Source: Web Search Revision Year: 2023
Treatment of hypertension in adults.
Ramipril/Amlodipine Glenmark is indicated as substitution therapy of patients with blood pressure adequately controlled with ramipril and amlodipine given concurrently at the same dose level.
Ramipril/Amlodipine Glenmark should not be used for initiating treatment of hypertension. The doses of each component should be individualised according to the patient profile and blood pressure control.
If a dose change is required, the dosing regimen should be individually determined using the individual components of ramipril and amlodipine first, and once established, it could be changed to Ramipril/Amlodipine Glenmark.
The recommended dose is one capsule daily. The maximum daily dose is one capsule 10 mg/10 mg.
To find the optimal starting dose and maintenance dose of patients with renal impairment, the patients should be individually titrated using the individual components of amlodipine and ramipril.
Ramipril is slightly dialysable, the medicinal product should be administered few hours after haemodialysis is performed.
Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.
Renal function and serum potassium levels should be monitored during therapy with Ramipril/Amlodipine Glenmark. In the case of renal function deterioration, the use of Ramipril/Amlodipine Glenmark should be discontinued and replaced by the individual components adequately adjusted.
The maximum daily dose is 2.5 mg ramipril, therefore this product is not suitable for subjects with hepatic impairment.
Lower initial dosage is recommended in the elderly and increase of the dosage should take place with care.
The safety and efficacy of Ramipril/Amlodipine Glenmark in children has not been established.
Currently available data are described in section 4.8, 5.1, 5.2 and 5.3 but no recommendation on a posology can be made.
Since food does not affect absorption of ramipril and amlodipine, Ramipril/Amlodipine Glenmark may be taken irrespective of meals. It is recommended that Ramipril/Amlodipine Glenmark is taken at the same time of the day.
Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
The patient should be closely monitored and the treatment should be symptomatic and supportive. Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration. Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.
In humans experience with intentional overdose is limited.
Available data suggest that gross overdosage 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.
Clinically significant hypotension due to amlodipine overdosage 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.
30 months.
Store below 30°C.
Store in the original package in order to protect from light.
PA/Aluminium/PVC/Aluminium blisters.
Pack sizes: 28, 30, 32, 56, 60, 90, 91, 96, 98, 100 capsules, hard.
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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