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Levorphanol (Oral route)

Pronunciation:

lee-VOR-fa-nol

Brand Names:

  • Levo-Dromoran

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Analgesic

Chemical—

Opioid

Uses of This Medicine:

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

When levorphanol 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 This Medicine:

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.

Children—

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

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Other 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
  • Anileridine
  • Bromazepam
  • Brotizolam
  • Buprenorphine
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Codeine
  • Dantrolene
  • Dezocine
  • Diazepam
  • Estazolam
  • Ethchlorvynol
  • Fentanyl
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fospropofol
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Ketazolam
  • Levorphanol
  • Lorazepam
  • Lormetazepam
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Midazolam
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nitrazepam
  • Nordazepam
  • Opium
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Perphenazine
  • Prazepam
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propoxyphene
  • Quazepam
  • Remifentanil
  • 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.

  • Perampanel
  • Risperidone

Other interactions—

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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's disease (adrenal gland problem) or
  • Alcohol abuse, history of or
  • Breathing or lung problems (e.g., chronic obstructive pulmonary disease [COPD], hypoxia) or
  • Drug dependence, especially narcotic abuse or dependence, or history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Hypothyroidism (an underactive thyroid) or
  • Infection, severe or
  • Mental illness, history of or
  • Problems with passing urine—Use with caution. May increase risk for more serious side effects.
  • Brain tumor or
  • Head injuries or
  • Increased pressure in your head—Some of the side effects of levorphanol can cause serious problems in people who have these medical problems.
  • Breathing problems (e.g., asthma), severe or
  • Gallbladder surgery—Should not be used in patients with these conditions.
  • Heart disease or
  • Hypotension (low blood pressure) or
  • Myocardial infarction (heart attack) or
  • Respiratory depression (hypoventilation or slow breathing)—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.
  • Stomach or digestion problems—This medicine may mask the diagnosis of these conditions.

Proper Use of This Medicine:

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).

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 (tablets):
    • For moderate to severe pain:
      • Adults—At first, 2 milligrams (mg) every 6 to 8 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 to 12 mg per day.
      • 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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using 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 the other medicines listed above 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 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.

Do not change your dose or suddenly stop using this medicine without first 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 neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child 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.

Side Effects of This Medicine:

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:

Incidence not known
Agitation
attempts at killing oneself
bluish lips or skin
blurred vision
change in consciousness
cold, clammy skin
confusion
decrease in the frequency of urination
decrease in urine volume
decreased urine output
depression
difficulty in passing urine (dribbling)
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
extra heartbeats
extremely shallow or slow breathing
fast, slow, irregular, pounding, or racing heartbeat or pulse
fast, weak pulse
hostility
lethargy
lightheadedness
loss of consciousness
muscle twitching
no blood pressure or pulse
not breathing
painful urination
rapid weight gain
seizures
stopping of the heart
stupor
sweating
swelling of the face, ankles, or hands
unconsciousness
unusual tiredness or weakness
wheezing

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

Symptoms of overdose
Chest pain or discomfort
constricted, pinpoint, or small pupils (black part of the eye)
decreased awareness or responsiveness
difficult or troubled breathing
difficulty with sleeping
dilated neck veins
disorientation
drowsiness to profound coma
extreme fatigue
hallucination
headache
irregular, fast or slow, or shallow breathing
no muscle tone or movement
not breathing
pale or blue lips, fingernails, or skin
shortness of breath
sleepiness or unusual drowsiness
swelling of the face, fingers, feet, 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:

Incidence not known
Abnormal dreams
absence of or decrease in body movement
acid or sour stomach
belching
change in personality
changes in vision
delusions
dementia
discouragement
double vision
dry mouth
feeling sad or empty
heartburn
hives or welts
increase in body movements
indigestion
irritability
itching
lack of appetite
loss of interest or pleasure
loss of memory
nausea
nervousness
problems with memory
redness of the skin
seeing double
skin rash
stomach discomfort, upset, or pain
sweating
tiredness
trouble concentrating
trouble sleeping
twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
upper abdominal or stomach pain
vomiting

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.


Last Updated: 4/4/2014

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