MedPath
HSA Approval

MINISON TABLET 1MG

SIN16122P

MINISON TABLET 1MG

MINISON TABLET 1MG

March 18, 2021

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

Regulatory Information

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

Formulation Information

TABLET

**Dosage and Administration:** Hypertension For maximum benefit, small increases should be continued until the desired effect is achieved or a total daily dosage of 20mg is reached. A diuretic or beta-adrenergic blocking agent may be added to enhance efficacy. The maintenance dosage of prazosin hydrochloride may be given as a twice- or three-times daily regimen. A. Patients Receiving No Antihypertensive Therapy It is recommended that therapy be initiated with 0.5mg given at bedtime, then 0.5mg two or three times daily for 3 to 7 days. Unless poor toleration suggests that the patient is unusually sensitive, this dosage should be increased to 1mg given two or three times daily for a further 3 to 7 days. Thereafter, as determined by the patient’s response to the blood pressure lowering effect, the dosage should be increased gradually to a maximum total daily dosage of 20mg given in divided doses. B. Patients Receiving Diuretic Therapy with Inadequate Control of Blood Pressure The diuretic should be reduced to a maintenance dosage level for the particular agent, and prazosin hydrochloride should be initiated with 0.5mg at bedtime, then proceeding to 0.5mg two or three times daily. After the initial period of observation, the dosage for prazosin hydrochloride should be gradually increased as determined by the patient’s response. C. Patients Receiving Other Antihypertensive Therapy but with Inadequate Control Because some additive effect is anticipated, the dosage level of other agents (e.g. beta-adrenergic blocking agents, methyldopa, reserpine, clonidine, etc.) should be reduced and prazosin hydrochloride initiated at 0.5mg at bedtime then proceeding to 0.5mg two or three times daily. Subsequent dosage increase should be made depending upon the patient’s response. There is evidence that adding prazosin hydrochloride to a beta-adrenergic blocking agent, calcium antagonists or angiotensin-converting enzyme (ACE) inhibitors may bring about a substantial reduction in blood pressure. Thus, the low initial dosage regimen is strongly recommended. D. Patients with Moderate to Severe Grades of Renal Impairment Evidence to date shows that prazosin hydrochloride does not further compromise renal function when used in patients with renal impairment. Because some patients in this category have responded to small doses of prazosin hydrochloride, it is recommended that therapy be initiated at 0.5mg daily and that dosage increases be instituted with caution.

ORAL

Medical Information

**Indication(s):** Prazosin is indicated for the treatment of hypertension.

**Contraindication(s):** Hypersensitivity to any component of this drug or quinazolines.

C02CA01

prazosin

Manufacturer Information

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

Y.S.P. Industries (M) Sdn. Bhd.

Active Ingredients

Prazosin Hydrochloride eqv Prazosin

1mg

Prazosin

Documents

Package Inserts

Minison Tablet_PI.pdf

Approved: March 18, 2021

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