Amcardia 10 Tablets 10 mg

Valsts: Tanzānija

Valoda: angļu

Klimata pārmaiņas: Tanzania Medicinces & Medical Devices Authority

Aktīvā sastāvdaļa:

Amlodipine Besylate

Pieejams no:

Unique Pharmaceutical Laboratories (A division of J.B. Chemicals & Pharmaceuticals Ltd), INDIA

ATĶ kods:

Selective calcium channel blockers with mainly vas

SNN (starptautisko nepatentēto nosaukumu):

Amlodipine Besylate

Deva:

10 mg

Zāļu forma:

Tablets

Ražojis:

UNIQUE PHARMACEUTICAL LABORATORIES, INDIA

Produktu pārskats:

Physical description: White to off white round flat faced, bevel edged uncoated tablet with break line on one side and plain on other side; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)

Autorizācija statuss:

Registered/Compliant

Autorizācija datums:

2022-09-21

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
AMCARDIA- 10 (Amlodipine Besylate Tablets USP 10mg)
2. CHEMICAL NAME AND STRUCTURE OF THE ACTIVE INGREDIENT:
CHEMICAL NAME: AMLODIPINE BESYLATE
STRUCTURE:
3. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains:
Amlodipine Besylate USP.
Eq. to
Amlodipine…….10mg
Excipients
q.s.
..................
White to off White round flat faced, bevel edged uncoated tablet with
break line on
one side and plain on the other side.
4. CLINICAL AND PHARMACEUTICAL PARTICULARS:
4.1.THERAPEUTIC INDICATIONS:
Hypertension
Amlodipine besylate is indicated for the treatment of hypertension. It
may be
used alone or in combination with other antihypertensive agents.
Chronic stable angina pectoris
Amlodipine besylate is indicated for the treatment of
chronic
stable
angina.
Amlodipine
besylate
may
be
used
alone
or
in
combination
with
other
antianginal agents.
Vasospastic (Prinzmetal’s) angina
Amlodipine besylate is indicated for the treatment of confirmed
or
suspected
vasospastic angina.
Amlodipine besylate may be used as monotherapy or in combination with
other
antianginal drugs.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
For both hypertension and angina, the usual initial dose is 5 mg
amlodipine
once daily which may be increased to a maximum dose of 10 mg depending
on
the individual patient’s response.
In hypertensive patients, Amlodipine has been used in combination with
a
thiazide diuretic, alpha blocker, beta blocker,
or an angiotensin converting
enzyme
inhibitor. For angina, amlodipine may be used as monotherapy or in
combination with other anti-anginal medicinal products in patients
with angina
that is refractory to nitrates and/or to adequate doses of beta
blockers.
No dose adjustment of amlodipine is required upon concomitant
administration
of
thiazide
diuretics,
beta
blockers,
and
angiotensin-converting
enzyme
inhibitors.
PEDIATRIC POPULATION
Safety and effectiveness of Amlodipine besylate
in
children
have
not
been
establis