Label: PRAZOSIN HYDROCHLORIDE capsule
- NDC Code(s): 67046-1532-3
- Packager: Coupler, LLC
- This is a repackaged label.
- Source NDC Code(s): 70756-430
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 19, 2025
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONFor Oral Use - Rx Only
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DESCRIPTIONPrazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy ...
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CLINICAL PHARMACOLOGYThe exact mechanism of the hypotensive action of prazosin is unknown. Prazosin causes a decrease in total peripheral resistance and was originally thought to have a direct relaxant action on ...
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INDICATIONS AND USAGEPrazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events ...
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CONTRAINDICATIONSPrazosin hydrochloride capsules are contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.
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WARNINGSAs with all alpha-blockers, prazosin hydrochloride capsules may cause syncope with sudden loss of consciousness. In most cases, this is believed to be due to an excessive postural hypotensive ...
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PRECAUTIONSGeneral - Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers. This variant of small pupil syndrome is ...
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ADVERSE REACTIONSClinical trials were conducted on more than 900 patients. During these trials and subsequent marketing experience, the most frequent reactions associated with prazosin hydrochloride capsules ...
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OVERDOSAGEAccidental ingestion of at least 50 mg of prazosin hydrochloride capsules in a two year old child resulted in profound drowsiness and depressed reflexes. No decrease in blood pressure was noted ...
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DOSAGE AND ADMINISTRATIONThe dose of prazosin hydrochloride capsules should be adjusted according to the patient's individual blood pressure response. The following is a guide to its administration: Initial Dose - 1 mg ...
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HOW SUPPLIEDPrazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin. The 1 mg capsule is White opaque cap/ white opaque body ...
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ReferencesLubbe, WF, and Hodge, JV: New Zealand Med J, 94 (691) 169–172, 1981. Davey, DA, and Dommisse, J: S.A. Med J, Oct. 4, 1980 (551–556). Manufactured for: Lifestar Pharma LLC - 1200 MacArthur ...
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INGREDIENTS AND APPEARANCEProduct Information