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POTASSIUM CITRATE MIXTURE

Active substance(s): POTASSIUM CITRATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Potassium Citrate Mixture

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Citrate 1.5g/5ml.
For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM
Solution

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
For the symptomatic relief of dysuria associated with mild urinary tract infections, especially
cystitis.
Indications stated on label: For the relief of the symptoms of cystitis and other mild urinary
tract infections.

4.2.

Posology and Method of Administration
Oral:
Recommended Doses

Unless directed otherwise by a doctor:
Adults including the elderly, and children over 6 years: 10ml.
Children 1 - 6 years: 5ml.
It should be taken well diluted with water, after meals.
Shake the bottle before use.
Dosage Schedule
The dose may be taken three times a day.

4.3.

Contra-Indications
Contraindicated in hyperkalaemia, renal dysfunction, ventricular arrhythmics and Addison’s
Disease.

4.4

Special warnings and precautions for use

Potassium Citrate Mixture provides symptomatic relief only and is not anti-bacterial.
Effective anti-bacterial therapy should be co-prescribed. It should be used with
caution when renal or cardiac dysfunction is present.
Labels to state: if symptoms persist consult your doctor. Discard any unused mixture 2
months after opening.
Use with caution in the elderly

4.5

Interaction with other medicinal products and other forms of interaction
Concurrent administration of potassium-containing drugs, potassium sparing diuretics or other
drugs that increase potassium levels (e.g. ACE inhibitors, ciclosporin, aliskiren) may lead to
hyperkalaemia. May interact with cardiac glycosides. Citrates alkalinise the urine and thus
may alter the urinary excretion of a number of drugs. This may lead to increased renal
clearance of acidic drugs, such as salicylates, tetracylines and barbiturates, and prolongation
of the half-life of basic drugs, such as sympathomimetics and stimulants. Particularly
noteworthy is the diminished anti-bacterial activity of nitrofurantoin and methenamine.

4.6.

Pregnancy and Lactation

No adverse effects are anticipated at recommended doses when used for initial symptomatic
relief only. Treatment with potassium citrate mixture is adjunctive and secondary to antibacterial treatment of urinary tract infection.

4.7.

Effects on Ability to Drive and Use Machines
No effect on mental alertness.

4.8

Undesirable effects
Mild nausea and occasionally vomiting may occur due to gastric irritation. Other side effects
are those due to hyperkalaemia (if this occurs).
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 reactions via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9.

Overdose
Overdosage is accompanied by nausea, vomiting, abdominal pain and symptoms due to
hyperkalaemia and metabolic acidosis. Fluid and electrolyte balance together with ECG
should be closely monitored.
Treatment is symptomatic and supportive. Moderate to severe hyperkalaemia is a medical
emergency requiring prompt correction.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties

Citrate and citric acid solutions are systematic and urinary alkalinizers thereby providing
symptomatic relief of dysuria.

5.2.

Pharmacokinetic Properties

Potassium Citrate is absorbed and the citrate is metabolised to bicarbonate. Citric
acid is metabolised to carbon dioxide and water. Oxidation is virtually complete with
less than 5% of citrate being excreted unchanged in the urine.

5.3.

Pre-clinical Safety Data
None.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Citric Acid Monohydrate
Quillaia Tincture
Lemon Oil Terpeneless
Ethanol (96%)
Sodium Benzoate
Purified Water
Syrup

6.2.

Incompatibilities
Incompatible with calcium and strontium salts.

6.3

Shelf life
200ml:

6.4.

36 months unopened

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container

200ml: Glass bottle with white 28mm polypropylene cap with tamper evident band and
EPE/AL/Melinex liner.

6.6.

Instruction for use and handling
None.

7.

MARKETING AUTHORISATION HOLDER
L.C.M. Ltd.,
Linthwaite Laboratories
Huddersfield
HD7 5QH
England

8.

MARKETING AUTHORISATION NUMBER
PL 12965/0031

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17.09.93 / 03.11.98

10

DATE OF REVISION OF THE TEXT
02/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

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