Prazosin Hydrochloride (Page 3 of 3)

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. Recovery was uneventful.

Should overdosage lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressors should then be used. Renal function should be monitored and supported as needed. Laboratory data indicate prazosin hydrochloride capsules are not dialysable because it is protein bound.

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 taking prazosin hydrochloride capsules.

HOW SUPPLIED

Product: 68151-2030

NDC: 68151-2030-1 1 CAPSULE in a BLISTER PACK

REFERENCES

1)
Lubbe, WF, and Hodge, JV: New Zealand Med J, 94 (691) 169-172,1981.
2)
Davey, DA, and Dommisse, J: SA. Med J, Oct.4, 1980 (551-556).

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 11/2016
PRSN:R16

PRAZOSIN HYDROCHLORIDE CAPSULE

Label ImageLabel Image
PRAZOSIN HYDROCHLORIDE
prazosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-2030(NDC:0378-1101)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAZOSIN HYDROCHLORIDE (PRAZOSIN) PRAZOSIN 1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERROSOFERRIC OXIDE
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
D&C YELLOW NO. 10
FD&C GREEN NO. 3
AMMONIA
PROPYLENE GLYCOL
SHELLAC
DIMETHICONE
Product Characteristics
Color GREEN (dark green opaque) , BROWN (light brown opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code MYLAN;1101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-2030-1 1 CAPSULE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072575 02/28/1989
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-2030)

Revised: 12/2017 Carilion Materials Management

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