POTASSIUM CITRATE MIXTURE Solution (2015)
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Περιεχόμενα
Name of the medicinal product
Potassium Citrate Mixture.
Qualitative and quantitative composition
Potassium Citrate 1.5g/5ml. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution.
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 ...
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 ...
Contraindications
Contraindicated in hyperkalaemia, renal dysfunction, ventricular arrhythmics and Addisons Disease.
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 ...
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. ...
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 anti-bacterial treatment of ...
Effects on ability to drive and use machines
No effect on mental alertness.
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 ...
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 ...
Pharmacodynamic properties
Citrate and citric acid solutions are systematic and urinary alkalinizers thereby providing symptomatic relief of dysuria.
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 ...
Preclinical safety data
None.
List of excipients
Citric acid monohydrate Quillaia tincture Lemon Oil terpeneless Ethanol (96%) Sodium benzoate Purified water Syrup
Incompatibilities
Incompatible with calcium and strontium salts.
Shelf life
Shelf life 200ml: 36 months unopened.
Special precautions for storage
Store below 25°C.
Nature and contents of container
200ml: Glass bottle with white 28mm polypropylene cap with tamper evident band and EPE/AL/Melinex liner.
Special precautions for disposal and other handling
None.
Marketing authorization holder
L.C.M. Ltd., Linthwaite Laboratories, Huddersfield, HD7 5QH, England
Marketing authorization number(s)
PL 12965/0031
Date of first authorization / renewal of the authorization
17.09.93 / 03.11.98
Date of revision of the text
02/07/2015
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