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Hytrin (Terazosin Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

HYTRIN (terazosin hydrochloride) is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with HYTRIN. The long-term effects of HYTRIN on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.

HYTRIN tablets are also indicated for the treatment of hypertension. HYTRIN tablets can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.

DOSAGE AND ADMINISTRATION

If HYTRIN administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen.

Benign Prostatic Hyperplasia

Initial Dose

1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose. Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response.

Subsequent Doses

The dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for the clinical response. Therefore, treatment with 10 mg for a minimum of 4–6 weeks may be required to assess whether a beneficial response has been achieved. Some patients may not achieve a clinical response despite appropriate titration. Although some additional patients responded at a 20 mg daily dose, there was an insufficient number of patients studied to draw definitive conclusions about this dose. There are insufficient data to support the use of higher doses for those patients who show inadequate or no response to 20 mg daily.

Use with Other Drugs

Caution should be observed when HYTRIN tablets are administered concomitantly with other antihypertensive agents, especially the calcium channel blocker verapamil, to avoid the possibility of developing significant hypotension. When using HYTRIN tablets and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary (see PRECAUTIONS). Hypotension has been reported when Hytrin has been used with phosphodiesterase-5 (PDE-5) inhibitors.

Hypertension

The dose of HYTRIN and the dose interval (12 or 24 hours) should be adjusted according to the patient's individual blood pressure response. The following is a guide to its administration:

Initial Dose

1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded. This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects.

Subsequent Doses

The dose may be slowly increased to achieve the desired blood pressure response. The usual recommended dose range is 1 mg to 5 mg administered once a day; however, some patients may benefit from doses as high as 20 mg per day. Doses over 20 mg do not appear to provide further blood pressure effect and doses over 40 mg have not been studied. Blood pressure should be monitored at the end of the dosing interval to be sure control is maintained throughout the interval. It may also be helpful to measure blood pressure 2-3 hours after dosing to see if the maximum and minimum responses are similar, and to evaluate symptoms such as dizziness or palpitations which can result from excessive hypotensive response. If response is substantially diminished at 24 hours an increased dose or use of a twice daily regimen can be considered. If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. In clinical trials, except for the initial dose, the dose was given in the morning.

Use With Other Drugs (see above)

HOW SUPPLIED

HYTRIN tablets (terazosin hydrochloride tablets) are available in four dosage strengths:

1 mg, white tablets (bears the Abbott “A” logo and the Abbo-Code DF):

Bottles of 100 (NDC 0074-3322-13).

2 mg, orange tablets (bears the Abbott“A” logo and the Abbo-Code DH):

Bottles of 100 (NDC 0074-3323-13).

5 mg, tan tablets (bears the Abbott“A” logo and the Abbo-Code DJ):

Bottles of 100 (NDC 0074-3324-13).

10 mg, green tablets (bears the Abbott“A” logo and the Abbo-Code DI):

Bottles of 100 (NDC 0074-3325-13).

Recommended storage

Store below 86°F (30°C).

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