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Naltrexone (Intramuscular route)

Pronunciation:

nal-TREX-one

Brand Names:

  • Vivitrol

Dosage Forms:

  • Powder for Suspension, Extended Release

Classifications:

Therapeutic—

Ethanol Dependency

Pharmacologic—

Opioid Antagonist

Uses of This Medicine:

Naltrexone injection is used to help narcotic dependents who have stopped taking narcotics to stay drug-free. It is also used to help alcoholics stay alcohol-free. The medicine is not a cure for addiction. It is used as part of an overall program that may include counseling, attending support group meetings, and other treatment recommended by your doctor.

Naltrexone is not a narcotic. It works by blocking the effects of narcotics, especially the "high'' feeling that makes you want to use them. It also may block the "high'' feeling that may make you want to use alcohol. It will not produce any narcotic-like effects or cause mental or physical dependence. It will not prevent you from becoming impaired while drinking alcohol.

Naltrexone will cause withdrawal symptoms in people who are physically dependent on narcotics. Therefore, naltrexone treatment is started after you are no longer dependent on narcotics. The length of time this takes may depend on which narcotic you took, the amount you took, and how long you took it. Before you start using this medicine, be sure to tell your doctor if you think you are still having withdrawal symptoms.

This medicine is to be given only by or under the direct supervision of your doctor.

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 naltrexone injection 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 naltrexone injection in the elderly.

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 receiving 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.

  • Alfentanil
  • Alphaprodine
  • Anileridine
  • Buprenorphine
  • Butorphanol
  • Codeine
  • Diacetylmorphine
  • Difenoxin
  • Dihydrocodeine
  • Diphenoxylate
  • Ethylmorphine
  • Fentanyl
  • Hydrocodone
  • Hydromorphone
  • Ketobemidone
  • Levorphanol
  • Meperidine
  • Methadone
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nicomorphine
  • Opium
  • Opium Alkaloids
  • Oxycodone
  • Oxymorphone
  • Papaveretum
  • Paregoric
  • Piritramide
  • Propoxyphene
  • Remifentanil
  • Sufentanil
  • Tapentadol
  • Tilidine
  • Tramadol

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.

  • Yohimbine

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:

  • Bleeding problems (eg, hemophilia) or
  • Kidney disease, moderate to severe or
  • Liver disease, mild to moderate or
  • Lung or breathing problems or
  • Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
  • Drug dependence, especially narcotic abuse or dependence, history of or
  • Failed the naloxone challenge test (medical test to check your dependence to opioid medicine) or
  • Liver disease (including acute hepatitis), severe or
  • Opioid withdrawal, acute or
  • Positive urine test for opioids or
  • Receiving opioid analgesics (eg, morphine)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into the buttocks (gluteal) muscle. It is usually given every 4 weeks or once a month.

Naltrexone injection should only be given to alcohol-dependent patients who can abstain from drinking alcohol and does not need an overnight stay in the hospital.

If you miss your scheduled dose, call your doctor to make another appointment as soon as possible.

This medicine usually comes with a Medication Guide. Read the information carefully and make sure you understand it before receiving this medicine. If you have any questions, ask your doctor.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. Your doctor may want to do certain blood and urine tests to see if the medicine is causing unwanted effects.

This medicine may cause serious problems with your liver. Call your doctor right away if you start having dark urine, pain in the upper stomach, or yellowing of the eyes or skin while you are using this medicine.

This medicine may increase your risk of having a lung disease called eosinophilic pneumonia. Tell your doctor right away if you have coughing or trouble breathing after receiving this medicine.

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.

You will need to stop using opioids (narcotics) for at least 7 to 10 days before you can start receiving naltrexone injection. Your doctor may need to do the naloxone challenge test or a urine test for opioids to make sure you are opioid-free.

This medicine blocks the "high" feeling you get from narcotic (opioid) drugs, including heroin. Since naltrexone injection may make you more sensitive to lower doses of opioids than you have previously used, you should not use heroin or any other narcotic drugs to overcome what the medicine is doing. You could overdose and develop serious problems.

This medicine may increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed. Also tell your doctor right away if you have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you feel tired all the time, sleep a lot more or a lot less than usual, feel hopeless or helpless, or if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared.

Remember that use of naltrexone is only part of your treatment. Be sure that you follow all of your doctor's orders, including seeing your therapist and/or attending support group meetings on a regular basis.

Do not try to overcome the effects of naltrexone injection by taking narcotics. To do so may cause coma or death. You may be more sensitive to the effects of narcotics than you were before beginning naltrexone treatment.

Naltrexone injection also blocks the useful effects of narcotics. Always use a non-narcotic medicine to treat pain, diarrhea, or a cough. If you have any questions about the proper medicine to use, check with your doctor.

Naltrexone injection will not prevent you from becoming impaired when you drink alcohol. Do not take naltrexone in order to drive or perform other activities while under the influence of alcohol.

After naltrexone is injected into your body, it is impossible to remove it.

It is recommended that you carry an identification card stating that you are receiving naltrexone injection. You may also need to carry a letter to let others know you are receiving this medicine in case you have a medical emergency.

You may experience a serious reaction at the site of the naltrexone injection that includes pain, swelling, tenderness, bruising, itching, and redness. Contact your doctor right away if this skin reaction does not improve or becomes worse within two weeks after receiving the injection. Your doctor should also refer you immediately to a surgeon.

You may experience nausea after the first injection of this medicine that should be mild and subside a few days afterwards. You will be less likely to have nausea with your next injections.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are receiving naltrexone injection.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

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 or nurse immediately if any of the following side effects occur:

More common
Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
body aches or pain
chills
congestion
cough
difficulty with breathing
discouragement
dryness or soreness of the throat
ear congestion
fear
feeling sad or empty
fever
headache
hoarseness
irritability
lack of appetite
loss of interest or pleasure
loss of voice
nasal congestion
nervousness
rash
runny nose
sneezing
sore throat
tender, swollen glands in the neck
trouble concentrating
trouble sleeping
trouble swallowing
unusual tiredness or weakness
voice changes
Incidence not known
Abdominal or stomach cramps or pain
arm, back, or jaw pain
black, tarry stools
bladder pain
bloating
bloody or cloudy urine
bloody stools
blurred vision
chest pain or discomfort
chest tightness or heaviness
chills
confusion
confusion as to time, place, or person
constipation
cough
cough producing mucus
decreased urination
diarrhea
difficult, burning, or painful urination
dilated neck veins
dizziness or lightheadedness
dry mouth
extreme fatigue
fainting
false or unusual sense of well-being
fast, irregular, pounding, or racing heartbeat or pulse
frequent urge to urinate
general feeling of discomfort or illness
hallucinations or seeing, hearing, or feeling things that are not there
headache, severe and throbbing
holding false beliefs that cannot be changed by fact
hyperventilation
increase in heart rate
increase in white blood cells
indigestion
irregular breathing
irritability
itching, pain, redness, swelling, tenderness, or warmth on the skin
joint or muscle pain
lightheadedness
lower back or side pain
nausea
nervousness
numbness or tingling of the face, hands, or feet
pain or discomfort in the arms, jaw, back, or neck
pain, redness, or swelling in the arm or leg
pounding in the ears
rapid breathing
redness and soreness of the eyes
restlessness
seizures
severe nausea or vomiting
shaking
shivering
skin rash
slow or fast heartbeat
sores in the mouth
stomach cramps or pain
sudden shortness of breath or troubled breathing
sunken eyes
sweating
swelling of the face, fingers, feet, or lower legs
swollen, painful, or tender lymph glands in the neck, armpit, or groin
tenderness
thirst
tightness in the chest
tooth or gum pain
unusual excitement, nervousness, or restlessness
vomiting
vomiting of blood or material that looks like coffee grounds
watery or bloody diarrhea
weight gain
wrinkled skin

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

Symptoms of overdose
Sleepiness or unusual drowsiness

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 with moving
muscle stiffness
swelling or redness in the joints
Incidence not known
Bleeding after defecation
bloated or full feeling
change in taste
decreased interest in sexual intercourse
drowsiness
excess air or gas in the stomach or intestines
feeling of warmth
feeling unusually cold
heartburn
inability to have or keep an erection
increased sweating
loss in sexual ability, desire, drive, or performance
loss of taste
night sweats
passing gas
redness of the face, neck, arms, and occasionally, upper chest
relaxed and calm
sleepiness
sudden sweating
toothache
uncomfortable swelling around anus
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
weight loss

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: 11/4/2014

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