Ascomp With Codeine
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Questions & Answers
Side Effects & Adverse Reactions
Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions. It should be ascertained if the patient is allergic to aspirin, although a specific history of allergy may be lacking.
Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders.
Aspirin administered pre-operatively may prolong the bleeding time.
In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of patients with head injuries.
Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.
Butalbital and codeine are both habit-forming and potentially abusable. Consequently, the extended use of ASCOMP® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) is not recommended.
Results from epidemiologic studies indicate an association between aspirin and Reye's Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
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.
Uses
ASCOMP® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy of ASCOMP® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: ASCOMP® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP), codeine, (Butalbital, Aspirin, and Caffeine Capsules, USP), and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. ASCOMP® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) proved statistically significantly superior to each of its components ASCOMP® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) and to placebo on measures of pain relief.
Evidence supporting the efficacy and safety of ASCOMP® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.
History
There is currently no drug history available for this drug.
Other Information
ASCOMP® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) is supplied in capsule form for oral administration.
Each capsule contains the following active ingredients:
Butalbital, USP ..................................................................................... 50 mg
Aspirin, USP ....................................................................................... 325 mg
Caffeine, USP ....................................................................................... 40 mg
Codeine Phosphate, USP ...................................................................... 30 mg
Butalbital:
 |
|
| C11H16N2O3 | 224.26 |
5-Allyl-5-isobutylbarbituric acid is a short-to intermediate-acting barbiturate.
Aspirin:
 |
|
| C9H8O4 | 180.16 |
Aspirin is benzoic acid, 2-(acetyloxy)-, an analgesic, antipyretic, anti-inflammatory.
Caffeine:
 |
|
| C8H10N4O2 | 194.19 |
1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles.
Codeine phosphate:
 |
|
| C18H24NO7P | 397.37 (Anhydrous) |
7,8-didehydro-4, 5α-epoxy-3- methoxy-I7-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, is a narcotic analgesic and antitussive, occurs as fine, white, needle-shaped crystals, or white, crystalline powder and affects by light.
Inactive Ingredients: Corn Starch, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc, and Titanium Dioxide.
Sources
Ascomp With Codeine Manufacturers
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Breckenridge Pharmaceutical, Inc.
![Ascomp With Codeine (Butalbital, Aspirin, Caffeine And Codeine Phosphate) Capsule [Breckenridge Pharmaceutical, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ascomp With Codeine | Breckenridge Pharmaceutical, Inc.
One or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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Nexgen Pharma, Inc.
Ascomp With Codeine | Nexgen Pharma, Inc.
One or two capsules every 4 hours. Total daily dosage should not exceed six capsules.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
![Ascomp With Codeine (Butalbital, Aspirin, Cafeine, And Codeine Phosphate) Capsule [Nexgen Pharma, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ca3fe6e9-21ad-4fba-a602-e1c364cf3981&name=d41932b8-c97c-4190-ba99-f17165960907-05.jpg)
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