Prazosin Hydrochloride
Generic Name: prazosin hydrochloride
Brand Names:
Prazosin Hydrochloride
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-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is: Molecular formula C 19 H 21 N 5 O 4 •HCl It is a white to tan powder, slightly soluble in water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87.
Overview
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-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is: Molecular formula C 19 H 21 N 5 O 4 •HCl It is a white to tan powder, slightly soluble in water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87.
Uses
INDICATIONS & USAGE Prazosin Hydrochloride Capsules, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
Dosage
DOSAGE & 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 two or three times a day (see WARNINGS). Maintenance Dose Dosage may be slowly increased to a total daily dose of 20 mg given in divided doses. The therapeutic dosages most commonly employed have ranged from 6 mg to 15 mg daily given in divided doses. Doses higher than 20 mg usually do not increase efficacy, however a few patients may benefit from further increases up to a daily dose of 40 mg given in divided doses. After initial titration some patients can be maintained adequately on a twice daily dosage regimen.
Side Effects
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 therapy are: dizziness 10.3%, headache 7.8%, drowsiness 7.6%, lack of energy 6.9%, weakness 6.5%, palpitations 5.3%, and nausea 4.9%. In most instances, side effects have disappeared with continued therapy or have been tolerated with no decrease in dose of drug. Less frequent adverse reactions which are reported to occur in 1% to 4% of patients are: Gastrointestinal: vomiting, diarrhea, constipation. Cardiovascular: edema, orthostatic hypotension, dyspnea, syncope. Central Nervous System: vertigo, depression, nervousness. Dermatologic: rash. Genitourinary: urinary frequency.
Interactions
DRUG INTERACTIONS Prazosin hydrochloride has been administered without any adverse drug interaction in limited clinical experience to date with the following: (1) cardiac glycosides-digitalis and digoxin; (2) hypoglycemics-insulin, chlorpropamide, phenformin, tolazamide, and tolbutamide; (3) tranquilizers and sedatives-chlordiazepoxide, diazepam, and phenobarbital; (4) antigout-allopurinol, colchicine, and probenecid; (5) antiarrhythmics-procainamide, propranolol (see WARNINGS however), and quinidine; and (6) analgesics, antipyretics and anti-inflammatories-propoxyphene, aspirin, indomethacin, and phenylbutazone. Addition of a diuretic or other antihypertensive agent to prazosin hydrochloride has been shown to cause an additive hypotensive effect.
Warnings
WARNINGS As with all alpha-blockers, prazosin hydrochloride may cause syncope with sudden loss of consciousness. In most cases, this is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe tachycardia with heart rates of 120–160 beats per minute. Syncopal episodes have usually occurred within 30 to 90 minutes of the initial dose of the drug; occasionally, they have been reported in association with rapid dosage increases or the introduction of another antihypertensive drug into the regimen of a patient taking high doses of prazosin hydrochloride. The incidence of syncopal episodes is approximately 1% in patients given an initial dose of 2 mg or greater. CONTRAINDICATIONS Prazosin Hydrochloride Capsules are contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.
Storage
HOW SUPPLIED Prazosin Hydrochloride Capsules, USP 1 mg for oral administration containing prazosin hydrochloride, USP equivalent to 1 mg of prazosin, are supplied as follows: Hard gelatin capsule shell with dark green colored cap and light brown colored body, imprinted with white ink as 019 on cap and novitium on body, filled with white to off-white powder blend.
Frequently Asked Questions
What is Prazosin Hydrochloride used for?▼
INDICATIONS & USAGE Prazosin Hydrochloride Capsules, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
What are the side effects of Prazosin Hydrochloride?▼
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 therapy are: dizziness 10.3%, headache 7.8%, drowsiness 7.6%, lack of energy 6.9%, weakness 6.5%, palpitations 5.3%, and nausea 4.9%. In most instances, side effects have disappeared with continued therapy or have been tolerated with no decrease in dose of drug. Less frequent adverse reactions which are reported to occur in 1% to 4% of patients are: Gastrointestinal: vomiting, diarrhea, constipation. Cardiovascular: edema, orthostatic hypotension, dyspnea, syncope. Central Nervous System: vertigo, depression, nervousness. Dermatologic: rash. Genitourinary: urinary frequency.
What are the important warnings for Prazosin Hydrochloride?▼
WARNINGS As with all alpha-blockers, prazosin hydrochloride may cause syncope with sudden loss of consciousness. In most cases, this is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe tachycardia with heart rates of 120–160 beats per minute. Syncopal episodes have usually occurred within 30 to 90 minutes of the initial dose of the drug; occasionally, they have been reported in association with rapid dosage increases or the introduction of another antihypertensive drug into the regimen of a patient taking high doses of prazosin hydrochloride. The incidence of syncopal episodes is approximately 1% in patients given an initial dose of 2 mg or greater. CONTRAINDICATIONS Prazosin Hydrochloride Capsules are contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.