Label: PRAZOSIN HYDROCHLORIDE capsule

  • 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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  • SPL UNCLASSIFIED SECTION
    For Oral Use - Rx Only
  • DESCRIPTION
    Prazosin 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 ...
  • CLINICAL PHARMACOLOGY
    The 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 ...
  • INDICATIONS AND USAGE
    Prazosin 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 ...
  • CONTRAINDICATIONS
    Prazosin hydrochloride capsules are contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.
  • WARNINGS
    As 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 ...
  • PRECAUTIONS
    General - 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 ...
  • ADVERSE REACTIONS
    Clinical trials were conducted on more than 900 patients. During these trials and subsequent marketing experience, the most frequent reactions associated with prazosin hydrochloride capsules ...
  • OVERDOSAGE
    Accidental 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 ...
  • DOSAGE AND ADMINISTRATION
    The 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 ...
  • HOW SUPPLIED
    Prazosin 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 ...
  • References
    Lubbe, 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 APPEARANCE
    Product Information