Source: Medicines Authority (MT) Revision Year: 2023 Publisher: Aspen Healthcare Malta Limited, 89, Level 0, Triq is-Siggiewi, Siggiewi, SGW2021, Malta
Clodipan is indicated for treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is already adequately controlled with the individual components given concurrently at the same dose levels as in the fixed combination, but as separate medicines.
The recommended dose of Clodipan is 1 capsule per day.
The fixed dose combination is not suitable for initiation therapy. Dose adjustment, if necessary, should be done with the individual components.
Before switching to Clodipan patients should be controlled on stable doses of the individual components taken at the same time.
The dose of Clodipan should be based on the doses of the individual components of the combination at the time of switching.
No dose adjustment is necessary for elderly patients. Caution is required when increasing the dosage. Limited information is available on use in the very elderly patients.
No dose adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in moderate renal impairment. Caution is advised because of limited experience available in patients with severe or end-stage renal impairment (Clcr<15 mL/min) or on haemodialysis.
Changes in amlodipine plasma concentrations are not correlated with stage of renal impairment, therefore the usual dosage is recommended. Amlodipine and candesartan cilexetil are not dialysable. See also section 4.4.
In patients with mild to moderate hepatic impairment Clodipan should be administered with caution. Clodipan is contraindicated in patients with severe hepatic impairment and/or cholestasis (see sections 4.3, 4.4 and 5.2).
The safety and efficacy of Clodipan in children aged below 18 years have not been established. No data are available.
Oral use.
Clodipan can be taken with or without food. It is recommended to take Clodipan with some liquid.
There is no experience of overdose with the fixed dose combination candesrtan/amlodipine in humans.
Available data suggest that gross overdose of amlodipine could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.
Based on pharmacological considerations, the main manifestation of an overdose of candesartan is likely to be symptomatic hypotension and dizziness. In individual case reports of overdose (of up to 672mg candesartan cilexetil) patient recovery was uneventful.
If symptomatic hypotension should occur, symptomatic treatment should be instituted and vital signs monitored. The patient should be placed supine with the legs elevated. If this is not sufficient, plasma volume should be increased by infusion of, for example, sodium chloride 9 mg/ml (0.9%) solution for infusion. Sympathomimetic medicinal products may be administered if the above-mentioned measures are not sufficient.
Candesartan is not removed by haemodialysis.
Clinically significant hypotension due to amlodipine overdose calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.
Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
3 years.
Do not store above 30°C.
PA/Aluminium/PVC/Aluminium blisters in a carton box.
Pack sizes of 28 hard capsules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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