Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
TERAZOSIN HYDROCHLORIDE (UNII: D32S14F082) (TERAZOSIN - UNII:8L5014XET7)
Preferred Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
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. The long term effects of terazosin 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. They can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents. Terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.
Terazosin Capsules, USP 2 mg, are available as size 3 yellow opaque cap and white opaque body hard gelatin capsules, imprinted with "736" on the cap and "2 mg" on the body in black ink, packaged in bottles of 30 capsules, NDC # 68788-8171-3 PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT AND MOISTURE Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 08/2021
Abbreviated New Drug Application
TERAZOSIN- TERAZOSIN CAPSULE Preferred Pharmaceuticals Inc. ---------- PATIENT INFORMATION ABOUT TERAZOSIN CAPSULES, USP (ter ay'zoe sin) Rx only When used to treat HYPERTENSION or BENIGN PROSTATIC HYPERPLASIA (BPH) Please read this leaflet before you start taking terazosin capsules. Also, read it each time you get a new prescription. This is a summary and should NOT take the place of a full discussion with your doctor who has additional information about terazosin capsules. You and your doctor should discuss terazosin capsules and your condition before you start taking it and at your regular check-ups. Terazosin capsules are used to treat high blood pressure (hypertension). Terazosin capsules are also used to treat benign prostatic hyperplasia (BPH) in men. This leaflet describes terazosin capsules as a treatment for hypertension or BPH. What is hypertension (high blood pressure)? Blood pressure is the tension of the blood within the blood vessels. If blood is pumped too forcefully, or if the blood vessels are too narrow, the pressure of the blood against the walls of the vessels rises. If high blood pressure is not treated, over time, the increased pressure can damage blood vessels or it can cause the heart to work too hard and may decrease the flow of blood to the heart, brain, and kidneys. As a result, these organs may become damaged and not function correctly. If high blood pressure is controlled, this damage is less likely to happen. Treatment options for hypertension Non-drug treatments are sometimes effective in controlling mild hypertension. The most important lifestyle changes to lower blood pressure are to lose weight, reduce salt, fat, and alcohol in the diet, quit smoking, and exercise regularly. However, many hypertensive patients require one or more ongoing medications to control their blood pressure. There are different kinds of medications used to treat hypertension. Your doctor has prescribed terazosin capsules for you. What Terazosin Capsules do to treat hypertension Terazosin capsules work by Baca dokumen lengkapnya
TERAZOSIN- TERAZOSIN CAPSULE PREFERRED PHARMACEUTICALS INC. ---------- TERAZOSIN CAPSULES, USP DESCRIPTION Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative. The chemical name for terazosin hydrochloride, USP is (RS)- Piperazine, 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2- furanyl)carbonyl]-, monohydrochloride, dihydrate. It has the following structural formula: Terazosin hydrochloride, USP is a white, crystalline substance, freely soluble in water and isotonic saline. Each capsule for oral administration, contains terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg or 10 mg terazosin. In addition, each capsule contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, talc and corn starch. The capsule shells and imprinting inks contain: titanium dioxide, gelatin, shellac glaze, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, D&C Yellow #10 aluminum lake and FD&C Blue #1. The 2 mg capsule shell also contains D&C Red #33. FDA approved dissolution test specifications differ from USP. CLINICAL PHARMACOLOGY PHARMACODYNAMICS _A. BENIGN PROSTATIC HYPERPLASIA (BPH)_ The symptoms associated with BPH are related to bladder outlet obstruction, which is comprised of two underlying components: a static component and a dynamic component. The static component is a consequence of an increase in prostate size. Over time, the prostate will continue to enlarge. However, clinical studies have demonstrated that the size of the prostate does not correlate with the severity of BPH symptoms or the degree of urinary obstruction. The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck, leading to constriction of the bladder outlet. Smooth muscle tone is mediated by sympathetic nervous stimulation of alpha-1 adrenoceptors, which are abundant in the prostate, prostatic capsule and bladder neck. The reduction in Baca dokumen lengkapnya