OPANA ER (Page 10 of 11)

Geriatrics

The steady-state plasma concentrations of oxymorphone are approximately 40% higher in elderly subjects than in young subjects (see CLINICAL PHARMACOLOGY and PRECAUTIONS). In general, caution should be exercised in the selection of the starting dose of OPANA ER for an elderly patient usually starting at the low end of the dosing range and slowly titrating to adequate analgesia.

Maintenance of Therapy and Supplemental Analgesia

The intent of the titration period is to establish a patient-specific every 12 hours dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. During titration and before a stable dose is achieved, OPANA or other immediate-release medications can be used as supplemental analgesia between dosings. Should pain recur, the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

During chronic therapy with OPANA ER, the continued need for around-the-clock opioid therapy should be reassessed periodically.

Cessation of Therapy

When the patient no longer requires therapy with OPANA ER tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient (see CLINICAL TRIALS: 12-Week Study in Opioid-Naïve Patients with Low Back Pain and CLINICAL TRIALS: 12-Week Study in Opioid-Experienced Patients with Low Back Pain).

SAFETY AND HANDLING

OPANA ER contains oxymorphone, which is a controlled substance. Oxymorphone is controlled under Schedule II of the Controlled Substances Act. Oxymorphone, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any OPANA ER tablets that are no longer needed.

OPANA ER may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy or State Control Board for information on how to detect or prevent diversion of this product.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Dispense in tight container as defined in the USP, with a child-resistant closure (as required).

HOW SUPPLIED

OPANA ER tablets are supplied as follows:

5 mg
Pink, octagon shape, film coated, convex tablets with “E907” over “5” in black print on one side and plain on the other.
Bottles of 60 with child-resistant closure NDC 21695-948-60

10 mg
Light orange, octagon shape, film coated, convex tablets with “E674” over “10” in black print on one side and plain on the other.
Bottles of 60 with child-resistant closure NDC 21695-949-60

Rx Only

CAUTION
DEA Order Form Required.

Manufactured for:
Endo Pharmaceuticals Inc.
Chadds Ford, Pennsylvania 19317

Manufactured by:
Novartis Consumer Health Inc.
Lincoln, NE 68517

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

TIMERx® -N is a registered Trademark of Penwest Pharmaceuticals Co., Danbury, Connecticut and is used herein pursuant to a license agreement between Penwest and Endo Pharmaceuticals.

Copyright © Endo Pharmaceuticals Inc. 2007

2002184/January, 2007

PATIENT INFORMATION

OPANA® ER (Ō-pan-a )
(Oxymorphone Hydrochloride) Extended-Release Tablets
CII
Rx Only

OPANA ER Tablets, 5 mg
OPANA ER Tablets, 10 mg
OPANA ER Tablets, 20 mg
OPANA ER Tablets, 40 mg

IMPORTANT: Keep OPANA ER in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes OPANA ER, get emergency help right away.

Read the Patient Information that comes with OPANA ER before you start taking it and each time you get a new prescription. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. Share the important information in this leaflet with members of your household.

What Is the Most Important Information I Should Know About OPANA ER?

  • OPANA ER can cause trouble breathing (hypoventilation), which can lead to death, if used differently than the way you were told to use it by your healthcare provider (see “What are the possible side effects of OPANA ER?”).
  • Swallow OPANA ER tablets whole. Do not break, crush, dissolve, or chew OPANA ER tablets before swallowing. If a tablet is broken, crushed, dissolved, or chewed, the full 12 hour dose can be taken into your body all at once. This is very dangerous. You could die from an overdose of the medicine. Use OPANA ER exactly the way your healthcare provider prescribes. If you cannot swallow tablets whole, tell your healthcare provider. You may need a different medicine.

What is OPANA ER?

  • OPANA ER is a prescription medicine that contains the opioid (narcotic pain medicine) oxymorphone. OPANA ER is used to treat adults with constant pain (around the clock) that is moderate to severe and is expected to last for an extended period of time. OPANA ER is not for occasional (“as needed”) use.
  • OPANA ER can cause physical dependence. Do not stop taking OPANA ER all of a sudden if you have been taking it for more than a few days. You could become sick with uncomfortable withdrawal symptoms because your body has become use to the medicine. Talk to your healthcare provider about slowly stopping OPANA ER to avoid getting sick with withdrawal symptoms. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  • OPANA ER is a controlled substance (CII) because it contains a narcotic painkiller that can be a target for people who abuse prescription medicines or street drugs. Keep your tablets in a safe place to protect them from being stolen. Never give your tablets to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others, even causing death, and is against the law.

Who Should Not Take OPANA ER?
Do not take OPANA ER if:

  • You had surgery within the past day (24 hours) and you were not taking OPANA ER before your surgery.
  • Your pain is mild or will go away in a few days.
  • Your pain can be controlled by the occasional use of other pain medicines.
  • You are having an asthma attack or have severe asthma, trouble breathing, or lung problems.
  • You have liver problems.
  • You are allergic to OPANA ER or anything in it. See the end of this leaflet for a complete list of ingredients in OPANA ER.

You have had severe allergic reactions to other narcotic pain medicines (such as morphine or codeine medicines). A severe allergic reaction includes a severe rash, hives, breathing problems, or dizziness.

OPANA ER is not for children under 18 years of age.

What Should I Tell My Healthcare Provider Before Starting OPANA ER?
Tell your healthcare provider about all of your medical problems, especially if you:

  • have trouble breathing or lung problems
  • have a head injury or brain problem
  • have liver or kidney problems
  • have adrenal gland problems, such as Addison’s disease
  • have convulsions or seizures
  • have thyroid problems
  • have problems urinating or prostate problems
  • have pancreas problems
  • have a drinking problem or alcoholism
  • have severe mental problems or hallucinations (see or hear things that are not really there)
  • have past or present drug abuse or drug addiction problems
  • are pregnant or plan to become pregnant. OPANA ER may harm your unborn baby.
  • are breastfeeding. OPANA ER may pass through your milk and may harm your baby. You should not breastfeed while taking OPANA ER.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may cause serious problems when taken with OPANA ER, especially if they cause sleepiness (like sleeping pills, anxiety medicines, antihistamines, or tranquilizers).

Do not take any new medicines while using OPANA ER until you have talked to your healthcare provider or pharmacist and they have told you it is safe.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How Should I Take OPANA ER?

  • Follow your healthcare provider’s directions exactly. Your healthcare provider may change your dose based on your reactions to the medicine. Do not change your dose unless your healthcare provider tells you to change it. Do not take OPANA ER more often than prescribed.
  • Swallow OPANA ER tablets whole. Do not break, crush, dissolve, or chew OPANA ER tablets before swallowing. If a tablet is broken, crushed, dissolved, or chewed, the full 12 hour dose can be taken into your body all at once. This is very dangerous. You could die from an overdose of the medicine. If you cannot swallow tablets whole, tell your healthcare provider. You may need a different medicine.
  • Take OPANA ER every 12 hours or as instructed by your healthcare provider. OPANA ER should be taken on an empty stomach, at least one hour before or two hours after meals. Talk to your healthcare provider if you feel sick taking OPANA ER on an empty stomach.
  • If you miss a dose , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once unless your healthcare provider tells you to. If you are not sure about your dosing call your healthcare provider.
  • If you take too much OPANA ER or overdose, call your local emergency number or poison control center right away.
  • Talk to your healthcare provider often about your pain. Your healthcare provider can decide if you still need OPANA ER.
  • If you have side effects that bother you or if you continue to have pain, call your healthcare provider.
  • Stopping OPANA ER. If your healthcare provider decides you no longer need OPANA ER, ask how to slowly reduce the dose of your medicine so you don’t get uncomfortable (withdrawal) symptoms such as nausea, sweating, and pain. You should not stop taking OPANA ER all at once if you have been taking it for more than a few days without talking to your healthcare provider. OPANA ER can cause physical dependence. You can get sick with withdrawal symptoms if you stop OPANA ER all at once, because your body has become use to it.

After you stop taking OPANA ER, flush the unused tablets down the toilet. Safely dispose of OPANA ER out of the reach of children and pets.

What Should I Avoid While Taking OPANA ER?

  • Do not drive, operate heavy machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine. OPANA ER can make you sleepy. Ask your healthcare provider to tell you when it is okay to do these activities.
  • Do not drink alcohol while using OPANA ER. It may increase the chance of having dangerous side effects including overdose and death.

What are the Possible Side Effects of OPANA ER?
OPANA ER can cause trouble breathing.
Call your healthcare provider or get medical help right away if:

  • your breathing slows down
  • you have shallow breathing (little chest movement with breathing)
  • you feel faint, dizzy, confused, or have any other unusual symptoms

These can be signs that you have taken too much OPANA ER (overdose) or the dose is too high for you, which can be dangerous and lead to death if not treated.

OPANA ER can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you are taking other medicines that can also lower your blood pressure.

OPANA ER can cause physical dependence. Your body will get used to OPANA ER if you take it more than a few days. You can get sick with withdrawal symptoms if you stop taking OPANA ER all at once. You can avoid getting sick with withdrawal symptoms by stopping OPANA ER slowly. Your healthcare provider will tell you how to do this.

There is a chance of abuse or addiction with OPANA ER. Abuse or addiction is different than a physical dependence. If you have abused prescription medicines, street drugs or alcohol in the past, you may have a higher chance of developing abuse or addiction again while using OPANA ER. If you have more concerns, talk to your healthcare provider for more information about abuse and addiction.

The most common side effects of OPANA ER are nausea, constipation, dizziness, vomiting, itching, sleepiness, headache, increased sweating, and sedation. Some of these side effects may decrease with continued use. Talk to your healthcare provider if you continue to have these side effects.

These are not all the possible side effects of OPANA ER. For a complete list, ask your healthcare provider or pharmacist.

Constipation (decrease in the usual number of hard bowel movements) is a common side effect of opioid medicines, including OPANA ER. Talk to your healthcare provider or pharmacist about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking OPANA ER.

How should I store OPANA ER?

  • Store OPANA ER at room temperature between 59° to 86°F (15° to 30°C).
  • Keep OPANA ER in a childproof container and store in a safe place to protect it from being stolen.
  • Keep OPANA ER out of the reach of children. Accidental overdose in children is an emergency and can result in death.

General Information about OPANA ER

  • Do not use OPANA ER for conditions for which it was not prescribed.
  • Do not give OPANA ER to other people, even if they have the same symptoms you have. It may harm them, even causing death, and it is against the law.

This leaflet summarizes the most important information about OPANA ER. If you would like more information, talk with your healthcare provider. Also, you can ask your pharmacist or healthcare provider for information about OPANA ER that is written for healthcare professionals.

For additional information, please go to www.Endo.com or www.opana.com

What are the ingredients in OPANA ER?
Active Ingredient: oxymorphone hydrochloride
Inactive Ingredients: hypromellose, iron oxide black, methylparaben, propylene glycol, silicified microcrystalline cellulose, sodium stearyl fumarate, TIMERx® -N, titanium dioxide, and triacetin. The 5 mg, 10 mg and 20 mg tablets also contain macrogol, and polysorbate 80. In addition, the 5 mg tablets contain iron oxide red. The 10 mg tablets contain FD&C yellow No. 6. The 20 mg tablets contain FD&C blue No. 1, FD&C yellow No. 6, and D&C yellow No. 10. The 40 mg tablets contain FD&C yellow No. 6, D&C yellow No.10, and lactose monohydrate.

CAUTION: Federal law prohibits dispensing without prescription.

Manufactured for:
Endo Pharmaceuticals Inc.
Chadds Ford, Pennsylvania 19317

Manufactured by:
Novartis Consumer Health Inc.Lincoln, NE 68517

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

TIMERx® -N is a registered Trademark of Penwest Pharmaceuticals Co., Danbury, Connecticut and is used herein pursuant to a license agreement between Penwest and Endo Pharmaceuticals.

Copyright © Endo Pharmaceuticals Inc. 2006

413442/June, 2006

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