1. Name Of The Medicinal Product
Co-Amilofruse 5/40mg Tablets
2. Qualitative And Quantitative Composition
Furosemide 40.00mg
Amiloride Hydrochloride (dihydrate) 5.68mg
For excipients, see 6.1.
3. Pharmaceutical Form
Tablet for oral use.
Pale orange circular, flat faced beveled edge tablets debossed with 'ARD' '|' 40 on one side and plain on the other side.
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4. Clinical Particulars
4.1 Therapeutic Indications
Co-amilofruse is indicated where a prompt diuresis is required especially in conditions where potassium conservation is important: congestive cardiac failure, nephrosis, fluid retention due to corticosteroid or oestrogen therapy and ascites associated with cirrhosis.
4.2 Posology And Method Of Administration
The starting dose is usually 5/40mg, subsequent dosage being adjusted to suit the needs of the patient.
Adults:
One to two tablets to be taken in the morning.
Children:
Not indicated for children.
Elderly:
The dosage should be adjusted according to diuretic response. Serum electrolytes and urea should be carefully monitored.
4.3 Contraindications
Known hypersensitivity to the active ingredients or any of the excipients. Hyperkalaemia (serum potassium> 5.5 mmol/litre), Addison's disease, acute renal failure, anuria, severe progressive renal disease, precomatose states associated with cirrhosis, concomitant potassium supplements or potassium sparing diuretics, electrolyte imbalance.
Co-amilofruse is contraindicated in children, as safety in this age group has not been established.
4.4 Special Warnings And Precautions For Use
Hyperkalaemia has been observed in patients receiving amiloride hydrochloride. Clinical condition and serum electrolytes must be carefully and continuously monitored if combination with an ACE inhibitor is deemed essential (see Interactions).
Serum uric acid levels may rise during treatment with Co-amilofruse and acute attacks of gout may be precipitated. Furosemide may cause latent diabetes to become manifest.
Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute urinary retention during diuretic therapy.
Patients who are being treated with this preparation require regular supervision, with monitoring of electrolyte status and fluid status to avoid excessive loss of fluid.
Co-amilofruse should be used with caution in elderly or those with potential obstruction of the urinary tract or disorders rendering electrolyte balance precarious.
Hyponatraemia, hypochloremia and raised blood urea nitrogen may occur during vigorous diuresis, especially in seriously ill patients. Careful monitoring of serum electrolytes and urea should therefore be undertaken in these patients. The haematopoietic state should be monitored regularly during treatment.
Co-amilofruse should be discontinued before a glucose tolerance test.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
ACE inhibitors may elevate serum potassium levels especially in the presence of renal impairment, and combination with Co-amilofruse is best avoided in elderly patients or in any others in whom renal function may be compromised. The dosage of concurrently administered antihypertensive agents, cardiac glycosides, lithium or non-depolarising muscle relaxants may require adjustment. It may be necessary to increase the dose of hypoglycaemic agents in diabetic patients. Concomitant use of Co-amilofruse with cephaloridine may increase cephaloridine-induced nephrotoxicity. Likewise, use with aminoglycoside antibiotics may increase the associated ototoxicity. Some NSAIDs e.g. indometacin, may antagonise the action of Furosemide.
4.6 Pregnancy And Lactation
There is no evidence of safety in either human pregnancy or lactation.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Nausea, vomiting, malaise, gastric upset, diarrhoea and constipation may occur. If skin rashes or pruritus occurs, treatment should be withdrawn.
Rare complications may include disturbances in liver function tests, ototoxicity and minor psychiatric disturbances. Bone marrow depression occasionally complicates treatment, necessitating withdrawal of the product.
4.9 Overdose
Treatment should be aimed at reversing dehydration and correcting electrolyte imbalance, particularly hyperkalaemia. If hyperkalaemia is seen, appropriate measures to reduce serum potassium must be instituted. Emesis should be induced or gastric lavage performed. Treatment is symptomatic and supportive.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Furosemide is a potent loop diuretic with a rapid action. Its effects are evident within one hour when administered orally, lasting four to six hours, and onset five minutes after intravenous injection, persisting for up to two hours. It has been reported to exert inhibiting effects on electrolyte reabsorption in the proximal and distal renal tubules, and in the ascending loop of Henle. Excretion of sodium, potassium and chloride ions is increased and water excretion enhanced.
Amiloride hydrochloride is a mild diuretic, which appears to act mainly on the distal renal tubules. It takes effect about two hours after oral administration and persists for up to 24 hours. The full effect may be delayed until after several days of treatment. It increases the excretion of sodium and chloride and reduces the excretion of potassium. Amiloride adds to the natriuretic but diminishes the kaliuretic effects of other diuretics and is used as an adjunct to Furosemide to conserve potassium.
5.2 Pharmacokinetic Properties
Furosemide is incompletely but fairly rapidly absorbed from the gastrointestinal tract. It has a biphasic half-life in the plasma with a terminal elimination phase that has been estimated to range up to one and a half-hours. It is up to 99% bound to plasma proteins, and is mainly excreted in the urine, largely unchanged, but also in the form of the glucuronide and free amine metabolites. Variable amounts are also excreted in bile, non-renal elimination being considerably increased in renal failure. Furosemide crosses the placental barrier and is excreted in milk.
Amiloride is incompletely absorbed from the gastrointestinal tract; peak serum concentrations are achieved about three to four hours after oral administration. It is excreted unchanged in the urine, and animal studies have shown little evidence of any biliary excretion. Amiloride has been estimated to have a serum half-life of about six hours.
5.3 Preclinical Safety Data
There are no pre-clinical data of any relevance to the prescriber, which are additional to those already included in other sections.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose monohydrate
Microcrystalline Cellulose
15005 Dispersed Sunset Yellow FCF Lake
Povidone K30
Sodium Starch Glycollate
Magnesium Stearate
Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Opaque white blister packs manufactured from UPVC and aluminium foil containing 28,30, 56, or 60 tablets.
Polypropylene or polyethylene tablet containers with a lid containing 100 or 500 tablets.
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
Aurobindo Pharma Limited
Ares Block, Odyssey Business Park
West End Road
South Ruislip
HA4 6QD
United Kingdom
8. Marketing Authorisation Number(S)
PL 20532/0084
9. Date Of First Authorisation/Renewal Of The Authorisation
27/03/2009
10. Date Of Revision Of The Text
27/03/2009
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