Furosemide is indicated in all conditions requiring prompt diuresis in patients who are unable
to take solid dose forms. Indications include cardiac, pulmonary, hepatic and renal oedema,
peripheral oedema due to mechanical obstruction or venous insufficiency and hypertension.

The medication should be administered in the morning to avoid nocturnal diuresis.
Adults (more than 18 years of age):
The usual initial daily dose is 40mg. This may be adjusted until an effective dose is achieved.
Elderly
In the elderly, furosemide is generally eliminated more slowly. Dosage should be titrated until
the required response is achieved.
Paediatric population
This product should not be used in children below 18 years of age (see section 4.4).
This product should not be mixed with food or beverages before use.
Method of administration
For oral administration only
The syringe adaptor should be placed in the neck of the bottle and the required dose should
be drawn from the container into the graduated oral syringe provided. The open end of the

syringe should be placed in the mouth of the patient, and the piston slowly depressed to
release the contents.

Hypovolaemia or dehydration. • Anuria. • Renal failure with anuria not responding to furosemide, or as a result of poisoning by nephrotoxic or hepatotoxic agents, or associated with hepatic coma. • Severe hypokalaemia and severe hyponatraemia. • Pre-comatose and comatose states associated with hepatic encephalopathy. • Breast feeding. • Hypersensitivity to Furosemide, sulphonamides or to any of the excipients listed in section 6.1. • Patients allergic to sulphonamides may show cross-sensitivity to furosemide.

This product should not be given to children because its ethanol content may affect their CNS.
Caution is required in patients liable to electrolyte deficiency. Regular monitoring of serum
sodium, potassium and creatinine is generally recommended during furosemide therapy;
particularly close monitoring is required in patients at high risk of developing electrolyte
imbalances or in case of significant additional fluid loss. Hypovolaemia or dehydration as well
as any significant electrolyte and acid-base disturbances must be corrected. This may require
temporary discontinuation of furosemide. Where indicated, steps should be taken to correct
hypotension or hypovolaemia before commencing therapy.
Urinary output must be secured. Patients with partial obstructions of urinary outflow for
example patients with prostatic hypertrophy or impairment of micturition have an increased
risk of developing acute urinary retention and require careful monitoring.
Particularly careful monitoring is necessary in:
• Patients with hypotension
• Patients who are at risk from a pronounced fall in blood pressure
• Patients with gout
• Patients with hepatorenal syndrome
• Patients with hypoproteinaemia, e.g. associated with nephrotic syndrome (the effect of
furosemide may be weakened and its ototoxicity potentiated).
Symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in
patients treated with furosemide, particularly in the elderly, patients on other medications
which can cause hypotension and patients with other medical conditions that are risks for
hypotension.

Cautious dose titration is required
• Patients that might manifest latent diabetes
• Diabetic patients who might show increased insulin requirements
The use of some diuretics is considered to be unsafe in acute porphyria therefore caution
should be exercised.
Concomitant use with risperidone: In risperidone placebo-controlled trials in elderly patients
with dementia, a higher incidence of mortality was observed in patients treated with
furosemide plus risperidone (7.3%; mean age 89 years, range 75-97 years) when compared
to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96 years) or
furosemide alone (4.1%; mean age 80 years, range 67-90 years). Concomitant use of
risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated
with similar findings.
No pathophysiological mechanism has been identified to explain this finding, and no consistent
pattern for cause of death observed. Nevertheless, caution should be exercised and the risks
and benefits of this combination or co-treatment with other potent diuretics should be
considered prior to the decision to use. There was no increased incidence of mortality among
patients taking other diuretics as concomitant treatment with risperidone. Irrespective of
treatment, dehydration was an overall risk factor for mortality and should therefore be avoided
in elderly patients with dementia (see section 4.3 Contraindications).
Furosemide is not recommended in patients at high risk for radiocontrast nephropathy - it
should not be used for diuresis as part of the preventative measures against radiocontrastinduced
nephropathy.

Excipient Warnings
This product contains:
Ethanol (E1510): This medicinal product contains 79.87mg of alcohol (ethanol) in each ml
which is equivalent to 7.987 % w/v. The amount in each ml of this medicinal product is
equivalent to less than 2ml beer or 1ml wine. The small amount of alcohol in this medicinal
product will not have any noticeable effects.
Maltitol liquid: Patients with rare hereditary problems of fructose intolerance should not take
this medicinal product.
Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to
say essentially 'sodium-free'.

ACE Inhibitors: Enhanced hypotensive effect when given with diuretics. A marked fall in blood
pressure and deterioration in renal function may be seen when ACE inhibitors are added to

furosemide therapy. The dose of furosemide should be reduced for at least three days, or the
drug stopped, before initiating the ACE inhibitor or increasing the dose of an ACE inhibitor.
Alpha-blockers: Enhanced hypotensive effect when diuretics are given with alpha-blockers,
also increased risk of first dose hypotension with post-synaptic alpha-blockers such as
prazosin.
Analgesics: Diuretics can increase the risk of nephrotoxicity of NSAIDs, also antagonism of
diuretic effect. Antagonism of diuretic effect (especially with indomethacin and ketorolac).
Salicylic toxicity may be increased by furosemide.
Angiotensin –II Receptor Antagonists: Enhanced hypotensive effect when diuretics given with
angiotensin-II receptor antagonists.
Anti-arrhythmics: Hypokalaemia caused by loop diuretics increases cardiac toxicity with
amiodarone, disopyramide, flecainide, and antagonises the action of lidocaine and mexiletine.
Antibacterials: Avoid the use of diuretics in lymecycline treatment. There is an increased risk
of ototoxicity when loop diuretics are given with aminoglycosides, polymyxins or vancomycin.
Since this may lead to irreversible damage, these drugs must only be used with furosemide if
there are compelling medical reasons. Impairment of renal function may develop in patients
receiving concurrent treatment with furosemide and high doses of certain cephalosporins.
Antidepressants: Possible increase of hypokalaemia when loop diuretics are given with
reboxetine. There is an enhanced hypotensive effect when diuretics are given with MAOIs.
There is an increased risk of postural hypotension when diuretics are given with tricyclic
antidepressants.
Antiepileptics: There is an increased risk of hyponatraemia when diuretics are given with
carbemazepine. The effects of furosemide are antagonised by phenytoin.
Antifungals: There is an increased risk of hypokalaemia when loop diuretics are given with
amphotericin.
Antipsychotics: Hypokalaemia caused by diuretics increase the risk of ventricular arrhythmias
with amisulpiride or sertindole. An enhanced hypotensive effect may be seen when diuretics
are given with phenothiazines. Hypokalaemia caused by diuretics increases risk of ventricular
arrhythmias with pimozide (avoid concomitant use).
Antivirals: Plasma concentration of diuretics may be increased by nelfinavir, ritonavir or
saquinavir.
Atomoxetine: Hypokalaemia caused by diuretics increases the risk of ventricular arrhythmias
with atomoxetine.
Barbiturates: Plasma concentrations of diuretics may be decreased. There may be an
increased risk of osteomalacia when diuretics are taken in combination with Phenobarbital.

Beta-blockers: There is an enhanced hypotensive effect when diuretics are given with betablockers.
Hypokalaemia caused by loop diuretics increases the risk of ventricular arrhythmias
with sotalol.
Cardiac glycosides: Hypokalaemia caused by loop diuretics increases cardiac toxicity with
cardiac glycosides.
Ciclosporin: there is an increased risk of nephrotoxicity and possibly hypermagnesaemia
when diuretics are given with ciclosporin.
Cisplatin: There is a risk of increased ototoxic effects if cisplatin and furosemide are given
concomitantly. In addition, nephrotoxicity of cisplatin may be enhanced if furosemide is not
given in low doses (e.g. 40mg in patients with normal renal function) and with positive fluid
balance when used to achieve forced diuresis during cisplatin treatment.
Corticosteroids: The diuretic effect of diuretics is antagonized by corticosteroids. There is an
increased risk of hypokalaemia when loop diuretics are given with corticosteroids.
Other Diuretics: There is an increased risk of hypokalaemia when loop diuretics are given with
acetazolamide. Profound diuresis is possible when metolazone is given with furosemide.
There is an increased risk of hypokalaemia when loop diuretics are given with thiazides and
related diuretics.
Lithium: Loop diuretics reduce the excretion of lithium, which may lead to increased plasma
concentrations and a risk of toxicity. Therefore, it is recommended that lithium levels are
carefully monitored and where necessary the lithium dosage is adjusted in patients receiving
this combination.
Potassium salts: There is an increased risk of hyperkalaemia when given with potassium salts.
Sucralfate: Furosemide and sucralfate must not be taken within 2 hours of each other as
sucralfate decreases the absorption of furosemide from the intestine and so reduces its effect.
Sympathomimetics, Beta2: There is an increased risk of hypokalameia when loop diuretics are
given with high doses of beta2 synpathomimetics.
Tacrolimus: There is an increased risk of hypokalaemia when given with tacrolimus.
Theophylline: There is an increased risk of hypokalaemia when loop diuretics are given with
theophylline.
Carbenoxolone, prolonged use of laxatives, liquorice: May increase the risk of developing
hypokalaemia.
Warfarin and clofibrate: Warfarin and clofibrate compete with furosemide in the binding to
serum albumin. This may have clinical significance in patients with low serum albumin levels
(e.g. in nephrotic syndrome). Furosemide does not change the pharmacokinetics of warfarin
to a significant extent, but a strong diuresis with associated dehydration may weaken the
antithrombotic effect of warfarin.

Probenecid, methotrexate and other drugs which, like furosemide, undergo significant renal
tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease
renal elimination of these drugs. In case of high-dose treatment (in particular, of both
furosemide and the other drugs), this may lead to increased serum levels and an increased
risk of adverse effects due to furosemide or the concomitant medication.
Risperidone: When administering risperidone, caution should be exercised and the risks and
benefits of the combination or co-treatment with furosemide or with other potent diuretics
should be considered prior to the decision to use. See section 4.4 Special warnings and
precautions for use regarding increased mortality in elderly patients with dementia
concomitantly receiving risperidone.

Pregnancy:
Results of animal work, in general, show no hazardous effect of furosemide in pregnancy.
There is clinical evidence of safety of the drug in the third trimester of human pregnancy;
however, furosemide crosses the placental barrier. It must not be given during pregnancy
unless there are compelling medical reasons. Treatment during pregnancy requires
monitoring of fetal growth.
Lactation:
Furosemide passes into breast milk and may inhibit lactation. Breastfeeding must be avoided
during treatment with furosemide.
Fertility:
No human data on the effect of furosemide on fertility are available. In rats, there was no effect
on mating or fertility with furosemide treatment.

Mental alertness may be reduced and the ability to drive or operate machinery may be
impaired.

The frequencies of adverse events are ranked according to the following:
Very common (≥1/10),
Common (≥1/100 to <1/10),
Uncommon (≥1/1,000 to <1/100),
Rare (≥1/10,000 to <1/1,000),
Very Rare (< 1/10,000),

Premature infants
In general, if furosemide is administered to premature infants during the first weeks of life, it
may increase the risk of persistence of patent ductus arteriosus. Risk of nephrocalcinosis/
nephroliathisis.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse.
To report any side effect(s):
 Saudi Arabia:
- The National Pharmacovigilance Centre (NPC)
Fax: +966-11-205-7662
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa
 Other GCC States:
Please contact the relevant competent authority.

Symptoms
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 – including A-V block and ventricular fibrillation.
Symptoms of these disturbances include severe hypotension (progressing to shock), acute
renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.

Treatment

There are no specific antidotes to furosemide. If the ingestion is recent, attempts to limit further
systemic absorption may be performed, through gastric lavage or others measures that may
minimize absorption (i.e. activated charcoal).
The clinically relevant fluid and electrolyte balance changes must be corrected. Along with the
prevention and treatment of serious complications resulting from such imbalances and other
effects in the body, this corrective action may require general and specific intensive medical
monitoring and therapeutic measures.

Pharmacotherapeutic group: High-Ceiling Diuretic Sulfonamide
ATC code: C03CA01
Furosemide is a potent loop diuretic which inhibits sodium and chloride reabsorption at the
Loop of Henle. The drug eliminates both positive and negative free water production.
Furosemide acts at the luminal face of the epithelial cells by inhibiting co-transport
mechanisms for the entry of sodium and chloride. Furosemide gains access to its site of action
by being transported through the secretory pathway for organic acids in the proximal tubule.
It reduces the renal excretion of uric acid. Furosemide causes an increased loss of potassium
in the urine and also increases the excretion of ammonia by the kidney.

Furosemide is a weak carboxylic acid which exists mainly in the dissociated form in the gastrointestinal
tract. Furosemide is rapidly but incompletely absorbed (60-70%) on oral
administration and its effect is largely over within four hours. The optimal absorption site is the
upper duodenum at pH 5.0. Regardless of route of administration, 69-97% of activity from a
radio-labelled dose is excreted in the first 4 hours after the drug is given. Furosemide is mainly
eliminated via the kidneys (80-90%); a small fraction of the dose undergoes biliary elimination
and 10-15% of the activity can be recovered from the faeces.
When oral doses of Furosemide are given to normal subjects the mean bioavailability of the
drug is approximately 52% but the range is wide. In plasma, Furosemide is extensively bound
to proteins mainly to albumin. The unbound fraction in plasma averages 2 - 4% at therapeutic
concentrations. The volume of distribution ranges between 170 - 270ml/Kg. The half life of the
ß phase ranges from 45 - 60 min. The total plasma clearance is about 200ml/min. Renal
excretion of unchanged drug and elimination by metabolism plus faecal excretion contribute
almost equally to the total plasma clearance. Furosemide is in part cleared by the kidneys in
the form of the glucuronide conjugate.

There are no pre-clinical data of relevance to the prescriber which are additional to that already
included in other sections of the SPC.

 

- Monopropylene glycol,
- potassium carbonate,
- hydroxyethylcellulose,
- sorbitol 70% solution,
- citric acid monohydrate,
- ethyl maltol,
- idacol fd&c yellow no.6 powder,
- orange flavor,
- saccharin sodium
- purified water

Not applicable.

2 years (24 Months).

store below 30 ºC and keep in the original pack to protect from light. Use within month after
opening

DROLINA 1mg/1ml Oral Solution is clear, yellowish solution free from foreign particles.
DROLINA 5mg/5ml oral solution are available as 150ml/Bottle

Any unused medicinal product or waste material should be disposed of in accordance with
local requirements, Keep out of the reach & sight of children