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Drug Catalog - Product Detail

TERAZOSIN HCL CP 10MG 100

NDC Mfr Size Str Form
00378-1570-01 MYLAN 100 10MG CAPSULE
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Description
DESCRIPTION Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name and structural formula: 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-(tetrahydro-2-furoyl)piperazine monohydrochloride dehydrate. Terazosin hydrochloride, USP is a white to pale yellow, crystalline powder, freely soluble in water and isotonic saline and has a molecular weight of 423.9. Each terazosin capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochloride, USP anhydrous. Each capsule contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D&C Red No. 28, D&C Red No. 33, FD&C Blue No. 1, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. In addition, the 1 mg capsule contains yellow iron oxide; the 2 mg and 5 mg capsules contain black iron oxide. The black imprinting ink for the 1 mg, 5 mg and 10 mg capsules contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. The white imprinting ink for the 2 mg capsules contains the following ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide. Terazosin Structural Formula
How Supplied
HOW SUPPLIED Terazosin Capsules, USP are available containing 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochloride, USP anhydrous. The 1 mg capsule is a hard-shell gelatin with a rich yellow opaque cap and a light lavender opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 2260 in black ink on both the cap and body. They are available as follows: NDC 0378-2260-01 bottles of 100 capsules The 2 mg capsule is a hard-shell gelatin with a black opaque cap and a light lavender opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 2264 in white ink on both the cap and body. They are available as follows: NDC 0378-2264-01 bottles of 100 capsules The 5 mg capsule is a hard-shell gelatin with an iron gray opaque cap and a light lavender opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 2268 in black ink on both the cap and body. They are available as follows: NDC 0378-2268-01 bottles of 100 capsules The 10 mg capsule is a hard-shell gelatin with a light lavender opaque cap and a light lavender opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 1570 in black ink on both the cap and body. They are available as follows: NDC 0378-1570-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense Patient Information Leaflet with each prescription.
Indications & Usage
INDICATIONS AND USAGE Terazosin capsules are 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 capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION If terazosin capsules 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 to 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. If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. Use With Other Drugs Caution should be observed when terazosin capsules are administered concomitantly with other antihypertensive agents, especially the calcium channel blocker verapamil, to avoid the possibility of developing significant hypotension. When using terazosin capsules and other antihypertensive agents concomitantly, dosage reduction and retitration of either agent may be necessary (see PRECAUTIONS ). Hypotension has been reported when terazosin capsules have been used with phosphodiesterase-5 (PDE-5) inhibitors. Hypertension The dose of terazosin capsules 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 to 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)