PEDIATRIC OTC FORMULARY

Once it has been decided to treat a pediatric patients symptoms without a visit to a physicians office, the pharmacist should consider the patients history and screen for contraindications and drug interactions. Parents should understand that these medications are for the relief of symptoms only, and that if the symptoms continue the child should be seen by a physician to determine the underlying cause of the symptoms.
ANALGESICS

Aspirin or other salicylates should not be given to children or teenagers (unless specified by a physician) because of the risk of Reyes syndrome. Nonprescription doses of acetaminophen and ibuprofen for children 2 to 11 years old are listed in the table below. Children 12 and older may receive the adult acetaminophen dose of 325-650 mg every 4-6 hours as needed, not to exceed 4 g/day or 3 days of use for fever >39.5C or 5 days of use for pain. They may receive the adult ibuprofen dose of 200 mg orally every 4-6 hours as needed. The dose may be increase to 400 mg every 4-6 hours if needed, not to exceed 1.2 g/day or 3 days of use for fever or pain.
AGE (YEARS) 2-3 4-5 6-8 9-10 11
1

WEIGHT (LB) 24-35 36-47 48-59 60-71 72-95

ACETAMINOPHEN DOSE (mg)1 160 240 320 400 480

IBUPROFEN DOSE (mg)2 100 150 200 250 300

Acetaminophen dose corresponds to 10-15 mg/kg and may be given every 4-6 hours as needed for fever or pain, not to exceed five doses per day or 3 days of use for fever >39.5C or 5 days of use for pain. 2 Ibuprofen dose corresponds to 7.5-10 mg/kg and may be given every 6-8 hours as needed for fever or pain, not to exceed four doses per day or 3 days of use for fever or pain.

COUGH AND COLD PRODUCTS

The AAP has advised against the use of combination cough and cold medications. It has recommended that single-ingredient medications targeted at the leading symptom be selected if medications must be used. Simple remedies such as tea with lemon and honey, chicken soup, and hot broths should be used preferably. Adequate fluid intake should be maintained.
GENERIC NAME Oral Decongestants Pseudoephedrine COMMON PRODUCTS
Sudafed Nasal Decongestant, Childrens Sudafed Nasal Decongestant Chewables, Sudafed Childrens Nasal Decongestant Liquid Medication, Dimetapp Decongestant Pediatric Drops, Triaminic Infant Oral Decongestant Drops

DOSAGE AGE 2-5 YEARS AGE 6-11 YEARS 15 mg every 4-6 hr, not to exceed 60 mg/day 30 mg every 4-6 hr, not to exceed 120 mg/day

AGE12 YEARS 60 mg every 4-6 hr, not to exceed 240 mg/day

Intranasal Decongestants Levmetamfetamine

Vicks Vapor Inhalor

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1 inhalation in eacnostril no more than every 2 hr

2 inhalations in each nostril no more than every 2

Phenylephrine

Neo-Synephrine Mild Formula, NeoSynephrine Regular Strength, NeoSynephrine Extra Strength, Vicks Sinex

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2 or 3 sprays of 0.25% solution in each nostril no more than every 4 hr 2 inhalations (~0.40.5 mg) in each nostril no more than every 2 hr 2 or 3 drops of 0.05% solution in each nostril no more than every 810 hr, not to exceed 3 doses in 24 hr 2 mg every 4-6 hr, not to exceed 12 mg in 24 hr

Propylhexedine

Benzedrex nasal inhalant

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Xylometazoline

Otrivin, Otrivin Pediatric Nasal Drops

2 or 3 drops of 0.05% solution in each nostril no more than every 810 hr, not to exceed 3 doses in 24 hr 0.125 mg/kg every 6 hr, not to exceed 6-8 mg/day

hr 2 or 3 drops or sprays of 0.5% or !% solution in each nostril no more than every 4 hr 2 inhalations (~0.4-0.5 mg) in each nostril no more than every 2 hr 2 or 3 sprays or drops of 0.1% solution in each nostril no more than every 8-10 hr

Oral Antihistamines Brompheniramine

Dimetane Extentabs, Dimetapp Allergy DyeFree Childrens Elixer, various combination products and dosage forms

Chlorpheniramine

Chlor-Trimeton 4 Hour Allergy, Chlo-Amine, Chlor-Trimeton Allergy Syrup, various combination products and dosage forms

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2 mg every 4-6 hr, not to exceed 12 mg in 24 hr

4 mg every 4-6 hr or 8 or 12 mg as extended-release tablet every 8-12 or 12 hr, respectively, not to exceed 24 mg in 24 hr 4 mg every 4-6 hr or 8 or 12 mg orally as an extended-release formulation twice daily in the morning and evening, not to exceed 24 mg in 24 hr 10-20 mg every 4 hr or 30 mg every 6-8 hr, not to exceed 120 mg/day 200-400 mg every 4 hr, not to exceed 2.4 mg/day

Other Oral Agents Dextromethorphan

Benylin Pedicatric Cough Suppressant

2.5 mg every 4 hr or 7.5 mg every 8 hr, not to exceed 30 mg/day 50-100 mg every 4 hr, not to exceed 600 mg/day

5-10 mg every 4 hr or 15 mg every 6-8 hr, not to exceed 60 mg/day 100-200 mg every 4 hr, not to exceed 1.2 g/day

Guaifenesin

Robitussin

LAXATIVES

Bowel movement patterns vary widely in children. Deviation from the childs usual pattern should be noted. Such things as emotional distress, febrile illness, family conflict, dietary changes, or environmental changes should be considered as causes of alteration in a childs bowel habits. Increasing fluids and bulk content of the childs diet may resolve constipation. Unbuttered popcorn is a good bulkcontaining snack for children.

AGENT Malt soup extract (Maltsupex)

PATIENTS AGE Breast-fed infant Bottle-fed infant

Corn syrup (Karo syrup) Glycerin suppositories Milk of magnesia Mineral oil Senna syrup (Senokot)

Infant <5 years >6 months >6 years 1-5 years 5-13 years

DOSAGE 5-10 mL in 2-4 oz. of water or fruit juice twice daily 7.5-30 mL in days total formula, or 5-10 mL in every second feeding Same as that of malt soup extract 1-3 mL/kg of body weight per day, in one to two doses 10-15 mL at bedtime 5 mL at bedtime; not to exceed 5 mL twice daily 10 mL at bedtime; not to exceed 10 mL three times daily

DIARRHEA

Diarrhea may be caused by viral, bacterial, or protozoal organisms; changes in diet, drug therapy; or may be a sign of an underlying pathology. Possible causes of the diarrhea and the degree of dehydration should be determined. Antidiarrheal drugs have no proven efficacy in infants and children, and may cause dangerous side effects. Managing acute diarrhea in children requires fluid and electrolyte rehydration and maintenance and nutritional therapy. Maintenance therapy consists of 10 mL/kg or 0.5-1 cup of ORS administered with each loose stool. If the child is vomiting, an extra 2 mL/kg per episode is necessary. For mild to moderate dehydration, 50-100 mL/kg ORS containing 50-90 mEq/L of sodium should be given over 2-4 hours in addition to maintenance therapy until symptoms have resolved, at which food may be reintroduced. Moderately or severely volume-depleted patients need medical care. Children under 3 years of age with acute or chronic diarrhea should be referred to a health care provider.
WHO-ORS 333 20 ORAL REHYDRATION SOLUTIONS Pedialyte Rehydralyte 249 304 25 25 Infalyte 200 30 Resol 269 20

Osmolarity (mOsm/L) Carbohydrates (g/L) Electrolytes (mEq/L) Sodium Potassium Chloride Citrate Calcium Magnesium Phosphate

90 20 80 30 -------

45 20 35 30 -------

75 20 65 30 -------

50 25 45 34 -------

50 20 50 34 4 4 5

LIQUID Cola Ginger ale Apple juice

Sodium (mEq/L) 2 3 3

CLEAR LIQUIDS Potassium Bicarbonate (mEq/L) (mEq/L) 0.1 13 1 20 4 0

Glucose (g/L) 50-150 glucose and fructose 50-150 glucose and fructose 100-150 glucose

Osmolarity (mM/L) 550 540 700

Chicken broth Tea Gatorade

250 0 20

5 0 3

0 0 3

and fructose 0 0 45 glucose and other sugars

450 5 330

REFERENCES

1. Covington TR, Berardi RR, Young LL,eds., et al. Handbook of Nonprescription Drugs. 11th ed. Washington, DC: American Pharmaceutical Association, 1996. 2. Newton GD, Nykamp D, Tietze KJ. Self-care of the common cold in pediatric patients. APhA Special Report. Washington, DC: American Pharmaceutical Association, 2000. 3. Vinson ML, Weitzel KW, Goode JV. Caring for kids: use of nonprescription medication in children. Pharmacy Times OTC Supplement. Pharmacy Times, September 2000.