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DESCRIPTION
Tablets and Suspensions
Sulfamethoxazole; trimethoprim is a synthetic antibacterial
combination product available in DS (double strength) tablets, tablets
and suspensions for oral administration. Each DS tablet contains
160 mg trimethoprim and 800 mg sulfamethoxazole plus magnesium stearate,
pregelatinized starch and sodium starch glycolate. Each tablet contains
80 mg trimethoprim and 400 mg sulfamethoxazole plus magnesium stearate,
pregelatinized starch, sodium starch glycolate, FD&C blue no.
1 lake, FD&C yellow no. 6 lake and D&C yellow no. 10 lake.
Each teaspoonful (5 ml) of the pediatric suspension or suspension
contains 40 mg trimethoprim and 200 mg sulfamethoxazole in a vehicle
containing 0.3 percent alcohol, edetate disodium, glycerin, microcrystalline
cellulose, parabens (methyl and propyl), polysorbate 80, saccharin
sodium, simethicone, sorbitol, sucrose, FD&C yellow no. 6, FD&C
red no. 40, flavors and water.
Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine.
It is a white to light yellow, odorless, bitter compound with a
molecular weight of 290.32 and a molecular formula of C14H18N4O3.
Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide.
It is almost white, odorless, tasteless compound with a molecular
weight of 253.28 and a molecular formula of C10H11N3O3S.
IV Infusion
Sulfamethoxazole; trimethoprim IV infusion is a sterile
solution for intravenous infusion only, and is a synthetic antibacterial
combination product. Each ml of Septra IV infusion contains 16 mg
trimethoprimn and 80 mg sulfamethoxazole compounded with 40% propylene
glycol, 10% ethyl alcohol, and 0.3% diethanolamine; 1% benzyl alcohol
and 0.1% sodium metabisulfite added as preservatives, water for
injection, and pH adjusted to approximately 10 with sodium hydroxide.
Trimethoprim is 5-[(3,4,5-trimethoxyphenyl)methyl]-2,4-pyrimidinediamin.
It is a white to light yellow, odorless, bitter compound with a
molecular weight of 290.32 and the molecular formula C14H18N4O3.
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