Best Article Directory Israel: Roxicodone Intensol

Generic Name: oxycodone (Oral route)

ox-i-KOE-done hye-droe-KLOR-ide

Oral route(Tablet, Extended Release)

Oxycodone hydrochloride is an opioid agonist and a Schedule II controlled substance with an abuse potential similar to morphine. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Oxycodone hydrochloride controlled-release tablets are indicated for continuous, around the clock analgesia for an extended period of time; not for use on an as needed basis. The 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg, are only for use in opioid-tolerant patients as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Oxycodone hydrochloride controlled-release tablets must be swallowed whole to avoid a rapid release of the drug which can be potentially fatal. Concomitant use with CYP3A4 inhibitors may result in an increase in oxycodone plasma concentrations and may cause potentially fatal respiratory depression .

Commonly used brand name(s)

In the U.S.

Dazidox

Eth-Oxydose

Oxecta

Oxycontin

Oxycontin CR

Oxydose

Oxyfast

Oxy IR

Roxicodone

Roxicodone Intensol

In Canada

Oxy-IR

Available Dosage Forms:

Tablet, Extended Release

Tablet

Capsule

Solution

Therapeutic Class: Analgesic

Chemical Class: Oxycodone

Uses For Roxicodone Intensol

Oxycodone is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Oxycodone acts on the central nervous system (CNS) to relieve pain.

When oxycodone 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 Roxicodone Intensol

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 oxycodone 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 oxycodone in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution and an adjustment in the dose for patients receiving oxycodone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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.

Acetophenazine

Adinazolam

Alfentanil

Alprazolam

Amobarbital

Anileridine

Aprobarbital

Atazanavir

Brofaromine

Bromazepam

Brotizolam

Buprenorphine

Buspirone

Butabarbital

Butalbital

Butorphanol

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Clarithromycin

Clobazam

Clonazepam

Clorazepate

Clorgyline

Codeine

Dantrolene

Desflurane

Dexmedetomidine

Dezocine

Diazepam

Diphenhydramine

Doxylamine

Enflurane

Erythromycin

Escitalopram

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Fentanyl

Flumazenil

Flunitrazepam

Fluphenazine

Flurazepam

Fluvoxamine

Fospropofol

Furazolidone

Halazepam

Halothane

Hydrocodone

Hydromorphone

Hydroxyzine

Indinavir

Iproniazid

Isocarboxazid

Isoflurane

Itraconazole

Ketamine

Ketazolam

Ketoconazole

Lazabemide

Levorphanol

Linezolid

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Mesoridazine

Metaxalone

Methdilazine

Methocarbamol

Methohexital

Midazolam

Moclobemide

Morphine

Morphine Sulfate Liposome

Nalbuphine

Nefazodone

Nelfinavir

Nialamide

Nitrazepam

Nitrous Oxide

Nordazepam

Opium

Oxazepam

Oxycodone

Oxymorphone

Pargyline

Pentazocine

Pentobarbital

Perphenazine

Phenelzine

Phenobarbital

Prazepam

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propiomazine

Propofol

Propoxyphene

Quazepam

Ramelteon

Rasagiline

Remifentanil

Ritonavir

Saquinavir

Secobarbital

Selegiline

Sertraline

Sevoflurane

Sodium Oxybate

Sufentanil

Tapentadol

Telithromycin

Temazepam

Thiethylperazine

Thiopental

Thioridazine

Toloxatone

Tranylcypromine

Triazolam

Trifluoperazine

Triflupromazine

Trimeprazine

Zaleplon

Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Miconazole

Rifampin

St John's Wort

Voriconazole

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 oxycodone

This section provides information on the proper use of a number of products that contain oxycodone. It may not be specific to Roxicodone Intensol. 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).

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

Oxycodone extended-release tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Measure the oral liquid concentrate with the calibrated dropper that comes with the package. Your doctor may have you mix the concentrate with a small amount of liquid or food. Carefully follow the instructions and take the medicine mixture right away.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Swallow the Oxecta® or OxyContin® tablet whole with water. Do not break, crush, cut, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth. Take one tablet at a time. Also, do not give this medicine through nasogastric or feeding tubes.

Oxycodone extended-release tablets work differently from the regular oxycodone oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

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:
  - Patients switching from regular oxycodone forms:
    - Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular oxycodone that is taken per day. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients switching from other narcotic medicines:
    - Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients who are not taking narcotic medicines:
    - Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.

For oral dosage form (immediate-release tablets):
- For moderate to severe pain:
  - Patients who are not taking narcotic medicines:
    - Adults—At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients switching from fixed-ratio oral narcotic/non-narcotic combinations:
    - Adults—Your doctor will determine whether or not to continue the non-narcotic pain medicine. Also, the total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients switching from other narcotic medicines:
    - Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.

For oral dosage forms (liquid concentrate, solution, or tablets):
- For moderate to severe pain:
  - Adults—10 to 30 milligrams (mg) every 4 hours as needed. 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.

Oxycodone 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 the unused extended-release tablets and immediate-release tablets down the toilet.

Precautions While Using Roxicodone Intensol

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

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 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 these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or 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 the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. 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 or not alert.

Using narcotics 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.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

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.

Roxicodone Intensol 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

Chills

cold sweats

confusion

difficult or labored breathing

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

fever

shortness of breath

tightness in the chest

twitching

wheezing

Rare

Abdominal or stomach pain

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine

burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

convulsions

cough

decrease in the frequency of urination

decrease in urine volume

decreased urine output

difficult or painful urination

difficulty in passing urine (dribbling)

difficulty with swallowing

dizziness

dry mouth

fainting

fast or irregular heartbeat

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

frequent urination

headache

hives

increase in heart rate

increased thirst

increased volume of pale, dilute urine

itching

lightheadedness

muscle pain or cramps

nausea or vomiting

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

rapid breathing

rapid weight gain

severe constipation

severe vomiting

shakiness in the legs, arms, hands, or feet

skin rash

sunken eyes

sweating

swelling or puffiness of the face

swollen, painful, or tender lymph glands in the neck, armpit, or groin

thirst

tingling of the hands or feet

trembling or shaking of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

wrinkled skin

Incidence not known

Blurred vision

choking

clay-colored stools

cold, clammy skin

dark urine

diarrhea

fast, weak pulse

gagging

irregular, fast, slow, or shallow breathing

loss of appetite

low blood pressure or pulse

pale or blue lips, fingernails, or skin

trouble with swallowing

unconsciousness

unpleasant breath odor

very slow breathing

very slow heartbeat

yellow eyes or skin

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

Symptoms of overdose

Change in consciousness

chest pain or discomfort

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

decreased awareness or responsiveness

extreme drowsiness

loss of consciousness

no muscle tone or movement

severe sleepiness

slow or irregular heartbeat

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)

drowsiness

lack or loss of strength

relaxed and calm feeling

sleepiness or unusual drowsiness

Less common

Abnormal dreams

acid or sour stomach

anxiety

belching

burning feeling in the chest or stomach

false or unusual sense of well-being

heartburn

hiccups

indigestion

nervousness

sleeplessness

stomach discomfort, upset, or pain

tenderness in the stomach area

trouble with sleeping

unable to sleep

weight loss

Rare

Absent, missed, or irregular menstrual periods

bad, unusual or unpleasant (after) taste

bloated or full feeling

body aches or pain

change in taste

change in walking and balance

changes in vision

clumsiness or unsteadiness

congestion

continuing ringing or buzzing or other unexplained noise in the ears

cracks in the skin

crying

decreased interest in sexual intercourse

dental caries or tooth decay

depersonalization

depression

difficulty with speaking

dry skin

dryness or soreness of the throat

dysphoria

excess air or gas in the stomach or intestines

excessive muscle tone

feeling of constant movement of self or surroundings

feeling of unreality

general feeling of discomfort or illness

headache, severe and throbbing

hearing loss

hives or welts

hoarseness

hyperventilation

inability to have or keep an erection

increase in body movements

increased appetite

increased cough

irritability

loss in sexual ability, desire, drive, or performance

loss of heat from the body

loss of memory

loss of strength or energy

mental depression

muscle pain or weakness

muscle stiffness

muscle tension or tightness

neck pain

paranoia

passing of gas

problems with memory

quick to react or overreact emotionally

rapidly changing moods

red, swollen skin

restlessness

runny nose

scaly skin

sensation of spinning

sense of detachment from self or body

severe sleepiness

stomach pain, fullness, or discomfort

stopping of menstrual bleeding

swelling or inflammation of the mouth

tender, swollen glands in the neck

unusual weak feeling

voice changes

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: Roxicodone Intensol side effects (in more detail)

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Roxicodone Intensol Side Effects (in more detail)
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Best Article Directory Israel

Sunday, 11 April 2010

Roxicodone Intensol