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FOSINOPRIL SODIUM is a brand name for Fosinopril. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypertension: Fosinopril Sodium 20mg Tablets are indicated in the treatment of hypertension. Fosinopril Sodium 20mg Tablets may be used alone as initial therapy or in combination with other antihypertensive agents. The antihypertensive effects of Fosinopril Sodium 20mg Tablets and diuretics used concomitantly are…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Fosinopril sodium should be administered orally in a single daily dose. As with all other medicinal products taken once daily, it should be taken at approximately the same time each day. The absorption of fosinopril sodium is not affected by food.
4). 4). 1).
Hypertensive patients not being treated with diuretics:
Starting dose The initial recommended dose is 10 mg once a day. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose.
The initiation of treatment should take place under medical supervision. Maintenance dose The usual daily dose is 10 mg to a maximum of 40 mg administered in a single dose. In general if the desired therapeutic effect cannot be achieved in a period of 3 to 4 weeks on a certain dose level, the dose can be further increased.
Hypertensive patients being treated with concomitant diuretic therapy:
Symptomatic hypotension may occur following initiation of therapy with fosinopril sodium. This is more likely in patients who are being treated currently with diuretics, especially in patients with heart failure, elderly patients (over 75 years) and patients with renal dysfunction.
Caution is recommended therefore, since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with fosinopril sodium. In hypertensive patients in whom the diuretic cannot be discontinued, therapy with fosinopril sodium should be initiated with a 10 mg dose.
Renal function and serum potassium should be monitored. The subsequent dosage of fosinopril sodium should be adjusted according to blood pressure response. 5). When treatment is initiated in a patient already taking diuretics, it is recommended that the treatment with fosinopril sodium is started under medical supervision for several hours and until blood pressure is stabilised.
Special populations Heart Failure:
The recommended initial dose is 10mg once daily, initiated under close medical supervision. If the initial dose is well tolerated patients should then be titrated to a dose of up to 40mg once daily. The appearance of hypotension after the initial dose should not preclude careful dose titration of Fosinopril Sodium 20mg Tablets, following effective management of the hypotension.
In the patients treated with Fosinopril sodium Tablets, the adverse effects were in general mild and transient. Very common: ≥1/10 Common: ≥1/100 and <1/10 Uncommon: ≥1/1000 and <1/100 Rare: ≥1/10 000 and <1/1000 Very rare: <1/10000 including isolated cases Not Known: (cannot be estimated from the available data) Infections and infestations Common: Upper respiratory infection, pharyngitis, rhinitis, viral infection Uncommon: Sinusitis, tracheobronchitis Rare: Pneumonia Not known: Laryngitis Blood and lymphatic system disorders Uncommon: Transient decrease in haemoglobin, decrease in haematocrit Rare: Transient anaemia, eosinophilia, leucopenia, lymphadenopathy, neutropenia, thrombocytopenia Very rare: Agranulocytosis Metabolism and nutrition disorders Uncommon: Decreased appetite, gout, hyperkalaemia Not Known: Appetite disorder, weight fluctuation Psychiatric disorders Common: Mood altered, sleep disorder Uncommon: Depression, confusion Not Known: abnormal behaviour Nervous system disorders Common: Dizziness, headache, paraesthesia Uncommon: Syncope, cerebral infarction, somnolence, tremor, stroke, taste disturbances, sleep disturbance Rare: Dysphasia, memory disturbances, disorientation Not Known: balance disorder Eye disorders Common: Eye disorder, visual disturbances Ear and labyrinth disorders Uncommon: Ear pain, tinnitus, vertigo Cardiac disorders Common: Tachycardia, arrhythmia, palpitations, angina pectoris Uncommon: Myocardial infarction or cerebrovascular accident, cardiac arrest, rhythm disturbances, conduction disturbances Not known: cardio-respiratory arrest, Vascular disorders Common: Hypotension, orthostatic hypotension Uncommon: Shock, hypertension, transitory ischaemia Rare: Flush, haemorrhage, peripheral vascular disease Not known: Hypertensive crisis Respiratory, thoracic and mediastinal disorders Common: Cough Uncommon: Dyspnoea Rare: Bronchospasm, epistaxis, pulmonary congestion Not known: Dysphonia, pleuritic pain Gastrointestinal disorders Common: Nausea, vomiting, diarrhoea, abdominal pain, dyspepsia, dysgeusia Uncommon: Constipation, dry mouth, flatulence Rare: Oral lesions, pancreatitis, swollen tongue, abdominal distension, dysphagia Very rare: Intestinal angioedema, (sub) ileus Hepatobiliary disorders Rare: Hepatitis Very rare: Hepatic failure Skin and subcutaneous tissue disorders Common: Rash, angioedema, dermatitis Uncommon: Hyperhidrosis, pruritus, urticaria Rare: Ecchymosis A symptom complex has been reported which may include one or more of the following: fever, vasculitis, myalgia, arthralgia/arthritis, a positive antinuclear antibodies (ANA), elevated red blood cell sedimentation rate (ESR), eosinophilia and leucocytosis, rash, photosensitivity or other dermatological manifestations may occur.
WARNING
Hypotension:
Fosinopril sodium has been rarely associated with hypotension in uncomplicated hypertensive patients. 8). Volume and/or salt depletion should be corrected before initiating therapy with fosinopril sodium. A transient hypotensive response is not a contraindication to further doses which may be given without difficulty after replenishment of salt and/or volume.
In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguria or azotemia and, rarely, with acute renal failure and death.
In such patients, fosinopril sodium therapy should be started under close medical supervision; they should be followed closely for the first 2 weeks of treatment and whenever the dose of fosinopril sodium or diuretic is increased. Consideration should be given to reducing the diuretic dose in patients with normal or low blood pressure who have been treated vigorously with diuretics or who are hyponatremic.
Hypotension is not per se a reason to discontinue fosinopril sodium. The magnitude of the decrease is greatest early in the course of treatment; this effect stabilizes within a week or two, and generally returns to pretreatment levels without a decrease in therapeutic efficacy.
The safety of an initial 10mg dose has not been studied in patients with severe heart failure NYHA IV. Similar considerations apply to patients with ischaemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
9%) solution. Aortic and mitral valve stenosis / hypertrophic cardiomyopathy As with other angiotensin-converting enzyme (ACE) inhibitors, fosinopril sodium should be given with caution to patients with mitral valve stenosis and obstruction in the outflow of the left ventricle such as aortic stenosis or hypertrophic cardiomyopathy.
1. • History of angioneurotic oedema • History of angioedema associated with previous ACE inhibitor therapy • Renal artery stenosis (bilateral or unilateral in single kidney), and • Cardiogenic shock. 6). 73m2). 1). • Concomitant use with sacubitril/valsartan therapy.
5).
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Fosinopril Sodium 20mg Tablets should be used in addition to diuretics and digitalis where appropriate. e. > 80mg furosemide), patients with hypovolaemia, hyponatraemia (serum sodium < 130 meq/l), pre-existing hypotension (systolic blood pressure <90 mmHg), patients with unstable cardiac failure and those on high-dose vasodilator therapy.
4). Paediatric population:Use in this age group is not recommended. 8). The optimum dosage has not been determined in children of any age. An appropriate dose strength is not available for children weighing less than 50kg. Elderly No dosage reduction is necessary in patients with clinically normal renal and hepatic function as no significant differences in the pharmacokinetic parameters or antihypertensive effect of fosinoprilat have been found compared with younger subjects.
Impaired hepatic function:
Treatment should be initiated at a dose of 10mg. Although the rate of hydrolysis may be slowed, the extent of hydrolysis is not appreciably reduced in patients with hepatic impairment. In this group of patients, there is evidence of reduced hepatic clearance of fosinoprilat with compensatory increase in renal excretion.
Renal impairmentTreatment should be initiated at a dose of 10mg, however caution is advised especially with a GFR of less than 10 ml/min. Depending on the response, the dose should then be titrated to achieve the desired therapeutic effect.
Absorption, bioavailability, protein binding, biotransformation and metabolism are not appreciably altered by reduced renal function. In patients with impaired renal function, the total body clearance of fosinoprilat is approximately 50% slower than that in patients with normal renal function.
e. including end-stage renal failure). Neither haemodialysis nor peritoneal dialysis is effective in clearing fosinoprilat. 23ml per minute. 5% of the administered dose. This corresponds to 7% and 2% respectively, of urea clearance. Hence no dose adjustment is necessary to correct for drug loss during these procedures.
NB Fosinopril sodium is NOT licensed for use in acute myocardial infarction. Method of […]
Musculoskeletal and connective tissue disorders Common:
Musuloskeletal pain, myalgia Rare: Arthritis Renal and urinary disorders Common: Micturition disorder Uncommon: Renal failure, proteinuria Rare: Prostatic disorders Very rare: acute renal failure Reproductive and breast disorders Common: Sexual dysfunction General disorders and administration site conditions Common: Fatigue, chest pain (non-cardiac), oedema, asthenia, weakness Uncommon: Fever, peripheral oedema, sudden death, thoracic pain Rare: Weakness in one extremity Not known: Pain pyrexia Investigations Common: Increase in alkaline phosphatase, increase in bilirubin, increase in LDH, increase in transaminases Uncommon: Weight increase, increases in blood urea, increases in serum creatinine Rare: Slight increase in haemoglobin, hyponatremia Not known: Liver function test abnormal In the clinical studies performed with fosinopril, the incidence of adverse effects did not differ between elderly (more than 65 years of age) and younger patients.
3% of patients. A symptom-complex of cough, bronchospasm, and eosinophilia has been observed in two patients treated with fosinopril Paediatric population Safety data in the paediatric population receiving fosinopril is still limited, only a short-term exposure has been evaluated.
9%). Different from the adults are this elevated CK reported in this trial (even transient and with no clinical symptoms). The long-term effects of fosinopril on growth, puberty, and general development have not been studied. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Impaired renal function:
In cases of renal impairment, the initial dosage of fosinopril sodium need not be adjusted. Routine monitoring of potassium and creatinine is part of normal medical practice for these patients. In hypertensive patients with renal artery stenosis in one or both kidneys, increases in blood urea nitrogen and serum creatinine may occur during treatment with an ACE inhibitor.
These increases are usually reversible upon discontinuation of therapy. In such patients, renal function should be monitored during the first few weeks of therapy. If renovascular hypertension is also present there is an increased risk of severe hypotension and renal insufficiency.
In these patients, treatment should be started under close medical supervision with low doses and careful dose titration. Some hypertensive patients with no apparent pre-existing renal vascular disease develop increases in blood urea nitrogen and serum creatinine, usually minor or transient, when fosinopril sodium is given concomitantly with a diuretic.
This effect is more likely to occur in patients with pre-existing renal impairment. Dosage reduction of fosinopril sodium may be required. In patients with severe congestive heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with an ACE inhibitor may be associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death.
Since treatment with diuretics may be a contributory factor to the above, they should be discontinued and renal function should be monitored during the first weeks of therapy with fosinopril sodium. Proteinuria In patients with pre-existing renal impairment proteinuria may occur in rare cases.
In clinically relevant proteinuria (greater than 1 g/day) Fosinopril should only be used after a very critical benefit/risk evaluation and with regular monitoring of the clinical and laboratory chemical parameters.
Anaphylactoid reactions during desensitization:
Two patients undergoing desensitizing treatment with hymenoptera venom while receiving another ACE inhibitor, enalapril, sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when the ACE inhibitor was temporarily withheld, but they reappeared upon inadvertent rechallenge.
Therefore, caution should be used in patients treated with ACE inhibitors undergoing such desensitizations procedures. Anaphylactoid reactions during high-flux dialysis/lipoprotein apheresis membrane exposure: Anaphylactoid reactions have been reported in patients hemodialyzed with highflux dialysis membranes while on therapy with an ACE inhibitor.
In these patients, consideration should be given to using a different type of dialysis membrane or a different class of medication. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
Hypersensitivity/angioedema:
Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated due to the increased risk of angioedema. Treatment with sacubitril/valsartan must not be initiated earlier than 36 hours after the last dose of fosinopril sodium.
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