Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Intrapharm Laboratories Limited, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT
Oxytetracycline is a broad spectrum tetracycline antibiotic with activity against a large number of gram positive and gram negative bacteria. The product acts by interfering with bacterial protein synthesis.
The tetracyclines are incompletely and irregularly absorbed from the gastrointestinal tract.
The degree of absorption is diminished by the soluble salts of divalent and trivalent metals, with which tetracyclines form stable complexes and to a variable degree by milk or food. Plasma concentrations will depend upon the degree of absorption. Peak plasma concentrations occur about 1 to 3 hours after ingestion.
It is recommended that tetracyclines should be given before food.
A dose of 500mg every 6 hours by mouth is reported to produce steady-state plasma concentrations of 3 to 4µg per ml.
In the circulation, tetracyclines are bound to plasma proteins in varying degrees, but reported values differ considerably: from about 20 to 40% for oxytetracycline.
They are widely distributed throughout the body tissues and fluids. Small amounts appear in saliva, and the fluids of the eye and lung.
Tetracyclines appear in the milk of nursing mothers where concentrations may be 60% or more of those in the plasma. They diffuse across the placenta and appear in the foetal circulation in concentrations of about 25 to 75% of those in the maternal blood. Tetracyclines are retained at sites of new bone formation and recent calcification and in developing teeth.
The tetracyclines are excreted in the urine and in the faeces. Renal clearance is by glomerular filtration.
The tetracyclines are excreted in the bile where concentrations 5 to 25 times those in plasma can occur. Since there is some enterohepatic reabsorption complete elimination is slow. Considerable quantities occur in the faeces after administration by mouth.
There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SPC.
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