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1 Tablet of Generic Roxicodone (Oxycodone Hydrochloride) 30mg

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$6.00
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Product Description

GENERIC NAME:

Oxycodone Hydrochloride

Drug NAME:

Roxicodone 30mg Tablets

DRUG DESCRIPTION:

ROXICODONE® (oxycodone hydrochloride tablets USP) is an opioid analgesic.

Each tablet for oral administration contains 5 mg, 15 mg or 30 mg of oxycodone hydrochloride USP.

Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).

Chemically, oxycodone hydrochloride is 4, 5a-epoxy-14-hydroxy-3-methoxy-17methylmorphinan-6-one hydrochloride

The 5 mg Roxicodone (oxycodone hydrochloride) tablet contains inactive ingredients:

microcrystalline cellulose and stearic acid. The 15 and 30 mg 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 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.6 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.

What are the possible side effects of oxycodone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using oxycodone and call your doctor at once if you have a serious side effect such as:

.shallow breathing, slow heartbeat;
.seizure (convulsions);
.cold, clammy skin;
.confusion;
.severe weakness or dizziness; or
.feeling like you might pass out.

Less serious side effects are more likely to occur, such as:

.nausea, vomiting, constipation,  loss of appetite;
.dizziness, headache, tired feeling;
.dry mouth;
.sweating; or
.itching.

What are the precautions when taking oxycodone hydrochloride (Roxicodone)?

PRECAUTIONS: Before taking oxycodone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Liquid products may contain sugar, aspartame, and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, or urinary problems.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

INDICATIONS:

ROXICODONE (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.

DOSAGE AND ADMINISTRATION:

ROXICODONE (oxycodone hydrochloride) ® is intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The dose should be individually adjusted according to severity of pain, patient response and patient size. If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required.

Patients who have not been receiving opioid analgesics should be started on ROXICODONE (oxycodone hydrochloride) ® in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient's response to their initial dose of ROXICODONE (oxycodone hydrochloride) ®. Patients with chronic pain should have their dosage given on an aroundthe-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient.

For control of severe chronic pain, ROXICODONE (oxycodone hydrochloride) ® should be administered on a regularly scheduled basis, every 4-6 hours, at the lowest dosage level that will achieve adequate analgesia.

As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of ROXICODONE (oxycodone hydrochloride) ®, attention should be given to: 1) the daily dose, potency, and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2) the reliability of the relative potency estimate to calculate the dose of oxycodone needed, 3) the degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences.
Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs

When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic. If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of ROXICODONE (oxycodone hydrochloride) ® in response to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen is continued as a separate single entity agent, the starting dose ROXICODONE (oxycodone hydrochloride) ® should be based upon the most recent dose of opioid as a baseline for further titration of oxycodone. Incremental increases should be gauged according to side effects to an acceptable level of analgesia.
Patients Currently on Opioid Therapy

If a patient has been receiving opioid-containing medications prior to taking ROXICODONE (oxycodone hydrochloride) ®, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.

In converting patients from other opioids to ROXICODONE (oxycodone hydrochloride) ® close observation and adjustment of dosage based upon the patient's response to ROXICODONE (oxycodone hydrochloride) ® is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of ROXICODONE (oxycodone hydrochloride) ® may be necessary, especially in patients who have disease states that are changing rapidly.
Maintenance of Therapy

Continual re-evaluation of the patient receiving ROXICODONE (oxycodone hydrochloride) ® is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain.

During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be re-assessed as appropriate.
Cessation of Therapy

When a patient no longer requires therapy with ROXICODONE (oxycodone hydrochloride) ® or other opioid analgesics for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see Drug Abuse and Dependence section for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of ROXICODONE (oxycodone hydrochloride) ® that treatment may be discontinued without risk of the opioid abstinence syndrome.

ROXICODONE® (oxycodone hydrochloride tablets, USP) are available as follows:

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

NDC 66479-580-25: Unit dose, 25 tablets per card, (reverse numbered), 4 card per shipper
NDC 66479-580-10: Bottles of 100 tablets

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

NDC 66479-581-10: Bottles of 100 tablets

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

NDC 66479-582-10: 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 are permitted to 15°-30°C (59°-86°F) [see
USP Controlled Room Temperature]

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