Co-Amilozide Tablets 5/50
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-amilozide tablets 5/50
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-amilozide tablets 5/50
1 tablet contains 5.68mg amiloride hydrochloride (5mg anhydrous amiloride hydrochloride) and 50mg hydrochlorothiazide.
3 PHARMACEUTICAL FORM
Tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Potassium-conserving diuretic and antihypertensive.
For the treatment of conditions requiring diuretic therapy with the maintenance of a safe serum potassium level, e.g. congestive heart failure, in particular when treated with digitalis, and other diuretic-treated cardiac conditions. Hypertension, when diuretic-induced hypokalaemia persists despite appropriate measures. Hepatic cirrhosis with ascites and oedema.
Co-amilozide can be given together with other antihypertensive drugs such as beta-adrenergic blocking agents.
4.2 Posology and method of administration
Adults:
Hypertension: initially 1/2 tablet daily, increasing if necessary to a maximum of 1 tablet daily.
Congestive heart failure: initially 1/2 tablet daily, increasing if necessary to a maximum of 2 tablets daily.
Oedema and ascites in cirrhosis of the liver: initially 1 tablet daily, increasing if necessary to a maximum of 2 tablets daily; dose should be reduced for maintenance if possible.
Elderly:
In elderly patients an initial dose of 1/2 tablet (or 1 Co-Amilozide 2.5/25 tablet) is recommended.
Children:
Co-Amilozide is not recommended for the treatment of children, as safety and effectiveness in children have not been established.
The tablets are intended for oral administration.
4.3 Contraindications
Known hypersensitivity to thiazides, related sulphonamides, or amiloride hydrochloride. Anuria. Acute renal insufficiency or rapidly advancing renal impairment (BUN> 10 mmol/l, serum creatinine> 130 micromol/1).
Diabetic nephropathy. Elevated serum potassium levels (>5.5mmol/1). Concomitant treatment with other potassium sparing agents. Potassium supplementation, unless serum potassium is carefully monitored. Seriously reduced hepatic function. Manifest gout.
4.4 Special warnings and precautions for use
Should not be given to patients with renal impairment, as the use of potassium conserving agents may result in the rapid development of hyperkalaemia, which may also be caused in diabetic patients. Hyperkalaemia in aged patients with normal renal function has been reported. Thiazide-induced hypokalaemia, hyponatraemia and raised blood urea nitrogen may occur. Regular monitoring of serum creatinine, serum electrolytes (particularly potassium and sodium), and blood urea nitrogen is important, especially in elderly and diabetic patients. Co-amilozide should be given with great care to patients at risk of developing metabolic or respiratory acidosis, such as those with cardiopulmonary disease or poorly controlled diabetes. Treatment should be discontinued prior to glucose tolerance testing. In cirrhotic patients the risk of hepatic encephalopathy should be borne in mind
4.5 Interaction with other medicinal products and other forms of interaction
Increased risk of hyperkalaemia if ACE-inhibitors are administered concomitantly.
4.6 Pregnancy and lactation
Not recommended during pregnancy. Hydrochlorothiazide crosses the placental barrier and may cause foetal or neonatal hyperglycaemia, thrombocytopenia or electrolyte disturbances. Hydrochlorothiazide is also excreted in breast milk, and lactation should be discontinued if the use of co-amilozide is considered of importance to the mother.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Nausea, vomiting, cramps in calf muscles, exanthem, hypotension and electrolyte disturbances.
4.9 Overdose
Nausea, vomiting, cramps in calf muscles, exanthem, hypotension and electrolyte disturbances. Symptomatic treatment.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Co-amilozide is a diuretic and antihypertensive combining the natriuretic action of hydrochlorothiazide with the potassium-conserving effect of amiloride hydrochloride.
5.2 Pharmacokinetic properties
Absorption:
Gastrointestinal absorption of hydrochlorothiazide ranges between 60-80%, and for amiloride it is about 50%. Both drugs are rapidly absorbed upon oral administration, and maximum plasma levels are reached 3-4 hours after administration.
Distribution:
Hydrochlorothiazide and amiloride are rapidly distributed, and observable diuresis occurs within 1-2 hours.
Biotransformation:
Amiloride is not bound to plasma proteins and has a plasma half life of 6-10 hours. Hydrochlorothiazide has a plasma half life of about 10 hours. Its biological half-life is up to 15 hours.
Excretion:
Amiloride and hydrochlorothiazide are excreted unchanged, mainly in the urine.
5.3 Preclinical safety data
As Co-Amilozide has been proven essentially similar to Moduretic, no preclinical testing has been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Rice starch, cellulose microcrystalline, lactose, magnesium stearate, povidone (K-valve 29-32) and talc. Alcohol (96 percent) and purified water are used during the manufacturing of Co-Amilozide tablets 5/50, but are not detectable in the finished product.
6.2 Incompatibilities
None relevant.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
None stated.
6.5 Nature and contents of container
Securitainers: Opaque polypropylene containers having snap on polyethylene lids with integral tear-off security seals, e.g. J & J “Securitainer” or Wrangby “Snap-Secure” container.
Pack size: 30 or 100 white or almost white tablets.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Genethics (UK) Limited
Boumpoulinas 11, 1st Floor
Nicosia
PC. 1060
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 34109/0006
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/03/2009
10 DATE OF REVISION OF THE TEXT
17/03/2009