1. Name Of The Medicinal Product
Potassium Citrate Mixture BP
2. Qualitative And Quantitative Composition
Potassium Citrate BP 1.5g/5ml.
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 Contraindications
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 anti-bacterial 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).
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 Preclinical Safety Data
None.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Citric acid monohydrate BP, quillaia tincture BP, lemon oil terpeneless BP, ethanol (96%) BP, chloroform BP, purified water BP, syrup BP.
6.2 Incompatibilities
Incompatible with calcium and strontium salts.
6.3 Shelf Life
|
|
6.4 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 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
L.C.M. Ltd.,
Linthwaite Laboratories
Huddersfield
HD7 5QH
England
8. Marketing Authorisation Number(S)
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
21.09.2010
No comments:
Post a Comment