Capital And Codeine
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Questions & Answers
Side Effects & Adverse Reactions
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 the 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.
Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Respiratory depression and death have occurred in children who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Deaths have also occurred in nursing infants who are exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine [see Precautions, Nursing Mothers].
Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) [see Overdosage].
Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy [see Contraindications].
When prescribing codeine-containing products, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose [see Overdosage].
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue CAPITAL® AND CODEINE ORAL SUSPENSION immediately and seek medical care if they experience these symptoms. Do not prescribe CAPITAL® AND CODEINE ORAL SUSPENSION for patients with acetaminophen allergy.
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
CAPITAL® AND CODEINE ORAL SUSPENSION is indicated for the relief of mild to moderate pain.
History
There is currently no drug history available for this drug.
Other Information
CAPITAL® AND CODEINE ORAL SUSPENSION (Acetaminophen and codeine phosphate oral suspension) is pharmacologically classified as an analgesic.
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:
C8H9NO2 M.W.=151.16
C8H9NO2 M.W.=151.16
C8H9NO2 M.W.=151.16
C8H9NO2 M.W.=151.16
C8H9NO2 M.W.=151.16
Codeine phosphate, 7,8-didehydro-4,5α-Epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:
C18H21NO3•H3PO4•½H2O
M.W.= 406.37
Each 5 mL, for oral administration contains:
| Acetaminophen |
120 mg |
|
| Codeine Phosphate |
12 mg |
In addition the following inactive ingredients are present: Artificial fruit mint flavor, artificial punch flavor, citric acid, D&C Red #33, FD&C Red #40, magnesium aluminum silicate, methylparaben, polysorbate-80, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol, sucrose.
Sources
Capital And Codeine Manufacturers
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Valeant Pharmaceuticals International
![Capital And Codeine (Acetaminophen And Codeine Phosphate) Suspension [Valeant Pharmaceuticals International]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Capital And Codeine | Valeant Pharmaceuticals International
Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
CAPITAL® AND CODEINE ORAL SUSPENSION (Acetaminophen and codeine phosphate oral suspension) contains 120 mg of acetaminophen and 12 mg of codeine phosphate per 5 mL (teaspoonful) and is given orally.
The recommended dose of codeine phosphate in children is 0.5 mg/kg body weight.
The usual doses are:
Children: (7 to 12 years): 10 mL (2 teaspoonfuls) 3 or 4 times daily.
(3 to 6 years): 5 mL (1 teaspoonful) 3 or 4 times daily.
(under 3 years): safe dosage has not been established.
Adults: 15 mL (1 tablespoonful) every 4 hours as needed.
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