Cardizem CD

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Diltiazem hydrochloride 360mg (30-35 mesh nonpareil seed);  

可用日期:

sanofi-aventis new zealand limited

INN（国际名称）:

Diltiazem hydrochloride 360 mg (30-35 mesh nonpareil seed)

剂量:

360 mg

药物剂型:

Modified release capsule

组成:

Active: Diltiazem hydrochloride 360mg (30-35 mesh nonpareil seed)   Excipient: Acetyl tributyl citrate Brilliant blue FCF   Diethyl phthalate Ethanol Gelatin Methacrylic acid copolymer Povidone Purified talc   Purified water   Simeticone Sodium laurilsulfate Sugar spheres Titanium dioxide  

每包单位数:

Blister pack, PVD/PE/PVDC Alu sample pack, 7 capsules

类:

Prescription

处方类型:

Prescription

厂商:

Finorga SA

疗效迹象:

CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications such as diuretics.

產品總結:

Package - Contents - Shelf Life: Blister pack, PVD/PE/PVDC Alu sample pack - 7 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVD/PE/PVDC Alu - 10 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE sample pack - 7 capsules - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE - 10 capsules -   - Bottle, plastic, HDPE - 28 capsules -   - Bottle, plastic, HDPE - 30 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE - 100 capsules -   - Calendar pack, PVD/PE/PVDC Alu - 28 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Calendar pack, PVD/PE/PVDC Alu - 30 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Calendar pack, PVD/PE/PVDC Alu - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture

授权日期:

1999-06-23

资料单张

Cardizem® CD capsules and Cardizem® tablets
_1_
CARDIZEM® CD CAPSULES AND CARDIZEM® TABLETS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CARDIZEM?
Cardizem CD capsules or Cardizem tablets both contain an active
ingredient diltiazem hydrochloride. Cardizem tablets are used to
prevent angina. Cardizem CD capsules are used to prevent angina or to
treat hypertension (high blood pressure).
For more information, see Section 1. Why am I using Cardizem?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CARDIZEM?
Do not use if you have ever had an allergic reaction to Cardizem CD
capsules or Cardizem tablets or any of the ingredients listed
at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Cardizem?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cardizem and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE CARDIZEM?
•
Cardizem CD capsules can be taken once a day, preferably at the same
time every day.
•
Cardizem tablets can be taken three or four times a day.
•
Swallow the capsules or the tablets with a glass of water. Do not chew
them.
•
Your doctor will tell you how often and how much Cardizem CD or
Cardizem tablets to take.
More instructions can be found in Section 4. How do I use Cardizem?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CARDIZEM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cardizem CD or Cardizem
tablets.
•
If you are taking these medicines for angina, tell your doctor if you
continue to have angina attacks or
if they become more frequent.
•
Take these medicines exactl

产品特点

cardizem-cd-ccdsv15-dsv20-24aug23
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Cardizem CD 180 mg modified release capsules
Cardizem CD 240 mg modified release capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diltiazem hydrochloride 180 mg or 240 mg in sustained release form.
Chemically diltiazem hydrochloride is the hydrochloride salt of (2S,
3S)-5-(2-
Dimethylaminoethyl)-2, 3, 4, 5-tetrahydro-2-(4-methoxyphenyl)-4-oxo-1,
5-benzothiazepin-3-yl
acetate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Modified release capsule
Cardizem CD is registered in 2 strengths:
180 mg:
Light turquoise blue/blue capsule
240 mg:
Blue/blue capsule
Cardizem CD contains a white to off-white crystalline powder with a
bitter taste. It is freely
soluble in water, methanol, and chloroform. Cardizem CD capsules
contain a blend of beads with
controlled dissolution characteristics for once-a-day administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cardizem CD is indicated for the treatment of hypertension. It may be
used alone or in
combination with other antihypertensive medications such as diuretics.
cardizem-cd-ccdsv15-dsv20-24aug23
Page 2
Cardizem CD is also indicated for the management of chronic stable
angina and angina due to
coronary artery spasm.
4.2
DOSE AND METHOD OF ADMINISTRATION
Patients controlled on diltiazem alone or in combination with other
medications may be safely
switched to Cardizem CD at the nearest equivalent total daily dose.
Subsequent titration to higher
or lower doses may be necessary and should be initiated as clinically
warranted. There is limited
clinical experience with doses above 360 mg. Therefore, treatment with
doses exceeding 360
mg/day is not recommended.
ADULTS
_HYPERTENSION _
Dosage needs to be adjusted by titration to individual patient needs.
When used as monotherapy,
reasonable starting doses are 180 to 240 mg once daily, although some
patients may respond to
lower doses. Maximum antihypertensive effect is usually observed by 14
days of chronic therapy;