Special precautions for use in animals
The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of water/milk animals should be treated parenterally using a suitable injectable product following the advice of the veterinarian. The use of the product should be combined with good management practices e.g. good hygiene, proper ventilation, no overstocking.
Since the product is potentially ototoxic and nephrotoxic, it is recommended to assess kidney function.
Special care should be taken when considering administration of the product to newborn animals due to the known higher gastrointestinal absorption of paromomycin in neonates. This higher absorption could lead to an increased risk of oto- and nephrotoxicity. The use of the product in neonates should be based on a benefit/risk assessment by the responsible veterinarian.
Prolonged or repeated use of the product should be avoided by improving management practices and through cleansing and disinfection.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official, national and regional antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to paromomycin and may decrease the effectiveness of treatment with aminoglycosides due to the potential for cross resistance.
Aminoglycosides are considered as critical in human medicine. Consequently, they should not be used as a first line treatment in veterinary medicine.
Pharmacotherapeutic group: intestinal anti-infective; antibiotics.
Use during pregnancy, lactation or lay
Laboratory studies in the rat and rabbit have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The use is not recommended during pregnancy.
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.
ATC vet code: QA07AA06.
Pharmacodynamic properties
Paromomycin belongs to the group of aminoglycoside antibiotics. Paromomycin changes the reading of messenger-RNA, which disrupts protein synthesis. The bactericidal activity of paromomycin is mainly attributed to its irreversible binding to ribosomes. Paromomycin has broad spectrum activity against numerous Gram-positive and Gram-negative bacteria, including E. coli.
Paromomycin acts in a concentration-dependent manner. Four mechanisms of resistance have been identified: changes of the ribosome, reduction of permeability, inactivation by enzymes and substitution of the molecular target. The first three resistance mechanisms arise from mutations of certain genes on chromosomes or plasmids. The fourth resistance mechanism only occurs following intake of a transposon or plasmid coding for resistance. Paromomycin selects for resistance and cross-resistance to other aminoglycosides at a high frequency in intestinal bacteria.
Pharmacokinetic properties
Following oral administration of paromomycin, hardly any absorption takes place and the molecule is eliminated unchanged via the faeces.
List of excipients
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Sodium metabisulfite (E223)
Purified water
Environmental properties
The active ingredient paromomycin sulfate is very persistent in the environment.