1. Name Of The Medicinal Product
Cedocard Retard 40
2. Qualitative And Quantitative Composition
Isosorbide Dinitrate BP 40.0 mg
3. Pharmaceutical Form
Uncoated sustained release tablets for oral administration.
4. Clinical Particulars
4.1 Therapeutic Indications
Cedocard Retard is indicated for prophylactic treatment of angina pectoris.
4.2 Posology And Method Of Administration
Children:
There is no recommended dose for children.
Adults:
One or two tablets to be taken twice daily.
Elderly:
Dosage as for other adults.
4.3 Contraindications
Isosorbide dinitrate is contra-indicated in patients with a history of sensitivity to the drug. Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates, or nitric oxide donors is therefore contra-indicated.
4.4 Special Warnings And Precautions For Use
Tolerance and cross-tolerance to other nitrates and nitrites may occur.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Tolerance and cross-tolerance to other nitrates and nitrites may occur. The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil.
4.6 Pregnancy And Lactation
No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide dinitrate in pregnancy. Safety in pregnancy however, has not been established. Isosorbide dinitrate should only be used in pregnancy if, in the opinion of the physician, the possible benefits of treatment outweigh the possible hazards. Lactation - there are no data available on the transfer of isosorbide dinitrate in breast milk or its effect on breast fed children.
4.7 Effects On Ability To Drive And Use Machines
Side effects include throbbing headache and dizziness. Patients are advised not to drive or operate machinery if so affected.
4.8 Undesirable Effects
Side effects include throbbing headache and dizziness. Patients are advised not to drive or operate machinery if so affected.
4.9 Overdose
No available data.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Isosorbide dinitrate is a vasodilator. It relaxes vascular smooth muscle and produces coronary vasodilation, reduction in peripheral resistance and venous return, alteration of myocardial metabolism and reduction of the myocardial oxygen demand.
5.2 Pharmacokinetic Properties
The mean plasma concentrations of ISDN at the end of each 12 hour dosage interval (Cmin) during the period of administration of 40 mg as the sustained release tablets were 0.6 ng/ml, 0.6 ng/ml, 0.9 ng/ml and 0.6 ng/ml after the first, second, third and fourth doses respectively and was 0.9 ng/ml at 12 hours after the last dose. At 1, 4 and 8 hours after the first dose the mean plasma levels of ISDN were 1.3 ng/ml, 4.0 ng/ml and 2.2 ng/ml respectively. At 1, 4 and 8 hours after the 3rd dose the mean plasma levels of ISDN were 2.1 ng/ml, 4.0 ng/ml and 2.0 ng/ml respectively and after the last dose, the peak plasma concentrations of ISDN of 12.7 ng/ml occurred at 5 hours and thereafter mean concentrations of ISDN declined to 0.4 ng/ml at 14 hours after the last dose.
5.3 Preclinical Safety Data
Due to the age and well established safety nature of this product, preclinical data has not been included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
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Polyvinyl acetate
Red (E124)
Yellow-orange S (E110)
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Water
Sodium chloride
Sodium sulphate
6.2 Incompatibilities
None known.
6.3 Shelf Life
60 months.
6.4 Special Precautions For Storage
Protect from heat and moisture.
6.5 Nature And Contents Of Container
PVC/Aluminium blisters in packs of 60 or 1000 tablets.
6.6 Special Precautions For Disposal And Other Handling
There are no special instructions for handling.
7. Marketing Authorisation Holder
Pharmacia Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
8. Marketing Authorisation Number(S)
PL 00032/0332
9. Date Of First Authorisation/Renewal Of The Authorisation
12 December 2002
10. Date Of Revision Of The Text
August 2007
Company Ref: CD1_0
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