Roxanol

Name: Roxanol

Roxanol and Lactation

Tell your healthcare provider if you are breastfeeding. Roxanol passes into human breast milk and may harm your baby.

Roxanol Usage

Follow the directions on your prescription label carefully. Take this medication as prescribed by your healthcare provider. Do not change your dose.

Oral (by mouth) Roxanol in a solution (liquid) to take by mouth.

  • The liquid is usually taken every 4 hours as needed for pain.

If you feel that your pain is not controlled, call your doctor. Do not change the dose of your medication without talking to your doctor.

Do not stop taking Roxanol without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop taking Roxanol, you may experience withdrawal symptoms such as restlessness; teary eyes; runny nose; yawning; irritability; anxiety; sweating; difficulty falling asleep or staying asleep; chills; back, muscle. or joint pain; nausea; vomiting; loss of appetite; diarrhea; stomach cramps; weakness; fast heartbeat; or fast breathing.

Roxanol Overdose

If you take too much Roxanol, call your local Poison Control Center or seek emergency medical attention right away.

Uses For Roxanol

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.

Morphine extended-release capsules or tablets should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain, or in situations when non-narcotic medication is effective. This medicine should not be used to treat pain that you only have once in a while or "as needed".

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

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 lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving morphine in order to avoid potentially serious side effects.

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.

  • Nalmefene
  • Naltrexone
  • Safinamide

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.

  • Abiraterone
  • Acepromazine
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Alvimopan
  • Amineptine
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Anileridine
  • Aripiprazole
  • Asenapine
  • Azithromycin
  • Baclofen
  • Benperidol
  • Benzphetamine
  • Bromazepam
  • Bromopride
  • Brompheniramine
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butorphanol
  • Captopril
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Carphenazine
  • Carvedilol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Cimetidine
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Cobicistat
  • Cocaine
  • Codeine
  • Conivaptan
  • Cyclobenzaprine
  • Cyclosporine
  • Desipramine
  • Desmopressin
  • Desvenlafaxine
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Dezocine
  • Diazepam
  • Dibenzepin
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diltiazem
  • Diphenhydramine
  • Diphenoxylate
  • Dolasetron
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Doxylamine
  • Dronedarone
  • Droperidol
  • Duloxetine
  • Eletriptan
  • Enflurane
  • Erythromycin
  • Escitalopram
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Felodipine
  • Fentanyl
  • Flibanserin
  • Fluoxetine
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fospropofol
  • Frovatriptan
  • Furazolidone
  • Granisetron
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Imipramine
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Itraconazole
  • Ivacaftor
  • Ketamine
  • Ketobemidone
  • Ketoconazole
  • Levomilnacipran
  • Levorphanol
  • Linezolid
  • Lisdexamfetamine
  • Lithium
  • Lofepramine
  • Lopinavir
  • Lorazepam
  • Lorcaserin
  • Loxapine
  • Meclizine
  • Melitracen
  • Melperone
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methamphetamine
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Methylnaltrexone
  • Midazolam
  • Milnacipran
  • Mirtazapine
  • Moclobemide
  • Molindone
  • Moricizine
  • Nalbuphine
  • Nalorphine
  • Naloxone
  • Naratriptan
  • Nefazodone
  • Nialamide
  • Nicomorphine
  • Nilotinib
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Palonosetron
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Pimozide
  • Piperacetazine
  • Pipotiazine
  • Piritramide
  • Prazepam
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Protriptyline
  • Quazepam
  • Quercetin
  • Quetiapine
  • Quinidine
  • Ramelteon
  • Ranolazine
  • Rasagiline
  • Remifentanil
  • Remoxipride
  • Ritonavir
  • Rizatriptan
  • Samidorphan
  • Secobarbital
  • Selegiline
  • Sertindole
  • Sertraline
  • Sibutramine
  • Simeprevir
  • Sodium Oxybate
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sumatriptan
  • Sunitinib
  • Suvorexant
  • Tapentadol
  • Telaprevir
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Tianeptine
  • Ticagrelor
  • Tilidine
  • Tizanidine
  • Tocophersolan
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Trazodone
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Trimipramine
  • Tryptophan
  • Venlafaxine
  • Verapamil
  • Vilazodone
  • Vortioxetine
  • Zaleplon
  • Ziprasidone
  • Zolmitriptan
  • Zolpidem
  • Zopiclone
  • Zotepine

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.

  • Esmolol
  • Gabapentin
  • Gabapentin Enacarbil
  • 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

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Addison disease (adrenal gland problem) or
  • Alcohol abuse, or history of or
  • Brain tumor, history of or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Depression, history of or
  • Drug dependence, especially with narcotics, or history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Gallbladder disease or gallstones or
  • Head injuries, history of or
  • Heart disease or
  • Hypothyroidism (an underactive thyroid) or
  • Hypovolemia (low blood volume) or
  • Increased pressure in the head or
  • Kyphoscoliosis (curvature of the spine with breathing problems) or
  • Mental health problems, history of or
  • Problems with passing urine or
  • Stomach or bowel problems (eg, blockage) or
  • Trouble swallowing or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation or swelling of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Lung or breathing problems, severe or
  • Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.

How is this medicine (Roxanol) best taken?

Use Roxanol (morphine oral concentrate (20 mg/mL)) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.
  • Do not inject or snort this medicine. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
  • Measure liquid doses carefully.
  • Only use the measuring device that comes with this liquid drug.

What do I do if I miss a dose?

  • If you take Roxanol on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

For the Consumer

Applies to morphine: oral capsule, oral capsule delayed release, oral capsule extended release, oral capsule extended release 24 hr, oral powder for suspension extended release, oral solution, oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

  • epidural suspension extended release
  • injection injectable, injection solution

Along with its needed effects, morphine (the active ingredient contained in Roxanol) 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 while taking morphine:

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
  • confusion
  • cough
  • decreased urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • headache
  • hives, itching, or skin rash
  • increased sweating
  • loss of appetite
  • nausea or vomiting
  • nervousness
  • 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
  • slow heartbeat
  • sweating or chills
Incidence not known
  • Black, tarry stools
  • cold, clammy skin
  • 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
  • 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
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • very slow heartbeat

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

Symptoms of overdose
  • Constricted, pinpoint, or small pupils (black part of the eye)
  • 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 of morphine 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
  • 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
  • agitation
  • bad, unusual, or unpleasant (after) taste
  • change in vision
  • depression
  • dry mouth
  • face is warm or hot to touch
  • floating feeling
  • halos around lights
  • heartburn or indigestion
  • loss in sexual ability, desire, drive, or performance
  • muscle stiffness or tightness
  • night blindness
  • overbright appearance of lights
  • problems with muscle control
  • redness of the skin
  • skin rash
  • stomach discomfort or upset
  • trouble sleeping
  • uncontrolled eye movements
Incidence not known
  • Abnormal dreams
  • change in walking and balance
  • change or problem with discharge of semen
  • clumsiness or unsteadiness
  • confusion as to time, place, or person
  • delusions
  • dementia
  • feeling of constant movement of self or surroundings
  • general feeling of discomfort or illness
  • holding false beliefs that cannot be changed by fact
  • problems with memory
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • unusual excitement, nervousness, or restlessness

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