UREMIDE Tablet Ref.[50293] Active ingredients: Furosemide

Source: Marketing Authorisation Holder  Revision Year: 2021  Publisher: Alphapharm Pty Ltd, Level 1, The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.mylan.com.au

4.1. Therapeutic indications

Oedema

Furosemide (frusemide) is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome. Furosemide (frusemide) is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired.

Hypertension

Furosemide (frusemide) may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide (frusemide) alone.

4.2. Posology and method of administration

Oedema

Therapy should be individualised according to patient’s response. This therapy should be titrated to gain maximal therapeutic response with the minimum dose possible to maintain that diuretic response.

Adults

The usual initial daily dose is 20 to 80 mg given as a single dose. If the diuretic response to a single dose of 20 to 80 mg is not satisfactory, increase this dose by increments of 20 to 40 mg not sooner than 6 to 8 hours after the previous dose, until the desired diuretic effect is obtained. This individually determined dose should be given once or twice (e.g. at 8 am and 2 pm) daily. The dose of furosemide (frusemide) may be carefully titrated up to 400 mg/day (except in advanced renal failure) in those patients with severe clinical oedematous states. The mobilisation of oedema may be most efficiently and safely accomplished by giving furosemide (frusemide) on 2 to 4 consecutive days each week. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical laboratory observations are particularly advisable.

Infants and Children

The usual initial dose of oral furosemide (frusemide) for infants and children is 2 mg/kg body weight given as a single dose. If the diuretic response is not satisfactory, the dose may be increased by 1 to 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses of greater than 6 mg/kg body weight are not recommended.

For maintenance therapy in infants and children, the dose should be adjusted to the minimum effective level.

Hypertension

Therapy should be individualised according to the patient’s response. This therapy should be titrated to gain maximal therapeutic response with the minimum dose possible to maintain that therapeutic response.

Adults

The usual initial daily dose of furosemide (frusemide) for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when furosemide (frusemide) is used with other antihypertensive drugs, especially during initial therapy.

To prevent an excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50% when furosemide (frusemide) is added to the regimen. As the blood pressure falls under the potentiating effect of furosemide (frusemide), a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.

4.9. Overdose

The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss; e.g. dehydration, blood volume reduction, hypotension, electrolyte imbalance, cardiac arrhythmias (including A-V block and ventricular fibrillation), hypokalaemia and hypochloraemic alkalosis, and extensions of its diuretic action. Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.

The acute toxicity of furosemide (frusemide) has been determined in mice, rats and dogs. In all three, the oral LD50 exceeded 1000 mg/kg body weight, while the intravenous LD50 ranged from 300 to 680 mg/kg. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide (frusemide) in biological fluids associated with toxicity or death is not known.

No specific antidote to furosemide (frusemide) is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredient by measures such as activated charcoal.

Treatment

Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Haemodialysis does not accelerate furosemide (frusemide) elimination.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

6.3. Shelf life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4. Special precautions for storage

Store below 30°C. Protect from light.

6.5. Nature and contents of container

Container type: HDPE bottle.

Pack sizes: 30, 50*, 60*, 90*, 100, 1000*

* Some strengths, pack sizes and/or pack types may not be marketed.

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

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