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Basic Drug Info
Drug Name:Oxycodone Hydrochloride
Manufacturer:Mallinckrodt Inc.
Other Info:

Dispense in tight, light-resistant container with child-resistant closure.Protect from moisture.

Protect from light.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

is a registered trademark of Mallinckrodt Inc.Mallinckrodt Inc.St.

Louis, MO 63134 U.S.A.tycoHealthcareMallinckrodtPrinted in U.S.A.Rev 081007



Clinical Trials:


Indications and Usage
Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
Contraindications

Oxycodone hydrochloride tablets are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated.

This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia.

Oxycodone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

LUNG FUNCTION DECREASED --

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Hypercapnia -- A clinical manifestation of abnormal increase in the amount of carbon dioxide in arterial blood.

Paralytic Ileus --

Warnings

Respiratory depression is the chief hazard from all opioid agonist preparations.

Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.Oxycodone hydrochloride tablets should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.

In such patients, even usual therapeutic doses of oxycodone hydrochloride tablets may decrease respiratory drive to the point of apnea.

In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
Branded Drugs
The following US Branded drugs contain Oxycodone Hydrochloride


OXYCODONE AND ACETAMINOPHEN -- ACTAVIS TOTOWA LLC

OXYCODONE AND ACETAMINOPHEN -- BARR LABORATORIES INC

OXYCODONE AND ACETAMINOPHEN -- DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC

OXYCODONE AND ACETAMINOPHEN -- ENDO PHARMACEUTICALS INC

OXYCODONE AND ACETAMINOPHEN -- HALSEY DRUG CO INC

OXYCODONE AND ACETAMINOPHEN -- MALLINCKRODT CHEMICAL INC

OXYCODONE AND ACETAMINOPHEN -- MUTUAL PHARMACEUTICAL CO INC

OXYCODONE AND ACETAMINOPHEN -- VINTAGE PHARMACEUTICALS INC

OXYCODONE AND ACETAMINOPHEN -- WATSON LABORATORIES INC

ROXILOX -- ROXANE LABORATORIES INC

TYLOX -- ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC

TYLOX-325 -- ORTHO MCNEIL PHARMACEUTICAL INC

OXYCODONE AND ACETAMINOPHEN -- MALLINCKRODT INC

ROXICET -- ROXANE LABORATORIES INC

OXYCET -- MALLINCKRODT INC

OXYCODONE 2.5/APAP 500 -- BRISTOL MYERS SQUIBB PHARMA CO

OXYCODONE 5/APAP 500 -- BRISTOL MYERS SQUIBB PHARMA CO

OXYCODONE AND ACETAMINOPHEN -- AMNEAL PHARMACEUTICALS NY LLC

OXYCODONE AND ACETAMINOPHEN -- COASTAL PHARMACEUTICALS INC

OXYCODONE AND ACETAMINOPHEN -- MIKART INC

OXYCODONE AND ACETAMINOPHEN -- WATSON LABORATORIES

PERCOCET -- ENDO PHARMACEUTICALS INC

ROXICET 5/500 -- ROXANE LABORATORIES INC

TYLOX -- ORTHO MCNEIL PHARMACEUTICAL INC

PERCODAN -- ENDO PHARMACEUTICALS INC

CODOXY -- HALSEY DRUG CO INC

OXYCODONE AND ASPIRIN -- MUTUAL PHARMACEUTICAL CO INC

OXYCODONE AND ASPIRIN -- WATSON LABORATORIES INC

OXYCODONE AND ASPIRIN (HALF-STRENGTH) -- ROXANE LABORATORIES INC

PERCODAN-DEMI -- ENDO PHARMACEUTICALS INC

ROXIPRIN -- ROXANE LABORATORIES INC

COMBUNOX -- FOREST LABORATORIES INC

OXYCODONE HYDROCHLORIDE AND IBUPROFEN -- ACTAVIS ELIZABETH LLC

OXYCODONE HYDROCHLORIDE AND IBUPROFEN -- BARR LABORATORIES INC

OXYCODONE HYDROCHLORIDE AND IBUPROFEN -- WATSON LABORATORIES INC

OXYCONTIN -- PURDUE PHARMA LP

ROXICODONE -- ROXANE LABORATORIES INC

ROXICODONE -- XANODYNE PHARMACEUTICALS INC


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