DROLINA 20 mg tablets
•  Oedema resulting from heart or liver disease 
•  Oedema due to kidney disease (treatment of the underlying disorder should be the 
priority in nephrotic syndrome) 
•  Arterial hypertension 

Dosage should be determined on a case-by-case basis, particularly in view of the therapeutic 
effect. The lowest dose providing the desired effect should always be used. In adults, the following dosage recommendations should be followed: 
DROLINA long 30 mg prolonged-release capsules 
Dosage 
Oedema resulting from heart or liver disease:
Treatment is usually started with a single daily dose of 2 x DROLINA long 30 mg prolonged-
release  capsules  (equivalent  to  60 mg  furosemide),  taken  in  the morning.  In more  severe 
cases, treatment can be initiated with 4 x DROLINA long 30 mg prolonged-release capsules 
(equivalent to 120 mg furosemide) daily. 
Maintenance dose: 2 x DROLINA long 30 mg prolonged-release capsules (equivalent to 60 
mg furosemide) daily or every 2nd or 3rd day. If the response is inadequate, 4 x DROLINA 
long 30 mg prolonged-release capsules (equivalent to 120 mg furosemide) should be given 
daily or every 2nd or 3rd day. 
The weight loss caused by increased diuresis should not exceed 1 kg per day. 
Oedema due to kidney disease:
Treatment is usually started with a single daily dose of 2 x DROLINA long 30 mg prolonged-
release  capsules  (equivalent  to  60 mg  furosemide),  taken  in  the morning.  In more  severe 
cases, treatment can be initiated with 4 x DROLINA long 30 mg prolonged-release capsules 
(equivalent to 120 mg furosemide) daily. 
Maintenance dose: 2 x DROLINA long 30 mg prolonged-release capsules (equivalent to 60 
mg furosemide) daily or every 2nd or 3rd day. If the response is inadequate, 4 x DROLINA 
long 30 mg prolonged-release capsules (equivalent to 120 mg furosemide) should be given 
daily or every 2nd or 3rd day. 
The weight loss caused by increased diuresis should not exceed 1 kg per day. 
In nephrotic syndrome, the dose must be carefully adjusted because of the risk of increased 
undesirable effects. 
Arterial hypertension: 
The usual dosage is a single dose of 2 x DROLINA long 30 mg prolonged-release capsules 
(equivalent to 60 mg furosemide) daily, alone or in combination with other medicinal products. 
In more severe cases, 4 x DROLINA long 30 mg prolonged-release capsules (equivalent to 
120 mg furosemide) daily can be administered initially. DROLINA 40 mg tablets 
Dosage 
Oedema resulting from heart or liver disease:
The  initial  dose  in  adults  is  usually  1  x  DROLINA  40  mg  tablet  (equivalent  to  40  mg 
furosemide). If adequate diuresis is not achieved, the single dose can be doubled after 6 hours 
to 2 x DROLINA 40 mg tablets (equivalent to 80 mg furosemide). If satisfactory diuresis is still 
not  attained,  4  x  DROLINA  40  mg  tablets  (equivalent  to  160  mg  furosemide)  can  be 
administered after a further 6 hours. If necessary, initial doses over 200 mg furosemide can 
be used in exceptional cases under careful clinical supervision. 
The daily maintenance dose is usually 1 - 2 DROLINA 40 mg tablets (equivalent to 40 - 80 mg 
furosemide). 
The weight loss caused by increased diuresis should not exceed 1 kg per day. 
Oedema due to kidney disease:
The  initial  dose  in  adults  is  usually  1  x  DROLINA  40  mg  tablet  (equivalent  to  40  mg 
furosemide). If adequate diuresis is not achieved, the single dose can be doubled after 6 hours 
to 2 x DROLINA 40 mg tablets (equivalent to 80 mg furosemide). If satisfactory diuresis is still 
not  attained,  4  x  DROLINA  40  mg  tablets  (equivalent  to  160  mg  furosemide)  can  be 
administered after a further 6 hours. If necessary, initial doses over 200 mg furosemide can 
be used in exceptional cases under careful clinical supervision. 
The daily maintenance dose is usually 1 - 2 DROLINA 40 mg tablets (equivalent to 40 - 80 mg 
furosemide). 
The weight loss caused by increased diuresis should not exceed 1 kg per day. 
In nephrotic syndrome, the dose must be carefully adjusted because of the risk of increased 
undesirable effects. 
Oedema due to burns:
The daily and/or single dose is between 1 and 2 ½ DROLINA 40 mg tablets (equivalent to 40 
- 100 mg furosemide). In exceptional cases with impaired renal function, up to 6 x DROLINA 
40 mg tablets (equivalent to 240 mg furosemide) can be administered. 
Intravascular volume depletion must be corrected before using DROLINA 40 mg tablets. 
Arterial hypertension: 
The usual dose is 1 x DROLINA 40 mg tablet (equivalent to 40 mg furosemide) once daily, 
alone or in combination with other medicinal products. Use in children:
Children generally receive 1 (to 2) mg furosemide per kg body weight/day, with a maximum of 
40 mg furosemide per day. 
 
DROLINA 500 mg Tabs 
Dosage 
Oliguria in advanced and terminal renal failure (predialysis and dialysis stages):
To  increase diuresis, daily doses of up  to 1,000 mg  furosemide can be administered while 
monitoring hydration and serum electrolyte levels. It should be checked whether furosemide 
is continuing to increase diuresis by occasionally discontinuing treatment. 
In patients with chronic renal failure, the dose must be carefully adjusted so that mobilisation 
of oedema fluid is achieved gradually. 
The switch to DROLINA 500 mg Tabs should only be made if there is an inadequate response 
to an oral dose of 120 mg  furosemide per day. The dose of ½  x DROLINA 500 mg Tabs 
(equivalent  to 250 mg  furosemide) can be  increased  to up  to 2 x DROLINA 500 mg Tabs 
(equivalent to 1,000 mg furosemide). 
DROLINA long 30 mg prolonged-release capsules / DROLINA 40 mg tablets / DROLINA 500 
mg Tabs 
Method of administration and duration of use
The  tablets  /  prolonged-release  capsules  should  be  taken  on  an  empty  stomach  and 
swallowed whole with adequate liquid (e.g. 1 glass of water). 
The duration of use depends on the nature and severity of the disorder. 

DROLINA long 30 mg prolonged-release capsules / DROLINA 40 mg tablets DROLINA long 30 mg prolonged-release capsules or DROLINA 40 mg tablets must not be used in the following cases: − hypersensitivity to furosemide, sulfonamides (possible cross sensitivity with furosemide) or to any of the excipients listed in section 6.1, − renal failure with anuria refractory to furosemide therapy, − hepatic coma and precoma associated with hepatic encephalopathy, − severe hypokalaemia (see section 4.8), − severe hyponatraemia, − hypovolaemia or dehydration, − breastfeeding mothers. DROLINA 500 mg Tabs DROLINA 500 mg Tabs must not be used in the following cases: − normal renal function or impaired renal function with glomerular filtration values greater than 20 ml/min because there is a risk of excessive water and electrolyte loss in these cases, − hypersensitivity to furosemide, sulfonamides (possible cross sensitivity with furosemide) or to any of the excipients listed in section 6.1, − renal failure with anuria refractory to furosemide therapy, − hepatic coma and precoma associated with hepatic encephalopathy, − severe hypokalaemia (see section 4.8), − severe hyponatraemia, − hypovolaemia or dehydration, − breastfeeding mothers.

the following situations:
−  hypotension,
−  manifest or latent diabetes mellitus (regular monitoring of blood sugar levels),
−  gout (regular monitoring of serum uric acid),
−  impaired micturition (e.g. in prostatic hypertrophy, hydronephrosis, ureteral stenosis),
−  hypoproteinaemia, e.g. in nephrotic syndrome (careful adjustment of the dose),
−  hepatorenal syndrome (rapidly progressing renal insufficiency combined with severe
liver disease, e.g. liver cirrhosis),
−  patients who would be at particular risk from an unwanted significant drop in blood
pressure, e.g. patients with cerebrovascular circulatory disorders or coronary heart
disease,
−  premature infants (risk of developing nephrocalcinosis/nephrolithiasis; monitoring of
renal function, kidney ultrasound).
In premature infants with respiratory distress syndrome, diuretic treatment with furosemide in
the first weeks of life can increase the risk of persistence of patent ductus arteriosus.
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.
In patients with micturition disorders (e.g. prostatic hypertrophy) furosemide should only be
used if provision has been made for free flow of urine since sudden urine production can lead
to urinary retention with overextension of the bladder. Furosemide leads to increased elimination of sodium and chloride and therefore water.
Elimination of other electrolytes (particularly potassium, calcium and magnesium) is also
increased. Since fluid-electrolyte balance disorders are often observed during treatment with
DROLINA due to increased electrolyte elimination, serum electrolytes should be monitored
regularly.
Particularly during long-term therapy with DROLINA, serum electrolytes (especially
potassium, sodium, calcium), bicarbonate, creatinine, urea and uric acid as well as blood
sugar levels should be monitored regularly.
Particularly close monitoring is required in patients with a high risk of developing electrolyte
disorders, or in the case of severe fluid depletion (e.g. due to vomiting, diarrhoea or intense
sweating). Hypovolaemia or dehydration and pronounced electrolyte disturbances or
disruption of the acid-base balance must be corrected. This may require temporary
discontinuation of treatment with furosemide.
Possible development of electrolyte disorders is affected by underlying disease (e.g. liver
cirrhosis, heart failure), concomitant medication (see Section 4.5) and diet.
The weight loss caused by increased urine excretion should not exceed 1 kg/day irrespective
of the extent of urine excretion.
In nephrotic syndrome, the dose must be carefully adjusted because of the risk of increased
undesirable effects.
Concomitant use with risperidone:
In placebo-controlled studies with risperidone 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 lowdose
thiazide diuretics) 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 before the decision to treat is made. 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).
The possibility exists of exacerbation or activation of systemic lupus erythematosus.
Use of DROLINA can yield positive results in doping tests. In addition, the abuse of DROLINA
as a doping agent can endanger health.

Warnings on specific excipients
Patients with the rare hereditary disorders galactose intolerance, lactase
deficiency or glucose-galactose malabsorption should not take DROLINA 40 mg tablets and
DROLINA 500 mg Tabs.
Patients with the rare hereditary disorders fructose intolerance, glucose-galactose
malabsorption or sucrose-isomaltase deficiency, should not take DROLINA long 30 mg
prolonged-release capsules. 

The simultaneous use of furosemide and glucocorticoids, carbenoxolone or laxatives can lead
to increased potassium depletion with the risk of hypokalaemia. In this respect, large amounts
of licorice act like carbenoxolone.
Non-steroidal anti-inflammatory drugs (e.g. indometacin and acetylsalicylic acid) can reduce
the effect of furosemide. In patients who develop hypovolaemia during furosemide therapy, or
in those who are dehydrated, the simultaneous administration of non-steroidal antiinflammatory
agents can trigger acute renal failure.
Probenecid, methotrexate and other medicinal products which, like furosemide, are
extensively secreted in the renal tubules, can reduce the effect of furosemide.
On concomitant administration with phenytoin, a reduced effect of furosemide has been
described.
As sucralfate reduces the uptake of furosemide from the intestine and therefore reduces its
effect, an interval of at least 2 hours should be allowed between administration of the two
medicinal products.
On concomitant administration with cardiac glycosides, furosemide-related hypokalaemia
and/or hypomagnesaemia increase the sensitivity of the myocardium to cardiac glycosides.
There is a greater risk of ventricular arrhythmias (including torsades de pointes) if furosemide
is used concomitantly with medicinal products that can cause a prolonged QT interval (e.g.
terfenadine, some class I and class III antiarrhythmic agents), and in patients with electrolyte
disturbances.
The toxicity of high-dose salicylates can be potentiated when they are administered
concomitantly with furosemide.
Furosemide can potentiate the harmful effects of nephrotoxic medicinal products (e.g.
antibiotics such as aminoglycosides, cephalosporins, polymyxins).
Deterioration in renal function may be observed in patients who are treated concomitantly with
furosemide and high doses of certain cephalosporins.
The ototoxicity of aminoglycosides (e.g. kanamycin, gentamicin, tobramycin) and other
ototoxic medicinal products
can be increased by the simultaneous administration of furosemide. Any hearing disorders
that occur may be irreversible. The simultaneous use of the above mentioned medicinal
products should therefore be avoided.
If cisplatin and furosemide are administered concomitantly, hearing damage may occur. If
forced diuresis with furosemide is attempted during cisplatin treatment, furosemide should
only be used at low doses (e.g. 40 mg in patients with normal renal function) and when there is a positive fluid balance. Otherwise, cisplatin nephrotoxicity may be enhanced.
The concomitant administration of furosemide and lithium leads to an increase in the cardiac
and neurotoxic effects of lithium via reduced lithium excretion. It is therefore recommended
that plasma lithium levels be carefully monitored in patients receiving this combination.
If other antihypertensive agents, diuretics or medicinal products with blood-pressure-lowering
potential are used at the same time as furosemide, a greater drop in blood pressure is to be
expected. A severe drop in blood pressure or even shock, and a deterioration in renal function
(in isolated cases acute renal failure), have been observed, particularly when an ACE inhibitor
or angiotensin-II-receptor antagonist were administered for the first time or for the first time in
higher doses. If possible, the furosemide therapy should therefore be temporarily
discontinued, or the dose at least reduced for three days before treatment with an ACE
inhibitor or angiotensin-II-receptor antagonist is started or doses are increased.
Furosemide can reduce the renal elimination of probenecid, methotrexate and other medicinal
products which, like furosemide, are extensively secreted in renal tubules. In high-dose
treatment (especially with both furosemide and the other medicinal product), this can lead to
elevated serum levels and a greater risk of undesirable effects due to furosemide or the
concomitant medication.
The effect of theophylline or curare-type muscle relaxants may be increased by furosemide.
The effect of antidiabetic agents or hypertensive sympathomimetics (e.g. epinephrine,
norepinephrine) may be reduced if furosemide is coadministered.
In patients treated with 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 before a decision to treat is made. (See Section 4.4 regarding increased mortality
in elderly patients with dementia receiving risperidone concomitantly.)
Levothyroxine: High doses of furosemide may inhibit binding of thyroid hormones to carrier
proteins
and thereby lead to an initial transient increase in free thyroid hormones, followed by an overall
decrease in total thyroid hormone levels. Thyroid hormone levels should be monitored.
Other interactions
The concomitant administration of cyclosporin A and furosemide is associated with an
increased risk of gouty arthritis as a result of furosemide-induced hyperuricaemia and
impairment of renal uric acid excretion by cyclosporin.
In patients who were at high risk of renal damage due to X-ray contrast media and who were
treated with furosemide, a deterioration in renal function occurred more frequently after a
contrast examination than in at-risk patients who received only an intravenous supply of fluid
(hydration) before the contrast-enhanced examination.
After intravenous administration of furosemide within 24 hours of treatment with chloral
hydrate, a feeling of heat, outbreaks of sweating, restlessness, nausea, a rise in blood
pressure, and tachycardia may be experienced in isolated cases. The simultaneous use of
furosemide and chloral hydrate should therefore be avoided. 

Pregnancy 
Furosemide should only be used in pregnancy for short periods and after the need to treat is 
carefully  weighed  as  it  crosses  the  placental  barrier. 
Diuretics are not suitable for the routine treatment of hypertension and oedema in pregnancy,  since  they  impair  placental  perfusion  and  thereby  intrauterine  growth. 
However,  if  furosemide  has  to  be  given  in  maternal  heart  failure  or  renal  insufficiency, 
electrolytes  and  haematocrit  as  well  as  the  foetal  growth  must  be  closely  monitored. 
Displacement  of  bilirubin  from  the  albumin  binding  site,  resulting  in  an  increased  risk  of 
kernicterus  in  hyperbilirubinaemia,  has  been  described  for  furosemide. 
Furosemide crosses the placental barrier and reaches 100% of maternal serum concentration 
in  cord  blood.  No  malformations  in  humans  that  could  be  associated  with  exposure  to 
furosemide  have  been  reported  to  date.  There  is  however  insufficient  data  to  provide  a 
conclusive assessment of possible damaging effects on  the embryo/foetus.  In utero  foetal 
urine  production may  be  stimulated.  Urolithiasis  has  been  observed  in  premature  infants 
treated  with  furosemide. 
Breastfeeding 
Furosemide is excreted in breast milk and inhibits lactation. Women should therefore not be 
treated  with  furosemide  if  they  are  breastfeeding.  If  necessary,  breastfeeding  should  be 
discontinued (also see Section 4.3). 

As individual reactions may vary, the ability to drive, use machines or work without a secure 
support may be impaired. This applies particularly at the start of treatment, when doses are 
increased or treatments are switched, or when the drug is taken with alcohol. 

The following categories are used to assess the incidence rates of undesirable effects: 
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) 
Not known (frequency cannot be estimated from the available data) 
The incidence rates of adverse effects are based on literature data and refer to studies that 
included a total of 1,387 patients receiving various doses of furosemide in a number of different 
indications. 
Blood and lymphatic system disorders:
Common: haemoconcentration (through excessive diuresis). 
Uncommon: thrombocytopenia. 
Rare: eosinophilia, leukocytopenia. 
Very rare: haemolytic anaemia, aplastic anaemia, agranulocytosis. 
Signs of agranulocytosis may include fever with shivering, mucous membrane changes and 
sore throat. 

Immune system disorders:
Uncommon:  allergic  skin  and mucous membrane  reactions  (see  "Skin and  subcutaneous 
tissue disorders”). 
Rare:  severe  anaphylactic  and  anaphylactoid  reactions  such  as  anaphylactic  shock  (for 
treatment, see Section 4.9). 
The  first  signs  of  shock  include  skin  reactions  such  as  flushing  or  urticaria,  restlessness, 
headache, sweating, nausea, cyanosis. 
Not known: exacerbation or activation of systemic lupus erythematosus. 
Metabolism and nutrition disorders (see Section 4.4):
Very common: Electrolyte disorders (including symptomatic manifestations), dehydration and 
hypovolaemia (particularly in elderly patients), elevated triglycerides. 
Common:  hyponatraemia  and  hypochloraemia  (particularly  in  restricted  sodium  chloride 
intake),  hypokalaemia  (particularly  in  concomitant  reduction  of  potassium  intake  and/or 
increased  potassium  losses,  e.g.  due  to  vomiting  or  chronic  diarrhoea);  elevated  blood 
cholesterol, elevated blood uric acid and episodes of gout. 
Uncommon:  reduced  glucose  tolerance  and  hyperglycaemia.  In  patients  with  manifest 
diabetes mellitus, this canlead to deterioration of the metabolic state. Latent diabetes mellitus 
may become manifest (see Section 4.4). 
Not known:  hypocalcaemia,  hypomagnesaemia,  metabolic  alkalosis,  Pseudo-Bartter 
syndrome in the context of misuse and/or long-term use of furosemide. 
Commonly  observed  symptoms  of  sodium  deficiency  include  apathy,  calf  cramps,  loss  of 
appetite, weakness, drowsiness, vomiting and confusion. 
Hypokalaemia  may  manifest  as  neuromuscular  signs  (muscle  weakness,  paraesthesia, 
paraesis),  intestinal  signs  (vomiting,  constipation,  meteorism),  renal  signs  (polyuria, 
polydipsia)  and  cardiac  signs  (disorders  of  impulse  formation  and  conduction).  Severe 
potassium depletion can result in paralytic ileus, consciousness disorders or even coma. 
Hypocalcaemia can cause tetany in rare cases. 
Tetany or  the development of cardiac arrhythmias have been observed  in  rare cases as a 
result of hypomagnesaemia. 
Nervous system disorders:
Common: hepatic encephalopathy in patients with hepatic insufficiency (see Section 4.3). 
Rare: paraesthesia. 
Not known: Dizziness, fainting and loss of consciousness, headache. 
Ear and labyrinth disorders:
Uncommon:  hearing  disorders,  mostly  reversible,  particularly  in  patients  with  renal 
insufficiency or hypoproteinaemia  (e.g.  in nephrotic syndrome) and/or on excessively  rapid 
intravenous injection. Deafness (sometimes irreversible). 
Rare: tinnitus.  Vascular disorders: 
Very common (on intravenous infusion): hypotension including orthostatic dysregulation (see 
Section 4.4). 
Rare: vasculitis. 
Not known: thrombosis (particularly in elderly patients). 
In excessive diuresis, circulatory disorders (even circulatory collapse) may occur, especially 
in  children  and  elderly  patients,  and  mainly  manifest  as  headaches,  dizziness,  visual 
disorders, dry mouth and thirst, hypotension and orthostatic dysregulation. 
Gastrointestinal disorders:
Uncommon: nausea. 
Rare: vomiting, diarrhoea. 
Very rare: acute pancreatitis. 
Hepatobiliary disorders:
Very rare: intrahepatic cholestasis, elevated transaminases. 
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, urticaria, rash, bullous dermatitis, erythema 
 
multiforme, pemphigoid, exfoliative dermatitis, purpura, photosensitivity. 
Not known:  Stevens-Johnson  syndrome,  toxic  epidermal  necrolysis,  acute  generalised 
exanthaemotic  pustulosis  (AGEP),  Drug  Rash  with  Eosinophilia  and  Systemic  Symptoms 
(DRESS). 
Musculoskeletal and connective tissue disorders:
Not known:  cases  of  rhabdomyolysis  have  been  reported,  often  in  the  context  of  severe 
hypokalaemia (see section 4.3) 
Renal and urinary disorders:
Very common: elevated blood creatinine. 
Common: increased urine volume. 
Rare: tubulointerstitial nephritis. 
Not known: elevated urine sodium, elevated urine chloride, elevated blood urea, symptoms 
of  impaired micturition  (e.g.  in patients with prostatic hypertrophy, hydronephrosis, ureteral 
stenosis)  to  urinary  retention  with  secondary  complications  (see  Section  4.4), 
nephrocalcinosis and/or nephrolithiasis  in premature  infants  (see Section 4.4),  renal  failure 
(see Section 4.5). 
Congenital, familial and genetic disorders:
Not known: increased risk of persistence of patent ductus arteriosus if premature infants are 
treated with furosemide in the first weeks of life. 

General disorders:
Rare: fever. 
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.

a) Symptoms of overdose
The clinical picture in acute or chronic overdose depends on the extent of water and 
electrolyte loss. Overdose can lead to hypotension, orthostatic dysregulation, electrolyte 
disturbances (hypokalaemia, hyponatraemia, hypochloraemia) or alkalosis. In more severe 
fluid depletion, pronounced hypovolaemia, dehydration, circulatory collapse and 
haemoconcentration with a tendency to thrombosis may occur. In rapid water and electrolyte 
losses, delirium may be observed. In rare cases, anaphylactic shock (symptoms: 
sweating, nausea, cyanosis, significant drop in blood pressure, consciousness disorders or 
even coma) may be observed. 
b) Treatment of overdose
In cases of overdose or in patients with signs of hypovolaemia (hypotension, orthostatic 
dysregulation), treatment with DROLINA must be discontinued immediately. 
If only a short time has passed since furosemide was taken orally, it is advisable to take 
steps for the primary elimination of poisoning (induced vomiting, gastric lavage) and 
absorption-reducing measures (activated charcoal). 
In more severe cases, vital signs must be monitored along with repeated assessments of the 
water and electrolyte balance, acid-base balance, blood sugar levels and substances 
excreted in urine, and any abnormal levels corrected if necessary. 
In patients with impaired micturition (e.g. prostatic hypertrophy) provision must be made for 
free flow of urine because sudden urine production can lead to urinary retention with 
overextension of the bladder. 
Treatment of hypovolaemia: volume replacement. 

Treatment of hypokalaemia: potassium replacement. 
Treatment of circulatory collapse: patients should be placed in the shock position, if 
necessary shock therapy. 
Emergency measures in the event of anaphylactic shock: 
At the first signs (e.g. skin reactions such as urticaria or flushing, restlessness, headache, 
outbreaks of sweating, nausea, cyanosis): 
-  place venous access, 
-  along with usual emergency measures, place the patient in a supine position with the 
legs raised, keep the airways clear and give oxygen, 
-  if  necessary,  implement  other  intensive  care  emergency  measures  (including  the 
administration of epinephrine, volume replacement fluids, glucocorticoids). 

Pharmacotherapeutic group: high-ceiling diuretic 
ATC code: C03CA01 
Furosemide is a potent, short- and fast-acting loop diuretic. By blocking the Na+/2Cl-/K+ ion 
carrier, it inhibits reabsorption of these ions in the ascending limb of the loop of Henle. 
Fractional sodium excretion can constitute up to 35% of the sodium that has undergone 
glomerular filtration. Increased sodium excretion leads to greater urine excretion and an 
increase in K+ secretion in the distal tubules via 
osmotically bound water. Excretion of Ca2+ and Mg2+ ions is also increased. In addition to 
the depletion of these electrolytes, reduced excretion of uric acid and disruption of the acid-
base balance leading to possible metabolic alkalosis may occur. 
Furosemide interrupts the tubuloglomerular feedback mechanism in the macula densa so 
that saluretic efficacy is not attenuated. 
Furosemide leads to dose-dependent stimulation of the renin-angiotensin-aldosterone 
system. 
In heart failure, furosemide causes an acute reduction in the preload on the heart by dilating 
the venous capacitance vessels. This early vascular effect appears to be mediated by 
prostaglandins and requires adequate renal function with activation of the renin-angiotensin-
aldosterone system and intact prostaglandin synthesis. 
Furosemide lowers blood pressure as a result of increased sodium chloride excretion and a 
reduced response of the smooth vascular musculature to vasoconstrictor stimuli, and through 
decreased blood volume. 

Approximately 65% of the dose is absorbed after oral administration. The plasma half-life is 
biphasic with a terminal elimination phase of about 1½ hours. Furosemide is up to 99% bound 
to plasma proteins and is mainly excreted in the urine, largely unchanged, but also excreted 
in  the bile, non-renal elimination being considerably  increased  in  renal  failure. Furosemide 
crosses the placental barrier and is excreted in the milk. 
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 4 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 bound 
to plasma albumin and little biotransformation takes place. 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. 
In renal/ hepatic impairment 
Where liver disease is present, biliary elimination is reduced up to 50%. Renal impairment has 
little effect on  the elimination  rate of  furosemide, but  less  than 20%  residual  renal  function 
increases the elimination time. 
The elderly 
The  elimination  of  furosemide  is  delayed  in  the  elderly  where  a  certain  degree  of  renal 
impairment is present. 
New born 
A sustained diuretic effect is seen in the newborn, possibly due to immature tubular function. 

Acute oral toxicity was found to be low in all the studied species. Chronic toxicity studies in 
rats and dogs gave rise to changes in the kidneys (including fibrosis and calcification). 
In vitro and in vivo genotoxicity studies with furosemide provided no clinically relevant 
evidence of genotoxic potential. 
Long-term studies in rats and mice showed no evidence of carcinogenic potential. 
Following  the  administration  of  high  doses  in  reproductive  toxicology  studies,  a  reduced 
number of differentiated glomeruli and skeletal anomalies  in  the scapula, humerus and ribs 
(due to hypokalaemia) were observed in rat foetuses, as well as hydronephrosis in mouse and 
rabbit foetuses. 

Lactose monohydrate supertab 11SD 
Croscarmellose sodium primellose 
Partially pregelatinized maize starch (starch 1500) 
Colloidal silicone dioxide aerosil 200 pharma 
Magnesium stearate 
Purified water 

Not applicable.  

2 years (24 Months).

Store below 30 ºC and keep in the original pack to protect from light, in a dry place. 

DROLINA 20 mg tablets are white to off-white, round, flat face bevel edge tablets debossed JS55 
on one side and plain on other side. 

DROLINA 20 mg tablets and DROLINA 40 mg tablets are available in pack containing 100 tablets. 

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