Prazosin Hydrochloride (Page 3 of 3)

DOSAGE AND ADMINISTRATION

The dose of prazosin hydrochloride capsules USP 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 USP should be reduced to 1 mg or 2 mg three times a day and retitration then carried out.

Concomitant administration of prazosin hydrochloride capsules USP 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 taking prazosin hydrochloride capsules USP.

HOW SUPPLIED

Prazosin hydrochloride capsules USP are available as follows:

1 mg: An ivory opaque capsule, filled with white powder, imprinted with “TEVA” on the cap and “4067” on the body, containing prazosin hydrochloride, USP equivalent to 1 mg of prazosin.

2 mg: A pink opaque capsule, filled with white powder, imprinted with “TEVA” on the cap and “4068” on the body, containing prazosin hydrochloride, USP equivalent to 2 mg of prazosin.

5 mg: A light blue opaque capsule, filled with white powder, imprinted with “TEVA” on the cap and “4069” on the body, containing prazosin hydrochloride, USP equivalent to 5 mg of prazosin.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-1075-1 2 MG 30 Capsules in a Blister Pack PINK 0093-4068

Keep away from children.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

REFERENCES

1. Lubbe, WF, and Hodge, JV: New Zealand Med J , 94 (691) 169-172, 1981.

2. Davey, DA, and Dommisse, J: S.A. Med J , Oct. 4, 1980 (551-556).

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

Prazosin Hydrochloride Capsules 1 mg 100s Label Text

NDC 0093-4067 -01

PRAZOSIN
HYDROCHLORIDE
Capsules USP
1 mg*

Rx only

100 CAPSULES

TEVA

Prazosin Hydrochloride Capsules 2 mg 100s Label Text

NDC 0093-4068 -01

PRAZOSIN
HYDROCHLORIDE
Capsules USP
2 mg*

Rx only

100 CAPSULES

TEVA

Prazosin Hydrochloride Capsules 5 mg 100s Label Text

NDC 0093-4069 -01

PRAZOSIN
HYDROCHLORIDE
Capsules USP
5 mg*

Rx only

100 CAPSULES

TEVA

PACKAGE LABEL

Label Image for 53808-1075 2mg

Label Image for 2mgLabel Image for 2mg
PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1075(NDC:0093-4068)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAZOSIN HYDROCHLORIDE (PRAZOSIN) PRAZOSIN 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
STARCH, CORN
FD&C BLUE NO. 1
FD&C RED NO. 40
D&C RED NO. 28
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code TEVA;4068
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-1075-1 30 CAPSULE (CAPSULE) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071995 11/01/2014
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-1075)

Revised: 01/2015 State of Florida DOH Central Pharmacy

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.