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Terazosin

Terazosin 
Таblets 2 mg,

Таblets 5 mg
ATC G04C A03

Prescription only medicine

Medicines reimbursed by the Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION


For oral use.

The dose of terazosin should be adjusted according to the patient’s response.

Guide to administration:
Initial dose
The lowest starting dose is 1 mg before bedtime for all patients, which should not be exceeded during the first week of treatment. Strict compliance with this recommendation should be observed to minimise potential acute first-dose hypotensive episodes.
Subsequent doses

Treatment of Mild to Moderate Hypertension

The single daily dosage may be increased by approximately doubling the dosage at weekly intervals to achieve the desired response. The maintenance dose should be adjusted depending on the patient’s response. A dose of 2 mg daily may be sufficient, with increases up to 10 mg daily, if necessary (clinical studies support the use of doses from 2 to 10 mg as a maintenance dose). The maximal daily dose of terazosin is 20 mg and this should not be exceeded.

Use with Thyazide Diuretics and Other Antihypertensives for Hypertension Treatment

When adding a thiazide diuretic or another antihypertensive agent, the dose of terazosin should be reduced or discontinued and retitration carried out if necessary. Caution should be observed when terazosin is administered with thiazide diuretic or other antihypertensive agents as hypotension may develop

Treatment of Bening Prostatic Hyperplasia (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 10mg once daily. Treatment should be initiated using 1 mg for 7 days, 2 mg for 14 days and 5 mg for 7 days. Response to treatment must be reviewed at 4 weeks. Transient side effects may occur at each titration step. If any side effects persist, consideration should be given to reducing the dose.

Dosage in Renal Insufficiency

Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the dosages.

]Dosage in Children and Adolescents

There are no data on the safety and efficacy of terazosine in children and adolescents under 18 years. Therefore, treatment with terazosin in this population is not recommended.

Dosage in Elderly Patients

Pharmacokinetic studies in elderly patients indicate that no alteration in dosage is required. However, particular caution should be taken with the titration of the terazosin dose. If the administration of the medicine is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.

Dosage in Hepatic Insufficiency

The terazosin dose should be titrated with particular caution in patients with impaired hepatic function since terazosin undergoes extensive hepatic metabolism and is mainly excreted by the biliary tract. As no clinical experience is available in patients with severe hepatic impairment, the use of terazosin is not recommended in this population.

Method of Administration

The first defined dose of medicine should be taken in the evening at bedtime. The following dose of the medicine with the same strength may be taken in the morning. The tablets should be taken with a sufficient amount of liquid (i.e. 1 glass of water). Therapy of hypertension with terazosin is a long-term treatment, which should only be interrupted on medical advice. If it is necessary to stop terazosin therapy, the dose should be re-titrated starting with 1 mg terazosin at bedtime.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

COMPOSITION

Each tablet contains 2 mg terazosin (in form of terazosin hydrochloride dehydrate), excipients.
Each tablet contains 5 mg terazosin (in form of terazosin hydrochloride dehydrate), excipients.

THERAPEUTIC INDICATIONS

Terazosin is indicated for:
• treatment of mild to moderate hypertension,
• symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH).

CONTRAINDICATIONS

Terazosin is contraindicated in:
• Patients with known hypersensitivity to terazosin, to other quinazolines (eg prazosin, doxazosin, alfuzosin, indoramin or tamsulosin) or to any of the excipients.
• In patients with a history of micturation syncope.

PACKAGING

Box with 30 tablets of 2 mg (3 blisters x 10 tablets)
Box with 30 tablets of 5 mg (3 blisters x 10 tablets)