Generic name: Hydrocodone Bitartrate 7.5mg in 15mL, Acetaminophen 325mg in 15mL
Dosage form: oral solution
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Important Dosage and Administration Instructions
Ensure accuracy when prescribing, dispensing, and administering ZYFREL Oral Solution to avoid dosing errors due to confusion between mg and mL, and with other hydrocodone bitartrate and acetaminophen oral solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.
Always use a calibrated measuring devise when administering ZYFREL Oral Solution to ensure the dose is measured and administered accurately. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS].
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS].
Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with ZYFREL Oral Solution and adjust the dosage accordingly [see WARNINGS].
Initiating Treatment with ZYFREL Oral Solution
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 is to be given every 4 to 6 hours as needed for pain. The total daily dosage for children should not exceed 6 doses per day. These dosages correspond to an average individual dose of 0.27 mL/kg of ZYFREL Oral Solution (providing 0.135 mg/kg of hydrocodone bitartrate and 5.85 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.
It is of utmost importance that the dose of ZYFREL 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 an oral device that can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage.
|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||4½ 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||1½ 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 = 60 mL|
|46 kg and up
101 lbs. and up
|14 years to adult||1 Tablespoonful = 15 mL||6 Tablespoonfuls = 90 mL|
Conversion from Other Opioids to ZYFREL Oral Solution
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of ZYFREL Oral Solution. It is safer to underestimate a patient's 24-hour ZYFREL Oral Solution dosage than to overestimate the 24-hour hydrocodone bitartrate and acetaminophen tablets dosage and manage an adverse reaction due to overdose.
Conversion from ZYFREL Oral Solution to Extended-Release Hydrocodone
The relative bioavailability of hydrocodone from ZYFREL Oral Solution compared to extended-release hydrocodone is unknown, so conversion to extended-release tablets must be accompanied by close observation for signs of excessive sedation and respiratory depression.
Titration and Maintenance of Therapy
Individually titrate ZYFREL Oral Solution to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving ZYFREL Oral Solution to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the ZYFREL Oral Solution dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of ZYFREL Oral Solution
When a patient who has been taking ZYFREL Oral Solution regularly and may be physically dependent no longer requires therapy with ZYFREL Oral Solution, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue ZYFREL Oral Solution in a physically-dependent patient [see WARNINGS, DRUG ABUSE AND DEPENDENCE].
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