"Jan. 28, 2013 -- It may become more difficult to get prescriptions for drugs containing hydrocodone combined with other pain relievers.
An FDA panel voted 17 to 10 in favor of reclassifying hydrocodone-containing compounds, such as Vico"...
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) (providing 0.135 mg/kg of hydrocodone bitartrate and 9 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.
|BODY WEIGHT||APPROXIMATE AGE|| DOSE
Every 4 to 6 hours
| MAXIMUM TOTAL DAILY DOSE
(6 doses per day)
| 12 to 15 kg
27 to 34 lbs.
|2 to 3 years|| ¾ teaspoonful
= 3.75 mL
| 4 ½ teaspoonfuls
= 22.5 mL
| 16 to 22 kg
35 to 50 lbs.
|4 to 6 years|| 1 teaspoonful
= 5 mL
| 6 teaspoonfuls
= 30 mL
| 23 to 31 kg
51 to 69 lbs.
|7 to 9 years|| 1 ½ teaspoonfuls
= 7.5 mL
| 9 teaspoonfuls
= 45 mL
| 32 to 45 kg
70 to 100 lbs.
|10 to 13 years|| 2 teaspoonfuls
= 10 mL
| 12 teaspoonfuls
| 46 kg and up
101 lbs. and up
|14 years to adult|| 1 Tablespoonful
= 15 mL
| 6 Tablespoonfuls
= 90 mL
The total daily dosage for children should not exceed 6 doses per day. It is of utmost importance that the dose of Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that care givers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage.
Lortab® Elixir (hydrocodone bitartrate and acetaminophen oral solution) is a yellow- colored tropical fruit punch flavored liquid containing hydrocodone bitartrate 7.5 mg and acetaminophen 500 mg per 15 mL, with 7% alcohol. It is supplied in containers of 1 pint (473 mL) NDC 50474-909-16
Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature] Dispense in a tight, light-resistant container with a child-resistant closure. A schedule CIII Narcotic
Manufactured for: UCB Pharma, Inc. Smyrna, GA 30080. Manufactured by: Mikart Inc. Atlanta, GA 30318. FDA rev date: 8/3/2000
Last reviewed on RxList: 1/30/2008
This monograph has been modified to include the generic and brand name in many instances.
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