Kamiren

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

doxazosin (doxazosin mesylate)

可用日期:

KRKA d.d.

INN（国际名称）:

doxazosin (doxazosin mesylate)

剂量:

4mg

药物剂型:

tablets

处方类型:

Prescription

产品特点

1.3.1
Doxazosin mesylate
SPC, Labeling and Package Leaflet
SmPCPIL039798_3
17.05.2013 – Updated: 09.12.2013
Page 1 of 7
1.
NAME OF THE MEDICINAL PRODUCT
Kamiren
®
4 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg doxazosin as 4.86 mg doxazosin mesylate,
respectively.
Excipient:
tablets of 4 mg
lactose
76 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
4 mg tablets: white, round, flat, bevel-edged, tablets with a score on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild and moderate hypertension (as monotherapy or in
combination with other
antihypertensive drugs).
Relief of symptoms in benign prostatic hyperplasia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage should be adjusted according to the response and/or possible
undesirable effects in individual
patients.
It is administrated once daily _per os_ (morning or evening)
irrespective of meal time, without chewing
and by washing down with enough water.
If a dose is missed, it should be taken as soon as possible. However,
if it is almost time for the next
scheduled dose, the patient should skip the missed one and go back to
the regular dosing schedule. It is
important that the drug is taken regularly. If a patient does not take
the drug for a few days, the new
therapeutic course should be started with the lowest dose.
The tablet for dosage 4 mg can be divided into equal halves.
_Hypertension_
The initial dose of doxazosin is 1 mg daily. The first dose should be
taken in the evening at bedtime.
With regard to the effect of the drug on blood pressure, the dosage
may be gradually, at 1- to 2-week
intervals, titrated upwards first to 2 mg, then to 4 mg and 8 mg
doxazosin once daily. Doses of 2 mg
to 8 mg doxazosin a day are usually sufficient. The maximum allowed
daily dose is 16 mg.
_Benign prostatic hyperplasia in normotensive patients_
The initial dose of doxazosin is 1 mg daily. The first dose should be
taken in the evening at bedtime.
With regard to the effect