Disclosure. OTC Review with a Pediatric Twist. Objectives. When to Call a Doctor for Infant. When to Call a Doctor for Child

Transcription

1 OTC Review with a Pediatric Twist Disclosure Consultant for Johnson and Johnson Baby Jill A. Morgan, PharmD, BCPS February 2015 Objectives List situations when a child should be referred to physician. List questions that should be asked to gather information before recommending an OTC product to a pediatric patient. Given a scenario, choose an appropriate OTC product for a pediatric patient for the treatment of cough, colds, fevers, and allergies. Given a pediatric patient, choose the appropriate thermometer. When to Call a Doctor for Infant Infant < 3 months old Rectal temp > 100.4F or < 97.5F Infant > 3 months Temp 102F Not feeding and does not have 3-4 wet diapers / day Can not be comforted Unusually quiet / lethargic Rapid, shallow, or problems breathing Constant pulling on ears Seizure Stomach feels hard Cold or flu > 7 days Unidentified skin rash Capillary refill time Jelly like stools When to Call a Doctor for Child Oral temp > 102F Temp x more than 2 days Vomiting for > 12 hours Diarrhea > 2 days No urine output in 12 hours Can not be comforted Unusually quiet / lethargic Rapid, shallow, or problems breathing Persistent ear pain > 48 hours Seizure Severe abdominal cramps / pain Stomach feels hard Cold or flu > 7 days Unidentified skin rash Capillary refill time Blurry or changes in vision A 3 year old child and Dad presents to your pharmacy asking for something to treat a fever of 102. The parents called the doctor s office and talked to a nurse. The nurse said this sounds like a virus. What do you ask the parent? 1

2 Temperature Measurements Rectal standard for infants and toddlers Digital results in 60 seconds Oral generally ok at 5 years Hot or cold drinks affect reading Must keep mouth closed Result 0.5 F < rectal Avoid: pacifier and forehead strips Axillary variable results (can use as screen), Armpit must be dry, Results affected by bundling Ear Ok, but not as accurate as rectal Fast, non-threatening Takes practice to do accurately adult size probe Temporal artery Sensitivity increased as temp increases (65% to 92%) Acetaminophen First line agent Dose = mg/kg/dose Q 4 to 6 hours not to exceed 5 doses in 24 hours Prolonged use can cause hepatotoxicity Watch product: concentrated drops (if any on shelves) vs liquids Fever Treatments Ibuprofen 6 months of age Dose = 5 to 10 mg/kg/dose Q 6 to 8 hours Avoid: GI bleeds/ulcer Caution: Aspirin sensitive, renal patients, dehydration, and anticoagulants (warfarin). Counsel: stop if rash appears or SOB, shake suspension before use, take with food/milk to decrease GI upset Dosing Charts A 3 year old child and Mom presents to your pharmacy looking for something to help treat a cold. The child has a runny nose and dry cough. The child has been taking acetaminophen, but there is no fever present. No other meds or past medical history. NKDA. What questions do you ask? Cough and Colds Expectorants / Cough suppressants Decongestants Oral or nasal Saline nasal spray / drops Antipyretics / Analgesics Cool mist humidifier, Nasal aspirators American Academy of Pediatrics Recommends against the use of codeine and dextromethorphan containing cough products Lack of efficacy Toxicities DM: behavioral disturbances and respiratory depression Codeine: respiratory depression, ataxia, vomiting, facial swelling 2

3 ACCP Guideline Chronic Cough in Pediatrics guideline and nasal decongestant combinations were not more likely than placebo to reduce acute cough Diphenhydramine and DM were no different than placebo to reduce nighttime cough or sleep disturbances Meta analysis looking at antihistamines for common cold were not effective to reduce symptoms except in 1 study with children > 12 years saw general benefit + improvement in nasal symptoms Some Numbers 2004 to children < 2 years treated in ER for ADE from cough and cold products 2005: 3 deaths age 1 6 months Detectable levels of: Pseudoephedrine Dextromethorphan Acetaminophen Jan 2002-May serious side effects in children 48% with cough and cold products Seizures Cardiac events Respiratory distress Hallucinations More common in multi ingredient products and products without specific dosing recommendations FDA News OTC cough and cold products should not be used in patients < 2 years Ages 2-11 years are under review Later in 2008, the Consumer Healthcare Products Association announced that they were voluntarily changing OTC pediatric cough/cold product labeling to state, Do not use in children under the age of four years Expectorants and Suppressants Expectorant Guiafenesin Decrease sputum thickness Counsel: may have some drowsiness Good water intake: > 12 years same as adult (Maintain fluid intake of 2-3 liters per day (unless MD has restricted)) 2-12 years: fluid intake based on maintenance equation > 10kg = 1 liter + 50ml/kg > 10 kg >20 kg = 1.5 liters + 20ml/kg > 20 kg Cough Suppressant Dextromethorphan Suppress cough reflex in medulla of brain SE: drowsiness, dizziness, nausea, caution in asthma patients Children s Robitussin Cough Long-acting 7.5 mg/5 ml [alcohol free; fruit punch flavor] do not suppress cough in a child 1 st Generation MOA: atropine-like drying action on mucous membranes Kinetics: Well absorbed orally onset: 30 minutes-2 hours duration: 4-12 hours liver metabolism MISC not recommended in kids less than 2 years caution use of first generation agents in asthma patients SE: drowsiness paradoxical excitement hypotension sedation thickening of mucus dizziness increased appetite dry mouth urinary retention Drug interactions alcohol other CNS sedatives MAO inhibitors Sedative effects Antihistaminic Anticholinergic Antiemetic Clemastine /+++ Diphenhydramine +++ +/ /+++ Brompheniramine Chlorpheniramine Loratadine +/- ++/+++ +/- Cetirizine + ++/+++ +/- 3

4 Oral Decongestants Nasal Decongestants Pseudoephedrine Constricts mucous membranes Duration 4-12 hours, renal elimination Drops, syrup, chew tabs Administer dose after feeding or with milk to decrease GI upset Warn parents about insomnia. Avoid long acting products in children Side Effects: caution in HTN patient anxiety restlessness tremor insomnia palpitations hallucinations Nausea Drug interactions: caffeine MAOI TCAs good luck! Do not use for more than 3-5 days rebound nasal stuffiness SE burning, stinging of nasal lining tremors, nervousness Phenylephrine lasts 4-6 hours ok if > 4 years but have to use 0.125% until reach 6 years Neo-Synephrine Mild 0.25% Little Remedies Decongestant Nose Drops 0.125% Oxymetazoline lasts hours only use if 6 years Afrin 0.05% Other Tips Allergies Nasal saline Use in any age Dose as needed Use before nasal aspirator Nasal aspirators Cool mist humidifier Be sure to clean Use distilled water Vaporizers can burn kids Herbals Zinc Lozenge Nasal Vitamin C Echinacea Nasal Symptoms Runny nose Congestion Sneezing Itchy nose Post nasal drip Eye symptoms Redness Itchy Tearing Corticosteroids Generic Name Brand Names OTC Dose (mcg/spray) Usual Dosing (per nostril) Beclomethasone Beconase AQ No sprays BID Budesonide Rhinocort Aqua No sprays daily Ciclesonide Omnaris No 50 2 sprays daily Flunisolide Nasarel No sprays TID- BID Fluticasone Flonase Soon sprays daily Mometasone Nasonex No sprays daily Triamcinolone Nasacort Yes sprays daily Do they work? Reduce both nasal and ocular symptoms of allergic rhinitis Superior in comparison to other agents Mast cell stabilizers (Cromolyn) Leukotriene receptor antagonists (Montelukast (Singulair)) Decongestants Anticholinergics (Atrovent) Maximum effectiveness reached within 7-14 days Immunol Allergy ClinN Am 25 (2005) Pharmacist s Letter 2007;23(6):

5 Side Effects for Corticosteroids Epistaxis (nose bleeds) Proper administration technique Local irritation (e.g., stinging, burning) Unpleasant taste Headache Pharyngitis Nasal septal perforation (rare, case reports) Growth suppression (beclomethasone) Second Generation Generic Name Brand Name OTC Dosage Forms Cetirizine Zyrtec Yes Chewable, Liquid, Tablet Fexofenadine Allegra Yes Capsule, Tablet, Liquid Loratidine Claritin Yes Reditab, Liquid, Tablet Usual Dose 2-5 yr: mg daily > 6 yr: 5-10 mg daily 6-11 yr: 30 mg BID >12 yr: 60 mg BID 2-5 yr: 5 mg daily >6 yr: 10 mg daily Comparing 1 st and 2 nd Generation Characteristics 1 st Generation 2 nd Generation Specificity for H 1 Low High receptor Lipophilicity High Low Central nervous system effects Anticholinergic effects Moderate to High Moderate to High Low to None None Symptom Effects of Allergy Treatments (-) Little benefit; (+) Mild effect; (++) Good effect; (+++) Very good effect; (++++) Excellent Agent Sneezing Itching Congestion Rhinorrhea Eye Corticosteroids Oral (RX) Oral Decongestants Decongestants Immunol Allergy ClinN Am 25 (2005) Questions 5