Ascomp with Codeine
- Generic Name: butalbital, aspirin, caffeine, and codeine phosphate capsules
- Brand Name: Ascomp with Codeine
Ascomp with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules) side effects drug center
Ascomp with Codeine Side Effects Center
Ascomp with Codeine (butalbital, aspirin, caffeine, and codeine phosphate capsules) is a combination of a barbiturate, an analgesic/antipyretic/anti-inflammatory, a central nervous system stimulant, and a narcotic analgesic/antitussive indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Common side effects of Ascomp with Codeine include:
- drowsiness,
- dizziness,
- lightheadedness,
- intoxicated feeling,
- nausea, and
- abdominal pain
The dose of Ascomp with Codeine is one or two capsules every 4 hours. The total daily dosage should not exceed six capsules. Ascomp with Codeine may interact with monoamine oxidase (MAO) inhibitors, corticosteroids, chronic use of aspirin, oral anticoagulants, oral antidiabetic drugs and insulin, 6-mercaptopurine, methotrexate, nonsteroidal anti-inflammatory drugs (NSAIDs), other narcotic analgesics, alcohol, general anesthetics, tranquilizers, sedative-hypnotics, other CNS depressants, and uricosuric drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Ascomp with Codeine; it is unknown how it would affect a fetus. Therapeutic doses of aspirin in pregnant women close to term may cause bleeding in mother, fetus, or neonate. During the last 6 months of pregnancy, regular use of aspirin in high doses may prolong pregnancy and delivery. The medications in Ascomp with Codeine pass into breast milk. Because of the potential for serious adverse reactions in nursing infants, breastfeeding while using Ascomp with Codeine is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Ascomp with Codeine.
Our Ascomp with Codeine (butalbital, aspirin, caffeine, and codeine phosphate capsules) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Ascomp with Codeine Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
- a slow heart rate or weak pulse;
- a light-headed feeling, like you might pass out;
- confusion, unusual thoughts or behavior;
- easy bruising or bleeding (nosebleeds, bleeding gums);
- severe constipation;
- symptoms of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
- low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women.
Common side effects include:
- nausea, vomiting, stomach pain, constipation;
- headache, dizziness, drowsiness; or
- feeling tired.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ascomp with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules)
Ascomp with Codeine Professional Information
SIDE EFFECTS
Commonly Observed
The most commonly reported adverse events associated with the use of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP and not reported at an equivalent incidence by placebo-treated patients were nausea and/or abdominal pain, drowsiness, and dizziness.
Associated With Treatment Discontinuation
Of the 382 patients treated with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP in controlled clinical trials, three (0.8%) discontinued treatment with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP because of adverse events. One patient each discontinued treatment for the following reasons: gastrointestinal upset; lightheadedness and heavy eyelids; and drowsiness and generalized tingling.
Incidence In Controlled Clinical Trials
The following table summarizes the incidence rates of the adverse events reported by at least 1% of the Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP treated patients in controlled clinical trials comparing Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP to placebo, and provides a comparison to the incidence rates reported by the placebo-treated patients.
The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.
Adverse Events Reported by at Least 1% of Butalbital, Aspirin, Caffeine, and Codeine Phosphate
Capsules , USP Treated Patients During Placebo Controlled Clinical Trial
| Body System/Adverse Event | Incidence Rate of Adverse Events Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP (N = 382) |
Placebo (N = 377) |
| Central Nervous | ||
| Drowsiness | 2.4% | 0.5% |
| Dizziness/Lightheadedness | 2.6% | 0.5% |
| Intoxicated Feeling | 1.0% | 0% |
| Gastrointestinal | ||
| Nausea/Abdominal Pain | 3.7% | 0.8% |
Other Adverse Events Reported During Controlled Clinical Trials
The listing that follows represents the proportion of the 382 patients exposed to Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP while participating in the controlled clinical trials who reported, on at least one occasion, an adverse event of the type cited. All reported adverse events, except those already presented in the previous table, are included. It is important to emphasize that, although the adverse events reported did occur while the patient was receiving Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, the adverse events were not necessarily caused by Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP.
Adverse events are classified by body system and frequency. “Frequent” is defined as an adverse event which occurred in at least 1/100 (1%) of the patients; all adverse events listed in the previous table are frequent. “Infrequent” is defined as an adverse event that occurred in less than 1/100 patients but at least 1/1000 patients. All adverse events tabulated below are classified as infrequent.
Central Nervous : headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, and sluggishness.
Autonomic Nervous: dry mouth and hyperhidrosis.
Gastrointestinal: vomiting, difficulty swallowing, and heartburn.
Cardiovascular: tachycardia.
Musculoskeletal: leg pain and muscle fatigue.
Genitourinary: diuresis.
Miscellaneous: pruritus, fever, earache, nasal congestion, and tinnitus.
Voluntary reports of adverse drug events, temporally associated with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, that have been received since market introduction and that were not reported in clinical trials by the patients treated with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, are listed below. Many or most of these events may have no causal relationship with the drug and are listed according to body system.
Central Nervous: Abuse, addiction, anxiety, depression, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sedation, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.
Autonomic Nervous: epistaxis, flushing, miosis, salivation.
Gastrointestinal: anorexia, appetite increased, constipation, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasm, hiccup, mouth burning, pyloric ulcer.
Cardiovascular: chest pain, hypotensive reaction, palpitations, syncope.
Skin: erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis.
Urinary: kidney impairment, urinary difficulty.
Miscellaneous: allergic reaction, anaphylactic shock, cholangiocarcinoma, drug interaction with erythromycin (stomach upset), edema.
The following adverse drug events may be borne in mind as potential effects of the components of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP. Potential effects of high dosage are listed in the OVERDOSAGE section of this insert.
Aspirin: occult blood loss, hemolytic anemia, iron deficiency anemia, gastric distress, heartburn, nausea, peptic ulcer, prolonged bleeding time, acute airway obstruction, renal toxicity when taken in high doses for prolonged periods, impaired urate excretion, hepatitis.
Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.
Codeine: nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.
Read the entire FDA prescribing information for Ascomp with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules)
&Copy; Ascomp with Codeine Patient Information is supplied by Cerner Multum, Inc. and Ascomp with Codeine Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.