediate medical attention if priapism occurs.

    Side Effects

    Abdominal pain
    Abnormal vision
    Amblyopia
    Anaphylactic reaction
    Angioedema
    Anxiety
    Arrhythmias
    Arthralgia
    Arthritis
    Asthenia
    Atrial fibrillation
    Back pain
    Blurred vision
    Bronchitis
    Chest pain
    Common cold
    Conjunctivitis
    Constipation
    Cough
    Cough increased
    Decrease in haematocrit
    Decrease in haemoglobin
    Decreased serum albumin
    Decreased total serum protein
    Depression
    Diarrhoea
    Dizziness
    Drowsiness
    Dry mouth
    Dyspepsia
    Dyspnoea
    Epistaxis
    Erectile dysfunction
    Facial oedema
    Fever
    Flatulence
    Gastro-intestinal symptoms
    Gout
    Headache
    Hypotension
    Impotence
    Influenza-like syndrome
    Insomnia
    Intraoperative floppy iris syndrome
    Joint disorder
    Light-headedness
    Myalgia
    Nasal congestion
    Nausea
    Neck pain
    Nervousness
    Oedema
    Painful extremities
    Palpitations
    Paraesthesia
    Peripheral oedema
    Pharyngitis
    Postural hypotension
    Priapism
    Pruritus
    Rash
    Reduced libido
    Rhinitis
    Shoulder pain
    Sinusitis
    Somnolence
    Sweating
    Syncope
    Tachycardia
    Thrombocytopenia
    Tinnitus
    Urinary frequency
    Urinary incontinence
    Urinary tract infections
    Vasodilation
    Vertigo
    Vomiting
    Weight gain
    White blood cell count decreased

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: January 2018

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 January 2018

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Terazosin Last revised: 10 March 2015
    Last accessed: 18 January 2018

    Summary of Product Characteristics: Benph tablets 2mg. Generics UK Ltd t/a Mylan. Revised August 2015.
    Summary of Product Characteristics: Benph tablets 5mg. Generics UK Ltd t/a Mylan. Revised August 2015.
    Summary of Product Characteristics: Hytrin tablets 2mg. Concordia International. Revised February 2016.
    Summary of Product Characteristics: Hytrin tablets 5mg. Concordia International. Revised February 2016.
    Summary of Product Characteristics: Hytrin tablets 10mg. Concordia International. Revised February 2016.
    Summary of Product Characteristics: Terazosin Teva tablets 2mg. Teva Pharma. Revised July 2015.
    Summary of Product Characteristics: Terazosin Teva tablets 5mg. Teva Pharma. Revised July 2015.
    Summary of Product Characteristics: Terazosin Teva tablets 10mg. Teva Pharma. Revised July 2015.

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