Dosing and uses of Notuss-DC (codeine/pseudoephedrine)
Adult dosage forms and strengths
codeine/pseudoephedrine
oral liquid: Schedule V
- (10mg/30mg)/5mL
- (20mg/60mg)5mL
capsule: Schedule III
- 20mg/60mg
Congestion with Cough
20 mg/60 mg PO q4-6hr PRN, up to 80 mg/240 mg per 24 hr
Pediatric dosage forms and strengths
codeine/pseudoephedrine
oral liquid: Schedule V
- (10mg/30mg)/5mL
- (20mg/60mg)5mL
capsule: Schedule III
- 20mg/60mg
Congestion with Cough
<6 years: not recommended
6-12 years: 10 mg/30 mg PO q4-6hr, up to 40 mg/120 mg in 24 hr
>12 years: 20 mg/60 mg PO q4-6hr, up to 80 mg/240 mg in 24 hr
Notuss-DC (codeine/pseudoephedrine) adverse (side) effects
>10%
Codeine
- Drowsiness
- Constipation
1-10%
Codeine
- 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
- Blurred vision, histamine release
Frequency not defined
Codeine (serious)
- Hypotension, With IV use
- Seizure, With excessive doses
- Anaphylactoid reaction (rare)
- Respiratory depression
Pseudoephedrine
- Insomnia
- Restlessness
- Tremor
- Nausea
- Vomiting
Warnings
Contraindications
Codeine
- Absolute: acute abdominal condition, diarrhea associated w/ toxins, pseudomembranous colitis, respiratory depression
- Relative: asthma (acute), inflammatory bowel disease, respiratory impairment
Pseudoephedrine
- Hypsesensitivity
- Severe HTN, severe CAD
- Nonselective MAO inhibitors: risk of hypertensive reaction
- Newborns, preemies
Cautions
Codeine
- Cardiac arrhythmias, drug abuse/dependence, emotional lability, gallbladder dz, head injury, hepatic impairment, hypothyroidism, incr ICP, prostatic hypertrophy, renal impairment, seizures w/ epilepsy, urethral stricture, urinary tract surgery
- Risk of life threatening side effects in nursing babies, especially if mother is an ultra rapid metabolizer of codeine
- Ibuprofen is more effective than codeine for pain from musculoskeletal injuries in children
Pseudophedrine
- Mild-mod HTN, cardiac dz, hyperthyroidism, hyperglycemia, BPH, DM, glaucoma
- Many combo formulations are switching to phenylephrine d/t restrictions arising from easy conversion to methamphetamine (The Combat Methamphetamine Epidemic Act of 2005 bans OTC sales of cold medicines that contain ingredients commonly used to make methamphetamine such as pseudoephedrine)
- Lactation
Pregnancy and lactation
Pregnancy category: C
Lactation: codeine and pseudoephedrine excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Notuss-DC (codeine/pseudoephedrine)
Codeine
Half-Life: 3-4 hr
Onset: 30-60 min
Metabolism: Inactive but metabolized to morphine by CYP2D6 (missing in 5-10% of population)
Duration: 4-6 hr
Peak Plasma Time: 0.5-1 hr
Protein Bound: 25%
Excretion: urine, feces
Pseudoephedrine
Half-Life: 5-8 hr
Onset: 30 min
Duration: 4-6 hr
Peak PlasmaTime: 1.97 hr
Metabolism: liver, by N-demethylation
Metabolites: inactive
Clearance: 7.3-7.6 mL/min/kg
Excretion: urine
Mechanism of action
Codeine: Narcotic agonist analgesic with antitussive activity, mu receptor agonist
Chlorpheniramine: Histamine H1-receptor antagonist
Pseudoephedrine: Alpha adrenergic agonist
