HITEN 4 (Perindopril tert-Butylamine Tablets 4 mg)

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

PERINDOPRIL ERBUMINE

Disponible desde:

HEALOL PHARMACEUTICALS SDN. BHD.

Designación común internacional (DCI):

PERINDOPRIL ERBUMINE

Unidades en paquete:

30tablet Tablets; 90 Tablets

Fabricado por:

Aurobindo Pharma Ltd

Ficha técnica

NAME OF DRUG
PRODUCT :
HITEN
2
(Perindopril
tert-Butylamine
Tablets 2 mg)
HITEN
4
(Perindopril
tert-Butylamine
Tablets 4 mg)
HITEN
8
(Perindopril
tert-Butylamine
Tablets 8 mg)
STRENGTH :
2 mg, 4 mg and 8 mg
PHARMACEUTICAL DOSAGE FORM: Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
HITEN 2 (_PERINDOPRIL TERT-BUTYLAMINE TABLETS 2 MG_):
Each un coated Tablet Contains:
Perindopril tert-Butylamine Ph.Eur 2 mg
HITEN 4 (_PERINDOPRIL TERT-BUTYLAMINE TABLETS 4 MG_):
Each un coated Tablet Contains:
Perindopril tert-Butylamine Ph.Eur 4 mg
HITEN 8 (_PERINDOPRIL TERT-BUTYLAMINE TABLETS 8 MG_):
Each un coated Tablet Contains:
Perindopril tert-Butylamine Ph.Eur 8 mg
PHARMACEUTICAL FORM:
_PERINDOPRIL TERT-BUTYLAMINE TABLETS 2 MG:_
White to off-white coloured round biconvex, uncoated tablets with
debossing “D” on one side and “57”on the other side.
_PERINDOPRIL TERT-BUTYLAMINE TABLETS 4 MG:_
White to off-white coloured capsule shaped, uncoated tablets with
debossing “D” on one side and “5” & “8” on either side of
the break
line on another side.
_PERINDOPRIL TERT-BUTYLAMINE TABLETS 8 MG:_
White to off-white coloured round biconvex, uncoated tablets with
debossing “D” on one side and “5” & “9” on either side of
the break
line on another side.
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS
_HYPERTENSION:_
Treatment of hypertension.
_HEART FAILURE [FOR HITEN 2 MG & 4 MG ONLY]:_
Treatment of symptomatic heart failure.
_STABLE CORONARY ARTERY DISEASE:_
Reduction of risk of cardiac events in patients with a history of
myocardial infarction and/or revascularisation
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
It is recommended that perindopril is taken once daily in the
morning before a meal with a sufficient amount of fluid (e.g. water).
The dose should be individualized according to the patient profile
and blood pressure response.
_HYPERTENSION:_
Perindopril may be used in monotherapy or in combination with
other classes of antihypertensive therapy.
The recommended starting dose is 4 mg given o