Terazosin Hydrochloride

Terazosin Hydrochloride

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Questions & Answers

Side Effects & Adverse Reactions

Syncope and "First-Dose" Effect

Terazosin hydrochloride capsules, like other alpha-adrenergic blocking agents, can cause marked lowering of blood pressure, especially postural hypotension, and syncope in association with the first dose or first few days of therapy. A similar effect can be anticipated if therapy is interrupted for several days and then restarted. Syncope has also been reported with other alpha-adrenergic blocking agents 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. Additionally, the possibility of the contribution of hemodilution to the symptoms of postural hypotension should be considered.

To decrease the likelihood of syncope or excessive hypotension, treatment should always be initiated with a 1 mg dose of terazosin, given at bedtime. The 2 mg, 5 mg and 10 mg capsules are not indicated as initial therapy. Dosage should then be increased slowly, according to recommendations in the Dosage and Administration section and additional antihypertensive agents should be added with caution. The patient should be cautioned to avoid situations, such as driving or hazardous tasks, where injury could result should syncope occur during initiation of therapy.

In early investigational studies, where increasing single doses up to 7.5 mg were given at 3 day intervals, tolerance to the first dose phenomenon did not necessarily develop and the "first-dose" effect could be observed at all doses. Syncopal episodes occurred in 3 of the 14 subjects given terazosin at doses of 2.5 mg, 5 mg and 7.5 mg, which are higher than the recommended initial dose; in addition, severe orthostatic hypotension (blood pressure falling to 50/0 mmHg) was seen in two others and dizziness, tachycardia, and lightheadedness occurred in most subjects. These adverse effects all occurred within 90 minutes of dosing.

In three placebo-controlled BPH studies 1, 2, and 3 (see CLINICAL PHARMACOLOGY), the incidence of postural hypotension in the terazosin treated patients was 5.1%, 5.2%, and 3.7% respectively.

In multiple dose clinical trials involving nearly 2,000 hypertensive patients treated with terazosin, syncope was reported in about 1% of patients. Syncope was not necessarily associated only with the first dose.

If syncope occurs, the patient should be placed in a recumbent position and treated supportively as necessary. There is evidence that the orthostatic effect of terazosin is greater, even in chronic use, shortly after dosing. The risk of the events is greatest during the initial seven days of treatment, but continues at all time intervals.

Priapism

Rarely, (probably less than once in every several thousand patients) terazosin and other α1-antagonists have been associated with priapism (painful penile erection, sustained for hours and unrelieved by sexual intercourse or masturbation). Two or three dozen cases have been reported. Because this condition can lead to permanent impotence if not promptly treated, patients must be advised about the seriousness of the condition (see PRECAUTIONS: Information for Patients).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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 terazosin hydrochloride. The long-term effects of terazosin hydrochloride on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.

Terazosin hydrochloride is also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.

History

There is currently no drug history available for this drug.

Other Information

Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following structural formula, molecular formula and chemical name:

Chemical Structure

Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, anhydrous.

Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459.93. Each terazosin hydrochloride capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochloride anhydrous. Each capsule contains the following inactive ingredients: crospovidone, lactose (monohydrate), magnesium stearate and microcrystalline cellulose. The capsule shells and imprinting inks contain: D & C Yellow # 10 Aluminum Lake, FD & C Blue # 1 Aluminum Lake, FD & C Blue # 2 Aluminum Lake, FD & C Red # 40 Aluminum Lake, gelatine, pharmaceutical glaze, propylene glycol, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide, and titanium dioxide. The 5 mg also contains; D & C Red # 28. 

Terazosin Hydrochloride Manufacturers


  • State Of Florida Doh Central Pharmacy
    Terazosin Hydrochloride Capsule [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Terazosin Hydrochloride Capsule [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Terazosin Hydrochloride Capsule [State Of Florida Doh Central Pharmacy]
  • Rebel Distributors Corp
    Terazosin Hydrochloride Capsule [Rebel Distributors Corp]
  • Remedyrepack Inc.
    Terazosin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Terazosin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Terazosin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Terazosin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Bryant Ranch Prepack
    Terazosin Hydrochloride (Terazosin Hydrochloride) Capsule [Bryant Ranch Prepack]
  • Remedyrepack Inc.
    Terazosin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Terazosin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Terazosin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Terazosin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Stat Rx Usa Llc
    Terazosin Hydrochloride Capsule [Stat Rx Usa Llc]
  • Preferred Pharmaceuticals, Inc
    Terazosin Hydrochloride Capsule [Preferred Pharmaceuticals, Inc]
  • Cardinal Health
    Terazosin Hydrochloride Capsule [Cardinal Health]
  • Bryant Ranch Prepack
    Terazosin Hydrochloride (Terazosin Hydrochloride) Capsule [Bryant Ranch Prepack]
  • Physicians Total Care, Inc.
    Terazosin Hydrochloride Capsule [Physicians Total Care, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Terazosin Hydrochloride (Terazosin) Capsule [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Lake Erie Medical Dba Quality Care Products Llc
    Terazosin Hydrochloride Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Terazosin Hydrochloride Capsule [Remedyrepack Inc. ]
  • Sandoz Inc
    Terazosin Hydrochloride Capsule [Sandoz Inc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Terazosin Hydrochloride Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Major Pharmaceuticals
    Terazosin Hydrochloride Capsule [Major Pharmaceuticals]
  • Aphena Pharma Solutions – Tennessee, Llc
    Terazosin Hydrochloride (Terazosin Hydrochloride) Capsule Terazosin Hydrochloride Capsule [Aphena Pharma Solutions – Tennessee, Llc]
  • Teva Pharmaceuticals Usa Inc
    Terazosin Hydrochloride Capsule [Teva Pharmaceuticals Usa Inc]

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