DIHYDROCODEINE BITARTRATE AND ASPIRIN AND CAFFEINE DC
-
dihydrocodeine bitartrate,
aspirin and
caffeine capsule
EUSA Pharma (USA), Inc.
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Dihydrocodeine bitartrate and aspirin and caffeineDESCRIPTION
Each 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.
The capsule 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 the dihydrocodeine bitartrate, aspirin, and caffeine capsule 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 the dihydrocodeine bitartrate, aspirin, and caffeine capsule 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. The dihydrocodeine bitartrate, aspirin, and caffeine capsule 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
The dihydrocodeine bitartrate, aspirin, and caffeine capsule should be given with caution to certain patients, such as the elderly or debilitated.
Drug Interactions
The CNS-depressant effects of the dihydrocodeine bitartrate, aspirin, and caffeine capsule 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 the dihydrocodeine bitartrate, aspirin, and caffeine capsule 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 range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS
The most frequently observed reactions include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions.
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the pain and the response of the patient. The dihydrocodeine bitartrate, aspirin, and caffeine capsule is given orally. The usual adult dose is two capsules every 4 hours as needed for pain.
HOW SUPPLIED
Dihydrocodeine bitartrate, aspirin, and caffeine Capsules are blue and gray, marked “CP” and “419”, supplied in:
Bottles of 100 capsules; NDC 57902-419-88
Store at room temperature, approx. 25°C (77°F). Keep tightly closed.
Dispense in tight container.
Manufactured for and distributed by:
EUSA Pharma (USA), Inc.One Summit Square, Suite 201
1717 Langhorne Newtown Rd.
Langhorne, PA 19047
www.eusapharma.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 57902-419-88
100 Capsules
Dihydrocodeine bitartrate, aspirin, and caffeine capsules
Each capsule contains: 16 mg drocode (dihydrocodeine) bitartrate (Warning–may
be habit-forming), 356.4 mg aspirin, and 30 mg caffeine.
SEALED FOR YOUR PROTECTION
Rx Only
EUSA Pharma (USA), Inc.
| DIHYDROCODEINE BITARTRATE AND ASPIRIN AND CAFFEINE
DC
dihydrocodeine bitartrate and aspirin and caffeine capsule |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA011483 | 04/25/2011 | |
| Labeler - EUSA Pharma (USA), Inc. (038596862) |