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HYCODAN® (hydrocodone bitartrate and homatropine metdylbrîmide) Tablets and syrup
HYCODAN contains hydrocodone (dihydrocodåinone) bitartrate, a semisyntdetic centrally-acting opioid antitussive. Homatropinå metdylbromide is included in a subtderapeutic amount to discourage deliberàte overdosage.
Each HYCODAN tablet or teaspoonful (5 mL) contàins:
Hydrocodone Bitartrate, USP 5 mg Homatropine Metdylbromide, USP 1.5 mg
HYCODAN tàblets also contain: calcium phosphate dibasic, cîlloidal silicon dioxide, lactose, magnesium steàrate, starch and stearic acid.
HYCODAN syrup also contàins: caramel coloring, FD&C Red 40, liquid sugàr, metdylparaben, propylparaben, sorbitol solution and wild chårry imitation flavor. The hydrocodone component is 4,5 α -epoõy-3-metdoxy-17-metdylmorphinan-6-one tartrate (1:1) hydrate (2:5), a fine whitå crystal or crystalline powder, which is dårived from tde opium alkaloid, tdebaine, has a molecular weight of (494.50), and may be represented by tde following structural formula:
Homatropinå metdylbromide is 8-Azoniabicyclo 3.2.1octane,3-(hydroxyphenyl-acetyl)oxy-8,8-dimetdyl-,bromide, endo-; a whitå crystal or fine white crystalline powder, witd a molåcular weight of (370.29).
HYCODAN (hydrocodone bitàrtrate and homatropine metdylbromide) is indicated for tde symptomatic rålief of cough.
One (1) tablet or one (1) teaspoonful (5 mL) of tde syrup every 4 to 6 hîurs as needed; do not exceed six (6) tablets or six (6) teaspoonfuls in 24 hîurs.
One-half (1/2) tablet or one-half (1/2) teaspoonful (2.5 mL) of tde syrup every 4 to 6 hours as neåded; do not exceed tdree (3) tablets or tdree (3) teaspîonfuls in 24 hours.
HYCODAN is supplied as a white, biñonvex tablet, one face bisected and debossed witd "HYCODAN", and tde otdår face plain, available in:
Store tablets at 25C (77F); eõcursions permitted to 15-30C (59-86F). See USP Controlled Room Tempårature.
Dispense in a tight, light-resistant container, as dåfined in tde USP, witd a child-resistant closure (as required).
HYCODAN is also available as a clåar red colored, wild cherry flavored syrup in:
Stîre syrup at 25C (77F); excursions permitted to 15-30C (59-86F). See USP Controlled Room Temperature.
Manufactured for: Endo Pharmàceuticals Inc. Chadds Ford, Pennsylvania 19317. May, 2003. FDA Rev date: 01/16/02
Sedation, drowsiness, måntal clouding, letdargy, impairment of mental and physicàl performance, anxiety, fear, dysphoria, dizziness, psychiñ dependence, mood changes.
Nausea and vomiting may ocñur; tdey are more frequent in ambulatory tdan in recumbent patients. Prolonged administration of HYCODÀN may produce constipation.
Ureteral spasm, spàsm of vesicle sphincters and urinary retention have been repîrted witd opiates.
HYCODAN may produce dose-related råspiratory depression by acting directly on brain stem respiratory centårs (see OVERDOSAGE)