Prazopress ER Tablet 5mg

Product Information

PRAZOPRESS ER

Prazopress-ER® Prazosin

Presentation

Prazopress-ER 2.5 tablet: Light violet, round-shaped tablet; each extended release tablet contains Prazosin Hydrochloride BP

equivalent to Prazosin 2.5mg.

Prazopress-ER 5 tablet: Light green, round-shaped tablet; each extended release tablet contains Prazosin Hydrochloride BP

equivalent to Prazosin 5mg.

Indication

Prazosin extended release tablet is indicated in the treatment of mild to moderate essential hypertension. It is employed in a

general treatment program in association with a thiazide diuretic and/or other antihypertensive agents as needed for proper

patient response.

Dosage & administration

Dosage should be individualized depending on patient tolerance and response. Therapy for hypertension must be initiated with

Prazosin extended release 2.5mg once daily. Prazosin extended release 5mg is not for initial dosing. Dosage may be increased

slowly, in general over a 7 to 14 day period, depending on the response to each dose level. Doses above 20mg once daily have not

been studied.

Maintenance dose: dosage may be increased as clinically indicated to 20mg given in once-daily doses. Hypertensive patients

controlled on Prazosin tablets alone or in combination with other antihypertensive medications may be switched to Prazosin

extended release tablets at the equivalent or nearest higher total daily dose, e.g. Prazosin tablets 4 mg daily equivalent to

Prazosin extended release tablets 5 mg once daily. Blood pressure measurements should be taken at the end of the dosing interval

to assure adequate blood pressure control is maintained throughout the 24 hour period. Further titration may be necessary in some

patients.

Contraindications, warnings etc.

Contraindication: Prazosin extended release tablet is contraindicated in patients with a known sensitivity to quinazolines.

Warnings: Prazosin may cause syncope and/or excessive hypotension 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

about of severe tachycardia with heart rates of 120-160 beats per minute. To decrease the likelihood of syncope or excessive

hypotension, treatment should always be initiated with Prazosin extended release 2.5 mg tablet. The 5 mg tablet is not indicated

as initial therapy. Patients should be made aware of the possibility of occurrence of symptoms associated with lowering of blood

pressure e.g. orthostatic symptoms, especially at the initiation of therapy and to avoid driving or hazardous tasks for 24 hours

after the first dose, after a dosage increase, and after interruption of therapy when treatment is resumed. Dizziness,

lightheadedness or fainting may occur, especially when rising from a supine or sitting position. If such an event occurs, patients

should be advised to lie down. Getting up slowly and going from a supine to a sitting position before standing up may help reduce

the problem. As with most other antihypertensive agents, while taking Prazosin extended release tablet patients should be careful

of their alcohol intake, use extra care during exercise or hot weather, and avoid standing for long periods, all of which can

contribute to the occurrence of orthostatic symptoms. If dizziness, lightheadedness, or palpitations are bothersome they should be

reported to the physician.

In patients with congestive cardiac failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to

mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial

disease. Adequate data are not yet available to establish efficacy in patients with heart failure due to recent myocardial

infarction.

Drug Interactions: Prazosin has been administered without any adverse drug interaction in clinical experience to date with the

following: Digitalis and digoxin, insulin, chlorpropamide, phenformin, tolazamide and tolbutamide, chlordiazepoxide, diazepam and

Phenobarbital, allopurinol, colchicine and probenecid, procainamide, propranolol and quinidine, propoxyphene, aspirin,

indomethacin and phenylbutazone. Interaction studies have not been performed with Prazosin extended release tablet. Addition of a

diuretic or other antihypertensive agent to Prazosin extended release tablet has been shown to cause an additive hypotensive

effect. An exaggerated hypotensive response has also been observed. 

Use in Pregnancy and Lactation: Although no teratogenic effects were seen in animal testing, there are no adequate and well

controlled studies which establish the safety of Prazosin extended release tablet in pregnant women. Prazosin extended release

tablet should be used during pregnancy only if in the opinion of the physician the potential benefit outweighs potential risk to

mother and child. Prazosin has been shown to be excreted in small amounts in human milk. Caution should be exercised when Prazosin

extended release tablet is administered to nursing mothers.

Adverse Reactions: Four hundred and eighty one (481) hypertensive patients from placebo controlled multiple-dose trials treated

with Prazosin extended release tablets were included in the evaluation of adverse effects. Adverse reactions requiring

discontinuation of therapy occurred in 2.9% of patients. In controlled clinical trials in 689 patients, the most serious adverse

reaction was syncope which occurred in one patient (0.1%) on the fourth day of dosing with Prazosin extended release tablet. The

most common adverse effects reported with Prazosin extended release tablet were headache, dizziness, fatigue, edema and

palpitations.

Overdose: Accidental ingestion of at least 50 mg of prazosin in a 2-year old child resulted in profound drowsiness and depressed

reflexes. No decrease in blood pressure was noted. Recovery was uneventful. Should over-dosage 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 including angiotensin should then be used. Renal function should be monitored and supported as needed.

Laboratory data indicate Prazosin is not dialysable because it is protein bound.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Prazopress-ER 2.5 tablet: Carton contains 20 tablets in alu-alu blister.

Prazopress-ER 5 tablet: Carton contains 20 tablets in alu-alu blister.