DESCRIPTION
Each Synalgos-DC capsule contains 16 mg drocode (dihydrocodeine) bitartrate (Warning–may be habit-forming), 356.4 mg aspirin, and 30 mg caffeine.
The inactive ingredients present are alginic acid, cellulose, D&C Red 28, FD&C Blue 1, gelatin, iron oxides, stearic acid, and titanium dioxide.
CLINICAL PHARMACOLOGY
Dihydrocodeine is a semisynthetic 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.
Synalgos-DC also contains the nonnarcotic antipyretic-analgesic, aspirin.
INDICATIONS AND USAGE
For the relief of moderate to moderately severe pain.
CONTRAINDICATIONS
Hypersensitivity to dihydrocodeine, codeine, or aspirin.
WARNINGS
Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities.
Drug Dependence
Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, dihydrocodeine is subject to the provisions of the Federal Controlled Substances Act.
Usage in Ambulatory Patients
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. The patient using Synalgos-DC should be cautioned accordingly.
Interactions with other Central Nervous System Depressants
Patients receiving other narcotic analgesics, general anesthetics, tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with Synalgos-DC may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Usage in Pregnancy
Reproduction studies have not been performed in animals. There is no adequate information on whether this drug may affect fertility in human males and females or has a teratogenic potential or other adverse effect on the fetus.
Usage in Children
Preparations containing aspirin should be kept out of the reach of children. Synalgos-DC is not recommended for patients 12 years of age and under. Since there is no experience in children who have received this drug, safety and efficacy in children have not been established.
PRECAUTIONS
Synalgos-DC should be given with caution to certain patients, such as the elderly or debilitated.
Drug Interactions
The CNS-depressant effects of Synalgos-DC may be additive with that of other CNS depressants. See “WARNINGS.”
Aspirin may enhance the effects of anticoagulants and inhibit the uricosuric effects of uricosuric agents.
Geriatric Use
Clinical studies of Synalgos-DC did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.
In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing ran
