DIUMIDE-K CONTINUS TABLETS
Active substance(s): FUROSEMIDE / POTASSIUM CHLORIDE
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diumide-K Continus Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film coated, round, orange/white bilayer tablet with 'DK' on the white layer.
Each tablet contains 40mg furosemide and 600mg potassium chloride within a
patented controlled release system.
3.
PHARMACEUTICAL FORM
Controlled release tablet.
4
CLINICAL PARTICULARS
4.1
Therapeutic Indications
For patients requiring diuresis and concomitant potassium supplementation.
Indications include cardiac oedema, pulmonary oedema, hepatic oedema, renal
oedema and peripheral oedema of various aetiologies.
4.2
Posology and Method of administration
For all indications:
Adults:
The usual adult dose is one tablet daily, normally in the
morning; this may be adjusted depending on the condition.
Children:
Not recommended.
The Elderly:
The normal adult dosage is recommended.
Administration:
4.3
Diumide-K Continus Tablets should be swallowed whole
with water, preferably prior to or during a meal. The tablets
should not be chewed as this will destroy the controlled
release system.
Contra-Indications
Porphyria, hyperkalaemia, precomatose states associated with liver cirrhosis,
Addison's disease and concomitant administration of potassium sparing
diuretics.
Although the Continus® controlled release system minimises the likelihood of
oesophageal ulceration, all solid forms of potassium medication are contraindicated in the presence of obstructions in the digestive tract (eg resulting
from compression of the oesophagus due to dilation of the left atrium or from
stenosis of the gut).
4.4
Special Warnings and Special Precautions for Use
Care should be exercised in patients with renal insufficiency where there is a
risk of hyperkalaemia. Diumide K Continus Tablets should not be chewed
but swallowed whole with water preferably prior to or during a meal.
4.5
Interaction with other medicinal products and other forms of interaction
Increased toxicity risk with cardiac glycosides, hypotensive agents, including
ACE inhibitors and nephrotoxic antibiotics. Serum lithium levels may be
increased with concomitant administration. Non-steroidal anti-inflammatory
drugs antagonise the diuretic effect.
4.6
Pregnancy and Lactation
Specific experience is unavailable with Diumide-K Continus tablets. Rat
studies have shown that the administration of furosemide (37.5 - 300mg/kg
twice daily) on days 6 - 17 of gestation produced dose related increases in
wavy ribs. When providing potassium chloride during the dosing period, the
incidence of wavy ribs reduced by 90% indicating that the teratogenicity was
probably related to hypokalaemia.
In humans, furosemide crosses the placenta. Oral doses of 25 to 40mg have
produced peak cord serum concentrations after approximately 9 hours.
Maternal and cord levels were equal at approximately 8 hours. Increased foetal
urine production after maternal furosemide therapy has been observed in
newborns exposed to furosemide shortly before birth. Urinary sodium and
potassium in treated neonates have been found to be significantly greater than
in non-exposed controls. Neonatal electrolyte disturbances may occur.
Whilst potassium chloride is a natural constituent of tissues and fluids, high or
low levels can be detrimental to maternal and foetal cardiac function and
serum levels should therefore be monitored closely.
Furosemide has been used in pregnancy, in labour and in the puerperium in
cases of excessive weight gain, oedema, hypertension and toxaemia of
pregnancy with satisfactory results and with no embryotoxic, foetotoxic or
teratogenic effects.
Diumide-K Continus tablets should not be administered during the first
trimester. Diuretics may reduce placental perfusion. After the first trimester,
Diumide-K Continus tablets should not be administered if the adequacy of
placental perfusion is suspect.
Nursing Mothers
Lactation may be inhibited due to maternal fluid depletion. Furosemide is
excreted into breast milk therefore Diumide-K Continus tablets should be
used with caution.
4.7
Effects on Ability to Drive and Use Machines
None known.
4.8
Undesirable Effects
Patients with prostatic hypertrophy or impairment of micturition have an
increased risk of developing acute urinary retention. Latent diabetes may
become manifest or the insulin requirements of diabetic patients may increase.
Water and electrolyte balance may be disturbed and serum calcium levels may
be reduced. Raised urea and creatinine levels may occur. Bone marrow
depression and acute pancreatitis have also been reported as rare
complications and therapy should be withdrawn.
Bullous pemphigoid among elderly patients has also been reported as very rare
complication: the therapy should be withdrawn.
4.9
Overdose
Overdosage is characterised by excessive diuresis. Replace fluids and correct
electrolyte imbalance.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Diumide-K Continus Tablets contain the diuretic furosemide and potassium
chloride. Furosemide is a loop diuretic, inhibiting resorption from the
ascending loop of Henlé. It is used for the treatment of oedematous states of
various aetiologies. Potassium chloride is present in the tablets to counteract
the urinary loss of potassium induced by furosemide.
5.2
Pharmacokinetic properties
The furosemide layer has normal release characteristics. Furosemide produces
a diuresis within one hour and it is complete within six hours. Furosemide has
a biphasic half life in the plasma with a terminal elimination phase of up to
about 11/2 hours. The potassium chloride in Diumide-K Continus Tablets is
incorporated in the controlled release system. This ensures a prolonged
release giving maximum absorption and avoiding 'flushing out' of the
potassium by the action of the diuretic.
5.3
Preclinical safety data
None relevant to the prescriber.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
The tablets also contains:
Lactose
Povidone (K25)
Pregelatinised maize starch
Talc
Hydroxyethyl cellulose
Gelatin powder
Cetostearyl alcohol
Magnesium stearate
FD & C Yellow No 6
Hydroxypropylmethyl cellulose
Polyethylene glycol 400
Purified water
6.2
Incompatibilities
None known.
6.3
Shelf Life
36 months.
6.4
Special Precautions for Storage
None.
6.5
Nature and Contents of Container
Blister pack containing 4 or 30 tablets. Securitainers with PE foam rondel
containing 250 or 1000 tablets.
6.6
Instructions for Use/Handling
Not relevant.
7
MARKETING AUTHORISATION HOLDER
TEOFARMA s.r.l
Via F.lli Cervi no 8
I-27010 Valle Salimbene (PV)
Italy
8.
MARKETING AUTHORISATION NUMBER
PL 16250/0001
9.
DATE OF
AUTHORISATION
FIRST
AUTHORISATION/RENEWAL
30th June 2001
10.
DATE OF (PARTIAL) REVISION OF TEXT
May 2003
OF
THE
1
NAME OF THE MEDICINAL PRODUCT
Diumide-K Continus Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film coated, round, orange/white bilayer tablet with 'DK' on the white layer.
Each tablet contains 40mg furosemide and 600mg potassium chloride within a
patented controlled release system.
3.
PHARMACEUTICAL FORM
Controlled release tablet.
4
CLINICAL PARTICULARS
4.1
Therapeutic Indications
For patients requiring diuresis and concomitant potassium supplementation.
Indications include cardiac oedema, pulmonary oedema, hepatic oedema, renal
oedema and peripheral oedema of various aetiologies.
4.2
Posology and Method of administration
For all indications:
Adults:
The usual adult dose is one tablet daily, normally in the
morning; this may be adjusted depending on the condition.
Children:
Not recommended.
The Elderly:
The normal adult dosage is recommended.
Administration:
4.3
Diumide-K Continus Tablets should be swallowed whole
with water, preferably prior to or during a meal. The tablets
should not be chewed as this will destroy the controlled
release system.
Contra-Indications
Porphyria, hyperkalaemia, precomatose states associated with liver cirrhosis,
Addison's disease and concomitant administration of potassium sparing
diuretics.
Although the Continus® controlled release system minimises the likelihood of
oesophageal ulceration, all solid forms of potassium medication are contraindicated in the presence of obstructions in the digestive tract (eg resulting
from compression of the oesophagus due to dilation of the left atrium or from
stenosis of the gut).
4.4
Special Warnings and Special Precautions for Use
Care should be exercised in patients with renal insufficiency where there is a
risk of hyperkalaemia. Diumide K Continus Tablets should not be chewed
but swallowed whole with water preferably prior to or during a meal.
4.5
Interaction with other medicinal products and other forms of interaction
Increased toxicity risk with cardiac glycosides, hypotensive agents, including
ACE inhibitors and nephrotoxic antibiotics. Serum lithium levels may be
increased with concomitant administration. Non-steroidal anti-inflammatory
drugs antagonise the diuretic effect.
4.6
Pregnancy and Lactation
Specific experience is unavailable with Diumide-K Continus tablets. Rat
studies have shown that the administration of furosemide (37.5 - 300mg/kg
twice daily) on days 6 - 17 of gestation produced dose related increases in
wavy ribs. When providing potassium chloride during the dosing period, the
incidence of wavy ribs reduced by 90% indicating that the teratogenicity was
probably related to hypokalaemia.
In humans, furosemide crosses the placenta. Oral doses of 25 to 40mg have
produced peak cord serum concentrations after approximately 9 hours.
Maternal and cord levels were equal at approximately 8 hours. Increased foetal
urine production after maternal furosemide therapy has been observed in
newborns exposed to furosemide shortly before birth. Urinary sodium and
potassium in treated neonates have been found to be significantly greater than
in non-exposed controls. Neonatal electrolyte disturbances may occur.
Whilst potassium chloride is a natural constituent of tissues and fluids, high or
low levels can be detrimental to maternal and foetal cardiac function and
serum levels should therefore be monitored closely.
Furosemide has been used in pregnancy, in labour and in the puerperium in
cases of excessive weight gain, oedema, hypertension and toxaemia of
pregnancy with satisfactory results and with no embryotoxic, foetotoxic or
teratogenic effects.
Diumide-K Continus tablets should not be administered during the first
trimester. Diuretics may reduce placental perfusion. After the first trimester,
Diumide-K Continus tablets should not be administered if the adequacy of
placental perfusion is suspect.
Nursing Mothers
Lactation may be inhibited due to maternal fluid depletion. Furosemide is
excreted into breast milk therefore Diumide-K Continus tablets should be
used with caution.
4.7
Effects on Ability to Drive and Use Machines
None known.
4.8
Undesirable Effects
Patients with prostatic hypertrophy or impairment of micturition have an
increased risk of developing acute urinary retention. Latent diabetes may
become manifest or the insulin requirements of diabetic patients may increase.
Water and electrolyte balance may be disturbed and serum calcium levels may
be reduced. Raised urea and creatinine levels may occur. Bone marrow
depression and acute pancreatitis have also been reported as rare
complications and therapy should be withdrawn.
Bullous pemphigoid among elderly patients has also been reported as very rare
complication: the therapy should be withdrawn.
4.9
Overdose
Overdosage is characterised by excessive diuresis. Replace fluids and correct
electrolyte imbalance.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Diumide-K Continus Tablets contain the diuretic furosemide and potassium
chloride. Furosemide is a loop diuretic, inhibiting resorption from the
ascending loop of Henlé. It is used for the treatment of oedematous states of
various aetiologies. Potassium chloride is present in the tablets to counteract
the urinary loss of potassium induced by furosemide.
5.2
Pharmacokinetic properties
The furosemide layer has normal release characteristics. Furosemide produces
a diuresis within one hour and it is complete within six hours. Furosemide has
a biphasic half life in the plasma with a terminal elimination phase of up to
about 11/2 hours. The potassium chloride in Diumide-K Continus Tablets is
incorporated in the controlled release system. This ensures a prolonged
release giving maximum absorption and avoiding 'flushing out' of the
potassium by the action of the diuretic.
5.3
Preclinical safety data
None relevant to the prescriber.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
The tablets also contains:
Lactose
Povidone (K25)
Pregelatinised maize starch
Talc
Hydroxyethyl cellulose
Gelatin powder
Cetostearyl alcohol
Magnesium stearate
FD & C Yellow No 6
Hydroxypropylmethyl cellulose
Polyethylene glycol 400
Purified water
6.2
Incompatibilities
None known.
6.3
Shelf Life
36 months.
6.4
Special Precautions for Storage
None.
6.5
Nature and Contents of Container
Blister pack containing 4 or 30 tablets. Securitainers with PE foam rondel
containing 250 or 1000 tablets.
6.6
Instructions for Use/Handling
Not relevant.
7
MARKETING AUTHORISATION HOLDER
TEOFARMA s.r.l
Via F.lli Cervi no 8
I-27010 Valle Salimbene (PV)
Italy
8.
MARKETING AUTHORISATION NUMBER
PL 16250/0001
9.
DATE OF
AUTHORISATION
FIRST
AUTHORISATION/RENEWAL
30th June 2001
10.
DATE OF (PARTIAL) REVISION OF TEXT
May 2003
OF
THE
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