roxycodone 30 mg 30 M (oxycodone hydrochloride tablets USP) is an opioid analgesic. Each tablet for oral administration contains 15 mg or 30 mg of oxycodone hydrochloride USP.

The tablets contain the following inactive ingredients: microcrystalline cellulose; sodium starch glycolate; corn starch; lactose; stearic acid; D&C Yellow No. 10 (15 mg tablet); and FD&C Blue No. 2 (15 mg and 30 mg tablets). The 15 mg and 30 mg tablets contain the equivalent of 13.5 mg and 27.0 mg, respectively, of oxycodone free base.

How supplier roxycodone 30 mg

ROXICODONE (oxycodone hydrochloride tablets USP) available as follows:

5 mg white tablets scored (Identified 54 582)
[Embossed 54 582 on one side]

NDC 23635-580-25: Unit Dose, 25 tablets per card, 4 cards per shipper
NDC 23635-580-10: Bottles of 100 tablets

15 mg green tablets scored (Identified 54 710)
[Embossed 54 710 on one side]

NDC 23635-581-10: Bottles of 100 tablets

30 mg blue tablets scored (Identified 54 199)
[Embossed 54 199 on one side]

NDC 23635-582-10: Bottles of 100 tablets

DEA Order Form Required

Dispense in a tight, light-resistant container.
Protect from moisture.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F)

Indication and usa

ROXICODONE (oxycodone HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve ROXICODONE for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):

Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Roxy 30’s is contraindicated in patients with:

Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to oxycodone

Description	Blue tablets scored
Generic Name	Oxycodone hydrochloride tablets USP
Dosage Strength	30 mg

Pharmacokinetics

The activity of ROXICODONE (oxycodone hydrochloride) tablets is primarily due to the parent drug oxycodone. ROXICODONE tablets are designed to provide immediate release of oxycodone.

SIDE EFFECTS

ROXICODONE tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. ROXICODONE tablets are associated with adverse experiences similar to those seen with other opioids.

Serious adverse reactions that may be associated with ROXICODONE therapy in clinical use are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock

Body As A Whole

abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis.

Cardiovascular

deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.

Digestive

anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting.

Hemic And Lymphatic

anemia and leukopenia.

Metabolic And Nutritional

edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema.

Musculoskeletal

arthralgia, arthritis, bone pain, myalgia and pathological fracture.

Nervous

agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation.

Respiratory

bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis.

Skin And Appendages

herpes simplex, rash, sweating, and urticaria.

Special Senses

amblyopia.

Urogenital

urinary tract infection.

QTY	1 Bottles 100 pills, 2 Bottles 200 pills, 5 Bottles 500 pills

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