AMILORIDE ROSEMONT Oral solution (2017)
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Περιεχόμενα
Name of the medicinal product
Amiloride Rosemont 5mg/5ml Oral Solution.
Qualitative and quantitative composition
Amiloride Hydrochloride BP 5.675mg equivalent to anhydrous Amiloride Hydrochloride 5mg.
Pharmaceutical form
Solution for oral administration.
Therapeutic indications
Potassium conserving agent; diuretic. Although Amiloride Hydrochloride may be used alone, its principal indication is as concurrent therapy with thiazides or more potent diuretics to conserve potassium ...
Posology and method of administration
Adults Amiloride Hydrochloride alone. The usual initial dosage is 10mg (as a single dose or 5mg twice a day). The total daily dose should not exceed 20mg (20ml) a day. After diuresis has been achieved, ...
Contraindications
Hyperkalaemia (plasma potassium over 5.5mmol/l) other potassium-conserving agents or potassium supplements (see Precautions); Addisons disease; anuria; acute renal failure, severe progressive renal disease, ...
Special warnings and precautions for use
Diabetes Mellitus To minimise the risk of hyperkalaemia in known or suspected diabetic patients, the status of renal function should be determined before initiating therapy. Amiloride Hydrochloride should ...
Interaction with other medicinal products and other forms of interaction
Lithium should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. When combined with thiazide diuretics, Amiloride can act synergistically with ...
Pregnancy and lactation
Because clinical experience is limited, Amiloride Hydrochloride is not recommended for use during pregnancy. The routine use of diuretics in otherwise healthy pregnant women with or without mild oedema ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Amiloride Hydrochloride is normally well tolerated, although minor side effects are reported relatively frequently. Except for hyperkalaemia, significant side effects are infrequent. Nausea, anorexia, ...
Overdose
No data are available; and it is not known whether the drug is dialysable. The most likely signs and symptoms are dehydration and electrolyte imbalance which should be treated by established methods. Therapy ...
Pharmacodynamic properties
Amiloride has mild diuretic and anti-hypertensive activity. It acts primarily in the distal tubule and does not require aldosterone for its action. Amiloride is a mild natriuretic which does not initiate ...
Pharmacokinetic properties
Amiloride is incompletely absorbed from the gastro-intestinal tract; only about 50% is recovered unchanged in the urine following an oral dose. The drug is not metabolised and can, therefore, be useful ...
Preclinical safety data
None stated.
List of excipients
Citric Acid Monohydrate Ph Eur Methyl Hydroxybenzoate Ph Eur Propyl Hydroxybenzoate Ph Eur Propylene Glycol Ph Eur Vanillin Ph Eur Compound Orange Spirit BP Liquid Maltitol Ph Eur Purified Water Ph Eur ...
Incompatibilities
None known.
Shelf life
Shelf life in marketed pack 12 months.
Special precautions for storage
Store at or below 25 °C, out of reach of children.
Nature and contents of container
Glass (Type III) amber bottle, with capacity of 150ml. Closures: HDPE EPE wadded, tamper evident, child resistant.
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial park, Braithwaite Street, Leeds, LS11 9XE
Marketing authorization number(s)
PL 00427/0091
Date of first authorization / renewal of the authorization
21 November 1995
Date of revision of the text
22/03/2017
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