TELFOCUS 20 Uncoated Tablets 20 mg

国: タンザニア

言語: 英語

ソース: Tanzania Medicinces & Medical Devices Authority

有効成分:

Telmisartan

から入手可能:

Aurobindo Pharma Limited, INDIA

ATCコード:

Angiotensin II receptor blockers (ARBs), plain

INN（国際名）:

Telmisartan

投薬量:

20 mg

医薬品形態:

Uncoated Tablets

製:

Aurobindo Pharma Limited, Unit-VII, INDIA

製品概要:

Physical description: White to off-white, round shaped, flat faced beveled edged uncoated tablets, debossed with. 'N 20' on one side and Plain on the other side; Local technical representative: GENERICS & SPECIALITIES LIMITED (9801)

認証ステータス:

Registered/Compliant

承認日:

2022-07-19

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
TELFOCUS 20
Telmisartan Tablets 20 mg
R
x
Only
1. NAME OF THE MEDICINAL PRODUCT:
Telmisartan Tablets 20 mg.
(TRADE) NAME OF THE PRODUCT:
TELFOCUS 20
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TELFOCUS 20 mg Tablets.
Each Uncoated Tablet Contains
Telmisartan Ph.Eur. 20 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
_TELFOCUS 20 mg Tablets: _
White to off-white, round shaped, flat faced beveled edged uncoated
tablets, debossed
with. 'N 20' on one side and Plain on the other side.
4.
CLINICAL PARTICULARS
1. THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults.
Cardiovascular prevention
Reduction of cardiovascular morbidity in adults with:
• manifest atherothrombotic cardiovascular disease (history of
coronary heart
disease, stroke, or peripheral arterial disease) or
• type 2 diabetes mellitus with documented target organ damage
2. POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
Treatment of essential hypertension
The usually effective dose is 40 mg once daily. Some patients may
already
benefit at a daily dose of 20 mg. In cases where the target blood
pressure is not
achieved, the dose of Telmisartan can be increased to a maximum of 80
mg once
daily. Alternatively, Telmisartan may be used in combination with
thiazide-type
diuretics such as hydrochlorothiazide, which has been shown to have an
additive
blood pressure lowering effect with Telmisartan. When considering
raising the
dose, it must be borne in mind that the maximum antihypertensive
effect is
generally attained four to eight weeks after the start of treatment
(see section
5.1).
Cardiovascular prevention
The recommended dose is 80 mg once daily. It is not known whether
doses lower
than 80 mg of telmisartan are effective in reducing cardiovascular
morbidity.
When initiating telmisartan therapy for the reduction of
cardiovascular morbidity,
close
monitoring
of
blood
pressure
is
recommended,
and
if
appropriate
adjustment of medications that lower blood pressure m