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SYNURETIC is a brand name for Hydrochlorothiazide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Potassium-conserving diuretic and antihypertensive. SYNURETIC 50 is indicated in patients with Hypertension and Congestive heart failure, Hepatic cirrhosis with ascites and oedema. In hypertension, SYNURETIC 50 may be used alone or in conjunction with other antihypertensive agents. SYNURETIC 50 is intended for the…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Hypertension:
Initially ½ tablet daily, increased if necessary to a maximum of 1 tablet daily or in divided doses.
Congestive cardiac failure:
Initially ½ tablet daily, subsequently adjusted if required but not exceeding 2 tablets a day. The optimal dosage is to be determined by the diuretic response and the plasma potassium level. Once an initial diuresis has been achieved, reduction in dosage may be attempted for maintenance therapy.
Maintenance therapy may be on an intermittent basis.
Hepatic cirrhosis with ascites:
Initiate therapy with a low dose. Initially 1 tablet a day, increased gradually if necessary until there is acceptable diuresis, but not exceeding 2 tablets a day. A gradual weight reduction is especially desirable in cirrhotic patients to reduce the likelihood of untoward reactions associated with diuretic therapy.
Maintenance dosage may be lower than those required to initiate diuresis; dosage reduction should be attempted when the patient's weight is stabilised.
Elderly:
Particular caution is needed in the elderly because of their susceptibility to electrolytre imbalance; the dosage should be carefully adjusted to renal function and clinical response. 3).
Method of administration:
Oral use
Although minor side effects are relatively common, significant side effects are infrequent. Reported side effects are generally associated with diuresis, thiazide therapy or with the underlying disease. No increase in the risk of adverse reactions has been seen over those of the individual components.
The reported adverse reactions of the combination:
Body as a whole: Headache*, weakness*, fatigue, malaise, chest pain, back pain, syncope, anaphylactic reaction.
Cardiovascular:
Arrhythmias, tachycardia, digitalis toxicity, orthostatic hypotension, angina pectoris.
Digestive:
Anorexia*, nausea*, vomiting, diarrhoea, constipation, abdominal pain, gastro-intestinal bleeding, appetite changes, abdominal fullness, flatulence, thirst, hiccups. 5 mmol/l), electrolyte imbalance, hyponatraemia (see special warning and precautions for use), gout, dehydration, symptomatic hyponatraemia.
Integumentary:
Rash*, pruritus, flushing, diaphoresis.
Musculoskeletal:
Leg ache, muscle cramps, joint pain.
Nervous:
Dizziness*, vertigo, paraesthesiae, stupor.
Psychiatric:
Insomnia, nervousness, mental confusion, depression, sleepiness.
Respiratory:
Dyspnoea.
Special senses:
5 mmol/l): This has been observed in patients receiving amiloride hydrochloride, either alone or with other diuretics, particularly in the aged or in hospital patients with hepatic cirrhosis or congestive heart failure who had known renal involvement, who were seriously ill, or were undergoing vigorous diuretic therapy.
Such patients should be carefully observed for clinical, laboratory and ECG evidence of hyperkalaemia (not always associated with abnormal ECG). Neither potassium supplements nor a potassium-rich diet should be used with SYNURETIC 50 except under careful monitoring in severe and/or refractory cases of hypokalaemia.
Some deaths have been reported in this group of patients.
Treatment of hyperkalaemia:
Should hyperkalaemia develop, SYNURETIC 50 should be discontinued immediately and, if necessary, active measures taken to reduce the serum potassium to normal.
Impaired renal function:
Renal function should be monitored because the use of SYNURETIC 50 in impaired renal function may result in the rapid development of hyperkalaemia. Thiazide diuretics become ineffective when creatinine levels fall below 30 ml/min.
Electrolyte imbalance and blood urea increases:
Although the likelihood of electrolyte imbalance is reduced by SYNURETIC 50 careful check should be kept for such signs of fluid and electrolyte imbalance as hypochloraemia, hypochloraemic alkalosis, hypokalaemia and hypomagnesaeia.
It is particularly important to make serum and urine electrolyte determinations when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid or electrolyte imbalance include: dryness of the mouth, weakness, lethargy, drowsiness, restlessness, seizures, confusion, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastro-intestinal disturbances such as nausea and vomiting.
5 mmol/l), other potassium- conserving diuretics, and potassium supplements or potassium-rich foods (except in severe and/or refractory cases of hypokalaemia under careful monitoring); concomitant use with spironolactone or triamterene; anuria; acute renal failure; severe progressive renal disease; severe hepatic failure, precoma associated with hepatic cirrhosis, Addison’s disease, hypercalcaemia, concurrent lithium therapy,diabetic nephropathy , patients with blood urea over 10 mmol/l , patients with diabetes mellitus, or those with serum creatinine over 130 μmol/l in whom serum electrolyte and blood urea levels cannot be monitored carefully and frequently.
Because the safety of amiloride hydrochloride for use in children has not been established, Co-Amilozide is not recommended for children under 18 years of age. 6 ‘Pregnancy and lactation’.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Bad taste, visual disturbance, nasal congestion.
Urogenital:
Impotence, dysuria, nocturia, incontinence, renal dysfunction including renal failure. * Side effects that have been reported most frequently during controlled clinical trials with ‘Co-amilozide’ The reported side effects of amiloride: Body as a whole: Neck/shoulder ache, pain in extremities.
Digestive:
Abnormal liver function, activation of probable pre-existing peptic ulcer, dyspepsia, jaundice.
Integumentary:
Dry mouth, alopecia.
Nervous:
Tremors, encephalopathy.
Haematological:
Aplastic anaemia, neutropenia.
Cardiovascular:
One patient with partial heart block developed complete heart block, palpitation.
Psychiatric:
Decreased libido, somnolence.
Respiratory:
Cough.
Special senses:
Tinnitus, increased intro-ocular pressure.
Urogenital:
Polyuria, urinary frequency, bladder spasm.
The reported side effects of hydrochlorothiazide:
Body as a whole: Fever.
Cardiovascular:
Necrotising angiitis (vasculitis, cutaneous vasculitis).
Digestive:
Jaundice (intrahepatic cholestatic jaundice), pancreatitis, cramp, gastric irritation.
Endocrine/Metabolic:
Glucosuria, hyperglycaemia, hyperuricaemia, hypokalaemia.
Integumentary:
Photosensitivity, sialadenitis, urticaria, toxic epidermal necrolysis.
Haematological:
Agranulocytosis, aplastic anaemia, haemolytic anaemia, leucopenia, purpura, thrombocytopenia.
Psychiatric:
Restlessness.
Renal:
Interstitial nephritis.
Respiratory:
Respiratory distress including pneumonitis, pulmonary oedema.
Eye disorders:
Transient blurred vision, xanthopsia, choroidal effusion (frequency not known).
Neoplasms Benign, malignant and unspecified (incl cysts and polyps):
Non- melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma).
Description of Selected Adverse Reactions Non-melanoma skin cancer:
Based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and NMSC has been observed. 1). Reporting of suspected adverse reactions Reporting suspected adverse reaction 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.
Hypokalaemia may develop, especially as a result of brisk diuresis, after prolonged therapy or when severe cirrhosis is present. , increased ventricular irritability). Diuretic-induced hyponatraemia is usually mild and asymptomatic. It may become severe and symptomatic in a few patients who will then require immediate attention and appropriate treatment.
Thiazides may decrease urinary calcium excretion. Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Therapy should be discontinued before carrying out tests for parathyroid function.
Azotaemia:
Azotaemia may be precipitated or increased by hydrochlorothiazide. Cumulative effects of the drug may develop in patients with impaired renal function. If increasing azotaemia and oliguria occur during treatment, SYNURETIC 50 should be discontinued.
3 ‘Contraindications’), since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Metabolic:
Hyperuricaemia may occur, or gout may be precipitated or aggravated, in certain patients receiving thiazides. Thiazides may impair glucose tolerance. 3 ‘Contraindications’). Dosage adjustment of antidiabetic agents, including insulin, may be required.
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. To minimise the risk of hyperkalaemia in diabetic or suspected diabetic patients, the status of renal function should be determined before initiating therapy with SYNURETIC 50.
Therapy should be discontinued at least three days before giving a glucose tolerance test. , patients with cardiopulmonary disease or patients with inadequately controlled diabetes. Shifts in acid-base balance alter the balance of extracellular/intracellular potassium, and the development of acidosis may be associated with rapid increases in plasma potassium.
Sensitivity reactions:
The possibility that thiazides may activate or exacerbate systemic lupus erythematosus.
Non-melanoma skin cancer:
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Photosensitizing actions of hydrochlorothiazide could act as a possible mechanism for NMSC. Patients taking hydrochlorothiazide should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions.
Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.
The use of hydrochlorothiazide may also need to be reconsidered in patients who have experienced previous NMSC. 8).
Eye disorders:
Choroidal effusion, acute myopia and secondary angle-closure glaucoma: Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible.
Prompt medical or […]