Isoptin

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Verapamil hydrochloride 40mg;  

Доступно од:

Abbott Laboratories (NZ) Ltd

INN (Међународно име):

Verapamil hydrochloride 40 mg

Дозирање:

40 mg

Фармацеутски облик:

Film coated tablet

Састав:

Active: Verapamil hydrochloride 40mg   Excipient: Acacia Calcium carbonate Carmellose sodium Colloidal silicon dioxide   Glycol montanate Calcium arachinate Lactose monohydrate Maize starch   Potato starch Povidone Purified talc   Purified water Quinoline yellow Sucrose Titanium dioxide

Јединице у пакету:

Blister pack, 100 tablets

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Abbott GmbH & Co. KG

Резиме производа:

Package - Contents - Shelf Life: Blister pack, - 100 tablets - 48 months from date of manufacture stored at or below 25°C

Датум одобрења:

1973-02-08

Карактеристике производа

Page 1 of 16
NEW ZEALAND DATA SHEET
ISOPTIN
®
ISOPTIN SR
®
1. PRODUCT NAME
ISOPTIN 40 mg and 80 mg tablets.
ISOPTIN SR 120 mg and 240 mg modified release tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ISOPTIN tablet contains 40 mg or 80 mg of verapamil
hydrochloride.
Each ISOPTIN SR tablet contains 120 mg or 240 mg verapamil
hydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ISOPTIN 40 mg tablets are white, film coated, marked “40” on one
side and with “Knoll-triangle” on
reverse side and have a diameter of about 7mm.
ISOPTIN 80 mg tablets are white, film coated, marked with “ISOPTIN
80” on one side and “Knoll” on
reverse side above the score and have a diameter of about 9mm.
ISOPTIN SR 120 mg sustained release tablets are white, biconvex and
film coated with dimensions
5mm x 10mm. The tablet is embossed with “120 SR” on one side and
“KNOLL” on the other side.
ISOPTIN SR 240 mg sustained release tablets are light green, capsule
shaped, scored and film
coated with dimensions 6.5 x 18.5mm. The tablet is embossed with a
double Knoll triangle on one
side. Sustained release characteristics are not altered when the
tablet is divided in half.
ISOPTION 40 mg, 80 mg tablets and ISOPTIN SR 120 mg tablet cannot be
divided into equal doses.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
ISOPTIN SR

Essential hypertension

Secondary prevention post myocardial infarction - for secondary
prevention after acute
myocardial infarction, especially where

blocking agents are not tolerated such as in patients
with asthma, diabetes, peripheral vascular disease with intermittent
claudication, etc.

Angina pectoris – for the prophylaxis and treatment of coronary
insufficiency: chronic stable
angina pectoris; angina at including vasospastic (Prinzmetal’s,
variant angina) and unstable
angina (crescendo, pre-infarction angina); angina pectoris post
myocardial infarction.
Page 2 of 16
ISOPTIN 40 MG OR 80 MG (IMMEDIATE RELEASE)

Essential h