Acetaminophen 325 MG / Oxycodone Hydrochloride 7.5 MG Oral Tablet
Generic Name: OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
Brand Name: OXYCODONE AND ACETAMINOPHEN
- Substance Name(s):
- OXYCODONE HYDROCHLORIDE
- ACETAMINOPHEN
WARNINGS
OVERDOSAGE
DESCRIPTION
Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: Oxycodone Hydrochloride USP ………………………………………………………………..5 mg* Acetaminophen USP …………………………………………………………………………….325 mg *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
Oxycodone Hydrochloride USP ……………………………………………………………..7.5 mg* Acetaminophen USP …………………………………………………………………………….325 mg *7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone Hydrochloride USP ……………………………………………………………..7.5 mg* Acetaminophen USP …………………………………………………………………………….500 mg *7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone Hydrochloride USP ……………………………………………………………….10 mg* Acetaminophen USP ……………………………………………………………………………..325 mg *10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
All strengths of oxycodone and acetaminophen tablets USP also contain the following inactive ingredients: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid.
Oxycodone, 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste.
It is derived from the opium alkaloid thebaine.
Oxycodone hydrochloride may be represented by the following structural formula: Acetaminophen, 4′-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
It may be represented by the following structural formula: Chemical Structure Chemical Structure
HOW SUPPLIED
Each oxycodone and acetaminophen tablet USP 7.5 mg/325 mg contains oxycodone hydrochloride 7.5 mg (equivalent to 6.7228 mg oxycodone) and acetaminophen 325 mg.
It is available as a white to off-white caplet shaped tablet debossed with “M522” on one side and “7.5/325” on the other side.
Bottles of 30 .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
NDC 42549-615-30 Bottles of 40 .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
NDC 42549-615-40 Bottles of 60 .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
NDC 42549-615-60 Bottles of 84 .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
NDC 42549-615-84 Bottles of 90 .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
NDC 42549-615-90 Bottles of 120 .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
NDC 42549-615-12 Bottles of 112 .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
NDC 42549-615-02 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
DEA Order Form Required.
Mallinckrodt Inc., Hazelwood, MO 63042 USA.
Printed in U.S.A.
COVIDIEN™ Mallinckrodt Rev 05/2009
GERIATRIC USE
Geriatric Use Special precaution should be given when determining the dosing amount and frequency of oxycodone and acetaminophen tablets for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when compared to younger patients.
INDICATIONS AND USAGE
Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
PREGNANCY
Pregnancy
NUSRING MOTHERS
Nursing Mothers Ordinarily, nursing should not be undertaken while a patient is receiving oxycodone and acetaminophen tablets because of the possibility of sedation and/or respiratory depression in the infant.
Oxycodone is excreted in breast milk in low concentrations, and there have been rare reports of somnolence and lethargy in babies of nursing mothers taking an oxycodone/acetaminophen product.
Acetaminophen is also excreted in breast milk in low concentrations.
INFORMATION FOR PATIENTS
Information for Patients/Caregivers The following information should be provided to patients receiving oxycodone and acetaminophen tablets by their physician, nurse, pharmacist, or caregiver: Patients should be aware that oxycodone and acetaminophen tablets contain oxycodone, which is a morphine-like substance.
Patients should be instructed to keep oxycodone and acetaminophen tablets in a secure place out of the reach of children.
In the case of accidental ingestions, emergency medical care should be sought immediately.
When oxycodone and acetaminophen tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.
Patients should be advised not to adjust the medication dose themselves.
Instead, they must consult with their prescribing physician.
Patients should be advised that oxycodone and acetaminophen tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
Patients should not combine oxycodone and acetaminophen tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician.
When co-administered with another CNS depressant, oxycodone and acetaminophen tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.
The safe use of oxycodone and acetaminophen tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking oxycodone and acetaminophen tablets.
Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue oxycodone and acetaminophen tablets because of the potential for serious adverse reactions to nursing infants.
Patients who are treated with oxycodone and acetaminophen tablets for more than a few weeks should be advised not to abruptly discontinue the medication.
Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.
Patients should be advised that oxycodone and acetaminophen tablets are a potential drug of abuse.
They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the pain and the response of the patient.
It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids.
If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule.
Oxycodone and acetaminophen tablets are given orally.
The total daily dose of acetaminophen should not exceed 4 grams.
Strength Usual Adult Dosage Maximal Daily Dose Oxycodone and acetaminophen tablets 5 mg/325 mg 1 tablet every 6 hours as needed for pain 12 Tablets Oxycodone and acetaminophen tablets 7.5 mg/325 mg 1 tablet every 6 hours as needed for pain 8 Tablets Oxycodone and acetaminophen tablets 7.5 mg/500 mg 1 tablet every 6 hours as needed for pain 8 Tablets Oxycodone and acetaminophen tablets 10 mg/325 mg 1 tablet every 6 hours as needed for pain 6 Tablets