INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo HEXARETIC TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

HEXARETIC TABLETS

COMPOSITION:
Each tablet contains:        Amiloride hydrochloride 
  equivalent to amiloride 5 mg
  Hydrochlorothiazide 50 mg

PHARMACOLOGICAL CLASSIFICATION:
A.18.1 Diuretics

PHARMACOLOGICAL ACTION:
HEXARETlC is a diuretic which combines the natriuretic and antihypertensive activity of hydrochlorothiazide with the potassium-conserving activity of amiloride.

INDICATIONS:
Essential hypertension.
Oedema of cardiac decompensation or associated with hepatic cirrhosis and corticosteroid therapy.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients.
Patients with hyperkalaemia, progressive renal failure or severe hepatic impairment.
Should not be given with other potassium-sparing medicines or potassium supplements.
Pregnancy and lactation.
Safety in children has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Oedema
: 1 to 2 tablets daily. Dosage may be increased if necessary but should not exceed 4 tablets daily. After initial diuresis, dosage reduction should be attempted for maintenance therapy.
Hypertension: ½ to 1 tablet daily, either alone or in conjunction with other antihypertensive agents. Dosage of up to two tablets have been recommended, but are rarely necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Amiloride hydrochloride may cause nausea, vomiting, abdominal pain, diarrhoea or constipation, paraesthesia, thirst, dizziness, skin rash, pruritus, weakness, muscle cramps and psychiatric or visual changes. Orthostatic hypotension and rises in blood-urea-nitrogen concentrations have been reported. Its potassium-sparing effect may lead to hyperkalaemia. Abnormalities in liver-function tests have been reported.
Amiloride hydrochloride should be given with care to patients likely to develop acidosis, to patients with diabetes mellitus and to those with impaired hepatic or renal function. Elderly patients, and patients with impaired renal function or diabetes mellitus are at particular risk of developing hyperkalaemia. Amiloride hydrochloride should be discontinued at least 3 days before glucose-tolerance tests are given to patients with diabetes mellitus because of the risks if patients are hyperkalaemic. Serum electrolytes and blood-urea-nitrogen should be estimated periodically.
Side-effects which may occur with hydrochlorothiazide include allergies, thirst, epigastric pain, anorexia, gastric irritation, nausea, vomiting, constipation, diarrhoea, headache, dizziness, muscle spasm, weakness, inflammation of the salivary glands, loss of libido, postural hypotension, paraesthesias and yellow vision.
Frequently occurring metabolic disturbances include hyperglycaemia and glycosuria in diabetic and other susceptible patients, hyperuricaemia and precipitation of attacks of gout in some patients. Administration may be associated with electrolyte imbalances including hypochloraemic alkalosis, hyponatraemia and hypokalaemia. Hypokalaemia intensifies the effect of digitalis on cardiac muscle and administration of digitalis and its glycosides may have to be temporarily suspended. Patients with severe coronary artery disease and cirrhosis of the liver are particularly at risk from hypokalaemia. Hyponatraemia may occur in patients with severe congestive heart failure who are very oedematous, particularly with large doses in conjunction with restricted salt in the diet. Electrolyte imbalances during long-term treatment with hydrochlorothiazide may be associated with an increased incidence of arrhythmias.
Signs of electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain and cramps and gastro-intestinal disturbances.
Sensitivity reactions include skin rashes, photosensitivity, pulmonary oedema and pneumonitis.
Cholestatic jaundice, pancreatitis and blood disorders including agranulocytosis, aplastic and haemolytic anaemia, thrombocytopenia, and leucopenia have occurred. Postural hypotension associated with hydrochlorothiazide therapy may be enhanced by concomitant ingestion of alcohol, barbiturates or opioids. Hyperparathyroidism has been associated with therapy, and changes in serum lipids have been noted.
The urinary excretion of calcium is reduced.
Hypomagnesaemia has also occurred.
Necrotizing vasculitis, Stevens-Johnson syndrome (erythema multiforme), purpura and acute pancreatitis have been reported.
Hydrochorothiazide should be used with caution in patients with impaired hepatic function or renal function, or with diabetes mellitus or adrenal disease. Patients should be carefully observed for signs of fluid and electrolyte imbalance, especially in the presence of vomiting or during parenteral fluid therapy.
Hydrochlorothiazide may exacerbate or activate systemic lupus erythematosus in susceptible patients.
Hydrochlorothiazide may enhance the toxicity of digitalis glycosides by depleting serum-potassium concentrations. It may enhance the neuromuscular blocking action of competitive muscle relaxants, such as tubocurarine. It may enhance the effect of anti-hypertensive agents such as guanethidine, methyldopa and rauwolfia alkaloids. The potassium-depleting effect of hydrochlorothiazide may be enhanced by corticosteroids, corticotrophin or carbenoxolone. Hydrochlorothiazide may diminish the response to pressor amines such as noradrenaline. Concomitant administration of hydrochlorothiazide and lithium are not generally recommended since this association may lead to toxic blood concentrations of lithium. Blood-glucose concentrations should be monitored in patients taking antidiabetic medicines, since requirements may change.
Hydrochlorothiazide may interfere with a number of diagnostic tests, including tests for parathyroid function. Serum concentrations of protein-bound iodine may increase without signs of thyroid disturbance.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to “Side effects and special precautions”.
Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
White to off white, round biplane, scored tablets.

PRESENTATION:
The tablets are packed in strips of 10 tablets in polyvinylchloride/aluminium blister packaging, and securitainers of 1000 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
27/18.1/0211

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Hexal Pharma (SA) (Pty) Ltd
Unit A
10 Fangio Road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 May 1993

Updated on this site: February 2000

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