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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