acetaminophen, caffeine and dihydrocodeine bitartrate- Acetaminophen, Caffeine and Dihydrocodeine Bitartrate tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), DIHYDROCODEINE BITARTRATE (UNII: 8LXS95BSA9) (CODEINE - UNII:Q830PW7520)

Tilgængelig fra:

MIKART, INC.

INN (International Name):

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate

Lægemiddelform:

TABLET

Sammensætning:

712.8 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are indicated for the relief of moderate to moderately severe pain. This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or in any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus. This combination product is subject to the provisions of the Controlled Substance Act, and has been placed in Schedule III. Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Like other opioid analgesics, dihydrocodeine may produce subjective effects other than analgesia (e.g., euphoria, relaxation), which may contribute to abuse by some patients. Psychological dependence, physical dependence, and tolerance ma

Produkt oversigt:

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine bitartrate* 32 mg, (*Warning: May be habit-forming), are supplied in bottles of 100 tablets NDC 0525-0032-01, and in bottles 500 tablets, NDC 0525-0032-05. Tablets are lavender, oval-shaped, single-scored and are debossed “PAL” on one side and “032” on the other side. Store at controlled room temperature, 15°-30°C (59°-86°F). Protect from moisture. Dispense in a tight, light-resistant container with a child resistant closure.

Produktets egenskaber

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE- ACETAMINOPHEN,
CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLET
MIKART, INC.
----------
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE* TABLETS CIII
712.8 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:
C H NO
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:
C H N O (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:
8
9
2
8
10
4
2
C
H NO C H O 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 co