Search PLR Article Directory Pakistan: Roxanol-T

Generic Name: morphine (Oral route)

MOR-feen

Oral route(Capsule, Extended Release)

Kadian(R): Capsule contains morphine sulfate, an opioid agonist and Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Kadian(R) is 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. The 100-mg and 200-mg capsules are for use in opioid-tolerant patients only. Kadian(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule pellets due to the risk of rapid release and absorption of a potentially fatal dose of morphine .

Oral route(Capsule, Extended Release, 24 HR)

Avinza(R): Capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. Avinza(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule beads due to the risk of rapid release and absorption of a potentially fatal dose of morphine. Avoid alcohol and alcohol-containing medications as consumption of alcohol may result in the rapid release and absorption of a potentially fatal dose of morphine .

Oral route(Solution)

Morphine oral solution is available in 10 mg/5 mL, 20 mg/5 mL and 100 mg/5 mL (20 mg/mL) concentrations. The 100 mg/5 mL (20 mg/mL) concentration is indicated for use in opioid-tolerant patients only. Take care to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Keep morphine oral solution out of the reach of children .

Oral route(Tablet, Extended Release)

MS Contin(R): 100 mg and 200 mg tablets are for use in opioid-tolerant patients only. MS Contin(R) tablets are a controlled-release formulation, should be swallowed whole and are not to be broken, chewed, dissolved, or crushed due to the risk of rapid release and absorption of a potentially fatal dose of morphine . Oramorph(R) SR: This is a sustained-release dosage form. Swallow the tablet whole; the tablet should not be broken in half, nor should it be crushed or chewed .

Commonly used brand name(s)

In the U.S.

Avinza

Kadian

Kadian ER

MS Contin

MSIR

Oramorph SR

Roxanol

Roxanol-T

Available Dosage Forms:

Capsule, Extended Release

Capsule, Extended Release, 24 HR

Tablet, Extended Release

Capsule

Tablet

Powder for Suspension, Extended Release

Solution

Capsule, Delayed Release

Syrup

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Roxanol-T

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

When morphine 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 Roxanol-T

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 morphine 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 morphine 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 morphine.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Brofaromine

Clorgyline

Furazolidone

Iproniazid

Isocarboxazid

Lazabemide

Linezolid

Moclobemide

Naltrexone

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

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

Chlorpromazine

Chlorzoxazone

Cimetidine

Clobazam

Clonazepam

Clorazepate

Codeine

Dantrolene

Dezocine

Diazepam

Estazolam

Ethchlorvynol

Fentanyl

Flunitrazepam

Fluphenazine

Flurazepam

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

Perphenazine

Phenobarbital

Prazepam

Prochlorperazine

Promazine

Promethazine

Propoxyphene

Quazepam

Remifentanil

Secobarbital

Sodium Oxybate

Sufentanil

Tapentadol

Temazepam

Thiethylperazine

Thiopental

Thioridazine

Triazolam

Trifluoperazine

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.

Cyclosporine

Esmolol

Gabapentin

Rifampin

Somatostatin

Yohimbine

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 morphine

This section provides information on the proper use of a number of products that contain morphine. It may not be specific to Roxanol-T. 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).

You may take this medicine with or without food.

Morphine extended-release capsules and 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.

Swallow the extended-release capsules and tablets whole. Do not break, crush, dissolve, or chew them. Do not use extended-release tablets that are broken.

If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow it right away without chewing.

While taking the extended-release tablet, part of the tablet may pass into your stool. This is normal and nothing to worry about.

Morphine extended-release capsules or tablets work differently from the regular morphine 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.

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.

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 capsules):
- For moderate to severe pain:
  - Patients switching from regular morphine forms:
    - Adults—The capsule is given once a day. The initial dose in milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
    - Children—Use and dose must be determined by your doctor.
  - Patients who are not taking narcotic medicines:
    - Adults—At first, 30 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
    - Children—Use and dose must be determined by your doctor.

For oral dosage form (extended-release tablets):
- For moderate to severe pain:
  - Patients switching from regular morphine forms:
    - Adults—The tablet is given every 8 hours or every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. The total amount per day will be divided and given as 2 or 3 doses during the day. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.

For oral dosage form (solution):
- For moderate to severe pain:
  - Adults—10 to 20 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.

For oral dosage form (tablets):
- For moderate to severe pain:
  - Adults—15 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.

Morphine 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 capsules, liquid, and tablets down the toilet.

Precautions While Using Roxanol-T

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.

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, confused, or disoriented. 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.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

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.

Roxanol-T 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

Abdominal or stomach pain

blurred vision

bulging soft spot on the head of an infant

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

change in the ability to see colors, especially blue or yellow

chest pain or discomfort

chills

confusion

cough

decreased urination

difficulty with breathing

difficulty with swallowing

dizziness

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

fainting

fast, pounding, or irregular heartbeat or pulse

headache

hives

increased sweating

insomnia

itching

loss of appetite

nausea

nervousness

noisy breathing

pounding in the ears

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

severe constipation

severe vomiting

shakiness in the legs, arms, hands, or feet

shortness of breath

skin rash

slow or irregular heartbeat

sweating

swelling

tightness in the chest

trembling or shaking of the hands or feet

trouble with breathing

trouble with urinating

unusual tiredness or weakness

vomiting

wheezing

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

bluish lips or skin

change in consciousness

chest pain or discomfort

cold, clammy skin

convulsions

decrease in the amount of urine

decrease in the frequency of urination

difficulty in passing urine (dribbling)

extremely shallow or slow breathing

fast, weak pulse

feeling of warmth or heat

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

irregular, fast or slow, or shallow breathing

lightheadedness

loss of consciousness

low blood pressure or pulse

nervousness

painful urination

pale or blue lips, fingernails, or skin

pale skin

pinpoint red spots on the skin

pounding in the ears

shakiness and unsteady walk

troubled breathing with exertion

unconsciousness

unsteadiness, trembling, or other problems with muscle control or coordination

unusual bleeding or bruising

very slow breathing

very slow heartbeat

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

Symptoms of overdose

Bloody urine

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

dark-colored urine

decreased awareness or responsiveness

extreme drowsiness

fever

increased blood pressure

increased thirst

lower back or side pain

muscle cramps or spasms

muscle pain or stiffness

no muscle tone or movement

severe sleepiness

swelling of the face, fingers, or lower legs

weight gain

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

Cramps

diarrhea

difficulty having a bowel movement (stool)

drowsiness

false or unusual sense of well-being

relaxed and calm feeling

sleepiness or unusual drowsiness

weight loss

Less common

Absent, missed, or irregular menstrual periods

acid or sour stomach

agitation

bad, unusual, or unpleasant (after) taste

belching

blurred or loss of vision

change in taste

decreased interest in sexual intercourse

depression

disturbed color perception

double vision

dry mouth

face is warm or hot to touch

fear

floating feeling

halos around lights

heartburn

inability to have or keep an erection

indigestion

loss in sexual ability, desire, drive, or performance

muscle stiffness or tightness

nervousness

night blindness

overbright appearance of lights

problems with muscle control

redness of the skin

seeing double

skin rash

sleeplessness

stomach discomfort, upset, or pain

stopping of menstrual bleeding

trouble sleeping

tunnel vision

unable to sleep

uncontrolled eye movements

upper abdominal or stomach pain

weakness

Incidence not known

Abnormal dreams

belching

burning while urinating

change in vision

change in walking and balance

change or problem with discharge of semen

clumsiness or unsteadiness

confusion as to time, place, or person

delusions

dementia

dry skin

eye pain

feeling of constant movement of self or surroundings

general feeling of discomfort or illness

hiccup

holding false beliefs that cannot be changed by fact

impaired vision

indigestion

loss of memory

problems with memory

seeing, hearing, or feeling things that are not there

sensation of spinning

thirst

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual excitement, nervousness, or restlessness

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: Roxanol-T side effects (in more detail)

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More Roxanol-T resources

Roxanol-T Side Effects (in more detail)
Roxanol-T Use in Pregnancy & Breastfeeding
Roxanol-T Drug Interactions
Roxanol-T Support Group
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Avinza Prescribing Information (FDA)

Avinza Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

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Infumorph Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Kadian Prescribing Information (FDA)

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MS Contin Prescribing Information (FDA)

MS Contin Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

MS Contin Consumer Overview

Morphine Sulfate Monograph (AHFS DI)

Oramorph SR Prescribing Information (FDA)

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Saturday, 8 October 2011

Roxanol-T