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Acetaminophen, Caffeine and Dihydrocodeine (Acetaminophen / Caffeine / Dihydrocodeine Bitartrate) - Description and Clinical Pharmacology

 
 



Acetaminophen, Caffeine and Dihydrocodeine Bitartrate* Tablets CIII
.8 mg/60 mg/32 mg

Rx only

Code 790Z00

Rev. 02/99

DESCRIPTION

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are supplied in tablet form for oral administration.

Each tablet contains:

Acetaminophen..........................................................712.8 mg

Caffeine.....................................................................60 mg

Dihydrocodeine Bitartrate*..........................................32 mg

(*Warning: May be habit forming)

Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C8H9NO2                                                                                                                                                                                 M.W. = 151.17

Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula:

C8H10N4O2 (anhydrous)                                                                                           M.W. = 194.19

Dihydrocodeine bitartrate (4,5α-Epoxy-3-methoxy-17-methylmorphinan-6α-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:

C18H23NO3•C4H6O6                                                                                                  M.W. = 451.48

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, D&C Red #27 Aluminum Lake, D&C Red #30 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.

CLINICAL PHARMACOLOGY

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets contain dihydrocodeine which is a semi-synthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components. The principal action of therapeutic value is analgesia.

This combination product also contains acetaminophen, a non-opiate, non-salicylate analgesic, and antipyretic.

This combination product contains caffeine as an analgesic adjuvant. Caffeine is also a central nervous system and cardiovascular stimulant.

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