Product Information:
| Product name |
Furosemide injection |
| Specification |
2ml:20mg |
| Packing |
Customizable |
| Standard |
Bp. USP. |
| Shelf life |
3 Years |
| Sample |
Available |
1. Name of the medicinal product
Furosemide 10 mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each 1ml solution contains 10mg Furosemide.
Each 2ml sterile solution for injection contains 20 mg of furosemide.
Each 5ml sterile solution for injection contains 50 mg of furosemide.
Excipients Sodium 0.3mmol per 2ml.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
A clear and colourless solution, essentially free from visible particles.
pH of the solution is between 8.00 and 9.30.
4. Clinical particulars
4.1 Therapeutic indications
When a prompt diuresis is required.. Use in emergencies or when oral therapy is precluded. Indications include
- Oedema caused by cardiac or hepatic diseases
- Oedema caused by renal diseases (in case of nephrotic syndrome, treatment of the underlying disease is essential)
- Pulmonary oedema (e.g. in case of acute heart failure)
4.2 Posology and method of administration
Route of administration: intravenous or intramuscular
General:
The parenteral administration of furosemide is indicated in cases where oral administration is not feasible or not efficient (for example in case of reduced intestinal absorption) or when a quick effect is required. 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.
Intravenous furosemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded and should never be given in association with other medicinal products in the same syringe.
Generally, Furosemide should be administered intravenously. Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration is feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.
In the absence of conditions requiring a reduced dose (see below) the initial dose recommended for adults and adolescents over 15 years, is of 20 mg to 40 mg furosemide (1 or 2 ampoules) by intravenous (or in exceptional cases intramuscular) administration; the maximum dose varying according to individual response.
If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours.
In adults, the recommended maximum daily dose of furosemide administration is 1500 mg.
Weight loss induced by enhanced diuresis should not exceed 1 kg/day.
Children and adolescents (up to 18 years of age):
The intravenous administration of furosemide to children and adolescents below 15 years is only recommended in exceptional cases.
The dosage will be adapted to the body weight, and the recommended dose ranges from 0.5 to 1 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
Renal impairment:
In patients with severe impairment of renal function (serum creatinine > 5 mg/dl) it is recommended that an infusion rate of 2.5 mg furosemide per minute is not exceeded.
Elderly:
The recommended initial dose is 20 mg/day, increasing gradually until the required response is achieved.
Special dosage recommendations:
For adults, the dose is based on the following conditions:
- Oedema associated to chronic and acute congestive heart failure
The recommended initial dose is 20 to 40 mg daily. This dose can be adapted to the patient´s response, as necessary. The dose should be given in two or three individual doses per day for chronic heart failure and as a bolus for acute congestive heart failure.
- Oedema associated with renal disease
The recommended initial dose is 20 to 40 mg daily. This dose can be adapted to the response as necessary. The total daily dose can be administered as a single dose or as several doses throughout the day.
If this does not lead to an optimal fluid excretion increase, furosemide must be administered in continuous intravenous infusion, with an initial rate of 50 mg to 100 mg per hour.
Before beginning the administration of furosemide, hypovolaemia, hypotension and acid-base and electrolytic imbalances must be corrected.
In dialyzed patients, the usual maintenance dose ranges from 250 mg to 1,500 mg daily.
In patients with nephrotic syndrome the dosage must be determined with caution, because of the risk of a higher incidence of adverse events.
- Oedema associated with hepatic disease
When intravenous treatment is absolutely needed, the initial dose should range from 20 mg to 40 mg. This dose can be adapted to the response as necessary. The total daily dose can be administered as a single dose or in several doses.
Furosemide can be used in combination with aldosterone antagonists in cases in which these agents in monotherapy are not sufficient. In order to avoid complications such as orthostatic intolerance or acid-base and electrolytic imbalances or hepatic encephalopathy, the dose must be carefully adjusted to achieve a gradual fluid loss. The dose may produce in adults a daily body weight loss of approximately 0.5 kg.
- Pulmonary oedema (in acute heart failure)
The initial dose to be administered is 40 mg furosemide by intravenous application. If required by the condition of the patient, another injection of 20 to 40 mg furosemide is given after 30 - 60 minutes.
Furosemide should be used in addition to other therapeutic measures.
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