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TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE is a brand name for Amiloride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of mild to moderate hypertension.
Verbatim from this product's MHRA label. Tap a section to expand.
1 to 2 tablets once a day, taken orally.
Use in the elderly:
Timolol/amiloride/hydrochlorothiazide has been shown to be as well tolerated in the elderly as in younger patients. The recommended starting dose is 1 tablet daily.
Children:
Because the safety and efficacy has not been established in children, it is not recommended for paediatric use.
Timolol/Amiloride/Hydrochlorothiazide is usually well tolerated, with significant side effects only infrequently reported. Most common effects experienced are dizziness, asthenia, fatigue, and bradycardia. Other clinical adverse reactions with Timolol/Amiloride/Hydrochlorothiazide reported are: Body as a whole: headache.
Cardiovascular: peripheral vascular disorder (cold extremities), hypotension, syncope, arrhythmia, angina pectoris. Respiratory: dyspnoea, wheezing. Digestive: nausea, dyspepsia, constipation, diarrhoea, vomiting, GI pain, anorexia, thirst, dry mouth, stomatitis.
Urogenital: impotence. Nervous: vertigo, paraesthesiae, tremors. Integumentary: sweating. Musculoskeletal: muscle cramps. Psychiatric: insomnia, nervousness, depression, somnolence, abnormal dreaming, sleep disturbance. Special senses: visual disturbances.
Additional side effects that have been reported with the individual components which should be considered as potential adverse effects of Timolol/Amiloride/Hydrochlorothiazide. Amiloride-related effects Body as a whole: weakness, back pain, chest pain, neck/shoulder ache, pain in extremities.
Digestive: abnormal liver function, activation of probable pre-existing peptic ulcer, jaundice, abdominal pain, GI bleeding, flatulence. Integumentary: alopecia, rash, pruritus. Haematological: aplastic anaemia, neutropenia. 5 mmol/l), hyponatraemia.
Cardiovascular: one patient with partial heart block developed complete heart block; palpitation, orthostatic hypotension. Psychiatric: decreased libido, mental confusion. Respiratory: cough. Nervous: encephalopathy. Special senses: tinnitus, increased intra-ocular pressure, nasal congestion.
Musculoskeletal: joint pain. Urogenital: polyuria, urinary frequency, bladder spasm, dysuria. Hydrochlorothiazide-related effects Body as a whole: anaphylactic reaction, fever. Cardiovascular: necrotising angiitis (vasculitis, cutaneous vasculitis).
Congestive cardiac failure:
Care should be exercised before and during treatment of patients with cardiomegaly or history of cardiac failure. Cardiac arrhythmias: patients at risk of congestive heart failure should be carefully observed for bradycardia, AV block and respiratory distress.
If congestive cardiac failure persists, Timolol/Amiloride/Hydrochlorothiazide should be withdrawn. Beta-adrenergic blocking agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow are observed, consideration should be given to discontinuing these agents.
Exacerbation of ischaemic heart disease following abrupt withdrawal: exacerbation of angina and, in some cases, myocardial infarction has occurred after abrupt withdrawal of beta-blocker therapy. Therefore, it is recommended that if Timolol/Amiloride/Hydrochlorothiazide is to be withdrawn, dosage should be gradually reduced.
Elective or emergency surgery:
Timolol/Amiloride/Hydrochlorothiazide should also be gradually withdrawn prior to elective surgery of anginal patients. Agonists such as isoprenaline, dopamine, dobutamine or norepinephrine (noradrenaline) may be used to counter the effects of beta- blockade in emergency surgery.
Renal and hepatic disease and electrolyte disturbances:
This product should be used with caution in patients with renal or hepatic disease and in those patients in whom fluid and electrolyte balance is critical. When creatinine clearance falls below 30 ml/min, thiazide diuretics are ineffective.
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 of renal disease, the diuretic should be discontinued.
1. • Patients with bronchial asthma or with a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second- or third- degree AV block, overt cardiac failure, right ventricular failure secondary to pulmonary hypertension, significant cardiomegaly and cardiogenic shock.
5 mmol/l). • Anuria, acute and chronic renal insufficiency, severe progressive renal disease, and diabetic nephropathy. • Patients with blood urea over 10 mmol/l or serum creatinine over 130 μmol/l or diabetes mellitus should not receive Timolol/Amiloride/Hydrochlorothiazide without careful and frequent serum urea and serum electrolyte monitoring.
• Anaesthetic agents causing myocardial depression, hypersensitivity to any component of the medicinal product or other sulphonamide-derived drugs. • Use with other potassium-conserving agents. Use with potassium-rich foods and potassium supplements except in severe and/or refractory cases of hypokalaemia when careful monitoring of the serum potassium level is necessary.
• The packaging carries the warning: ‘Do not take this medicine if you have a history of wheezing or asthma’. 6.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Amiloride in United Kingdom.
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Digestive: jaundice (intrahepatic cholestatic jaundice), pancreatitis, cramping, gastric irritation. Integumentary: photosensitivity, toxic epidermal necrolysis, urticaria. Endocrine/metabolic: glycosuria, hypoglycaemia, hyperglycaemia, hyperuricaemia, electrolyte imbalance, including hypokalaemia and hyponatraemia, sialadenitis.
Psychiatric: restlessness. Eye disorders: choroidal effusion (frequency not known) Renal: renal dysfunction, interstitial nephritis, renal failure. Respiratory: respiratory distresses including, pneumonitis, pulmonary oedema. Special senses: transient blurred vision, xanthopsia.
Haematological: agranulocytosis, aplastic anaemia, haemolytic anaemia, leucopenia, purpura, thrombocytopenia. Neoplasms benign, malignant and unspecified (incl. cysts and polyps): Not known (cannot be estimated from the available data): Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma).
Timolol maleate-related effects Body as a whole: chest pain, extremity pain, decreased exercise tolerance, weight loss. Cardiovascular: cardiac arrest, cerebral vascular accident, palpitation, second- or third-degree AV block, sino-atrial block, oedema and pulmonary oedema, cardiac failure, Raynaud’s phenomenon, claudication, worsening of arterial insufficiency and angina pectoris, vasodilatation.
Digestive: diarrhoea, hepatomegaly. Endocrine: hypoglycaemia, hyperglycaemia. Integumentary: rash, pruritus, skin irritation, increased pigmentation, exfoliative dermatitis (one case). Musculoskeletal: arthralgia. Nervous system: local weakness.
Psychiatric: diminished concentration, hallucination, decreased libido. Haematological: non-thrombocytopenic purpura. Respiratory: bronchial spasm, rales, cough. Special senses: tinnitus, visual disturbances, diplopia, ptosis, eye irritation, dry eyes.
Urogenital: micturition difficulties.
Clinical laboratory tests:
Clinically important changes in standard laboratory tests associated with timolol maleate are rare. Slight increases in blood urea, serum potassium and serum uric acid, and slight decreases in haemoglobin and haematocrit occurred but were not progressive or associated with clinical manifestations.
1). 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.
Metabolic or respiratory acidosis: acid-base balance should be monitored frequently in severely ill patients at risk of respiratory or metabolic acidosis.
Electrolyte and fluid balance:
Hyponatraemia, hypochloraemic alkalosis, hypokalaemia, hyperkalaemia or hypomagnesaemia may occur. Warning signs or symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, seizures, confusion, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastro-intestinal disturbances such as nausea and vomiting.
Serum and urine electrolyte determinations should be made in patients vomiting excessively or receiving parenteral fluids. Dilutional hyponatraemia may occur in oedematous patients in hot weather, which calls for appropriate therapy.
Hypochloraemia requires specific treatment only under exceptional circumstances. If hyperkalaemia occurs, Timolol/Amiloride/Hydrochlorothiazide should be discontinued immediately and, if necessary, active measures taken to reduce the plasma potassium level.
Diabetes mellitus, hypoglycaemia:
Timolol/Amiloride/Hydrochlorothiazide should be given with caution to diabetic patients and to patients subject to spontaneous hypoglycaemia, as the symptoms and signs of acute hypoglycaemia may be masked. To minimise the risk of hyperkalaemia in diabetic or suspected diabetic patients, the status of the renal function should be known before initiating therapy with this product.
Therapy should be discontinued at least three days prior to glucose tolerance testing. Thiazide therapy may impair glucose tolerance. Dosage adjustments of antidiabetic agents, including insulin, may be required. Skin and sensitivity reactions: there have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs.
The reported incidence is small and in most cases the symptoms have cleared when treatment was withdrawn. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. Withdrawal should be gradual.
Sensitivity reactions to this medicinal product may occur with or without a history of allergy or bronchial asthma. Possible exacerbation or activation of systemic lupus erythematosus reactions have been reported with thiazide diuretics.
Risk from anaphylactic reaction:
While taking ß-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens, either accidental, diagnostic, or therapeutic.
Such patients may be unresponsive to the usual doses of epinephrine (adrenaline) used to treat anaphylactic reactions. Metabolic and endocrine: beta-adrenergic blocking agents may mask the signs of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta blockade which might precipitate a thyroid storm.
Hypercalcaemia and hypophosphataemia have been reported with thiazide diuretics. Timolol/Amiloride/Hydrochlorothiazide should be discontinued in patients prior to testing for parathyroid function. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Hyperuricaemia or acute gout may be precipitated in some patients.
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 surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy Musculoskeletal: beta-blockers have been reported […]