New PLR Article Directory Ethiopia: Opana ER

Generic Name: oxymorphone (Oral route)

ox-i-MOR-fone

Oral route(Tablet, Extended Release)

Opana(R) ER contains oxymorphone, a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Opana(R) ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time; not indicated for use as an as needed analgesic. Extended release tablets should be swallowed whole; not cut, broken, chewed, dissolved, or crushed. Avoid alcohol and alcohol-containing medications as consumption of alcohol may result in increased plasma levels and a potentially fatal overdose of oxymorphone .

Commonly used brand name(s)

In the U.S.

Opana

Opana ER

Available Dosage Forms:

Tablet, Extended Release

Tablet

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Opana ER

Oxymorphone tablets are used to relieve pain. The extended-release tablets are used to relieve moderate to severe pain.

Oxymorphone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts in the central nervous system (CNS) to relieve pain. Many of its side effects are also caused by actions in the CNS.

When oxymorphone is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using Opana ER

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of oxymorphone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxymorphone in the elderly. However, elderly patients are more likely to have age-related liver, kidney or heart problems, which may require caution and an adjustment in the dose for patients receiving oxymorphone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adinazolam

Alfentanil

Alprazolam

Amobarbital

Anileridine

Aprobarbital

Bromazepam

Brotizolam

Buprenorphine

Butabarbital

Butalbital

Butorphanol

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorzoxazone

Clobazam

Clonazepam

Clorazepate

Codeine

Dantrolene

Dezocine

Diazepam

Estazolam

Ethchlorvynol

Fentanyl

Flunitrazepam

Flurazepam

Fospropofol

Halazepam

Hydrocodone

Hydromorphone

Ketazolam

Levorphanol

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Midazolam

Morphine

Morphine Sulfate Liposome

Nalbuphine

Nitrazepam

Nordazepam

Opium

Oxazepam

Oxycodone

Oxymorphone

Pentazocine

Pentobarbital

Phenobarbital

Prazepam

Propoxyphene

Quazepam

Remifentanil

Secobarbital

Sodium Oxybate

Sufentanil

Tapentadol

Temazepam

Thiopental

Triazolam

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of oxymorphone

This section provides information on the proper use of a number of products that contain oxymorphone. It may not be specific to Opana ER. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

It is best to take this medicine on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you are using the extended-release tablets:

Take the tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Do not break, cut, crush, dissolve, lick, or chew it.

While taking this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.

This medicine comes with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release tablets):
- For moderate to severe pain:
  - For patients who are not taking narcotic medicines:
    - Adults—At first, 5 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
    - Children—Use and dose must be determined by your doctor.
  - For patients switching from Opana® to Opana® ER:
    - Adults—At first, the dose is half of the total oral Opana® that you are taking per day, every 12 hours. Your doctor may adjust your dose as needed.
    - Children—Use and dose must be determined by your doctor.
  - For patients switching from oxymorphone injection to Opana® ER:
    - Adults—At first, the dose is 10 times the total oxymorphone injection dose that you are receiving per day divided into two equal doses. Your doctor may adjust your dose as needed.
    - Children—Use and dose must be determined by your doctor.
  - For patients switching from oral opioids to Opana® ER:
    - Adults—At first, the dose is half of the total daily dose that you are taking per day, every 12 hours. Your doctor may adjust your dose as needed.
    - Children—Use and dose must be determined by your doctor.

For oral dosage form (tablets):
- For pain:
  - Adults—At first, 5 milligrams (mg) every 4 to 6 hours. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Oxymorphone can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush all unused medicine down the toilet after you have finished your treatment. Also flush old medicine after the expiration date has passed. This medicine is one of only a few medicines that should be disposed of this way.

Precautions While Using Opana ER

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

Oxymorphone may increase your risk of having serious breathing problems. Check with your doctor right away if you are having difficult or troubled breathing; irregular, fast, slow, or shallow breathing; pale or blue lips, fingernails, or skin; or shortness of breath.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

Oxymorphone may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or lightheaded.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Using this medicine for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using oxymorphone.

If you have been using this medicine regularly for several weeks or more, do not change your dose or suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Withdrawal side effects may occur when the medicine is stopped suddenly because your body has become used to this medicine.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Opana ER Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blurred vision

confusion

decreased urination

difficult or labored breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fast, pounding, racing, or irregular heartbeat or pulse

headache

nervousness

pounding in the ears

rapid breathing

shortness of breath

sunken eyes

sweating

swelling of the hands, ankles, or feet

thirst

tightness in the chest

unusual tiredness or weakness

wheezing

wrinkled skin

Rare

Abdominal or stomach pain

chest pain or discomfort

chills

cold sweats

cough

decrease in consciousness

decrease in urine volume

difficulty in passing urine (dribbling)

difficulty with sleeping

difficulty with swallowing

disorientation

drowsiness to profound coma

fear

fever

hallucination

hives

hyperventilation

hoarseness

irregular, slow, or shallow breathing

irritability

irritation

itching

joint pain, stiffness, or swelling

lethargy

mood or other mental changes

painful urination

pale or blue lips, fingernails, or skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

restlessness

severe constipation

severe vomiting

shaking

shortness of breath

skin rash

swelling of the eyelids, face, or lips

trouble in holding or releasing urine

trouble with sleeping

troubled breathing or swallowing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Cold and clammy skin

constricted, pinpoint, or small pupils (black part of the eye)

decreased awareness or responsiveness

muscle weakness

no blood pressure or pulse

not breathing

severe sleepiness or unusual drowsiness

stopping of heart

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement (stool)

feeling of constant movement of self or surroundings

increased sweating

nausea or vomiting

relaxed and calm

sensation of spinning

sleepiness

Less common

Acid or sour stomach

belching

decreased appetite

decreased weight

diarrhea

discouragement

excess air or gas in the stomach or intestines

feeling of warmth

feeling sad or empty

full or bloated feeling

heartburn

indigestion

lack of appetite

loss of interest or pleasure

passing gas

pressure in the stomach

redness of the face, neck, arms, and occasionally, upper chest

sleeplessness

stomach discomfort or upset

swelling of the abdominal or stomach area

tiredness

trouble concentrating

unable to sleep

Rare

Blistering, crusting, irritation, itching, or reddening of the skin

cracked, dry, scaly skin

difficulty with thinking or concentrating

disturbed color perception

double vision

false or unusual sense of well-being

feeling jittery

halos around lights

loss of vision

mental depression

night blindness

nightmares or unusually vivid dreams

overbright appearance of lights

sudden sweating

tunnel vision

welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Opana ER side effects (in more detail)

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More Opana ER resources

Opana ER Side Effects (in more detail)
Opana ER Use in Pregnancy & Breastfeeding
Drug Images
Opana ER Drug Interactions
Opana ER Support Group
43 Reviews for Opana ER - Add your own review/rating

Opana ER Prescribing Information (FDA)

Opana ER Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Oxymorphone Prescribing Information (FDA)

Oxymorphone MedFacts Consumer Leaflet (Wolters Kluwer)

Opana MedFacts Consumer Leaflet (Wolters Kluwer)

Opana Consumer Overview

Opana Prescribing Information (FDA)

Opana Monograph (AHFS DI)

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Pain

New PLR Article Directory Ethiopia

Wednesday, September 21, 2016

Opana ER