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CUENCA is a brand name for Valsartan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypertension Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 18 years of age. Recent myocardial infarction Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Hypertension The recommended starting dose of Cuenca is 80 mg once daily. The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg.
Cuenca may also be administered with other antihypertensive agents. The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients. Recent myocardial infarction In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction.
After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks. The starting dose is provided by the 40 mg divisible tablet. The target maximum dose is 160 mg twice daily.
In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient's tolerability.
If symptomatic hypotension or renal dysfunction occur, consideration should be given to a dose reduction. g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics. 1). Evaluation of post-myocardial infarction patients should always include assessment of renal function.
Heart failure The recommended starting dose of Cuenca is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics.
The maximum daily dose administered in clinical trials is 320 mg in divided doses. Valsartan may be administered with other heart failure therapies. 1). Evaluation of patients with heart failure should always include assessment of renal function.
Additional information on special populations Elderly No dose adjustment is required in elderly patients. 2). 3). 3). 2). In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg.
Paediatric population Paediatric hypertension Children and adolescents 6 to 18 years of age The initial dose is 40 mg once daily for children weighing below 35 kg and 80 mg once daily for those weighing 35 kg or more. The dose should be adjusted based on blood pressure response.
In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan. The incidence of ADRs did not appear to be related to dose or treatment duration and also showed no association with gender, age or race.
The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed below according to system organ class. Adverse reactions are ranked by 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 ranked in order of decreasing seriousness.
For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a "not known" frequency. - Hypertension Blood and lymphatic system disorders Not known Decrease in haemoglobin, Decrease in haematocrit, Neutropenia, Thrombocytopenia Immune system disorders Not known Hypersensitivity including serum sickness Metabolism and nutrition disorders Not known Increase of serum potassium, Hyponatraemia Ear and labyrinth system disorders Uncommon Vertigo Vascular disorders Not known Vasculitis Respiratory, thoracic and mediastinal disorders Uncommon Cough Gastrointestinal disorders Uncommon Abdominal pain Hepato-biliary disorders Not known Elevation of liver function values including increase of serum bilirubin Skin and subcutaneous tissue disorders Not known Angioedema, Rash, Pruritus Musculoskeletal and connective tissue disorders Not known Myalgia Renal and urinary disorders Not known Renal failure and impairment, Elevation of serum creatinine General disorders and administration site conditions Uncommon Fatigue Paediatric population Hypertension The antihypertensive effect of valsartan has been evaluated in two randomised, double- blind clinical studies in 561 paediatric patients from 6 to 18 years of age.
) is not recommended. Monitoring of potassium should be undertaken as appropriate. Impaired renal function There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients.
2). 2). Sodium- and/or volume-depleted patients In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Cuenca.
Sodium and/or volume depletion should be corrected before starting treatment with Cuenca, for example by reducing the diuretic dose. Renal artery stenosis In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Cuenca has not been established.
Short-term administration of Cuenca to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN).
However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Kidney transplantation There is currently no experience on the safe use of Cuenca in patients who have recently undergone kidney transplantation. Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with Cuenca as their renin- angiotensin system is not activated.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
1. - Severe hepatic impairment, biliary cirrhosis and cholestasis. 6). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For maximum doses studied in clinical trials please refer to the table below. Doses higher than those listed have not been studied and are therefore not recommended. 2. However, safety and efficacy of Cuenca in children aged 1 to 6 years have not been established.
Use in paediatric patients aged 6 to 18 years with renal impairment Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients.
No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min. 2). 2). There is limited clinical experience with Cuenca in paediatric patients with mild to moderate hepatic impairment. The dose of valsartan should not exceed 80 mg in these patients.
Paediatric heart failure and recent myocardial infarction Cuenca is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.
Method of administration Cuenca may be taken independently of a meal and should be administered with water.
With the exception of isolated gastrointestinal disorders (like abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to 18 years and that previously reported for adult patients.
Neurocognitive and developmental assessment of paediatric patients aged 6 to 16 years of age revealed no overall clinically relevant adverse impact after treatment with Cuenca for up to one year. In a double-blind randomized study in 90 children aged 1 to 6 years, which was followed by a one-year open-label extension, two deaths and isolated cases of marked liver transaminases elevations were observed.
These cases occurred in a population who had significant comorbidities. A causal relationship to Cuenca has not been established. In a second study in which 75 children aged 1 to 6 years were randomised, no significant liver transaminase elevations or death occurred with valsartan treatment.
Hyperkalaemia was more frequently observed in children and adolescents aged 6 to 18 years with underlying chronic kidney disease. The safety profile seen in controlled-clinical studies in adult patients with post-myocardial infarction and/or heart failure varies from the overall safety profile seen in hypertensive patients.
This may relate to the patients underlying disease. ADRs that occurred in adult patients with post-myocardial infarction and/or heart failure patients are listed below. - Post-myocardial infarction and/or heart failure (studied in adult patients only) Blood and lymphatic system disorders Not known Thrombocytopenia Immune system disorders Not known Hypersensitivity including serum sickness Metabolism and nutrition disorders Uncommon Hyperkalaemia Not known Increase of serum potassium, Hyponatraemia Nervous system disorders Common Dizziness, Postural dizziness Uncommon Syncope, Headache Ear and labyrinth system disorders Uncommon Vertigo Cardiac disorders Uncommon Cardiac failure Vascular disorders Common Hypotension, Orthostatic hypotension Not known Vasculitis Respiratory, thoracic and mediastinal disorders Uncommon Cough Gastrointestinal disorders Uncommon Nausea, Diarrhoea Hepato-biliary disorders Not known Elevation of liver function values Skin and subcutaneous tissue disorders Uncommon Angioedema Not known Rash, Pruritis Musculoskeletal and connective tissue disorders Not known Myalgia Renal and urinary disorders Common Renal failure and impairment Uncommon Acute renal failure, Elevation of serum creatinine Not known Increase in Blood Urea Nitrogen General disorders and administration site conditions Uncommon Asthenia, Fatigue Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Pregnancy Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti- hypertensive treatments which have an established safety profile for use in pregnancy.
6). 1). Therefore, the combination of valsartan with an ACE inhibitor is not recommended. Caution should be observed when initiating therapy in post-myocardial infarction patients. 2). 2). 1). This combination apparently increases the risk for adverse events and is therefore not recommended.
Caution should be observed when initiating therapy in patients with heart failure. 2). 2). g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Cuenca may be associated with impairment of the renal function. History of angioedema Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors.
8). Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS) Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system.
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. 3). Paediatric population Impaired renal function Use […]