Ibuprofen - DOSE TO WEIGHT
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Ibuprofen

Infants’ and Children’s Ibuprofen

 

The original New Drug Application (NDA) for the approval of Children’s and Infants Ibuprofen recite safety and efficacy studies in fixed dosing of mg to kg. In fact, the majority of all clinical and pivotal safety studies in support of the approval of pediatric ibuprofen,1 such as the Boston Fever Study,2 were conducted and published also in fixed dosing, in either 5mg/kg or 10mg/kg. Moreover, the Food and Drug Administration’s Medical Reviewer’s final comments for pediatric approval, concluded the safety of OTC Ibuprofen in pediatric populations at the two doses tested, 5mg and 10mg.3

 

Collectively, the clinical data supported the approval of the NDA for Pediatric OTC Ibuprofen and the NDA continues to recite a fixed dose of either 5mg or 10mg/kg; depending on the patient’s baseline temperature or other condition.4 The American Association of Pediatrics also recommends a fixed dose of 10mg/kg,5 as well as other worldwide health agencies recommend a fixed dose to pediatric patient weight.

 

Contrary to all of the collective data, the current U.S. mL dosing regimen provides a highly variable dosing to these subtle pediatric patients. For example, current mL dosing provides the lowest weight and youngest patients (12lb at 6 months), the near maximum dose of 4.17mg/lb (9.2mg/kg) and the heaviest weight and oldest patient within that same range the lowest dose of 2.94mg/lb (6.48mg/kg). The current regimen prodes extreme dosing variations, such as offering a 17lb patient 2.9mg/lb and an 18lb patient 4.2mg/lb, a percentage change of over 44% despite a one pound difference in weight.

 

The American Academy of Pediatrics and U.S. FDA advisory panel, among others, recommend to dose OTC Children’s to a child’s weight, and then age if the weight is not known. Conversely, no oral applicators included within ibuprofen products have a weight or age indicia.

 

Studies and statistical data continue to corroborate the leading causes of medication error during the administration of children’s and infants OTC medications. The most common documented errors, stem from measuring confusion with the dosing device, and misunderstanding the product instruction label or dosing chart.

 

The Dose-Weight Syringe® is specifically calibrated to administer a precise patient specific dose of ibuprofen between the approved New Drug Application for Ibuprofen and the original safety and efficacy studies for the dosing of 5mg or 10mg/kg. More specifically, the Dose-Weight Syringe® is designed to deliver a highly precise enhanced dose to a specific patient characteristic, such as BMI, BSA, weight, or age within this range. The Dose-Weight Syringe® may be calibrated to deliver an optimal mid-point dose from the published safety and efficacy studies of infants and children’s Ibuprofen, such as 3.40mg/lb (7.5mg/kg), among other fixed doses within the recommended range.

Infants’
Ibuprofen

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Children’s
Ibuprofen

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Ibuprofen
Brochure

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1 U.S. FDA – Medical Officer Review Division of Over The Counter Drug Products NDA 20-812,SE5-003

2 Boston University Fever Study, (BUFS) Slone Epidemiology Center

3 U.S. FDA – Medical Officer Review Division of Over The Counter Drug Products NDA 20-812,SE5-003 – Page 18-19

4 Ibuprofen Suspension 100mg/5ml NDA 19-842/s-019 – Page 12 Dosage and Administration, Pediatrics

5 AAP Reports on the Use of Antipyretics for Fever in Children, March 2011

Ibuprofen Oral Dispensers

Researchers have shown that only 30% of caregivers are able to demonstrate both an accurately measured and correct dose for their child.1 Generally over-the-counter (OTC) medications are considered safe, however they are the most frequently implicated pharmaceuticals involved in cases reported to the American Association of Poison Control Center’s National Poison Data System.2

Current dosing recommendations for OTC oral medications commonly specify a volume of medication for a weight or age range, rather than using the dosage strength of the medication specific to an individual patient weight. This dosing regimen results with patients in a designated range receiving the same amount of medication, even though their individual weight may differ more than 40% (12-23lb); and patients in different ranges receiving an increase in dosage of 50% (50-75mg) despite having a difference in weight of only 1lb, (17-18lb).

1 Simon, H. K., & Weinkle, D. A. (1997). Over-the-counter medications: do parents give what they intend to give?  Archives of pediatrics & adolescent medicine151(7), 654-656.

2 Bronstein AC, Spyker DA, Cantilena LR, Green JL, Rumack BH, Heard SE. 2007 annual report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 25th Annual Report. Clin Toxicol (Phila). 2008; 46(10):927-1057.

3 Adjusted for Current U.S. Market Dosing and mL conformity – (adjusted from 3.4 mg/lb. to 3.25 mg/lb)

Dose-2-Weight Syringe®

The patented Dose-2-Weight Syringe® is the next generation liquid medication dispenser. Each Dose-2-Weight Syringe® is calibrated to the dosage strength of a specific medication and marked with multiple correlated measurements. These measurements may include, among others, weight or other patient characteristic, medication dosage or volume of the medication. The enhanced multi-indicia display increases the overall safety and accuracy of administration, by providing the ability to intuitively correlate the unit dosage to a specific patient characteristic.

The Dose-2-Weight Syringe® eliminates the need to correlate a volume, unit dosage or patient feature from a medication package or other media to the delivery device. These features circumvent the procedures shown to be the primary cause of error during the preparation and administration of OTC liquid medications.

The Dose-2-Weight Syringe® provides un-matched safety and convenience during preparation and administration, while in parallel, providing ultra-precise dosing and visual reverification of the correct amount of medication for the specific patient.

Benefits:

  • Calibrated Measurements Indicia for Weight, Age, BSA and Volumetric Dosage
  • Ultra-Precise Dosing
  • Optional keyed tip paired to container closures or valve restrictions
  • Convenient
  • Calculation free
  • Lower incremental indicia
  • Easy to read markings
  • Ergonomic
  • Safe
  • CE/ISO/WHO/TUV certified

ORDERING INFORMATION

Dose-2-Weight Syringe®
Calibrated for specific medication

Three-part oral dispenser

  • Short or long tip barrel
  • Silicone O-ring plunger
  • No rubber, latex free
  • BPA free
  • 100% vision inspected calibration lines
  • Dishwasher safe, maintains print quality
  • CE registration
  • Multiple barrel and plunger colors available
Size Graduations Sterility Material Packaging Barrel
1, 2, 3, 5, 10, 20, 30, 50, 60 mL Weight: kg, lb

Age: mo, yr

Dosage: mg, mL

SA: ft2, m2

Sterile

Non-sterile

Barrel: PP

Plunger: HDPE

PE

Blister

Bulk

Round

Press-in bottle adapter

Diameter Size Sterility Material Packaging
20, 24, 28mm Sterile/non-steril LDPE Bulk

Custom Dispensing System

Our team of design engineers will work with your specific requirements to provide you a customized dispensing system.  Please contact us for customized design, color(s), graduation(s), labeling and packaging.

To request samples or pricing or for additional information, call 1-941-360-0029 or email us at sales@asepsismedical.com

*not available in all territories

©Copyright 2017 by Asepsis Medical Technologies, LLC. Sarasota, FL.
All Rights Reserved, including the right of reproduction in whole or in part in any form

Dose-2-Weight Syringe® is a registered trademark of Asepsis Medical Technologies, LLC., and covered by one or more patents

including U.S. Patent 9,192,723 , U.S. Patent 9,302,050 , U.S. Patent 9750883  and Patents Pending

INFANTS IBUPROFEN

Current Dosing Schedule 1
Ibuprofen 40 mg/mL
mL mg mg/lb
lb Current Current Current
12.0 1.25 50 4.17
13.0 1.25 50 3.85
14.0 1.25 50 3.57
15.0 1.25 50 3.33
16.0 1.25 50 3.12
17.0 1.25 50 2.94
18.0 1.875 75 4.17
19.0 1.875 75 3.95
20.0 1.875 75 3.75
21.0 1.875 75 3.57
22.0 1.875 75 3.41
23.0 1.875 75 3.26
Average: 3.59
Dose-2-Weight Schedule 2,3,4
Ibuprofen 40 mg/mL
mL mg mg/lb
lb D2W D2W D2W
12.0 0.975 39.00 3.25
13.0 1.06 42.25 3.25
14.0 1.14 45.50 3.25
15.0 1.22 48.75 3.25
16.0 1.30 52.00 3.25
17.0 1.38 55.25 3.25
18.0 1.46 58.50 3.25
19.0 1.54 61.75 3.25
20.0 1.63 65.00 3.25
21.0 1.71 68.25 3.25
22.0 1.79 71.50 3.25
23.0 1.87 74.75 3.25
Average: 3.25

1] Motrin® Infants Dosing Charts for Children and Infants

2] Adjusted for Current U.S. Market Dosing and mL conformity – (adjusted from 3.4 mg/lb. to 3.25 mg/lb.)

3] US Food and Drug Administration – Medical Officer Review – Division of over the Counter Drug Products NDA 20-603, SE3-003 Children’s Motrin® –  Efficacy and Safety Studies published and approved at 2.27 mg/lb. and second study at 4.54 mg/lb. Submission Study mid-point of 3.4 mg/lb.

4] Boston University Fever Study – Pivotal Safety Study used in support of approval of Children’s Motrin® Dosing at 2.27 mg/lb. and also at 4.54 mg/lb. Study mid-point of 3.4 mg/lb.

Motrin® is a registered trademark of Johnson & Johnson.

CHILDRENS IBUPROFEN

Current Dosing Schedule 1
Ibuprofen 20 mg/mL
mL mg mg/lb
lb Current Current Current
24.0 5 100 4.17
25.0 5 100 4.00
26.0 5 100 3.85
27.0 5 100 3.70
28.0 5 100 3.57
29.0 5 100 3.45
30.0 5 100 3.33
31.0 5 100 3.23
32.0 5 100 3.13
33.0 5 100 3.03
34.0 5 100 2.94
35.0 5 100 2.86
36.0 7.5 150 4.17
37.0 7.5 150 4.05
38.0 7.5 150 3.95
39.0 7.5 150 3.85
40.0 7.5 150 3.75
41.0 7.5 150 3.66
42.0 7.5 150 3.57
43.0 7.5 150 3.49
44.0 7.5 150 3.41
45.0 7.5 150 3.33
46.0 7.5 150 3.26
47.0 7.5 150 3.19
48.0 10 200 4.17
49.0 10 200 4.08
50.0 10 200 4.00
51.0 10 200 3.92
52.0 10 200 3.85
53.0 10 200 3.77
54.0 10 200 3.70
55.0 10 200 3.64
56.0 10 200 3.57
57.0 10 200 3.51
58.0 10 200 3.45
59.0 10 200 3.39
Average: 3.61
Dose-2-Weight Schedule 2,3,4
Ibuprofen 20 mg/mL
mL mg mg/lb
lb D2W D2W D2W
24.0 4.08 81.6 3.40
25.0 4.25 85.0 3.40
26.0 4.42 88.4 3.40
27.0 4.59 91.8 3.40
28.0 4.76 95.2 3.40
29.0 4.93 98.6 3.40
30.0 5.10 102.0 3.40
31.0 5.27 105.4 3.40
32.0 5.44 108.8 3.40
33.0 5.61 112.2 3.40
34.0 5.78 115.6 3.40
35.0 5.95 119.0 3.4
36.0 6.12 122.4 3.40
37.0 6.29 125.8 3.40
38.0 6.46 129.2 3.40
39.0 6.63 132.6 3.40
40.0 6.80 136.0 3.40
41.0 6.97 139.4 3.40
42.0 7.14 142.8 3.40
43.0 7.31 146.2 3.40
44.0 7.48 149.6 3.40
45.0 7.65 153.0 3.40
46.0 7.82 156.4 3.40
47.0 7.99 159.8 3.40
48.0 8.16 163.2 3.40
49.0 8.33 166.6 3.40
50.0 8.50 170.0 3.40
51.0 8.67 173.4 3.40
52.0 8.84 176.8 3.40
53.0 9.01 180.2 3.40
54.0 9.18 183.6 3.40
55.0 9.35 187.0 3.40
56.0 9.52 190.4 3.40
57.0 9.69 193.8 3.40
58.0 9.86 197.2 3.40
59.0 10.03 200.6 3.40
Average: 3.40

1] Motrin® Infants Dosing Charts for Children and Infants

2] US Food and Drug Administration – Medical Officer Review – Division of over the Counter Drug Products NDA 20-603, SE3-003 Children’s Motrin® –  Efficacy and Safety Studies published and approved at 2.27 mg/lb. and second study at 4.54 mg/lb. Submission Study mid-point of 3.4 mg/lb.

3] Boston University Fever Study – Pivotal Safety Study used in support of approval of Children’s Motrin® Dosing at 2.27 mg/lb. and also at 4.54 mg/lb. Study mid-point of 3.4 mg/lb.

Motrin® is a registered trademark of Johnson & Johnson.