Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
SULFAMETHOXAZOLE; TRIMETHOPRIM
TEVA CANADA LIMITED
J01EE01
SULFAMETHOXAZOLE AND TRIMETHOPRIM
40MG; 8MG
SUSPENSION
SULFAMETHOXAZOLE 40MG; TRIMETHOPRIM 8MG
ORAL
100/400/800ML
Prescription
SULFONAMIDES
Active ingredient group (AIG) number: 0208901002; AHFS:
APPROVED
2014-02-07
PRODUCT MONOGRAPH Including Patient Medication Information PR TEVA-TRIMEL TABLETS PR TEVA-TRIMEL DS TABLETS sulfamethoxazole and trimethoprim tablets PR TEVA-TRIMEL ORAL SUSPENSION sulfamethoxazole and trimethoprim oral suspension ANTIBACTERIAL AGENT Teva Canada Limited DATE OF REVISION: 30 Novopharm Court February 2, 2018 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Submission Control: 205917 _ _ _ _ _TEVA-TRIMEL _ 2 of 43 _ _ PRODUCT MONOGRAPH PR TEVA-TRIMEL TABLETS AND ORAL SUSPENSION (sulfamethoxazole and trimethoprim) ANTIBACTERIAL AGENT CLINICAL PHARMACOLOGY Teva-Trimel (sulfamethoxazole and trimethoprim) is an antibacterial agent with a wide spectrum of activity. It contains two active antibacterial components, sulfamethoxazole and trimethoprim, which act synergistically on many species of bacteria. FIGURE 1 Sulfamethoxazole and trimethoprim act sequentially in two successive steps in the biosynthesis of nucleic acids. Trimethoprim is an inhibitor of dihydrofolate reductase, the enzyme which reduces dihydrofolic acid to its tetrahydro form. This biochemical step is essential in the production of the folate coenzymes which are involved in the biosynthesis of thymine, purine, serine and methionine. Sulfamethoxazole exerts its antibacterial activity by competing with para- aminobenzoic acid. Most pathogenic bacteria meet their need for dihydrofolic acid by synthesizing it from para- aminobenzoic acid, pteridine and glutamic acid. Animals, in contrast, depend on exogenous sources for their needs of folic acid and do not rely upon intracellular synthesis. Under usual circumstances, sulfamethoxazole or trimethoprim acting alone do not produce complete block in this biosynthesis of nucleic acids. Instead, they cause sufficient reduction in the synthesis of folate coenzymes to produce bacteriostasis. When the two agents act together, the superimposition of their effects produces a complete block in the synthesis, leading to death _ _ _ _ _TEVA-TRIMEL _ 3 of 43 _ _ of the organism. Thus the effect of the dual Baca dokumen lengkapnya