codeine/guaifenesin

Adult Dosing

Cough

10-20 mg PO q4-6 hrs with plenty of water
Max: 120 mg/day
Note: Dose is based on codeine component

Pediatric Dosing

Cough

6-11 yrs

5-10 mg PO q4-6 hrs with plenty of water; Max: 60 mg/day
Alt: 1-1.5 mg/kg/day PO div q4-6 hrs

>12 yrs

10-20 mg PO q4-6 hrs with plenty of water
Max: 120 mg/day

Note: Dose is based on codeine component

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Temporary control of cough caused by minor throat and bronchial irritation
Assists in loosening phlegm (mucus) and thins bronchial secretions
Treatment of lower respiratory tract symptoms, including asthma

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Hypersensitivity to morphine derivatives
Respiratory depression
Acute or severe asthma
Paralytic ileus
Children <2yrs
Pregnancy
Lactation

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Severe hepatic impairment: Use with caution

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Avoid use in patients with heart diseases/high blood pressure/thyroid disease/diabetes/having difficulty in urination/asthmatic patients
Aggravation of constipation may occur
Codeine component of this drug exhibits potential for abuse
Orthostatic hypotension have occurred in patients
Persistent cough is a sign of a serious condition
Extreme sleepiness, confusion, or shallow breathing have occurred
Avoid increasing dosage of codeine if cough fails to respond; reevaluate in 5 days or sooner for possible underlying pathology
Emesis has occurred from doses larger than those required for expectorant action

Cautions: Use cautiously in

Renal impairment
Hepatic impairment
Arrhythmias
Hypotension
Recent GI or urinary tract surgery
Prostatic hypertrophy
Pseudomembranous colitis
Inflammatory bowel disease
Ulcerative colitis
Acute abdominal condition
Prostatic hypertrophy
Severe CNS depression
Seizure disorder
Increased intracranial pressure
Severe head injury
Biliary disease
Addison disease
Hypothyroidism
Severe respiratory depression
Patients prone to respiratory depression
Acute alcoholism
Pulmonary disease
Patients with decreased respiratory reserve
Ultra-rapid CYP2D6 metabolizer
Patients with phenylketonuria
Young patients
Atopic children
Geriatrics
Debilitated patients
Fever

Supplemental Patient Information

Advise patients to consult health care provider for a cough of >1 wk duration or for a cough accompanied by fever, rash, or persistent headache
Advise patients to avoid using for chronic or persistent cough, cough accompanied by excessive phlegm (mucus), shortness of breath, or chronic pulmonary disease without consulting health care provider
Advise women of child bearing potential to consult a clinician before using this medication

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Higher dosages of oral narcotics in mothers while breastfeeding can cause infant drowsiness. Newborn infants are particularly sensitive to the effects of even small dosages of narcotic analgesics, particularly in the first week of life. Newborn's dosage is limited by the small volumes of colostrum in the first 2-3 days postpartum. Once the mother's milk comes in, it is best to use a nonnarcotic analgesic and limit the maternal dosage and duration of treatment with codeine and combinations to 4 days. Mothers with ultrarapid CYP2D6 metabolism may excrete unexpectedly higher amounts of morphine into their milk after use of codeine and increase the risk of adverse effects in infant. Effect of guaifenesin on breastfed infant has not been studied. This medication can be given to infants of 2 months of age. Unlikely that with usual maternal doses amounts in milk are as large as those given directly to infants or that breastfed infants would be harmed by the drug in breastmilk, especially in infants over 2 months of age. Avoid the use of products with high alcohol content while nursing. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 7 January 2011). Manufacturer advises caution.

Adverse Reactions ⬆ ⬇

RESP: Respiratory depression
CNS: CNS depression, orthostatic hypotension, syncope, seizures, increased ICP, dependency, abuse, drowsiness, dizziness, nervousness, weakness, malaise, confusion
CV: Bradycardia, hypotension
GI: Paralytic ileus, biliary spasm, nausea, vomiting, constipation, dry mouth
DERM: Pruritus, rash, urticaria
GU: Urinary retention
EENT: Vision changes
MISC: Anaphylactoid reactions

Clinical Pharmacology ⬆ ⬇

Codeine

Narcotic analgesic; precise mechanism of action in relieving pain is unknown; binds to mu, delta, and kappa opioid receptors in the CNS and changes perception of pain
Readily absorbed from GI tract
Metabolized by liver; CYP450: CYP2D6
Excreted in urine and feces
Half-life: 2.9 hrs

Guaifenesin

Expectorant; enhances output of respiratory tract fluid by reducing adhesiveness and surface tension, facilitates removal of viscous mucus and making nonproductive coughs more productive and less frequent
Undergoes hydrolysis; CYP450: Unknown
Excreted in urine
Half-life: 1 hrs

Brands and Availability ⬆ ⬇

US Trade Name(s)

Cheratussin AC
Iophen C-NR

US Availability

codeine/guaifenesin (generic)

TABS: 10 mg/300 mg
SOLN: [10 mg/100 mg]/5 mL

Cheratussin AC

SOLN: [10 mg/100 mg]/5 mL

Iophen C-NR

SOLN: [10 mg/100 mg]/5 mL

Canadian Trade Name(s)

Canadian Availability

UK Trade Name(s)

UK Availability

Australian Trade Name(s)

Australian Availability

[Outline]

Classification ⬆ ⬇

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations

Allergy/Cold

Antitussive, Combinations