hydrocodone/phenylephrine/guaifenesin (Discontinued)

Brand and Other Names:Tussafed HC
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

hydrocodone/phenylephrine/guaifenesin

oral syrup: Schedule III

  • (2.5mg/7.5mg/5mg)/5mL
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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

Dosage Forms & Strengths

hydrocodone/phenylephrine/guaifenesin

oral syrup: Schedule III

  • (2.5mg/7.5mg/5mg)/5mL
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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

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Adverse 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
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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
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Pregnancy & 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.

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Pharmacology

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

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Images

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