Dosing and uses of Novahistine DH (codeine/chlorpheniramine/phenylephrine)
Adult dosage forms and strengths
dihydrocodeine/chlorpheniramine/phenylephrine
oral liquid: Schedule III
- (7.5mg/2mg/5mg)/5mL
oral syrup: Schedule V
- (3mg/2mg/7.5mg)/5mL
- (3mg/5mg/20mg)/5mL
Cough and Congestion
5-10 mL PO q4-6hr, up to 40 mL/24 hr
Pediatric dosage forms and strengths
dihydrocodeine/chlorpheniramine/phenylephrine
oral liquid: Schedule III
- (7.25mg/2mg/5mg)/5mL
oral syrup: Schedule V
- (3mg/2mg/7.5mg)/5mL
- (3mg/5mg/20mg)/5mL
Cough and Congestion
< 2 years: Not recommended
2-6 years: 1.25-2.5 mL PO q4-6hr PRN, up to 10 mL/24 hr
6-12 years: 2.5-5 mL PO q4-6hr, up to 20 mL/24 hr
>12 years: 5-10 mL PO q4-6hr, up to 40 mL/24 hr
Novahistine DH (codeine/chlorpheniramine/phenylephrine) 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
- Burning at injection site, blurred vision, histamine release
Frequency not defined
Chlorpheniramine
- Anticholinergic
- Somnolence
- Constipation
- Diarrhea
- Nausea
- Vomiting
- Blurred vision
Codeine
- Hypotension, with IV use
- Seizure, with excessive doses
- Anaphylactoid reaction (rare)
- Respiratory depression
Phenylephrine
- Hypertension
- Severe peripheral and visceral vasoconstriction
- Pallor
- Reflex tachycardia
- Anxiety
- Dizziness
- Headache
- Insomnia,Nervousness
- Restlessness
- Metabolic acidosis
- Gastric irritation
- Nausea
- Decreased renal perfusion
- Extravasation of IV administration may lead to necrosis and sloughing of surrounding tissue
- Excitability
Warnings
Contraindications
Codeine
- Hypersensitivity
- Acute abdominal condition, diarrhea associated w/ toxins, pseudomembranous colitis, respiratory depression
- Asthma (acute), inflammatory bowel disease, respiratory impairment
Chlorpheniramine
- Acute asthma, sleep apnea
Phenylephrine
- Hypsesensitivity
- Severe HTN, severe CAD
- Within 14 days of nonselective MAO inhibitor therapy (risk of hypertensive reaction)
- Newborn, preemies
Cautions
Codeine
- Cardiac arrhythmias, drug abuse/dependence, emotional lability, gallbladder disease, head injury, hepatic impairment, hypothyroidism, increased ICP, prostatic hypertrophy, renal impairment, seizures with 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
Chlorpheniramine
- May cause CNS depression (patient should not operate heavy machinery
- Caution in patients with asthma, thyroid dysfunction, hypertension, ischemic heart disease, increased intraocular pressure, or prostatic hyperplasia/urinary obstruction
Phenylephrine
- Caution in diabetes mellitus, cardiovascular disease, prostatic hyperplasia, hyperthyroidism, and increased intraocular pressure
Pregnancy and lactation
Pregnancy category: C
Not known whether distributed 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 Novahistine DH (codeine/chlorpheniramine/phenylephrine)
Mechanism of action
Dihydrocodeine: Narcotic agonist analgesic with antitussive activity, mu receptor agonist
Chlorpheniramine: Histamine H1-receptor antagonist
Phenylephrine: Alpha-adrenergic stimulator with weak beta-adrenergic activity; produces systemic vasoconstriction of arteries and arterioles.
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
Vd: 3-6 L/kg
Bioavailability: 53%
Protein Bound: 25%
Excretion: Urine (90%), feces
Chlorpheniramine
Half-Life: 10-13 hr (children); 14-24 hr (adults)
Duration: 24 hr
Onset: 6 hr
Peak Plasma Time: 2-3 hr
Protein Bound: 29-37%
Vd: 4-7 L/kg (children); 6-12 L/kg (adults)
Metabolism: GI mucosa, liver
Metabolites: Monodesmethylchlorpheniramine, didesmethylchlorpheniramine
Excretion: Urine
Sedative effect: Low
Antihistamine activity: Moderate
Anticholinergic acitivity: Moderate
Phenylephrine
Half-Life: 2-3 hr
Duration: 2-4 hr
Onset: 10-15 min (IM/SC); immediate (IV)
Vd: 340 L (mean)
Bioavailability: < 38%
Peak Plasma Time: 0.75-2 hr
Metabolism: Hepatic
Excretion: Urine
