Dihydrocodeine Bitartrate Recall
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Questions & Answers
Side Effects & Adverse Reactions
Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Respiratory depression is the most dangerous acute reaction produced by opioid agonist preparations, although it is rarely severe with usual doses. Opioids decrease the respiratory rate, tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory depression occurs most frequently in elderly or debilitated patients, usually after large initial doses in nontolerant patients, or when opioids are given in conjunction with other agents that depress respiration. This combination product should be used with caution in patients with significant chronic obstructive pulmonary disease or corpulmonale and in patients with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or respiratory depression. In such patients, alternative non-opioid analgesics should be considered, and opioids should be admin- istered only under careful medical supervision at the lowest effective dose.
This combination product should be used cautiously in the presence of head injury or increased intracranial pressure. The effects of opioids on pupillary response and consciousness may obscure neurologic signs of increases in intracranial pressure in patients with head injuries. The respiratory depressant effects including carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions, or other causes of increased intracranial pressures.
Dihydrocodeine, like all opioid analgesics, may cause hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or who receive concurrent therapy with drugs such as phenothiazines or other agents which compromise vasomotor tone.
Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets may produce orthostatic hypotension in ambulatory patients. This combination product should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.
Dihydrocodeine can produce drug dependence of the codeine type and has the potential of being abused (See DRUG ABUSE AND DEPENDENCE).
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are indicated for the relief of moderate to moderately severe pain.
There is currently no drug history available for this drug.
Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are supplied in tablet form for oral administration.
Each tablet contains:
Dihydrocodeine* bitartrateִִִִִִִִִִִִִִִִִִִִִִ32 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:
Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder, is a central nervous system stimulant. It has the following structural formula:
Dihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmorphinan-6a-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:
C18H23NO3 C4H6O6 M.W.=451.47
In addition, each tablet also contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.