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Drugs reference index «naltrexone Intramuscular»

naltrexone (Intramuscular route)

nal-TREX-one

Intramuscular routePowder for Suspension, Extended Release

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. Naltrexone does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of naltrexone should be discontinued in the event of symptoms and/or signs of acute hepatitis .

Naltrexone can cause hepatocellular injury when given in excessive doses, is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis .

Oral routeTablet

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to only five-fold or less. Naltrexone does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis .

Can cause hepatocellular injury when given in excessive doses. Contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis .

Commonly used brand name(s):

In the U.S.

  • Vivitrol

Available Dosage Forms:

  • Powder for Suspension, Extended Release

Therapeutic Class: Ethanol Dependency

Pharmacologic Class: Opioid Antagonist

Uses For naltrexone

Naltrexone is used to help narcotic addicts 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 taking naltrexone, be sure to tell your doctor if you think you are still having withdrawal symptoms.

Naltrexone is available only with your doctor's prescription.

Before Using naltrexone

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 naltrexone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to naltrexone 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 naltrexone 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 naltrexone 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.

Interactions with Medicines

Using naltrexone 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
  • Codeine
  • Dihydrocodeine
  • Ethylmorphine
  • Fentanyl
  • Hydrocodone
  • Hydromorphone
  • Levorphanol
  • Meperidine
  • Methadone
  • Morphine
  • Morphine Sulfate Liposome
  • Oxycodone
  • Oxymorphone
  • Propoxyphene
  • Sufentanil

Using naltrexone 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

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. 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 naltrexone. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems (e.g., hemophilia) or
  • Kidney disease, moderate to severe or
  • Liver disease, mild to moderate—Use with caution. May make these conditions worse.
  • Drug dependence, especially narcotic abuse or dependence, history of or
  • Hepatitis, acute or
  • Liver disease, severe or
  • Opioid withdrawal, acute—Should not be used in patients with these conditions.

Proper Use of naltrexone

A nurse or other trained health professional will give you naltrexone. naltrexone is given as a shot into the buttocks (gluteal) muscle.

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

Precautions While Using naltrexone

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

naltrexone 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 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. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

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 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 therapy.

Naltrexone 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 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 identification stating that you are taking naltrexone. Identification cards may be available from your doctor.

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 injectionYour doctor should also refer you immediately to a surgeon.

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

naltrexone 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 taking naltrexone.

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

More common
  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site
  • body aches or pain
  • chills
  • congestion
  • cough
  • difficulty in breathing
  • discouragement
  • dryness or soreness of 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 neck
  • trouble concentrating
  • trouble in swallowing
  • trouble sleeping
  • 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 skin
  • joint or muscle pain
  • lightheadedness
  • lower back or side pain
  • nausea
  • nervousness
  • numbness or tingling of face, hands, or feet
  • pain or discomfort in arms, jaw, back, or neck
  • pain, redness, or swelling in arm or leg
  • pounding in the ears
  • rapid breathing
  • redness and soreness of eyes
  • restlessness
  • seizures
  • severe nausea or vomiting
  • shaking
  • shivering
  • shortness of breath
  • skin rash
  • slow or fast heartbeat
  • sores in mouth
  • stomach cramps
  • stomach pain
  • sudden shortness of breath or troubled breathing
  • sunken eyes
  • sweating
  • swelling of face, fingers, feet, or lower legs
  • swollen, painful, or tender lymph glands in neck, armpit, or groin
  • tenderness
  • thirst
  • tightness in chest
  • tooth or gum pain
  • trouble sleeping
  • troubled breathing
  • unusual excitement, nervousness, or restlessness
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
  • watery or bloody diarrhea
  • weight gain
  • wheezing
  • 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 in moving
  • muscle stiffness
  • swelling or redness in joints
Incidence not known
  • Bleeding after defecation
  • bloated
  • change in taste
  • decreased interest in sexual intercourse
  • drowsiness
  • excess air or gas in stomach or intestines
  • feeling of warmth
  • feeling unusually cold
  • full feeling
  • 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
  • stuffy nose
  • 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.

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