Classes
DEA Class; OTC
Common Brand Names; Diabetic Tussin Nighttime Cold & Flu
- Cough/Cold, Non-narcotic Combos;
- Analgesic/Antihistamine/Antitussive Combos
Description
Acetaminophen blocks pain impulse generation peripherally and may inhibit the generation of prostaglandin in the CNS; reduces fever by inhibiting the hypothalamic heat-regulating center
Diphenhydramine: competitively blocks histamine from binding to H1 receptors; significant antimuscarinic activity and penetrates CNS, which causes pronounced tendency to induce sedation
Dextromethorphan is a cough suppressant that acts centrally on the cough center in the medulla
Indications
Indicated for relief of cold and flu symptoms
Contraindications
Hypersensitivity
Hepatitis or hepatic/renal dysfunction, alcoholism
Repeated administration in patients with anemia or cardiac, pulmonary, or renal disease
Use within 14 days of MAO inhibitor therapy
Lower respiratory disease, eg, asthma (controversial)
Premature newborns and neonates
Nursing women
Adverse Effects
Common
Nausea/Vomiting
Thick sputum
Constipation
Drowsiness
Dizziness
Sedation
Blurred vision
Nystagmus
Less Common
Angioedema, Laryngeal edema
Disorientation, Dizziness, Sedation, Confusion, Decreased cognitive function in elderly
Pruritic maculopapular rash, Rash, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Urticaria
Agranulocytosis, Leukopenia, Neutropenia, Pancytopenia, Thrombocytopenia
Thrombocytopenic purpura
Hepatotoxicity, Liver failure Gastrointestinal hemorrhage, Nephrotoxicity, Pneumonitis, Anaphylactoid reactions
Anticholinergic effects, Xerostomia, Dry nasal mucosa, Pharyngeal dryness
Warnings
Acetaminophen is found in many other dosage forms and products, check label carefully to avoid overdose
Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash
Risk of hepatotoxicity is higher in alcoholics or with use of more than one acetaminophen-containing product
G6PD deficiency
Phenylketonuria (phenylalanine in orange flavoring)
Driving or operating machinery
Avoid alcohol
Caution in narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction
Pregnancy and Lactation
Pregnancy Category
Acetaminophen: Class B
Diphenhydramine: Class B
Dextromethorphan: Class C
Lactation
Acetaminophen: Excreted in breast milk; compatible with breastfeeding
Diphenhydramine: Enters breast milk/contraindicated
Dextromethorphan: Unknown if excreted in breast milk, use caution
Maximum Dosage
10 mL PO q4hr PRN; not to exceed 6 doses/24 hr
Pediatric
<6 years: Safety and efficacy not established
6-12 years: 5 mL PO q4hr PRN; not to exceed 6 doses/24 hr
>12 years: As adults; 10 mL PO q4hr PRN; not to exceed 6 doses/24 hr