Classes
DEA Class; Rx
Common Brand Names; Mytussin AC, Tussi-Organidin NR, Cheratussin AC, Guiatuss AC, Iophen C-NR, Virtussin AC
- Antitussives, Narcotic Combos
Description
Codeine is an opiate agonist antitussive agent; guaifenesin is an expectorant
Used in combination to treat cough
Not indicated in pediatric patients under 18 years of age; contraindicated for cough and cold in neonates, infants and children less than 12 years of age; contraindicated in adolescent pediatric patients 12 to 18 years after tonsillectomy or adenoidectomy
Indications
Indicated for the temporary relief of nonproductive cough due to minor throat and bronchial irritation as may occur with the common cold, acute bronchitis, or inhaled irritants.
Contraindications
Codeine
Absolute: Acute abdominal condition, diarrhea associated with toxins, pseudomembranous colitis, respiratory depression
Relative: Asthma (acute), inflammatory bowel disease, respiratory impairment
Guaifenesin
Do not use as self-medication in chronic or persistent coughs
Hypersensitivity
Adverse Effects
Codeine
- Drowsiness
- Constipation
- Bradycardia, hypotension, tachycardia
- Confusion, dizziness, false feeling of well being, headache, lightheadedness, malaise, paradoxical CNS stimulation, restlessness, weakness
- Rash, urticaria
- Anorexia, nausea, vomiting, xerostomia
- LFT’s increased
- Ureteral spasm, urination decreased
- Dyspnea
- Burning at injection site, blurred vision, histamine release
- Hypotension, with IV use
- Seizure, with excessive doses
- Anaphylactoid reaction (rare)
- Respiratory depression
Guaifensesin
- Headache
- Rash
- Nausea
- Vomiting
Warnings
Use caution in cardiac arrhythmias, emotional lability, gallbladder disease, hepatic impairment, renal impairment, surethral stricture, urinary tract surgery
Ibuprofen is more effective than codeine for pain from musculoskeletal injuries in children
Children are particularly sensitive to the respiratory depressant effects of codeine; because of risk of life-threatening respiratory depression and death, the use of codeine products is contraindicated in children less than 12 years of age, and in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy
Use in children also exposes them to risks of addiction, abuse, and misuse, which can lead to overdose and death; because benefits of symptomatic treatment of cough associated with allergies or common cold do not outweigh risks of use of codeine in pediatric patients, use is not indicated in patients younger than 18 years of age
Life-threatening respiratory depression and death have occurred in children who received codeine; codeine is subject to variability in metabolism based upon CYP2D6 genotype; based upon post-marketing reports, children < 12 years appear to be more susceptible to respiratory depressant effects of codeine, particularly if there are risk factors for respiratory depression; cases of death have been reported in the post-operative period following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine
Pregnancy and Lactation
Pregnancy category: C; category D if used for prolonged periods or in high doses at term
Lactation: excreted in breast milk; caution advised
Maximum Dosage
Codeine 120 mg/day PO and guaifenesin 2,400 mg/day PO.
Codeine 120 mg/day PO and guaifenesin 2,400 mg/day PO.
Safety and efficacy have not been established.
12 years: Safety and efficacy have not been established.
Less than 12 years: Use is contraindicated.
Use is contraindicated.
How supplied
Codeine/guaifenesin
Schedule V
oral liquid
- (6.3mg/100mg)/5mL
- (8mg/200mg)/5mL
- (10mg/200mg)/5mL
- (10mg/100mg)/5mL
- (10mg/300mg)/5mL
oral solution
- (10mg/100mg)/5mL
- (7.5mg/225mg)/5mL
oral syrup
- (10mg/100mg)/5mL