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Pharmaceutical precautions
List of excipients
Methyl parahydroxybenzoate (E218) 1.0mg
Propyl parahydroxybenzoate 0.1mg
Sodium metabisulfite (E223) 4.0mg
Purified water
Major Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Interaction with other medicinal products and other forms of interaction
General anaesthetics and muscle relaxing products increase the neuro-blocking effect of aminoglycosides. This may cause paralysis and apnoea.
Do not use concurrently with strong diuretics and potentially oto- or nephrotoxic substances.
Pharmacological Immunological Properties
Pharmacotherapeutic group: intestinal anti-infectives; antibiotics.
ATCvet code: QP 51 AA 06.
Pharmacodynamic properties
Paromomycin has antiprotozoal activity, although its mechanism of action is unclear. In in vitro studies using HCT-8 and Caco-2 cell lines inhibitory activity against C. parvum was observed.
Resistance of cryptosporidia to paromomycin has not been described to date. Nevertheless, the use of aminoglycosides is associated with the occurrence of bacterial resistance. Paromomycin may select for cross-resistance to other aminoglycosides..
Pharmacokinetic particulars
The bioavailability of paromomycin when administered as a single oral dose of 35 000 IU paromomycin/kg bodyweight to 2 - 6 week old calves was 2.75%. With regard to the absorbed fraction, the mean peak plasma concentration (Cmax) was 1.48 mg/l, the mean time to attain the peak plasma concentration (Tmax) was 4.5 hours and the mean terminal half-life (t1/2, el) was 11.2 hours. The main part of the dose is eliminated unchanged in the faeces while the absorbed fraction is excreted almost exclusively in urine as unchanged paromomycin. Paromomycin displays age-related pharmacokinetics, with the greatest systemic exposure occurring in newborn animals.
Environmental properties
The active ingredient, paromomycin sulphate, is persistent in soil.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.