Skopryl plus tablets

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

lisinopril (lisinopril dihydrate), hydrochlorothiazide

Tersedia dari:

Alkaloid AD Skopje

Kode ATC:

C09BA03

INN (Nama Internasional):

lisinopril (lisinopril dihydrate), hydrochlorothiazide

Dosis:

20mg+ 12,5mg

Bentuk farmasi:

tablets

Unit dalam paket:

(20/2x10/) in blister, (30/3x10/) in blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2023-04-07

Karakteristik produk

Skopryl plus

20 mg/12.5 mg tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Skopryl plus
®
20 mg/12.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate
21.78 mg) and 12.5 mg
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Round, biconvex, ochre-violet tablets with bisection line on one side.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Skopryl Plus is indicated in the management of mild to moderate
hypertension in patients who
have been stabilised on the individual components given in the same
proportions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
PRIMARY HYPERTENSION
The usual dosage is 1 tablet, administered once daily. As with all
other medication taken once
daily, Skopryl Plus should be taken at approximately the same time
each day.
In general, if the desired therapeutic effect cannot be achieved in a
period of 2 to 4 weeks at
this dose level, the dose can be increased to 2 tablets administered
once daily.
RENAL IMPAIRMENT
Thiazides may not be appropriate diuretics for use in patients with
renal impairment and are
ineffective at creatinine clearance values of 30 ml/min or below (i.e.
moderate or severe renal
insufficiency).
Skopryl Plus is not to be used as initial therapy in any patient with
renal insufficiency.
Skopryl plus

20 mg/12.5 mg tablets
Summary of Product Characteristics
2
In patients with creatinine clearance of >30 and <80 ml/min, Skopryl
Plus may be used, but
only after titration of the individual components. The recommended
dose of lisinopril, when
used alone, in mild renal insufficiency, is 5 to 10 mg.
PRIOR DIURETIC THERAPY
Symptomatic hypotension may occur following the initial dose of
Skopryl Plus: this is more
likely in patients who are volume and/or salt depleted as a result of
prior diuretic therapy. The
diuretic therapy should be