COMPAZINE®
brand of
prochlorperazine
antiemetic• antipsychotic • tranquilizer
DESCRIPTION
Compazine (prochlorperazine) is a phenothiazine derivative, present in Compazine tablets and Spansule sustained release capsules as the maleate. Its chemical name is 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl]-10 H -phenothiazine (Z)-2-butenedioate (1:2).
prochlorperazine maleate
Compazine vials and syrup contain prochlorperazine as the edisylate salt and Compazine suppositories contain prochlorperazine base. Empirical formulas (and molecular weights) are: prochlorperazine maleate—C20H24CIN3S•2C4H4O4 (606.10); prochlorperazine edisylate—C20H24CIN3S•C2H6O6S2 (564.14); and prochlorperazine base—C20H24CIN3S (373.95).
Tablets −Each round, yellow-green, coated tablet contains prochlorperazine maleate equivalent to prochlorperazine as follows: 5 mg imprinted SKF and C66; 10 mg imprinted SKF and C67.
5 mg and 10 mg Tablets −Inactive ingredients consist of cellulose, lactose, magnesium stearate, polyethylene glycol, sodium croscarmellose, titanium dioxide, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Yellow No. 6, FD&C Red No. 40, iron oxide, starch, stearic acid and trace amounts of other inactive ingredients, including aluminum lake dyes.
Spansule ® sustained release capsules −Each Compazine ® Spansule capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Food slows absorption of prochlorperazine and decreases Cmax by 23% and AUC by 13%.
Each capsule, with black cap and natural body, contains prochlorperazine maleate equivalent to prochlorperazine. The 10 mg capsule is imprinted 10 mg and 3344 on the black cap and is imprinted 10 mg and SB on the natural body. The 15 mg capsule is imprinted 15 mg and 3346 on the black cap and is imprinted 15 mg and SB on the natural body. Inactive ingredients consist of ammonio methacrylate co-polymer, D&C Green No. 5, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hydroxypropyl methylcellulose, propylene glycol, silicon dioxide, simethicone emulsion, sodium lauryl sulfate, sorbic acid, sugar spheres, talc, triethyl citrate, and trace amounts of other inactive ingredients.
Vials, 2 mL (5 mg/mL) and 10 mL (5 mg/mL)−Each mL contains, in aqueous solution, 5 mg prochlorperazine as the edisylate, 5 mg sodium biphosphate, 12 mg sodium tartrate, 0.9 mg sodium saccharin and 0.75% benzyl alcohol as preservative.
Suppositories −Each suppository contains 2½ mg, 5 mg or 25 mg of prochlorperazine; with glycerin, glyceryl monopalmitate, glyceryl monostearate, hydrogenated cocoanut oil fatty acids and hydrogenated palm kernel oil fatty acids.
Syrup −Each 5 mL (1 teaspoonful) of clear, yellow-orange, fruit-flavored liquid contains 5 mg of prochlorperazine as the edisylate. Inactive ingredients consist of FD&C Yellow No. 6, flavors, polyoxyethylene polyoxypropylene glycol, sodium benzoate, sodium citrate, sucrose and water.
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