INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PRATSIOL 1 mg, 2 mg, 5 mg (tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

PRATSIOL 1 mg, 2 mg, 5 mg (tablets)

COMPOSITION
Pratsiol 1 mg: Each tablet contains 1,095 mg prazosin hydrochloride equivalent to 1 mg
prazosin.
Pratsiol 2 mg: Each tablet contains 2,190 mg prazosin hydrochloride equivalent to 2 mg prazosin.
Pratsiol 5 mg: Each tablet contains 5,475 mg prazosin hydrochloride equivalent to 5 mg prazosin.

PHARMACOLOGICAL CLASSIFICATION
A 7.1 Vasodilators, hypotensive medicines.

PHARMACOLOGICAL ACTION
The hypotensive effect of Pratsiol is due to vasodilation.
Although the mechanism of action of prazosin is not completely understood it appears to act predominantly as an alpha-adrenergic blocking agent on vascular smooth muscle.
The major current hypothesis is that prazosin is a selective blocking agent at postsynaptic alpha-(1)-adrenergic receptors.
Prazosin decreases arterial pressure and reduces arterial resistance and venous tone.
During chronic administration of prazosin to hypertensive patients, the cardiac index is increased, peripheral vascular resistance is reduced and the heart rate is moderately increased.
More than 99% of prazosin is metabolised, and there may be substantial first pass metabolism.
Bioavailability averages 57%. In normal volunteers the plasma half-life of prazosin is about 3 hours; this value is probably not altered in renal failure. However, when prazosin is given orally to patients with congestive heart failure, concentrations in the blood are higher and the half-life is prolonged.

INDICATIONS
Pratsiol alone or in combination with other hypotensive agents, is indicated in the treatment of mild to moderate hypertension.

CONTRA-INDICATIONS
Known hypersensitivity to the medicine.
The safety of Pratsiol in pregnancy has not been established.
Pratsiol is not recommended for use in children under 12 years of age.

WARNINGS
Pratsiol may cause syncope, sudden loss of consciousness and acute tachycardia which may have serious consequences and will need immediate attention. These effects maybe noted at the initiation of therapy or at any stage during treatment usually after dose increments. The risk of these complications may be reduced by initiating therapy with a dose of 0,5 mg and ensuring that any increment of therapy is introduced cautiously.

DOSAGE AND DIRECTIONS FOR USE
Initial dose:
In order to avoid a rapid hypotensive reaction the average initial dose should be low, 0,5 mg two to three times daily. The first dose should be taken at bedtime.
Maintenance dose: The dose may slowly be increased until an antihypertensive effect is achieved. Up to 20 mg per day may eventually be required for maximal efficacy.
If an adequate response is not obtained a thiazide diuretic or a beta-adrenergic blocking agent may be added to the therapy.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Sudden collapse may follow the initial dose of Pratsiol. Side-effects commonly include nasal congestion, dryness of mouth, depression, diarrhoea, drowsiness, headache, postural hypertension, lethargy, nausea, nervousness, oedema, chest pain and palpitations. Constipation, dyspnoea, urinary frequency, blurred vision, paraesthesia, reddened sclera, tinnitus, skin rashes, pruritus, diaphoresis, syncope, tachycardia, impotence and vomiting may also occur.
Paroxysmal tachycardia and vivid dreams have occured in association with Pratsiol. When Pratsiol is given orally to patients with congestive heart failure, blood concentrations are higher and the half-life is prolonged. Smaller than usual doses are required for such patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Manifestations of overdosage would be an extension of the pharmacological action of Pratsiol. See "SIDE-EFFECTS AND SPECIAL PRECAUTIONS" above.
Treatment is symptomatic and supportive. Cautious administration of a pressor agent may be utilised to treat the hypotensive effect.
CAUTION
Adrenalin should not be given to antagonise the hypotensive effects of Pratsiol since it may enhance any cardiac-accelerating effects which may occur.

IDENTIFICATION
Pratsiol 1 mg: A white or slightly yellowish, flat, bevel edged, uncoated, scored tablet 7 mm in diameter, imprinted with “ORN 27”.
Pratsiol 2 mg: A white or slightly yellowish, flat, bevel edged, uncoated, scored tablet 9 mm in diameter, imprinted with “ORN 335”.
Pratsiol 5 mg: A white or slightly yellowish, flat, bevel edged uncoated, scored tablet 10 mm diameter.

PRESENTATION
Amber bottles containing 30 and 100 tablets.

STORAGE INSTRUCTIONS
Store in a cool (below 25°C) dry place, protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS
Pratsiol 1 mg: S/7.1/321.
Pratsiol 2 mg: S/7.1/322.
Pratsiol 5 mg: S/7.1/323.

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Pharmacare Limited
7 Fairclough Road
Korsten
Port Elizabeth, 6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
10 June 1987

308173 030807        Harry's Printers-K30418 103

Updated on this site: May 2004
Source: Community Pharmacy

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