Bromotrimidine Powder 250gm
Trimethoprim 86 mg,
Bromhexine hydrochloride 8.6 mg
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|Drug Name and Strength||Each g contains Sulfadimidine 430 mg,
Trimethoprim 86 mg,
Bromhexine hydrochloride 8.6 mg
|Indication||Respiratory infections in horses due to organisms susceptible to the combination of sulfadimidine and trimethoprim, or where such organisms are implicated as secondary pathogens, e.g. pneumonia in foals, strangles, equine viral respiratory disease.Bromhexine is an effective mucolytic, reducing clinical signs and complications of respiratory disease. The use of Bromotrimidine Powder avoids the adverse side effects (e.g. sweating, excitation, tachycardia) which may result from the administration of β-adrenergic bronchodilators.|
|Actions||Antimicrobial and mucolytic.The correlation of antibacterial sensitivity in vitro compared with in vivo is among the highest of all antimicrobial agents.The spectrum of bacteria sensitive to the combination includes Staphylococci, Streptococci, Fusobacterium, Enterobacter, Corynebacterium (excluding Corynebacterium (Rhodococcus) equi), Salmonella, Shigella, Klebsiella, Pasteurella, Haemophilus, Proteus sp. and most Escherichia coli; some Brucella and Nocardia sp. Most Pseudomonas sp. are insensitive.Resistance to the combination by Gram-negative bacteria is associated with the presence of R factors. Resistance by Staphylococcus aureus and Haemophilus sp. is chromosomal, and is rarely encountered except in patients previously exposed to the combination.MICs of the 5:1 combination of sulfadimidine and trimethoprim for the major bacterial respiratory pathogens (primary and secondary) considered of clinical significance in the horse under Australian conditions have been established. Microorganisms used in MIC determination were isolated from clinical cases of respiratory disease, and are therefore of particular relevance to equine practice in Australia. A microorganism is considered susceptible if the mean drug concentration is twice the MIC for that microorganism. The following bacteria were demonstrated sensitive to the combination at the recommended dose rate: Actinobacillus equuli, Actinobacillus suis- like, E. coli, Pasteurella caballi, Proteus vulgaris, Staph. aureus, Staph. intermedius, Streptococcus equi subspecies equi and zooepidemicus. The degree of potentiation attained by combining the two antimicrobial agents was demonstrated in that study which revealed in all susceptible pathogens substantially lower MICs for the combination than for either agent alone. Antimicrobial activity of the combination was found to be up to 1,024 times that of sulfadimidine alone, and up to 128 times that of trimethoprim alone. Trimethoprim. Trimethoprim is a diaminopyrimidine antimicrobial agent. It acts by preventing the reduction of dihydrofolate to tetrahydrofolate which is required by bacteria for biosynthesis of purines, pyrimidines and some amino acids. Bromhexine hydrochloride. Bromhexine hydrochloride is a synthetic derivative of the alkaloid, vasicine. Bromhexine acts selectively on mucopolysaccharide producing goblet cells in the respiratory tract to a far greater extent than in other organs. Its action is threefold.Firstly, it causes depolymerisation of mucopolysaccharide, reducing viscosity and tenacity of respiratory mucus. This facilitates expectoration and suppresses tussive irritation. Increased production of highly viscous bronchial and alveolar secretion is not only a clinical sign of, but also an exacerbating factor in, respiratory disease. Disordered ciliary function and difficult expectoration set up a vicious cycle in which mucus tenacity may lead to chronic bronchitis. Bromhexine is a specific agent to prevent this complication. It has minimal secretolytic effect where mucus viscosity is initially low.Secondly, Bromhexine increases the permeability of the alveolar/capillary barrier. This increases the concentration of antibacterial agents in respiratory secretions, obtaining a greater luminal dose effect at the site of the disease.Thirdly, there are specific protein changes in bronchial secretion following bromhexine administration. After 2 to 3 days there is a significant increase in γ-globulin and a decline in albumin and α-globulin. The γ-globulins which increase are IgA and IgG; IgM is unchanged. Trimethoprim. Trimethoprim is readily absorbed from the gastrointestinal tract and, like sulfadimidine, rapidly reaches therapeutic levels in plasma. It is widely distributed in body tissues/fluids including bone, prostate, CSF, pleural, peritoneal, synovial and ocular fluids. Studies in humans and several animal species have demonstrated that trimethoprim reaches higher concentrations in all tissues, except brain, than those achieved in plasma. The drug is extensively metabolised in the horse and is excreted in the urine by glomerular filtration and active tubular secretion. Plasma half-life in the horse has been variously estimated at between 4.1 and 4.6 hours. Bromhexine. Bromhexine is rapidly absorbed following oral administration, peak plasma levels being reached within approximately one hour. It is lipophilic and is rapidly redistributed from plasma into respiratory, liver and adipose tissue. Bromhexine undergoes extensive hepatic metabolism and is excreted via the urine and bile. Bioavailability. Pharmacokinetic trials in horses have established that both sulfadimidine and trimethoprim are readily and rapidly absorbed after oral administration of Bromotrimidine Powder and reach therapeutic plasma levels within approximately 30 minutes of administration. Trial results demonstrate that the formulation is efficiently absorbed even when administered with food. Dosage frequency. MICs of the sulfadimidine/trimethoprim combination vary widely for the range of respiratory pathogens which are of significance in equine respiratory disease. In order to ensure efficacy against the major equine respiratory pathogens, the dose rate of Bromotrimidine Powder has been calculated to produce drug levels which would be therapeutic against those pathogens for which the MIC is greatest.Once daily dosing at recommended rates will produce average steady state levels of sulfadimidine/trimethoprim which are effective against many of the major bacterial respiratory pathogens of clinical significance in horses in Australia. Trial results explain the long standing success of once daily dosing of Bromotrimidine and Trimidine powders in treating clinical cases of respiratory infection. Twice daily dosing is recommended in preference to once daily dosing as the minimum (trough) concentrations of sulfadimidine and trimethoprim are potentially subtherapeutic in some individuals for some pathogens under a once daily dose regimen.Microbiology Sulfadimidine and trimethoprim have similar antibacterial spectra, trimethoprim being approximately 20 times more potent than sulfadimidine. The combination blocks two sequential obligate enzymatic reactions in the microbial folate synthetic pathway. A synergistic action is demonstrated by the substantially enhanced antimicrobial activity (potentiation) of the combination compared with the antimicrobial activity of either agent singly. The minimum inhibitory concentrations (MICs) of the combination for susceptible bacteria are substantially lower than those of either of the individual agents. The combination of sulfonamide/trimethoprim is bactericidal while either drug alone is bacteriostatic. Folate synthesising bacteria which are resistant or moderately resistant to either drug alone are frequently susceptible to the combination.Pharmacology Sulfadimidine. Sulfadimidine is a pyrimidine sulfonamide antimicrobial agent. Sulfonamides, being structural analogues of ρ-aminobenzoic acid (PABA), competitively inhibit the incorporation of PABA into dihydropteric acid, the precursor of folic acid. Subsequent reduction in the level of folic acid reduces the production of nucleic acids in sensitive bacteria. Mammalian cells require preformed folic acid and thus are unaffected by sulfonamides. The antibacterial actions of sulfonamides are reduced in the presence of blood, pus and tissue breakdown products, which contain purines and thymidine, as the bacterial requirement for folic acid is decreased in such media.Pharmacokinetics Sulfadimidine. Sulfadimidine is readily absorbed following oral administration and therapeutic plasma levels are rapidly attained. Sulfadimidine is widely distributed to all body tissues and fluids. Concentrations are above plasma levels in kidney; similar to plasma levels in pleural, peritoneal, synovial and ocular fluids; slightly lower in CSF, muscle and milk. Sulfadimidine undergoes extensive metabolism via acetylation, hydroxylation, oxidation and conjugation. The parent compound and its metabolites are excreted predominantly in the urine by glomerular filtration. Sulfadimidine undergoes passive tubular resorption thus prolonging the time course of drug action. Plasma half-life in the horse has been variously estimated at between 6.4 and 9.8 hours.|
|Precautions||Bacterial culture and sensitivity testing should be carried out in cases of nonresponsive or chronic infection.|
|Dosage and Administration||For oral use only. 1 level large scoop/200 kg bodyweight twice daily. Give on dampened food or mixed with honey or molasses. 1 level large scoop ≡ sulfadimidine 5 g, trimethoprim 1 g, bromhexine hydrochloride 100 mg (total: Bromotrimidine Powder 12 g).|
|Storage||Store below 30°C (room temperature). Protect from light.|
|MSDS (external link)||Bromotrimidine Powder 250gm MSDS|
|Label (external link)||Bromotrimidine Powder 250gm Label|
|Manufacturer||International Animal Health Products Pty Ltd|