Cough syrups for kids

No clarity exists till date about safety and efficacy and dosing of most cough preparations. The authorities can not ban or support cough syrup preparations as there is no robust data for or against their usage. The cough syrups are here to stay.However, we should make sure we do no harm by wrong dosing. If you like my slides please press like button. ;)
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Dr Shailesh Mehta

1. Cough Syrups for kids What really works? DR SHAILESH MEHTA M.D. PEDIATRICS

2. Use of Cough Suppressants in Children Expert Roundtable Meeting April 27, 2017 FDA White Oak Campus, Silver Spring, MD Similar conclusions are expected after our round table meet.

3. Some masoom sawaals for you? OTC Cough Preparations 10 mg ……………………………….? 5 mg ………………………..? 1mg or 2mg or 4mg ……………………? 50 mg ………………..? 125 or 250 mg ……………….? 15 or 30mg ………………………? 1.25 mg………………………………?

4. EK AKELA IS SHEHER MEIN Dextromethorphan 30MG/5ML

5. MINI AND MEGA COCKTAILS MINI COCKTAILS ( per 5 ml) Chlorpheniramine maleate 4mg Dextromethorphan 10mg MEGA PUNCH COCKTAILS (per 5ml) Dextromethorphan 10mg Guaiphesin 50 mg Phenylephrine 5mg Chlorpheniramine maleate 4mg

6. Pehchan kon ?

7. Pehchan kon ?

8. LUNG CLEANSING MEGAMIX Per 5 ml Levosalbutamol 1mg Ambroxol 30mg Guaiphesin 50mg Ambroxol 15 mg Terbutaline sulphate 1.25 mg

9. PHENYL EPH 5/ CPM 2 Jodi number one

10. P125/ PHENYLEPH 5/ CPM 1 TRIDEV COMBO

11. CASE DISCUSSION KEJRIWAL , 3 YRS OLD MALE , WEIGHT 14KG Cough since 3 DAYS No diurnal variation Associated runny nose Undocumented fever - 2 DAYS NO REFUSAL TO FEED , NO RAPID BREATHING CLINICAL FINDINGS INCONCLUSIVE EXCEPT MILD THROAT CONGESTION WRITE A PRESCRIPTION FOR HIM

12. DID YOU NOTICE ? PPA are out Diphenhydramine is rarely seen (except BENADRYL) Pseudoephidrine is not seen in most of pediatrics formulas (variant of amphetamine) Phenylephrine is the most widely used decongestant nowadays (working same as epinephrine on alpha receptors)

13. While prescribing remember All 1 ST Gen antihistaminics like CPM, DIPHENHYDRAMINE have side effects which are predominantly Anticholinergic - dry mouth, tachycardia, constipation, nausea, hypotention , confusion,ECG changes, delerium,psychosis , sezures , coma CPM dose in children – 0.3 mg/kg/d in div doses 2–5 y: 1 mg q 4–6 h 6–11 y: 2 mg q 4–6 h

14. While prescribing remember Most decongestants e.g., PHENYLEPHRINE, PSEUDOEPHEDRINE- Have side effects mimicking sympathetic nervous system over stimulation like- - mydriasis , - confusion, - tachycardia,hypertention , - arrythmias , SVT, reflex severe bradycardia , -headache, agitation Phenylephrine dose - 4–6 y: 2.5 mg q 4 h prn 6–12 y: 5 mg q 4 h prn

15. Dextromethorphan Commonly used in OTC cough and cold preparations. It is the D-isomer of the codeine analog of levorphanol Dose controversy/ error Indian Pediatr 2014;51: 1019 Dextromethorphan dose-(Internationally) 2–6 y: 2.5–7.5 mg q 4–8 h 7–12 y: 5–10 mg q 4–8 h

16. Beware of litigations The formal regulatory review of OTC drugs, including CCMs, started in 1972 in the United States . At that time, most OTC CCMs were generally recognized as safe and effective. In 2007, this changed dramatically by a citizen petition submitted to the FDA, raising significant concerns about the safety and efficacy of CCMs in children under the age of 6 years. This petition resulted in a public health advisory by the FDA, recommending that CCMs should not be used in children under 2 years of age because of the risk of serious and life-threatening effects.

17. No safety and efficacy studies for Noscapine Br J Clin Pharmacol . 2011 Jun; 71(6): 943–950. doi :  10.1111/j.1365-2125.2010.03860.x No data available for pediatric dosing. Adult use studies show 50mg dosing 8 hourly

18. Pholcodine has a half life of 50 hrs! IAP Drug formulary Dose – 1 month to 6 yrs-2mg/dose at 6- 8 hourly intervals 6- 12 yrs 2.5 mg 12-18 yrs 5-10 mg Internationally not used below 6 yrs Leconte S, Valentin S, Dromelet E, De Jonghe M. Prolonged Cough in Pediatric Population First Line Care, Belgian Guidelines . Open Respir Med J . 2017 ;11:54–66. Published 2017 Aug 21. doi:10.2174/187430640171101005

19. Market mein naya hai Levodropropizine Zanasi A, Lanata L, Fontana G, Saibene F, Dicpinigaitis P, De Blasio F. Levodropropizine for treating cough in adult and children: a meta-analysis of published studies. Multidiscip Respir Med . 2015 ;10(1):19. Very promising peripherally acting molecule. Studied in children > 2 yrs

20. OTC COUGH PREPARATIONS Over-the-counter (OTC)medications for acute cough in children and adults in community settings. Cochrane Database of Systematic Reviews 2014 , Issue 11. Art. No.: CD001831. DOI: 10.1002/14651858.CD001831.pub5. Objectives-To assess the effects of oral OTC cough preparations for acute cough in children and adults in community settings. Included 29 trials (19 in adults, 10 in children ) - involving 4835 people (3799 adults and 1036children). -All studies were placebocontrolled RCTs

21. Cochrane Database of Systematic Reviews 2014 , Issue 11. Art. No.: CD001831. DOI: 10.1002/14651858.CD001831.pub5 No studies using expectorants ( No study met inclusion criteria due to poor design) The results of one trial favoured active treatment with mucolytic letosteine over placebo. There is no good evidence for or against the effectiveness of over the- counter (OTC) cough medicines , and from the studies included in this review It remains unclear whether these medications are helpful for the treatment of acute cough Dextromethorphan and Honey equally effective

22. CONCLUSIONS Dextromethorphan is the most widely studied anti tussive in children Honey is as effective as Dextromethorphan . Dextromethorphan and honey are more effective than a placebo TRIALS ON EXPECTORANTS WERE POORLY DESIGNED AND NONE MET THE INCLUSION CRITERIA FOR META-ANALYSIS OTC COUGH REMEDIES CAN NOT BE BANNED AS THERE IS NO DATA WITH THE REGULATORY AUTHORITIES , FOR OR AGAINST THEIR USE

23. DO NO HARM In case we plan to prescribe a cough syrup, we should do that only after complete knowledge about its INGREDIENTS, DOSES AND SIDE EFFECTS. Anti tussives are to be avoided in children below 2 yrs age