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Rasitrio is a brand name for Aliskiren. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rasitrio is indicated for the treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose level as in the combination.
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose of Rasitrio is one tablet per day. Patients receiving aliskiren, amlodipine and hydrochlorothiazide from separate tablets given concurrently at the same time of the day may be switched to a fixed combination tablet of Rasitrio containing the same component doses.
The fixed dose combination should only be used after a stable effect on the monocomponents, given concurrently, has been established after dose titration. Dose should be individualised and adjusted according to the patient’s clinical response.
Special populations Elderly patients aged 65 years and over There is evidence of an increased risk of adverse events related to hypotension in patients aged 65 years or older treated with Rasitrio. Therefore, particular caution should be exercised when administering Rasitrio in patients aged 65 years or over.
The recommended starting dose of aliskiren in this group of patients is 150 mg. 2). The use of Rasitrio in patients aged 75 years or older should be restricted to patients for whom blood pressure control has been established for the free combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently without accompanying safety concerns, in particular hypotension.
2). 2). 73 m2). 2). Hepatic impairment Rasitrio is contraindicated in patients with severe hepatic impairment. Caution should be exercised when administering Rasitrio in patients with mild to moderate hepatic impairment or patients with progressive liver disease.
4). Paediatric population The safety and efficacy of Rasitrio in children and adolescents below age 18 have not been established. No data are available. Method of administration Oral use. The tablets should be swallowed whole with some water.
Rasitrio should be taken with a light meal once a day, preferably at the same time each day. 5).
Summary of the safety profile Aliskiren/amlodipine/hydrochlorothiazide combination The safety profile of Rasitrio presented below is based on clinical studies performed with Rasitrio and the known safety profile of the individual components aliskiren, amlodipine and hydrochlorothiazide.
Safety information for Rasitrio in patients aged 75 years and older is limited. The most frequent adverse reactions observed with Rasitrio are hypotension and dizziness. The adverse reactions previously reported with one of the individual components of Rasitrio (aliskiren, amlodipine and hydrochlorothiazide) and listed in the respective paragraphs on the individual components may occur with Rasitrio.
Tabulated list of adverse reactions:
The adverse reactions for aliskiren, amlodipine and hydrochlorothiazide are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Information on Rasitrio Nervous system disorders Common Dizziness Vascular disorders Common Hypotension General disorders and administration site conditions Common Peripheral oedemaLegemidlet er ikke lenger godkjent for salg 15 Peripheral oedema is a known, dose-dependent adverse reaction of amlodipine and has also been reported with aliskiren therapy in post-marketing experience.
0% for aliskiren/hydrochlorothiazide dual combinations. 7% with dual combinations. 4% with dual combinations. Additional information on individual components Other adverse reactions previously reported with one of the individual components may occur with Rasitrio even if not observed in clinical trials.
8). As with any antihypertensive medicinal product, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. Symptomatic hypotension occurred with higher frequency in patients with non-complicated hypertension treated with Rasitrio than in patients treated with dual combinations of aliskiren/amlodipine, aliskiren/hydrochlorothiazide or amlodipine/hydrochlorothiazide.
Hypersensitivity reactions to hydrochlorothiazide may occur in patients, but are more likely in patients with allergy and asthma. Systemic lupus erythematosus Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosus.
The safety and efficacy of amlodipine in hypertensive crisis have not been established. 1). Dual blockade of the renin-angiotensin-aldosterone system by combining aliskiren with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) is therefore not recommended.
Close monitoring of blood pressure, renal function and electrolytes should be exercised if co-administration is considered absolutely necessary. 3). Geriatric patients aged 65 years and over Particular caution should be exercised when administering Rasitrio in patients aged 65 years or older.
Symptomatic hypotension occurred with higher frequency in patients with non-complicated hypertension treated with Rasitrio than in patients treated with dual combinations of aliskiren/amlodipine, aliskiren/hydrochlorothiazide or amlodipine/hydrochlorothiazide.
2). Geriatric patients aged 75 years and over Very limited efficacy and safety data are available on the use of Rasitrio in patients aged 75 years or older. 2). Heart failure Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
1, to other dihydropyridine derivatives, or to other sulphonamide-derived substances. History of angioedema with aliskiren. Hereditary or idiopathic angioedema. 6). Anuria. 73 m2). Hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia and refractory hypokalaemia.
Severe hepatic impairment. g. 5). 1). Severe hypotension. Shock (including cardiogenic shock). g. high grade aortic stenosis). Legemidlet er ikke lenger godkjent for salg 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Aliskiren in European Union.
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Aliskiren Serious adverse reactions include anaphylactic reaction and angioedema which have been reported in post-marketing experience and may occur rarely (less than 1 case per 1,000 patients). The most common adverse reaction is diarrhoea.
Tabulated list of adverse reactions:
The known aliskiren adverse reactions are presented in the table below using the same convention as described previously for the fixed combination. Immune system disorders Rare Anaphylactic reactions, hypersensitivity reactions Cardiac disorders Common Dizziness Uncommon Palpitations, oedema peripheral Vascular disorders Uncommon Hypotension Respiratory, thoracic and mediastinal disorders Uncommon Cough Gastrointestinal disorders Common Diarrhoea Hepatobiliary disorders Not known Liver disorder*, jaundice, hepatitis, liver failure** Skin and subcutaneous tissue disorders Uncommon Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome, toxic epidermal necrolysis (TEN), oral mucosal reactions, rash, pruritus, urticaria Rare Angioedema, erythema Musculoskeletal and connective tissue disorders Common Arthralgia Renal and urinary disorders Uncommon Acute renal failure, renal impairment Investigations Common Hyperkalaemia Uncommon Liver enzyme increased Rare Haemoglobin decreased, haematocrit decreased, blood creatinine increased *Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked hepatic dysfunction.
Legemidlet er ikke lenger godkjent for salg 16 Description of selected adverse events: Hypersensitivity reactions including anaphylactic reactions and angioedema have occurred during treatment with aliskiren. In controlled clinical trials, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators.
Cases of angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have also been reported in post-marketing experience. A number of these patients had a history of angioedema or symptoms suggestive of angioedema which in some cases was associated with the administration of other medicinal products known to cause angioedema, including RAAS blockers (ACEIs or ARBs).
In post-marketing experience, cases of angioedema or angioedema-like reactions have been reported when aliskiren was co-administered with ACEIs and/or ARBs. 4). 4). Arthralgia has been reported in post-marketing experience. In some cases this occurred as part of a hypersensitivity reaction.
4).
Investigations:
In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of aliskiren. In clinical studies in hypertensive patients, aliskiren had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Haemoglobin and haematocrit: […]
1). g. those receiving high doses of diuretics) or Combined use of aliskiren with other agents acting on the RAAS. The volume or salt depletion should be corrected prior to administration of Rasitrio, or the treatment should start under close medical supervision.
Electrolyte imbalance Treatment with Rasitrio should only start after correction of hypokalaemia and any coexisting hypomagnesaemia. Thiazide diuretics can precipitate new onset hypokalaemia or exacerbate pre- existing hypokalaemia.
Thiazide diuretics should be administered with caution in patients with conditions involving enhanced potassium loss, for example salt-losing nephropathies and prerenal (cardiogenic) impairment of kidney function. If hypokalaemia develops during hydrochlorothiazide therapy Rasitrio should be discontinued until stable correction of the potassium balance.
Hypokalaemia may develop with the use of thiazide diuretics. 8). Conversely, increases in serum potassium have been observed with aliskiren in post-marketing experience and these may be exacerbated by concomitant use of other agents acting on the RAAS or by non-steroidal anti-inflammatory drugs (NSAIDs).
Consistent with standard medical practice, periodic determination of renal function including serum electrolytes is advised if co-administration is considered necessary. 8). Thiazide diuretics can precipitate new onset hyponatraemia and hypochloroaemic alkalosis or exacerbate pre-existing hyponatraemia.
Hyponatraemia, accompanied by neurological symptoms (nausea, progressive disorientation, apathy) has been observed. Treatment with hydrochlorothiazide should only be started after correction of pre-existing hyponatraemia. In case severe or rapid hyponatraemia develops during Rasitrio therapy, the treatment should be discontinued until normalisation of natraemia.
All patients receiving thiazide diuretics should be periodically monitored for imbalances in electrolytes, particularly potassium, sodium and magnesium. Thiazides reduce urinary calcium excretion and may cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Rasitrio is […]