Prazosin Hydrochloride 2 mg/1
Prazosin Hydrochloride · CAPSULE · Marlex Pharmaceuticals Inc
Prazosin Hydrochloride is a capsule containing prazosin hydrochloride at 2 mg/1, taken oral. Manufactured by Marlex Pharmaceuticals Inc.
Key Facts
- Brand Name
- Prazosin Hydrochloride
- Generic Name
- Prazosin Hydrochloride
- NDC Code (Product)
10135-667- Manufacturer
- Marlex Pharmaceuticals Inc
- Strength
- 2 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210971
- Marketing Start
- 10/01/2018
Recall History
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Teva Pharmaceuticals USA, Inc
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Teva Pharmaceuticals USA, Inc
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Amerisource Health Services LLC
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Amerisource Health Services LLC
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Amerisource Health Services LLC
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Teva Pharmaceuticals USA, Inc
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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, 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. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concl…
Dosage & Administration
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 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. Use With Other Drugs When adding a diuretic or other antihypertensive agent, the dose of prazosin hydrochloride capsules should be reduced to 1 mg or 2 mg three times a day and retitration then carried out. Concomitant administration of prazosin hydrochloride capsules with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension; therefore, PDE-5 inhibitor therapy should be initiated at the lowest dose in patients…
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 to 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. Clinical trials conducted during the investigational phase of this drug suggest that syncopal episodes can be minimized by limiting the initial dose of the drug to 1 mg, by subsequently increasing the dosage slowly, and by introducing any additional antihypertensive drugs into the patient’s regimen with caution (see DOSAGE AND ADMINISTRATION ) . Hypotension may develop in patients given prazosin hydrochloride who are also receiving a beta-…
Contraindications
CONTRAINDICATIONS Prazosin hydrochloride capsules are contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.
Drug 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. This effect can be minimized by reducing the prazosin hydrochloride dose to 1 mg to 2 mg three times a day, by introducing additional antihypertensive drugs cautiously, and then by retitrating prazosin hydrochloride based on clinical response. Concomitant administration of prazosin hydrochloride with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension (see DOSAGE A…
Adverse Reactions
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. EENT: blurred vision, reddened sclera, epistaxis, dry mouth, nasal congestion. In addition, fewer than 1% of patients have reported the following (in some instances, exact causal relationships have not been established): Gastrointestinal: abdominal discomfort and/or pain, liver function abnormalities, pancreatitis. Cardiovascular: tachycardia. Central Nervous System: paresthesia, hallucinations. Dermatologic: prurit…
Frequently Asked Questions
What is Prazosin Hydrochloride used for?
Prazosin Hydrochloride contains Prazosin Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is Prazosin Hydrochloride a controlled substance?
Prazosin Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Prazosin Hydrochloride?
The generic name for Prazosin Hydrochloride is Prazosin Hydrochloride. There are 3 other brand versions of Prazosin Hydrochloride.
What is the NDC code for Prazosin Hydrochloride 2 mg/1?
The NDC (National Drug Code) for Prazosin Hydrochloride 2 mg/1 is 10135-667, listed by Marlex Pharmaceuticals Inc.
Other Prazosin Hydrochloride Dosages
- Prazosin Hydrochloride5 mg/176282-723
- Prazosin Hydrochloride1 mg/110135-666
- Prazosin Hydrochloride1 mg/163629-8750
- Prazosin Hydrochloride1 mg/168788-7335
- Prazosin Hydrochloride1 mg/10378-1101
- Prazosin Hydrochloride1 mg/176282-721
- Prazosin Hydrochloride1 mg/151079-630
- Prazosin Hydrochloride5 mg/151079-632
- Prazosin Hydrochloride2 mg/10378-2302
Other Prazosin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)