MINIPRESS Capsule (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Laboratories Div Pfizer Inc

Λέξεις κλειδιά

0069-4310 0069-4370 0069-4380

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1. Description

MINIPRESS (prazosin hydrochloride), 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) ...

2. 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 vascular smooth ...

3. Indications and Usage

MINIPRESS 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 ...

4. Contraindications

MINIPRESS is contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.

5. Warnings

<b>As with all alpha-blockers, MINIPRESS 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 ...

6.1. 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 characterized by the combination ...

6.2. Information for Patients

Dizziness or drowsiness may occur after the first dose of this medicine. Avoid driving or performing hazardous tasks for the first 24 hours after taking this medicine or when the dose is increased. Dizziness, ...

6.3. Laboratory Tests

In clinical studies in which lipid profiles were followed, there were generally no adverse changes noted between pre- and post-treatment lipid levels.

6.4. Drug Interactions

MINIPRESS 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, ...

6.5. Drug/Laboratory Test Interactions

In a study on five patients given from 12 to 24 mg of prazosin per day for 10 to 14 days, there was an average increase of 42% in the urinary metabolite of norepinephrine and an average increase in urinary ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenic potential was demonstrated in an 18 month study in rats with MINIPRESS at dose levels more than 225 times the usual maximum recommended human dose of 20 mg per day. MINIPRESS was not mutagenic ...

6.7. Pregnancy

MINIPRESS has been shown to be associated with decreased litter size at birth, 1, 4, and 21 days of age in rats when given doses more than 225 times the usual maximum recommended human dose. No evidence ...

6.9. Nursing Mothers

MINIPRESS has been shown to be excreted in small amounts in human milk. Caution should be exercised when MINIPRESS is administered to a nursing woman.

6.10. Pediatric Use

Safety and effectiveness in children have not been established.

7. Adverse Reactions

Clinical trials were conducted on more than 900 patients. During these trials and subsequent marketing experience, the most frequent reactions associated with MINIPRESS therapy are: dizziness 10.3%, headache ...

9. Overdosage

Accidental ingestion of at least 50 mg of MINIPRESS in a two year old child resulted in profound drowsiness and depressed reflexes. No decrease in blood pressure was noted. Recovery was uneventful. Should ...

10. Dosage and Administration

The dose of MINIPRESS should be adjusted according to the patients individual blood pressure response. The following is a guide to its administration: Initial Dose 1 mg two or three times a day (see WARNINGS.) ...

11. How Supplied

Strength Capsule Color Capsule Code NDC Package Size MINIPRESS 1 mg White 431 0069-4310-71 250s MINIPRESS 2 mg Pink and White 437 0069-4370-71 250s MINIPRESS 5 mg Blue and White 438 ...

14. 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).