Atley Pharmaceuticals

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Adults and Children over 10: Usual dose is one 150 mg capsule three times daily as required. If necessary, up to 600 mg daily may be given.

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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 approximately 2 ¼ teaspoonfuls every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 13 ½ teaspoonfuls.

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 0.20 mL/kg of ZOLVITTM (providing 0.135 mg/kg of hydrocodone bitartrate and 4.0 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

2.8 mL

(approx. ½ teaspoonful)

16.8 mL

(approx. 3¼ teaspoonfuls)

16 to 22 kg

(35 to 50 lbs.) 4 to 6 years

3.75 mL

(approx. ¾ teaspoonful)

22.5 mL

(approx. 4½ teaspoonfuls)

23 to 31 kg

(51 to 69 lbs.) 7 to 9 years

5.6 mL

(approx. 1 teaspoonful)

33.6 mL

(approx. 6½ teaspoonfuls)

32 to 45 kg

(70 to 100 lbs.) 10 to 13 years

7.5 mL

(approx. 1½ teaspoonful)

45 mL

(approx. 9 teaspoonfuls)

46 kg and up

(101 lbs. and up) 14 years to adult

11.25 mL

(approx. 2¼ teaspoonfuls)

67.5 mL

(approx. 13½ teaspoonfuls)

The total daily dosage for children should not exceed 6 doses per day.

It is of utmost importance that the dose of ZOLVITTM 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.