Dosing and uses of Tussafed HC (hydrocodone/phenylephrine/guaifenesin)
Adult dosage forms and strengths
hydrocodone/phenylephrine/guaifenesin
oral syrup: Schedule III
- (2.5mg/7.5mg/5mg)/5mL
Cough with Congestion
Temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions when these conditions are complicated by tenacious mucus or mucus plugs and congestion
5 mg/15 mg/100 mg (10 mL) PO q4-6hr, up to 30 mg/90 mg/600 mg (60 mL) in 24 hr
Other Information
Administer with special measuring device for accurate dose
Administer with food if GI upset occurs
Pediatric dosage forms and strengths
hydrocodone/phenylephrine/guaifenesin
oral syrup: Schedule III
- (2.5mg/7.5mg/5mg)/5mL
Cough with Congestion
3 to <6 years: 1.25 mg/3.75 mg/25 mg (2.5 mL) PO q4-6hr, up to 7.5 mg/22.5 mg/150 mg (15 mL) in 24 hr
6 to <12 years: 2.5 mg/7.5 mg/50 mg (5 mL) PO q4-6hr, up to 15 mg/45 mg/300 mg (30 mL) in 24 hr
12 years and older: As in adults
Tussafed HC (hydrocodone/phenylephrine/guaifenesin) adverse (side) effects
Frequency not defined
Hydrocodone
- Bradycardia, anticholinergic effects (dry mouth, palpitation, tachycardia)
- Angina, arrhythmias, cardiac arrest, myocardial infarction, QT-interval prolongation, pectoris, syncope, severe cardiac ST segment elevation, ventricular tachycardia
- Agitation, coma, dizziness, mental clouding/depression, dysphoria, euphoria, faintness, restlessness, nervousness, weakness, sedation, seizures, visual disturbances
- Flushing, sweating, pruritus, urticaria, warmness of the face/neck/upper thorax
- Constipation, nausea, vomiting
- Urinary retention, oliguria
- Respiratory/circulatory depression, respiratory arrest, shock, cardiac arrest
Phenylephrine
- Hypertension, reflex bardycardia
- Anxiety, headache
- Extravasation
- Burning, rebound congestion, sneezing
- Pulmonary edema
Guaifenesin
- Headache
- Rash
- Nausea
- Vomiting
Warnings
Contraindications
Hydrocodone
- Absolute: acute abdominal condition, diarrhea associated with toxins, paralytic ileus, pseudomembranous colitis, respiratory depression
- Relative: asthma (acute), cardiac arrhythmia, cardiac disease, congestive heart failure, coronary artery DX, bladder outlet obstruction, GI tract obstruction, glaucoma (open & closed), hemorrhage, hiatal hernia, inflammatory bowel disease, intestinal atony, mitral valve stenosis, myasthenia gravis, obstructive uropathy, prostatic hypertrophy, reflux esophagitis, respiratory impairment, tachycardia, ulcerative colitis, urinary retention
Phenylephrine
- Hypersensitivity to phenylephrine or sulfites; severe HTN, VTach, closed angle glaucoma
- See Interactions below
Guaifenesin
- Do not use as self-medication in chronic or persistent coughs
- Hypersensitivity
Contraindications
Hydrocodone
- Autonomic neuropathy, brain damage in children, cardiac arrhythmias, chronic lung disease, Down Syndrome, drug abuse/dependence, emotional liability, gallbladder disease, head injury, hepatic impairment, hypertension, hyperthyroidism, increased intracranial pressure, renal impairment, seizures with epilepsy, spastic paralysis in children, toxemia of pregnancy, urethral stricture, urinary tract surgery, xerostomia
Phenylephrine
- Cerebrovascular insufficiency, CVD, HTN, DM, thyroid dz, prostatic hypertrophy, geriatrics
Guaifenesin
- Do not use as self-medication in chronic or persistent coughs
- Hypersensitivity
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown; use with 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 Tussafed HC (hydrocodone/phenylephrine/guaifenesin)
Mechanism of action
Hydrocodone: Narcotic agonist analgesic
Phenylephrine: Alpha adrenergic agonist
Guaifenesin: Reduces viscosity of secretions by increasing amount of respiratory tract fluid
Hydrocodone
Half-life: 3.3-4.4 hr
Duration: 4-8 hr
Peak PlasmaTime: 1.3 hr
Metabolism: liver (O-demethylation, N-demethylation, 6-keto reduction); hepatic P450 enzyme CYP2D6
Excretion: urine (mainly)
Phenylephrine
Duration: 2-4 hr
Onset: 15-20 min
Metabolism: liver & intestine by MAO
Excretion: urine
Guaifenesin
Half-Life: 1 hr
Onset: 30 min
Duration: 4-6 hr
Metabolism: liver
Metabolite: b-(2-methoxyphenoxy) lactic acid
Excretion: urine