OTC

Question 1

APAP

Answer 1

• Premature Infant: Q6-8 hours
• Rectal absorption erratic, 10-20mg/kg/dose
• Maximum Daily Dose
  
  • 75 mg/kg/day and not to exceed 5 doses/day
• OTC Max: daily dose 3,250 mg/day (4g mg/day under prescriber supervision)
• eGFR < 10 mL/min/1.73 m2 – Administer Q8 hours

2 serious skin reactions

• SJS
• Toxic epidermal necrolysis (TEN)

Less serious skin reaction

• Acute generalized exanthematous pustulosis (AGEP)
  
  • Usually resolves within 2 weeks of stopping APAP

Question 2

Ibuprofen

Answer 2

Dosing

• Not recommended for infants < 6 months
• <12y
  
  • 5-10 mg/kg/dose Q6-8
  • Maximum daily dose 40 mg/kg/day; maximum 4 doses/day
• 12y+
  
  • 200-400 mg Q4-6
  • OTC Max: daily dose 1,200 mg/day (2,400 mg/day under prescriber supervision)

Renal impairment

• eGFR 30-60 mL/min/1.73m² - Avoid if at risk for AKI
• eGFR <30 mL/min/1.73m² – Avoid use

Question 3

Aspirin

Answer 3

Analgesic Dosing

• 10-15 mg/kg/dose Q4-6 hours
• 325-650 mg Q4-6 hours
• Maximum 90 mg/kg/day or 4g/day

Risk of Reye’s Syndrome

• Generalized disturbance in mitochondrial metabolism resulting in metabolic failure in the liver and brain
• Death occurs in ~30-40% of cases
• Avoid in patients recovering from viral illnesses especially chickenpox or influenza

Question 4

Benzocaine

Answer 4

• Topical oral analgesic – gels, ointments, solutions
  
  • Anbesol, Orabase, Orajel
• FDA is warning to not use to treat infants and children younger than 2 years
  
  • Why: Cause life-threatening methemoglobinemia
• FDA Label requirements:
• Adding a warning about methemoglobinemia; adding contraindications, FDA’s strongest warnings, directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years

Question 5

Dextromethorphan

Answer 5

• 4y+
• Indication: non-productive cough
  
  • Not for use in chronic or productive cough
• MoA: acts in the medulla by suppressing cough impulses
  
  • No analgesis, sedative, resp depressant, or addictive properties at usual antitussive doses
• AE: drowsiness, n/v, stomach pain, constipation

Question 6

Guaifenesin

Answer 6

• 4y+
• Indication: acute, ineffective productive cough
• MoA: stimulates lower respiratory tract secretions, making coughs more productive (take with water for max effect)
• AE: n/v/d, dizziness/HA, drowsiness

Question 7

Decongestants

Answer 7

• MoA: adrenergic agonists (sympathomimetic), which causes vasoconstriction, thereby decreasing sinusoid vessel engorgement and mucosal edema

Direct-acting decongestants (only act on alpha receptors)

• Phenylephrine, oxymetazoline

Mixed decongestants - direct & indirect activity (both alpha + beta receptors- more side effects)

• Pseudoephedrine
  
  • SE: ^{CV stimulus, dry nose, dyspnea, pharyngeal edema, wheezing, paradoxycal congestion, CNS stimulation}

Formulations:

• 4y+
  
  • Oral: phenylephrine (PE), pseudoephedrine
• 2y+
  
  • Nasal sprays: phenylephrine, oxymetazoline

Question 8

Antihistamines

Answer 8

• MoA: compete with histamine at central & peripheral histamine1-receptor sites, preventing the histamine– receptor interaction and release

First generation (sedating)

• Diphenhydramine, chlorpheniramine

Second generation (generally non-sedating)

• Also inhibit release of mast cell mediators and may decrease cellular recruitment
• Loratidine, allegra, zyrtec* (*is sedating)

Question 9

Intranasal Corticosteroids

Answer 9

• Indication: Allergic Rhinitis clinical dx, 2y+, s/sx affect QOL
• AE: acute sinusitis, blood in nasal mucosa, bronchitis, cough, dry nose, nasal congestion, nasal mucosa ulcer (includes nasal septal ulceration)

OTC

• Fluticasone (Flonase) 2 years of age
• Triamcinolone (Nasacort) 2 years of age
• Budesonide (Rhinocort) 6 years of age

Question 10

Dietary Supplements

Answer 10

• FDA defines as vitamins, minerals, herbs, or other botanicals, or amino acids
  
  • Label statement of “dietary supplement”, name/address of manufacturer, complete ingredient list, serving size; cannot be marketed as prevention or cure
  • Not FDA approved, no required proof of efficacy
• “USP” verified third party quality assurance- does not assess efficacy, but label reflects what is in the product

Regulations

• Dietary Supplement Health and Education Act
  
  • Requires good manufacturing practice (GMP)
    
    • Must be manufactured in a quality manner without adulterants or impurities and labeled accurately
• Dietary Supplement & Non-Prescription Drug Consumer Protection Act
  
  • Requires notification to FDA of serious AEs
    
    • Death, life threatening event, hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect
    • Adverse effect that requires surgery or medical intervention

Question 11

Echinacea

Answer 11

• Use: Upper respiratory infection & common cold
• Adverse Reactions
  
  • GI upset (N/V/D, abdominal pain)
  • Rash (more common in children)
• Some preparations have high alcohol content
• Safety
  
  • Avoid in immunocompromised patients, and in asthma
• Efficacy (mixed)
  
  • No efficacy once a cold occurs
  • Possibly reduction in duration of a cold by ~1 day

Question 12

Melatonin

Answer 12

• Use: Jet lag, insomnia
• MoA: Melatonin is in our body (affects sleep/wake cycle)
• AE:
  
  • Daytime drowsiness, headache, and dizziness
• Efficacy: Melatonin appears to improve the time to fall asleep in children with developmental disabilities, including cerebral palsy, autism, and mental retardation