acetaminophen/diphenhydramine/dextromethorphan (Diabetic Tussin Nighttime Cold and Flu)
Classes: Cough/Cold, Non-narcotic Combos; Analgesic/Antihistamine/Antitussive Combos
- Dosing and uses of Diabetic Tussin Nighttime Cold & Flu (acetaminophen/diphenhydramine/dextromethorphan)
- Diabetic Tussin Nighttime Cold & Flu (acetaminophen/diphenhydramine/dextromethorphan) adverse (side) effects
- Warnings
- Pregnancy
- Pharmacology of Diabetic Tussin Nighttime Cold & Flu (acetaminophen/diphenhydramine/dextromethorphan)
Dosing and uses of Diabetic Tussin Nighttime Cold and Flu (acetaminophen/diphenhydramine/dextromethorphan)
Adult dosage forms and strengths
acetaminophen/diphenhydramine/dextromethorphan
oral solution
- (325mg/12.5mg/10mg)/5mL
Cold & Flu
Indicated for relief of cold and flu symptoms
10 mL PO q4hr PRN; not to exceed 6 doses/24 hr
Pediatric dosage forms and strengths
acetaminophen/diphenhydramine/dextromethorphan
oral solution
- (325mg/12.5mg/10mg)/5mL
Cold & Flu
Indicated for relief of cold and flu symptoms
<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
Diabetic Tussin Nighttime Cold and Flu (acetaminophen/diphenhydramine/dextromethorphan) adverse (side) effects
Frequency not defined
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
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
Cautions
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
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 Diabetic Tussin Nighttime Cold and Flu (acetaminophen/diphenhydramine/dextromethorphan)
Mechanism of action
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
Pharmacokinetics
Acetaminophen
- Peak plasma time: 10-60 min (PO immediate release); 60-120 min (PO extended release); 6 hr (PO 500 mg tablet); 8 hr (PO 650 mg extended release tablet)
- Vd: 1 L/kg
- Protein binding: 10-25%
- Metabolism: Liver (microsomal enzyme systems); conjugation (glucuronic acid)
- Half-life: 1.25-3hr
- Excretion: Urine
Diphenhydramine
- Bioavailability: 42-62% (PO)
- Onset: 15-30 min
- Duration: 4-6 hr
- Peak plasma time: 2 hr (PO)
- Protein bound: 98.5%
- Vd: 22 L/kg (children); 17 L/kg (adults); 14 L/kg (Elderly)
- Half-life: 5 hr (children); 9 hr (adults); 13.5 hr (elderly)
- Excretion: Urine (50-75%)
Dextromethorphan
- Onset: 15-30 min
- Duration: 3-6 hr
- Metabolism: Hepatic P450 enzyme CYP2D6
- Excretion: Urine
- Half-life: 2-4 hr (extensive metabolizers); 24 hr (poor metabolizers)
- Peak plasma time: 2-3 hr