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Riprazo HCT is a brand name for Aliskiren. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of essential hypertension in adults. Riprazo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Riprazo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given…
Verbatim from this product's EMA label. Tap a section to expand.
The recommended dose of Riprazo HCT is one tablet per day. Riprazo HCT should be taken with a light meal once a day, preferably at the same time each day. Grapefruit juice should not be taken together with Riprazo HCT. The antihypertensive effect is largely manifested within 1 week and the maximum effect is generally seen within 4 weeks.
Posology in patients not adequately controlled with aliskiren or hydrochlorothiazide monotherapy Individual dose titration with each of the two components may be recommended before changing to the fixed combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
5 mg alone. If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Riprazo HCT 300 mg/25 mg daily. Medicinal product no longer authorised 3 Posology as substitution therapy For convenience, patients receiving aliskiren and hydrochlorothiazide from separate tablets may be switched to a fixed combination tablet of Riprazo HCT containing the same component doses.
2). 73 m2). 2). 2). 4). Elderly patients (over 65 years) The recommended starting dose of aliskiren in elderly patients is 150 mg. No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients.
2).
Aliskiren/hydrochlorothiazide combination The safety of Riprazo HCT has been evaluated in 9 clinical trials with more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year. The incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity.
Treatment with Riprazo HCT had an overall incidence of adverse experiences at doses up to 300 mg/25 mg similar to placebo. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The most common adverse drug reaction observed with Riprazo HCT is diarrhoea. The adverse drug reactions previously reported with one of the individual components of Riprazo HCT (aliskiren and hydrochlorothiazide) and listed in the respective paragraphs on the individual components may occur with Riprazo HCT.
The frequency of adverse reactions listed below is defined 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) and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Gastrointestinal disorders Common:
Diarrhoea Diarrhoea: Diarrhoea is a dose-related adverse drug reaction for aliskiren. 9% for hydrochlorothiazide-treated patients. 5 mg or 25 mg) on serum potassium approximately balanced each other in many patients. In other patients, one or the other effect may be dominant.
5). Additional information on individual components Other adverse reactions previously reported with one of the individual components may occur with Riprazo HCT even if not observed in clinical trials. Aliskiren Treatment with Aliskiren up to 300 mg resulted in an overall incidence of adverse reactions similar to placebo.
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. Medicinal product no longer authorised 4 Heart failure Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV).
Riprazo HCT should be used with caution in patients with heart failure due to limited clinical efficacy and safety data. Angioedema As with other agents acting on the renin-angiotensin system, angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.
8). 8). 8) especially at the beginning of the treatment. If angioedema occurs, Riprazo HCT should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Where there is involvement of the tongue, glottis or larynx adrenaline should be administered. In addition, measures necessary to maintain patent airways should be provided. Sodium- and/or volume-depleted patients In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Riprazo HCT.
Riprazo HCT should be used only after correction of any pre-existing sodium and/or volume depletion. Electrolyte imbalance Treatment with Riprazo HCT 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.
1), or to other sulphonamide-derived substances. History of angioedema with aliskiren. Hereditary or idiopathic angioedema. 6). Anuria. 73 m2). Refractory hypokalaemia, hyponatraemia, hypercalcaemia and symptomatic hyperuricaemia.
Severe hepatic impairment. g. 5). 1).
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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Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The most common adverse drug reaction is diarrhoea.
Medicinal product no longer authorised 12 Nervous system disorders Common:
Dizziness Vascular disorders Uncommon: Hypotension Gastrointestinal disorders Common: Diarrhoea Immune system disorders Rare: Hypersensitivity reactions Skin and subcutaneous tissue disorders Uncommon: Rash, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions Rare: Angioedema Musculoskeletal and connective tissue disorders Common: Arthralgia Renal and urinary disorders Uncommon: Acute renal failure, renal impairment General disorders and administration site conditions Uncommon: Oedema peripheral Investigations Common: Hyperkalaemia Rare: Haemoglobin decreased, haematocrit decreased Rare: Blood creatinine increased Angioedema and hypersensitivity reactions 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 medicines known to cause angioedema, including RAAS blockers (ACE inhibitors or ARBs).
Hypersensitivity reactions have also been reported in post-marketing experience. 4). Arthralgia has been reported in post-marketing experience. In some cases this occurred as part of a hypersensitivity reaction. 16 volume percent, respectively) were observed.
No patients discontinued therapy due to anaemia. This effect is also seen with other agents acting on the renin- angiotensin system, such as ACEI and ARBs.
Serum potassium:
Increases in serum potassium have been observed with aliskiren and these may be exacerbated by concomitant use of other agents acting on the RAAS or by NSAIDs. Consistent with standard medical practice, periodic determination of renal function including serum electrolytes is advised if co-administration is considered necessary.
4). There have also been reports of peripheral oedema, increase in blood creatinine and severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions. Hydrochlorothiazide Hydrochlorothiazide has been […]
If hypokalaemia develops during hydrochlorothiazide therapy Riprazo HCT should be discontinued until stable correction of the potassium balance. Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with aliskiren may reduce diuretic-induced hypokalaemia.
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. Medicinal product no longer authorised 5 There is no evidence that Riprazo HCT would reduce or prevent diuretic-induced hyponatraemia.
Chloride deficit is generally mild and usually does not require treatment. 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.
Riprazo HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre- existing hypercalcaemia. Riprazo HCT should be discontinued if hypercalcaemia develops during treatment. Serum levels of calcium should be periodically monitored during treatment with thiazides.
Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function. Renal impairment and kidney transplantation Thiazide diuretics may precipitate azotaemia in patients with chronic kidney disease.
When Riprazo HCT is used in patients with renal impairment, periodic monitoring of serum electrolytes including potassium, creatinine and uric […]