LASIX Solution for injection or infusion Ref.[50765] Active ingredients: Furosemide

General: The dose used must be the lowest that is sufficient to achieve the desired effect.

Route of administration: intramuscular or intravenous

Furosemide is given intravenously only when oral administration is not feasible or is ineffective (e.g. in impaired intestinal absorption) or if a rapid effect is required. If intravenous therapy is used, it is recommended that transfer to oral therapy be carried out as soon as possible. Intravenous furosemide must always be injected or infused slowly, a rate of 4mg per minute must not be exceeded. The diuretic effect of Lasix is proportional to the dosage.

In patients with severe impairment of renal function (serum creatinine >5 mg/dl), it is recommended that an infusion rate of 2.5 mg per minute is not exceeded.

Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration are feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.

To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections. Where continuous furosemide infusion is not feasible for follow-up treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approx. 4 hours) is to be preferred to a regimen with higher bolus doses at longer intervals.

Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they be given by slow intravenous infusion.

The recommended maximum daily dose of furosemide administration is 1500mg. For information on handling and dilution please see section 6.6 Instructions for use/handling

Children: Parenteral doses for children range from 0.5-1.5 mg/kg body weight daily up to a maximum total daily dose of 20mg.

Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss, e.g. hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias due to excessive diuresis. Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.

Treatment should therefore be aimed at fluid replacement and correction of the electrolyte imbalance. Together with the prevention and treatment of serious complications resulting from such disturbances and of other effects on the body, this corrective action may necessitate general and specific intensive medical monitoring and therapeutic measures.

No specific antidote to furosemide 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 gastric lavage or those designated to reduce absorption (e.g., activated charcoal).

36 months.

Keep the vials in the outer carton.

Type I, PhEur glass ampoules in packs of 5 × 2ml glass ampoules.

Injections of Lasix must not be mixed with any other preparations.

Lasix is a solution with a pH of about 9 with no buffering capacity. Therefore, the active ingredient may precipitate at lower pH values.

Normal saline solution is suitable as diluent. It is recommended that diluted solutions be used as soon as possible.

Opened ampoules should be used immediately and any remainder discarded.