Oramorph SR

This medication may cause serious side effects. See "Drug Precautions".

Common side effects include:

• dizziness
• drowsiness
• nausea
• vomiting
• constipation
• diarrhea
• loss of appetite
• weight loss
• dry mouth
• sweating
• weakness
• headache
• agitation
• nervousness
• mood changes
• confusion
• small pupils (black circles in the middle of the eyes
• flu symptoms
• difficulty urinating or pain when urinating

Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing
• shortness of breath
• fast heartbeat
• chest pain
• swelling of your face
• tongue or throat
• extreme drowsiness, or you are feeling faint

These are not all the possible side effects of morphine. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. 

Keep this and all medications out of the reach of children.

Morphine is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep this medication in a safe place to prevent misuse and abuse. Selling or giving away morphine may harm others, and is against the law.

In the U.S.

• Arymo ER
• AVINza
• Kadian
• Kadian ER
• Morphabond
• Morphabond ER
• MS Contin
• Oramorph SR
• Roxanol
• Roxanol-T

Available Dosage Forms:

• Capsule, Extended Release
• Capsule, Extended Release, 24 HR
• Solution
• Tablet, Extended Release
• Capsule
• Tablet
• Powder for Suspension, Extended Release
• Capsule, Delayed Release
• Syrup

Therapeutic Class: Analgesic

Chemical Class: Opioid

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

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.

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 central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you 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. This effect may last for a few days after you stop using this medicine. 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 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 sleeping.

Do not take too much of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

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.

Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

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.

In clinical settings, morphine's primary actions of therapeutic value are analgesia and sedation. Opiate analgesia involves at least three anatomical areas of the central nervous system: the periaqueductal-periventricular gray matter, the ventromedial medulla, and the spinal cord. Morphine appears to increase the patient's tolerance for pain, and to decrease the discomfort, although the presence of pain itself may still be recognized.

While there is considerable variability in the relationship between morphine blood concentration and analgesic response, effective analgesia probably will not occur below some minimum blood level in a given patient. The minimum effective blood level for analgesia will vary among patients, especially among patients who have been previously treated with potent μ-agonist opioids. Similarly, there is considerable variability in the relationship between morphine plasma concentration and untoward clinical responses, but higher concentrations are more likely to be toxic.

In contrast to immediate-release morphine, after dosing with Oramorph SR, the morphine blood levels show reduced fluctuation between peak and trough plasma levels; that means that they are more centered within the theoretical 'therapeutic window'. On the other hand, the reduced fluctuation in morphine plasma concentration might conceivably affect other phenomena, as for example, the rate of tolerance induction.

Oramorph SR is an analgesic intended for patients who require chronic morphine analgesia and who will have, in consequence, markedly different degrees of pharmacodynamic tolerance for opioid drugs. Morphine and similar opioids induce tolerance to their effects, so that a shortening of the duration of satisfactory analgesia may be the first sign of an increase in tolerance.

Once patients are started on morphine, the dose required for satisfactory analgesia will rise, with the rate of development of tolerance varying, depending on the patient's prior narcotic use, level of pain, degree of anxiety, use of other CNS-active drugs, circulatory status, total daily dose, and the dosing interval.

Oramorph SR is contraindicated in patients with respiratory depression in the absence of resuscitative equipment, in patients with acute or severe bronchial asthma and in patients with known hypersensitivity to morphine.

Oramorph SR is contraindicated in any patient who has or is suspected of having a paralytic ileus.

Adverse reactions caused by morphine are essentially those observed with other opioid analgesics. They include the following major hazards: respiratory depression, and less frequently, circulatory depression, apnea, shock and cardiac arrest secondary to respiratory and/or circulatory depression.

Most Frequently Observed Reactions:

Constipation, nausea, vomiting, lightheadedness, dizziness, sedation, dysphoria, euphoria, and sweating. Some of these effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain. Some adverse reactions in ambulatory patients may be alleviated if the patient is in a supine position.

Less Frequently Observed Reactions:

Body as a Whole: Edema, antidiuretic effect, chills, muscle tremor, muscle rigidity.

Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension.

Gastrointestinal: Dry mouth, biliary tract spasm, laryngospasm, anorexia, diarrhea, cramps, taste alterations.

Genitourinary: Urine retention or hesitance, reduced libido and/or potency.

Nervous System: Weakness, headache, agitation, tremor, uncoordinated muscle movements, seizure, paresthesia, alterations of mood (nervousness, apprehension, depression, floating feelings), dreams, transient hallucination and disorientation, visual disturbances, insomnia, increased intracranial pressure.

Skin: Pruritus, urticaria and other skin rashes.

Special Senses: Blurred vision, nystagmus, diplopia, miosis.

Opioid analgesics may cause psychological and physical dependence (see WARNINGS). Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug, or these symptoms may be precipitated through the administration of drugs with antagonistic activity, e.g., naloxone or mixed agonist/antagonist analgesics (pentazocine, etc.; see also OVERDOSAGE). Physical dependence usually does not occur, to a clinically significant degree, until several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required to produce the same degree of analgesia, is initially manifested by a shortened duration of analgesic effect and, subsequently, by decreases in the intensity of analgesia. In patients with chronic pain, as well as in opioid-tolerant cancer patients, the administration of Oramorph SR (morphine sulfate) should be guided by the degree of tolerance manifested. Physical dependence, per se, is not ordinarily a concern when one is dealing with opioid-tolerant patients whose pain and suffering is associated with an irreversible illness.

If Oramorph SR is abruptly discontinued, an abstinence syndrome may occur. Withdrawal symptoms, in patients dependent on morphine, begin shortly before the time of the next scheduled dose, reaching a peak at 36 to 72 hours after the last dose, and then slowly subside over a period of 7 to 10 days. Symptoms include yawning, sweating, lacrimation, rhinorrhea, restless sleep, dilated pupils, gooseflesh, irritability, tremor, nausea, vomiting, and diarrhea.

Treatment of the abstinence syndrome is primarily symptomatic and supportive, including maintenance of proper fluid and electrolyte balance. If withdrawal has inadvertently been precipitated in a patient who requires narcotics for pain management, the withdrawal syndrome can be terminated rapidly by the administration of an appropriate dose of a pure agonist opioid, such as morphine. The degree of physical dependence of a patient on Oramorph SR can be intentionally reduced by a gradual reduction of dosage and symptomatic treatment of withdrawal symptomatology.

Overdosage of morphine is characterized by respiratory depression, with or without concomitant CNS depression. Since respiratory arrest may result either through direct depression of the respiratory center, or as the result of hypoxia, primary attention should be given to the establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted, or controlled, ventilation. The narcotic antagonist, naloxone, is a specific antidote. An initial dose of 0.4 to 2 mg of naloxone should be administered intravenously, simultaneously with respiratory resuscitation. If the desired degree of counteraction and improvement in respiratory function is not obtained, naloxone may be repeated at 2 to 3 minute intervals. If no response is observed after 10 mg of naloxone has been administered, the diagnosis of narcotic-induced, or partial narcotic-induced, toxicity should be questioned. Intramuscular or subcutaneous administration may be used if the intravenous route is not available.

As the duration of effect of naloxone is considerably shorter than that of Oramorph SR, repeated administration may be necessary. Patients should be closely observed for evidence of renarcotization.

When indicated, gut decontamination should be performed via emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) with cathartic. Since Oramorph SR is a sustained release product, absorption may be expected to continue for many hours, particularly following an overdose, combined with decreased peristaltic activity of the gastrointestinal tract.

Supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.