Cardizem CD

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diltiazem hydrochloride 240mg;  ;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Diltiazem hydrochloride 240 mg

Dosage:

240 mg

Pharmaceutical form:

Modified release capsule

Composition:

Active: Diltiazem hydrochloride 240mg     Excipient: Brilliant blue FCF   Castor oil Colloidal silicon dioxide Ethylcellulose Fumaric acid Gelatin Methacrylic acid copolymer Purified talc   Simeticone Stearic acid Sugar spheres Titanium dioxide   Tributyl citrate White beeswax

Units in package:

Blister pack, PVC/PE/PVDC/Al foil sample pack, 7 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Hoechst Marion Roussel Inc. located at Dow Chemical Company

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.

Product summary:

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

Authorization date:

1992-06-04

Patient Information leaflet

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

Summary of Product characteristics

cardizem-cd-ccdsv16-dsv21-02apr24
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-ccdsv16-dsv21-02apr24
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;